(83 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 1st tarsometatarsal joint, available in different sizes, which are implanted 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 oreates a single /screw unit fixed into the bone. The osteosynthesis screws must be driven into the bone through the holes in the plate. 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 510(k) premarket notification for the Newdeal SAS Lapidus Plates describes a medical device, not an AI/ML-enabled device. Therefore, the questions related to AI/ML device performance, such as acceptance criteria for AI models, sample sizes for test sets in AI studies, expert qualifications for AI ground truth, multi-reader multi-case studies, and training set details, are not applicable.
The document demonstrates the device's substantial equivalence through mechanical testing and comparison to predicate devices, rather than clinical efficacy against acceptance criteria derived from AI performance metrics.
Here's an analysis of the provided text in the context of the device's regulatory submission:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document does not explicitly state numerical acceptance criteria in the way an AI/ML device would. Instead, the primary acceptance criterion for this 510(k) submission is substantial equivalence to legally marketed predicate devices. This means that the device must perform at least as well as or be equivalent in function and safety to the predicate devices.
- Reported Device Performance:
Performance Metric Reported Device Performance Bending Resistance "greater than predicate devices (Synthes Modular Foot System)" Equivalence "substantially equivalent to commercially marketed devices" (Acumed K033639, Synthes K010321, Synthes K001941) Novel Issues "do not raise any new issues of scientific technology, safety or effectiveness"
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 (N/A): This is a mechanical device, not an AI/ML device that uses data for performance evaluation. The "test set" here refers to the physical devices tested.
- Sample Size: Not explicitly stated as "sample size" in relation to a patient cohort. The "Testing and Test Results" section refers to an "evaluation of the bending resistance based upon mechanical calculations." This implies a mechanical engineering analysis, likely involving a limited number of physical prototypes or simulations.
- Data Provenance: N/A for this type of device. The "data" pertains to mechanical properties.
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 (N/A): As this is not an AI/ML device, there's no need for experts to establish a "ground truth" for a test set in the conventional sense of image or data interpretation. The "ground truth" for mechanical performance criteria would be established through engineering standards and testing protocols.
- Qualifications of Experts: Not specified, but would typically involve mechanical engineers or materials scientists for the design and testing of such implants.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable (N/A): Adjudication methods like 2+1 or 3+1 are used in clinical studies or AI evaluations to resolve discrepancies in expert opinions on ground truth. This is a mechanical device submission. The "adjudication" for mechanical testing would involve engineering verification against established test standards.
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: A multi-reader multi-case (MRMC) study is typically performed for imaging or diagnostic devices where human readers interpret data, often with or without AI assistance. This is a bone fixation plate, a passive implant, and such a study is irrelevant for its clearance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No: This question is specifically for AI/ML algorithms. The Lapidus Plate is a physical surgical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Mechanical Engineering Standards and Predicate Device Performance: The "ground truth" for this device's performance relies on established mechanical engineering principles, calculations, and the safety and effectiveness profile of the legally marketed predicate devices. The "Conclusion" explicitly states that the device "do not raise any new issues of scientific technology, safety or effectiveness," implying its performance meets accepted industry benchmarks and regulatory requirements for similar devices.
8. The sample size for the training set
- Not Applicable (N/A): This is a mechanical device, not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable (N/A): This is a mechanical device, not an AI/ML device that requires a training set or ground truth in this context.
§ 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.