(60 days)
The Vigor Compression Hip Screw is indicated as a means of rigid internal fixation of stable and unstable fractures of the proximal femur in which a stable medial buttress can be reconstructed and is intended for the management of intertrochanteric, subtrochanteric and basilar neck fractures and selected trochanteric non-unions.
The Vigor Compression Hip Screw System is intended as a means of rigid internal fixation for fractures of the proximal femur. The Vigor System implants consist of Bone Screws; Compression Screws, Lag Screws and Side Plates, and are offered in a wide, incremental range of sizes to ensure optimum selection for a proper fixation. The Vigor full-length threaded Bone Screws and Compression Bone Screws are available in a range of sizes from 22.0 mm to 60.0 mm in length. Vigor Lag Screws and Super Lag Screws feature a flattened, square base that engages the inner surface of the implant barrel for increased rotational stability. These Lag Screws are available in a range of sizes from 50.0 mm to 150.0 mm in length, in 5.0 mm increments. And, finally, a trio of low-profile Side Plates are included in the system. Vigor offers the standard 4-hole, 5-hole and 6hole plates, each available in a 135°, 140° or 145° configuration.
The Vigor System instrumentation set consists of the standard instrumentation required for each indicated procedure.
This document describes a medical device submission (510(k)) for the Vigor Compression Hip Screw System. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than conducting a de novo clinical study to prove novel efficacy or meet specific acceptance criteria with defined performance metrics. Therefore, many of the requested categories related to clinical study design, acceptance criteria, sample sizes, expert involvement, and ground truth establishment are not applicable.
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Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied by 510(k)) | Reported Device Performance |
|---|---|
| Material: 316L Stainless Steel | 316L Stainless Steel |
| Design: Bone, Compression and Lag Screws, low-profile, angled side plates and associated instrumentation | Bone, Compression and Lag Screws, low-profile, angled side plates and associated instrumentation |
| Function: Rigid internal fixation to fractures of the proximal femur | Rigid internal fixation to fractures of the proximal femur |
| Indication for Use: Rigid internal fixation of stable and unstable fractures of the proximal femur (intertrochanteric, subtrochanteric, basilar neck fractures, selected trochanteric non-unions) | Rigid internal fixation of stable and unstable fractures of the proximal femur (intertrochanteric, subtrochanteric, basilar neck fractures, selected trochanteric non-unions) |
| Sterilization: Non-sterile, requires sterilization to 10-6 sterility assurance level | Non-sterile, requires sterilization to 10-6 sterility assurance level |
Explanation: For a 510(k) submission, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a legally marketed predicate device. The device "performs as well as" the predicate if it matches the predicate's material, design, function, and intended use. The table above highlights how the Vigor system directly matches the predicate in these key aspects.
2. Sample size used for the test set and the data provenance:
- Not Applicable. This submission is a 510(k) demonstrating substantial equivalence. It does not involve a clinical "test set" in the context of an efficacy or performance study with human subjects or a large dataset for AI evaluation. The "data" provided is a comparison of product specifications and functions against a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. See point 2. There is no specific "ground truth" to be established by experts for a test set in this type of submission. The ground truth for the predicate device's safety and effectiveness was established when it was initially cleared by the FDA.
4. Adjudication method for the test set:
- Not Applicable. See point 2. No test set requiring adjudication was used.
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 a physical medical device (hip screw), not an AI/software device. Therefore, MRMC studies and AI-assisted reading improvements are irrelevant to this submission.
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:
- Substantial Equivalence to a Predicate Device. The "ground truth" for this 510(k) submission is the prior FDA clearance of the Synthes Dynamic Hip Screw (K791619), which serves as the established safe and effective benchmark. The Vigor Compression Hip Screw System's "performance" is considered sufficient if it is substantially equivalent to this predicate.
8. The sample size for the training set:
- Not Applicable. This device submission does not involve a "training set" for an algorithm or a clinical trial in the traditional sense of a de novo device.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
§ 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.