(45 days)
The Synthes LCP Modular Foot Plates are intended for use in selective trauma, fractures, osteotomies, reconstructive procedures and replantations of small bones including the foot and ankle.
Synthes LCP Modular Foot Plates consist of locking cuboid, navicular and talus plates used to treat small bone fractures. The plates are attached to bone via 2.4 and 2.7 mm cortex and locking screws.
The provided text describes a 510(k) premarket notification for a medical device, the Synthes (USA) LCP Modular Foot Plates. This type of regulatory submission in the United States is focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel efficacy or performance against explicit acceptance criteria with detailed statistical studies.
Therefore, much of the requested information regarding acceptance criteria, specific study designs, sample sizes, expert ground truth establishment, MRMC studies, standalone performance, and training set details are not applicable (N/A) in the context of this 510(k) summary. The primary "proof" of the device's acceptability is its substantial equivalence to an existing device.
Here's an analysis based on the provided document:
Acceptance Criteria and Device Performance
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | Concluded to be substantially equivalent to Synthes (USA) Modular Foot System. |
| Intended Use | Intended for use in selective trauma, fractures, osteotomies, reconstructive procedures and replantations of small bones including the foot and ankle. |
| Classification | Class II medical device, §888.3030 – Single/multiple component bone fixation appliances and accessories. |
| Material/Design | Consist of locking cuboid, navicular and talus plates. Attached to bone via 2.4 and 2.7 mm cortex and locking screws. |
Study Details
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. The 510(k) summary does not describe a clinical study with a "test set" in the traditional sense to prove device performance against specific metrics. The focus is on demonstrating substantial equivalence to a predicate device, which typically involves comparing design principles, materials, intended use, and performance claims. This usually doesn't involve new clinical data demonstrating efficacy, but rather engineering tests or comparisons to existing data for the predicate.
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)
- N/A. No "ground truth" establishment by experts for a test set is mentioned or required for this type of 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. No adjudication method is mentioned as there's no described test set or expert review process for performance data.
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
- N/A. This device is a bone plate, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This device is a bone plate, it does not involve algorithms or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A. No specific "ground truth" in the context of clinical outcomes or diagnostic accuracy is detailed. The "ground truth" for a 510(k) would be the established performance and safety of the predicate device, against which the new device is compared.
8. The sample size for the training set
- N/A. This device is a bone plate, not an AI model. Therefore, no training set is applicable.
9. How the ground truth for the training set was established
- N/A. Not applicable, as there is no training set for this type of 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.