Search Results

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
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

The subject devices, Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeves, are cylindrical components designed to slide onto the distal end of a cemented femoral stem prior to insertion into the femoral canal.

This submission proposes a new bioburden reduction manufacturing process that includes a new contact material for the Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve.

The provided document is a 510(k) summary for the Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that a device meets specific acceptance criteria through a study with performance metrics in the way one might expect for a diagnostic AI or imaging device.

Therefore, the requested information, particularly regarding acceptance criteria performance, sample sizes for test/training sets, expert consensus, adjudication methods, MRMC studies, standalone performance, and ground truth types and establishment, is not applicable to this type of submission. This submission is for a physical medical device (a hip prosthesis component) and its substantial equivalence is based on technological characteristics and biocompatibility.

Here's a breakdown of what can be extracted and what is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: For this 510(k) submission, the "acceptance criteria" are not reported as specific performance metrics (e.g., sensitivity, specificity). Instead, they are implied by demonstrating substantial equivalence to a predicate device (K193546 Distal Centralizers). The criteria revolve around showing that the new device shares similar technological characteristics (intended use, indications for use, materials, design features, sterilization) and biocompatibility with the predicate.
• Reported Device Performance:
  • Non-Clinical Tests: A biocompatibility assessment was performed in accordance with ISO 10993-1. The data confirmed the biocompatibility of the candidate manufacturing process flow for the device in long-term contact with patient bone and tissues. No specific numerical performance metrics are provided, as this is a qualitative assessment of biocompatibility.
  • Clinical Tests: None were provided for this submission.

2. Sample Size Used for the Test Set and Data Provenance

• Not Applicable. This submission does not involve a "test set" in the context of evaluating an algorithm or AI. The biocompatibility assessment is a laboratory test on device materials, not a study on a human subject population with a test set of data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable. Ground truth in the context of expert consensus for diagnostics is not relevant here. Biocompatibility assessment relies on standardized testing procedures and interpretation by qualified laboratory personnel.

4. Adjudication Method for the Test Set

• Not Applicable. No test set or expert adjudication is involved.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• Not Applicable. This is a physical device, not an AI or diagnostic tool that would involve human readers.

6. If a Standalone Performance (Algorithm Only) Was Done

• Not Applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

• Not Applicable. For the biocompatibility assessment, "ground truth" would be established by the results of the ISO 10993-1 tests themselves, interpreted against the standard's requirements. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense applied to diagnostic performance.

8. The Sample Size for the Training Set

• Not Applicable. No training set is involved as this is not an AI/algorithm submission.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. No training set is involved.

In summary, the provided document is a regulatory submission for a physical medical device, not a diagnostic or AI product. Therefore, most of the requested information about "acceptance criteria" and "studies" related to performance metrics, test/training sets, and expert evaluations is not applicable to this specific type of device and submission.

Ask a specific question about this device