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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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The Stryker CrossFlow Integrated Arthroscopy Pump is a dual arthroscopic pump system intended to provide fluid distension and irrigation of the knee, shoulder, hip, elbow, ankle and wrist joint cavities and fluid suction during diagnostic and operative arthroscopic procedures.

The Stryker CrossFlow Integrated Arthroscopy Pump (CrossFlow) is a microprocessorcontrolled dual (inflow and outflow) pump system designed to provide liquid distension and irrigation of joint cavities and aspiration of liquids out of the joint cavities during diagnostic and operative arthroscopy. Both the irrigation and aspiration pump of the device function according to the peristaltic principle. The Stryker CrossFlow Integrated Arthroscopy Pump consists of the following main components: console housing, power supply, two peristaltic pumps, three pinch valves, and a touch-screen display panel. The device is to be used with specially designed irrigation and aspiration tube sets and can be operated by remote hand and foot controls. A constantly-performed pressure sensing algorithm controls the value of the actual pressure in the joint cavity as compared to the set pressure determined by the user.

The proposed software modification consists of a graphical user interface (GUI) aesthetic update and the addition of a temperature estimation algorithm and on-screen indicator.

The provided document is an FDA 510(k) clearance letter for the Stryker CrossFlow Integrated Arthroscopy Pump, with a focus on a software modification (GUI aesthetic update and addition of a temperature estimation algorithm with an on-screen indicator).

This document does not contain the detailed, quantitative acceptance criteria and study results typically found for AI/ML-driven diagnostic or prognositic devices that require extensive performance data demonstrating accuracy in the context of human interpretation, such as sensitivity, specificity, AUC, or reader studies.

The device discussed here, the Stryker CrossFlow Integrated Arthroscopy Pump, is a medical device with a software component, not primarily an AI/ML-driven diagnostic/prognostic algorithm. The software modification is focused on estimating in-joint temperature and implementing mitigating actions to reduce high temperatures, and a GUI aesthetic update. The performance testing is engineering-centric, verifying that the temperature estimation algorithm meets accuracy specifications and reduces the occurrence of high fluid temperature.

Therefore, a significant portion of the requested information regarding AI/ML study specifics (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training ground truth establishment) is not applicable or not present in this type of 510(k) submission for this specific device.

However, I can extract and infer information based on the document related to the software modification's performance data:

Acceptance Criteria and Device Performance for Stryker CrossFlow Integrated Arthroscopy Pump (Software Modification)

Given the nature of the device as an arthroscopic pump with a new temperature estimation algorithm, the "acceptance criteria" discussed are largely functional and performance-based for the new software feature, rather than diagnostic accuracy metrics common for AI/ML image analysis.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a number of "cases" or "patients" in the context of an algorithm evaluation study. Performance testing involved "software verification testing" and "bench performance testing," and "design validation testing" in a "simulated-use environment." The sample size refers to the number of tests performed or configurations evaluated, not a patient cohort. No specific numbers are provided beyond that these tests were conducted.
• Data Provenance: Not applicable. This is not a study derived from patient data in the sense of image analysis. The "data" tested are simulated or real-time measurements within the pump system during bench and simulated-use testing. It is implicitly prospective testing done in a lab/simulated environment. No country of origin for data is relevant as it's not a clinical data set.

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

• Number of Experts: Not explicitly stated for generating "ground truth" as it would be for diagnostic imaging. For "Design validation testing," it states it was conducted by "surgeon and nurse users." This implies clinical experts.
• Qualifications: "Surgeon and nurse users." No specific years of experience or board certifications are mentioned. Their role was to assess usability of the GUI and intended use, not to establish data-driven ground truth for temperature estimation. For the temperature estimation accuracy, the ground truth is likely established by precise measurement instruments in a lab setting, not human experts.

4. Adjudication method for the test set:

• Method: Not applicable. This is not a study requiring adjudication of human expert interpretations. The validation of the temperature algorithm would rely on objective physical measurements.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• Done?: No. This type of study (comparative effectiveness of human readers with/without AI assistance) is not applicable to an arthroscopic pump's temperature estimation algorithm and GUI update.
• Effect Size: Not applicable.

