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Tornier Humeral Reconstruction System (Tornier HRS)

IN ANATOMIC:
The Tornier HRS is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain. The Tomier HRS is indicated for use as a replacement of shoulder joints disabled by:

• · Rheumatoid arthritis with pain
• · Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
• · Correction of functional deformity
• · Fractures of the humeral head
• · Traumatic arthritis
• · Revision of other devices if sufficient bone stock remains

IN REVERSE:
The Tornier HRS is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle with pain disabled by:

• · Rheumatoid arthritis
• · Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
• · Correction of functional deformity
• · Fractures of the humeral head
• · Traumatic arthritis
• · Massive and non-repairable rotator cuff tear
• · Revision of other devices if sufficient bone stock remains

The reversed tray and polyethyiene inset are in the conversion from an anatomic to reversed shoulder arthroplasty without the removal of the humeral assembly during revision surgery for patients with a functional deltoid muscle.

Notes:

• · All components are single use.
• · The coated humeral stem is intended for cemented or cementless use.
• · The all-poly glenoid components are intended for cemented use only
• · The glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation.
• · Titanium humeral heads are intended for patients with suspected cobalt alloy material sensitivity.
• The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack a suspected material sensitivity to cobalt alloy.

Tornier Perform Humeral System - Stem (Tornier PHS-Stem)

In Anatomic:
The humeral stem, humeral head coupler and humeral head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with a glenoid implant, as a total replacement.

The PERFORM™ Humeral System – Stem is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility, and to relieve pain. The PERFORM Humeral System - Stem is indicated for use as a replacement of shoulder joints disabled by:
· Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis

• · Proximal humeral malunions
• · Post-traumatic arthritis
• · Revisions or fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains

Titanium humeral heads are intents with suspected cobalt alloy material sensitivity. The wear properties of titanium and titanium alloys are inferior to that of cobalt alloy. A titanium humeral head is recommended for patients with a suspected material sensitivity to cobalt alloy.

All components are single use. The humeral stems are intended for cementless use.

The PERFORM Humeral System – Stem is intended to be used with cemented components, in a total shoulder arthroplasty.

In Reverse:
The PERFORM™ Humeral System – Stem is indicated for use as a replacement of a shoulder joint for patients with a functional deltoid muscle, grossly deficient rotator cuff, and pain disabled by one or more of the following:
· Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis

• · Pseudoparalysis or anterior superior escape
• · Rotator cuff tear arthropathy
• · Proximal humeral malunions
• · Post-traumatic arthritis
  · Revisions or fractures of the humere adequate fixation can be achieved and adequate bone stock remains

The reversed insert is indicated for use for the conversion from an anatomic to reverse shoulder prosthesis without the removal of a well fixed humeral stem for patients with a functional deltoid muscle.

All components are single use. The humeral stems are intended for cementless use. The PERFORM Humeral System – Stem is intended to be used with glenoid implants that are anchored to the bone with screws for non-cemented fixation.

Tornier HRS (formerly branded Aequalis Flex Revive Shoulder System) is a fully convertible anatomic and reversed shoulder arthroplasty system that is designed to be used with existing Tornier implant systems. It is a non-constrained system intended for total or partial replacement of the glenohumeral articulation.

The Tornier Humeral Reconstruction System (Tornier HRS) is a line existing Aequalis™ Flex Revive™ Shoulder System (AFR) (K191318, cleared June 14, 2019) that builds upon the AFR system with additional sized distal stems, proximal bodies, and reversed insert trays, new monoblock stems, humeral head couplers and MR Conditional labeling for Tornier HRS line extension components.

The Tornier Perform Humeral System (Tornier PHS-Stem) (K2013 15) is also being expanded to include additional sized Vitamin E UHMWPE reversed inserts and a renaming of these inserts for clarity.

This is a 510(k) Premarket Notification from the FDA for a medical device called the Tornier Humeral Reconstruction System (Tornier HRS) and the Tornier Perform Humeral System - Stem (Tornier PHS-Stem). This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing new acceptance criteria and proving performance against them through a clinical study.

Therefore, the sections of your request regarding acceptance criteria, study details, expert consensus, and effects size are not applicable (N/A) in this context. The primary evidence presented here is non-clinical testing to show that the modified device and its extensions are as safe and effective as the predicate devices.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not applicable. The document refers to "non-clinical testing," which typically involves bench testing of components and assemblies, not human subjects.
• Data Provenance: Not applicable. The testing is described as non-clinical performance testing, likely conducted in a laboratory setting by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not applicable. This type of non-clinical testing does not involve establishing ground truth from expert consensus in the way a diagnostic AI would. The "ground truth" is determined by established engineering and material science standards and test methods.
• Qualifications of Experts: N/A.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review in clinical studies or for establishing ground truth in diagnostic performance evaluations, which is not what occurred here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• MRMC Study: No. The document explicitly states: "No clinical studies were performed."
• Effect Size: Not applicable.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:

• Standalone Performance: Not applicable. This is a physical orthopedic implant system, not a software algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Type of Ground Truth: Not applicable. For non-clinical performance testing of medical devices, "ground truth" in the diagnostic sense is not typically generated. Instead, performance is measured against established engineering specifications, material properties, and mechanical limits as defined by relevant standards (e.g., ISO, ASTM).

8. The sample size for the training set:

• Training Set Sample Size: Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established:

• Ground Truth for Training Set: Not applicable. This is not a machine learning or AI device.

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The BLUEPRINT™ Glenoid Guides are patient-specific drill guides. They have been specially designed to assist in the intraoperative positioning of glenoid components used with total anatomic or reversed shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans.

Blueprint® is a medical device for surgeons.

Blueprint® is intended to be used as a pre-surgical planner for shoulder replacement surgery. Blueprint® requires CT scan images showing the anatomical shoulder structure in a DICOM format. Blueprint® allows surgeons to visualize, measure, reconstruct, and annotate anatomic data. Blueprint® allows surgeons to design patient specific components (patient-specific instruments and Shoulder iD™ Primary Reversed Glenoid*) based on the pre-surgical plan.

Blueprint® leads to the generation of a planning report.

Blueprint® is to be used for adult men and women patients only whose bone maturity is reached and should not be used for diagnostic purpose.

