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Hardware: 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.

Software: 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 instruments and Tornier Perform patient-matched 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.

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

Hardware: The BLUEPRINT ™ Glenoid Guides are patient-specific instruments specially designed to facilitate the implantation of glenoid prostheses. The BLUEPRINT™ Glenoid Guides are designed and manufactured based on a pre-operative plan generated only by the software Blueprint®.

Software: Blueprint® is a software connected to an Online Management System (OMS). The user interface software is installed on a computer 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 components when appropriate.

The provided text is a 510(k) premarket notification for the BLUEPRINT™ Patient Specific Instrumentation, which includes both hardware (Glenoid Guides) and software (Blueprint®). While it describes the device, its intended use, and comparison to predicate devices, it does not contain the detailed performance data or acceptance criteria typically found in a study report.

Therefore, I cannot provide the requested information regarding specific acceptance criteria, reported device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, or MRMC study details. The document states that "Technological differences between the subject and predicate software devices are supported by software verification and validation activities. These activities include functional tests, validation and compatibility for new implant integration, as well as the validation and reproducibility of anatomical measures, planning measures, planning features, and segmentation." However, it does not present the results or specific criteria of these activities.

In the absence of a detailed study report within the provided text, I can only state that the document asserts that:

• Differences in design specifications do not raise different questions of safety and effectiveness over the predicate device as demonstrated in validation testing.
• The subject device, the BLUEPRINT™ Patient Specific Instrumentation, does not raise new questions of safety or effectiveness.
• Differences in technological characteristics have been addressed by software verification and validation activities.

To answer your request, a more detailed study report or validation protocol would be necessary.

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The Tornier Humeral Nail System is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications according to AO classification include Type A-Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact humeral head, or Humeral Fractures according to Neer-Classification (2, 3 and 4 part fractures).

The Tornier Humeral Nail and Tornier Long Humeral Nail include intramedullary nails and screws. The Tornier Humeral Nail is a straight, cannulated intramedullary nail available in 9mm proximal diameter with a tapered 7mm distal diameter with nail lengths of 210mm, 230mm, 250mm, and 270mm long and a tapered 8mm distal diameter with nail lengths of 130mm, 210mm. 230mm. 250mm, and 270mm long. Both distal diameter sizes are available in right and left configurations. The proximal end of the nail contains screw holes in four axes for proximal locking using 5mm cannulated screws. The proximal end of the nail also contains a cannulated polyethylene insert with screw holes aligned with those of the nail. This insert is intended to help prevent the proximal screws from backing out. The distal end of the 130mm nails incorporate two or three screw holes for distal stabilization using 4.3mm screws. The nails and screws are manufactured from anodized titanium alloy. The polyethylene insert is manufactured from ultrahigh molecular weight polyethylene (UHMWPE).

This document is a 510(k) premarket notification for the Tornier Humeral Nail and Tornier Long Humeral Nail. It seeks to establish substantial equivalence to a predicate device.

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

The document does not provide specific acceptance criteria or reported device performance in terms of metrics like sensitivity, specificity, accuracy, or other quantitative measures typically associated with AI/ML device evaluations. The submission focuses on establishing substantial equivalence to a predicate device based on technological characteristics and non-clinical testing for MR compatibility.

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

No test set for an AI/ML component is mentioned.

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

Not applicable, as no AI/ML component requiring ground truth establishment is described.

4. Adjudication method for the test set:

Not applicable, as no AI/ML component requiring a test set or adjudication 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:

Not applicable, as this submission does not involve an AI assist feature for human readers.

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

Not applicable, as this submission does not involve a standalone algorithm for performance evaluation.

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

Not applicable, as no ground truth is required for the evaluation presented in this document.

8. The sample size for the training set:

Not applicable, as this submission does not involve an AI/ML component with a training set.

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

Not applicable, as this submission does not involve an AI/ML component requiring ground truth for a training set.

Summary of Device Evaluation:

The Tornier Humeral Nail and Tornier Long Humeral Nail were evaluated for Magnetic Resonance (MR) compatibility through non-clinical testing. The submission explicitly states:

• "The Tornier Humeral Nail and Tornier Long Humeral Nail has been evaluated in a Magnetic Resonance Environment through non-clinical testing as outlined in the FDA guidance document 'Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment – Guidance for Industry and FDA Staff', dated October 10, 2023."
• "This testing was conducted to characterize the compatibility of the Tornier Humeral Nail System in the MR environment."
• "No clinical studies were performed."

