(62 days)
The IQS fixator is intended for use in the treatment of bone conditions including fracture fixation and other bone conditions which are amenable to treatment by the use of external fixation.
The ids fixator construct comprises of a main body which incorporates a central portion with larger ends with three 10mm diameter holes in each to accommodate bone screws. It is available in two lengths - 70 mm and 110mm. A screw sleeve fits into each hole and the bone screw is passed through each sleeve and into the bone fragment through the skin. The bone screw is secured to the fixator using a grub screw (passing through the sleeve) and tightening onto the screw directly. The ids fixator is a single use device.
The provided text describes a medical device, the i[phi]s External Fixation Device, and its clearance through the 510(k) pathway. This pathway relies on demonstrating "substantial equivalence" to a legally marketed predicate device rather than independent proof of safety and effectiveness through clinical trials with specific acceptance criteria and performance data.
Therefore, the document does not contain the information requested in points 1-9 regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a new device.
The information that can be extracted relates to the substantial equivalence determination:
1. A table of acceptance criteria and the reported device performance:
This information is not available in the provided text as the device followed the 510(k) pathway, which focuses on substantial equivalence to a predicate device rather than direct proof against pre-defined acceptance criteria for performance. The text only states:
| Criterion | Reported Performance |
|---|---|
| Substantial Equivalence to Predicate Device | Established based on similarities in intended use, materials, design, and mechanical performance to K031919 – EBI XFIX DFS system. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. The 510(k) summary does not detail a "test set" in the context of a new efficacy study with human subjects. The substantial equivalence was demonstrated through "mechanical performance" (likely bench testing) and comparison to the predicate, not a clinical test set.
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 such clinical "test set" requiring expert ground truth establishment is described for this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No clinical "test set" 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:
Not applicable. The device is an external fixation system, not an AI or imaging diagnostic device that would typically involve MRMC studies with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a hardware medical device (external fixator), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the substantial equivalence claim, the "ground truth" was implicitly the performance and characteristics of the predicate device (K031919 – EBI XFIX DFS system) and the mechanical properties (e.g., strength, durability) of the i[phi]s fixator itself, assessed through engineering principles and testing. No clinical "ground truth" for efficacy in human subjects is described.
8. The sample size for the training set:
Not applicable. No "training set" in the context of an algorithm or AI model development is mentioned.
9. How the ground truth for the training set was established:
Not applicable. No "training set" is mentioned.
§ 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.