Search Results

The Speed Triad is indicated for: Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.

The Speed Triad is a nitinol implant that comes in a range of sizes for use in extremity bone fragment fixation, osteotomy fixation, and joint arthrodesis of the hand and foot. The implant is delivered to the operating room in an "open" state in a constraining plastic inserter. The implant is then released from the inserter and transformed by ambient temperature and body heat after insertion, and contracts to a "closed" and compressive state. The implants do not require any external heating; they are completely transformed at room temperature. The Speed Triad incorporates design changes from the Speed Shift. The design is changed to include a third leg to provide additional fixation. Importantly, the Speed Triad uses the same raw material as the predicate Speed Shift and the same manufacturing process (heat treatment, surface treatment, and passivation).

This document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the Speed Triad™ bone staple.

1. Table of Acceptance Criteria and Reported Device Performance

Method: Performed according to ASTM F564-10 (2010), comparing all three sizes of Speed Triad to a comparably sized predicate OSSplate. | Result: The Speed Triad demonstrated substantially equivalent pull-out resistance when compared to the predicate OSSplate implant. |
| Mechanical Strength | Goal: Substantially equivalent bending stiffness compared to the predicate OSSplate.

Method: Performed according to ASTM F564-10 (2010), comparing all three sizes of Speed Triad to a similar-sized predicate OSSplate. | Result: The Speed Triad implants achieved substantially equivalent bending stiffness when compared to the predicate OSSplate. |
| Corrosion Resistance | Goal: Substantially equivalent corrosion resistance compared to the predicate OSSplate and SmartToe.

Method: Performed according to ASTM F2129-08, comparing representative samples of the Speed Triad to the predicate OSSplate and the secondary predicate SmartToe (K070598). | Result: Test results demonstrate the substantially equivalent corrosion resistance of the Speed Triad compared to the predicate OSSplate and SmartToe. |
| Material Composition | Goal: Use of a material that meets established standards and is the same as predicate devices.

Method: Not explicitly described as a specific test, but material specification is provided for comparison. | Result: Nitinol, per ASTM F2063-12 (same as predicate Speed Shift and OSSplate).
Grey PC #5816, SS 17-4, SS-303 (same patient-contacting materials as predicate Speed Shift and OSSplate, with the exception of OSSplate not listing Grey PC #5816). |
| Manufacturing Process | Goal: Use of the same raw material, manufacturing process (heat treatment, surface treatment, and passivation) as the predicate Speed Shift.

Method: Not explicitly described as a specific test, but process equivalence is stated. | Result: The Speed Triad uses the same raw material as the predicate Speed Shift and the same manufacturing process (heat treatment, surface treatment, and passivation).
Surface Finish: Mechanical tumbling, acid cleaning, and chemical passivation (same as Speed Shift, but different from OSSplate which is mechanical tumbling only). |
| Functional State | Goal: Fully transformed at room temperature.

Method: Not explicitly described as a specific test, but functional characteristic is stated. | Result: Fully transformed at room temperature (same as Speed Shift, different from OSSplate which uses an electrical heating unit). |
| Sterilization & Storage | Goal: Sterile packaged and stored at room temperature until used.

Method: Not explicitly described as a specific test, but storage conditions are provided. | Result: Sterile packaged stored at room temp until used (same as both Speed Shift and OSSplate predicates). |

2. Sample Sizes Used for the Test Set and the Data Provenance

The provided text details performance bench testing. For all three types of tests (pull-out strength, mechanical strength, and corrosion resistance), the sample size is described as "Specimens of all three sizes of the Speed Triad were used" and "representative samples of the new Speed Triad." The exact number of specimens per size or per test is not specified.

The data provenance is from bench testing conducted by the manufacturer, BioMedical Enterprises, Inc., in San Antonio, Texas, USA. This is an in vitro study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable to the provided document. The "ground truth" in this context refers to the absolute physical properties (e.g., pull-out strength, bending stiffness, corrosion resistance) measured through standardized ASTM methods, not through expert human interpretation of medical images or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not applicable to the provided document. Adjudication methods (like 2+1, 3+1) are typically used for studies involving human interpretation or clinical endpoints where there's a need to resolve discrepancies among observers. This study involves standardized mechanical and material property testing, where the results are quantitative and directly measured.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This study solely focuses on the mechanical and material characteristics of the device through bench testing, comparing it to predicate devices. It does not involve human readers, case interpretations, or an assessment of human performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

This information is not applicable as the device (Speed Triad™) is a physical bone staple, not an algorithm or AI software. Therefore, there is no "algorithm only" performance to evaluate. The study assesses the standalone physical characteristics of the device.

7. Type of Ground Truth Used

The "ground truth" used for this study is based on objective, quantitative measurements of physical properties, specifically defined and validated by industry standards:

• ASTM F564-10 (2010) for pull-out strength and mechanical strength (bending stiffness).
• ASTM F2129-08 for corrosion resistance.

These standards provide the methodology for determining the "true" physical performance of the device under specific test conditions.

8. Sample Size for the Training Set

This information is not applicable as the device is a physical bone staple, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as the device is a physical bone staple, not an AI or machine learning model.

Ask a specific question about this device