Note: Measures and patient specific guide design are provided depending on the case profiles. *Only if patient-specific instruments or Shoulder iD™ Primary Reversed Glenoid are available in your geography.

The Shoulder iD™ Primary Reversed Glenoid implant is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by:

· Rheumatoid arthritis

• · Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
• · Correction of functional deformity
• · Fractures of the humeral head
• · Traumatic arthritis
• · Revision of glenohumeral joint if sufficient native glenoid bone remains

All components are single use.

The Shoulder iD™ Primary Reversed Glenoid implant is anchored to the bone with screws and is for non-cemented fixation.

Note: A CT Scan is used to create the Shoulder iD™ Primary Reversed Glenoid implant

BLUEPRINT™ Patient Specific Instrumentation
Blueprint Patient Specific Instrumentation is composed of two components: Blueprint Glenoid Guides (hardware) and Blueprint Planning Software (software)

Blueprint™ Glenoid Guides
The Blueprint Glenoid Guides are patients specially designed to facilitate the implantation of Wright-Tornier glenoid prostheses.

The Blueprint Glenoid Guides are designed and manufactured based on a pre-operated only by the software Blueprint Planning Software.

Blueprint™ Planning Software
Blueprint Planning Software is a software connected to an Online Management System (OMS). The user interface software is installed on a computer and is intended to be used by orthopedic surgeons, as a preoperative planning software for shoulder arthroplasty surgery (anatomic and reversed).

It is intended to help to plan an operation by allowing surgeons to:

• · Plan for shoulder arthroplasty cases
• · Position and select glenoid and humeral implants,
• · Simulate the prosthetic range of motion,
• · Interact with implants and different computed measurements
• · Generate information required to design a patient-specific glenoid component when appropriate.

Shoulder iD™ Primary Reversed Glenoid
The Shoulder iD Primary Reversed Glenoid implant (Shoulder iD) is intended to replace the native glenoid surface of the scapulohumeral joint as part of a reverse shoulder prosthesis.

The glenoid implant is composed of a baseplate with a press-fit post, peripheral anchoring screws, and a glenosphere. Ancillary instruments are also provided for the implantation of the prosthesis.

This FDA 510(k) clearance letter and its accompanying summary focus on demonstrating substantial equivalence to predicate devices for two components: "Blueprint Patient-Specific Instrumentation" (software and hardware) and "Shoulder iD Primary Reversed Glenoid" (implant). The document primarily addresses the comparison of indications for use and technological characteristics, and broadly mentions performance testing.

Crucially, the provided text does not contain detailed information about specific acceptance criteria or the study data proving the device meets those criteria in the format requested. The document mentions "performance testing" and "verification and validation evaluations" but does not elaborate on the specific metrics, results, or methodologies used.

Therefore, I cannot populate the table or answer most of the questions directly. However, I can extract what is implied or stated generally:

Implicit information from the FDA 510(k) context:

• Acceptance Criteria (Implied): For a 510(k) clearance, the primary acceptance criterion is substantial equivalence to existing legally marketed devices. This means demonstrating that the new device is as safe and effective as the predicate, and does not raise new questions of safety or effectiveness. For the software, this typically involves demonstrating accuracy, reliability, and functionality consistent with its intended use (pre-surgical planning). For the hardware (guides) and the implant, this involves demonstrating appropriate mechanical properties, fit, and biocompatibility.
• Study Type (Implied): Given it's a 510(k) without clinical studies, the studies would primarily be non-clinical performance testing (e.g., mechanical testing, dimensional accuracy, software verification and validation).

Here's what can be extracted and what is missing based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing specific details:

• Quantitative acceptance thresholds (e.g., accuracy +/- X mm, specific mechanical test results).
• Detailed breakdown of results for each criterion.

2. Sample Size and Data Provenance:

• Test Set Sample Size: Not specified. The document mentions "cadaveric test" for the guides and "Non-clinical Reverse Glenoid Loosening testing" for the implant, but no sample sizes are given for these tests. For software verification and validation, typically a set of test cases is used, but the size or nature of these cases is not described.
• Data Provenance: The company (Stryker Corporation (Tornier, S.A.S.)) is based in France. The letter does not specify the country of origin of the test data. The studies are non-clinical (e.g., benchtop, cadaveric, software testing), not clinical trials on patients, therefore the retrospective/prospective distinction for patient data does not directly apply in the usual sense.

3. Number of Experts and Qualifications for Ground Truth:

• Not specified. Given that no clinical studies were performed, and the emphasis is on substantial equivalence through non-clinical testing and software V&V, the "ground truth" would likely be established through engineering specifications, validated simulation models, or anatomical measurements rather than expert clinical consensus on patient data.
• If expert review was involved in the software V&V or cadaveric studies (e.g., assessing anatomical landmark identification), their number and qualifications are not mentioned.

4. Adjudication Method for the Test Set:

• Not applicable / Not specified. Without details on how ground truth was established by experts on a test set (e.g., image annotations), an adjudication method cannot be inferred.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, not specified. The document explicitly states: "No clinical studies were performed." MRMC studies typically involve human readers interpreting medical images, usually in a clinical context, which wasn't part of this submission for demonstrating substantial equivalence. The device is a planning software and instrumentation, not primarily one for diagnostic interpretation by human readers.

6. Standalone (Algorithm-Only) Performance:

• Implicitly yes, for software verification and validation. The document states that "Technological differences between the subject and predicate software are supported with verification and validation evaluations." This suggests testing of the software's algorithms and functionalities independently. However, specific standalone performance metrics (e.g., accuracy of measurements, success rate of planning) are not detailed. The software is described as a "pre-surgical planner" that allows surgeons to "visualize, measure, reconstruct, and annotate anatomic data" and "design patient-specific components." The V&V would assess these capabilities.

7. Type of Ground Truth Used:

• For the hardware (guides): Likely dimensional measurements (engineering specifications) and anatomical landmarks/fit in cadaveric models.
• For the software: Likely engineering specifications, validated computational models, known anatomical dimensions from source CT data, and consistency checks against surgeon input/expectations during planning scenarios.
• For the implant: Mechanical testing standards and measurements (e.g., loosening, fatigue strength) compared against predicate performance.

