EBI DYNAFIX COMPRESSION BONE SCREW

• K Number: K030706
• Device Name: EBI DYNAFIX COMPRESSION BONE SCREW
• Manufacturer: EBI, L.P.
• Date Cleared: 2003-03-20 ( 14 days)
• Product Code: HWC
• Regulation Number: 888.3040
• Type: Traditional
• Panel: OR
• Reference & Predicate Devices: K792022 , K930834 , K020791

Intended Use

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

Device Description

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.

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.