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Hemiarthroplasty/Conventional Total Application:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• Rheumatoid arthritis.
• Correction of functional deformity.
• Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
• Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.

Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.

Reverse Application:
Identity Revision Humeral Stem products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

The Identity Revision Humeral Stem is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component or reverse components for total shoulder arthroplasty (conventional or reverse applications). The humeral components may be used cemented or uncemented (biological fixation).

The Identity Revision Humeral Stems are comprised of titanium alloy. The diameters of the stems range in 1mm increments from 4mm to 18mm in a revision length of 133-134mm. The stem is designed with a distal portion that is cylindrical in shape with a tapered and a proximal portion that is flared, eight-sided shape. The devices have a machine finish distally and a plasma-spray titanium porous coating proximally. To support placement and bone reconstruction in fracture cases, the Identity Revision Humeral Stems feature proximal suture holes as well as etch lines for stem length respect to the native humeral head. The humeral stems employ an oval reverse taper which allows the attachment of either an Identity Humeral Stem Adapter for hemi- and anatomic total shoulder applications or an Identity Humeral Tray for reverse shoulder applications.

I apologize, but the provided FDA 510(k) clearance letter for the "Identity Revision Humeral Stems" does not contain any information about acceptance criteria or a study that proves the device meets those criteria for software-related performance.

This document is for a medical device (humeral stems, which are a type of orthopedic implant) and focuses on the mechanical, material, and design aspects of the device, comparing it to predicate devices to establish substantial equivalence.

Specifically, the "Non-Clinical and/or Clinical Tests Summary & Conclusions" section lists:

• Fatigue Testing
• Range of Motion Analysis
• Magnetic Resonance Imaging (MRI)

It explicitly states: "No animal or clinical testing provided." This reinforces that the clearance is based on bench testing and comparison to existing devices, not on a human-in-the-loop study involving AI or a comprehensive performance study as you've described in your request.

Therefore, I cannot fulfill your request for information regarding:

1. A table of acceptance criteria and reported device performance (for AI-related metrics).
2. Sample sizes for test sets or data provenance.
3. Number of experts, qualifications, or adjudication methods for ground truth establishment.
4. MRMC studies, effect sizes, or standalone algorithm performance.
5. Type of ground truth used (expert consensus, pathology, outcomes data).
6. Sample size for the training set or how its ground truth was established.

This document pertains to a physical orthopedic implant, not a software or AI-driven diagnostic/therapeutic device that would typically involve the types of studies and acceptance criteria you've asked about.

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Hemiarthoplasty/Conventional Total Application:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• Rheumatoid arthritis.
• Correction of functional deformity.
• Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
• Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.

Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.

Reverse Application:

Zimmer Biomet Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants, and a functional deltoid muscle is necessary.

The Zimmer Biomet Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component or reverse components for total shoulder arthroplasty (conventional or reverse applications). The humeral components may be used cemented or uncemented (biological fixation).

The Titanium Humeral Head and Glenosphere components are indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head or Glenospheres not recommended for patients who lack suspected material sensitivity to cobalt alloy.

Comprehensive Nano Stemless Shoulder System

1. Primary total shoulder arthroplasty.
2. Non-inflammatory degenerative joint disease including

Comprehensive Nano Stemless Shoulder humeral components have a porous coated surface coating and are indicated for uncemented biological fixation applications.

The Comprehensive Modular Hybrid Glenoid is intended to be implanted with bone cement. The porous titanium peg may be inserted without bone cement.

The Identity Shoulder System is previously cleared (K213856/K240876) as a comprehensive collection of components designed with the intention of providing the modularity and adaptability necessary to facilitate individual anatomical adjustment and restoration of the glenohumeral joint during shoulder arthroplasty. The Identity Shoulder System is cleared for hemi-arthroplasty and conventional total shoulder replacement in both the anatomic and reverse configurations. The current submission is for the anatomic configuration.

The subject Comprehensive Humeral Head Adapter (CHHA) is a line extension to the Identity Shoulder System (K213856) cleared for the hemi-arthroplasty configuration and anatomic Total Shoulder Configuration.