8. Sample Size for the Training Set:

• Not specified. The document describes a "Blueprint Planning Software" but does not explicitly state it's an AI/machine learning model that requires a "training set" in the sense of supervised learning. It's described as software that allows surgeons to perform planning functions, implying it might be a rule-based system or an advanced visualization and measurement tool, rather than a learning algorithm. If there is an AI component, the training set size is not provided.

9. How the Ground Truth for the Training Set was Established:

• Not specified and not directly applicable unless the "Blueprint Planning Software" incorporates machine learning and has a distinct "training set." If it does, and assuming the software assists in identifying anatomical landmarks or making measurements, the ground truth for training data would typically be established by expert radiologists or orthopedic surgeons annotating CT scans.

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IN ANATOMIC:

The proximal body, stem, assembly screw, locking cap, optional spacer(s), and humeral head may be used together, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement.

The Tornier HRS Shoulder System is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and to relieve pain. The Tornier HRS Shoulder System is indicated for use as a replacement of shoulder joints disabled by:

• Rheumatoid arthritis with pain
• Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
• Correction of functional deformity
• Fractures of the humeral head
• Traumatic arthritis
• Revision of other devices if sufficient bone stock remains

IN REVERSE:

The Tornier HRS Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle with pain disabled by:

• Rheumatoid arthritis
• Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
• Correction of functional deformity
• Fractures of the humeral head
• Traumatic arthritis
• Massive and non-repairable rotator cuff tear
• Revision of the devices if sufficient bone stock remains

The reversed tray and polyethylene insert are indicated for use in the conversion from an anatomic to reversed shoulder arthroplasty without the removal of the humeral assembly during revision surgery for patients with a functional deltoid muscle.

Notes:

• All components are single use.
• The coated humeral stem is intended for cemented or cementless use.
• The all-poly glenoid components are intended for cemented use only.
• The glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation.
• Titanium humeral heads are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack a suspected material sensitivity to cobalt alloy.

Tornier HRS (formerly branded Aequalis™ Flex Revive™ Shoulder System) is a fully convertible anatomic and reversed shoulder arthroplasty system that is designed to be used with existing Tornier implant system intended for total or partial replacement of the glenohumeral articulation. Tornier HRS includes a proximal body (metaphysis), a stem, assembly screw, and locking cap. The proximal body has a female taper that is compatible with Tornier Flex (formerly branded Ascend Flex) Humeral Heads and Tornier Flex (formerly branded Ascend Flex) reversed trays and poly inserts.

Tornier HRS is implanted by a surgeon and is designed to select the components to size the shoulder system for the patient. It allows the shoulder to be constructed in an anatomical or reversed configuration using cleared Tornier Flex (formerly branded Ascend Flex) Humeral Heads and Tornier Flex (formerly branded Ascend Flex) reversed trays and inserts. In addition, Tornier HRS can be transformed from anatomic to reverse shoulder prosthesis without the humeral implant assembly during revision surgery.

The humeral length is measured to determine the overall humeral implant construct length is assembled from 120 mm (using the short proximal body and stem) to 300 mm (using the standard proximal body, spacers, and stem) in 10 mm increments with the spacers as needed and either of the two available lengths of the proximal body for patient specificity.

The proximal body, stem, and spacers are made from Ti6A4V per ASTM F-136. The proximal body and stem have a Titanium plasma spray coating. The assembly screw and locking cap are made of CoCr per ISO 5832-12. All implant parts are single use and packaged sterile, using gamma radiation at a minimum dose of 25 kGy to an SAL of 1x10-6.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "Tornier Humeral Reconstruction System (Tornier HRS)." This document primarily focuses on demonstrating substantial equivalence to already legally marketed predicate devices, rather than presenting a study to prove the device meets specific acceptance criteria for a novel AI or diagnostic system.

The "study" described is a non-clinical testing in a Magnetic Resonance (MR) Environment to characterize the compatibility of the Tornier HRS. This is a safety assessment for an implantable device, not a performance study for, for example, a diagnostic AI.

Therefore, many of the requested elements (acceptance criteria for device performance, sample sizes for test/training sets, expert ground truth, MRMC studies, standalone AI performance, etc.) are not applicable in the context of this specific regulatory document.

However, I can extract the relevant information regarding the non-clinical testing performed:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document states "The Tornier HRS system does not raise different questions of safety or effectiveness," which implies the device met the safety requirements for MR compatibility.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified (refers to the devices evaluated in MR environment, not typically "sample size" in the context of clinical or AI studies).
• Data Provenance: Not applicable in the traditional sense; this is non-clinical lab testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. The "ground truth" here is the physical interaction of the device with an MR field, evaluated against established safety standards.

4. Adjudication method for the test set:

• Not applicable. This was based on non-clinical testing against FDA guidance.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, an MRMC comparative effectiveness study was not done. This device is not an AI diagnostic tool that human readers would use.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is not a software algorithm or AI device.

7. The type of ground truth used:

• The ground truth for this non-clinical testing is compliance with established safety standards and guidance for medical devices in an MR environment (as outlined in "FDA guidance document 'Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment – Guidance for Industry and FDA Staff'").

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:

• Not applicable.

In summary: The provided document is for a traditional medical implantable device, not an AI or diagnostic system. The "study" mentioned is non-clinical testing for MR compatibility to ensure safety, not a performance study in the context of AI or diagnostic accuracy.

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HipCheck assists the surgeon to determine quantitative measurements for femoroacetabular impingement (FAI) procedures. HipCheck provides static localization information derived from image processing of intra-operatively acquired static fluoroscopic images, by superposition of virtual measurement tools onto those X-ray images for skeletally mature patients.

HipMap FAI Analysis is a patient-specific report used to support surgeon or radiologist pre-operative clinical decision making. HipMap femoroacetabular impingement (FAI) Analysis provides a morphological analysis of a skeletally mature hip with potential FAI, including measurements and visualizations that describe hip impingement and stability.

HipCheck enables the surgeon to intraoperatively measure alpha angle during hip arthroscopy procedures for femoroacetabular impingement. The software is provided to the user pre-installed on a mobile touchscreen tablet for which it has been tested for compatibility.

Alpha angle is a value used to indicate cam deformity of the femoral head, seen in patients presenting with femoroacetabular impingement. HipCheck provides a visualization tool for surgeons to determine the alpha angle intraoperatively, using virtual measurement tools superimposed on X-ray images collected during the procedure, which informs clinical decision making.

