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The SOCRATES System is indicated for use in general cardiothoracoscopy, general cardiothoracic surgery, general laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy, and sinuscopy where a general laparoscope/endoscope is indicated for use. A few example indications are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic & thorascopic anterior spinal fusion, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement. Use of the SOCRATES System enables a remote surgeon to telecommunicate with any AESOP™ Robotic System and assist the local surgeon with field-of-view positioning.

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The provided text describes the SOCRATES Robotic Telemonitoring System (K013804) and its safety and effectiveness summary. However, it does not include information about acceptance criteria or a specific study proving the device meets those criteria.

The document focuses on:

• Device identification: Proprietary name, common name, classification, and substantial equivalence to a prior device (K003661).
• Intended Use: Broad range of endoscopic surgical procedures where a rigid laparoscope/endoscope is indicated.
• Standards compliance: Lists several IEC, UL, EN, and CAN/CSA standards the device is designed and tested to. These are primarily electrical safety and electromagnetic compatibility standards.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, or details about a study demonstrating adherence to such criteria, because this information is not present in the provided text.

Specifically, the following requested information is not available in the document:

1. A table of acceptance criteria and the reported device performance: The document lists general standards the device is tested against (e.g., IEC 601-1), but does not specify performance-based acceptance criteria (e.g., "accuracy of +/- X degrees," "latency less than Y ms") or provide results from performance testing against such criteria.
2. Sample size used for the test set and the data provenance: No information about a test set or its provenance is given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set or ground truth establishment is described.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of human readers improving with AI vs. without AI assistance: Not applicable. The device is a telemonitoring/telecollaboration system for surgical assistance, not an AI diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The device is fundamentally designed for human-in-the-loop operation ("remote surgeon to assist the local surgeon").
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no ground truth for a diagnostic or performance test is described.
8. The sample size for the training set: Not applicable, as no machine learning or AI training is described for this device.
9. How the ground truth for the training set was established: Not applicable.

The provided document is a 510(k) summary for a robotic telemonitoring system, primarily focusing on its regulatory classification, intended use, and compliance with general safety and electrical standards, rather than detailed performance study results typical for diagnostic AI devices.

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