Search Results

K993438, K011110, K042037, K043537, K061423, K062995:

1. Non-inflammatory degenerative joint disease including avascular necrosis, diastrophic variant, fracture of the pelvis, fused hip, Legg Perthes, osteoarthritis, slipped capital epiphysis, subcapital fractures, and traumatic arthritis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
5. Revision of previously failed total hip arthroplasty.

K002379, K003363:

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Revision procedures where other treatment or devices have failed.
5. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

The systems consist of acetabular cups, femoral heads, and adapters and inserts. The Co-Cr-Mo head articulates with Co-Cr-Mo.

This 510(k) summary is for the Biomet® Metal-on-Metal Hip Systems-Expanded Contraindications. Based on the provided document, the device did not undergo clinical testing to prove its acceptance criteria because it was determined to be "substantially equivalent" to predicate devices already on the market.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document explicitly states: "Non-Clinical Testing: Non-clinical laboratory testing is not provided as a basis for substantial equivalence. Clinical Testing: None provided as a basis for substantial equivalence." The basis for clearance was "substantial equivalence" to legally marketed predicate devices, meaning that the technological characteristics (materials, design, sizing, and indications) are considered identical. The only change highlighted is "Contraindications have been expanded to include patients with chronic renal failure and patients who are pregnant or may become pregnant." This indicates a change in labeling rather than a change requiring new performance data.

2. Sample size used for the test set and the data provenance

Not applicable, as no new clinical or non-clinical testing was performed as a basis for substantial equivalence. The clearance was based on demonstrating equivalence to existing predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as no new clinical or non-clinical testing was performed.

4. Adjudication method for the test set

Not applicable, as no new clinical or non-clinical testing was performed.

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 hip prosthesis, not an AI-assisted diagnostic tool or imaging system.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a hip prosthesis, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable, as no new clinical or non-clinical testing was performed. The "ground truth" for the clearance was the existing performance and safety profile of the predicate devices.

8. The sample size for the training set

Not applicable, as no new development or testing using training sets (as in machine learning) was conducted. The device is a physical hip prosthesis.

9. How the ground truth for the training set was established

Not applicable, as no training set was used.

Ask a specific question about this device