(24 days)
The CHARLOTTE™ Small MTP Fusion Plate 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 hallus 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 metatarsal-phalangeal joint
- Revision procedures where other treatments or devices have failed; and
- Chronic instability in the first metatarsal-phalangeal joint
The CHARLOTTE™ Small MTP Fusion Plate consists of plates, and previously cleared screws. The design features of the CHARLOTTE™ Small MTP Fusion Plate are summarized below:
Plate
- Manufactured from ASTM F139
- Left and Right configurations
This document is a 510(k) Summary of Safety and Effectiveness for a medical device called the "CHARLOTTE™ Small MTP Fusion Plate." A 510(k) submission is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device.
For a 510(k) submission, the "study that proves the device meets the acceptance criteria" is typically not a clinical trial demonstrating efficacy against a specific clinical outcome. Instead, it's a demonstration of substantial equivalence to a predicate device. This is primarily done through comparison of design features, material composition, indications for use, and performance testing (e.g., mechanical testing, biocompatibility testing) to show that the new device performs as intended and is as safe and effective as the predicate.
Given this context, I will extract information related to the device's characteristics and the evidence provided for substantial equivalence, rather than a traditional clinical study's acceptance criteria and performance metrics.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrated for Substantial Equivalence) | Reported Device Performance (vs. Predicate Device) |
|---|---|
| Design Features: Comparable design to predicate device. | The design features of the CHARLOTTE™ Small MTP Fusion Plate are substantially equivalent to WMT's Bone Fusion Plate. |
| Material: Manufactured from appropriate and safe materials. | Manufactured from ASTM F139 (a recognized medical-grade material for stainless steel). |
| Indications for Use: Same or very similar indications as the predicate device. | The indications for use of the CHARLOTTE™ Small MTP Fusion Plate are substantially equivalent to WMT's Bone Fusion Plate. |
| Safety and Effectiveness: Adequate support from information and data. | The safety and effectiveness of the CHARLOTTE™ Small MTP Fusion Plate is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This submission does not describe a clinical "test set" in the sense of patient data. The evaluation for substantial equivalence would involve bench testing (e.g., mechanical strength, fatigue testing) of the device itself and a review of existing data/literature for the materials and predicate device.
- Sample Size for Test Set: Not applicable in the context of human clinical data. The "test set" would refer to mechanical test specimens of the device. The specific number of devices or components tested is not provided in this summary.
- Data Provenance: Not applicable for clinical data. The "analysis data" mentioned would be from bench testing conducted by the manufacturer.
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)
This is not applicable. "Ground truth" in the context of a 510(k) for a plate device refers to the established performance characteristics and safety profile of the predicate device and the materials used, as well as the results of in-vitro physical and mechanical testing. There would not be human experts establishing "ground truth" on a test set in the way one would for diagnostic imaging.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This device is not assessed using a clinical adjudication method with multiple readers/experts.
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 is not an AI-assisted diagnostic device or a device where human interpretation is a primary performance metric.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is an orthopedic implant, not a software algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for substantial equivalence for this device is based on:
- Established performance of the predicate device: The safety and effectiveness profile of the WMT Bone Fusion Plate.
- Material standards: Conformance to ASTM F139.
- Engineering and biomechanical principles: Underlying the design and function of bone fusion plates.
- Bench testing data: Mechanical and materials analysis data derived from testing the device itself to ensure it meets performance specifications (though specific results are not detailed in this summary).
8. The sample size for the training set
Not applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
Not applicable. 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.