(179 days)
The Implex Screw and Washer System is indicated for use in the attachment of ligaments, tendons and other soft tissue to bone.
The Implex Screw and Washer System consists of the Implex Continuum Bone Screw configured with a Hedrocel®/CP titanium Washer. The Implex Continuum Bone Screw has a 5 mm diameter and is offered in lengths from 15 to 65 mm, in 5 mm increments. The Washer is offered in two versions. Washer-A and Washer-A has a flat tissue-contacting Washer-B. surface and Washer-B has a flat tissue-contacting surface with recessed grooves. Both versions are round, and offered in three outer diameters, 14 mm, 17 mm, and 20 mm.
The provided text is a 510(k) summary for the Implex Screw and Washer System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through performance data related to material and structural properties, rather than clinical studies involving human readers or AI.
Therefore, many of the requested elements for describing an acceptance criteria study, particularly those related to AI and human reader performance, are not applicable to this document.
Here's an analysis of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria for various performance metrics in a readily quantifiable format. Instead, it refers to a Material Approval File (MAF) and mechanical testing.
Acceptance Criteria (Inferred from Performance Data Section):
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Material and Structural Properties of Washer | Suitable for the intended use of the device (MAF#920) | Demonstrated suitability in MAF#920 |
| Strength of CP Titanium/Hedrocel® Interface | Sufficient for the intended use (implied, demonstrated through mechanical testing) | Mechanical testing included in 510(k) demonstrated sufficient strength |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The term "test set" in the context of device performance usually refers to the specimens used for mechanical or material testing. The document states "Mechanical testing demonstrating the strength of the CP Titanium/Hedrocel® interface is included in this 510(k) Premarket Notification," but does not detail the sample size or provenance of these tests.
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)
This is not applicable as the study described is a mechanical/material performance study, not a study requiring expert interpretation of results to establish ground truth in the way clinical or AI studies do.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept is relevant for clinical studies or those involving human interpretation, not mechanical testing.
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 physical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the mechanical testing, the "ground truth" would be the direct physical measurement of material properties and interface strength against established engineering standards or internal specifications for safety and performance in its intended use. It is based on direct physical measurement and engineering principles.
8. The sample size for the training set
Not applicable. This device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI algorithm requiring a training set.
§ 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.