EBI X FIX DYNAFIX MINI EXTERNAL FIXATION SYSTEM by EBI, L.P.

The EBI X FIX™ DynaFix® Mini External Fixation System consists of fixator components and bone screws. The fixator frame consists of fixator rails which are connected by a central component. The fixator frame attaches to the bone via bone screws which penetrate the patient's skin. The fixator frame secures to the shanks of the bone screws with bone screw clamps. The EBI X FIX™ DynaFix® Mini External Fixation System is capable of providing physicians with capability to lengthen. The EBI X FIX™ DynaFix® Mini External Fixation System frame components are composed of aluminum alloy, titanium alloy and stainless steel. The EBI X FIX™ DynaFix® Mini External Fixation System bone screws are made of 316L stainless steel.

AI/ML Overview

This document describes a 510(k) summary for a medical device, the EBI X FIX™ DynaFix® Mini External Fixation System. It focuses on demonstrating substantial equivalence to predicate devices based on mechanical performance testing. This is not a study involving AI, image analysis, or human readers, so many of the requested fields are not applicable.

Here's the closest interpretation of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (Implicit)	Reported Device Performance
Mechanical Strength (Static)	At least equivalent to predicate device (Orthofix® Mini Fixator and Mini Lengthener)	"the EBI X FIX™ DynaFix® Mini External Fixation System has greater mechanical strength than the Orthofix® Mini Fixator and Mini Lengthener."
Mechanical Strength (Fatigue)	At least equivalent to predicate device (Orthofix® Mini Fixator and Mini Lengthener)	"the EBI X FIX™ DynaFix® Mini External Fixation System has greater mechanical strength than the Orthofix® Mini Fixator and Mini Lengthener."

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not explicitly stated in terms of number of devices tested. It is implied that "Comparative testing" was performed on test articles of the EBI X FIX™ DynaFix® Mini External Fixation System and the Orthofix® Mini Fixator and Mini Lengthener.
Data Provenance: Not explicitly stated. The testing was performed for EBI, a US-based company, suggesting the tests were likely conducted in the US, but this is not confirmed. The study is prospective in the sense that the tests were performed specifically for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A. This is a mechanical device performance study, not a study involving expert assessment of images or clinical outcomes. The "ground truth" here is the physical performance as measured by engineering tests.

4. Adjudication method for the test set

N/A. As above, this is a mechanical testing study. Results are based on physical measurements, not human judgment requiring adjudication.

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

No. This document describes a 510(k) submission for an external fixation system, focusing on its mechanical equivalence to predicate devices. It does not involve AI, image analysis, or human readers.

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

N/A. This device is a physical medical implant, not an algorithm.

7. The type of ground truth used

Mechanical Performance Data: The "ground truth" is established through standardized engineering testing for static and fatigue strength, measured according to relevant national or international standards (though not explicitly cited, this is typical for device testing). The performance of the predicate device serves as the benchmark.

8. The sample size for the training set

N/A. There is no "training set" as this is not an AI/machine learning study.

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

N/A. There is no "training set" or corresponding ground truth establishment process for this type of device submission.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Electro Biology, Inc. The logo consists of the letters "EBI" in large, bold, black font, followed by the words "Electro Biology" in a smaller, italicized font. There is a line above the word "Electro" and a small symbol above the "I" in "EBI".

Enhancing Bone Healing through Applied Science

970290

510(k) SUMMARY FOR THE X FIX™ DynaFix® Mini External Fixation System

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The EBI X FIX™ DynaFix® Mini External Fixation System is a unilateral external fixation device intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis. fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality. External fixators are recommended for Class II by the Orthopedic Panel (Single/Multiple Component Metallic Bone Fixation Appliance, 21 CFR 888.3030).

The EBI X FIX™ DynaFix® Mini External Fixation System is substantially equivalent to the Orthofix® Mini Fixator and Orthofix® Mini Lengthener (Orthofix® S.R.L., Verona Italy) the Synthes Mini External Fixator (Synthes, USA) and the Hoffman Mini External Fixator (Howmedica, Inc.).

Comparative testing of the EBI X FIX™ DynaFix® Mini External Fixation System and the Orthofix® Mini Fixator and Mini Lengthener was performed. The testing included static and fatigue testing. The results demonstrate that in general, the EBI X FIX™ DynaFix® Mini External Fixation System has greater mechanical strength than the Orthofix® Mini Fixator and Mini Lengthener.

In summary, the results of the static and fatigue testing and the comparison of the systems' intended uses, components and designs demonstrate that the EBI X FIX™ DynaFix® Mini External Fixation System is substantially equivalent to the Orthofix® Mini Fixator and Orthofix® Mini Lengthener, the Synthes Mini External Fixator and the Hoffman Mini External Fixator.

X. Sarto

Jon Caparolta Manager, Regulatory Affairs Electro-Biology, Inc.

1/23/97
Date

ion with this submission regarding a determination of subs lawfully marketed without pre-market approval or reclassification and is not in ad on he Inter sion or any other type of evidence of infinement litication (Fatablishment Register) Norification Processor. Finel Reminion Programme, August 23, 1977 42 FR 4230 (Tacker N RA-03551

Regulation Number and Section

§ 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.