(43 days)
The Wristore™* Distal Radius Fracture Fixator is indicated for external fixation of the upper extremity.
The Wristore Distal Radius Fracture Fixator is a single use external fixator designed to provide stable fracture fixation. The lightweight, radiolucent construct incorporates self-drilling bone pins and K-wires to provide secure fracture fixation and to capture fracture fragments.
Here's an analysis of the provided text regarding the Wristore™ Distal Radius Fracture Fixator's acceptance criteria and study information:
Based on the provided Traditional 510(k) Premarket Notification for the Zimmer Wristore™ Distal Radius Fracture Fixator, the information regarding acceptance criteria and detailed study specifics for device performance is very limited. This document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical or standalone performance study.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Explicit acceptance criteria are not defined in the provided document. | The document states: "The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective." |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified.
- Data Provenance: The document only mentions "non-clinical (laboratory) performance testing." There is no indication of human subject data, country of origin, or whether it was retrospective or prospective.
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):
- Not applicable as no human-expert-validated ground truth is mentioned for the "non-clinical (laboratory) performance testing." The evaluations were likely based on engineering or mechanical criteria rather than expert interpretation of clinical data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No expert adjudication method is mentioned.
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. The document describes a medical device (external fixator), not an AI/software-as-a-medical-device (SaMD) or diagnostic imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or reported.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device. The "non-clinical (laboratory) performance testing" is analogous to a standalone performance evaluation of the device's mechanical properties, but it's not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "non-clinical (laboratory) performance testing," the ground truth would typically be established based on engineering standards, biomechanical benchmarks, and material specifications. This would involve mechanical testing (e.g., strength, stiffness, fatigue) and possibly biocompatibility tests. No clinical ground truth (like pathology or outcomes data) is referenced here, as it's a pre-market notification relying on substantial equivalence and laboratory testing, not clinical trials.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable for the same reason as above.
Summary of the Study Proving Device Meets Acceptance Criteria:
The provided document indicates that the device's safety and effectiveness were demonstrated through "non-clinical (laboratory) performance testing." This implies a series of mechanical, material, and/or benchtop tests designed to evaluate the physical properties and functionality of the external fixator. The specific details of these tests, including methodologies, performance metrics, and the results beyond a general statement of "safe and effective," are not included in this summary. The 510(k) process often relies heavily on demonstrating substantial equivalence to predicate devices, and the laboratory testing primarily serves to confirm that the new device performs comparably or acceptably under defined conditions.
§ 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.