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Comprehensive 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 Comprehensive 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.

Titanium glenospheres are intended for patients with Cobalt Alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A Cobalt Alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy.

Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.

Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

The devices are a line extension of the Comprehensive Reverse Shoulder System and consists of new 36mm and 40mm tray and liner locking mechanism designs as well a a new 40mm glenosphere. The highly cross-linked ultrahigh molecular weight (HXPE) polyethylene liners are offered either in Prolong® (Standard) or Vivacit-E (Vitamin E). The tray taper geometry as well as the material (Ti-6AL-4V and Co-28Cr-6Mo) and thickness offerings are identical (standard, +5mm, +10mm) to the predicate. The trays will still be offered with a centric (standard) taper as well as two other offset tapers (+3 and +6) to provide more offerings to the surgeon.

The provided document is a 510(k) summary for the Zimmer Comprehensive Reverse Shoulder System, which describes a medical device rather than an AI/ML algorithm. Therefore, many of the requested criteria related to AI/ML device performance (like experts for ground truth, adjudication methods, MRMC studies, training set details) are not applicable.

However, I can extract the relevant information regarding the device's acceptance criteria and the study (non-clinical testing) that proves it meets those criteria.

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

The document doesn't explicitly list "acceptance criteria" for each test with numerical thresholds. Instead, it states that non-clinical testing "demonstrated that the proposed devices meets performance requirements as defined by Design Control activities and is substantially equivalent to the predicate device in terms of safety and efficacy." The listed tests are the means by which this performance was evaluated.

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

The document lists "Non-Clinical Tests," which typically involve physical models, simulations, or benchtop experiments rather than patient data. No sample sizes are specified for these non-clinical tests. Data provenance in terms of country of origin or retrospective/prospective is not applicable or provided.

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 a mechanical device evaluation, not an AI/ML diagnostic or prognostic tool requiring expert ground truth for interpretation of patient data.

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

Not applicable. Adjudication methods are typically used for establishing ground truth in clinical studies involving interpretation of medical data, which is not the case here.

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

Not applicable, as this is a mechanical device, not an AI-assisted diagnostic tool.

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

Not applicable, as standalone performance refers to AI algorithm performance without human intervention, which is irrelevant to a shoulder implant.

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

The "ground truth" for this device would be established by engineering standards, validated testing methodologies, and comparison to the predicate device's established performance. It's based on objective physical and mechanical properties and behaviors, not clinical interpretations or pathological findings in the context of an AI/ML algorithm.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for physical device testing in the context of this 510(k) submission.

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

Not applicable, as there is no training set mentioned or implied.

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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.
  The device is indicated for use when both cruciate ligaments have been excised.
  The device is intended for use as part of a cemented or uncemented knee prosthesis.

The NexGen LPS-Flex Prolong articular surfaces are part of the NexGen system of semiconstrained,

The provided document describes a 510(k) premarket notification for a medical device, specifically NexGen® Complete Knee Solution LPS-Flex Prolong™ Highly Crosslinked Polyethylene Articular Surfaces. The document focuses on demonstrating substantial equivalence to predicate devices rather than a de novo study with explicit acceptance criteria and performance data.

Therefore, many of the requested categories (2-9) are not directly applicable or explicitly stated in this type of submission which primarily relies on equivalence to devices already on the market.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission is a 510(k), which asserts substantial equivalence to predicate devices rather than establishing new performance acceptance criteria and showing performance against them in a de novo study. The "Performance Data" section explicitly states "Non-Clinical Performance and Conclusions: Performance testing completed as part of the design assurance process demonstrated that this device is safe and effective and substantially equivalent to the predicate device. Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device."

Therefore, a table of explicit acceptance criteria and reported device performance, as one would see in a de novo study, is not provided in this type of submission. The 'acceptance criterion' for a 510(k) is demonstrating substantial equivalence to a legally marketed predicate. The 'performance' is therefore inherently linked to the performance of the predicate device.

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

Not applicable. No dedicated "test set" or clinical study with a prospectively collected sample size is described as clinical data was not needed. The non-clinical performance refers to design assurance testing, which would typically involve laboratory testing, not a clinical test set. The provenance of such non-clinical data would be internal lab reports.

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

Not applicable. As clinical data and a test set requiring ground truth establishment by experts were not needed or presented, this information is not provided.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring expert adjudication is described.

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

Not applicable. No clinical study, let alone an MRMC study comparing human readers with or without AI assistance, was performed or presented for this 510(k) submission.

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

Not applicable. This device is a physical knee prosthesis component, not an algorithm or AI. Therefore, a standalone performance study in the context of an algorithm's performance is not relevant.

7. Type of Ground Truth Used

Not applicable, as no external "ground truth" for a clinical assessment was required. The "truth" in this context is established through engineering and material science testing that demonstrates the physical properties and performance characteristics (e.g., wear, strength) of the device are equivalent to the predicate.

8. Sample Size for the Training Set

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

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

Not applicable. As this is not an AI/ML device, there is no training set or ground truth in that context.

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