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

• Done?: Yes, to a degree. The "Software verification testing" and "Bench performance testing" of the "temperature estimation algorithm" are effectively standalone performance tests, ensuring the algorithm itself calculates and acts on temperature data correctly, independently of user interaction beyond setting parameters. The results state it "performed according to specification" and "meets accuracy specifications."

7. The type of ground truth used:

• Type:
  • For the temperature estimation algorithm: Objective measurements from calibrated physical sensors during bench testing.
  • For the GUI user experience: User feedback/success criteria from "surgeon and nurse users" in a "simulated-use environment."

8. The sample size for the training set:

• Sample Size: Not applicable/not disclosed. This is a software modification (algorithm update + GUI change) to an existing device, not an AI/ML system that undergoes traditional training on large datasets in the way a diagnostic image analysis algorithm would. The algorithm's parameters and logic would be developed and refined using engineering principles and calibration data, not a "training set" in the common AI/ML sense.

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

• Method: Not applicable. Given the nature of the device's software update, there isn't a "training set" with established "ground truth" in the manner of AI/ML diagnostic tools. The development of the temperature estimation algorithm would involve engineering design, thermodynamic modeling, and empirical calibration using temperature sensors, not a ground truth derived from clinical experts on a patient dataset.

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HipCheck provides static localization information derived from image processing of intra-operatively acquired X-ray images, by superposition of virtual measurement tools onto those X-ray images.

HipCheck assists the surgeon to determine quantitative measurements during femoroacetabular impingement procedures.

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.

The femoral head detection algorithm on which the alpha angle algorithm is built, is based on the Femoral Head Detector algorithm used in the FluoroMap 1.0 software, which belongs to the secondary predicate device, the FluoroMap Computer Assisted Surgery System (K103400).

The provided text does not contain specific acceptance criteria, reported device performance metrics, or detailed study results for HipCheck. While it mentions various types of testing conducted (software, alpha angle performance, mechanical, electrical safety, EMC, simulated-use), it only states that all testing had "overall passing results" and "demonstrates that HipCheck performs as intended."

Therefore, I cannot fulfill all parts of your request with the given information. Below is a summary of what can be extracted and indications of what is missing.

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly detailed in the provided document. The document states that testing was conducted for "overall passing results" but does not specify the numerical acceptance criteria or the measured performance values for HipCheck.

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

The document does not specify the sample size for any test sets used. It only mentions "simulated-use environment by surgeon and nurse users" for design validation. There is no information about the country of origin of the data or whether it was retrospective or prospective.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth for any test sets. It mentions "surgeon and nurse users" for simulated-use testing but not in the context of ground truth establishment.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used for the test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it provide an effect size for human readers with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study

The document describes "Alpha Angle Performance Testing" including "verification testing based on the identified design requirements and software requirement specifications of the Alpha Angle Core Algorithm," which suggests standalone algorithm testing. However, no specific performance metrics (e.g., accuracy, precision, recall) are reported for this standalone performance.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for any of the testing. For example, it doesn't mention whether pathology, expert consensus, or outcomes data were used.

8. Sample Size for the Training Set

The document does not mention any training set or its sample size.

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

Since no training set is mentioned, there is no information on how its ground truth was established.

Summary of Device Features and Testing Mentioned:

• Device Name: HipCheck
• Purpose: Provides static localization information derived from image processing of intra-operatively acquired X-ray images, by superposition of virtual measurement tools onto those X-ray images. Assists the surgeon to determine quantitative measurements (specifically alpha angle) during femoroacetabular impingement procedures.
• Core Technology: Alpha angle algorithm built on the Femoral Head Detector algorithm from the FluoroMap 1.0 software (secondary predicate K103400).
• Testing Conducted:
  • Software testing (considered "moderate" level of concern).
  • Alpha Angle Performance Testing (verification and validation to meet design requirements and user needs).
  • Mechanical testing (battery life, tablet weight, securement, UI temperature/functionality, RF ablation interference, mounting arm staying force, simulated-use testing).
  • Electrical safety and Electromagnetic Compatibility (EMC) testing (compliant with IEC 60601-1 and IEC 60601-1-2 standards).
• Results: All testing had "overall passing results" and "demonstrates that HipCheck performs as intended."
• No Clinical Studies or Animal Studies: The device was supported by non-clinical testing only.