The new CHHA (PN SAHHA002) allows additional compatibility with the previously cleared Identity Humeral Heads (K213856) and the Comprehensive humeral components, excluding fracture stems, as noted below:

• Comprehensive Humeral Stems (K193038); and
• Comprehensive Nano Stemless shoulder component (K182516).

Based on the provided FDA 510(k) clearance letter for the "Identity Shoulder System" (K250848), here's an analysis of the acceptance criteria and the study that proves the device meets them:

Crucial Observation: The provided document is a 510(k) clearance letter for a medical device that does not appear to be software or an AI/ML enabled device. It is for an orthopedic implant (shoulder system). Therefore, several of the requested points related to AI/ML (e.g., sample size for training set, number of experts for ground truth, MRMC studies, standalone algorithm performance) are not applicable to this type of traditional medical device submission.

The "acceptance criteria" for this device are generally based on non-clinical performance testing to demonstrate the device's physical and mechanical properties meet established standards and are substantially equivalent to predicate devices. There are no "reported device performance" metrics in the sense of clinical performance (like sensitivity/specificity for AI, diagnostic accuracy, etc.) because it's a physical implant, not a diagnostic or AI-driven system.

Acceptance Criteria and Study Details (Based on the provided document)

Since the document provided is for a physical orthopedic implant, the "acceptance criteria" and "study" are interpreted in the context of demonstrating substantial equivalence for a traditional medical device, primarily through non-clinical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

Note: For traditional orthopedic implants, specific numerical values for acceptance criteria and device performance (e.g., "Fatigue life > X cycles at Y load") are typically contained within the full 510(k) submission and are not usually detailed in the public clearance letter. The letter only states that these verifications were "successfully performed" and support the conclusion of substantial equivalence.

AI/ML Specific Questions (Answered as "Not Applicable" for this device)

Given that this is a 510(k) for a physical orthopedic implant and not an AI/ML device, the following points are not applicable (N/A):

2. Sample sizes used for the test set and the data provenance: N/A. This device does not have a "test set" of patient data in the typical sense for AI/ML validation involving images or clinical parameters. Its evaluation involves mechanical testing of physical samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. Ground truth establishment by experts for clinical data is not relevant for this device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A. This applies to review of clinical data, not mechanical testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: N/A. MRMC studies are for evaluating human reader performance, typically with diagnostic images, in conjunction with AI. This is not a diagnostic or AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A. The "ground truth" for this device's performance is derived from standardized mechanical testing methods and compliance with material specifications.
8. The sample size for the training set: N/A. This device does not use a "training set" as it's not an AI/ML model.
9. How the ground truth for the training set was established: N/A.

Summary of the Study:

The "study" that proves the device meets the acceptance criteria is described as a series of non-clinical verifications. These tests are designed to objectively assess the physical and mechanical properties of the Comprehensive Humeral Head Adapter (CHHA) and its compatibility within the Identity Shoulder System, thereby demonstrating its substantial equivalence to previously cleared predicate devices.

The specific non-clinical tests performed include:

• Fatigue Verification: Assesses the device's ability to withstand repeated stress without failure, simulating long-term use.
• Fretting Corrosion Verification: Evaluates the device's resistance to material degradation caused by small-amplitude oscillatory motion between contacting surfaces.
• Fixation Stability Verification: Confirms the secure attachment and stability of components under load.
• Static Modular Junction Strength Verification: Measures the strength of the connections between modular parts under static loading conditions.
• ROM Verification: Ensures the device allows for the intended range of motion within the joint.
• MRI Verification: Confirms the device's safety and compatibility when exposed to magnetic resonance imaging environments.

The results of these tests, along with the asserted identicality of intended use, indications for use, materials, packaging, and sterilization, and similarity in design features, were deemed sufficient by the FDA to conclude that:

• any differences do not raise different questions of safety and effectiveness; and
• the proposed device is as safe and effective as the legally marketed predicate device.

This conclusion of substantial equivalence is the basis for the 510(k) clearance for the Identity Shoulder System's new line extension, the Comprehensive Humeral Head Adapter.

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The Affixus® Tibial Nailing System is indicated for temporary stabilization of tibial fractures and osteotomies including proximal, metaphyseal, and distal shaft fractures, closed fractures, open fractures, pathologic fractures, non-unions, malunions and deformity corrections.

