(262 days)
Bladder Neck Suspension
The Linvatec Preloaded Soft Tissue Anchor is indicated for bladder neck suspension for femine urinary incontinence due to urethral hypermobility.
The Preloaded Soft Tissue Anchor has an attached non-absorbable braided polyester suture through the eyelet. The suture is attached to a threading wire by a shrink tubing sleeve. Once the anchor is securely seated in the driver, the suture is cut on the device side of the shrink tubing and implantation can proceed.
The material used for this device is:
Anchor: Titanium Alloy
Suture: Non-absorbable braided polyester
Sleeve: Shrink tubing
Threading Wire: 316 Stainless Steel
The provided document does not contain a study that proves the device meets specific acceptance criteria in the manner requested. Instead, it is a 510(k) summary for a medical device (Linvatec Preloaded Soft Tissue Anchor) seeking clearance based on substantial equivalence to predicate devices.
Therefore, many of the requested sections regarding a specific study's methodology, results against acceptance criteria, sample sizes, expert involvement, and ground truth establishment cannot be extracted from this document.
However, I can provide information based on the overall purpose of a 510(k) submission, which is to demonstrate substantial equivalence to legally marketed predicate devices, implying that the new device is as safe and effective.
Here's what can be inferred or directly stated from the document:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify formal "acceptance criteria" in terms of performance metrics (e.g., tensile strength, pull-out force) with specific numerical targets and the device's performance against them. Instead, the "acceptance criteria" for a 510(k) submission are implicitly met if the device demonstrates substantial equivalence to predicate devices.
The document indicates:
- Acceptance Criteria (Implied for 510(k)): Substantial equivalence in intended use, material, and function to legally marketed predicate devices.
- Reported Device Performance: The document states, "Testing supports the equivalency to the predicate devices." (Page 2) and "The Preloaded Soft Tissue Anchor is substantially equivalent in function and intended use to the Mitek GII Anchor and the Zimmer Statak device." (Page 2).
| Criterion (Implied) | Performance Demonstrated (Abridged from document) |
|---|---|
| Intended Use Equivalence | "Soft tissue to bone fixation" and "Bladder neck suspension for female urinary incontinence due to urethral hypermobility." (Matches predicates) |
| Material Equivalence | Anchor: Titanium Alloy 6Al-4V-ELI; Suture: Non-absorbable Braided Polyester (Similar/Equivalent to predicates which use Titanium Alloy and Braided Suture) |
| Function Equivalence | Functions as a "soft tissue to bone fixation device." (Implied by substantial equivalence claim; supported by "Testing supports the equivalency.") |
| Safety and Effectiveness (Implied by equivalence) | Demonstrated through comparison to legally marketed predicate devices, with dissimilarities not raising new questions of safety or effectiveness. |
2. Sample size used for the test set and the data provenance
The document does not describe a clinical "test set" with a specific sample size. The evaluation for substantial equivalence would typically involve engineering testing (e.g., mechanical strength tests) comparing the new device to predicate devices, rather than a clinical trial with human subjects for efficacy for 510(k). No information about data provenance (country of origin, retrospective/prospective) is provided, as it's not a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. No clinical "test set" requiring ground truth established by experts is mentioned or described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable. No clinical "test set" or adjudication method is described.
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
This information is not applicable. The device is a soft tissue anchor, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study, human readers, or AI assistance is relevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a mechanical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Ground truth in the clinical sense (e.g., for diagnostic accuracy) is not described. The basis for safety and effectiveness is substantial equivalence to predicates, which relies on a comparison of design, materials, intended use, and potentially performance data (e.g., mechanical testing) that demonstrates comparable characteristics without raising new safety or effectiveness concerns.
8. The sample size for the training set
This information is not applicable. The device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable. The device is not an AI/ML algorithm.
§ 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.