Search Results

1. External fixation of long bone fractures.
2. External fixation and stabilization of surgical osteotomy sites.
3. Leg lengthening procedures.
4. Knee, hip and ankle arthrodesis.
5. External fixation of septic and aseptic non-union of long bones
6. Pelvic fixation

The Trauma-Fix® External Fixator is offered as both a unilateral (uni-bar) and quadrilateral style (also called multi-plane) external fixation frame. External fixators known as unibar and multi-plane are typical of present industry standard designs. The uni-bar fixator concept is an outgrowth of the multi-plane fixator varying chiefly in the use of half-pins rather than the transfixing pins typical of multi-plane fixation, though occasionally half-pins are used with multi-plane fixators.

The Trauma-Fix® External Fixator line is made up of the following items: Fixator Pin Holder Clamps, 5 & 8 mm diameter Articulation Coupling, 5 & 8 mm diameter Connecting Rods, 5 & 8 mm diameter Adjustable Telescopic Connecting Rods, 5 & 8 mm diameter Small Lengthining Device for Forearm Colles Forearm Frame Half-Pins Full-Pins/Transfixing Pins KTB Wires Uni-Bar Pin Clamp Uni-Bar Smooth Rods Uni-Bar Compression & Distraction Rod Uni-Bar Connector Instruments Drill Brace Chuck, 3, 4, 5, 6, mm T-Wrench Open Wrench Hex Screw Driver Drill Bit Trochar & Sleeve

The provided text is a 510(k) premarket notification for the Trauma-Fix® External Fixator. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a study. Therefore, most of the requested information cannot be found in this document.

Here's an breakdown of the available and missing information based on the request:

1. A table of acceptance criteria and the reported device performance

This information is not present in the document. The document primarily focuses on a comparison of features to predicate devices to establish substantial equivalence, not on specific performance metrics or acceptance criteria for the Trauma-Fix® External Fixator itself.

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

This information is not present. No specific test set or study data are presented for the Trauma-Fix® External Fixator's performance. The submission relies on the "long standing safety and effectiveness use of the concept" and comparison 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)

This information is not present. No test set requiring expert-established ground truth is described.

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

This information is not present. No test set 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

This information is not present. The device is an external fixator, not an AI-powered diagnostic tool, so an MRMC study with human readers improving with AI assistance would not be applicable.

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

This information is not present. The device is a physical medical device, not an algorithm, so this type of study is not applicable.

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

This information is not present. No specific ground truth for performance testing is mentioned. The ground for equivalence is based on the "long standing safety and effectiveness use of the concept" and comparison to legally marketed predicate devices.

8. The sample size for the training set

This information is not present. No training set is applicable as this is not a machine learning device.

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

This information is not present. No training set is applicable.

Summary of available information related to equivalence, not performance criteria:

The document demonstrates equivalence to predicate devices based on:

• Intended Use: All predicate devices and the Trauma-Fix® External Fixator share the same intended uses for external fixation of long bone fractures, surgical osteotomy stabilization, leg lengthening, arthrodesis, and fixation of septic/aseptic non-unions, and pelvic fixation.
• Operating Principles (Features):
  • Distraction: Yes for all devices.
  • Compression: Yes for all devices.
  • Half Pins: Yes for all devices.
  • Transfix Pins: Yes for all devices.
  • Instruments: Yes for all devices.
  • Performance Standards: All meet ASTM - ISO.
• Materials: While there are differences (Trauma-Fix® uses Aluminum & Stainless; Zimmer uses Stainless steel; OrthoFrame uses Composite; Ace uses Al, Ti & Stainless), the document implies these differences do not raise new questions of safety or effectiveness.
• Design: Trauma-Fix® offers both Uni-lateral & Quadrilateral designs, similar to the range offered by predicate devices (Zimmer: Quadrilateral; OrthoFrame: Uni-lateral; Ace: Uni-lateral & Multi-plane).
• Sterilization: All use Steam sterilization, though the Trauma-Fix® is disposable while others are not. The document confirms validation of the recommended steam sterilization cycle for the Trauma-Fix®.

Conclusion from the document:

The FDA’s letter states: "We have reviewed your Section 510(k) notification... 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..." This is the "acceptance" that the device meets the regulatory requirements for market clearance based on substantial equivalence, not performance acceptance criteria from a specific study.

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