The Affixus Tibial Nalling System is a long bone nailing system that offer implants designed to treat a range of tibial fractures from simple to complex, with versatile locking options. They restore the shape of preinjured bone and are available in a variety of lengths and diameters to meet assorted anatomical needs. Screws and End Caps are included in the system. All implants are made of Ti-6Al-4V. The Affixus platform of instrumentation is designed to provide options and flexibility for many intraoperative approaches while maintaining ease of use and commonality. This submission introduces 4mm Cortical Bone Screws are also made of Ti-6AL-4V and feature a double-lead thread design with a self-tapping tip. Screw options include Ø4mm: 20mm - 60mm, increments of 2 mm 60mm - 90mm, increments of 5mm Note: 4mm Screws are inserted through distal locking holes of 8mm Tibia nails only.

It appears that the provided document is an FDA 510(k) clearance letter for a medical device (Affixus Tibial Nailing System - 4mm screws). This type of document is for device clearance based on substantial equivalence to a predicate device, not for the clearance of an Artificial Intelligence/Machine Learning (AI/ML) device.

Therefore, the document does not contain any information regarding:

• Acceptance criteria for an AI/ML model
• Study design for testing an AI/ML model's performance
• Sample sizes for test or training sets for an AI/ML model
• Expert involvement in ground truth establishment or adjudication for an AI/ML model
• Multi-reader multi-case (MRMC) comparative effectiveness studies
• Standalone algorithm performance
• Ground truth types specific to AI/ML
• Training set details for an AI/ML model

The clearance is based on the device's material, design, packaging, and sterilization being substantially equivalent to existing predicate devices, and supported by non-clinical tests demonstrating mechanical properties (e.g., fatigue strength, bending strength, torque, pullout strength) and MR compatibility.

Conclusion:

Based on the provided text, it is not possible to describe the acceptance criteria and the study that proves an AI/ML device meets those criteria, as this document pertains to a traditional medical device (intramedullary fixation rod) and not an AI/ML product.

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The Affixus® Tibial Nailing System is indicated for temporary stabilization and fixation of tibial fractures and osteotomies including proximal. metaphyseal. and distal shaft fractures. closed fractures, open fractures, pathologic fractures, non-unions, malunions and deformity corrections.

The Affixus® Antegrade Femoral Nailing System is indicated for temporary stabilization and fixation of femoral fractures and osteotomies including proximal, metaphyseal, and distal shaft fractures, trochanteric and subtrochanteric fractures, closed fractures, pathologic fractures, non-unions, malunions and deformity corrections.

The Affixus Tibial Nailing System and the Affixus Antegrade Femoral (AF) Nailing System are long bone nailing systems that offer implants designed to treat a range of tibial and femoral fractures from simple to complex, with versatile locking options. They restore the shape of preinjured bone and are available in a variety of lengths and diameters to meet assorted anatomical needs. Screws and End Caps are included in the system. All implants are made of Ti-6Al-4V. The Affixus platform of instrumentation is designed to provide options and flexibility for many intraoperative approaches while maintaining ease of use and commonality.

This is a 510(k) premarket notification for a medical device, specifically the Affixus Tibial and Antegrade Femoral Nailing System. These notifications are submitted to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device, meaning it is at least as safe and effective.

The provided text does not contain the detailed information necessary to complete all sections of your request regarding acceptance criteria and a study that proves the device meets those criteria, particularly in the context of an AI/algorithm-based device. This document is for a traditional medical implant, not an AI software as a medical device (SaMD).

Therefore, many of the requested fields are not applicable or cannot be extracted from the given text. However, I can provide information based on what is available.

Here's the breakdown of what can be inferred and what is missing:

Acceptance Criteria and Device Performance Study

As this is a 510(k) for a physical medical implant (intramedullary fixation rod), the concept of "acceptance criteria" and "device performance" in the context of an AI/algorithm is not directly applicable in the same way. Instead, the "acceptance criteria" can be interpreted as demonstrating substantial equivalence to predicate devices through various non-clinical tests. The "device performance" is demonstrated by meeting the standards and benchmarks set by these tests.