HipCheck is not patient contacting. The user is instructed to appropriately drape the tablet when used in the sterile field.

Stryker HipMap FAI Analysis is a patient-specific report intended for use by surgeons or radiologists to support pre-operative clinical decision making by providing a morphological analysis of a skeletally mature hip with potential femoroacetabular impingement (FAI), including measurements and visualizations that describe hip impingement and stability. HipMap provides three-dimensional analyses, 3D surface reconstructions, and annotated images to support surgeons with pre-operative clinical decision-making.

Here's a summary of the acceptance criteria and study details for the HipCheck device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: 745 fluoroscopic images.
  • 184 images: Did not contain images of hips, used to test false positive detection.
  • 561 images: From 81 hips.
• Data Provenance: Geographically, images came from 6 clinical sites in the United States, Netherlands, and Germany. The images were collected during product development cadaver labs or from anonymized log files from patients undergoing surgery. This data appears to be a mix of prospective (cadaver labs) and retrospective (anonymized log files) sources.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of "Experts" (Taggers): Two people.
• Qualifications of Experts: They were "trained to use the software" for labeling the femur with the precise location of the femoral head and neck. Specific professional qualifications (e.g., radiologist, orthopedist) or years of experience are not specified in the provided text.

4. Adjudication Method for the Test Set

• For the object detection AI/ML model, testing was done against the average value of the two taggers. This implies a form of consensus or averaging for ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study involving human readers with and without AI assistance is explicitly described for the HipCheck Alpha Angle algorithm.
• However, for the HipMap FAI Analysis (a component of the HipCheck device), a segmentation accuracy and reliability study was conducted. This study reviewed:
  • "Performance of Stryker personnel segmenting pelvic CT scans using HipMap workflow software against trained third-party personnel performing image segmentation of the same scans using 510(k) cleared software."
  • "Reliability of segmentation between Stryker personnel (inter-rater reliability)."
  • "Reliability of the HipMap FAI Analysis by comparing clinical measurement outputs generated from the third-party segmentation (external rater vs internal rater), Stryker employee segmentations (inter-rater reliability), and iterations of segmentations performed by the same Stryker employee (intra-rater reliability)."
  • This is a comparative study, but it's focused on segmentation accuracy and reliability between different personnel and software, rather than the "human readers + AI vs. human readers alone" paradigm. Effect sizes are not mentioned in the provided text for this comparison.

6. Standalone Performance (Algorithm Only) Study

• Yes, a standalone performance testing was conducted for the object detection AI/ML model, which is part of the HipCheck device's image processing pipeline. The results are detailed in the table above (90% Lower Bound of -97.5% for detection, and percentage/degree accuracies for coordinate and angle measurements).

7. Type of Ground Truth Used

• For the object detection AI/ML model's standalone performance testing: Expert Consensus/Annotation (labeled by two trained individuals, with the average value used as ground truth).

8. Sample Size for the Training Set

• The sample size for the training set is not explicitly stated in the provided text. It only mentions that the test dataset was "independent of the data used during model training."

9. How the Ground Truth for the Training Set Was Established

• The method for establishing ground truth for the training set is not explicitly stated in the provided text. It can be inferred that it likely followed a similar annotation process to the test set, but specific details are absent.

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Connected OR Hub with Device and Voice Control:

The use of the Connected OR Hub with Device and Voice Control is to allow for voice control and remote control of medical device settings by surgeons or operating room personnel, thereby eliminating the need to manually operate those devices compatible with the Connected OR Hub with Device and Voice Control or to rely on verbal communication between the surgeon and other operating room personnel in order to adjust the surgical equipment. It also has additional digital documentation functionality to electronically capture, transfer, store and display medical device data (non-medical device function), which is independent of the functions or parameters of any attached Stryker device.

SDC4K Information Management System with Device and Voice Control

The use of the SDC4K Information Management System with Device and Voice Control is to allow for voice control and remote control of medical device settings by surgeons or operating room personnel, thereby eliminating the need to manually operate those devices compatible with the SDC4K Information Management System with Device and Voice Control or to rely on verbal communication between the surgeon and other operating room personnel in order to adjust the surgical equipment. It also has additional digital documentation functionality to electronically capture, transfer, store and display medical device data (non-medical device function), which is independent of the functions or parameters of any attached Stryker device.

The Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control are network compatible hardware platforms that carry out Medical Device Data System (MDDS) functionalities and allows the user to control the state, selection, and settings of comected endoscopic and general surgery devices both wired and wirelessly.

The Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control consists of the following components:

1. Base Console which includes:

a) Medical Device Data System (MDDS) functionalities

b) Optional Device Control feature

d) Optional Video Image Processing (VIP) feature

2. Device Control Package (software activation USB dongle and a handheld Infrared (IR) remote control)

3. Voice Control Package (software activation USB dongle and a wireless headset and base station)

4. Video Image Processing package (software activation USB dongle)

5. Connected OR Spoke (MDDS)

The Connected OR Hub and SDC4K consoles carry out the Medical Device Data System (MDDS) functionalities (i.e. Non-medical function) and can be marketed as standalone devices. When upgraded with the Device Control package, the consoles extend their functionalities to control compatible devices from their touchscreen graphical user interface (GU), spoken commands via headset (voice control input), and an IR remote control or directional keypad from a camera head (device control input). The received user commands are then processed and communicated with the connected controllable devices, allowing the user to control the state, selection, and settings of those devices.

In addition, the Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control provide compatibility with the Connected OR Spoke (also referred to as "Spoke") which is a standalone Medical Device Data System. Once the Connected OR Hub with Device and Voice Control or SDC4K Information Management System with Device and Voice Control is connected to the Spoke, Device Control can be extended to compatible devices which are directly connected to the Spoke.

When upgraded with the Video Image Processing (VIP) package, the Connected OR Hub automates an image enhancing algorithm, and removal of surgical smoke through a compatible insufflator.

This FDA 510(k) summary for the Stryker Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control does not contain the detailed information required to fill out a table of acceptance criteria and reported device performance related to diagnostic accuracy or clinical effectiveness measures for AI/ML performance.

Instead, this document focuses on non-clinical testing to establish the safety and performance of the device's voice and remote control functionalities and its compliance with relevant medical device standards. This device appears to be an enabling technology for controlling medical devices, rather than a diagnostic or prognostic AI/ML system that would typically have the kind of performance metrics you've requested.

