(41 days)
The CHARLOTTE™ MTP Bone Fusion Plate System is intended to help increase the rate of bony union, and to maintain the position of the toe during fusion. Once the joint has fused, the plate is secondary in the transmission of gait forces.
Indications for Use:
- · Fractures, osteotomies or arthrodesis of the first metatarsal-phalangeal joint
- · Deformity due to hallux valgus
- · Deformity due to arthritis in the first metatarsal-phalangeal joint
- Loss of motion- hallux rigidus
- · Pain associated with osteoarthritis or rheumatoid arthritis in the first metatarsalphalangeal joint
- · Revision procedures where other treatments or devices have failed: and
- · Chronic instability in the first metatarsal-phalangeal joint
The CHARLOTTE™ MTP Bone Fusion Plate System consists of plates in left and right configurations and screws. All screws and plates are manufactured from stainless steel (ASTM F138).
The design features and function of the screws included in the CHARLOTTE™ MTP Bone Fusion Plate System are substantially equivalent to the design features previously cleared under the Bone Fusion Plate (renamed and from here on referred to as: CHARLOTTETM MTP Bone Fusion Plate System). The system includes 2.7mm and 3.7mm screws in lengths from 8mm to 24mm.
The provided document is a 510(k) summary for the CHARLOTTE™ MTP Bone Fusion Plate System, intended to demonstrate substantial equivalence to a predicate device. This type of regulatory submission does not typically include clinical studies or data on AI/human performance. Instead, it relies on non-clinical evidence (mechanical testing) and a comparison of technological characteristics to show that the new device is as safe and effective as a previously cleared device.
Therefore, many of the requested items related to acceptance criteria, specific study designs, human reader performance, training data, and ground truth establishment (which are common for AI/ML device submissions) are not applicable to this document.
Here's an analysis based on the information provided:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Equivalence: Performance of subject screw is statistically equivalent or greater than the predicate screw in Torsional Yield Strength per ASTM F543-02. | The mechanical testing, including Torsional Yield Strength per ASTM F543-02, has shown that the performance of the subject screw is statistically equivalent or greater than the predicate screw. |
| Technological Characteristics: Identical indications for use, same overall features, identical material. | The CHARLOTTE™ MTP Bone Fusion Plate System and the legally marketed predicate CHARLOTTE™ MTP Bone Fusion Plate System Screw have identical indications, have the same overall features, and are identical in material. |
| Safety and Effectiveness: No new types of questions of safety or effectiveness. | The design characteristics of the subject devices do not raise any new types of questions of safety or effectiveness. From the evidence submitted, the subject devices can be expected to perform at least as well as the predicate systems and are substantially equivalent. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. The document describes mechanical testing of components, not a clinical test set with 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. This pertains to clinical data review, which was not part of this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set.
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, not done. This is a medical device (plate and screw system), not an AI/ML diagnostic aid. Clinical effectiveness studies are not typically required for 510(k) submissions where substantial equivalence can be demonstrated through non-clinical means. The document explicitly states "N/A" for "Substantial Equivalence- Clinical Evidence."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the mechanical testing, the "ground truth" or reference for performance was established by ASTM F543-02 standard and the performance of the predicate screw.
8. The sample size for the training set
- Not applicable. There is no training set as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. There is no 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.