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The Bio-Modular® Reverse Shoulder is 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 Bio-Modular® 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.

The Bio-Modular ® Reverse Shoulder is intended for total shoulder replacement in a reverse shoulder configuration. Unlike traditional total shoulder replacement, a reverse shoulder employs a ball for articulation on the glenoid side of the joint and a polyethylene bearing surface on the humeral side of the joint. The components may be used as a primary procedure or during the revision of a failed shoulder prosthesis.

For a reverse shoulder application, a Glenosphere Baseplate with a Glenosphere is implanted into the qlenoid side of the joint. The Glenoid Baseplate is attached to the natural bone with the use of a Central Screw and Peripheral Screws. A Humeral Tray with a Humeral Bearing is attached to a Bio-Modular® Humeral Stem to complete the humeral side of the joint. The use of a standard Bio-Modular ® humeral component provides the surgeon with the option of leaving a well-fixed humeral stem from a previous total or hemishoulder surgery in place while still being able to convert the shoulder to a reverse configuration. It also would facilitate the conversion of a reverse configured shoulder to a hemi-shoulder in the future if the need were to arise.

I am sorry, but the provided text does not contain the acceptance criteria or a study proving that the Bio-Modular® Reverse Shoulder device meets such criteria. The document is a 510(k) premarket notification letter from the FDA to Biomet Manufacturing Corporation and an associated 510(k) Summary.

This type of document primarily focuses on establishing "substantial equivalence" to a legally marketed predicate device, rather than demonstrating performance against specific acceptance criteria through a dedicated study.

Here's what the document does say about testing:

• Non-Clinical Testing: "Non-clinical laboratory testing (fatigue testing) and engineering analysis (separation loads, change of face angle, assembly/disassembly and range of motion) were performed to determine substantial equivalence. The results indicated that the device was functional within its intended use. Magnetic Resonance Imaging (MRI) studies have been conducted."
• Clinical Testing: "None provided as a basis for substantial equivalence."

This means that while some non-clinical tests were conducted to support the claim of substantial equivalence, the document does not provide:

1. A table of acceptance criteria and reported device performance against those criteria.
2. Details on sample sizes for test sets, data provenance, or ground truth establishment for such tests.
3. Information about expert involvement for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness study results.
6. Standalone performance details.
7. Type of ground truth used for performance evaluation.
8. Training set sample size or ground truth establishment for training.

The document states that clinical testing was not provided as a basis for substantial equivalence, implying that the detailed performance evaluation typically associated with acceptance criteria and clinical studies was not part of this specific submission for substantial equivalence.

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