(88 days)
Use of the Modular Radial Head Implants may be considered for :
- Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
- joint destruction and/or subluxation visible on x-ray; and/or
- resistance to conservative treatment.
- Primary replacement after fracture of the radial head.
- Symptomatic sequelae after radial head resection.
- Revision following failed radial head arthroplasty.
The Modular Radial Head is manufactured from Cobalt Chrome (ASTM F 1537) . The stem is designed to be a two-piece modular design that is assembled at the time of implantation. The proximal portion of the head is concave and has rounded contours. The head and stem are available in standard sizes and +2 and +4 configurations.
The information provided describes a medical device submission (K991915) for a "Modular Radial Head" prosthesis. However, the provided text does not contain specific acceptance criteria, details of a clinical study, or performance metrics beyond a statement about mechanical test data.
Therefore, I cannot fulfill most of your request based on the given input. The document focuses on the regulatory submission process, intended use, and the FDA's determination of substantial equivalence.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not provided. The document states, "Mechanical test data demonstrated that it meets the requirements cited in the FDA Guidance Documents," but it does not specify what those requirements (acceptance criteria) were or what the specific test results were.
- Reported Device Performance: Not provided. Only a general statement about meeting requirements is present.
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 (Test Set): Not provided. The document refers to "mechanical test data" but gives no details about the size or nature of any test set (e.g., number of implant samples, number of patients).
- Data Provenance: Not provided. There is no mention of country of origin or whether any data was retrospective or prospective. Given it's "mechanical test data," it's likely bench testing, not patient data in the typical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. The "ground truth" concept usually applies to studies involving human interpretation or clinical outcomes. This document only mentions "mechanical test data," which typically relies on established engineering standards and measurements, not expert consensus on interpretations.
4. Adjudication method for the test set:
- Not applicable / Not provided. Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in expert opinions, which is not relevant to mechanical testing.
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:
- No. This is a medical device for orthopedic joint replacement, not an AI-assisted diagnostic tool. An MRMC study is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not provided (but implied by "mechanical test data"): For mechanical testing of an implant, the "ground truth" would typically be defined by engineering specifications, material properties, and performance benchmarks (e.g., load-bearing capacity, fatigue life) measured objectively. The document does not specify these.
8. The sample size for the training set:
- Not applicable / Not provided. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable / Not provided. This is not an AI/machine learning device.
In summary, the provided text is a regulatory clearance letter and a summary of the device's intended use and design. It confirms that "Mechanical test data demonstrated that it meets the requirements cited in the FDA Guidance Documents" but does not detail the specific criteria, the study methodology, or the results of those mechanical tests.
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SEP 13 1999
Attachment 2
Summary
510(k) Summary
Company: Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002
Date: June 7, 1999 Trade Name: Modular Radial Head Common Name: Radial Head Prosthesis Predicate Device: Metallic Radial Head Implant
Description/Intended Use:
The Modular Radial Head is manufactured from Cobalt Chrome (ASTM F 1537) . The stem is designed to be a two-piece modular design that is assembled at the time of implantation. The proximal portion of the head is concave and has rounded contours. The head and stem are available in standard sizes and +2 and +4 configurations.
Use of the Modular Radial Head Implants may be considered for :
- Replacement of the radial head for degenerative or post-traumatic ● disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
- a. joint destruction and/or subluxation visible on x-ray; and/or b. resistance to conservative treatment.
- Primary replacement after fracture of the radial head. .
- Symptomatic sequelae after radial head resection. .
- Revision following failed radial head arthroplasty. .
The Modular Radial Head was declared substantially equivalent to the predicate devices. Mechanical test data demonstrated that it meets the requirements cited in the FDA Guidance Documents.
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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or other bird with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 3 1999
Ms. Lynne Witkowski Regulatory Affairs Associate Wright Medical Technology Inc. 5677 Airline Road Arlington, Tennessee 38002
Re: K991915 Trade Name: Modular Radial Head Regulatory Class: II Product Code: KWI Dated: June 4, 1999 Received: June 7, 1999
Dear Ms. Witkowski:
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 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 - Ms. Lynne Witkowski
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,
Colin M. Witter, Ph.D., M.D.
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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| Attachment 3 | Indications for Use Statement |
|---|---|
| 510(k) Number(if known) | K991915 |
| Device Name | Modular Radial Head |
| Indications for Use | Intended UseUse of the Modular Radial Head Implants may be considered for : Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with: joint destruction and/or subluxation visible on x-ray; and/orresistance to conservative treatment.Primary replacement after fracture of the radial head.Symptomatic sequelae after radial head resection.Revision following failed radial head arthroplasty. |
Revision following failed radial head arthroplasty. .
PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF
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Concurrence of CDRH, Office of Device Evaluation (ODE)
X Prescription Use (per 21 CFR 801.109)
OR
Over-The Counter Use
P cóll
(Division Sigh-Off) Division of General Restorative Devices 510(k) Number -
§ 888.3170 Elbow joint radial (hemi-elbow) polymer prosthesis.
(a)
Identification. An elbow joint radial (hemi-elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone elastomer used to replace the proximal end of the radius.(b)
Classification. Class II.