Search Results

Prosthetic replacement of the femoral head associated with a hip prosthesis having a taper compatible with the head taper, and with a prosthetic UHMWPE acetabulum having an inside diameter compatible with that of the head.

The alumina head can only be used with polyethylene inserts.

This prothesis may be used for degenerative ioint disease such as osteoarthritis and avascular necrosis, correction of functional deformity, rheumatoid arthritis, revision procedure where other devices or treatments have failed, congenital dislocation, femoral neck and trochanteric fractures, traumatic arthritis, fused diastrophic variant, slipped capital hip, epiphysis, non-union.

Alumina heads are made of Biolox forte alumina (trademark of CERAMTEC) according to ISO 6474 standard.

Alumina heads have a 12/14 cone and are available in two diameters: 28mm and 32mm, with three offsets: -3.5; 0; +3.5.

This special 510 (k) is being submitted to propose an extension at the 10/12 cone in diameter : 32 mm with three offsets: -3.5; 0; +3.5. This heads are made in HIP Vitox® alumina (trademark of Morgan Advanced Ceramics Ltd according to ISO 6474 standard.

The provided text describes a 510(k) premarket notification for "ALUMINA HEADS," which are ceramic femoral heads for hip prostheses. The submission is an extension for additional cone sizes. The document outlines material characteristics and performance tests, but it does not describe an AI/device acceptance criteria study.

Therefore, many of the requested categories cannot be answered from the provided text.

Here's a breakdown of what can be answered based on the input:

1. Table of Acceptance Criteria and Reported Device Performance

The document references compliance with established standards and FDA guidelines rather than defining specific numerical acceptance criteria.

• 10/12 cone alumina heads reach all requirements set up in this guidance document. |
  | Performance - Fatigue Test | - Results in compliance with selected standard (implied, as part of overall performance claim).
• All results were in compliance with the requirements set forth by the FDA. |
  | Performance - Static Compression Test to Rupture | - Results in compliance with selected standard (implied, as part of overall performance claim).
• All results were in compliance with the requirements set forth by the FDA. |
  | Performance - Pre-loading of femoral head and extraction force measurement | - Results in compliance with selected standard (implied, as part of overall performance claim).
• All results were in compliance with the requirements set forth by the FDA. |

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

Not applicable. This is a medical device for orthopedic surgery, not an AI/software device. The tests performed are mechanical in nature, on the device itself, not on data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. (See #2)

4. Adjudication Method for the Test Set

Not applicable. (See #2)

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

Not applicable. This document describes a physical medical device (ceramic femoral head), not an AI algorithm or diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. (See #5)

7. The Type of Ground Truth Used

Not applicable. The "ground truth" for this device's performance is established by its compliance with predefined mechanical performance standards (e.g., ISO 6474) and FDA guidance documents for ceramic hip systems.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

Ask a specific question about this device

Prosthetic replacement of the femoral head associated with a hip prosthesis having a taper compatible with the head taper, and with a prosthetic acetabulum having an inside diameter compatible with that of the head. The alumina head can only be used with polyethylene inserts. This prosthesis may be used for degenerative joint disease such as osteoarthritis and avascular necrosis, correction of functional deformity, rheumatoid arthritis, revision procedure where other devices or treatments have failed, congenital dislocation, femoral neck and trochanteric fractures, traumatic arthritis, fused hip, diastrophic variant, slipped capital epiphysis, non-union.

Alumina heads are made of Biolox forte alumina (trademark of CERAMTEC) according to ASTM F 6474 standard. Alumina heads have a 12/14 cone and are available in two diameters: 28mm and 32mm, with three offsets: -3.5; 0; +3.5.

Here's an analysis of the provided text, focusing on the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the numerical sample size used for the test set for the performance tests (fatigue, static compression, head extraction). It only mentions "two series of tests."

The data provenance is not specified beyond the tests being performed by the manufacturer seeking clearance in France ("Fournitures Hospitalières Industrie"). It is retrospective, as the tests were conducted prior to the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable as the studies are performance tests on a physical device, not an AI/software device that requires human expert ground truth for labeling data. The "ground truth" for these tests is the physical behavior of the device under stress, measured against engineering standards.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools or systems where human readers interpret medical images or data. The device in question is a physical orthopedic implant (alumina femoral head), which does not involve human readers for its primary function.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable as the device is a physical medical implant, not an algorithm or AI system. The "performance" being evaluated is the mechanical integrity and material properties of the implant itself.

7. Type of Ground Truth Used

The ground truth for the device's performance is based on:

• Engineering Standards: Specifically ASTM F 6474 for the material (Biolox forte alumina).
• Regulatory Requirements: "Requirements set forth by the FDA" for the performance tests, and "FDA's guideline: 'Guidance document for the preparation of prematerial notifications for ceramic ball hip systems' dated January 10, 1995" for material characteristics.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical implant, not an AI/ML algorithm that requires a "training set." The manufacturing process would involve process controls and quality assurance, but not in the sense of a data training set for an AI model.

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

This information is not applicable for the same reason as point 8.

Ask a specific question about this device