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

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

• Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis .
• Correction of functional deformity
• Post-traumatic arthritis 0
• o Revisions or fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains

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 humeral stems are intended for cementless use.

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

In Reverse:
The PERFORM™ Humeral System - Stem is indicated for use as a replacement of a shoulder joint for patients with a functional deltoid muscle, grossly deficient rotator cuff, and pain disabled by one or more of the following:

• o Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis
• Pseudoparalysis or anterior superior escape ●
• Rotator cuff tear arthropathy
• Correction of functional deformity
• Post-traumatic arthritis
• o Revisions or fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains

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

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

The PERFORM Humeral System - Stem is an inlay convertible humeral system intended for anatomic, reverse, and hemiarthroplasty of the shoulder system also allows for conversion from an anatomic to a reverse shoulder prosthesis in the case of revision. The PERFORM Humeral System - Stem is implanted with existing Tornier glenoid systems for total anatomic and reverse shoulder arthroplasty.

The PERFORM Humeral System – Stem includes titanium humeral stems, cobalt chrome and titanium humeral heads, titanium humeral head couplers, conventional and Vitamin E UHMWPE reversed inserts, and titanium humeral spacers. The system also includes reusable instruments used to implant the shoulder prosthesis.

This FDA 510(k) summary describes the Tornier PERFORM™ Humeral System - Stem, a shoulder prosthesis. The document does not describe an AI/ML powered device, therefore, the requested information cannot be fully provided.

However, based on the provided text, here is what can be extracted regarding the device (a physical medical implant) and its non-clinical performance testing:

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

The document does not provide a table with specific quantitative acceptance criteria or reported device performance values in a comparative format. Instead, it lists the types of non-clinical performance testing conducted to support substantial equivalence to a predicate device.

The following information cannot be determined from the provided text as it pertains to AI/ML or clinical studies, neither of which are described for this conventional medical device.

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

• This information is not applicable as no clinical or AI/ML-related test set is described. The document refers to non-clinical testing of the physical device.

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 as this is not an AI/ML device and no expert-based ground truth for a test set is described.

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

• Not applicable as no AI/ML test set is described.

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

• No MRMC study was done, as this is a physical implant and not an AI/ML-assisted diagnostic device. The document explicitly states: "No clinical studies were performed."

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

• Not applicable, as this is a physical medical device and not an algorithm.

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

• Not applicable, as this is a physical medical device and not an AI/ML model requiring ground truth for performance evaluation in the context of diagnostic or predictive tasks. The "ground truth" for the non-clinical tests would be the specific pass/fail criteria defined by the relevant ASTM/ISO standards.

8. The sample size for the training set

• Not applicable, as this device does not involve a training set for an AI/ML algorithm.

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

• Not applicable, for the same reasons as point 8.

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

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

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

IN REVERSE:
The AEQUALIS™ FLEX REVIVE™ Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle with pain disabled by:

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

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

AEQUALIS™ FLEX REVIVE™ Shoulder System (AFR) is a fully convertible anatomic and reversed shoulder arthroplasty system that is designed to be used with existing Tornier implant systems. It is a non-constrained system intended for total or partial replacement of the glenohumeral articulation. AFR includes a proximal body (metaphysis), a stem, assembly screw, and locking cap. The proximal body has a female taper that is compatible with Ascend Flex Humeral Head and Ascend Flex reversed trays and poly inserts.

The AFR Shoulder System is implanted by a surgeon and is designed to allow the surgeon to select the components to size the shoulder system for the patient. It allows the shoulder to be constructed in an anatomical or reversed configuration using cleared Flex humeral heads or Ascend Flex reversed trays and inserts. In addition, the AFR Shoulder System can be transformed from anatomic to reverse shoulder prosthesis without the removal of the humeral implant assembly during revision surgery.

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

The proximal body, stem, and spacers are made from Ti6A14V per ASTM F-136. The proximal body and stem have a Titanium plasma spray coating. The assembly screw and locking cap are made of CoCr per ISO 5832-12. All implant parts are single use and packaged sterile, using gamma radiation at a minimum dose of 25 kGy to an SAL of 1x10-6.

The provided text describes a 510(k) premarket notification for a medical device, the AEQUALIS™ FLEX REVIVE™ Shoulder System. This document focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo study or a clinical trial to establish the device's performance against specific acceptance criteria for diagnostic output.

