(138 days)
The Synthes 2.4 mm / 2.7 mm Variable Angle LCP Forefoot / Midfoot System is indicated for fixation of osteotomies, fusions, fractures, nonunions, malunions and replantations of small bones and small bone fragments in adult and adolescent (12 - 21 years) patients, including the foot and ankle, and particularly in osteopenic bone.
The Synthes 2.4/2.7 mm Variable Angle LCP Forefoot / Midfoot System consists of anatomic and procedure specific plates, including 1st MTP Fusion, TMT Fusion, Opening Wedge Osteotomy, X and Straight Fusion, Navicular, Cuboid, and Mesh Plates, with variable angle locking screws and cortex screws to aid in reconstructive foot surgery. The system components are offered in versions composed of implant grade stainless steel and titanium alloy.
The information provided describes a medical device, the Synthes 2.4 mm / 2.7 mm Variable Angle (VA)-LCP Forefoot / Midfoot System, and its 510(k) summary for clearance by the FDA. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study with acceptance criteria and performance data as one would typically find for a new, non-substantially equivalent device.
Therefore, many of the requested data points (like sample size for test sets, number of experts for ground truth, MRMC studies, etc.) are not applicable in this context. The clearance is based on the device's design similarity, material composition, and mechanical properties compared to already approved devices.
Here's an attempt to answer the questions based on the provided text, indicating where information is not available or not applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Indications for Use: Same as predicate devices. | The proposed plates have the same indications for use as the predicate devices: fixation of osteotomies, fusions, fractures, nonunions, malunions, and replantations of small bones and small bone fragments in adult and adolescent (12-21 years) patients, including the foot and ankle, particularly in osteopenic bone. |
| Design: Similar to predicate devices. | The proposed plates are similar in design to the predicate devices. This includes anatomic and procedure specific plates (e.g., 1st MTP Fusion, TMT Fusion, Opening Wedge Osteotomy, X and Straight Fusion, Navicular, Cuboid, and Mesh Plates) with variable angle locking screws and cortex screws. |
| Fundamental Product Technology: Same as predicate devices. | The proposed plates incorporate the same fundamental product technology as the predicate devices (implied to be rigid fixation for small bone fragments). |
| Materials: Composed of the same materials as predicate devices. | The system components are offered in versions composed of implant grade stainless steel and titanium alloy, which are the same materials used in the predicate devices (as implied by comparison to ASTM F138-03 and ASTM F1295-05 standards for these materials). |
| Bending Strength: Supports substantial equivalence to predicate devices based on geometric and material analyses. | Calculations comparing the bending strength of the subject and predicate devices based on geometric analyses and the material characteristics defined in standards: ASTM F138-03 and ASTM F1295-05 were performed. The results support substantial equivalence. (Specific numerical performance values for bending strength are not provided, only that they support equivalence to predicate devices conforming to these standards). |
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. This 510(k) submission describes a device for which substantial equivalence is primarily established through comparisons of design, materials, indications, and mechanical testing (bending strength calculations) against legally marketed predicate devices. It does not involve a clinical study with a "test set" of patients or data in the traditional sense. The evaluation is based on engineering principles and regulatory precedent.
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. See point 2. No ground truth based on expert review of clinical cases was established for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 2.
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 fixation system (plates and screws), not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical implant, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" in this context is the established safety and effectiveness profile of the predicate devices, supported by their various regulatory clearances and adherence to recognized material and performance standards (e.g., ASTM F138-03 and ASTM F1295-05 for materials, and implied mechanical performance consistent with the predicate devices' intended use). The new device demonstrates "substantial equivalence" to this existing "ground truth."
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML device requiring a 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.