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The Footed Attachments and Cutting Accessories are intended to be used with the Stryker Consolidated Operating Room Equipment (CORE®) Console and electric and pneumatic motors. When used with these motors, the Footed Attachments and Cutting Accessories are intended to cut bone in the following manner: drilling, reaming, shaping, dissecting, shaving and smoothing for the following medical applications: Neuro: Spine: Ear, Nose, and Throat (ENT) / Otology /Neurotology/Otorhinolaryngology; Craniofacial (bones of the skull and supraorbital region); and Sternotomy.

Specific applications include Craniectomy, Pterional Craniotomy, Sub Occipital/Retro Sigmoid/Posterior Fossa Craniotomy, Sphenoid Wing Dissection, Laminotomy/Laminectomy, and Orthopedic Spine.

These devices are also usable in the preparation for the placement of screws, metal, wires, pins, and other fixation devices.

Footed Attachments are prescription medical devices that are designed to provide an interface between a cutting accessory and a high speed motor. When used with a motor and a cutting accessory, the Footed Attachments are intended cut, drill, ream, dissect and shape bone in a variety of surgical procedures including the following specialty areas: Neuro, Spine, ENT, Sternotomy and Orthopedics.

The Stryker Footed Attachments are available in footed and non-footed configurations. The primary difference is the addition of the foot feature at the end of the nose tube.

The footed attachment is offered in two configurations: Fixed Footed Attachments and Rotating Footed Attachments. The primary difference between the Fixed and the Rotating Footed Attachment is the ability to rotate the foot portion of the device independently from the motor.

Cutting accessories are single use, sterile devices which have a mount or notch machined at their proximal end and a head with a sharp cutting edge at their distal end. The cutting accessories when used with a high speed drill and Footed Attachments are intended to cut, drill, ream, decorticate, shape, dissect, shave and smooth bone in a variety of surgical procedures.

The document provided is a 510(k) Premarket Notification for Stryker Footed Attachments and Cutting Accessories. It outlines the device's indications for use, describes the device, and discusses performance and biocompatibility testing. However, it does not include an acceptance criteria table with reported device performance in the manner typically seen for diagnostic or AI-driven devices (e.g., sensitivity, specificity, AUC).

Instead, the document details a comparative study against predicate and reference devices, focusing on demonstrating substantial equivalence for a medical device that cuts bone. The "acceptance criteria" here are met through various non-clinical performance tests and biocompatibility assessments, and by showing similarity to legally marketed devices.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts, adjudication method for ground truth, MRMC study, standalone performance, training set sample size and ground truth establishment) are not applicable in the context of this device and the type of information presented in a 510(k) for a surgical tool like this one. This document focuses on demonstrating physical, functional, and material equivalence rather than diagnostic performance metrics.

Here's an attempt to answer the questions based on the provided document, noting where information is not present or not applicable:

Acceptance Criteria and Device Performance Study

The acceptance criteria for the Stryker Footed Attachments and Cutting Accessories are demonstrated through a series of non-clinical performance tests and biocompatibility evaluations, aimed at showing that the device meets its performance requirements and is substantially equivalent to legally marketed predicate devices. The study detailed is primarily a bench-testing and comparative analysis rather than a clinical trial or diagnostic performance study.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify sample sizes for the individual non-clinical performance and biocompatibility tests. It indicates these were "verification tests" performed to demonstrate performance. The data provenance is internal to Stryker Instruments, as these are non-clinical bench tests. There is no mention of country of origin for data as it's not a clinical study involving patients. The tests are prospective in nature, as they are part of the device development and verification process.

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

Not Applicable (N/A). For this type of device (a surgical cutting tool), "ground truth" as it pertains to diagnostic accuracy (e.g., for an AI algorithm) is not relevant. The "ground truth" for performance is established by engineering specifications, safety standards, and functional requirements for cutting bone, which are verified through the described non-clinical tests.

4. Adjudication Method for the Test Set

Not Applicable (N/A). There is no "adjudication method" in the context of diagnostic agreement, as this is not a diagnostic device or a study involving subjective assessment of output by multiple readers.

