(84 days)
The Synthes Mini External Fixator stabilizes and provides treatment for fractures of the hand and foot.
Synthes Mini External Fixator includes the following components: Threaded Kirschner Wires, Wire-to-Rod and Rod-to-Rod Clamps, Rods and an Angled Connecting Bar. The wires are manufactured from stainless steel; the clamps and angled connecting bar from various grades of stainless steel, the rods from carbon fiber reinforced epoxy.
This appears to be a 510(k) summary for a medical device (Synthes Mini External Fixator) submitted to the FDA in 1996. The provided text describes the device and its comparison to a predicate device (Howmedica Mini Hoffmann External Fixation System) based on mechanical testing.
However, the request asks about acceptance criteria and a study proving a device meets these criteria in the context of AI or diagnostic performance, including details like sample sizes, ground truth establishment, expert qualifications, and MRMC studies.
The provided document describes a mechanical device (external fixator) and its mechanical performance comparison to a predicate device. It does not involve any AI, diagnostic performance, image interpretation, or human-in-the-loop assessments. Therefore, most of the requested fields are not applicable to this type of device and study.
Here's how I can address the request based on the provided input:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Equivalence/Stiffness to Predicate Device | "Synthes Mini External Fixator provides fixation that is at least equivalent to or stiffer than the Howmedica Mini Hoffmann External Fixation System." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided text. This would refer to the number of fixator systems tested.
- Data Provenance: Not specified. It's likely an in-vitro laboratory study conducted by the manufacturer, but the location is not mentioned.
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. This is a mechanical engineering test, not a diagnostic or AI performance study requiring expert human interpretation for ground truth. The "ground truth" would be the objective measurements of mechanical properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 3.
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 is a mechanical device study, not an AI or diagnostic imaging study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Objective Mechanical Measurements: The "ground truth" would be the quantitative measurements of mechanical properties (e.g., stiffness, load-bearing capacity) obtained from standardized engineering tests.
8. The sample size for the training set
- Not Applicable. This is not an AI or machine learning study, so there is no "training set." The study involved mechanical testing, likely of representative samples of the device and its predicate.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
In summary, the provided document describes a 510(k) submission for a mechanical external fixator, focusing on its equivalence in mechanical performance to a predicate device. The questions posed are primarily relevant to AI/diagnostic performance studies, which do not apply to this specific document.
§ 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.