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Prosthetic replacement with this device (Aequalis PerFORM+ glenoid component and humeral component) may be indicated to relieve severe pain or significant disability caused by:

• · Degenerative pathologies: arthrosis, rheumatoid arthrosis, post traumatic arthrosis
• · Primary and secondary necrosis of the humeral head
• · Displaced 4-part upper humeral fracture
• · Humeral head fracture
• · Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable
• · Revision surgery when other treatments or devices have failed
• The Aequalis PerFORM+ glenoids are intended for cemented use only.

The Aequalis monobloc stem is for cemented use

The Aequalis Press-Fit is for uncemented use

The Aequalis PerFORM+ Shoulder System is a modular system consisting of a metaphyseal humeral stem component, anatomic humeral heads and glenoid for a total shoulder athroplasty. Surgical instruments are designed to facilitate proper implantation of the system.

The provided text describes a 510(k) premarket notification for the "Aequalis PerFORM+ Shoulder System." This document is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study for meeting specific acceptance criteria related to AI/software performance.

Therefore, the requested information regarding acceptance criteria and studies (especially those related to AI/software performance, such as sample size, ground truth, expert involvement, MRMC studies, or standalone algorithm performance) is not applicable or cannot be extracted from this document, as it pertains to a traditional orthopedic implant rather than an AI/software-based medical device.

The "studies" mentioned are non-clinical performance data for the physical device, mainly mechanical and biocompatibility testing.

Here's a breakdown of the information that can be extracted or clarified as "not applicable" based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to mechanical and biocompatibility tests of the physical shoulder implant components, not a dataset for an AI/software. No information on the number of samples for these tests or data provenance is provided beyond the "results" column being "Acceptable."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/software (e.g., expert consensus on medical images) is not relevant to the non-clinical performance tests of an orthopedic implant.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This concept is for resolving discrepancies in expert labeling of data, which is not part of the described 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 shoulder implant, not an AI diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical shoulder implant, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to the non-clinical tests performed. The "ground truth" for mechanical testing is based on engineering standards and measurements, and for endotoxin, it's a quantitative lab result compared to a threshold.

8. The sample size for the training set: Not applicable. This is not an AI/software device that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is for a traditional medical device (shoulder implant) and therefore lacks the information requested about AI/software performance studies and related aspects.

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Prosthetic replacement with this device (Aequalis PerFORM+ glenoid component and humeral component) may be indicated to relieve severe pain or significant disability caused by:

• . Degenerative pathologies: arthrosis, rheumatoid arthritis, post-traumatic arthrosis.
• Primary or secondary necrosis of the humeral head. ●
• Displaced 4-part upper humeral fracture .
• Humeral head fracture ●
• Other pathologies where arthrodesis or resectional arthroplasty of the humeral . head are not acceptable.
• . Revision surgery when other treatments or devices have failed.

The Aequalis monobloc stem is cemented use. The Aequalis press-fit is for uncemented use. Glenoid component is for cemented use.

The Aequalis PerFORM+ Shoulder System is a modular system consisting of a metaphyseal humeral stem component, anatomic humeral heads and glenoid for a total shoulder athroplasty. Surgical instruments are designed to facilitate proper implantation of the system.

The provided text describes a 510(k) premarket notification for a medical device called the Aequalis PerFORM+ Shoulder System. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring formal acceptance criteria and a study proving those criteria are met for a new, standalone device in the same way a novel AI or diagnostic might.

Therefore, the concept of "acceptance criteria and a study that proves the device meets the acceptance criteria" as it applies to an AI/diagnostic device does not directly translate here. Instead, the document discusses "Performance Data" to demonstrate substantial equivalence to a predicate device.

Regarding the Aequalis PerFORM+ Shoulder System:

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

The following information cannot be extracted from the provided text, as it pertains to a different type of device evaluation (e.g., AI/diagnostic software) than the mechanical shoulder implant described:

• Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method for the test set
• If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc)
• The sample size for the training set
• How the ground truth for the training set was established

The document explicitly states: "Clinical studies were not required to demonstrate substantial equivalence between the subject device and the predicate device." This reinforces that the evaluation method for this orthopedic implant is based on engineering and mechanical testing to demonstrate equivalence, not clinical performance or expert interpretation as would be the case for an AI/diagnostic system.

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