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

No. A MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks, which is not the purpose of this submission for a surgical instrument.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not Applicable (N/A). This device is a mechanical surgical tool, not an algorithm or AI system. Therefore, a standalone performance study in that context is not relevant. The device implicitly performs "stand-alone" in its function as a tool, but its performance is measured against engineering and safety criteria, not AI metrics.

7. Type of Ground Truth Used

The "ground truth" in this context refers to the engineering specifications, functional requirements, and safety standards for a device intended to cut bone. For biocompatibility, the ground truth is established by international standards (e.g., AAMI/ANSI/ISO 10993-1) for biological evaluation of medical devices. The assessment of "substantial equivalence" is based on comparing the subject device's features and performance to those of legally marketed predicate devices.

8. Sample Size for the Training Set

Not Applicable (N/A). This device is not an AI/ML algorithm that requires a training set.

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

Not Applicable (N/A). As there is no training set, this question is not applicable.

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The Elite and Heavy Duty Attachments are intended to be used with the Stryker Consolidated Operating Room Equipment (CORE) console and electric and pneumatic motors. When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are intended to cut bone cement in the following manner: drilling, reaming, decorticating, shaping, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose and Throat (ENT)/Otology/Neurotology/Otothinolaryngology; Craniofacial and Maxillofacial; Dental; and Endoscopic applications.

The specific applications include Craniectomy, Laminotomy/Laminectomy, Minimally Invasive Surgery (MIS) Spine. Expanded Endonasal (EEA)/Anterior Skull Base/Endoscopic/Transnasal/Transphenoidal, and Orthopedic Spine.

When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are intended to cut teeth in the following manner: sectioning, splitting, fragmenting, extracting, removing, drilling, and reaming.

When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are also usable in the preparation for the placement of screws, metal, wires, pins, and other fixation devices, or the cutting of screws, metal, wires, pins, and other fixation devices in the following manner: sectioning, smoothing or shaping of metal, and removing/rounding sharp edges.

The Stryker® Elite and HD Attachments are used within a system consisting of a variety of devices, including a console, powered motors, and cutting accessories. The attachments connect to the motors and the cutting accessories to complete the system for physician use. The Stryker® Elite and HD Attachments are offered for prescription use only. The Elite and HD Attachments are intended to serve as interfaces between powered motors and cutting accessories for the purposes of:

• Cutting bone, bone cement, and teeth; ●
• Placing or cutting screws, metal, wires, pins, and other fixation devices; and ●
• Providing a location for the user to hold and grip the device system. ●

The Elite and HD Attachments are provided in straight and angled configurations. The subject Elite Attachments are offered in the following lengths: 7cm, 12cm, 14cm, 17cm, and 20cm. The Stryker® HD Attachments are offered in the following lengths: 9cm and 14cm.

The Elite and HD Attachments are powered by, and compatible with, the Stryker electric and pneumatic motors. The attachments are also used with the cutting accessories (burs). All the attachments demonstrate a rotary mode of action by transmitting torque.

The Elite and HD Attachments are made of stainless steel (SST). The attachments display a color band on the outer surface. The color bands serve to enhance the distinction of attachment and cutting accessory compatibility. The Elite and HD Attachment outer profiles feature a sleeker design. The Elite and HD Attachment outer surface textures include laterally grooved and continuous knurling textures for improved user grip.

The Elite and HD Attachments are reusable, provided non-sterile, and end user sterilized. The attachments may be cleaned by manual or mechanical (automated) cleaning procedures. The attachment end user sterilization method is moist heat (steam) and the sterility assurance level (SAL) is 10-6. The Elite and HD Attachments have an expected life of one (1) year. The attachments are individually packaged in a sealed retention insert. The attachment labels contain a label specified part description, quantity, lot number, and contact information. There are no known contraindications for the Elite and HD Attachments.

The provided text describes the acceptance criteria and study results for the Stryker Elite and Heavy Duty (HD) Attachments. However, it is important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a comprehensive detailing of a standalone clinical study for device effectiveness in a clinical setting. The tests described are primarily non-clinical performance and safety tests.

Here's a breakdown of the requested information 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

The document explicitly states: "No clinical testing was deemed necessary for this 510(k) premarket notification." Therefore, there is no test set in the sense of patient data. The testing performed was non-clinical (laboratory/bench testing). The provenance of this (non-clinical) data is from Stryker Instruments' testing.