Therefore, many of your requested items, such as expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and sample sizes for training sets, are not applicable (N/A) in the context of this specific device's submission summary.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

This information is not provided in a format that allows for a table of "acceptance criteria" and "reported device performance" in terms of diagnostic or clinical metrics. The document instead describes compliance with engineering and safety standards and successful verification and validation testing for its functionalities.

• Acceptance Criteria (General): Conformity with recognized safety standards, design input specifications, user needs, and intended uses.
• Reported Device Performance (General): Verification and validation testing successfully completed demonstrated that the device conforms with these requirements.

Without a specific performance metric (like accuracy, sensitivity, or specificity for a diagnostic task), a direct "performance" table cannot be constructed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• N/A. The document discusses "software function testing" and "verification and validation testing," but these are engineering tests, not clinical performance studies on patient data. There is no mention of a "test set" in the context of diagnostic or clinical data in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• N/A. As this is not a diagnostic device using AI for interpretation, there's no "ground truth" established by medical experts for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• N/A. Not applicable, as there is no test set for clinical ground truth.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• N/A. The document explicitly states: "The subject devices do not require clinical studies to support the determination of substantial equivalence." This confirms no MRMC study was conducted or required. The device's function is to control other medical devices via voice/remote, not to assist in interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• N/A. This is not an AI algorithm for diagnostic interpretation in that sense. Its "intelligence" is in processing voice commands and mapping them to device controls. Its performance would be evaluated on the accuracy of carrying out those commands, not on a diagnosis.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• N/A. The "ground truth" for this device's performance would relate to whether it accurately executes commands (e.g., "increase insufflator pressure" results in the correct pressure change) and whether it adheres to safety protocols. This is confirmed through engineering and software testing, not medical ground truth types.

8. The sample size for the training set

• N/A. In the context of a diagnostic AI/ML device, this refers to the data used to train the model. This device's capabilities (voice control, device control) would involve training data for speech recognition models, but the 510(k) summary does not detail the specifics of such training or sample sizes for that purpose. It focuses on the validation of the system as a whole.

9. How the ground truth for the training set was established

• N/A. Similar to point 8, this level of detail is not provided for speech recognition components, given the nature of this 510(k) submission.

In summary, this document is for a medical device that provides control and information management functionalities, rather than an AI/ML-driven diagnostic or prognostic tool. Therefore, the typical metrics and study designs for evaluating AI/ML performance in clinical decision-making are not present here.

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The Stryker Q Guidance System, with the Cranial Guidance Software, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer-assisted surgery. The system is indicated for any medical condition in which the use of computer-assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a rigid anatomical structure can be identified. The system assists in the positioning of instruments for cranial procedures, including: Cranial biopsies Craniotomies Craniectomies Resection of tumors and other lesions Skull base procedures Transnasal neurosurgical procedures Transsphenoidal pituitary surgery Craniofacial procedures Skull reconstruction procedures Orbital cavity reconstruction procedures General ventricular catheter and shunt placement Pediatric ventricular catheter and shunt placement

The Q Guidance System is intended as an aid for precisely locating anatomical structures in open or percutaneous computer assisted surgery. The system is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate and where reference to a rigid anatomical structure such as the skull, vertebra, or long bone can be identified.

The Stryker CranialMask Tracker is intended to be used as an accessory to the CranialMap and the Cranial Guidance software applications. It is intended to be placed on the patient's facial skin and used in combination with preoperative and intraoperative imaging devices to enable automatic patient registration for open or percutaneous computer-assisted surgery. The Stryker CranialMask Tracker can be used as a noninvasive patient tracker to support open or percutaneous cranial neurosurgical procedures.

The Stryker EM Stylet is indicated for use as an accessory to the Stryker Q Guidance System when used with the Cranial Guidance Software and electromagnetic navigation. It is indicated for use in locating anatomical structures during navigated cranial procedures. The system is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT-based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. The EM Stylet is indicated for use in the following procedures: General ventricular catheter and shunt placement Pediatric ventricular catheter and shunt placement

The Stryker Navigated Biopsy Needle is intended to be used as an accessory to the Stryker Q Guidance System when used with the Cranial Guidance Software. It is a side cutting cannula where the cutting action is achieved by rotation of an inner cannula within an outer cannula for use in the stereotaxic biopsy of cranial tissue. The Stryker Navigated Biopsy Needle may be used as part of the Stryker Cranial Guidance System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.

The Q Guidance System with Cranial Guidance Software is a computer-assisted stereotaxic, image-guided, planning, and intraoperative guidance system intended to enable open or percutaneous computer-assisted surgery. It assists the surgeon in precisely positioning instruments and locating patient anatomy during cranial surgery. The Q Guidance System with Cranial Guidance Software system is comprised of a computer platform. Cranial Guidance Software, navigated instruments (e.g., patient/ instrument trackers, pointers), and various system components. The system provides intraoperative guidance to the surgeon using electromagnetic, passive and active wireless optical tracking technologies. The computer platform consists of a computer, camera, electromagnetic field generator and box to plug in electromagnetic instruments, big touchscreen monitor, and a small touchscreen monitor. The Cranial Guidance Software is dedicated to cranial surgical procedures as defined in the indications for use. Required navigated instruments include instruments such as a patient tracker, an instrument tracker, pointers, suction tubes, seekers, etc. An instrument battery is required when a battery powered instrument or calibration device is used. The Cranial Guidance Software displays the intraoperative location of navigated surgical instruments relative to imported patient medical images via electromagnetic or wireless optical tracking technology. The software provides the functions to perform the indicated navigated cranial surgical procedures. The software guides the user through the necessary preoperative and intraoperative steps required to set-up and perform the navigated cranial surgical procedures. The Q Guidance System was initially cleared in premarket notification K220593. The only change to this device from its initial clearance is the addition of the electromagnetic tracking technology and the integration of the Zeiss Microscope using the Zeiss Microscope Tracker. The Cranial Guidance Software includes the following system components described below.

