(85 days)
The Dynamic Hip Screw System devices are used in the treatment of femoral neck fractures in the pertrochanteric, intertrochanteric and high subtrochanteric regions of the femur, or in the treatment of combinations of these fractures.
Pertrochanteric fractures occur from the greater to lesser trochanter. Intertrochanteric fractures occur within the trochanteric area. High subtrochanteric fractures occur immediately below the trochanter.
The devices provide support to the femur and femoral head during the natural process of bone regeneration to repair the femoral fracture.
The devices are designed to withstand the in vivo loads experienced during normal activity throughout the life of the implant.
The Dynamic Hip Screw System comprises stainless steel Dynamic Compression Plates and Compression Lag Screws and optional Hexagonal Screw for use in the fixation of femoral neck fractures.
The devices provide support to the femur and femoral head during the natural process of bone regeneration to repair the femoral neck fracture. The devices are designed to withstand the in vivo loads experienced during normal activity throughout the life of the implant.
A dedicated Corifix Dynamic Hip Screw instrument set is used to implant the devices or Stratetc (Synthes) instruments may be used.
Each of the implantable devices is manufactured form stainless steel which in certified to BS 7252 Part 1.
This is a 510(k) summary for the Corifix Dynamic Hip Screw System, a medical device for femoral neck fractures. The document is a premarket notification for a traditional medical device, not an AI/ML SaMD, so the requested information about acceptance criteria and study data relevant to AI/ML performance is not applicable. The device is a physical implant, and its equivalence is based on material and structural similarity to a predicate device.
Here's a breakdown of why this submission doesn't contain the requested AI/ML-specific information:
- Device Type: This is a physical orthopedic implant (Dynamic Hip Screw System), not a software device or an AI/ML-powered system.
- Approval Pathway: This is a 510(k) submission, specifically demonstrating substantial equivalence to a predicate device (Stratec (Synthes) DHS System). This pathway focuses on comparing the new device's design, materials, and intended use against a legally marketed predicate, rather than providing extensive clinical trial data for novelty or performance claims.
Therefore, the following points from your request are not present or applicable in this document:
- A table of acceptance criteria and the reported device performance: This document doesn't provide specific performance metrics in the way an AI/ML study would (e.g., sensitivity, specificity, AUC). Acceptance criteria here relate to manufacturing standards (BS 7252 Part 1 for stainless steel) and design similarities to the predicate.
- Sample size used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an AI/ML model.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML model is not relevant here.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 does not involve human readers or AI assistance.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI/ML sense. The "ground truth" for this device's acceptance is its substantial equivalence to the predicate device, supported by material specifications and design dimensions.
- The sample size for the training set: Not applicable. There is no training set for an AI/ML model.
- How the ground truth for the training set was established: Not applicable.
Summary of Device Acceptance Information from the Document:
Acceptance Criteria & Reported Performance (Based on Substantial Equivalence):
| Acceptance Criterion (Similarity to Predicate) | Reported Device Performance (Corifix DHS System) |
|---|---|
| Material | Manufactured from 316 LVM stainless steel |
| Plate Angles & Holes | Similar range of plate angles and holes |
| Intended Use | Designed to treat proximal hip fractures |
| Plate Thickness & Width | Same thickness and width as predicate |
| Outside Barrel Diameter | Same outside barrel diameter as predicate |
| Clinical Use History | In clinical use outside USA for three years with no postoperative problems reported. Competitor's device has been in clinical use for over twenty years with no significant problems. |
Study Information Pertaining to Traditional Device Submission:
- Study That Proves the Device Meets Acceptance Criteria: The submission is a comparison study demonstrating substantial equivalence to the Stratec (Synthes) DHS System, which is a legally marketed predicate device. The "proof" lies in the direct comparison of design characteristics and materials.
- Sample Size Used: Not applicable in the sense of a clinical trial or AI test set. The comparison is made against the specifications and design of the predicate device.
- Data Provenance: Not applicable for AI/ML. For this traditional device, the data provenance relates to the specifications of the Corifix device and the predicate device. Clinical use history mentioned (3 years for Corifix outside USA, 20+ years for predicate) is likely gathered from market surveillance or internal records, not a specific "study" with a defined sample size in the clinical trial sense.
- Ground Truth: The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate device. The Corifix system is deemed substantially equivalent because its characteristics sufficiently match those of the predicate, and it uses materials certified to a recognized standard (BS 7252 Part 1).
§ 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.