(35 days)
The proposed bone anchor system is intended for use in procedures that require placement of a bone anchor for the purpose of soft tissue reinforcement and support inclusive of, but not limited to, suspending sutures and/or placement of a sling for the treatment of urinary stress incontinence attributable to hypermobility and/or intrinsic sphincter deficiency such as: Pubourethral, Urethrovesical, Pubovaginal, and bladder neck support/stabilization; Urethral and Vaginal prolapse repair; and reconstruction of the pelvic floor.
Bone anchor system
This document describes the acceptance criteria and the study for a Bone Anchor System III.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Performance Characteristics | Substantially equivalent to predicate devices | Substantially equivalent to predicate devices |
Note: The document explicitly states that "The proposed device has been tested and results compared to the predicate devices. The results show that the proposed device is substantially equivalent to the predicate devices in terms of the performance characteristics that were tested." However, it does not provide specific quantitative acceptance criteria or detailed numerical performance results. The acceptance is based on demonstrating substantial equivalence to already marketed predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the test data). It only mentions "Product Testing" was conducted to compare the device to predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The study described is a comparison of performance characteristics to predicate devices, not a study involving expert assessment of a medical condition.
4. Adjudication Method for the Test Set
This information is not applicable as the study described is based on product testing and comparison to predicate devices, not on expert adjudication of medical cases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The study focuses on the performance characteristics of the bone anchor system itself compared to predicate devices, not on the improvement of human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable to the device described. The Bone Anchor System III is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context is the performance characteristics of the predicate devices. The study aims to demonstrate that the proposed device's performance characteristics are "substantially equivalent" to these established predicate devices. There is no mention of pathology, outcomes data, or expert consensus in relation to establishing ground truth for a medical condition.
8. The Sample Size for the Training Set
This information is not provided and is not applicable as the device is a physical bone anchor system, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable for the same reason as above.
§ 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.