Here's a breakdown of the acceptance criteria and study information for the Stryker Q Guidance System with Cranial Guidance Software, EM Stylet, and Navigated Biopsy Needle, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The document explicitly states the system's design goal for accuracy is a mean of 2mm positional and 2° angular displacement. The reported performance includes a 99% Confidence Interval (Upper) which exceeds the 2mm/2° stated design goal in some instances (e.g., Optical Nav Positional Displacement 2.65mm, Optical Nav Trajectory Angle Displacement 2.93°, EM Nav Positional Displacement 2.57mm, EM Nav Trajectory Angle Displacement 2.82°). However, the document concludes that "All requirements were met and no new issues of safety or effectiveness were raised," implying these results were considered acceptable within the overall context of the safety and performance evaluation.

2. Sample Size Used for the Test Set and the Data Provenance

• Accuracy Testing:
  • Pediatric patients: Non-clinical accuracy testing was performed using pediatric models made based on a neonate image set. The exact number of models is not specified.
  • Adult patients: Accuracy testing was performed via a Simulated Use study with cadavers. The exact number of cadavers is not specified.
• Intended Use/User Needs Validation: Conducted in "cadaver labs or simulated use tests." The exact number of participants or cases is not specified.
• Data Provenance: The document does not explicitly state the country of origin for the datasets used in testing (pediatric models, cadavers). The testing seems to be prospective (i.e., designed as part of the validation process) rather than retrospective clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The document does not provide information on the number or qualifications of experts used to establish ground truth specifically for the accuracy testing of the device (i.e., for the positional and angular displacement measurements). The "Intended Use/User Needs" validation involved "intended users," but their specific number or qualifications (e.g., years of experience as surgeons) are not detailed.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for establishing ground truth for the performance metrics. The accuracy measurements appear to be objective, engineering-style measurements against a known reference. For the "Intended Use/User Needs" validation, it simply states that all requirements were met, implying a qualitative assessment by the "intended users."

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. The 510(k) summary explicitly states: "No clinical testing was performed." Therefore, no MRMC comparative effectiveness study was conducted, and no effect size on human reader improvement with AI assistance is reported.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

The primary performance data reported (positional and angular displacement accuracy) are standalone algorithm/device accuracy metrics, as they quantify the device's ability to precisely locate structures and guide instruments in a controlled testing environment (using pediatric models and cadavers), independent of a human surgeon's subjective interpretation or decision-making beyond the act of using the device. This testing is focused on the device's intrinsic measurement capabilities.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the accuracy measurements (positional and angular displacement), the ground truth would be based on precisely measured, known physical locations or trajectories within the test setup (pediatric models or cadavers). This is an engineering- or physics-based ground truth, where the "true" position or angle is established by highly accurate measurement systems or a known fiducial reference.

8. The sample size for the training set

The document does not provide any information about a training set size. This 510(k) summary describes a navigation system and its accessories, not a machine learning or AI algorithm that typically requires a separate training set. While the "Cranial Guidance Software" is mentioned, the performance evaluation focuses on the accuracy of the navigation system components rather than a pattern recognition or diagnostic AI.

9. How the ground truth for the training set was established

Since no information on a training set or its size is provided, the method for establishing its ground truth is also not described. As noted above, the device's evaluation is primarily based on the accuracy of its navigation capabilities, which rely on precise physical measurements rather than annotated data for training.

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The 37cm iQ Large tip and sleeve sets, when used with the appropriate Sonopet iQ handpiece, are intended for use in surgical procedures where fragmentation, emulsification, and aspiration of tissue is desirable.
The 37cm iQ Large tip and sleeve sets intended for soft tissue may be used in surgical procedures including gastrointestinal and affiliated organ surgery, urological surgery, general surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and thoracoscopic surgery.
CONTRAINDICATION: This ultrasonic surgical aspirator device is not indicated for and should not be used for the fragmentation, emulsification, and aspiration of uterine fibroids.

The Sonopet iQ Ultrasonic Aspirator System is an ultrasonically vibrating surgical device which, in combination with irrigation and aspiration, emulsifies fragments and removes unwanted tissue. The system consists of a console to provide control and power functions, a surgical handpiece to provide ultrasonic mechanical energy (25kHz), sixteen (16) tips with irrigation sleeves and a cassette for irrigation and suction. Users may choose from three different styles of foot pedals. The sixteen tips and sleeves consist of a soft tissue family and a hard tissue family.
The Sonopet iQ 37cm iQ Large (5500-25S-601) is the subject device of this submission and is an extension to the family of Sonopet iQ soft tissue tips and sleeves which are commercially available in the United States. The Sonopet iQ 37cm iQ Large is a single use device that forms part of the Sonopet iQ Ultrasonic Aspirator System.

This document is a 510(k) premarket notification for the Stryker Sonopet iQ 37cm iQ Large ultrasonic surgical aspirator. It describes the device, its intended use, and the non-clinical testing performed to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "All pre-defined acceptance criteria for the above tests have been met." However, it does not provide specific quantitative acceptance criteria or detailed reported performance for each test. It only lists the categories of non-clinical testing performed.

2. Sample Size for the Test Set and Data Provenance:

The document does not provide details on the sample size used for the test set for any of the non-clinical tests. It also does not specify the data provenance (e.g., country of origin of the data, retrospective or prospective) for these tests. All testing appears to be non-clinical, implying laboratory-based or simulated environments, rather than human clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. Given that the testing is non-clinical (engineering, simulated use), the concept of "experts establishing ground truth" in the clinical sense (e.g., radiologists interpreting images) is not directly applicable here. "Ground truth" for engineering tests would typically be established by validated measurement techniques, standards, or specifications defined by engineers/designers.

4. Adjudication Method for the Test Set:

This information is not provided as it's not relevant to non-clinical engineering and performance testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation or subjective assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC comparative effectiveness study was done. The document explicitly states: "Clinical testing was not required for this traditional 510(k)." The device is an ultrasonic surgical aspirator, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device is a physical surgical instrument, not an algorithm. Therefore, the concept of "standalone algorithm performance" is not applicable. The performance evaluated related to the physical characteristics and function of the device in a surgical context, specifically its fragmentation, emulsification, and aspiration capabilities. The "Simulated Use Validations" would assess the device's performance in a simulated surgical environment.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the non-clinical tests listed (Sterilization, Biocompatibility, EMC/Electrical Safety, Design Verification, Human Factors, Simulated Use), the "ground truth" would be established by:

• Sterilization and Package Integrity: Industry standards (e.g., ISO standards), validated sterilization cycles, and package testing specifications.
• Biocompatibility: ISO 10993 series of standards and associated tests.
• EMC and Electrical Safety: IEC 60601 series of standards.
• Design Verification: Engineering specifications, design requirements, and validated test methods.
• Human Factors and Usability: Usability standards (e.g., IEC 62366) and defined user tasks with performance metrics.
• Simulated Use Validations: Performance specifications (e.g., tissue fragmentation rate, aspiration efficiency) evaluated against realistic simulated tissue or models.

