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

The AETOS 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 AETOS Shoulder System is indicated for use as a replacement of shoulder joints disabled by:

• Rheumatoid arthritis
• Non-inflammatory degenerative joint disease
• Correction of functional deformity
• Fractures of the humeral head
• Traumatic arthritis
• Revision of other devices if sufficient bone stock remains

The coated humeral component is intended for uncement is intended for cement is intended for cemented use only.

In Reverse:
The AETOS Shoulder System is 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
• Correction of functional deformity
• Fractures of the humeral head
• Traumatic arthritis
• Revision of devices if sufficient bone stock remains

The humeral liner component is indicated for use in the AETOS Shoulder System as a primary reverse total shoulder replacement and for use when converting an anatomic AETOS Shoulder System into a reverse shoulder construct. This facilitates the conversion without the removal of the humeral stem during revision surgery for patients with a functional deltoid muscle. The component is permitted to be used in the conversion from anatomic to reverse if the humeral stem is well fixed, the patient has a functional deltoid muscle; the arthroplasty is associated with a massive and non-repairable rotator cuff tear.

The coated humeral stem is indicated for uncemented use. The coated glenoid baseplate is intended for cementless application with the addition of screws for fixation.

Note: All implant components are single use.

The AETOS Shoulder System consists of:

In an anatomic configuration: A humeral stem (Titanium) with a plasma spray coating (Titanium), a compatible humeral head (CoCr) with a compatible glenoid (UHMWPE). The AETOS Shoulder System stem and head may be used by themselves for hemiarthroplasty.

In a reverse configuration: A humeral stem (Titanium) with a plasma spray coating (Titanium), a compatible liner (UHMWPE), glenoid baseplate (Titanium with Titanium plasma spray), glenosphere (CoCr with Titanium retaining component), peripheral screws (Titanium), center screw (Titanium), optional humeral spacer (Titanium), and optional post extension (Titanium with Titanium plasma spray).

This document is a 510(k) Premarket Notification from the FDA regarding the AETOS Shoulder System. It is primarily concerned with establishing substantial equivalence to previously cleared devices based on non-clinical performance data and technological similarities/differences.

Therefore, a study proving the device meets acceptance criteria related to AI/algorithm performance (as described in your prompt, e.g., sensitivity, specificity, human reader improvement) was not performed nor is it relevant to this specific FDA submission.

The document explicitly states: "Clinical performance data were not necessary to demonstrate substantial equivalence of the subject device."

Instead, the acceptance criteria for this device are established through engineering and mechanical testing, ensuring the physical device components meet design specifications and performance standards comparable to legally marketed predicate devices.

Here's how to interpret the available information in the context of your request:

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

The acceptance criteria are implied by the non-clinical performance data testing listed, which assess the mechanical integrity and function of the shoulder system components. The "reported device performance" is that the device met these standards, demonstrating substantial equivalence to the predicate devices. This type of submission relies on the device performing as well as the predicate in relevant mechanical and material property tests to prove safety and effectiveness.

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

• Sample Size: Not explicitly stated in terms of patient data. The "test set" here refers to the physical components of the shoulder system subjected to mechanical testing. The sample size for these engineering tests would typically be a specific number of manufactured components.
• Data Provenance: This is not patient- or human-read data. It's likely from internal laboratory testing conducted by the manufacturer (Smith & Nephew, Inc. at Cordova, Tennessee). It's not retrospective or prospective clinical data.

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

This is not applicable. The "ground truth" for mechanical performance of an orthopedic implant is established through standardized engineering tests (e.g., ASTM standards) and material science principles, not expert consensus from medical professionals. The "experts" would be engineers, material scientists, and quality assurance personnel.

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

Not applicable, as this refers to human expert review of clinical data, which was not the basis of this submission. The "adjudication" is met by demonstrating compliance with established engineering and material standards through 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:

Not applicable. This device is a physical orthopedic implant, not an AI/software as a medical device (SaMD) that assists human readers.

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

Not applicable. This is not an algorithm.

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

The "ground truth" for this device's acceptance is established through compliance with existing engineering standards and successful completion of specified mechanical and material property tests. These tests are designed to simulate physiological loads and conditions to ensure the device's durability and performance.

8. The sample size for the training set:

Not applicable. This device does not involve a training set for an algorithm.

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

Not applicable.