Therefore, the information requested in your prompt regarding acceptance criteria, performance studies, sample sizes, expert involvement, and ground truth establishment, which are typical for studies evaluating the performance of an AI/diagnostic device, is not applicable to this document.

Here's why and what information can be extracted from the document:

• Type of Device: The AEQUALIS™ FLEX REVIVE™ Shoulder System is a shoulder joint prosthesis, not a diagnostic device, AI software, or a device that produces a measurable output requiring a performance study against specific acceptance criteria like sensitivity, specificity, or accuracy.
• Regulatory Pathway: The document is a 510(k) submission, which aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves performance bench testing, biocompatibility, and sometimes design verification, but rarely requires large-scale clinical studies proving diagnostic or AI performance with clearly defined acceptance criteria in the way you've described.
• "Non-clinical Performance Testing" Section: This section explicitly states the types of tests performed:
  • Packaging Validation Testing
  • Biocompatibility Evaluation
  • Press-Fit Analysis
  • Simulated Use Test
    These are engineering, material, and mechanical tests, not diagnostic performance evaluations.
• "Clinical Testing" Section: This section explicitly states: "No clinical studies were performed." This is crucial as it directly answers point 5 and 6 of your prompt, indicating that no studies were done to assess human reader improvement with AI or standalone algorithm performance.

Based on the provided text, none of the specific details about acceptance criteria for AI/diagnostic performance studies, sample sizes for those studies, expert involvement, adjudication methods, MRMC studies, or specific ground truth for such studies can be extracted because they are not relevant to this type of device submission.

However, if we interpret "acceptance criteria" broadly in the context of this 510(k) submission, it refers to passing the non-clinical performance tests and demonstrating substantial equivalence to the predicate device.

Information that can be extracted or inferred from the document related to its regulatory acceptance is presented below, though it does not align with your specific questions about AI/diagnostic performance studies.

Acceptance Criteria and Device Performance (in the context of a 510(k) for a prosthesis):

Study Details (as they pertain to this 510(k) submission, not an AI/diagnostic study):

1. Sample sizes used for the test set and the data provenance: Not applicable in the context of AI/diagnostic performance. The document describes "non-clinical bench testing" and "process validations" for which specific sample sizes (e.g., number of components tested for strength, wear, etc.) are performed but not detailed in this summary document. There is no "test set" of patient data for diagnostic performance.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is an implant, not a diagnostic tool requiring expert interpretation of images or data for ground truth.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There is no "test set" of patient cases or diagnostic interpretations for adjudication.
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: No MRMC study was done. The document explicitly states: "No clinical studies were performed." This is not an AI-assisted diagnostic device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone algorithmic performance study was done. This is not an AI/algorithmic device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for an AI/diagnostic context. For the device itself, the "ground truth" for its performance would be engineering specifications, material standards, and mechanical test results (e.g., passing pre-defined load limits, wear rates, etc.).
7. The sample size for the training set: Not applicable. This device does not use a training set for an AI model.
8. How the ground truth for the training set was established: Not applicable. This device does not have a training set.

In summary, the provided document is a regulatory communication for a medical device (a shoulder prosthesis) seeking 510(k) clearance based on substantial equivalence, not a study evaluating the performance of an AI or diagnostic device against specific clinical or imaging acceptance criteria.

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The Aequalis™ PerFORM™ Reversed Glenoid and Aequalis™ PerFORM™+ Reversed Glenoid are indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle 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

The Aequalis™ PerFORM™ Reversed Glenoid and Aequalis™ PerFORM™+ Reversed Glenoid shoulder system is a modular system consisting of a Glenoid Component Assembly and a Humeral Component Assembly for total shoulder arthroplasty. The associated shoulder surgical instruments are intended to facilitate proper implantation of this shoulder system. The Aequalis™ PerFORM™ Reversed Glenoid and Aequalis™ PerFORM™+ Reversed Glenoid shoulder system is designed and indicated for replacement of the shoulder joint to reduce pain and improve shoulder mobility in comparison with preoperative status.

Unfortunately, I cannot fulfill your request to provide a detailed table of acceptance criteria and reported device performance, information about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set details.

The provided document is a 510(k) summary from the FDA for a medical device (Aequalis™ PerFORM™ Reversed Glenoid and Aequalis™ PerFORM™+ Reversed Glenoid). While it states that non-clinical bench testing and process validations were performed to demonstrate substantial equivalence, it does not include the detailed acceptance criteria or the specific results of these tests.