The conclusion is that "The Tornier Humeral Nail System does not raise different questions of safety or effectiveness. Based upon a comparison of the intended use, materials, summary of technological characteristics, and non-clinical evaluation, the subject Tornier Humeral Nail and Tornier Long Humeral Nail is considered substantially equivalent to the current Tornier Humeral Nail and Tornier Humeral Long Nail (cleared as Aequalis Humeral Nail System on K133376)."

This document focuses on regulatory clearance for a medical device (intramedullary fixation rod) by demonstrating substantial equivalence to a predicate device, specifically addressing MR compatibility. It does not involve the evaluation of an AI/ML component or associated criteria like performance metrics for an AI system.

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Blueprint® Mixed Reality system is indicated for use during Total Shoulder Arthroplasty using Stryker's FDA cleared implants that are also implants cleared for pre-operative planning with the Blueprint® Software. Blueprint® Mixed Reality system is intended to allow surgeons to visualize the Blueprint® 3D preoperative planning intra-operatively. Blueprint® Mixed Reality system is also indicated for stereotaxic surgery to guide the placement of a glenoid pin provided that registration between the patient's anatomical landmarks / surfaces can be established on the preoperative CT based plan. Blueprint® Mixed Reality system is to be only used for skeletally matured adult patients.

The Blueprint® Mixed Reality system is used to intraoperatively display stereoscopic threedimensional images of the Blueprint shoulder arthroplasty preoperative plan and to guide and enable the insertion of a pin following the reaming axis aimed at preparing the glenoid fossa surface to facilitate the placement of the implant. The Blueprint Mixed Reality system allows the user to both see the patient in real-time and their internal boney anatomy displayed on seethrough screens of a head-mounted device (goggles).

The Blueprint Mixed Reality system assists surgeons in visualizing stereoscopic threedimensional images of the patient's boney anatomy and intraoperatively aid by guiding the pin during placement through real-time feedback.

The Blueprint Mixed Reality system is composed of three main components including the HOLOBLUEPRINT software, Microsoft® HoloLens 2 Goggles, and Instrumentation.

The Blueprint Mixed Reality system runs the HOLOBLUEPRINT software application on the Microsoft HoloLens 2 using Microsoft Windows Holographic Operating System. The Blueprint Mixed Reality system leverages the reference device by receiving planned glenoid cases as input for visualizing and guiding the placement of the pin during the shoulder arthroplasty procedure. The digital components of the system interface with specialized surgical instrumentation to enable intra-operative guidance through real-time feedback to the surgeon.

The components of the subject device are as follows:

HOLOBLUEPRINT™ Software
HOLOBLUEPRINT is designed and written by Tornier SAS specifically for use on the Microsoft HoloLens 2 goggles (hardware). The HOLOBLUEPRINT software is to be installed on the hardware to be used by the surgeon as part of the Blueprint Mixed Reality system.

HoloLens 2 goggles (HoloLens 2)
The HoloLens 2 is a Microsoft hardware that runs Microsoft Windows 10 Holographic Operating System. HoloLens 2 is a see-through, mixed reality headmounted smart glasses.

Instrumentations (Instruments)
There are four reusable instruments and one single-use (sterile) instrument designed specifically for use with the Blueprint Mixed Reality system (subject device). The subject device system instruments include a Glenoid Pin Guide, Glenoid Digitizer, Instruments Check Block, Coracoid Clamp, and a Depth Stop Pin (Sterile).

The subject device is compatible with all Tornier (Stryker) commercially FDA-cleared glenoid implants (Except Patient Matched Implants) available in the reference device (K211359). The compatibility of implants with the reference device was validated and verification was performed for glenoid guidance and visualization of the patient's boney anatomy.

The provided document is a 510(k) premarket notification for the Blueprint Mixed Reality system. It describes the device's indications for use, technological characteristics, and non-clinical performance evidence to demonstrate substantial equivalence to a predicate device.

Based on the content, here's a description of the acceptance criteria and the study that proves the device meets them:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily focused on the accuracy and repeatability of the system, and that the software performs as per requirements and specifications. The document states that the system was validated through cadaver testing to demonstrate its accuracy and establish performance equivalency to the predicate device.

