Search Results

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

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.

Ask a specific question about this device

Ask a specific question about this device

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.
• Fractures or vascular necroses.
• Status following earlier operations, such as joint reconstruction (osteotomy), arthrodesis, hemiarthroplasty of total hip prosthesis (THP).

The MS-30 is a highly polished metallic femoral component manufactured from forged stainless steel alloy (Protasul S30, ISO 5832-9). It is available in six sizes. The stem features a three dimensional conical wedge shape with rounded edges to aid in rotational stability, self centering in the femoral canal, and creation of a favorable cement mantle. The proximal aspect of the stem has a male 12/14 type morse taper for attachment of a Sulzer Orthopedics metallic or ceramic femoral The most distal aspect of the stem has a small pilot hole for attachment of a distal head. centralizer. The stem is intended for cemented use only.

The MS-30 also features an optional distal centralizer which is manufactured from PMMA (ISO 5833-1) with a wrought CoCr alloy locating pin (Protasul 10, ISO 5832-6). The pin provides for slip fit connection to the distal stem. The centralizer is conically shaped with a small proximal tab that prevents rotation about the stem upon insertion into the canal.

This document is a 510(k) Summary for the Sulzer Orthopedics MS-30 Femoral Stem, a medical device for hip replacement, and does not contain the type of information requested regarding acceptance criteria and a study proving device performance.

The provided text focuses on:

• Product Description: Materials, design, and sizes of the femoral stem and optional distal centralizer.
• Specific Diagnostic Indications: Conditions for which the device is intended.
• Substantial Equivalence: Comparison to other commercially available devices and a general statement that "Testing/analysis indicated that the device would survive physiologic loading."

It does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Details on experts for ground truth establishment.
4. Adjudication methods.
5. Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Results from standalone performance studies.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is primarily for regulatory submission to demonstrate substantial equivalence to previously cleared devices, rather than a detailed performance study report.

Ask a specific question about this device