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

Explanation of Performance: The document explicitly states: "The information provided herein demonstrates that: any differences do not raise different questions of safety and effectiveness; and the proposed device is at least as safe and effective as the legally marketed predicate devices." This is the ultimate "performance" metric for a 510(k) submission, achieved by passing the listed non-clinical tests and demonstrating material, design, packaging, and sterilization similarity to predicate devices. The specific values or pass/fail thresholds for each test are not provided in this summary, but the successful submission implies they were met.

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

• Sample Size: Not specified in the provided text. For mechanical testing of implants, sample sizes typically adhere to relevant ASTM standards.
• Data Provenance: Not specified in the provided text. These are non-clinical lab tests, so country of origin for "data" is typically the testing lab's location. The tests are prospective in the sense that they are specifically conducted for the submission.

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. This is a physical implant, not an AI/algorithm requiring expert-established ground truth on image data or other patient data. The "ground truth" for these tests are the defined mechanical properties and physical characteristics as per the ASTM standards.

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

• Not Applicable. This is a physical implant. The mechanical tests are objective measurements, not subject to adjudication by human interpreters.

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 for a physical implant. No AI component is mentioned, and therefore, no MRMC study or human reader improvement with AI assistance is relevant.

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

• Not Applicable. This is for a physical implant. No algorithm is mentioned.

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

• Mechanical Test Standards: The "ground truth" for the non-clinical tests are the specified mechanical properties and performance requirements outlined in the referenced ASTM standards (e.g., ASTM F1264, ASTM F543, ASTM F2182, etc.). These standards define acceptable ranges for strength, fatigue, torque, etc., which the device must meet or exceed.

8. The sample size for the training set

• Not Applicable. This is for a physical implant; there is no "training set" in the context of an AI/machine learning model.

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

• Not Applicable. As there is no training set, this question is not relevant.

Summary of what the document does indicate for this physical device:

The submission highlights that the Affixus Tibial and Antegrade Femoral Nailing System is deemed substantially equivalent to predicate devices based on:

• Similar indications for use.
• Similar technological characteristics (materials, design features, packaging, sterilization).
• Successful completion of a battery of non-clinical mechanical and MR compatibility tests.

The goal of this 510(k) is to demonstrate that the new device does not raise new questions of safety or effectiveness compared to legally marketed predicate devices. The listed non-clinical tests are the evidence used to support this claim.

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Hemiarthoplasty/Conventional Total Application:
· Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.

• Rheumatoid arthritis.
• · Correction of functional deformity.
  · Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
  • Difficult clinical management problems, including cuff arthropathy, where other may not be suitable or may be inadequate.
  Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.
  Reverse Application:
  Zimmer Biomet Reverse Shoulder products are in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
  The Zimmer Biomet Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
  The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component or reverse components for total shoulder arthroplasty (conventional or reverse applications). The humeral components may be used cemented or uncemented (biological fixation).
  The Titanium Humeral Head and Glenosphere components are indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head or Glenospheres is not recommended for patients who lack suspected material sensitivity to cobalt alloy.

The Identity Shoulder System cleared previously in K213856 is a comprehensive collection of components designed with the intention of providing the modularity and adaptability necessary to facilitate individual anatomical adjustment and restoration of the glenohumeral joint during shoulder arthroplasty.
The Identity Shoulder System in the anatomic configuration is comprised of several individual components such as Humeral Stem, Fixed Angle Humeral Stem Adapter, Humeral Head. This configuration can be used as a hemi-athroplasty with the humeral head articulating against the natural glenoid bone or as an anatomic total shoulder replacement with a compatible glenoid component.
The components of the Identity Shoulder System may also be used in the reverse configuration. Individual components include a Humeral Stem, Humeral Tray and Humeral Bearing, This construct is intended to be used with a compatible glenosphere/baseplate component.
The current 510(k) is for additional sizes/styles of humeral trays and bearings for the reverse configuration. Extra Extended trays in 3 heights in a neutral configuration are being additional lateralization. A uniforn thickness bearing is also being added in an effort to improve internal/external range of motion and reduce potential of scapular notching.

This document is a 510(k) premarket notification decision letter from the FDA to Zimmer Inc. for their Identity Shoulder System. It primarily discusses the substantial equivalence of the device to previously marketed predicate devices.

