(14 days)
The NEWDEAL Lapidus Plates are intended to be used for bone fixation such as: - Arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus - Lisfranc arthrodesis - Mono or bi-cortical osteotomies or fractures near the 1st metatarsocuneiform joint.
The NEWDEAL® Lapidus Plate consists of an osteosynthesis plate designed to bridge the 1* tarsometatarsal joint, available in different sizes, which will be fixed using NEWDEAL® locking system fixation screws and washers. The NEWDEAL® locking System includes as many fixation screws as there are threaded lipped sockets on the plate and as many washers as implanted screws. The NEWDEAL® locking system creates a single plate/screw unit fixed into the bone. The ostedsynthesis screws must be driven into the bone through the holes in the mo one. The system is locked by means of washers drilled into the threaded lipped socket at the top of each hole, thus blocking each screw head.
The provided text describes a 510(k) summary for Lapidus Plates and a letter from the FDA. It does not contain information about acceptance criteria, device performance metrics, or details of a study that would demonstrate the device meets such criteria in the way typically seen for AI/ML medical devices (e.g., sensitivity, specificity, AUC).
Instead, this document pertains to a traditional medical device (bone fixation plates) and its equivalence to a predicate device based on mechanical testing.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Mechanical properties similar to predicate device (K060476) | "Mechanical tests have been carried out. Results have shown that the mechanical properties of the modified LAPIDUS PLATES are thus similar to the properties of the unmodified devices, Lapidus Plates, K060476." |
| No change in intended use or fundamental scientific technology | "The modifications do not change the intended use or fundamental scientific technology of the device..." |
| No new issues of safety or effectiveness | "...and do not raise any new issues of safety or effectiveness." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. "Mechanical tests" were performed, but the number of plates tested is not mentioned.
- Data Provenance: Not applicable. This refers to mechanical testing, not clinical data or patient data.
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. Ground truth as typically defined for AI/ML devices (e.g., expert labels on images) is not relevant for mechanical testing of bone plates. The "truth" here is the physical measurement of mechanical properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept is for resolving disagreements among human readers or labelers in diagnostic studies.
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. This is a mechanical device, not an AI/ML diagnostic aid.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a mechanical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Ground Truth: For mechanical testing, the "ground truth" would be the objectively measured physical properties (e.g., strength, stiffness, fatigue resistance) of the devices, compared against the known properties of the predicate device.
8. The sample size for the training set
- Not applicable. This device does not involve a training set as it's not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable. This device does not involve a training set.
§ 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.