(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.
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510(k) SUMMARY APR 2 9 2004
| SPONSOR NAME: | Centerpulse Orthopedics, Inc.9900 Spectrum DriveAustin, TX 78717 |
|---|---|
| 510(k) CONTACT: | Robert M. WolfarthPhone: (512) 432-9324E-Mail: Robert.Wolfarth@Zimmer.com |
| TRADE NAME: | MS-30 Femoral Stem, Standard and Lateral |
| COMMON NAME: | Hip joint metal/ceramic/polymer semi-constrained cemented ornonporous uncemented prosthesis |
| CLASSIFICATION: | Hip joint metal/ceramic/polymer semi-constrained cemented ornonporous uncemented prostheses (Product Code 87 LZO) are ClassII per 21 CFR §888.3353, reviewed by the Orthopedic Devices pane |
PREDICATE DEVICES:
MS-30 Femoral Stem standard: K993043, K001078 MS-30 Femoral Stem lateral: K020713
DEVICE DESCRIPTION:
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.
INTENDED USE:
The MS-30 Fernoral 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).
BASIS OF SUBSTANTIAL EQUIVALENCE:
Performance tests, design comparisons, and functional analyses conducted on the MS-30 Femoral Stem demonstrate that it is substantially equivalent to the predicate devices.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
APR 2 9 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert M. Wolfarth Regulatory Affairs Programs Manager Zimmer. Inc. 9900 Spectrum Drive Austin, Texas 78717
Rc: K040803 Trade/Device Name: MS-30 Femoral Stem Standard and Lateral Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prostheses Regulatory Class: II Product Code: LZO Dated: March 26, 2004 Received: March 30, 2004
Dear Mr. Wolfarth:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial cquivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2- Mr. Robert M. Wolfarth
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
sincerely yours,
Mark A. Millman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: MS-30 Femoral Stem Standard and Lateral
Indications For Use:
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).
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Mikkelsen
Page 1 of Division of General, Restorative. and Neurological Devices
510(k) Number K040803
§ 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.