(86 days)
Synthes 4,5 mm Cannulated Screws are intended for fracture fixation of long bones and long bone fragments.
Synthes 4.5 mm Cannulated Screws are available in various thread length configurations (partially or fully threaded). The 4.5 mm Cannulated Screw features self-drilling/self-tapping flutes and cancellous threads for use in cancellous bone. The screws are used in conjunction with a guide wire for precise placement in bone. Synthes 4.5 mm Cannulated Screws are manufactured from stainless steel or Ti Alloy. Synthes 4.5 mm Cannulated Screws will be provided sterile, gamma radiation will be used to sterilize the device.
This document describes a medical device submission from 1996 for Synthes 4.5 mm Cannulated Screws. The provided information is insufficient to answer most of the questions related to acceptance criteria and study design for AI/machine learning devices. The document details a traditional mechanical device, not an AI or diagnostic imaging device. Therefore, many questions regarding ground truth, expert readers, and AI performance metrics are not applicable.
However, based on the provided text, here's what can be extracted and inferred for a mechanical device submission:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| At least equivalent to Synthes 4.0 mm Cancellous Screws (in terms of mechanical properties) | Synthes 4.5 mm Cannulated Screws are at least equivalent to Synthes 4.0 mm Cancellous Screws. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample size: Not specified. For mechanical testing, this would typically refer to the number of screws or test specimens used in various mechanical loads.
- Data provenance: Not specified. Mechanical tests are usually conducted in a lab environment rather than being related to patient data provenance.
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. This device is a mechanical implant, not a diagnostic or AI device requiring expert interpretation for ground truth. "Ground truth" for mechanical testing is established by engineering standards and measurements.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human experts in evaluating diagnostic or AI performance. For mechanical testing, results are typically objective measurements.
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 mechanical 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. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Mechanical Testing Standards/Measurements: The "ground truth" for mechanical equivalence would be derived from established engineering standards for strength, torsion, fatigue, etc., and direct quantitative measurements from the tests performed on both screw types.
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of mechanical device testing as described. This concept applies to machine learning models.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set" for this type of device submission.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.