(21 days)
The Contour Labral Nail™ is intended for use to maintain the proximity between soft tissue and bone to facilitate soft tissue reattachment in the repair of shoulder injuries. The Contour Labral Nail™ will be specifically indicated for use to provide internal fixation of soft tissue to bone for repair of anterior shoulder instability by reattachment of the glenoid labrum and/or inferior glenohumeral ligament in patients with primary or reoccurrent anterior dislocation or subluxation of the shoulder (i.e., Bankart lesions).
The Contour Labral Nail™ is an absorbable device designed to maintain the proximity between soft tissue and bone to facilitate soft tissue reattachment in the repair of shoulder injuries. The Contour Labral Nail™ is composed of poly-L,Dlactide copolymer, its length is 20mm and diameter 3.5mm.
The provided text is a 510(k) Summary for the Bionx Implants Inc. Contour Labral Nail™. This document describes a medical device and its intended use, demonstrating substantial equivalence to a predicate device for regulatory clearance. It does not present a study with acceptance criteria and device performance results in the way requested in the prompt (e.g., in the context of AI/software performance).
The request asks for information typically found in a clinical or performance study report for a diagnostic device or AI algorithm, particularly points related to ground truth, expert review, sample sizes for training/test sets, and comparative effectiveness studies.
Since the provided document is a 510(k) summary for a physical medical implant (a biodegradable soft tissue fixation fastener), these specific types of studies and acceptance criteria are not applicable or present in the text. The basis for clearance is demonstrating "substantial equivalence" to existing cleared devices, rather than a performance study meeting specific statistical criteria for accuracy, sensitivity, or specificity.
Therefore, I cannot fulfill the request as stated with the provided input.
However, based on the principle of substantial equivalence, the "acceptance criteria" can be inferred as demonstration of similar characteristics and performance to the predicate device.
Here's how the information in the document relates to the prompt, albeit with caveats due to the nature of the device:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Inferred from Substantial Equivalence): The device must have "the same intended use, similar principles of operation and technological characteristics" as the predicate devices, and "the minor technological differences... do not raise any new issues of safety or effectiveness."
- Reported Device Performance: The document does not provide quantitative performance metrics (e.g., success rates, complication rates) for the Contour Labral Nail™. Substantial equivalence is the basis for its clearance, implying its performance is expected to be similar to the predicate devices which are already on the market.
2. Sample sized used for the test set and the data provenance: Not applicable. This is not a study testing an algorithm on a dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no "ground truth" establishment in the context of an AI/diagnostic algorithm for this physical implant.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 a physical implant, not an AI or diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
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JAN 1 2 2001
510(k) Summary Bionx Implants Inc. Contour Labral Nail™
Submitter's Name, Address, Telephone Number, and Contact Person
Bionx Implants, Inc. 1777 Sentry Parkway West Gwynedd Hall, Suite 400 Bluebell, PA 19422
Contacts:
Gerard S. Carlozzi President, CEO Phone: (215) 643-5000 Facsimile: (215) 653-0984
| Bionx Implants Ltd. | |
|---|---|
| Tuija Annala | |
| Quality Manager | |
| P.O.Box 3 | |
| FIN-33721 Tampere | |
| Finland | |
| Phone: | 358-3-316 5679 |
| Facsimile: | 358-3-316 5688 |
Date prepared:
December 14th, 2000
Name of the device:
Trade or Proprietary Name: Contour Labral Nail™ A.
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| B. | Common Name: |
|---|---|
| C. | Classification Name: |
Bionx Contour Labral Nail Biodegradable soft tissue fixation fasteners
- D. Device Product Code: 87 MAI
Predicate Device:
Bionx Implants Inc. Bankart Tack™ Biodegradable soft tissue fixation fastener (K973849) and Anatomical Bankart Tack™ (the current Contour Labral Nail™) Biodegradable soft tissue fixation fastener (K992567).
Intended Use:
The Contour Labral Nail™ is intended for use to maintain the proximity between soft tissue and bone to facilitate soft tissue reattachment in the repair of shoulder injuries. The Contour Labral Nail™ will be specifically indicated for use to provide internal fixation of soft tissue to bone for repair of anterior shoulder instability by reattachment of the glenoid labrum and/or inferior glenohumeral ligament in patients with primary or reoccurrent anterior dislocation or subluxation of the shoulder (i.e., Bankart lesions).
Device Description:
The Contour Labral Nail™ is an absorbable device designed to maintain the proximity between soft tissue and bone to facilitate soft tissue reattachment in the repair of shoulder injuries. The Contour Labral Nail™ is composed of poly-L,Dlactide copolymer, its length is 20mm and diameter 3.5mm.
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Substantial Equivalence:
The Contour Labral Nail™ is substantially equivalent to the cleared Bionx Bankart Tack™ (K973849) and Anatomical Bankart Tack™ (the current Contour Labral Nail™) (K992567). All three devices have the same intended use, similar principles of operation and technological characteristics. Furthermore, the minor technological differences between the Contour Labral Nail™ and the predicate devices do not raise any new issues of safety or effectiveness.
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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing right, with flowing lines beneath them.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 2 2001
Bionx Implants, Inc. Ms. Tuija Annala Quality Manager c/o Bionx Implants, LTD Hermiankatu 6-8 L Tampere, Finland
Re: K003970
Trade Name: Contour Labral Nail™ Regulatory Class: II Product Code: MAI, MNN and MRY Dated: December 19, 2000 Received: December 22, 2000
Dear Ms. Annala:
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 - Ms. Tuija Annala
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, (Jaase 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,
Miriam C. Provost for
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(K) Number (if known): K003970
Device Name:
Contour Labral Nail™
Indications for Use:
The Bionx Contour Labral Nail™ is intended for use to maintain the proximity between soft tissue and bone to facilitate soft tissue reattachment in the repair of shoulder injuries. The Bionx Contour Labral Nail™ will be specifically indicated for use to provide internal fixation of soft tissue to bone for repair of anterior shoulder instability by reattachment of the glenoid labrum and/or inferior glenohumeral ligaments in patients with primary or recurrent anterior dislocation or subluxation of the shoulder (i.e. Bankart lesions).
(Please do not write below this line - continue on another page is needed) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ﮐﮯ (Per 21 CFR 801.109)
Over-The-Counter Use_ OR
Muriam C. Provost
of General Restorative Devices 510(k) Number_ K003970
§ 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.