(64 days)
The intended use of the distal radius fracture fixation plate system is internal fixation of fractures and osteotomies of the distal radius. This may include:
- Displaced or non-displaced fracture which may or may not involve angulation or . fragmentation of bone,
- Failed fracture fixation with or without bone graft, ●
- Osteotomy and repair of distal radius malunion with or without bone graft. .
The distal radius plate like the predicate device includes various size plates, right, left, small, large, accessories and instruments. The bone screws enable the plate to be coupled to bone by securing the screws for the intended use. The various components within the system are provided to accommodate various anatomies and injuries.
The provided text is a 510(k) summary for a medical device (Distal Radius Fracture Fixation Plate System) and does not describe primary studies with acceptance criteria or performance metrics for a novel diagnostic or AI-driven device. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on design and intended use.
Therefore, most of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types and establishment methods) cannot be extracted from this document as it pertains to a different type of regulatory submission and device evaluation.
However, I can provide the following based on the available information:
1. A table of acceptance criteria and the reported device performance
This document does not present acceptance criteria or reported device performance in the manner requested for a diagnostic or AI device. The "performance" being assessed here is the substantial equivalence of the new device's design, materials, and intended use to existing predicate devices.
| Feature | Predicate Devices (Orthomet, Synthes) | Avanta Orthopaedics (New Device) |
|---|---|---|
| Plates | Implantable | Implantable |
| Screws | Implantable | Implantable |
| Material | 316L | 316L |
Study Proving Device Meets Acceptance Criteria:
The study is a comparison of the new device to predicate devices based on design characteristics and intended use to demonstrate "substantial equivalence" as required for a 510(k) application. The document explicitly states: "The device and the predicate device have similar design characteristics and intended use. The new device is substantially equivalent to the predicate device."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a comparison of device specifications, not a clinical trial or performance study involving a test set of data.
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. Ground truth as typically understood for diagnostic/AI devices is not relevant to this type of device comparison. The "truth" being established is the similarity in design and function to legally marketed predicate devices, which is assessed by the FDA based on the provided technical documentation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set or adjudication process in the context of a performance study described here.
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 not an AI-assisted diagnostic device, and therefore no MRMC study addressing human reader improvement with AI would have been conducted or reported here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the sense of clinical ground truth for diagnostic accuracy. The "ground truth" for this 510(k) submission is the established design, material, and intended use of the predicate devices, against which the new device is compared for substantial equivalence.
8. The sample size for the training set
Not applicable. There is no training set for an AI algorithm described.
9. How the ground truth for the training set was established
Not applicable. There is no training set for an AI algorithm described.
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4/29/99
Image /page/0/Picture/1 description: The image shows a handwritten string of alphanumeric characters. The string appears to be "K990596". The characters are written in a cursive style, with some connections between the letters and numbers. The image has a white background, and the characters are written in black ink.
510 (k) Summary
Summary of 510 (k) safety and effectiveness information upon which the substantial equivalence determination is based:
February 4, 1999 Prepared:
Applicant: Avanta Orthopaedics, Inc. 9369 Carroll Park Drive, Suite A San Diego, CA 92121
| Telephone: | 619-452-8580 |
|---|---|
| Fax: | 619-452-9945 |
| Contact: | Louise M. Focht |
Device Name:
Device Trade Name:
Device Classification: Reviewing Panel: Regulation Number Product Code: Accessories Predicate Device:
Single/Multiple Component Metallic Bone Fixation Appliance and Accessories Distal Radius Fracture Fixation Plate System Class II Orthopaedic 888.3030 87HRS
Orthomet K943853 Synthes K953644 Avanta K981715
Device Description:
The distal radius plate like the predicate device includes various size plates, right, left, small, large, accessories and instruments. The bone screws enable the plate to be coupled to bone by securing the screws for the intended use. The various components within the system are provided to accommodate various anatomies and injuries.
Intended Use:
The intended use of the distal radius fracture fixation plate system is internal fixation of fractures and osteotomies of the distal radius. This may include:
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- Displaced or non-displaced fracture which may or may not involve angulation or . fragmentation of bone,
- Failed fracture fixation with or without bone graft, ●
- Osteotomy and repair of distal radius malunion with or without bone graft. .
Comparison to Predicate Device:
The table below summarizes similarities and differences between the Orthomet, Synthes and the Avanta Orthopaedics devices.
| Feature | Orthomet | Synthes | Avanta Orthopaedics |
|---|---|---|---|
| Plates | Implantable | Implantable | Implantable |
| Screws | Implantable | Implantable | Implantable |
| Material | 316L | 316L | 316L |
Summary:
The device and the predicate device have similar design characteristics and intended use. The new device is substantially equivalent to the predicate device.
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Image /page/2/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, stacked on top of each other. The profiles are connected and appear to be flowing or waving. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 9 1999
Ms. Louise M. Focht Director of Operations Avanta Orthopaedics, Inc. 9369A Carroll Park Drive San Diego, California 92121
K990596 Re: Distal Radius Fracture Fixation Plate System Trade Name: Regulatory Class: II Product Codes: HRS and HWC Dated: February 4, 1999 February 24, 1999 Received:
Dear Ms. Focht:
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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 requlations 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 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 requlatory 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.
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Page 2 - Ms. Louise M. Focht
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 Also, please note the Office of Compliance at (301) 594-4639. 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,
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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Indications for Use:
K990596 510(k) Number:
Distal Radius Fracture Fixation Plate Device Name:
The intended use of the distal radius fracture fixation plate system is internal fixation of fractures and osteotomies of the distal radius. This may include:
- Displaced or non-displaced fracture which may or may not involve angulation or . fragmentation of bone,
- Failed fracture fixation with or without bone graft, ●
- Osteotomy and repair of distal radius malunion with or without bone graft. .
Pcoegle
ign-Off) n of General Restorative Devices k) Number .
Prescription Use
(Per 21 CFR 801.109)
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.