The document does not detail specific ground truth criteria for each test but indicates they were "pre-defined acceptance criteria."

8. The Sample Size for the Training Set:

This information is not applicable as the device is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable for the same reason as point 8.

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The Aviator® Anterior Cervical Plating System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
• Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• Trauma (including fractures)
• Tumors
• Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
• Pseudarthrosis
• Failed previous fusion
• Decompression of the spinal cord following total or partial cervical vertebrectomy
• Spondylolisthesis
• Spinal stenosis

The LITe® Plate System Universal, Sacral, 2 Screw and 4 Screw Plates are indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of the thoracic and thoracolumbar (T1-L5) spine or via an anterior approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
• Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);
• Pseudoarthrosis;
• Spondylolysis:
• Spondylolisthesis;
• Spinal stenosis;
• Tumors:
• Trauma (i.e. Fractures or Dislocation)
• Deformities (i.e. Scoliosis, Kyphosis or Lordosis)
• Failed Previous Fusion
The LITe® Plate System Buttress Plate is intended to stabilize the allograft or autograft at one level (T1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.

The DynaTran™ Anterior Cervical Plating System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
• Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• Trauma (including fractures)
• Tumors
• Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
• Pseudarthrosis
• Failed previous fusion
• Decompression of the spinal cord following total or partial cervical vertebrectomy
• Spondylolisthesis
• Spinal stenosis

The Reflex™ Hybrid ACP System is intended for anterior intervertebral screw fixation of the cervical spine from C2 – T1. These systems are indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
• Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• Decompression of the spinal cord following total or partial cervical vertebrectomy
• Trauma (including fractures)
• Tumors
• Deformities or curvatures (including kyphosis, lordosis or scoliosis)
• Pseudoarthrosis
• Failed previous fusions
• Spondylolisthesis
• Spinal stenosis

The UniVise™ Spinous Process Fixation Plate is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The UniVise™ Spinous Process Fixation Plate is intended for use with bone graft and not intended for stand-alone use.

The previously cleared devices consist of a variety of plate systems designed to provide support across implanted levels in the cervical, thoracolumbar, and lumbosacral spine until fusion is achieved. The primary purpose of this submission is to establish an MR Conditional labeling claim for these implants.

This document is a 510(k) summary for several spinal plate systems, primarily aimed at establishing an "MR Conditional" labeling claim. It describes a standalone performance study to demonstrate MR compatibility.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific numerical or qualitative acceptance criteria defined by ASTM F2503 and applied for this submission are not detailed in the provided text. The document broadly states that the devices met these criteria.

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size: Not explicitly stated. The document refers to "the subject devices" which is a collection of 5 different plate systems, each with potentially various sizes and configurations.
• Data Provenance: Not explicitly stated. The study described is a laboratory performance test (MR Compatibility testing per ASTM F2503), not a clinical study involving patient data. Therefore, concepts like country of origin or retrospective/prospective don't directly apply in the same way they would for a clinical trial.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• Not applicable. This study is a technical performance test (MR Compatibility), not a clinical study requiring expert assessment for ground truth. The "ground truth" here is the physical property of MR compatibility as defined by the ASTM standard.

4. Adjudication Method for the Test Set

• Not applicable. As the study is a technical performance test, there is no adjudication process involving human reviewers. The assessment is based on objective measurements against the ASTM F2503 standard.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• No. This document describes a technical MR compatibility study, not a clinical MRMC comparative effectiveness study involving human readers and AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Yes. The described study is a standalone performance study focused on the physical properties of the devices themselves (MR compatibility) without any human-in-the-loop component. It's a laboratory test of the device's inherent characteristics.

7. The Type of Ground Truth Used

• Standardized Test Methods (ASTM F2503): The ground truth for MR compatibility is established by the specified industry standard (ASTM F2503), which outlines the methodologies and criteria for evaluating MR safety of medical implants. The "ground truth" is adherence to and performance within the limits defined by this standard.

8. The Sample Size for the Training Set

• Not applicable. This is a performance study for MR compatibility, not an AI/machine learning study. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set was Established

• Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to the described study.

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The intended use of the OptaBlate™ Radiofrequency (RF) Generator System is as follows:

• Palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.
• · Coagulation and ablation of tissue in bone during surgical procedures including palliation of pain associated with

metastatic lesions involving bone in patients who have failed or are not candidates for standard therapy.

· Ablation of benign bone tumors such as osteoid osteoma.

The OptaBlate™ Radiofrequency (RF) Generator system is a bipolar, high frequency electrosurgical system. The OptaBlate™ RF Generator will be used in conjunction with OptaBlate™ Probes, OptaBlate™ Microinfuser™ Infusion Device, OptaBlate 150 mm Temperature Sensor, MultiGen 2 Splitter Cable, and other currently marketed Stryker compatible accessories to produce lesions by the direct application of radiofrequency currents. The generator applies temperature-controlled, radiofrequency (RF) energy into the probe. During lesion creation, targeted tissue is exposed to RF energy using an active probe inserted into a cannula. The application of RF energy causes a thermal reaction at the targeted tissue site to create a lesion. Each OptaBlate™ Radiofrequency (RF) Generator System is composed of a RF generator, a Splitter Cable, Temperature Sensor, and a choice of 4 disposable kit options. The kits contain disposable probes and infusion devices.

This submission is for a Radiofrequency Generator System, which is an electrosurgical cutting and coagulation device. This type of device does not typically involve AI/ML and therefore the concept of training and test sets, ground truth establishment by experts, and MRMC studies does not apply in the context of diagnostic AI/ML devices. Therefore, I will focus on the performance testing carried out to demonstrate substantial equivalence to the predicate device.

