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The Mosaic™ Non-modular Proximal Body and EAS Offset Modular Humeral Heads are for rne in primary and revision shoulder joint replacement procedures in cases of:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Rheumatoid arthritis
• · Revision where other devices or treatments have failed
• · Correction of functional deformity
• Conceasin of ranicuonal consic fractures with humeral epicondyle (elbow) involvement or humeral head (shoulder), which are unmanageable using other treatment methods
• · Oncology applications

The Mosaic™ components are made of Co-Cr-Mo per ASTM F 75 and are Device Description: The Prosac componenes and mass offset modular designs are used to wailable in a non-modular proximal body and an EAS offset modular designs are used wallable in a non-modular proximal bone surface or with cleared glenoid components.

The provided text is a 510(k) summary for a medical device (Mosaic™ Non-modular Proximal Body and EAS Offset Modular Humeral Head), which is a premarket notification to the FDA.

Based on the content of this 510(k) summary, the device did not undergo clinical testing to establish substantial equivalence. Instead, the substantial equivalence was demonstrated through non-clinical testing. This means that a study proving the device meets acceptance criteria in the clinical context, as outlined in your request, was not performed or described in this document.

The document explicitly states:

• "Non-Clinical Testing: Non-clinical testing demonstrated substantial equivalence between this device and the predicate devices." (Page 0)
• "Clinical Testing: Clinical testing was not used to establish substantial equivalence." (Page 0)

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving clinical performance, as such a study was not conducted or reported for this 510(k) submission.

To directly answer your numbered points based on the provided text, where applicable:

1. A table of acceptance criteria and the reported device performance: Not applicable. Clinical acceptance criteria and device performance based on a study proving it meets these criteria are not reported.
2. Sample size used for the test set and the data provenance: Not applicable, as no clinical test set was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set requiring expert ground truth was used.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no clinical test set was used.
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. No clinical study, including MRMC, was conducted. This device is a shoulder joint prosthesis, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical ground truth was established for a performance study.
8. The sample size for the training set: Not applicable, as no clinical training set was used for an AI/algorithm.
9. How the ground truth for the training set was established: Not applicable, as no clinical training set was used.

In summary, this 510(k) relies on substantial equivalence to predicate devices, supported by non-clinical testing, rather than a clinical performance study with acceptance criteria.

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