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

Not applicable, as no clinical testing with a "test set" requiring expert ground truth assessment was conducted. The "ground truth" for the non-clinical tests is established by the specified acceptance criteria for each test (e.g., maximum temperature, whip displacement, material properties).

4. Adjudication Method for the Test Set

Not applicable, as no clinical testing with a "test set" requiring adjudication was conducted.

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

Not applicable. This device is a surgical attachment (drill handpiece accessory), not an AI-assisted diagnostic or imaging device used by "human readers." No MRMC study was conducted.

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

Not applicable. This is a mechanical surgical device, not an algorithm or AI.

7. The Type of Ground Truth Used

For the non-clinical performance and safety tests, the "ground truth" is defined by established engineering and biocompatibility standards and internal specifications set by Stryker. For example, for biocompatibility, the ground truth is "non-cytotoxic," "non-sensitizing," etc., as defined by the referenced ISO standards. For functional tests like temperature, it's a quantitative limit (≤ 46°C).

8. The Sample Size for the Training Set

Not applicable, as there is no "training set" for this type of mechanical device.

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

Not applicable, as there is no "training set" for this type of mechanical device.

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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 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 FusionThe 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 LITe® Plate System is an anterior/anterolateral/lateral plate system that may be used in the thoracic, lumbar, and sacral spine (T1-S1). The LITe® Plate System consists of plates and screws manufactured from titanium alloy (Ti6Al4V) per ASTM F136 and ISO 5832-3, as well as associated manual general surgical instrumentation. The implants are available in a variety of sizes to accommodate various patient anatomies.

The provided text describes a 510(k) premarket notification for the "LITe® Plate System," a spinal intervertebral body fixation orthosis. The document focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study demonstrating the device meets those criteria in the context of diagnostic or AI-driven performance.

Therefore, many of the requested categories related to AI device performance evaluation (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set information) are not applicable to this type of medical device submission.

The "acceptance criteria" discussed in this document refer to the mechanical performance of the implant and its ability to meet established ASTM standards for orthopedic devices. The "study" demonstrating this is mechanical testing.

Here's the breakdown of the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size: Not specified in terms of clinical patient data. For mechanical testing, the number of samples tested per condition is not explicitly stated, but typically follows standard testing protocols for ASTM standards.
• Data provenance: Not applicable in the context of clinical or image data. The "data" pertains to mechanical test results.

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

• Not Applicable. Ground truth for mechanical devices is established by engineering specifications and recognized consensus standards (like ASTM F1717-14), not by expert human readers.

4. Adjudication method for the test set:

• Not Applicable. Mechanical testing results are objective measurements against defined standards, not subjective assessments requiring adjudication.

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:

• Not Applicable. This is a mechanical implant, not an AI diagnostic device.

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

• Not Applicable. This is a mechanical implant, not an AI diagnostic device.

7. The type of ground truth used:

• Mechanical Standards and Predicate Device Performance: The "ground truth" for this device's performance relies on meeting the specifications outlined in ASTM F1717-14 and demonstrating comparable mechanical properties and functional equivalence to its predicate devices.

8. The sample size for the training set:

• Not Applicable. This is a mechanical implant, not an AI device that requires a training set.

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

• Not Applicable.

Summary of the Study:

The "study" referenced in the document is a risk analysis and mechanical testing comparison to predicate devices, not a clinical trial or AI performance study. The submission aimed to demonstrate substantial equivalence to already approved devices.

The key points of the study are:

• Mechanical Testing: The device underwent static and dynamic compression testing per ASTM F1717-14, static torsion testing per ASTM F1717-14, and buttress plate expulsion testing.
• Acceptance Criteria for Mechanical Testing: Predefined acceptance criteria associated with these tests were met. These criteria would be derived from the ASTM standards and comparisons to predicate device performance.
• Comparison to Predicates: The LITe® Plate System was compared to its primary predicate (Stryker Spine, LITe® Plate System, K142699) and additional predicates (Stryker Spine, CENTAUR™ Spinal System, K994347, K001844). The comparison covered intended use, material composition, principles of operation, and design.
• Conclusion: The risk analysis performed demonstrated that any minor differences between the LITe® Plate System and its predicates do not impact device performance, leading to the determination of substantial equivalence.

