(268 days)
The Newfix® External Fixation System, consisting of axial fixators and frame components, is indicated for stabilization of open and/or unstable fractures where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting. NEWFIX® External Fixation System is intended for the fixation and for temporary or extended stabilization in cases such as: open fractures, closed fractures, poly-trauma fractures, supplement in the stabilization of minimal fixations in intra and extra articular fractures.
The Newfix® External Fixation System lengthening components (rail systems) are unilateral external fixation devices and components intended for use in adults and pediatrics in the treatment of bone conditions including leg lengthening (osteotomies), arthrodesis, fracture fixation, and other bone conditions amendable to treatment by use of the external fixation modality.
The Tecnología y Diseño Industrial, S.A. de C.V. Newfix® External Fixation System consists of various components including fixators, clamps, bars, distractors, carbon fiber rod, and stainless steel rods for use in orthopedic and trauma treatments.
TDI's Newfix® External Fixation System (Newfix External Fixation System 4.1 K101338 and Newfix Screws, Wires and Pins K101254 and this submission under review) consists of bone screws, pins and wires and external fixation components and lengthening systems. The System is utilized in the following manner: bone screws are inserted through the patient's skin and soft fissue and into the bone. The fixator frame of the Newfix® External Fixation System is attached to the shanks of the bone screws. The intended use and product technology of this submission have not changed from the earlier cleared submissions.
The present submission adds axial and pelvic fixation devices (including radiolucent wrist fixator), straight and angled clamps and rail lengthening transport systems.
The Newfix® External Fixation System is supplied non sterile and is intended for single patient use. None of the components of the Newfix System are reusable. The Newfix® External Fixation System includes instruments and accessory devices necessary for its use.
Here's a breakdown of the acceptance criteria and the study details for the Newfix® External Fixation System, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalency to Predicate Devices: Performance should be at least as safe and effective as legally marketed predicate devices. | Demonstrated equivalency through performance tests against various components of Orthofix predicate devices. |
| Locking Mechanism Validation: Validation of locking mechanism for various clamps (Lateral Cylinder, T-Shaped, Angled, Ankle, Radiolucent Wrist Axial Fixator Clamp). | Performance tests were conducted to validate the locking mechanism, with no specific quantitative results given, but the conclusion states equivalency was demonstrated. |
| Performance Testing for Specific Components: Successful testing for rail system for lengthening (dynamization clamp), multiplanar clamp, pelvic fixator and links, radiolucent wrist fixator, and radiolucent ankle clamp. | Performance testing for these components was completed successfully. Specific quantitative results are not provided; the conclusion implies they met the criteria for equivalency. |
| New Indications Performance: Performance testing supporting new indications for lengthening and arthrodesis. | Performance testing supporting these new indications were included in the reports and were successful. |
| "Worst Case" Construct Testing: Testing conducted using a worst-case construct as provided in ASTM F1541. | Testing was conducted using a worst-case construct as provided in ASTM F1541 in both static and dynamic testing modes. |
| Loosening of System Components: No observation of loosening of system components, including dynamization clamp, multiplanar clamp, and pelvic links. | Testing resulted in no observation of loosening of system components. |
| Adherence to Standards: Testing conducted according to ASTM F 1541 and ASTM E 4. | Referenced standards ASTM F 1541 (Standard Specification and Test Methods for External Skeletal Fixation Devices) and ASTM E 4 (Practices for Force Verification of Testing Machines) were used. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for the test set (e.g., number of devices tested). It lists the specific TDI products and predicate devices that were tested, but not the quantity of each or the number of tests performed.
- Data Provenance: The origin of the data is not explicitly stated in terms of country or retrospective/prospective. Given that the applicant is from Mexico, it's possible that the testing was conducted there, but this is not confirmed. The testing seems to be prospective in nature, as it involves physical performance tests of manufactured devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the study did not involve human interpretation or subjective assessment of medical images or patient data to establish ground truth. The "ground truth" here is objective performance data (e.g., locking mechanism integrity, absence of loosening) derived from mechanical testing, measured against established engineering standards (ASTM).
4. Adjudication Method for the Test Set
This section is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in human expert interpretations (e.g., in medical image reading studies). The current study involves physical performance testing with objective measurements.
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 section is not applicable. This submission is for a physical medical device (an external fixation system), not an AI/software device that assists human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. This is a physical medical device, not an algorithm. The "standalone" performance here refers to the device's mechanical integrity and functionality on its own.
7. The Type of Ground Truth Used
The ground truth used was objective performance data based on established engineering standards and comparative testing against predicate devices. Specifically:
- Measurement of locking mechanism function and integrity.
- Observation of component loosening.
- Compliance with "worst-case construct" testing outlined in ASTM F1541.
- Comparison of performance characteristics to legally marketed predicate devices.
8. The Sample Size for the Training Set
This section is not applicable. This is a physical medical device. The concept of "training set" is relevant for machine learning algorithms, not for the mechanical validation of medical hardware. The design and manufacturing processes are iteratively refined rather than "trained."
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reason as #8.
§ 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.