(69 days)
The GEO 1st MTP Joint Arthrodesis Plating System is indicated for use in the stabilization and fixation of the first metatarsal-phalangeal joint in the foot for surgical fusion (arthrodesis), osteotomy, nonunion or revision surgery.
The GEO 188 MTP Joint Arthrodesis Plating System consists of anatomically contoured, low- profile plates in a variety of configurations of length, left and right versions, and degrees of dorsiflexion and abduction. The plates accept both fixed angle locking screws and non-locking screws. Fixed angle cortical locking screws are available in diameters of 2.7mm and 3.5. Non-locking cortical screws are available in 2.7mm, 3.5mm and 4.0mm; and non-locking cancellous screws in 4.0mm. All screws are offered in lengths of 10-40mm. The system also includes associated instrumentation consisting of plate tacks, quide-wire, drill bit, drill bit, drill guides (locking and non-locking), AO driver tip, reamers, depth gauge, non-locking drill guide handle, AO driver handle, and templates for plate and reamer sizing. All GEO 1ª MTP Joint Arthrodesis Plating System components (implants and instruments) are provided sterile and for single use only.
This document is a 510(k) premarket notification for a medical device called the "GEO 1st MTP Joint Arthrodesis Plating System." As such, it describes a mechanical device for internal fixation of bones, not a software algorithm or AI-powered diagnostic tool. Therefore, the questions related to AI/algorithm performance, such as sample size for test sets, expert ground truth, MRMC studies, standalone performance, and training sets, are not applicable to the content provided.
The performance data section for this type of device focuses on physical and mechanical testing to ensure its safety and effectiveness when used for bone fixation.
Here's the relevant information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| In accordance with ASTM F382-17-17 Standard Specification and Test Methods for Metallic Bone Plates | Performance testing demonstrated substantial equivalence to the predicate device. |
| In accordance with ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws | Performance testing demonstrated substantial equivalence to the predicate device. |
Note: The document highlights compliance with these standards and concludes substantial equivalence, implying the device met the performance requirements outlined in these standards. Specific numerical results or pass/fail thresholds against explicit acceptance criteria are not detailed in this summary document.
2. Sample size used for the test set and the data provenance
Not applicable for this type of mechanical device testing. The testing would involve physical samples of the plates and screws, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for a mechanical device is established through physical and mechanical testing against recognized standards.
4. Adjudication method for the test set
Not applicable. Mechanical testing is typically objectively measured against established engineering 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
Not applicable, as this is a mechanical bone fixation device, not an AI or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a mechanical bone fixation device, not an algorithm.
7. The type of ground truth used
For a mechanical device, the "ground truth" is typically defined by the established performance requirements and specifications outlined in the referenced ASTM standards (ASTM F382-17-17 and ASTM F543-17). These standards detail specific tests (e.g., bending strength, fatigue, pull-out strength for screws) and criteria that the device must meet.
8. The sample size for the training set
Not applicable, as this is a mechanical bone fixation device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.