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The Xia® 3 Spinal System is intended for use in the non-cervical spine. When used as an anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the Xia® 3 Spinal System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
• Degenerative Disc Disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• Spondylolisthesis
• Trauma (i.e. fracture of dislocation)
• Spinal stenosis
• Curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• Tumor
• Pseudarthrosis
• Failed previous fusion
The 5.5 mm rods from the Stryker Spine Radius™ Spinal System and 6.0 mm Vitallium rods from the Xia® Spinal System are intended to be used with the other components of the Xia® 3 Spinal System.
When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Xia® 3 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Xia® 3 Spinal System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Xia® 4.5 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation for the following indications:
• Degenerative Disc Disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• Spondylolisthesis
• Trauma (i.e. fracture of dislocation)
• Spinal stenosis
• Curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• Tumor
• Pseudarthrosis
• Failed previous fusion
The Stryker Spine DIAPASON™ Spinal System, Opus™ Spinal System, and Xia® 4.5 Spinal System can be linked to the Xia® 4.5 Spinal System via the rod-to-rod connector when used for the aforementioned indications in skeletally mature patients as an adjunct to fusion.
Except for the staples, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the Xia® 4.5 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis. kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Xia® 4.5 Spinal System is intended to treat pediatic patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

1. Xia® 3 Spinal System
   The Xia® 3 Spinal System is comprised of screws, blockers, and hooks that affix rods and connectors to vertebrae of the spinal column for purposes of stabilization, or corrective action through the application of force.

2. Xia® 4.5 Spinal System
   The Xia® 4.5 Spinal System is comprised of monoaxial and polyaxial bone and reduction screws, hooks, dual staples, and blockers that affix rods, rod-to-rod connectors, and cross connectors to vertebrae of the spinal column.

The provided document is a 510(k) premarket notification for the Stryker Spine Xia® 3 and Xia® 4.5 Spinal Systems. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through testing or data analysis.

Instead, this document focuses on demonstrating substantial equivalence to previously cleared predicate devices for an expansion of indications for use.

Here's why and what information is available:

The document explicitly states:

• "This submission seeks to build upon predicate Xia® 3 and Xia® 4.5 Spinal Systems through expansion of indications only. Therefore, no additional performance data is necessary." (Page 6, "Summary of Performance Data")

This means the submission is not presenting new performance studies or acceptance criteria for a novel device or a significantly modified device. Instead, it's arguing that the expanded indications for the Xia® 3 and Xia® 4.5 Spinal Systems are substantially equivalent to the indications already cleared for a primary predicate device (Medtronic Sofamor Danek, CD HORIZON® Spinal System cleared under K140276) and previous versions of the Xia® systems.

Therefore, for the information requested:

1. A table of acceptance criteria and the reported device performance: This information is not provided in the document as no new performance data was deemed necessary for this submission. The device is implicitly accepted based on its substantial equivalence to predicate devices, which would have undergone performance testing during their original clearance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no new performance studies were conducted for this 510(k). The document only mentions predicate device clearances.
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): Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This device is a spinal fixation system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) relies on the safety and effectiveness demonstrated by its predicate devices for its original indications and argues that the expanded indications are within the scope of what was already established for similar, legally marketed devices. It is a regulatory submission for a spinal implant, which typically doesn't involve the kind of performance studies (e.g., diagnostic accuracy, reader studies) that would generate the detailed data requested in your prompt regarding acceptance criteria, sample sizes, and expert ground truth for an AI/diagnostic device.

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The ICONIX All Suture Anchor System is intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, hand, wrist, elbow and shoulder. Specific Indications are listed below.

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair
Hand/Wrist: Scaphulolunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of Collateral Ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP Joints for all Digits, Digital Tendon Repair
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction
Knee: Medial Collateral Ligament Repair. Lateral Collateral Ligament Repair. Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.
Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair

The ICONIX All Suture Anchors are intended for single use only.

The ICONIX All Suture Anchors are soft-tissue fixation devices with a push-in design, provided preloaded on a disposable inserter. They are composed of a sheath structure that contains one or more working sutures. As the anchor is deployed, the sheath bunches and fixates in bone.

