(20 days)
The SC Ceramic Ball Heads are indicated for use in the treatment of severely disabled hip joints resulting from painful osteo-,rheumatoid and post-traumatic arthritis, and the late stages of avascular necrosis, and for revision of previous hip surgeries. The SC Femoral Hip Stem is indicated for use with or without bone cement. The SC Acetabular Cup is for use with bone cement only.
We added 6 sizes, 28 S, 28 M, 28 L, 32 S, 32 M, and 32 L of ceramic ball heads to the SC Total Hip System, which was cleared for marketing by FDA on 10/15/03 (K031474). These ball heads allow the surgeon a further option to meet the patient's needs.
This document is a 510(k) summary for a medical device modification, specifically the addition of new sizes of SC Ceramic Ball Heads to an existing hip replacement system. It is a regulatory submission, not a study report, and therefore does not contain the detailed information typically found in clinical or performance studies.
Therefore, many of the requested sections (2-9) cannot be answered from the provided text as the information is not present.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical properties equivalent to other similar implants | "The test results were equivalent to other similar implants and are sufficient for in vivo loading." |
Information Not Available in the Provided Text:
The following information is not present in the 510(k) summary, as it is a regulatory document focused on demonstrating substantial equivalence rather than a detailed report of a specific study's methodology:
- 2. Sample sizes for the test set and data provenance: No information on the actual number of ceramic ball heads tested, or where the data came from (e.g., country of origin, retrospective/prospective).
- 3. Number of experts used to establish ground truth and their qualifications: Not applicable, as this was a biomechanical test, not an AI or diagnostic study.
- 4. Adjudication method for the test set: Not applicable, as this was a biomechanical test, not an AI or diagnostic study.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable, as this was a biomechanical test, not an AI or diagnostic study.
- 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this was a biomechanical test, not an AI or diagnostic study.
- 7. The type of ground truth used: For biomechanical tests, the "ground truth" would be the measured physical properties. The document states "Biomechanical tests have been performed," but does not detail the specific measurements or reference standards used.
- 8. The sample size for the training set: Not applicable, as this was a biomechanical test, not an AI or machine learning study.
- 9. How the ground truth for the training set was established: Not applicable, as this was a biomechanical test, not an AI or machine learning study.
Summary of the Study (as described in the document):
The document refers to "Biomechanical tests" that were performed to demonstrate the equivalence of the new SC Ceramic Ball Heads to existing, similar implants. The study's conclusion, as stated, is that "The test results were equivalent to other similar implants and are sufficient for in vivo loading." This indicates the device met the implicit acceptance criteria of performing comparably to already cleared devices. However, the specifics of these tests (e.g., fatigue testing, static strength, wear resistance, the standards followed, the number of devices tested) are not detailed in this 510(k) summary. This type of information would typically be found in the full 510(k) submission, not in the publicly available summary.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.