Based on the provided text, there is no information about testing related to acceptance criteria for an AI device. The document describes a medical device (shoulder system implants), not an AI/software device that would typically have the associated performance metrics (e.g., sensitivity, specificity, accuracy).

The "Non-Clinical Tests Summary & Conclusions" section on page 6 of the provided document does not mention any AI-related tests or performance metrics. The tests listed are:

• Finite Element Analysis (FEA)
• Range of Motion Analysis
• Magnetic Resonance Imaging (MRI)

These are standard engineering and safety tests for implantable medical devices, not performance evaluations for an AI diagnostic or assistance tool. The conclusion states that "Non-clinical testing demonstrated that the new devices do not represent new worst-case configurations than the predicate, and the subject device is substantially equivalent to the predicate device identified." This reinforces that the evaluation was for the physical implant components, not an AI system's performance.

Therefore, since the input document does not pertain to an AI device, I cannot fulfill the request to describe acceptance criteria and associated studies as requested in the prompt's points 1-9.

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Hemiarthoplasty/Conventional Total Application:

• · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• · Rheumatoid arthritis.
• · Correction of functional deformity.
• · Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
  · Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.
  Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.
  Reverse Application:
  Zimmer Biomet Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically suited to receive the implants and a functional deltoid muscle is necessary.
  The Zimmer Biomet Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
  The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component or reverse components for total shoulder arthroplasty (conventional or reverse applications). The humeral components may be used cemented or uncemented (biological fixation).
  The Titanium Humeral Head and Glenosphere components are indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head or Glenospheres not recommended for patients who lack suspected material sensitivity to cobalt alloy.

The Identity Shoulder System is a comprehensive collection of components designed with the intention of providing the modularity and adaptability necessary to facilitate individual anatomical adjustment and restoration of the glenohumeral joint during shoulder arthroplasty.
The Identity Shoulder System in the anatomic configuration is comprises of several individual components such as Humeral Stem, Fixed Angle Humeral Stem Adapter, Humeral Head Adapter, and Humeral Head. This configuration can be used as a hemiarthroplasty with the humeral head articulating against the natural glenoid bone or as an anatomic total shoulder replacement with a compatible glenoid component.
The components of the Identity Shoulder System may also be used in the reverse configuration. Individual components include a Humeral Stem, Humeral Tray and Humeral Bearing. This constructed is intended to be used with a compatible glenospheres/baseplate component.

This FDA 510(k) summary for the "Identity Shoulder System" does not contain any information about acceptance criteria or a study proving the device meets said criteria.

The document is a premarket notification for a medical device seeking substantial equivalence to previously cleared devices. It primarily focuses on:

• Indications for Use: What the device is intended for (e.g., non-inflammatory degenerative joint disease, rheumatoid arthritis, fractures).
• Device Description: A high-level overview of the components and configurations (hemiarthroplasty, total shoulder replacement, reverse configuration).
• Technological Characteristics: How the device is similar to predicate devices in terms of intended use, indications for use, materials, design features, and sterilization.
• Non-Clinical Tests/Justifications: A list of non-clinical tests performed (e.g., FEA, Axial Pull Off, Fatigue, Corrosion) to support substantial equivalence, but no results or acceptance criteria are provided for these tests in this summary document.
• Clinical Tests: Explicitly states "None provided."

Therefore, based solely on the provided text, I cannot answer the requested questions regarding acceptance criteria and studies proving the device meets them because this information is not present. This type of detail is typically found in the full 510(k) submission, not in the public summary.

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• 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• 2. Rheumatoid arthritis.
• 3. Correction of functional deformity.
• 4. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
• 5. Difficult clinical management problems, where other methods of treatment may not be inadequate.

Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.

The Alliance Monoblock glenoid components are indicated for cemented application only. The Alliance Modular Glenoid components are intended to be implanted with bone cement. The TM and porous posts may be inserted without bone cement.

The Alliance Glenoid system is a series of glenoid components which includes previously cleared (K191814) monoblock glenoids with 2 or 3 pegs and modular glenoids with 3 or 4 pegs. In addition to the predicate neutral (flat) modular 4-pegged design, an augmented configuration for correction of glenoid bone defects is being added to the product line. All glenoid types are available in various sizes. The posts of the modular glenoids are made of either a Tivanium® substrate with Trabecular Metal (TM) sleeve or the Tivanium® substrate with Porous Plasma Spray (PPS) coating.

