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Primary, secondary or post-traumatic osteoarthritis, rheumatoid arthritis, severe joint pain of osteoarticular origin compromising the patients quality of life, joints which are defective in shape and function, a revision intervention on a previous arthroplasty, and disorders in which arthrodesis is not an acceptable option.

The present device modification submits the addition of one larger diameter to the previous The present device modification submission concerns and includes in one size already covered by the range of Acqualis Press-in Shoulder Prosthesis. The glenoid component are unchanged. previous STV(k) clearance. The numeral lead and die grenote of the subjected device are identical to the predicate device.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies conducted to prove the device meets acceptance criteria. The document is a 510(k) premarket notification for a device modification (addition of one larger diameter) to the AEQUALIS Press-fit Shoulder Prosthesis, and it primarily focuses on regulatory approval based on substantial equivalence to a predicate device.

The document contains information such as:

• Device name: AEQUALIS Press-fit Shoulder Prosthesis
• Manufacturer: Tornier S.A.
• Classification: Class II
• Indications for use: Primary, secondary or post-traumatic osteoarthritis, rheumatoid arthritis, severe joint pain of osteoarticular origin compromising the patient's quality of life, joints which are defective in shape and function, a revision intervention on a previous arthroplasty, and disorders in which arthrodesis is not an acceptable option.
• Device description: Addition of one larger diameter to the previous range of Acqualis Press-in Shoulder Prosthesis. The humeral head and glenoid components are unchanged.
• Materials: Stem from Titanium alloy, Humeral head from Cobalt-Chromium alloy, Glenoid components from UHMWPE with a cobalt-chrome pin.

However, it does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any test sets.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. Information about multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Results of standalone (algorithm only) performance studies.
7. The type of ground truth used (expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How the ground truth for the training set was established.

This is a regulatory submission for a device modification, and the provided text primarily addresses the administrative aspects of FDA clearance based on substantial equivalence, rather than detailing clinical study results or performance data against specific acceptance criteria.

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