Study Details:

1. Sample Size and Data Provenance:

   • Test Set Sample Size: The document mentions "cadaver testing" and "simulated use cases" for validation. It does not specify the numerical sample size (e.g., number of cadavers or simulated cases) used for the test set.
   • Data Provenance: The document does not explicitly state the country of origin of the data. The company is based in France, but the testing locations are not specified. The studies were non-clinical, involving cadavers and simulated use. It is a prospective study in the sense that the testing was performed specifically to evaluate this device.

2. Number of Experts and Qualifications:

   • The document does not provide details on the number of experts used or their specific qualifications (e.g., "radiologist with 10 years of experience") for establishing ground truth or evaluating performance. The testing involved "cadaver testing" and "simulated use cases," implying technical personnel or surgeons would be involved in assessing accuracy, but their roles and expertise are not elaborated upon.

3. Adjudication Method for the Test Set:

   • The document does not specify an adjudication method (e.g., 2+1, 3+1) for the test set. Given it's a technical accuracy and performance study on a medical device system, it's more likely that technical measurements and predefined tolerance limits were used for "ground truth" rather than subjective expert consensus requiring adjudication.

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

   • No, an MRMC comparative effectiveness study was not explicitly done. The document states, "Clinical testing was not deemed necessary for the determination of substantial equivalence." The evaluation was based on non-clinical performance evidence (bench testing, system accuracy validation through cadaver testing, functional and performance testing, software verification/validation). Therefore, there is no reported effect size of how much human readers improve with AI vs. without AI assistance.

5. Standalone (Algorithm Only) Performance:

   • Yes, a form of standalone performance was assessed. The "Bench Testing conducted to demonstrate the HOLOBLUEPRINT™ software performs as per the systems requirements and specifications" can be considered an assessment of the algorithm's performance in isolation from the full human-in-the-loop use case, focusing on its computational accuracy and adherence to specifications. The "System Accuracy Validation... through cadaver testing" also evaluates the system's (including the software) ability to provide accurate guidance measurements, independent of a specific surgeon's subjective interpretation (though a surgeon would utilize the output).

6. Type of Ground Truth Used:

   • The ground truth for the accuracy studies (cadaver testing) would likely be established through highly precise measurements using a gold-standard reference system (e.g., coordinate measuring machine, highly accurate optical tracking system, or direct physical measurements) to verify the device's reported position and orientation accuracy against the true anatomical features. For software performance, the ground truth would be defined by the pre-defined system requirements and specifications.

7. Training Set Sample Size:

   • This document describes the validation of a medical device system, not specifically a machine learning model where a distinct "training set" for an AI algorithm would be relevant. While the system incorporates "HOLOBLUEPRINT™ Software," the text does not indicate that this software is an adaptive AI model requiring a separate training phase with a specific data set size. Therefore, no sample size for a training set is provided or implied.

8. How Ground Truth for Training Set was Established:

   • Given that the document does not describe the use of an adaptive AI model with a training set, the concept of establishing ground truth for a training set is not applicable here. The software validation is against pre-defined specifications and requirements, not against an annotated training dataset for learning.

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The Tornier Pyrocarbon Humeral Head associated with the Tornier Flex Stem is indicated for use as a replacement of deficient humeral heads disabled by:

• Non-inflammatory degenerative joint diseases (osteoarthritis, avascular necrosis) .
• . Traumatic arthritis.

The Tornier Pyrocarbon Humeral Head Shoulder Prosthesis, combined with the Tornier Flex Humeral Stem, are to be used only in patients with an intact or reconstructable rotator cuff and if the native glenoid surface is intact or sufficient, where they are intended to increase mobility, stability, and relieve pain.

Note: The coated humeral stem is intended for cementless use. The noncoated humeral stem is for cemented use only

The Tornier Pyrocarbon Humeral Head is a prescription use device that is comprised of the pyrolytic carbon (pyrocarbon) articulating surface and a cobalt chromium alloy double taper neck. The humeral head is provided pre-assembled to the double taper to the end user and is compacted onto 510(k) cleared compatible humeral stems (K151293) for replacement of deficient humeral heads disabled by noninflammatory arthritis, or traumatic arthritis. The pyrocarbon articulating surface is made of a graphite substrate core, coated with a layer of pyrolytic carbon deposited onto the substrate via chemical vapor deposition. The pvrocarbon articulating surface is pressed into the cobalt chromium alloy double taper neck during the manufacturing process, is provided as a singular construct to the end user, and is not intended to be disassembled by the end user. Compatible monoblock humeral stems are available in titanium plasma spray coated or uncoated versions. The humeral stems are designed with a female taper connection to accept the mating male taper connection of the pyrocarbon humeral heads.