The document merely states that:

• "The addition of a short Press-fit Post to the Aequalis™ PerFORM™ Reversed Glenoid and Aequalis™ PerFORM™+ Reversed Glenoid shoulder system meets the device testing acceptance criteria described in the predicate submission (K161742), and is substantially equivalent to predicate long Press-fit Post."
• "Both the short and the long Press-fit Posts can be configured with the Half-Wedge Augment Baseplate and Full-Wedge Augment Baseplate. These configurations meet the appropriate acceptance criteria."

This document focuses on the regulatory clearance process based on substantial equivalence to a predicate device (K161742), rather than a detailed report of the performance study itself. It explicitly states that "Clinical studies were not required to demonstrate substantial equivalence between the subject device and the predicate device."

To obtain the information you're looking for, you would typically need to review the full 510(k) submission (which is much more extensive than this summary) or potentially the predicate device's submission (K161742) if the acceptance criteria are indeed described there.

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IN ANATOMIC:

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

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

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

IN REVERSE:

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

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

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

Notes:

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

AEQUALIS FLEX REVIVE Shoulder System (AFR) is a fully convertible anatomic and reversed shoulder arthroplasty system that is designed to be used with existing Tornier implant systems. It is a non-constrained system intended for total or partial replacement of the glenohumeral articulation. AFR includes a proximal body (metaphysis), spacer(s), a stem, assembly screw, and locking cap. The proximal body has a female taper that is compatible with Ascend Flex Humeral Head and Ascend Flex reversed trays and poly inserts.

The AFR Shoulder System is implanted by a surgeon and is designed to allow the surgeon to select the components to size the shoulder system for the patient. It allows the shoulder to be constructed in an anatomical or reversed configuration using cleared Ascend Flex humeral heads or Ascend Flex reversed trays and inserts. In addition, the AFR Shoulder System can be transformed from anatomic to reverse shoulder prosthesis without the removal of the humeral implant assembly during revision surgery.

The humeral length is measured to determine the overall humeral implant construct length. The length is assembled from 120 mm (using the short proximal body and stem) to 180 mm (using the standard proximal body, spacers, and stem) in 10mm increments with the spacers as needed and either of the two available lengths of the proximal body for patient specificity.

The proximal body, stem, and spacers are made from Ti6Al4V per ASTM F-136. The proximal body and stem have a Titanium plasma coating. The assembly screw and locking cap are made from of CoCr per ISO 5832-121. They are single use and packaged sterile, using gamma radiation at a minimum dose of 25 KGy to an SAL of 1x10-6.

The provided text describes the AEQUALIS FLEX REVIVE Shoulder System, a medical device, and summarizes the non-clinical performance testing conducted to support its substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document summarizes non-clinical performance testing which typically involves bench testing of mechanical properties and material characteristics, not clinical studies with patient data. Therefore, the concepts of "test set sample size" and "data provenance (e.g., country of origin, retrospective/prospective)" as they relate to clinical data are not applicable here. The tests are performed on manufactured device components.

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

Not applicable. Ground truth for mechanical and material tests is established by engineering specifications, recognized standards (ASTM, ISO), and analytical methods, not by expert consensus from clinical professionals for individual test cases.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies for reconciling discrepancies in expert opinions on patient data. For non-clinical performance testing, compliance with predetermined acceptance criteria against recognized standards is the primary method of evaluation.

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 submission for a shoulder implant system, not an AI-powered diagnostic or assistive device for human readers.

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

Not applicable. This is a physical medical device (shoulder implant), not an algorithm or AI system.

7. The Type of Ground Truth Used:

The ground truth for the non-clinical performance testing and acceptance criteria is based on:

• Recognized Industry Standards: ASTM (e.g., F1378-12, D4169-16), ISO (e.g., 10993-1, 5832-121).
• Internal Engineering Specifications: Derived from device design, intended use, and comparison to predicate devices (e.g., specific torque values, cement mantle thickness targets).
• Comparative Analysis to Predicate Devices: Demonstrating that the new device's performance is not significantly inferior to that of a legally marketed predicate device.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not a machine learning model, so there is no training set in the AI sense. The "training" for the device's design and manufacturing would involve engineering principles, materials science, and previous product development experience.

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

Not applicable. See point 8.

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