(31 days)
The MS-30 Femoral Stem is intended for cemented use in treatment of the following:
- Advanced wear of the joint due to degenerative, posttraumatic or rheumatic diseases. t
- Fractures or vascular necroses. .
- Status following earlier operations, such as joint reconstruction (osteotomy), arthrodesis, hemiarthroplasty of total hip prosthesis (THP).
The MS-30 Stem is a highly polished, collarless femoral component manufactured from forged stainless steel alloy. It is available in six standard sizes and six lateral sizes. The lateral version offers the surgeon a 12% offsct versus the standard version. The MS-30 Stem is intended for cemented use.
This document provides a 510(k) summary for the MS-30 Femoral Stem, intended for cemented use in total hip arthroplasty. It states that the device is substantially equivalent to predicate devices based on "Performance tests, design comparisons, and functional analyses." However, it does not contain specific acceptance criteria or detailed study results that would allow for a comprehensive description of performance as requested.
Therefore, many of the requested sections regarding the study and acceptance criteria cannot be fulfilled from the provided text.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. The document states "Performance tests, design comparisons, and functional analyses conducted on the MS-30 Femoral Stem demonstrate that it is substantially equivalent to the predicate devices," but does not list specific criteria or results of these tests. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not specified.
- Data provenance: Not specified. The studies mentioned ("Performance tests, design comparisons, and functional analyses") are not described in detail.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not specified. The document does not describe studies involving expert evaluation or ground truth establishment in this manner. The "performance tests" likely refer to mechanical or material tests rather than clinical or image-based evaluations requiring expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified.
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 is a medical device (femoral stem) and not an AI/software device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device (femoral stem) and not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable/Not specified. For a mechanical device like a femoral stem, "ground truth" would typically relate to successful mechanical performance, material integrity, and biological compatibility, likely established through bench testing (e.g., fatigue strength, wear resistance) and potentially pre-clinical animal studies, rather than clinical outcomes or pathology data in the context of this 510(k) summary. These details are not provided.
8. The sample size for the training set
- Not applicable. This is a medical device (femoral stem) and not an AI/software device that would have a "training set."
9. How the ground truth for the training set was established
- Not applicable. This is a medical device (femoral stem) and not an AI/software device.
Summary based on available information:
The 510(k) summary indicates that the MS-30 Femoral Stem was determined to be substantially equivalent to predicate devices based on "Performance tests, design comparisons, and functional analyses." However, the document does not provide the specific details of these tests, including acceptance criteria, sample sizes, methodology, or results. This type of 510(k) clearance primarily relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through engineering and bench testing, rather than extensive clinical trials with human subjects that generate the detailed data points requested in the prompt for AI/diagnostic devices.
§ 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.