The provided text describes the acceptance criteria and a clinical study that proves the Tornier Pyrocarbon Humeral Head device meets these criteria. However, it does not detail a study involving AI or human readers for diagnostic image analysis. Instead, the "study" referenced is a clinical trial evaluating the safety and effectiveness of a medical implant.

Therefore, many of the requested points related to AI model evaluation, such as "number of experts used to establish ground truth," "adjudication method," and "MRMC comparative effectiveness study," are not applicable to this document's content.

I will provide the information that is available in the document regarding the acceptance criteria and the clinical study of the implant.

Acceptance Criteria and Device Performance for Tornier Pyrocarbon Humeral Head (Hemiarthroplasty Implant)

The acceptance criteria for this medical device are primarily defined through bench testing (non-clinical performance) and clinical study endpoints (safety and effectiveness in patients).

1. Table of Acceptance Criteria and Reported Device Performance

A. Bench Testing (Non-Clinical Mechanical Performance)

B. Clinical Performance (Primary Endpoint for Clinical Success at 24 Months)

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

• Sample Size (Test Set):
  • Pyrocarbon (Investigational) Group: 157 subjects enrolled.
  • Control Group: 169 subjects selected after Propensity Score (PS) matching from a historical dataset.
• Data Provenance:
  • Pyrocarbon Group: Prospective, multi-center, single-arm investigational study (IDE G140202 - Pyrocarbon IDE Study). Data collected from 18 sites within the US.
  • Control Group: Retrospective, derived from the Aequalis Post-Market Outcomes Study dataset. The exact country of origin for the Aequalis dataset is not explicitly stated, but given context with US-based clinical trials, it is likely also primarily US data or from similar western healthcare systems.

3. Number of Experts and Qualifications for Ground Truth

This question is not applicable as the document describes a clinical trial for a medical implant, not an AI model requiring human expert labeling of data. The "ground truth" for the clinical study is the patient's actual clinical outcome, measured through direct observation (e.g., revision surgery, radiographic findings) and patient-reported outcomes (e.g., Constant score changes).

4. Adjudication Method for the Test Set

This question is not applicable in the context of diagnostic performance evaluation for an AI model. For the clinical study of the implant:

• The primary endpoint was a composite outcome, objectively defined.
• "Unanticipated Adverse Device Effects" were determined by an independent medical monitor.
• Clinical data collection and evaluation would have followed standard clinical trial protocols, typically involving investigators at sites and a data monitoring committee. Explicit "adjudication" in the sense of resolving disagreements among multiple human readers of image data is not relevant here.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is specific to evaluating the diagnostic performance of AI or other tools when used by human readers (e.g., radiologists interpreting images). The study described is a clinical trial comparing a new implant to a historical control.

6. If a Standalone (Algorithm Only) Performance Study was done

No, this question is not applicable as the document is about a physical medical implant, not an AI algorithm. Its "standalone performance" is demonstrated through bench testing (mechanical performance, biocompatibility, sterility) rather than diagnostic accuracy.

7. The Type of Ground Truth Used

For the clinical study:

• Clinical Outcomes Data: This includes hard endpoints such as occurrence of revision surgery, radiographic evidence of system disassembly or fracture, and presence of system-related serious adverse events.
• Patient-Reported Outcomes (PROs): These are quantitative measures of patient experience and function, such as the Constant score, ASES score, SANE, EQ-5D, and VAS pain scale. Improvement in these scores contributes to the definition of "success."

For the bench testing:

• Direct Measurement/Observation: Mechanical properties are empirically measured (e.g., force to cause disassembly, visual inspection for cracks, measured ROM).
• Comparative Data: For some tests without absolute acceptance criteria (e.g., taper disassembly, fretting/corrosion, third-body wear), performance was compared to another cleared humeral head with the same intended use.

