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The Biomet® Bi-Polar Shoulder System is indicated for use in:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
2. Rheumatoid arthritis
3. Revision where other devices or treatments have failed
4. Correction of functional deformity
5. Treatment of acute fracture of the humeral head unmanageable using other treatment methods
6. Cuff tear arthroplasty
   This is a single use implant for use with cemented or uncemented humeral components. It is intended for use with Biomet's humeral components previously cleared by the FDA.

The Biomet® Bi-Polar Shoulder Prosthesis is a self-retaining humeral shell that can be used with either the Bi-Angular® humeral prosthesis or the Bio-Modular® humeral prosthesis. In assembling, the liner is place over a modular inner head that is already impacted to an implanted humeral stem. The shell is then placed over the liner and the Ring-Loc lock ring snaps into the outer groove of the liner, which completes assembly of the prosthesis. The shell is available in six spherical diameters, 40 mm, 48 mm, 52 mm, 56 mm and 60 mm. The liner and Ring-Loc® locking ring are modular, i.e. there is only one size of each, and each is used with all six shell sizes.

The provided text describes a medical device submission (K002998) for the Biomet® Bi-Polar Shoulder System. However, it does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria.

The document is primarily a Notice of Substantial Equivalence from the FDA, indicating that the device is substantially equivalent to a previously marketed predicate device (Biomet® Bi-Polar Shoulder, K991585). This type of FDA clearance (510(k)) focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials to establish efficacy and safety from scratch.

Therefore, I cannot provide the requested information. The text does not elaborate on:

1. A table of acceptance criteria and the reported device performance: No such criteria or performance data are presented.
2. Sample size used for the test set and the data provenance: No test set or corresponding data is described.
3. Number of experts used to establish the ground truth... and their qualifications: No ground truth establishment is detailed.
4. Adjudication method: Not applicable as no ground truth establishment is described.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned.
6. Standalone (algorithm only without human-in-the-loop performance): This device is a physical shoulder prosthesis, not an algorithm, so this is not applicable.
7. The type of ground truth used: Not applicable as no ground truth assessment is described.
8. The sample size for the training set: Not applicable as this is a physical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

The document mainly focuses on:

• Sponsor and contact information.
• Device name and classification.
• Intended use and device description.
• Potential risks associated with the device (general risks for joint replacement).
• Identification of the predicate device.
• The FDA's official letter of substantial equivalence.
• The Indications for Use statement.

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