(139 days)
The Bio-Interference Screw is intended for fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee.
The Bio-Interference Screw is a biodegradable interference screw intended for interference fit fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee. The device is offered in varying diameters and lengths.
The provided text describes the 510(k) premarket notification for the Innovasive Bio-Interference Screw. Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Device Performance |
|---|---|
| Substantially equivalent ultimate holding strength to predicate device | Testing demonstrates substantially equivalent performance between the Innovasive Bio-Interference Screw and the Arthrex Bio-Interference Screw. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size used for the bone model testing or the data provenance (e.g., country of origin, retrospective or prospective). It only mentions "Bone Model Testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The study involves mechanical testing on a bone model, not expert assessment of images or data that would require "ground truth" established by experts in the typical sense for medical imaging algorithms.
4. Adjudication method for the test set
This information is not applicable and not provided. The study involves mechanical testing, not a process that would typically require adjudication.
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
An MRMC comparative effectiveness study was not done. This document describes a medical device (an interference screw) and its mechanical performance, not an AI algorithm for diagnosis or interpretation that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a physical medical implant, not a standalone algorithm.
7. The type of ground truth used
The "ground truth" in this context is the mechanical performance of the predicate device (Arthrex Bio-Interference Screw). The Innovasive Bio-Interference Screw's performance was compared directly to this established device. This is a form of functional equivalence based on established device performance.
8. The sample size for the training set
This information is not applicable and not provided. The device is not an AI algorithm that would have a "training set."
9. How the ground truth for the training set was established
This information is not applicable and not provided, as there is no "training set" for this type of medical device.
§ 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.