The provided text describes the ICONIX All Suture Anchor System and its expanded indications for use. However, it does not include information about acceptance criteria or a study that specifically proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, or reader improvement. This is likely because the device is a medical implant (suture anchor) and not an AI-powered diagnostic or assistive tool, which typically have performance metrics and studies as detailed in the prompt.

The "study" mentioned here is confined to non-clinical comparative bench testing to support expanded indications, not a clinical study involving human performance or diagnostic accuracy.

Here's an analysis based on the provided document, addressing the prompt's questions where possible and noting where information is not applicable or unavailable:

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

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

• Sample Size for Test Set: Not explicitly stated in the document. The text only mentions "comparative bench testing" for "cyclic testing followed by ultimate tensile strength".
• Data Provenance: The study was "non-clinical comparative bench testing," implying it was conducted in a lab setting, likely within the United States where Stryker Endoscopy is based (San Jose, CA). It is prospective in nature for device validation.

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 question is not applicable to this type of device and study. The testing involved mechanical properties (fixation strength, tensile strength) which are measured quantitatively, not subjectively assessed by human experts for ground truth.

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

• This question is not applicable as the "test set" involves physical device performance, not human interpretation or diagnostic assessment.

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 type of study is relevant for diagnostic or AI-assisted devices that involve human interpretation of medical images or data. The ICONIX All Suture Anchor System is a physical surgical implant.
• Therefore, an effect size of human improvement with/without AI assistance is not applicable.

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

• This question is not applicable. This device is a physical medical implant, not an algorithm, and does not have standalone "algorithm only" performance.

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

• The "ground truth" for this device's performance was established via objective mechanical measurements of fixation strength and ultimate tensile strength in a bench testing environment according to engineering principles. It was compared against the performance of predicate devices.

8. The sample size for the training set

• This question is not applicable as there is no "training set" in the context of mechanical bench testing for a physical medical device. This term is specific to machine learning and AI model development.

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

• This question is not applicable since there is no training set for this type of device validation.

Summary of the Study:

The "study" described in the document is a non-clinical comparative bench test. Its purpose was to demonstrate that the ICONIX All Suture Anchors, when used for Gluteal Tendon Repair of the Hip (an expanded indication), show equivalent mechanical fixation strength to predicate devices. This type of testing is standard for demonstrating substantial equivalence for physical medical devices, especially when expanding indications without significant design changes. Clinical testing was explicitly stated as "not required for this submission." The FDA's 510(k) clearance (K133671) acknowledges this bench testing as sufficient to support the claim of substantial equivalence.

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The MEMORY METAL STAPLES (MEMOCLIP, EASYCLIP, and FOR FUSION) are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.

This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market Easy Clip. Additional sizes to the existing range and modifications are being made existing cleared Easy Clip' devices (K070031).

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the "Easy Clip" device:

It is important to note that the provided documents are a 510(k) Summary and an FDA clearance letter for a Class II medical device (Staple, Fixation, Bone). For this type of device, the "acceptance criteria" and "study" are typically focused on demonstrating substantial equivalence to an existing legally marketed device (predicate device) through non-clinical testing, rather than performing a clinical trial with specific performance metrics like those for AI/Software as a Medical Device (SaMD).

Therefore, many of the requested categories related to clinical studies, expert-established ground truth, and AI-specific metrics (like MRMC studies) are not applicable to this submission.

Here's a breakdown based on the provided information:

Acceptance Criteria and Reported Device Performance

Note: For this type of device, "acceptance criteria" are not reported as specific performance metrics (e.g., sensitivity, specificity) in the same way as for AI/SaMD. Instead, the acceptance criteria are implicitly that the modified device remains safe and effective, and performs comparably to the predicate device in relevant non-clinical tests. The "reported device performance" is the conclusion that these tests support substantial equivalence.

Study Details

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

   • Sample Size: Not applicable. For non-clinical testing of a medical device like a surgical staple, "sample size" refers to the number of physical units tested for mechanical properties. This specific number is not provided in the 510(k) summary.
   • Data Provenance: Not applicable in the context of clinical data. The testing was non-clinical laboratory testing of the physical device.

