(219 days)
The X-FIX is an external fixation system intended for use in the treatment of complex fracture dislocations, stable and unstable dislocations, fracture luxations, and pilon fractures in the PIP joint.
The AREX USA X-FIX is a single use, lightweight, low profile external fixation system designed to treat fractures dislocations of the digits of the hand. The device is designed to help restore proper digit alignment and range of motion while permitting mobilization and normal anatomical movement.
The provided text is a 510(k) premarket notification summary for the AREX USA X-FIX, an external PIP joint distraction device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies with specific acceptance criteria as might be seen for novel devices. Therefore, much of the requested information regarding study design, sample sizes, expert involvement, and ground truth establishment is not present in this document.
Here's an analysis of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed performance metrics against such criteria. The basis for clearance is substantial equivalence to a predicate device, the AREX USA Ligamentotaxor (K094043).
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (AREX USA Ligamentotaxor K094043) | Claimed Substantially Equivalent: The document explicitly states: "The design, materials, and indications for use of the Arex USA X-FIX are equivalent to the Arex USA Ligamentotaxor (K094043) previously approved for market in the United States. No new technology has been employed in the design. The Arex USA X-FIX presents no new issues regarding safety and effectiveness." |
| Biocompatibility | "The materials employed have an established history of biocompatibility and attached medical literature demonstrates that they are non-irritant and non-toxic." |
| Safety and Efficacy (due to changes from predicate) | "Performance testing demonstrates that the changes do not affect safety or efficacy." (Note: specific changes or tests are not detailed.) |
| Risk Assessment Compliance | "Risk Assessment was conducted in compliance with ISO 14971." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The submission relies on demonstrating substantial equivalence, not a clinical study with a "test set" in the traditional sense of evaluating device performance on patients. The "performance testing" mentioned likely refers to bench testing rather than clinical trials.
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. No ground truth establishment by experts for a test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method is mentioned as there is no specific "test set" requiring expert adjudication.
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
Not applicable. This device is a mechanical external fixation system, not an AI-powered diagnostic or assistive technology. Therefore, MRMC studies or AI-related effectiveness are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical external fixation system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The submission focuses on substantial equivalence based on material properties, design, and intended use compared to a predicate device. "Ground truth" in a clinical study context is not relevant here.
8. The sample size for the training set
Not applicable. The document describes a medical device, not an AI model, so there is no training set mentioned or implied.
9. How the ground truth for the training set was established
Not applicable. There is no training set.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.