8. The Sample Size for the Training Set

This question is not applicable as the document describes a physical medical device (implant) and its clinical evaluation, not an AI model that requires a "training set" of data in the machine learning sense. The "training" for this device would refer to its manufacturing process and quality control, and the "data" is the clinical and bench testing data.

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

This question is not applicable for the reasons stated above.

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In Anatomic:
The Tornier Perform Humeral System - Fracture combined with a 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 Tornier Perform Humeral System - Fracture is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility, stability, and to relieve pain.
The Tornier Perform Humeral System - Fracture is indicated for use as a replacement of shoulder joints disabled by: • Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral head fracture and displaced 3-or 4-part proximal humeral fractures
· Fracture sequelae

• Revisions where adequate fixation can be achieved and adequate bone stock remains after final reconstruction
  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 without a suspected material sensitivity to cobalt alloy.
  All components are single use. The fracture stems are intended for cementless use. In cementless use, the fracture stems are intended for use with or without cortical screws. In a total shoulder arthroplasty, the Tornier Perform Humeral System - Fracture is intended to be used with cemented polyethylene glenoid components.

In Reverse:
The Tornier Perform Humeral System - Fracture combined with a reverse insert is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle, grossly deficient rotator cuff, and pain disabled by: • Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint, including humeral head fracture and displaced 3-or 4-part proximal humeral fractures
• Proximal humerus bone defect
· Fracture sequelae
• Revisions where adequate fixation can be achieved and adequate bone stock remains after final reconstruction
The reversed insert is indicated for use for the conversion from an anatomic to reverse shoulder prosthesis without the removal of a well fixed fracture stem for patients with a functional deltoid muscle.
All components are single use. The fracture stems are intended for cementless use. In cementless use, the fracture stems are intended for use with or without cortical screws. The Tornier Perform Humeral System – Fracture is intended to be used with glenoid implants that are anchored to the bone with screws for non-cemented fixation.

The Tornier Perform Humeral System – Fracture is a convertible humeral fracture system for anatomic, reverse, and hemiarthroplasty of the shoulder. The system also allows for conversion from an anatomic to a reverse shoulder prosthesis in the case of revision. The Tornier Perform Humeral System - Fracture is implanted with existing Tornier glenoid systems for total anatomic and reverse shoulder arthroplasty.
The Tornier Perform Humeral System – Fracture includes titanium fracture stems, titanium couplers, titanium spacers and titanium screws. The system is compatible with commercially available Perform humeral heads and reversed inserts. The system also includes reusable instruments used to implant the shoulder prosthesis.

This document is a 510(k) premarket notification for a medical device (Tornier Perform Humeral System - Fracture), not a study evaluating an AI device's performance. Therefore, most of the requested information regarding acceptance criteria, study design, ground truth, and sample sizes for AI model training and testing is not applicable.

The document describes the device, its indications for use, and a comparison to predicate devices. It states that no clinical studies were performed to prove the device meets acceptance criteria. Instead, non-clinical performance testing was conducted to demonstrate substantial equivalence to predicate devices.

Here's a breakdown of the information provided in the document as it relates to your request:

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

The document does not provide a formal table of acceptance criteria with corresponding performance metrics for a digital health or AI device. The "performance" described refers to the results of non-clinical engineering tests to demonstrate the device's physical properties and compatibility, rather than clinical efficacy or diagnostic accuracy.

Non-clinical Performance Testing Performed:

• Fatigue testing
• Static taper evaluation
• ASTM F543 screw testing
• Evaluations for compatibility with existing components
• Range of motion analysis
• MRI compatibility evaluation
• Biocompatibility, sterilization, cleaning, endotoxin, packaging, shelf life, and distribution assessments (in accordance with recognized consensus standards).

Reported Device Performance:
The document states: "The results of performance testing for the Tornier Perform Humeral System – Fracture support substantial equivalence to the predicate Aequalis Reversed Fracture Shoulder Prosthesis and Aequalis Shoulder Fracture System (K131231)." This implies that the device performed adequately in these non-clinical tests to be considered comparable to the predicate. Specific quantitative results or acceptance thresholds are not detailed in this summary.

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. No clinical test set. The "testing" referred to是在工程实验室进行的非临床性能测试，而不是对临床数据进行的测试。

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. No clinical test set or ground truth established by experts.

