(28 days)
The MicroTac Bone Anchor System is intended for soft tissue fixation to the pubic bone by means of bone anchors threaded with sutures. It is indicated for cystourethropexy and vaginal sling procedures for the treatment of stress type (female) urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
The MicroTac Bone Anchor System, consisting of the MicroTac Bone Anchor and the MicroTac Bone Anchor Inserter. The inserter of the MicroTac Bone Anchor System is designed for single use and is manual.
The provided text describes a 510(k) submission for the MicroTac Bone Anchor System, comparing it to a predicate device (In-Tac Bone Anchor System). This document focuses on demonstrating substantial equivalence for a medical device, which is a different regulatory pathway than providing detailed clinical study results with acceptance criteria and specific performance metrics for AI/software-based devices.
Therefore, the input does not contain the information necessary to fill out the requested table or answer most of the questions, as the submission primarily discusses device modifications and risk analysis to show equivalence. It does not present a study with quantitative acceptance criteria for its performance in the context of AI or diagnostic accuracy.
However, I can extract information related to the device and its regulatory context:
Device Information:
- Device Name: MicroTac Bone Anchor System
- Intended Use: Soft tissue fixation to the pubic bone by means of bone anchors threaded with sutures.
- Indications for Use: Cystourethropexy and vaginal sling procedures for the treatment of stress type (female) urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
- Predicate Device: Influence, Inc.'s In-Tac Bone Anchor System (cleared under K964953)
Response to Specific Questions based on the Provided Text:
As the provided text describes a 510(k) submission for a physical medical device (bone anchor system) and not an AI/software-based one, the requested detailed information about acceptance criteria, study design for AI models, ground truth establishment, expert adjudication, MRMC studies, or standalone performance for an algorithm is not applicable and therefore not available in this document.
The submission focuses on establishing substantial equivalence through risk analysis and performance testing related to the modifications from the predicate device. It indicates that "performance data gathered" and "performance testing" were used to demonstrate equivalence, but it does not provide specific quantitative acceptance criteria or detailed results in the format requested for an AI/diagnostic study.
Therefore, it's impossible to create the table or answer the specific questions as if this were a study proving an AI device meets acceptance criteria. The document's purpose is to show that the device modifications do not raise new questions of safety or effectiveness compared to a predicate device.
Summary of Unavailable Information:
- Acceptance Criteria Table: Not specified in the document.
- Device Performance: Not detailed in quantitative metrics that would align with AI/diagnostic studies. The document states "performance testing provided in the application demonstrates equivalence," but no data points are given.
- Sample Size (Test Set) and Data Provenance: Not applicable/not provided for an AI study.
- Number/Qualifications of Experts for Ground Truth: Not applicable/not provided.
- Adjudication Method: Not applicable/not provided.
- MRMC Comparative Effectiveness Study: Not applicable/not performed for this type of device submission.
- Standalone Performance (Algorithm Only): Not applicable, as this is a physical medical device.
- Type of Ground Truth: Not applicable/not provided (no diagnostic accuracy study).
- Sample Size (Training Set): Not applicable/not provided.
- How Ground Truth for Training Set was Established: Not applicable/not provided.
§ 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.