The Alliance Glenoids are intended to be used with existing humeral stem and head components to complete a total shoulder replacement construct.

The provided FDA 510(k) document for the Alliance Augmented Glenoid focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that a device meets specific acceptance criteria for performance in an AI/software context.

The document discusses a medical device (an augmented glenoid component for shoulder replacement), not an AI/software device. Therefore, the questions related to AI/software performance metrics, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, and standalone performance are not applicable to this document.

The "Summary of Performance Data" explicitly states "Non-Clinical Tests: o Glenoid Loosening (Rocking Horse) (ASTM F2028)" and "Clinical Tests: o None provided." This indicates that the performance evaluation was based on mechanical testing, a common approach for physical medical implants, not a clinical study involving human patients or an evaluation of an AI algorithm's diagnostic capabilities.

Here's a breakdown of the relevant information provided in the document based on your request, along with explanations of why certain points are not applicable:

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

The document doesn't define specific "acceptance criteria" in terms of numerical performance thresholds for diagnostic accuracy, sensitivity, or specificity, as would be expected for an AI/software device. Instead, it relies on demonstrating that the Alliance Augmented Glenoid is substantially equivalent to a legally marketed predicate device (Alliance Glenoid K191814) through design similarities and non-clinical mechanical testing.

The primary performance data reported is for Glenoid Loosening (Rocking Horse) (ASTM F2028). The document implies that the results of this test demonstrated comparable performance to the predicate device, thereby supporting the claim of substantial equivalence. However, the specific metrics or acceptance values from this test are not explicitly detailed in the provided text.

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. This is a physical medical device (implant), not an AI/software device evaluated on patient data. The "test set" would refer to the physical components subjected to mechanical testing. The document does not specify the number of physical samples tested under ASTM F2028.

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. Ground truth, in the context of diagnostic performance, is not relevant here as this is a physical implant. The evaluation is based on engineering and materials science principles, typically involving qualified engineers and technicians performing the ASTM F2028 mechanical test.

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

• Not Applicable. Adjudication methods are used to establish ground truth in diagnostic studies, which is not relevant for this physical device.

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. MRMC studies are for evaluating diagnostic performance (often with AI assistance), which is not the subject of this 510(k). The document explicitly states "Clinical Tests: o None provided."

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

• Not Applicable. This is not an algorithm or AI device.

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

• Not Applicable. Ground truth in the diagnostic sense is not relevant here. The "ground truth" for the device's mechanical integrity would be derived from the objective results of the ASTM F2028 mechanical stress test.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not Applicable. As there is no training set.

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• Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• Rheumatoid arthritis.
• Correction of functional deformity.
• Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
• Revision procedures where other treatment or devices have failed.
• Dislocation risks.
  Dual Mobility Hip Bearings are single-use implants, intended for uncemented applications.

The G7 Dual Mobility System and Active Articulation System are dual articulation systems wherein there are two articulating surfaces in the same joint space. The systems include a polyethylene (UHMWPE) bearing which is assembled over a femoral head. The femoral head articulates on the inner, concave surface of the bearing. The resultant assembly then articulates within a metal liner (G7 Dual Mobility System) or acetabular shell (Active Articulation System). The G7 Dual Mobility and Active Articulation Systems are designed for both primary and revision surgeries, where all device components associated with the wear couple are removed and replaced.

It seems there is a misunderstanding. The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device, "Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings."

This document does not describe the acceptance criteria and study proving a device meets those criteria in the context of an AI/Machine Learning device, as implied by the detailed questions about ground truth, expert adjudication, MRMC studies, training sets, and standalone performance.

Instead, this document is for a traditional medical implant (hip bearings) and the "performance data" referred to are related to mechanical and material properties of the physical implant, not algorithmic performance.

Therefore, I cannot extract the information requested for acceptance criteria and study design related to AI/ML device performance from the provided text. The questions you've asked are applicable to AI/ML-based medical devices, which this product is not.