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

Not applicable. No clinical test set.

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 medical implant device, not an AI-assisted diagnostic tool. 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 medical implant device, not an algorithm.

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

Not applicable. No clinical ground truth was established as no clinical studies were performed. The "ground truth" equivalent for this device would be engineering specifications and standards for its physical and material properties.

8. The sample size for the training set

Not applicable. This is a medical implant device, not an AI model requiring a training set.

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

Not applicable. No training set for an AI model.

In summary: The provided document is an FDA 510(k) clearance letter and its associated Indications for Use and Device Description/Comparison. It describes a medical implant device that demonstrated substantial equivalence through non-clinical performance testing, not through clinical trials or the evaluation of an AI-powered diagnostic/therapeutic tool. Therefore, the questions related to AI device performance evaluation are not relevant to this document.

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The nucleus, humeral head coupler and humeral head are used in conjunction with a glenoid implant as a total replacement.

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

• · Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis
• · Post-traumatic arthritis

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 without a suspected material sensitivity to cobalt alloy.

All components are single use and intended for cementless use.

The Tornier Perform Humeral System - Stemless is intended to be used with cemented polyethylene glenoid components, in an anatomic total shoulder arthroplasty.

The Tornier Perform Humeral System - Stemless is metaphyseal humeral system intended for anatomic total shoulder arthroplasty. The Perform Humeral System - Stemless is implanted with existing Tornier anatomic glenoid systems.

The Tornier Perform Humeral System – Stemless includes new titanium nucleus components and previously-cleared modular humeral heads (K201315). The system also includes reusable instruments used to implant the shoulder prosthesis.

The provided document is a 510(k) premarket notification for a medical device, the Tornier Perform Humeral System - Stemless. This type of submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing rather than clinical studies proving acceptance criteria through device performance.

Therefore, the requested information on acceptance criteria and a study proving the device meets those criteria, specifically concerning human performance, is largely not applicable to this document. The document explicitly states: "No clinical studies were performed."

However, I can extract information about the non-clinical testing performed to demonstrate substantial equivalence, which serves a similar purpose in the context of a 510(k) by showing the device performs comparably to an already cleared device.

Here's a breakdown of the available information based on your request:

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

Since no clinical studies were performed to establish performance against pre-defined acceptance criteria in terms of human-in-the-loop performance or diagnostic accuracy, such a table cannot be created from this document. The document focuses on demonstrating substantial equivalence to an existing predicate device through non-clinical performance testing.

The types of "performance" mentioned are related to mechanical and material properties:

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. No "test set" in the context of clinical or AI performance evaluation was used. The testing was non-clinical (laboratory/mechanical).

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

Not applicable. No "ground truth" for a test set based on expert review was established or required for this type of submission focused on mechanical device equivalence.

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

Not applicable. No "test set" requiring adjudication by experts was used.

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 orthopedic implant, not an AI-assisted diagnostic or therapeutic device that would involve human "readers" or AI assistance in that context.

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

Not applicable. This is a mechanical orthopedic implant, not an algorithm or AI.

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

Not applicable. The "ground truth" for the non-clinical tests would have been established engineering specifications, material standards, and performance of the predicate device.

8. The sample size for the training set:

Not applicable. This is a mechanical orthopedic implant, not an AI or algorithm that requires a training set.

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

Not applicable.

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Tornier Perform™ Patient-Matched Primary Reversed Glenoid: The Tornier Perform™ Patient-Matched 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 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 Patient-Matched Glenoid implant is anchored to the bone with screws and is for non-cemented fixation. Note: A CT Scan is used to create the Tornier Perform Patient-Matched Primary Reversed Glenoid implant.

BLUEPRINT™ Patient Specific Instrumentation:
BLUEPRINT ™ Glenoid Guides: The BLUEPRINT™ Glenoid Guides are intended to be used as surgical instruments 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™ 3D Planning Software: BLUEPRINT™ 3D Planning Software is a medical device for surgeons. BLUEPRINT™ 3D Planning Software is intended to be used as a pre-surgical planner for shoulder replacement surgerv. BLUEPRINT™ 3D Planning Software requires CT scan images showing the anatomical shoulder structure in a DICOM format. BLUEPRINT™ 3D Planning Software allows surgeons to visualize, measure, reconstruct, and annotate anatomic data. BLUEPRINT™ 3D Planning Software allows surgeons to design patient specific components (Patient-Specific instruments and Tornier Perform™ Patient-Matched Primary Reversed Glenoid*) based on the pre-surgical plan. BLUEPRINT™ 3D Planning Software leads to the generation of a planning report. BLUEPRINT™ 3D Planning Software 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 Tornier Perform™ Patient-Matched Primary Reversed Glenoid are available in your geography.