In summary: The provided document is a 510(k) clearance for a physical medical device (shoulder system). The "acceptance criteria" and "study" details you requested are tailored to AI/software products. For this device, acceptance is based on non-clinical (engineering) performance data demonstrating substantial equivalence to older, already cleared devices, rather than clinical trials or AI performance metrics.

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The Arthrex Univers Revers CA Heads and Adapters are indicated for

• . salvage of a failed reverse total shoulder, with an irreparable rotator cuff tear and a well-fixed humeral stem, to an anatomic hemi-shoulder replacement; or
• . conversion of a primary reverse total shoulder, for the relief of pain secondary to severe rotator cuff arthropathy and an irreparable rotator cuff tear, to anatomic hemi-shoulder replacement when insufficient glenoid bone stock is encountered intraoperatively after the humeral stem has been implanted.
  The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device

The Arthrex Univers Revers CA Heads and Adapters consist of a line of CA Heads and Adapters which are designed to be used with the existing well-fixated Revers stem of the Univers Revers Shoulder Prosthesis System (K130129 and K142863). The Arthrex Univers Revers CA Heads and Adapters will convert existing reversed shoulder prosthesis to a hemi anatomic configuration. The cobalt chrome CA Head were designed with a larger area of articulation to allow for articulation with the acromion in patients with gross rotator cuff deficiency, similar to the Univers II The proposed Arthrex Univers Revers CA Heads have a CA Heads (K130675). similar spherical articulating surface as that of the previously cleared heads and are available in 14 nominal sizes. The Adapters are manufactured from Titanium and UHMWPE and are available in 3 nominal sizes.

The provided text describes a 510(k) premarket notification for a medical device called "Arthrex Univers Revers CA Heads and Adapters." This submission aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than establishing de novo safety and effectiveness criteria. Therefore, the document does not contain information about acceptance criteria and a study to prove the device meets specific performance metrics in the way your request outlines for AI/software-based devices.

The information provided only discusses the substantial equivalence summary based on bench testing. Here's a breakdown of what is available and what is not in relation to your request:

1. Table of acceptance criteria and reported device performance:

• Acceptance Criteria: Not explicitly stated as pass/fail criteria for clinical performance in a typical sense for AI, but rather a demonstration of equivalence to predicates. The acceptance for this 510(k) submission is that the device's design, materials, and mechanical performance are comparable to cleared predicate devices and do not raise new questions of safety or effectiveness.
• Reported Device Performance: The document states that in-vitro testing (static loading, endurance, fretting corrosion, disengagement, torque out) was performed and demonstrated that the performance of the proposed devices is "substantially equivalent to that of the predicate devices." No specific numerical performance metrics from these tests are provided, nor are the acceptance criteria for these mechanical tests detailed.

Table (based on available information, highly summarized):

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

• Test Set (for in-vitro mechanical testing): Not specified in this document. Since it's mechanical testing, the "sample size" would refer to the number of devices tested for each mechanical property.
• Data Provenance: The nature of in-vitro testing suggests it's likely conducted in a lab setting, presumably by the manufacturer (Arthrex, Inc.). No country of origin is mentioned for the test data itself, but the manufacturer is based in Naples, Florida, USA. The testing is prospective in the sense that it's performed to support the 510(k) submission for this specific device.

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

• Not applicable. This document describes mechanical testing of a physical implant, not clinical performance based on expert review or ground truth labeling like in an AI study.

4. Adjudication method for the test set:

• Not applicable. This relates to clinical or interpretative studies, not mechanical bench testing.

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

• No. This type of study applies to diagnostic imaging or interpretation devices, typically AI-powered. The device in question is a physical orthopedic implant. The document explicitly states: "Clinical data and conclusions are not needed for this device."

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

• Not applicable. This is a physical medical implant, not an algorithm.

7. The type of ground truth used:

• Not applicable. For mechanical testing, the "ground truth" would be the measured physical properties against established engineering standards or predicate device performance.

8. The sample size for the training set:

• Not applicable. This device is a passive implant; there is no "training set" in the context of machine learning.

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

• Not applicable. Again, no training set for a physical implant.

In summary: The provided document is a 510(k) clearance letter for a physical orthopedic implant, focusing on its substantial equivalence to previously cleared predicates through in-vitro mechanical testing. It does not contain the detailed performance criteria, clinical study designs, or AI-specific information requested.

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