If you can provide a text that describes the evaluation of an AI/ML medical device, I would be happy to help.

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• 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• 2. Rheumatoid arthritis.
• 3. Correction of functional deformity.
• 4. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
• 5. Difficult clinical management problems, where other methods of treatment may not be suitable or may be inadequate.

Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.

The Alliance Monoblock Glenoid components are indicated for cemented application only. The Alliance Modular Glenoid components are intended to be implanted with bone cement. The TM and porous posts may be inserted without bone cement.

The Alliance Glenoid is a series of glenoid components which includes monoblock polyethylene glenoids with 2 or 3 pegs and modular glenoids with 3 or 4 pegs glenoids. All glenoid types are available in various sizes. The central posts of the modular glenoids are made of either a Tivanium® substrate with Trabecular Metal (TM) sleeve or the Tivanium substrate with Porous Plasma Spray (PPS) coating.

The Alliance Glenoids are intended to be used with existing humeral stem and head components to complete a total shoulder replacement construct.

This regulatory submission for the "Alliance Glenoid" device (K191814) does not contain information about acceptance criteria or a study proving that the device meets such criteria in the context of an AI/ML medical device.

The document describes a medical device, specifically shoulder glenoid components for total shoulder replacement. The "Summary of Performance Data" section lists various non-clinical tests performed (e.g., accelerated corrosion, fatigue, glenoid loosening, range of motion, wear analysis, porous structure characterization, MR Evaluation). It explicitly states "Clinical Tests: None provided."

Therefore, I cannot fulfill your request as the provided text does not describe an AI/ML device or its associated performance study with acceptance criteria.

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This device is indicated for patients with severe knee pain and disability due to:

• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Collagen disorders, and/or avascular necrosis of the femoral condyle.
• Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
• Moderate valgus, varus, or flexion deformities.
• The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
  Porous components may be used cemented or uncemented (biological fixation). Augments may be attached via bone cement or screw to the tibial plates and/or femoral components. Splined stem extension components are intended to be used press-fit (uncemented). All other femoral component, tibial plate, stem extension, and femoral and tibial augment components are indicated for cemented use only.

The Persona Revision Knee System is a semi-constrained total knee prosthesis consisting of anatomically shaped components designed to resurface the articulating surface of the femoral and tibial bones including:

• Femoral components
• Articular surfaces
• Tibial components
• Stem extensions
• Femoral and tibial augments
• Femoral and tibial cones.
  The large modularity of the componentry of the Persona Revision knee system including articular surfaces with different levels of constraint, augments, cones and stem extensions provides numerous possible configurations to optimally address the bone and joint condition of the patient in a primary or revision TKA surgery.
  The Persona Revision Knee System also includes nonimplantable tools, or instrumentation, that facilitate the implantation of above described implant components as well as cases and trays to hold these instruments during sterilization and their subsequent storage.

I'm sorry, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text.

The provided text is an FDA 510(k) clearance letter for a Persona Revision Knee System, which is a medical device (a knee prosthesis). This document primarily focuses on the regulatory clearance process, stating that the device is "substantially equivalent" to legally marketed predicate devices.

It does NOT contain information about:

• Specific acceptance criteria metrics (e.g., in terms of sensitivity, specificity, accuracy for an AI/algorithm-based device).
• Detailed performance study results for an AI/algorithm-based device.
• Sample sizes for test sets or training sets in the context of an AI/algorithm.
• Information about expert consensus, ground truth establishment methods, multi-reader multi-case studies, or standalone algorithm performance.

The document mentions "Non-Clinical Tests" and "Clinical Tests" but these refer to mechanical and sterility testing of the knee implant and associated instruments, not to the performance evaluation of an AI or algorithmic medical device. For example, "Stem housing cantilever fatigue" and "Cadaveric design validation" are relevant to a physical medical implant, not a software algorithm. The document explicitly states, "Clinical data was not deemed necessary for the subject device," further indicating that a a large-scale clinical performance study (as would be typical for an AI/ML device) was not conducted or required for this particular type of device clearance.

Therefore, your request, which is structured around the evaluation of an AI or algorithm-based medical device, cannot be answered using the provided text, as the text describes a hardware medical implant, not a software device.

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