Tornier Perform™ Patient-Matched Primary Reversed Glenoid: The Tornier Perform™ Patient-Matched Primary Reversed Glenoid implant (Patient-Matched Glenoid) 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.

BLUEPRINT™ Patient Specific Instrumentation: BLUEPRINT™ Patient Specific Instrumentation is composed of two components: BLUEPRINT™ Glenoid Guides (hardware) and BLUEPRINT™ 3D Planning Software (software). BLUEPRINT™ Patient Specific Instrumentation which includes the BLUEPRINT™ Glenoid Guides and BLUEPRINT™ 3D Planning Software is the responsibility of Tornier is the legal manufacturer for the hardware and the software.
BLUEPRINT ™ Glenoid Guides: The BLUEPRINT ™ Glenoid Guides are patient-specially designed to facilitate the implantation of WRIGHT-TORNIER glenoid prostheses. The BLUEPRINT™ Glenoid Guides are designed and manufactured based on a pre-operative plan generated only by the software BLUEPRINT™ 3D Planning Software.
BLUEPRINT™ 3D Planning Software: BLUEPRINT™ 3D Planning Software is a software connected to an Online Management System (OMS). The user interface software is installed on a computer 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.

This document, K211359, is a 510(k) premarket notification for the Tornier Perform™ Patient-Matched Primary Reversed Glenoid (implant) and BLUEPRINT™ Patient Specific Instrumentation (hardware and software). The core of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving absolute safety and effectiveness through clinical trials. As such, the information provided focuses on non-clinical performance and verification/validation, largely relying on the predicate device's established safety and effectiveness.

Therefore, the following information, which typically applies to AI/software as a medical device (SaMD) clearances involving complex algorithms and clinical performance studies, is largely not present in this 510(k) summary. The provided text explicitly states that "No clinical studies were performed." This indicates that the device's performance was not evaluated through a study comparing it to an established ground truth in the way a traditional AI/SaMD clinical study would.

Here is a breakdown based on the provided document and the limitations:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes non-clinical performance testing for both the implant and the instrumentation. These are engineering/material specifications rather than clinical performance metrics for an AI algorithm.

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

• Test Set Sample Size: Not applicable in the context of a clinical performance test for an AI algorithm. The tests described are non-clinical engineering/materials tests (e.g., pullout, fatigue). For the software, "verification and validation evaluations" were performed, but no specific number of cases or data provenance is detailed, as it's a conformity assessment to the predicate's operating principle.
• Data Provenance: Not applicable for an AI algorithm evaluation in this context. The document mentions "cadaveric test performed on the subject device" for the hardware, which would be test data, but not a "test set" in the sense of clinical images for an AI.

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

• Not applicable as no clinical study or AI algorithm evaluation with human expert ground truth was performed.

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

• Not applicable as no clinical study or AI algorithm evaluation with adjudicated ground truth was performed.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical studies were performed." Therefore, there is no effect size on human reader improvement with AI assistance.

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

• For the BLUEPRINT™ 3D Planning Software, "verification and validation evaluations" were performed. While these evaluations assess the algorithm's functionality, they are not presented as a standalone performance study in a clinical context (e.g., measuring diagnostic accuracy against a ground truth dataset). The software is a planning tool, not a diagnostic AI.

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

• For the non-clinical tests (implant): Engineering specifications, material properties, and established consensus standards serve as the "ground truth" for the physical device's performance.
• For the software: The ground truth would be the accuracy and correctness of the planning outputs and measurements generated by the software, compared to expected or designed values. This is typically assessed through software verification and validation against a golden standard or internal reference data, not clinical ground truth like pathology or outcomes.

8. The sample size for the training set:

• Not applicable, as this is a 510(k) for an orthopedic implant and a planning software, not a deep learning AI model that requires a "training set" in the same sense. The software's design and programming are based on established anatomical and biomechanical principles.