**1. A table of acceptance criteria and the reported device performance.
**
The document does not explicitly present a table of "acceptance criteria" against which "reported device performance" is measured in the classical sense of an AI/ML model's performance metrics (e.g., accuracy, sensitivity, specificity). Instead, substantial equivalence is demonstrated through comparative bench-top verification testing and a literature review. The performance testing focuses on demonstrating that the subject device produces similar ablation characteristics to the predicate device and that the technology is safe and effective for its intended uses.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Bench-top Verification Testing: The document states that "Tissue models consisted of fresh chicken muscle and bovine bone." However, the exact sample size (number of tissues/ablations) used for this testing is not specified in the provided text.
• Clinical Literature Review: For the clinical evaluation, Stryker identified 175 unique publications, which were screened based on predefined criteria. A "thorough full-text review of 41 manuscripts" was performed. This represents a retrospective analysis of existing published data. The provenance of this data (e.g., specific countries of origin of the studies) is not detailed, but peer-reviewed publications are generally global in nature.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This section is not applicable in the traditional sense for this device as it is not an AI/ML diagnostic device requiring ground truth labeled by experts for a test set. The performance evaluation relies on physical measurements in bench-top models and a systematic review of existing clinical literature on RF ablation.

• For the bench-top testing, lesion dimensions and temperature measurements were the "ground truth", which are directly measurable physical quantities.
• For the literature review, the "ground truth" on safety and efficacy is derived from reported outcomes in peer-reviewed clinical studies.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This section is not applicable for this type of device and study design. Adjudication methods are typically used in AI/ML performance studies where multiple human readers assess cases and their interpretations need to be reconciled to establish a ground truth or resolve discrepancies.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable as the OptaBlate RF Generator System is not an AI-assisted diagnostic or treatment planning device, and therefore, no MRMC study was performed to assess human reader improvement with AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This section is not applicable as the OptaBlate RF Generator System is a medical device, not a standalone algorithm. Its function is to deliver RF energy for ablation, which is a clinician-performed procedure.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Bench-top Verification Testing: For the in-vitro comparison study, the ground truth was direct physical measurement. For chicken muscle, lesion lengths and widths were directly measured. For bovine bone, tissue temperature at a given ablation zone boundary was indirectly measured as an indicator of lesion size.
• Clinical Efficacy/Safety: The "ground truth" for clinical efficacy and safety was established through a literature review of reported clinical outcomes and vigilance databases. This includes "clinical and technical success, improvements in pain through validated measures (VAS), and the need for repeat procedures" for efficacy, and "reported complications" for safety.

8. The sample size for the training set

This section is not applicable as the OptaBlate RF Generator System is a hardware device, not an AI/ML model that undergoes "training."

9. How the ground truth for the training set was established

This section is not applicable as there is no "training set" for this type of device.

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The Stryker ENT Navigation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomy.

Example procedures include, but are not limited to the following ENT procedures:

• Transphenoidal access procedures;

• Intranasal procedures;

• Sinus procedures, such as maxillary antrostomies, sphenoidotomies/sphenoid explorations, turbinate resections, and frontal sinusotomies;

• ENT related anterior skull based procedures.

The Stryker ENT Navigation System is a computer-assisted image-guided surgery system. The system displays the position of navigated instruments on a model of the patient's anatomy based on preoperative images (CT or MRI) using electromagnetic tracking technology. The position of the instruments and the patient are localized within an electromagnetic field produced by a field generator. The navigation of instruments relative to the patient's anatomy is established via registration of the patient's anatomy to the preoperative images via anatomical landmarks, or surface matching. The position of navigated instruments is then displayed with respect to preoperative images.

The system comprises a computer platform, the software, patient trackers, pointers and suction tubes, instrument trackers, and a dedicated calibration body.

This submission is about the new version 3.6 of the Scopis software application, and the updated computer platform called Electromagnetic Navigation Unit with the new operating system version 3.6.A.

The provided text describes the Stryker ENT Navigation System and its associated software, but it does not include a study that proves the device meets specific acceptance criteria in the way described in the prompt's request.

Instead, the document states:

• "To ensure accuracy, subject devices are tested in accordance with ASTM F2554. The devices meet state-of-the-art acceptance criteria for point accuracy, precision, and distance accuracy."
• "Scopis software applications were subject to verification and validation testing in compliance with IEC 62304 and FDA guidances. All testing criteria were met."

This indicates that internal testing was conducted against existing standards and internal acceptance criteria, but the specific results of such a study are not detailed in the provided K221098 510(k) summary. The summary focuses on demonstrating substantial equivalence to predicate devices, not on presenting a detailed clinical or performance study with specific metrics as requested.

Therefore, many of the requested fields cannot be directly extracted from the provided text.

Here's what can be inferred or explicitly stated from the document, along with what is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Not explicitly stated for accuracy testing. The document mentions "subject devices are tested," implying device-level testing rather than patient data.
• The "Performance Data" section discusses non-clinical testing. Clinical testing was "deemed unnecessary."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not stated. No clinical study involving expert ground truth establishment is described or referenced. The testing mentioned is non-clinical.

4. Adjudication method for the test set:

• Not applicable/Not stated. No clinical study or expert review process is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. The document explicitly states, "No clinical testing was deemed necessary for this Traditional 510(k) submission." This is not an AI-assisted diagnostic device for image interpretation by human readers. It's an image-guided surgery navigation system.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Yes, in spirit, for the non-clinical performance aspects. The accuracy, software, electrical safety, safety, and security tests can be considered "standalone" evaluations of the device's functional and safety characteristics without human-in-the-loop performance in a clinical context. However, this isn't a traditional "algorithm only" performance evaluation as one might see for an AI diagnostic device. It's about the technical performance of the navigation system components.

7. The type of ground truth used:

• For the Accuracy testing (ASTM F2554), the ground truth would typically be established by highly accurate measurement systems and physical phantoms.
• For Software testing (IEC 62304), the "ground truth" would be the specified software requirements and expected behavior, validated through testing protocols.
• For Electrical Safety, EMC, Safety, and Security, the "ground truth" is adherence to the technical standards and regulations.

8. The sample size for the training set:

• Not applicable/Not stated. This device is a navigation system, not a machine learning model that requires a "training set" in the traditional sense for medical image analysis. Its "training" is in its engineering design and software development, not in learning from a large dataset.

9. How the ground truth for the training set was established:

• Not applicable/Not stated. As explained above, this isn't a machine learning model that involves a training set with established ground truth from data.

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