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This device is designed as an organ and tissue retractor for the use in minimally invasive surgical procedures to elevate organs and tissues to provide better access as well as visualization and stabilization of surgical sites.

The Surgical Retractor is a Reusable device intended for mobilizing and maneuvering organ and tissue within the cavity during laparoscopic Surgical procedures.

The provided text describes a 510(k) premarket notification for a "Surgical Retractor." This device is a reusable surgical instrument, not an AI/ML-driven device or a diagnostic tool that would typically have performance metrics like sensitivity, specificity, or accuracy, or require studies involving ground truth, expert readers, or training sets in the way the prompt describes.

Therefore, most of the requested information regarding acceptance criteria, study details, ground truth, and expert involvement is not applicable to this type of device and is not present in the provided documentation.

However, I can extract the relevant information from the document:

Device Type: Surgical Retractor (a physical, reusable surgical instrument).

Acceptance Criteria and Reported Device Performance:

Since this is a physical surgical instrument, the "acceptance criteria" are related to its functional and safety performance, implied by its "substantial equivalence" to predicate devices. The document does not provide specific numerical performance metrics for acceptance criteria and reported device performance. Instead, the device is deemed acceptable because it is substantially equivalent to legally marketed predicate devices.

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

  • Not applicable. The document does not describe a "test set" in the context of clinical data for performance evaluation in the way an AI/ML device would. Substantial equivalence for this type of device relies on comparisons to predicate devices and adherence to general controls, likely supported by engineering testing rather than clinical study data.

• Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

  • Not applicable. "Ground truth" in the diagnostic/AI sense is not established for this type of device.

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

  • Not applicable.

• 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 device is a surgical instrument, not an AI-assisted diagnostic tool.

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

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

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

  • Not applicable.

• The sample size for the training set:

  • Not applicable. This is a physical surgical instrument, not an AI/ML model requiring a training set.

• How the ground truth for the training set was established:

  • Not applicable.

Summary of the study/submission for this device:

The "study" or justification for market clearance is based on the concept of substantial equivalence to legally marketed predicate devices. The submission (K112659) details that the "Surgical Retractor" is "substantially equivalent" to:

• Laparoscopic Retractors (Diamond-Flex) (K092684) - Cardinal Health
• Nathanson Liver Retractor (K942002) - Automated Medical Products
• Endo-Retract (K914190) - Covidien

This substantial equivalence argument implies that the device performs as safely and effectively as these predicates for its intended use, and therefore meets the necessary regulatory "acceptance criteria" for a Class II medical device under 21 CFR 876.1500 (Endoscope and accessories, Product Code GCJ). The document does not detail specific performance studies beyond this declaration of equivalence.

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