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

• Not applicable, as no external "training set" with established ground truth, typical for AI model development, is mentioned.

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The Tornier Perform Reversed Glenospheres are 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 the devices if sufficient bone stock remains

Notes:

• · All components are single use.
• The glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation.

The Tornier Perform™ Reversed Glenoid Cannulated Glenospheres are part of a reverse shoulder prosthesis consisting of cannulated cobalt chromium and titanium alloy glenospheres. The Tornier Perform Reversed Glenoid Cannulated Glenospheres are intended for replacement of the shoulder joint to reduce pain and improve shoulder mobility in comparison with preoperative status.

The Tornier Perform Reversed Glenoid Cannulated Glenospheres must be used in association with a compatible Tornier reversed glenoid and humeral component. The cannulated glenosphere can be used as part of the glenoid implant. The glenoid implant is composed of a baseplate with central and peripheral anchoring screws and a glenosphere. An optional press-fit post is available that can be used in lieu of the central anchoring screw.

Ancillary instruments are also provided for the implantation of the prosthesis.

The provided text describes a 510(k) premarket notification for a medical device, the Tornier Perform™ Reversed Glenoid Cannulated Glenospheres. This document does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of an AI/ML powered device.

The document states:

• "Non-clinical bench testing and process validations were performed to demonstrate substantial equivalence to the predicate device."
• "No clinical studies were performed."

Therefore, there is no information available in the provided text to answer the specific questions about acceptance criteria for an AI/ML device, performance studies, sample sizes, expert involvement, or ground truth establishment. The document describes mechanical bench testing (Glenosphere Loosening, Taper Disassembly, Glenosphere Fatigue) and simulated use to demonstrate substantial equivalence to a legally marketed predicate device, K161742.

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Hardware: 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.

Software: BLUEPRINT™ 3D Planning Software is a medical device for surgeons. BLUEPRINT™ 3D Planning Software is intended to be used as a pre-surgical planner for shoulder orthopedic surgery. BLUEPRINT™ 3D Planning Software requires CT scan images showing the anatomical shoulder structure in a DICOM format. BLUEPRINT™ 3D Planning Software allows surgeons to visualize, measure, reconstruct, and annotate anatomic data. BLUEPRINT™ 3D Planning Software allows surgeons to design patient specific guides based on the pre-surgical plan. BLUEPRINT™ 3D Planning Software leads to the generation of a planning report. BLUEPRINT™ 3D Planning Software is to be used for adult men and women only whose bone maturity is reached and should not be used for diagnostic purpose.

BLUEPRINT™ Patient Specific Instrumentation is composed of two components: BLUEPRINT™ Glenoid Guides (hardware) and BLUEPRINT™ 3D Planning Software (software).

Hardware: The BLUEPRINT IM Glenoid Guides are patient-specific instruments specially designed to facilitate the implantation of WRIGHT-TORNIER glenoid prostheses. The BLUEPRINT™ Glenoid Guides are designed and manufactured based on a pre-operative plan generated only by the software BLUEPRINT™ 3D Planning Software.

Software: BLUEPRINT™ 3D Planning Software is a software connected to an Online Management System (OMS). The user interface software is installed on a computer 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, Design a patient specific guide for the glenoid component when appropriate.

The provided text does not contain information about the acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) premarket notification letter from the FDA to Tornier SAS, indicating clearance for their BLUEPRINT™ Patient Specific Instrumentation.

It describes the device, its intended use, comparison to predicate devices, and a general statement about performance data and verification/validation testing. However, it does not detail:

1. Specific acceptance criteria values.
2. Reported device performance metrics.
3. Sample sizes for test or training sets.
4. Data provenance.
5. Number or qualifications of experts.
6. Adjudication methods.
7. MRMC study results or effect sizes.
8. Standalone algorithm performance.
9. Type of ground truth or how it was established for training/test sets.

The text states: "Technological differences between the subject and predicate software devices are supported with verification and validation evaluations. The operating principle of the subject device is the same as that of the predicate device." and "The differences in design specifications do not raise new questions of safety and effectiveness over the predicate device as demonstrated in validation testing." These are general statements about the testing performed, but no specific study details are provided.

Therefore, I cannot fulfill your request for the detailed table and study information based solely on the provided text.

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