(45 days)
This bone band is indicated for use in orthopedic surgery as an aid for the positioning of bone fixation plates.
This bone band is indicated for use in orthopedic surgery as an aid for reducing fractures and for the positioning of bone fixation plates.
The bone band device consists of a 0.20" wide by 0.05" thick by 17.0" long strip of biocompatable nylon with a 0.1" wide x 0.5" long slot at each end. The surface of the band is smooth with radiused edges.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the "Bone Band" device.
Unfortunately, the provided text does not contain information about a study that proves the device meets specific acceptance criteria. The document is a 510(k) summary for a medical device ("Bone Band"), which primarily focuses on demonstrating substantial equivalence to a predicate device.
Instead of performance criteria and a study demonstrating compliance, the document provides a comparison of the characteristics of the submitted device to a predicate device. This is typical for a 510(k) submission where the primary argument for market clearance is that the new device is as safe and effective as an already legally marketed device, and therefore may not require extensive new clinical or performance studies if the differences are minor.
Therefore, for most of your requested points, the answer will be that the information is not present in the provided text.
Here's a breakdown based on the information available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Not specified. | Material of construction: Biocompatible Nylon |
| (No specific | Length x Width x Thickness: 17.0 x 0.20 x 0.05 |
| performance | Reuseability: Single Patient Use |
| criteria listed) | Sterility: Sterile |
| Implantation: Non-implantable |
Note: The document states the predicate device is Stainless Steel, reusable, non-sterile. The submitted device has different characteristics in these attributes, but the 510(k) process aims to show these differences do not raise new questions of safety or effectiveness.
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. The document does not describe a performance or clinical study; it focuses on a comparison of device characteristics to a predicate device.
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. No test set or ground truth establishment by experts is described for a performance study. The "ground truth" in a 510(k) is implicitly the safety and efficacy of the predicate device, which is already on the market.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set requiring adjudication is described.
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 device is a physical bone band, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical bone band.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. In the context of a 510(k) substantial equivalence, the "ground truth" is often the established safety and effectiveness of the legally marketed predicate device, rather than a specific ground truth for a new performance study.
8. The sample size for the training set
- Not applicable. No training set is involved for this type of device and submission.
9. How the ground truth for the training set was established
- Not applicable. No training set or associated ground truth establishment is described.
In summary: The provided document is a 510(k) summary for a basic orthopedic surgical aid. The primary argument for market clearance is substantial equivalence to an existing predicate device, not the demonstration of performance against specific acceptance criteria through a new study. Therefore, most of the requested information regarding study design, sample sizes, ground truth, and expert evaluation is not present in this type of regulatory submission.
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Chapel and Associates
DEC 4 1998 1019 Ridgecrest Circle Denton, Texas 76205 (940)380-2958
510(K) Summary
Date: 14 October 1998
Trade Name:Bone Band
Common Name: Bone Band
Classification Name: Unknown
Device Description: The bone band device consists of a 0.20" wide by 0.05" thick by 17.0" long strip of biocompatable nylon with a 0.1" wide x 0.5" long slot at each end. The surface of the band is smooth with radiused edges.
Intended Use: This bone band is indicated for use in orthopedic surgery as an aid for the positioning of bone fixation plates.
Substantial Equivalence: This bone band submitted device is substantially equivalent to the Particate device currently being sold in the United States by Zimmer, Inc. P.O. Box 708, Warsaw, IN 46581. To the best of our knowledge, this predicate devices is being "legally" marketed
Predicate Device
Stainless steel
7.56 x 0.20 x 0.025
Reuseable
Non-sterile
Non-implantable
mparison to Predicate Device:
Attribute Material of construction Length x Width x Thickness (inches Reuseability Sterility Implantation
Submitter's Name Submitter's Address: Submitter's Phone #: Submitter's Contact Person: Chapel and Associates 1019 Ridgecrest Circle, Denton, TX 76205 (940) 380-2958 James F. Chapel
Submitted Device Biocompatable Nylon 17.0 x 0.20 x 0.05 Single Patient Use Sterile Non-implantable
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Image /page/1/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 depiction of a human figure embracing a globe, symbolizing the department's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC = 4 1998
Mr. James F. Chapel President Chapel and Associates 1019 Ridgecrest Circle Denton, Texas 76205
Re : K983685 Bone Band Regulatory Class: II Product Code: LYT Dated: October 14, 1998 Received: October 20, 1998
Dear Mr. Chapel:
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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Requlations, 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 requlation 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.
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Page 2 - Mr. James F. Chapel
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 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Colin M. Whitten, Ph. D.
M. Witten, Ph.D., M.D. Celia 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:
Device: Bone band
Indications For Use: This bone band is indicated for use in orthopedic surgery as an aid for reducing fractures and for the positioning of bone fixation plates.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| (Division Sign-Off) | ||
| Division of General Restorative Devices | ||
| 510(k) Number | K983685 | |
| Prescription Use(Per 21 CFR 801.109) | OR | Over-the-Counter Use |
(Optional Format 1-2-96)
§ 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.