(84 days)
Bladder neck suspension for female urinary incontinence due to urethral hypermobility. Fixation in pubic bone for the purpose of bladder neck suspension using USP #2 Class I, non-absorbable, synthetic suture (e.g., polypropylene). A minimum of two LM Anchors should be used in this (modified MMK, Raz, or Stamey, i.e., Benderev) procedure.
Made from surgical grade stainless steel (316L) or titanium (6A1-4V ELI), the LM Anchor Products are designed with a crown and a center pin through which suture is passed to provide a means for soft tissue to bone attachment.
This 510(k) summary describes a device, the LM Anchor Products, not an AI/ML powered device. Therefore, many of the requested categories related to AI performance, such as sample sizes for test and training sets, expert qualifications, and MRMC studies, are not applicable.
However, I can extract the available performance information from the provided text for the medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence in mean pullout strength to Mitek anchors. | The mean pullout strength of the LM Anchor Products was substantially equivalent to the mean pullout strength of the Mitek anchors. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated as a number of devices or subjects. The document mentions "cadaver specimen," implying human cadaveric tissue was used.
- Data Provenance: "Pre-clinical testing in cadaver specimen." This indicates a laboratory study using cadavers, not live human subjects. The country of origin is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a mechanical performance test, not a diagnostic or interpretative one that would require expert ground truth establishment in the traditional sense. The "ground truth" here is the measured pullout strength.
4. Adjudication method for the test set
Not applicable. This is a direct measurement of pullout strength. No adjudication method typically applies to such biomechanical 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 is a non-AI mechanical device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a non-AI mechanical device. The test measures the device's inherent mechanical property.
7. The type of ground truth used
The "ground truth" in this context is the measured pullout strength of both the LM Anchor Products and the predicate Mitek anchors, obtained through pre-clinical cadaveric testing.
8. The sample size for the training set
Not applicable. This is a hardware device; there is no "training set" in the AI/ML sense.
9. How the ground truth for the training set was established
Not applicable. There is no training set. The "ground truth" (measured pullout strength) for the performance evaluation was established through direct experimental measurement on cadaveric specimens.
§ 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.