EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS by ELECTRO-BIOLOGY, INC.

The EBI X FIX DynaFix® Hydroxyapatite® (HA) Coated Screws are intended for use in external fixation for the treatment of bone conditions including limb lengthening, corrective osteotemies, arthrodesis, fracture fixation, acute or gradual multiplanar correction and other bone conditions amenable to treatment by use of the external fixation modality.

Device Description

The bone screws have a tapered thread diameter and are available in a variety of diameters and lengths in both cortical and cancellous thread patterns. The screws will be available with and without the additional proprietary hydroxapatite surface coating on the threads, and will be sold sterile and nonsterile. The coating has been shown to enhance fixation at the pin-bone interface and to reduce the incidence of pin loosening. Furthermore, osseointegration with direct contact between the bone and the screw thread was seen on histologic examination.

AI/ML Overview

The provided text describes a 510(k) summary for the EBI X FIX® DynaFix® System HA Coated Bone Screws, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed studies proving performance against specific acceptance criteria in the manner of a new drug or novel medical device requiring extensive clinical trials.

Therefore, the input does not contain the specific information required to complete tables or answer questions related to acceptance criteria, device performance studies, sample sizes, expert ground truth, or MRMC studies. The document primarily discusses the device description, intended use, materials, comparison to predicate devices, and regulatory approval.

Explanation of Missing Information:

Acceptance Criteria and Reported Device Performance: This device is a bone screw. The "performance" in this context would typically relate to mechanical strength (fatigue, pull-out strength), biocompatibility, and perhaps evidence of enhanced bone integration. While the summary mentions "biocompatibility, fatigue, and effectiveness testing," it does not provide the specific quantitative acceptance criteria or the reported results from these tests to compare against such criteria. For example, it doesn't say "fatigue strength must be X, and our device achieved Y."
Sample Size, Ground Truth, Adjudication for Test Set: These details are relevant for studies involving diagnostic or AI-powered devices where a "test set" of data is evaluated against a "ground truth" established by experts. This is not applicable to a physical implant like a bone screw in the context of this 510(k) summary.
MRMC Comparative Effectiveness Study: An MRMC study is used to evaluate the impact of a diagnostic aid (e.g., AI) on human reader performance. This is not relevant to a bone screw.
Standalone Performance: "Standalone performance" refers to the algorithm's performance without human intervention, again applicable to AI/diagnostic tools, not a physical implant.
Type of Ground Truth: The concept of "ground truth" in the context of a bone screw's performance evaluation would involve objective measures from mechanical testing (e.g., stress-strain curves, failure points), histological analysis (for osseointegration), or potentially animal model outcomes. The summary mentions "osseointegration with direct contact between the bone and the screw thread was seen on histologic examination," but this is a general statement, not a detailed ground truth methodology for a formal study.
Training Set Sample Size and Ground Truth Establishment (Training Set): The bone screw does not involve a "training set" in the sense of machine learning. Its development would involve material science, engineering design, and biomechanical testing, not data-driven model training.

Summary of Available Information (and lack thereof for your specific questions):

The 510(k) summary identifies the predicate device, states that the device underwent "biocompatibility, fatigue, and effectiveness testing," and mentions "osseointegration with direct contact between the bone and the screw thread was seen on histologic examination." However, it does not provide the granular detail requested about acceptance criteria, numerical performance data, sample sizes, expert involvement, or specific study methodologies typical for AI/diagnostic devices.

Summary

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K99 2367

510(k) Summary of Safety & Effectiveness

This 510(k) Summary of Safety and Effectiveness for the EBI X FIX® DynaFix® System is provided as required per Section 513(I)(3) of the Food, Drug and Cosmetic Act.

1. Submitter: Jon Caparotta, RA Manager Electro-Biology, Inc. 100 Interpace Parkway Parsippany, NJ 07054
  Contact Person: Jonas Wilf, RA Specialist Telephone: (973) 299-9022 X2208 Fax: (973) 257- 0232

Date prepared: July 14, 1999

EBI X FIX® DynaFix® System HA Coated Bone Screws 2. Proprietary Name: Common Name: External Fixation Bone Screws Classification Name/Code: Pin, Fixation, Threaded (888.3040)/JDW
1. Predicate or legally marketed devices that are substantially equivalent:
- 트 Orthofix® External Fixation Screw with Hydroxapatite Coating-Orthofix Srl
Description of the device: The bone screws have a tapered thread diameter and are available in a variety of 4. diameters and lengths in both cortical and cancellous thread patterns. The screws will be available with and without the additional proprietary hydroxapatite surface coating on the threads, and will be sold sterile and nonsterile. The coating has been shown to enhance fixation at the pin-bone interface and to reduce the incidence of pin loosening. Furthermore, osseointegration with direct contact between the bone and the screw thread was seen on histologic examination.

Intended Use: The EBI X FIX® DynaFix® System Hydroxyapatite (HA) Coated Screws are intended for use in association with the external fixation of bone.

1. Materials: The HA Coated bone screws are manufactured from stainless steel, 316L per ASTM F138. The HA coating is applied by a proprietary process according to Device Master File MAF-339 and ASTM F 1185.
1. Comparison of the technological characteristics of the device to predicate devices: There are no significant differences between the HA coated bone screws and other currently marketed bone screws since the addition of a HA coating does not adversely affect the use of the bone screws. The coated screws underwent biocompatibility, fatigue, and effectiveness testing to determine if the device was safe and effective. It is substantially equivalent* to the predicate devices in design and function.

* Any statement made in conjunction resarcing a determination of substantial equivalence to any other product is intended only to relate to whether the product can be lawfully me-market approval or reclassification and is not intended to be interpreted as an admission or any other type of evidence in patent litigation (Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]

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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three parallel lines forming its wings and head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 23 1999

Mr. Jon Caparotta Manager, Regulatory Affairs Electro-Biology, Inc. 100 Internace Parkway Parsippany, New Jersey 07054

Re: K992367

Trade Name: EBI X FIX® DynaFix® System Hydroxyapatite (HA) Coated Bone Screws Regulatory Class: II Product Code: HWC Dated: July 14, 1999 Received: July 15, 1999

Dear Mr. Caparotta:

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.

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Page 2 - Mr. Jon Caparotta

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) 594-4595. 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" (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,

tcolleto

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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K992367

Statement of Indications for Use:

Datter

(Division Sigh 11992367 Division of General 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Regulation Number and Section

§ 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.