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SuperStitch is indicated for use in performing vascular stitching in general surgery, including endoscopic procedures. It is not intended for blind vascular closure.

The SuperStitch Vascular Suture Delivery Device is a hand-held and operated device designed for use with or without an access device (e.g. trocar, sheath, or cannula), depending on the endoscopic technique, for use during minimally invasive surgical procedures, or for application directly to a vessel or wound site in an open setting. The SuperStitch applies one nonabsorbable monofilament suture. After deployment of the device, the physician completes the closure by tying the appropriate surgical knots. Optional accessories for use with the SuperStitch include the KnotPusher for advancing the knot to the wound site and the Kwiknot knot tying device. The principal difference between the modified SuperStitch and the cleared SuperStitch is a change in one of the shaft materials. The Sutura SuperStitch is a prescription device, restricted to use by or on the order of physicians. The Sutura SuperStitch is sterilized by ethylene oxide and is non-pyrogenic in an unopened undamaged package, for single use only.

The provided text describes a 510(k) premarket notification for a medical device, the SuperStitch® Vascular Suture Delivery Device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with specific acceptance criteria, and thus the provided text does not contain the detailed information requested in the prompt (acceptance criteria, study details, sample sizes, ground truth establishment, MRMC studies, etc.).

Here's a breakdown of what can be extracted or inferred from the provided information, and what cannot:

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

• Cannot be extracted. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It does not typically include a table of pre-defined acceptance criteria (e.g., specific performance metrics like accuracy, sensitivity, specificity) for device performance or reported device performance against such criteria. The "study" mentioned is a comparison to a predicate, not a performance study against specific acceptance metrics for a "new" device.

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 extracted. Since there isn't a "test set" in the sense of a clinical or image-based study to evaluate performance metrics, this information is not present. The "testing" referred to is around design control and material properties, not a clinical performance validation against specific disease states or measurements.

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):

• Cannot be extracted. No ground truth establishment for a test set is mentioned.

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

• Cannot be extracted. No adjudication method is mentioned as there's no test set requiring ground truth establishment.

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:

• Cannot be extracted. This device is a surgical suture delivery device and not an AI/imaging device. Therefore, MRMC and human reader improvement with AI assistance are not relevant and are not discussed.

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

• Cannot be extracted. This is not an algorithm-based device.

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

• Cannot be extracted. No ground truth is established for device performance in the context of clinical outcomes or diagnostic accuracy. The "ground truth" for this submission would be the performance and safety characteristics of the predicate device.

8. The sample size for the training set:

• Cannot be extracted. This is not an AI/machine learning device. No training set is used.

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

• Cannot be extracted. No training set or associated ground truth establishment is mentioned.

Summary based on the provided text:

The provided document, K020940, describes a 510(k) premarket notification for the Sutura SuperStitch® Vascular Suture Delivery Device. The primary purpose of this submission is to demonstrate substantial equivalence to a previously cleared predicate device (Sutura SuperStitch®, K012865), rather than to establish specific performance criteria through a standalone clinical study.

Acceptance Criteria and Device Performance:

• The acceptance criteria for this 510(k) submission are implicitly tied to demonstrating that the modified SuperStitch device performs as safely and effectively as the predicate device.
• The "reported device performance" is essentially that the device maintains the same intended use, functionality, and reliability as the predicate device, following a material change in one of the shaft components.
• The document states: "The differences in the technological characteristics and size of the modified SuperStitch have been evaluated through appropriate design control procedures. These methods assessed the new characteristics with regard to functionality and reliability under simulated and actual conditions of use. Results of scientific testing have ensured that the materials are biocompatible and physical properties are appropriate for the intended use."
• No specific quantitative performance metrics (e.g., success rates, complication rates, specific mechanical test results with associated acceptance thresholds) are provided in this summary document. This level of detail would typically be in the full submission, not the public summary.

Study Type and Details:

• The "study" conducted for this 510(k) was a comparison to a predicate device to demonstrate substantial equivalence. It was not a comparative effectiveness study involving human readers or a standalone performance study with defined clinical endpoints.
• The evaluation focused on material changes, biocompatibility, and physical properties under simulated and actual conditions of use.
• Sample Size, Ground Truth, and Adjudication: These concepts (test set, training set, ground truth established by experts, adjudication methods, MRMC studies) are not applicable to this type of device and 510(k) submission. The assessment was primarily engineering and material-based, ensuring the modified device's characteristics were equivalent to the cleared predicate.

In conclusion, the requested detailed information (acceptance criteria, specific study parameters, sample sizes, ground truth, MRMC, etc.) is not present in this 510(k) summary because it primarily addresses substantial equivalence for a non-AI surgical device with a material modification, rather than a clinical performance study with predefined metrics for a "new" device concept.

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