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

   • Not Applicable. This submission relied on non-clinical engineering and material tests, not expert-established clinical ground truth. The "ground truth" for these tests would be the established engineering standards (e.g., ASTM F2129) and the characteristics of the predicate device.

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

   • Not Applicable. No human adjudication of clinical cases was performed.

4. 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:

   • Not Applicable. This is a physical medical device (staple), not an AI/SaMD product. No MRMC study was conducted.

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

   • Not Applicable. This is a physical medical device, not an algorithm.

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

   • Engineering Standards and Predicate Device Characteristics: The "ground truth" for this submission was based on established engineering and material standards (e.g., ASTM F2129 for corrosion) and the known performance and characteristics of the legally marketed predicate device (K070031). The goal was to demonstrate that modifications did not negatively impact these established benchmarks.

7. The sample size for the training set:

   • Not Applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

   • Not Applicable. No training set was used.

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The Hoffmann 3 Modular External Fixation System components are external fixation frame components for use with the components of the Hoffmann II MRI and Hoffmann II Compact MRI External Fixation Systems, in conjunction with Apex Pins. It is intended to provide stabilization of open and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments such as IM rods, casts or other means of internal fixation.

The indications for use of external fixation devices include:

• Bone fracture fixation
• Osteotomy
• Arthrodesis
• Correction of deformity
• Revision procedure where other treatments or devices have been unsuccessful
• Bone reconstruction procedures

This Traditional 510(k) submission is intended to address the addition of new components to the previously cleared Hoffmann 3 Modular External Fixation System. The Hoffmann 3 Modular External Fixation System consists of Rods. Posts: Couplings, Clamps and Pins that can be combined to construct different frame configurations that are MR conditional. The additional components consist of a Multiplanar Rod to Rod Coupling, Multiplanar Pin to Rod Coupling, 30° Rod Coupler, 4/5 Apex Pin, 5/6 Transfixing Pin and a Ø11mm Semi Circular Rod. This external fixation system may also be used with the components in other Howmedica Osteonics external fixation systems such as the Hoffmann II MRI and Hoffmann II Compact MRI External Fixation Systems and in conjunction with other commercially available Apex Pins.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Hoffmann 3 Modular External Fixation System

1. Acceptance Criteria and Reported Device Performance

Overall Conclusion: The non-clinical testing demonstrated that the Hoffmann 3 System components are substantially equivalent to devices currently cleared for marketing. No specific quantitative performance metrics beyond "substantially equivalent" are provided in this summary.

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

• Test Set Sample Size: Not explicitly stated. The document refers to "non-clinical laboratory testing and engineering evaluations," which implies various test samples were used for each type of mechanical and material test.
• Data Provenance: The testing was "non-clinical laboratory testing and engineering evaluations," which suggests the data was generated in a controlled laboratory environment (likely in the US, given the FDA submission). It is considered prospective testing for the purpose of this submission.

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

• Not applicable. This submission relies on engineering and laboratory testing for substantial equivalence, not clinical data or expert interpretation of clinical outcomes. Ground truth in this context refers to established engineering and material science standards.

4. Adjudication Method for the Test Set

• Not applicable. This was based on objective engineering and material testing against established predicate device performance and standards, not on subjective human assessment requiring adjudication.

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

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical Testing: Clinical testing was not required for this submission." This indicates that the FDA deemed non-clinical, bench testing sufficient for this 510(k) submission, likely because it was an addition of new components to an already cleared system.

6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study

• Not applicable. This is a medical device (external fixation system), not an AI algorithm. Its performance is inherent in its physical and mechanical properties, not in an interpretive algorithm.

7. Type of Ground Truth Used

• Engineering and Material Standards: The "ground truth" for the non-clinical testing was based on established engineering principles, material science standards, and performance characteristics demonstrated by the legally marketed predicate devices (K111786 Hoffmann 3 Modular External Fixation System, K051306 Hoffmann II MRI External Fixation System, K053472 Hoffmann II MRI Components, K001886 Apex Fixation Pins).

8. Sample Size for the Training Set

• Not applicable. This device is not an AI/ML algorithm or software that requires a training set. The "training" for proving substantial equivalence came from the existing knowledge of the predicate devices and established engineering principles.

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

• Not applicable, as there is no training set mentioned or implied for this type of device submission.

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