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The sole difference the wabject and device and the predicate device, is that the prodicate device is indicated for endosessic surgery while the subject device is only indicated for open and thoracoscopic surgery (non-insufflated).

The AUTO SUTURE* Suction / Irrigation** device is identical in safety and effectiveness to its currently marketed predicate - U.S. Surgical Corp.'s Endoscopic Suction / Irrigation ** device - 510(k) #K903207. United States Surgical Corporation has been manufacturing hand instruments as accessories in surgical procedures for a number of years. It is now the intention of USSC to expand the utility of the AUTO SUTURE* Endoscopic Suction / Irrigation ** device to allow the surgeon to gently blow blood and debris from the surgical site.

This document is a 510(k) summary for a medical device (AUTO SUTURE* Suction / Irrigation** device). It describes the device's substantial equivalence to a predicate device, rather than providing a detailed study report with acceptance criteria and performance data for a novel device.

Therefore, most of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not present in the provided text.

Here's what can be extracted based on the limited information provided:

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

No explicit quantitative acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy) are provided in this document. The summary focuses on demonstrating substantial equivalence to a predicate device.

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

Not provided. The document does not describe a performance study with a test set.

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 provided.

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

Not provided.

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 not an AI-enabled device, and no MRMC study is mentioned.

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

Not applicable. This is a manual surgical instrument, not an algorithm.

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

Not applicable. The "proof" of meeting criteria here is based on substantial equivalence arguments, not on a performance study against a defined ground truth. The summary states: "The information included in this notification demonstrates that the device is substantially equivalent to its predicate in respect to design, function, performance, labeling and sterilization."

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device requiring a training set.

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

Not applicable.

Summary of available information related to "acceptance criteria" and "study":

The "study" or evidence presented in this 510(k) summary is a comparative analysis intended to demonstrate substantial equivalence to an existing predicate device (U.S. Surgical Corp.'s Endoscopic Suction / Irrigation device - 510(k) #K903207).

The "acceptance criteria" are implicitly met by demonstrating that:

• The device is "identical in safety and effectiveness to its currently marketed predicate."
• It performs "the exact same functions."
• It is "manufactured in the same facilities, using similar processes and controls."
• It is "packaged in the same facilities using similar processes and controls."
• It "perform[s] the exact same function in the same way."
• It is "manufactured from the exact same bio-approved materials."

The "proof" is presented through these comparative statements rather than quantitative performance metrics from a new study. The only difference highlighted is the intended use indication (open and thoracoscopic surgery for the subject device vs. endoscopic surgery for the predicate).

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