(75 days)
Zimmer TransFx External Fixation Devices are indicated for fractures of the long bones and pelvis, joint fusion, limb lengthening, osteotomies, and periarticular fractures.
The TransFx" External Fixation System is a modular system. Device description: The system design is designed to provide options in frame construction, simplicity in frame components, and ease of transition from one frame size to another.
This document describes a 510(k) submission for Reprocessed External Fixation Devices. The acceptance criteria and supporting study information are derived from the "Performance data" and "Technological characteristics" sections.
Here’s a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Device is safely reprocessed without introducing hazards. | "Validation of reprocessing" conducted. |
| Effectiveness: Device performs as originally intended. | "Function test(s)" conducted. "Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended." |
| Sterility: For sterile devices, sterility is maintained. | "Sterilization Validation (for sterile devices)" conducted. |
| Equivalence to Predicate: Design, materials, intended use, mechanism of action, claims, clinical applications, patient population, performance specifications, and method of operation are identical to predicate devices. | "The design, materials, and intended use of the Reprocessed External Fixation Devices are identical to the predicate devices. The mechanism of action... is identical... in that the same standard mechanical design, materials, shapes and sizes are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation." |
2. Sample size used for the test set and the data provenance
The document does not specify a separate "test set" in the context of a clinical study with human subjects. The performance testing appears to be primarily bench and laboratory-based. Therefore:
- Sample Size for Test Set: Not explicitly stated as a clinical "test set" in the traditional sense. The testing was conducted on "Reprocessed External Fixation Devices," implying a sample of these reprocessed devices was tested.
- Data Provenance: The studies were "Bench and laboratory testing." No information on country of origin or whether it was retrospective/prospective is provided, as these are typically applicable to clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to the submitted data. The studies performed were bench and laboratory tests, not clinical evaluations requiring expert consensus for ground truth.
4. Adjudication method for the test set
This information is not applicable. No clinical test set or subjective evaluation requiring adjudication 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
No multi-reader multi-case (MRMC) comparative effectiveness study was done. This device is a reprocessed medical device (external fixation devices), not an AI/imaging diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical, reprocessed external fixation device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the bench and laboratory testing:
- Ground Truth for performance: The performance of the predicate (original) devices serves as the functional "ground truth." The reprocessed devices are evaluated against the expectation that they perform "as originally intended," meaning identically to the new, non-reprocessed versions. This would involve comparing mechanical properties, material integrity, and functional operation to established standards for new devices.
- Ground Truth for sterility: Sterility validation would be against recognized sterility assurance levels (e.g., ISO standards) for medical devices.
- Ground Truth for reprocessing validation: This would be against established procedures and standards for effective cleaning, disinfection, and sterilization to remove contaminants and pathogens.
8. The sample size for the training set
This information is not applicable. The device is a physical medical device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for this device.
§ 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.