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The LARIAT II Suture Delivery Device facilitates suture placement and knot tying for use in surgical applications where soft tissue are being approximated and/or ligated with a pre-tied polyester suture.

The LARIAT II Suture Delivery Device is a one-piece, single-use suture delivery and deployment device with a pre-tied size 0 polyester suture loop that is pre-loaded on the device. A lumen within the LARIAT II is designed for aspiration, flushing during the delivery, capture or release of the LARIAT II Suture.

The LARIAT II is packaged with a guide cannula and a dilator which may be used for guidance and placement of the LARIAT II, and a surgical blade which is used for cutting excess suture.

The suture is itself a cleared medical device as a part of Pre-Market Notification K021019.

The provided document, K090385, describes the LARIAT II Suture Delivery Device, its intended use, and substantial equivalence to predicate devices. However, it does not contain the detailed information required to fill out all sections of your request regarding acceptance criteria and a specific study proving device performance against those criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices. It states that "Functional testing was conducted to support the claim of substantial equivalence and to demonstrate the LARIAT II is safe and effective for its intended use" and "Results of testing demonstrate the LARIAT II is biocompatible." However, it does not provide the specific acceptance criteria for this functional testing, nor does it detail the study design, sample sizes, ground truth establishment, or expert involvement that you've requested.

Therefore, many of your requested fields cannot be populated from the provided text.

Here's a breakdown of what can and cannot be answered based on the input:

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

• Cannot be provided. The document states "Functional testing was conducted to support the claim of substantial equivalence," but it does not list specific acceptance criteria or the reported performance data against those criteria.

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

• Cannot be provided. The document only mentions "Functional testing" without any details on sample size or data provenance.

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/Cannot be provided. This type of information is typically relevant for studies involving subjective human assessment (like image interpretation). For a suture delivery device, "ground truth" would likely be objective mechanical or functional performance, not expert consensus on an interpretation. The document does not describe any such expert-based ground truth establishment.

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

• Not applicable/Cannot be provided. Similar to point 3, this is not relevant for the type of testing described (functional performance of a mechanical device).

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

• No. This type of study is completely irrelevant for a suture delivery device, which is a physical surgical tool, not an AI-powered diagnostic or assistive reading tool.

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

• No. This is also irrelevant as the device is a manual surgical tool, not an algorithm.

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

• Cannot be provided definitively. Based on the general description of "functional testing," the ground truth would likely be based on objective measurements of mechanical performance (e.g., suture integrity, delivery success, knot security, material strength, biocompatibility), rather than expert consensus, pathology, or outcomes data in the traditional sense of diagnostic devices. However, the specific metrics and how they constitute "ground truth" are not detailed.

8. The sample size for the training set

• Not applicable. The LARIAT II Suture Delivery Device is a physical medical device, not an AI or machine learning model that requires a training set.

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

• Not applicable. As above, no training set for an algorithm exists for this device.

In summary, the provided K090385 document is a regulatory submission focused on substantial equivalence rather than a detailed scientific study report. It states that functional testing was performed but lacks the granular data and methodological details you are seeking.

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