(623 days)
Traufix medical devices are intended for fixation of fractures and osteotomies of various bones including the pelvis, clavicle, scapula, humerus, ulna, radius, femur, tibia, olecranon, and fibula.
Traufix osteosynthesis medical devices are metal implants (stainless steel per ASTM F138, or ASTM F139, or titanium-alloy per ASTM F136) fixed adjacent to the bone for the treatment and consolidation of fractures, osteotomies, and/or joint ossification. The devices include different types and sizes of plates and screws.
The provided text is a 510(k) summary for the Traufix osteosynthesis, osteotomy, and arthrodesis devices. It states that the device has been found substantially equivalent to predicate devices and therefore does not include a separate section outlining acceptance criteria or results from a study specifically designed to demonstrate meeting those criteria.
However, it does describe the non-clinical performance testing performed to support substantial equivalence. Based on the information provided, here's a breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a table format with specific pass/fail thresholds. Instead, it describes comparative engineering analysis against predicate devices and adherence to ASTM/ISO standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Single cycle bend testing according to ASTM F382 (for plates) | Performed according to ASTM F382. (Implicitly, the device performed acceptably or comparably to the predicate for substantial equivalence). |
| Breaking torque testing according to ISO 6475 (for screws) | Performed according to ISO 6475. (Implicitly, the device performed acceptably or comparably to the predicate for substantial equivalence). |
| Structural properties comparison (bending stiffness, bending structural stiffness, and bending strength) per ASTM F382 A1 of subject proximal tibia plate vs. predicate proximal tibia plate | Engineering analysis performed. The conclusion of substantial equivalence implies these properties were comparable and did not raise new safety or effectiveness concerns. |
| Design and dimensions comparison with predicate plates and screws | Engineering analysis and comparison of technology performed. Minor differences were found but did not raise new questions of safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "sample size used for the test set" in terms of number of devices or data points beyond stating that "non-clinical testing was performed in the subject devices." Given that this is a 510(k) summary for a medical device (bone fixation appliances), the "test set" would typically refer to the specific device designs and materials tested in the non-clinical mechanical tests. The provenance is internal testing conducted by or for Fixier, S.A. de C.V. It is retrospective in the sense that the testing has already been completed to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable to the non-clinical performance testing described. Ground truth is not established by human experts in the context of mechanical performance tests against engineering standards.
4. Adjudication Method for the Test Set
This is not applicable to the non-clinical performance testing described. Adjudication methods are typically used in clinical studies or human expert review scenarios.
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 is not applicable. The device is a physical bone fixation implant, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This is not applicable. The device is a physical bone fixation implant, not an algorithm.
7. The Type of Ground Truth Used
For the non-clinical testing, the "ground truth" is defined by the industry standards and the properties of the legally marketed predicate devices. The testing aims to demonstrate that the subject device's mechanical properties are equivalent to or better than previously cleared devices, as measured by established ASTM and ISO standards for bend testing and torque testing.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical implant and does not involve AI or machine learning algorithms that require a "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no "training set" for this type of device submission.
§ 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.