(64 days)
- Joint impairment from arthritis (rheumatoid, osteo and post traumatic).
- Revision of failed femoral head replacements.
- When alternative reconstructive techniques are not viable.
- When arthrodesis is contraindicated.
- Avascular necrosis or fracture of the femoral head.
- Congenital defects that will allow adequate function of the system.
The 26 mm CoCr Head and Hooded Liner are manufactured from biocompatible materials: Co-Cr-Mo alloy and ultra-high molecular-weight polyethylene (UHMWPE). These materials are in current use in numerous hip systems and their use has been established through many years of successful clinical application.
This document is a 510(k) summary for a medical device (26 mm Cast CoCr Head and Polyethylene Acetabular Shell Liner) and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically seen for a diagnostic or AI-driven medical device.
Instead, the document focuses on demonstrating substantial equivalence to existing devices, which is a different regulatory pathway. The "studies" mentioned are performance tests, but they are not presented as typical clinical trials with acceptance criteria and statistical analyses of performance metrics like sensitivity or specificity.
Here's an analysis based on the provided text, highlighting why the requested information for acceptance criteria and a detailed study is not present:
The 510(k) summary focuses on the materials and size modification of an existing hip replacement component. The primary "proof" of its safety and effectiveness, in this regulatory context, comes from:
- Established Biocompatibility: The materials (Co-Cr-Mo alloy and UHMWPE) are stated to be "biocompatible" and "in current use in numerous hip systems," with "many years of successful clinical application." This is a qualitative reference to past performance rather than a specific study within this submission.
- Prior 510(k) Submissions: "Fatigue testing of the stem and 26 mm head was satisfied under previously released 510(k) submissions." Similarly, "the liner testing was satisfied under previous 510(k) submissions since only the I.D. has been changed." This indicates that the critical performance tests (like fatigue) were conducted and passed for the predicate device, and the current device (with a size change) is considered to meet those same criteria by virtue of its similarity and established performance of the components.
Therefore, the requested information cannot be fully provided from this document. However, I can extract what is implicitly or explicitly stated about the type of assessment conducted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance (Implicit/Explicit) |
|---|---|
| Material Biocompatibility and Clinical History | Co-Cr-Mo alloy and ultra-high molecular-weight polyethylene (UHMWPE) are biocompatible materials with many years of successful clinical application in numerous hip systems. |
| Fatigue Strength (Stem & CoCr Head) | "Fatigue testing of the stem and 26 mm head was satisfied under previously released 510(k) submissions." (Implies meeting established fatigue standards for hip implants). |
| Liner Performance (Specific to ID Change) | "the liner testing was satisfied under previous 510(k) submissions since only the I.D. has been changed." (Implies that the change in inner diameter did not negatively impact the liner's performance, which had already met established test criteria in prior submissions). |
| Enhancement of Polyethylene Minimal Thickness (Design Goal) | "A smaller CoCr head with appropriate liner was manufactured to increase polyethylene minimal thickness in the smaller diameter acetabular cups." (This is a design intent, and the device's construction achieves this by combining the 26mm head with a compatible liner for smaller cups, thus fulfilling the design goal rather than a measured performance metric). |
2. Sample size used for the test set and the data provenance
This document does not provide specific sample sizes for tests. It refers to tests being "satisfied under previously released 510(k) submissions." The data provenance for any mentioned tests (e.g., fatigue testing) is not specified, but usually, such tests are conducted in a laboratory setting. There is no indication of retrospective or prospective clinical human data for this specific submission; instead, it relies on the clinical history of the materials and predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided in the document. For mechanical testing (like fatigue), ground truth is established by test standards and physical measurements, not expert consensus in the diagnostic sense.
4. Adjudication method for the test set
This information is not applicable and not provided. Mechanical tests do not typically involve adjudication.
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
This information is not applicable and not provided. This is a medical implant, not an AI-driven diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. This is a medical implant, not an algorithm.
7. The type of ground truth used
For the mechanical performance (e.g., fatigue testing), the "ground truth" would be established by physical measurements against ISO or ASTM standards for orthopedic implants. For the material biocompatibility, the "ground truth" relies on historical clinical evidence and generally accepted scientific principles for the specified materials. There is no pathology or outcomes data specifically generated for this submission detailed here.
8. The sample size for the training set
This information is not applicable and not provided. This is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not applicable and not provided. This is not an AI/ML device.
In summary: The provided text is a regulatory submission demonstrating substantial equivalence for a medical implant, rather than a clinical study report for a diagnostic device (especially an AI-driven one). The "proof" of performance relies on established materials, prior testing of predicate devices, and meeting design objectives.
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Image /page/0/Picture/1 description: The image shows the logo for StelKast company. The logo features a stylized letter "S" above the company name. The word "StelKast" is in a bold, italicized font, with a horizontal line running through the middle of the word. Below "StelKast" is the word "company" in a smaller, non-italicized font.
May 4, 1999
26 MM CAST CoCr HEAD AND POLYETHYLENE ACETABULAR SHELL LINER
Summary of Safety and Effectiveness Information Upon Which The Substantial Equivalence Determination is Based [510(k) Summarv]
The 26 mm CoCr Head and Hooded Liner are manufactured from biocompatible materials: Co-Cr-Mo alloy and ultra-high molecular-weight polyethylene (UHMWPE). These materials are in current use in numerous hip systems and their use has been established through many years of successful clinical application.
Fatigue testing of the stem and 26 mm head was satisfied under previously released 510(k) submissions. Likewise, the liner testing was satisfied under previous 510(k) submissions since only the I.D. has been changed.
A smaller CoCr head with appropriate liner was manufactured to increase polyethylene minimal thickness in the smaller diameter acetabular cups. These components will supplement 28 mm CoCr heads and liners already released in the ProForm and Provident Hip Systems.
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Phone: (412) 322-8280
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 14 1999
Mr. Donald A. Stevens President StelKast Company 800 Vinial St., Suite B-210 Pittsburgh, Pennsylvania 15212
Re: K991622
Trade Name: 26 mm CoCr Head and Polyethylene Liner Regulatory Class: II Product Code: JDI/LPH Dated: May 4, 1999 Received: May 11, 1999
Dear Mr. Stevens:
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 control provisions of the Act. The general control 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 Regulation (QS) for Medical Devices: General Regulation (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 regulation may result in regulatory action. In addition, FDA may publish further announcements 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 regulations.
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.
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Page 2 -- Mr. Donald A. Stevens
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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. 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): 26 mm Cast CoCr Head and Polyethylene Acetabular Shell Liner Device Name:
Indications For Use:
-
Joint impairment from arthritis (rheumatoid, osteo and post traumatic).
-
Revision of failed femoral head replacements.
-
When alternative reconstructive techniques are not viable.
-
- When arthrodesis is contraindicated.
-
- Avascular necrosis or fracture of the femoral head.
-
- Congenital defects that will allow adequate function of the system.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
$\infty$
neral Restorative Devices
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use
se HB
(Optional Format 1-2-96)
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.