(132 days)
Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis.
Revision of previous unsuccessful unicompartmental knee replacement or other procedure.
As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.
This device consists of a distal femoral resurfacing component and a proximal tibial resurfacing component. It is intended to be used to replace the medial or lateral compartments of the knee joint, specifically the femorotibial joint damaged as a result of inflammatory and non-inflammatory joint disease or trauma. These components are intended for cemented use only. The femoral component is manufactured from a cobalt-chromium alloy, which conforms to ASTM F-75. The tibial component is manufactured from ultra-high molecular weight polyethylene, which conforms to ASTM F-648.
This is a K99 Summary for a medical device called the "First Step Unicompartmental Knee System." It is a 510(k) submission, which means it evaluates the device's substantial equivalence to existing, legally marketed predicate devices, rather than requiring a full clinical trial for safety and effectiveness. Therefore, it does not contain the typical "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the way a clinical trial submission would for a novel device.
The "study" in this context is the demonstration of substantial equivalence to predicate devices, focusing on design, materials, and intended use, rather than a clinical performance study with specific acceptance criteria like accuracy, sensitivity, or specificity.
Here's an analysis based on the provided document and the typical content of a 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, a 510(k) summary for a device like this does not typically present a table of quantitative "acceptance criteria" and "reported device performance" in the way one would for an AI diagnostic device. Instead, the "acceptance criteria" for a 510(k) submission are met by demonstrating substantial equivalence to predicate devices.
The "performance" is implicitly deemed equivalent to the predicate devices if substantial equivalence is successfully demonstrated. The document states:
"The substantial equivalence of this device is based on equivalence in intended use, materials, design and operational principles to other predicate devices indicated for unicompartmental knee surgery. These devices include Howmedica Osteonics Corp.'s Duracon Unicompartmental Knee and SCR Uni Knee Systems."
Therefore, the "acceptance criteria" are qualitative comparability to the predicate devices across these aspects. There are no reported numerical performance metrics for the First Step Unicompartmental Knee System in this document.
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a "test set" in the context of an AI study. The "test set" for a 510(k) in this case is the comparison of the new device to existing predicate devices. The "provenance" is the existing knowledge and performance of the specified predicate devices already on the market (Howmedica Osteonics Corp.'s Duracon Unicompartmental Knee and SCR Uni Knee Systems).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. There is no "ground truth" establishment in the context of an AI study or a diagnostic test in this document. The assessment is based on engineering and design comparisons to predicate devices.
4. Adjudication Method for the Test Set
Not applicable. There is no "adjudication method" as this is not a diagnostic performance study requiring expert consensus on outputs.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This device is a mechanical implant, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone performance study was not done. This is a mechanical implant.
7. The Type of Ground Truth Used
Not applicable. As this is a mechanical implant seeking substantial equivalence to predicate devices, there isn't a "ground truth" in the sense of a medical outcome or diagnosis that an AI algorithm would be evaluated against. The "truth" in this context is the established safety and effectiveness of the predicate devices.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" for an AI algorithm in this context.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no "ground truth" or "training set" for an AI algorithm in this context.
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First Step Unicompartmental Knee System
510(k) Summary
ಕ್ಕೆ
9922
510(k) Summary
| Device: | First Step Unicompartmental Knee |
|---|---|
| Common Name: | Unicompartmental Knee System |
| Classification Name: | Knee joint femorotibial metal/ polymer non-constrained cementedprosthesis 21 CFR §.888.3520 |
| Regulatory Class: | Class II |
| Product Code: | 87 HSX |
| For Information contact: | Karen Ariemma, Regulatory Affairs SpecialistHowmedica Osteonics Corp.59 Route 17Allendale, NJ 07401-1677(201) 760-8187Fax: (201) 934-4368 |
This device consists of a distal femoral resurfacing component and a proximal tibial resurfacing component. It is intended to be used to replace the medial or lateral compartments of the knee joint, specifically the femorotibial joint damaged as a result of inflammatory and non-inflammatory joint disease or trauma. These components are intended for cemented use only. The femoral component is manufactured from a cobalt-chromium alloy, which conforms to ASTM F-75. The tibial component is manufactured from ultra-high molecular weight polyethylene, which conforms to ASTM F-648.
The substantial equivalence of this device is based on equivalence in intended use, materials, design and operational principles to other predicate devices indicated for unicompartmental knee surgery. These devices include Howmedica Osteonics Corp.'s Duracon Unicompartmental Knee and SCR Uni Knee Systems.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines suggesting movement or connection. The profiles are arranged in a way that they appear to be interconnected. Encircling the image is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 6 1999
Ms. Terry Sheridan Powell Requlatory Affairs Team Stryker Howmedica Osteonics Corporation 59 Route 17 07401-1677 Allendale, New Jersey
Re: K992287 First Step Unicompartmental Knee System Trade Name: Regulatory Class: II Product Code: HSX September 13, 1999 Dated: Received: September 17, 1999
Dear Ms. Powell:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K 99 JJK 7
Device Name: Howmedica Osteonics® First Step Unicompartmental Knee System
The First Step Unicompartmental Knee System consists of a distal femoral resurfacing component and a proximal tibial resurfacing component. The subject components of the First Step Unicompartmental Knee System are single use devices which are sold sterile. The First Step Unicompartmental Knee System is intended for cemented use only.
The specific indications and contraindications of the First Step Unicompartmental Knee System are stated in the following sections.
Indications
- Moderately disabling joint disease of the knee resulting from painful osteo- or post ● traumatic arthritis.
- Revision of previous unsuccessful unicompartmental knee replacement or other procedure.
- As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ Prescription Use X OR
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Acosta
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.