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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

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.

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UltraFix RC: Shoulder (rotator cuff repair)
UltraFix Mini: Hand/Wrist (ulnar or lateral collateral ligament reconstruction, radial collateral ligament, scapholunate ligament reconstruction), Foot/Ankle (hallux valgus reconstruction, midfoot reconstructions, lateral stabilization, medial stabilization, achilles tendon), Elbow (biceps tendon, ulnar collateral ligament, radial collateral ligament)
UltraFix: Shoulder (bankart repair, rotator cuff repair, SLAP lesion, acromio-clavicular separation, biceps tenodesis, deltoid repair, capsular shift reconstruction, capsulolabral reconstruction), Hand/Wrist (ulnar or lateral collateral ligament reconstruction, radial collateral ligament, scapholunate ligament reconstruction), Foot/Ankle (hallux valgus reconstruction, midfoot reconstructions, lateral stabilization, medial stabilization, achilles tendon), Elbow (biceps tendon, ulnar collateral ligament, radial collateral ligament), Knee (medial collateral ligament, lateral collateral ligament, patellar tendon, patellar ligament avulsions, posterior oblique ligament, joint capsule to tibia, iliotibial band tenodesis).

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.

The provided text describes a 510(k) summary for the LM Anchor Products, focusing on their substantial equivalence to predicate devices, specifically Mitek Surgical Products GII QuickAnchor. However, the document does not contain the information needed to answer your specific questions about acceptance criteria and a study proving a device meets them.

The 510(k) summary mentions "Performance Data" with "Pre-clinical testing in cadaver specimen showed that the mean pullout strength of the LM Anchor Products were substantially equivalent to the mean pullout strength of the Mitek anchors." This statement is the closest to addressing performance, but it lacks the detailed information you requested.

Here's why I cannot provide the requested information based on the input:

• Acceptance Criteria: The document does not explicitly state any numerical or qualitative acceptance criteria for the LM Anchor Products' performance. It only states that their pullout strength was "substantially equivalent" to the predicate device.
• Reported Device Performance: While it mentions "mean pullout strength," it doesn't provide the actual numerical values for either the LM Anchor Products or the Mitek anchors.
• Sample Size (Test Set) and Data Provenance: The document states "cadaver specimen" but does not specify the number of specimens (sample size) or any details about their origin (e.g., country of origin). It is implicitly retrospective as it's pre-clinical testing.
• Number of Experts and Qualifications: This information is entirely absent. There's no mention of experts establishing ground truth for the pullout strength measurements.
• Adjudication Method: Not applicable or mentioned as there's no expert-based evaluation or scoring.
• MRMC Comparative Effectiveness Study: There is no indication of an MRMC study. This type of study is typically for evaluating a diagnostic AI device's impact on human readers, which is not relevant to a bone anchor's pullout strength.
• Standalone Performance: The pre-clinical testing mentioned is a standalone performance evaluation of the device itself (its mechanical properties), but the details are missing.
• Type of Ground Truth: For the pullout strength, the "ground truth" would be the measured physical force. However, this is not explicitly stated in the provided text.
• Sample Size for Training Set: There's no mention of a "training set" as this is not an AI/machine learning device.
• How Ground Truth for Training Set was Established: Not applicable.

In summary, the provided 510(k) summary is very high-level and only states that pre-clinical cadaver testing showed substantial equivalence in pullout strength to a predicate device. It does not provide the detailed scientific study design or results that your questions require.

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Shoulder (bankart repair, rotator cuff repair, SLAP lesion, acromio-clavicular separation, biceps tenodesis, deltoid repair, capsular shift reconstruction, capsulolabral reconstruction), Hand/Wrist (ulnar or lateral collateral ligament reconstruction, radial collateral ligament, scapholunate ligament reconstruction), Foot/Ankle (hallux valgus reconstruction, midfoot reconstructions, lateral stabilization, medial stabilization, achilles tendon), Elbow (biceps tendon, tennis elbow, ulnar collateral ligament, radial collateral ligament), Knee (medial collateral ligament, lateral collateral ligament, patellar tendon, patellar ligament avulsions, posterior oblique ligament, joint capsule to tibia, iliotibial band tenodesis).

Made from surgical grade stainless steel (316L), the LM Anchor is designed with a crown and a center pin through which suture is passed to provide a means for soft tissue to bone attachment.

The provided text describes a medical device, the "LM Anchor," and its performance compared to predicate devices. However, the information DOES NOT contain the level of detail required to answer your specific questions regarding acceptance criteria, study design, expert qualifications, and ground truth establishment for an AI/ML-based device.

The provided document is a 510(k) summary for a bone anchor, which outlines its design, intended use, and pre-clinical performance. It describes a physical medical device, not an AI/ML diagnostic or assistive technology. Therefore, the questions about AI/ML-specific study design elements (e.g., test set, training set, ground truth experts, adjudication methods, MRMC studies) are not applicable to this document.

Here's an attempt to answer the relevant questions based on the provided text, while highlighting the absence of AI/ML-specific information:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not explicitly stated. The document mentions "cadaver specimen" but does not provide the number of specimens or anchors tested.
• Data Provenance: Not specified, but the data is from "pre-clinical testing in cadaver specimen," implying a controlled laboratory environment rather than patient data. No country of origin is mentioned. The study is prospective in nature for a pre-clinical assessment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This relates to an AI/ML diagnostic device where experts establish ground truth for image or data interpretation. For a physical bone anchor, the "ground truth" is measured physical properties (e.g., pullout strength) determined by mechanical testing, not expert interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. Adjudication methods are used in AI/ML performance studies to resolve discrepancies in expert labeling or diagnoses. For mechanical testing of a physical device, the outcome is a measurable physical property, not subject to expert interpretation disputes in the same way.

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. MRMC studies are specific to evaluating AI-assisted diagnostic tools where human readers (e.g., radiologists) interpret cases with and without AI assistance. This document describes a physical surgical implant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This question pertains to the performance of an AI algorithm operating independently. The LM Anchor is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Mechanical Measurement: The "ground truth" for the LM Anchor's performance is its mean pullout strength as measured in pre-clinical cadaveric testing. This is a direct physical measurement.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML model and therefore does not have a "training set."

9. How the ground truth for the training set was established

• Not applicable. As there is no training set for an AI/ML model, this question is not relevant.

In summary, the provided K960439 document is for a physical medical device (bone anchor) and does not contain the information requested for AI/ML device evaluation.

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