(161 days)
The NEWDEAL Lisfranc Plates are intended for fractures, fusions, osteotomies and replantations of small bones at the tarsometatarsal joints (Lisfranc joints)
The NEWDEAL® Lisfranc Plate consists of an osteosynthesis plate designed to bridge the tarsometatarsal joints (Lisfranc joints). It is available in different sizes, and is implanted using 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® 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.
Here's an analysis of the provided 510(k) summary regarding the Newdeal Lisfranc Plates, focusing on acceptance criteria and supporting studies:
This 510(k) summary describes a traditional device clearance process for a new medical implant, not an AI/ML-driven diagnostic device. Therefore, many of the requested categories (such as sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable or not provided in this type of submission. The focus for mechanical devices like bone plates is on performance testing against a predicate device and material specifications.
Here's a breakdown of the available information:
Description of Acceptance Criteria and Study Findings
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion | Acceptance Metric | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Performance testing (e.g., strength, durability, fatigue resistance) that demonstrates substantial equivalence to a legally marketed predicate device. This typically involves biomechanical tests to ensure the new device can withstand the same forces and stresses as the predicate in a simulated environment, without failure or significant difference in performance. | Performance testing was conducted and the "Lisfranc Plates performed comparably in all mechanical aspects relevant to the intended use." (This is an inference based on the "comparable results" statement, as specific metrics are not detailed in the summary.) |
| Material/Biocompatibility | Materials used are biocompatible and meet established standards for medical devices implanted in the human body. | The document implies that the materials are standard for such devices, as no new material issues are raised and the device is deemed substantially equivalent. Specific material composition or biocompatibility test results are not detailed. |
| Design/Functionality | The plate design, screw locking mechanism, and overall system function are safe and effective for their intended use in stabilizing Lisfranc joints, consistent with the predicate device. | The device description outlines a locking system with threaded lipped sockets and screws, operating similarly to existing technology. The conclusion states no new issues of scientific technology, safety, or effectiveness are raised. |
| Intended Use | The device is suitable for its stated indications (fractures, fusions, osteotomies, replantations of small bones at the tarsometatarsal joints). | The intended use is clearly stated and aligns with the function of bone plates for these types of injuries/procedures. |
Study that proves the device meets acceptance criteria:
The primary study cited is performance testing conducted compared to a legally marketed predicate device. The key finding is that the Lisfranc Plates demonstrated "comparable results" in all mechanical aspects relevant to the intended use when compared to the predicate device. This implies that the device met the mechanical performance standards set by the predicate.
2. Sample size used for the test set and the data provenance
- Not Applicable / Not Provided. For mechanical performance testing of an orthopedic implant, "test set" typically refers to the number of devices or constructs tested in a laboratory setting. This 510(k) summary does not specify the number of samples tested biomechanically. The concept of "data provenance" (country of origin, retrospective/prospective) is not relevant for this type of mechanical testing submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Provided. "Ground truth" established by experts is typically for diagnostic imaging or clinical outcome data. For mechanical devices, the "ground truth" is defined by established engineering and biomechanical standards and the performance of predicate devices.
4. Adjudication method for the test set
- Not Applicable / Not Provided. Adjudication methods (like 2+1, 3+1) are used for expert review of clinical cases or diagnostic interpretations, which is not relevant for a mechanical device performance study described here. The "adjudication" for mechanical testing would be the interpretation of engineering data by qualified biomechanical engineers.
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 device is a bone plate, not an AI-driven diagnostic or assistive technology. Therefore, an MRMC study is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical bone plate, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For this type of device, the "ground truth" is based on:
- Biomechanical engineering standards: Established testing protocols for strength, fatigue, pull-out strength, etc., relevant to bone fixation.
- Predicate device performance: The performance characteristics of the legally marketed predicate device serve as the benchmark for substantial equivalence.
- Material standards: Compliance with recognized standards for biocompatibility and material properties.
8. The sample size for the training set
- Not Applicable / Not Provided. The concept of "training set" applies to AI/ML models. This is a mechanical device.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. As there is no training set mentioned, this question is not relevant.
In summary: The 510(k) for the Lisfranc Plates relies on the principle of substantial equivalence to existing, legally marketed predicate devices. The "study" proving this equivalence is mechanical performance testing that demonstrates comparable results to the predicate. The detailed methodologies commonly found in AI/ML or clinical trial submissions (like expert panels, detailed sample sizes, adjudication, etc.) are not part of this type of traditional device submission.
§ 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.