EBI DYNAFIX COMPRESSION BONE SCREW by EBI, L.P.

The EBI® DynaFix® Compression Bone Screw is intended to be inserted across the fracture site. The EBI® DynaFix® Compression Bone Screw will provide compression across the fracture site.

AI/ML Overview

This document is a 510(k) summary for a medical device called the EBI® DynaFix® Compression Bone Screw. It is a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, rather than a study designed to prove acceptance criteria through performance evaluation against specific metrics. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not applicable to this type of FDA submission.

Here's a breakdown of the relevant and non-relevant information based on your request:

1. Table of acceptance criteria and the reported device performance:

Not Applicable. This 510(k) submission does not present specific quantitative acceptance criteria or reported device performance metrics in the way a clinical or technical validation study would for a new device. The basis for marketing is demonstrating "substantial equivalence" to existing predicate devices, not meeting novel performance benchmarks.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not Applicable. No explicit test set or clinical data is described in this 510(k) summary. The submission relies on a comparison of technological characteristics (intended use, materials, function) to predicate devices.

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, in the context of expert review, is not relevant here as there is no human review of output for performance evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable. No test set or related adjudication process 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 mechanical bone screw, not an AI-powered diagnostic or assistive tool. MRMC studies are completely irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

Not Applicable. "Ground truth" as an established definitive diagnosis or outcome is not a concept applied in this 510(k) filing. The "truth" considered by the FDA in this context is whether the device is sufficiently similar to legally marketed devices.

8. The sample size for the training set:

Not Applicable. This 510(k) is not for an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:

Not Applicable. See point 8.

Summary of Relevant Information from the Document:

While the document doesn't fit the typical "acceptance criteria and study" format for AI or diagnostic devices, here's what can be extracted regarding the basis for its market acceptance:

Device Name: EBI® DynaFix® Compression Bone Screw
Intended Use: The EBI® DynaFix® Compression Bone Screws are indicated for fusions, fractures, or osteotomies of the upper and lower extremities.
Basis for Acceptance: Substantial Equivalence to legally marketed predicate devices.
Predicate Devices:
- Zimmer Herbert Screw (K792022)
- Acumed Acutrak (K930834)
- Millennium HBS Headless Bone Screw (K020791)
Comparison Rationale: "There are no significant differences between the EBI® DynaFix® Compression Bone Screws and other currently marketed internal fixation systems. It is substantially equivalent to the predicate device in regards to intended use, materials, and function."
Materials: Stainless steel as per ASTM F-899.
FDA Determination: The FDA reviewed the 510(k) premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. This determination allows the device to be marketed.

Summary

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MAR 2 0 2003

030706
page 1 of 2

510(k) Summarv

This 510(k) Summary for the EBI® DynaFix® Compression Bone Screws is provided as required per Section 513(3) of the Food, Drug and Cosmetic Act.

1. Submitter: EBI, L.P. 100 Interpace Parkway Parsippany, NJ 07054
  Contact Person: Frederic Testa Phone: (973)299-9300, ext. 2208

Date prepared: March 3, 2003

2. Proprietary Name:	EBI® DynaFix® Compression Bone Screw
Common Name:	Internal Fixation Device
Classification Names:	Smooth or Threaded Metallic BoneFixation Fastener, 21 CFR 888.3040

1. Predicate or legally marketed devices that are substantially equivalent:
- Zimmer Herbert Screw (K792022) ●
- Acumed Acutrak (K930834) .
- Millennium HBS Headless Bone Screw (K020791) ●
Description of the device: The EBI® DynaFix® Compression Bone Screw is 4. intended to be inserted across the fracture site. The EBI® DynaFix® Compression Bone Screw will provide compression across the fracture site.
1. Intended Use: The EBI® DynaFix® Compression Bone Screws are indicated for fusions, fractures, or osteotomies of the upper and lower extremities.

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Materials: The components of the System may be manufactured from stainless steel as per ASTM F-899.

7. Comparison of the technological characteristics of the device to predicate

devices: There are no significant differences between the EBI® DynaFix®

Compression Bone Screws and other currently marketed internal fixation systems. It

is substantially equivalent* to the predicate device in regards to intended use,

materials, and function.

* Any statement made in conjunction with this submission regarding a determination of substantial equivalence to any other product is intended only to relate to whether the product can be lawfully marketed without pre-market approval or reclassification and is not interpreted as an admission or any other type of evidence in patent infringement litigation. [Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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 symbol featuring three abstract human profiles facing to the right, with flowing lines beneath them, possibly representing water or movement.

MAR 2 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Frederic Testa, RAC Senior Regulatory Affairs Specialist EBI, L.P. 100 Interpace Parkway Parsippany, NJ 07054

Re: K030706

Trade/Device Name: EBI® DynaFix® Compression Bone Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: March 3, 2003 Received: March 6, 2003

Dear Mr. Testa:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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.

L. Mark N. Melkerson

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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STATEMENT OF INDICATIONS FOR USE

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: EBI® DynaFix® Compression Bone Screw

Indications For Use:

The EBI® DynaFix® Compression Bone Screws are indicated for fusions, fractures, or osteotomies of the Upper and Lower Extremities.

(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

(Optional Format 1-2-96)

Mark N Millann

Division Sign-Off Division of General. Restorative and Neurological Dovices

510(k) Number K030706

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.