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The Advantage System Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Advantage surgical mesh during urogynaecological procedures.

The Advantage Fit System Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Advantage Fit surgical mesh during urogynaecological procedures.

The Lynx System Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Lynx surgical mesh during urogynaecological procedures.

The Solyx SIS Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Solyx SIS surgical mesh during urogynaecological procedures.

The Obtryx (Curved) Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Obtryx surgical mesh during urogynaecological procedures.

The Obtryx (Halo) Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Obtryx surgical mesh during urogynaecological procedures.

The Obtryx II (Curved) Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Obtryx II surgical mesh during urogynaecological procedures.

The Obtryx II (Halo) Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Obtryx II surgical mesh during urogynaecological procedures.

The subject devices are not sold individually and are only offered packaged as part of a surgical mesh system. Device descriptions specific to each delivery device are italicized below within each existing system description.

Advantage™ System and Advantage Fit™ System: The disposable delivery device consists of a handle with a curved needle, and a pusher component. The delivery device is designed to facilitate the passage of the mesh assembly through bodily tissues for transvaginal placement.

Lynx™ System: The disposable delivery device consists of a handle with a curved needle. The needle is designed to facilitate the passage of the mesh assembly through bodily tissues for suprapubic placement.

Solyx™ SIS System: The disposable delivery device consists of a handle, a stainless steel shaft and a deployment mechanism. The delivery device is designed to facilitate the passage of the mesh assembly through bodily tissues for placement into the obturator internus muscle.

Obtryx™ System (Curved & Halo): The disposable delivery devices consist of a handle with a stainless steel needle. The needle is designed to facilitate the passage of the mesh assembly through bodily tissues for placement through the obturator foramen.

Obtryx™ II System (Curved & Halo): The disposable delivery devices consist of a handle with a stainless steel needle. The needle is designed to facilitate the passage of the mesh assembly through bodily tissues for placement through the obturator foramen.

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what is present and noting what is absent as per your request.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or corresponding reported device performance values in a table format for a diagnostic or AI device. Instead, it details that the device met "applicable design and performance requirements" and various "special controls."

However, we can infer the types of performance aspects that were evaluated:

2. Sample size used for the test set and the data provenance

The document does not provide information on specific sample sizes for test sets, nor does it detail the data provenance (e.g., country of origin, retrospective/prospective) for any performance data. The tests described are related to device engineering and material performance, not clinical data or diagnostic accuracy.

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 and not provided as the submission is for a surgical delivery device, not a diagnostic device requiring expert interpretation for ground truth establishment. The "performance testing" described is for mechanical, material, and sterility validation.

4. Adjudication method for the test set

This information is not applicable and not provided for the same reasons as point 3.

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 and not provided as the device is a surgical delivery tool, not an AI-assisted diagnostic or interpretation system.

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

This information is not applicable and not provided as the device is a physical surgical delivery tool, not an algorithm.

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

The concept of "ground truth" in the context of diagnostic or AI performance is not applicable here. For the engineering and biocompatibility tests, the "truth" is established by adherence to recognized standards, test methodologies, and objective measurements (e.g., sterility validation protocols, mechanical stress limits, chemical analysis for biocompatibility).

8. The sample size for the training set

This information is not applicable and not provided as the device is a physical surgical instrument and does not involve AI or machine learning models that require a "training set."

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

This information is not applicable and not provided for the reasons stated in point 8.

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