(79 days)
Synthes Button Plate is intended for augmentation of transosseous rotator cuff repair, especially in massive tears and reruptures in proximity to osteopenic bone.
Synthes Button Plate is a pre-bent plate consisting of seven holes for passing up to #5 sutures. The plate is 0.7 mm thick, 10 mm in width, and is 17 mm in length. The Button Plate is manufactured from titanium and is MRI safe.
The provided text is a 510(k) summary for the Synthes Button Plate, a medical device. This document describes the device, its intended use, and its equivalence to a predicate device. However, it does not contain the detailed information needed to fill out many of the requested fields regarding acceptance criteria, specific study designs, sample sizes, expert qualifications, or ground truth establishment.
This type of regulatory submission typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a full efficacy study with detailed performance metrics against pre-defined acceptance criteria relevant to AI/device performance as requested.
Therefore, I can only fill out the table and provide information that is explicitly stated in the document.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance (Explicitly Stated in Document) |
|---|---|
| Substantial equivalence to predicate device (Arthrex's Bio-Button) for stated indications for use. | The FDA determined the device is substantially equivalent for the indications for use stated in the enclosure. |
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 mentioned in the document.
- Data provenance: Not mentioned in the document. This document primarily focuses on regulatory submission for substantial equivalence based on device design and intended use, not a clinical study with a test set.
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)
- Number of experts: Not mentioned in the document.
- Qualifications of experts: Not mentioned in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not mentioned in the document.
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
- MRMC study: Not mentioned in the document. Since this is a physical implant device, an MRMC study comparing human readers with and without AI assistance is not applicable in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance study: Not mentioned in the document. This is a physical device, not an algorithm, so a standalone performance study in the context of AI is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of ground truth: Not mentioned in the document. The substantial equivalence determination is based on the comparison of specifications, materials, and intended use with a predicate device, rather than a "ground truth" as typically understood in AI performance studies.
8. The sample size for the training set
- Sample size for training set: Not applicable. This document describes a physical medical device, not an AI/ML algorithm that would typically have a "training set."
9. How the ground truth for the training set was established
- How ground truth was established: Not applicable, as this is not an AI/ML algorithm.
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Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a stylized image inside. A small circled "R" trademark symbol is located to the right of the word.
: MAR 1 5 2000
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Image /page/0/Picture/2 description: The image contains a sequence of alphanumeric characters that appear to be handwritten. The characters are 'K994364', with the 'K' being a capital letter followed by a series of numbers. The handwriting is somewhat stylized, with some characters connected and others distinct.
:
| Attachment VI | Summary of Safety and Effectiveness Information[510(k) Summary] |
|---|---|
| SUBMITTER | Synthes (USA)1690 Russell RoadPaoli, PA 19301(610) 647-9700Contact: Sheri L. Musgnung |
| DEVICE NAME: | Synthes Button Plate |
| COMMON OR USUALNAME | Fastener, Fixation, nondegradable, Soft Tissue |
| DEVICECLASSIFICATION: | Class II, 21 CFR 808.3030 |
| PREDICATE DEVICE: | Arthrex's Bio-Button |
| DESCRIPTION: | Synthes Button Plate is a pre-bent plate consisting of seven holesfor passing up to #5 sutures. The plate is 0.7 mm thick, 10 mmin width, and is 17 mm in length. The Button Plate ismanufactured from titanium and is MRI safe. |
| INTENDED USE: | Synthes Button Plate is intended for augmentation oftransosseous rotator cuff repair, especially in massive tears andreruptures in proximity to osteopenic bone |
CONFIDENTIAL
000049
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mar 1 5 2000
Ms. Sheri L. Musgnung Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301
Re: K994364 Trade Name: Synthes Button Plate Regulatory Class: Class II Product Codes: MBI, KGS Dated: December 23, 1999 Received: December 27, 1999
Dear Ms. Musgnung:
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 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). 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 requirements, 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. Sheri L. Musgnung
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) 594-4595. 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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Niel R. Ogle
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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| 1 | |||
|---|---|---|---|
| A Children Controller------------ | AAA | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------A .- CHEVROL COLL LEVELLE .- CHE .- CHE .- CHERE A LA | |
| 510(k) Number (if known): | K994364 |
|---|---|
| --------------------------- | --------- |
Device Name: Synthes Button Plate
Indications For Use:
Synthes Button Plate is intended for augmentation of transosseous rotator cuff repair, especially in massive tears and reruptures in proximity to osteopenic bone.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
× Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
NRO fvc cmw
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K994364 |
|---|---|
| --------------- | --------- |
CONFIDENTIAL
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.