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The Medtronic Octopus TE Stabilizer is used to stabilize the epicardial surface of the non-arrested heart during coronary artery surgery. It is intended to be used by trained medical professionals in operating room environments.
The Stabilizer is intended to stabilize the epicardial surface of the nonarrested heart during coronary artery surgery. It is intended to be used only by medical professionals in operating room environments.

The non-sterile, reusable Medtronic Octopus TE Heart Stabilizing System is a suction-based tissue stabilizer with a collapsible pod assembly, a rigid shaft and 5 articulating links designed to enable transfer into the thoracic cavity via a 12 mm thoracic port or traditional sternotomy access. It is comprised of four distinct elements: (1) the Medtronic Octopus TE Tissue Stabilizer, (2) the Medtronic Octopus TE Suction Lines, (3) the Medtronic Octopus TE Vacuum Lines, and (4) the Medtronic Octopus TE Irrigator (optional).
The Medtronic Octopus TE Heart Stabilizer is secured to a flexible arm and universal mounting rail, which attached to the operating table rail. Vacuum is delivered to the pod assembly by a disposable suction line inserted through the shaft of the stabilizer and a disposable vacuum line that connects the stabilizer to the vacuum source. The accessories are sold separately.

The provided text is a 510(k) summary for the Medtronic Octopus® TE Stabilizer & Accessories, which is a cardiovascular surgical instrument. It outlines the device's description, intended use, and substantial equivalence to predicate devices. However, the document does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as it would apply to a diagnostic or AI-driven medical device.

This 510(k) pertains to a physical surgical instrument, not a device that generates data or requires performance metrics like sensitivity, specificity, or accuracy. The assessment of such a device focuses on "substantial equivalence" to legally marketed predicate devices in terms of design, materials, manufacturing processes, and intended use, rather than a clinical performance study with statistical endpoints.

Therefore, most of the requested information (acceptance criteria, device performance table, sample sizes, data provenance, expert qualifications, adjudication, MRMC study, standalone performance, ground truth types and establishment) is not applicable to this type of regulatory submission and is not present in the provided text.

Here's a breakdown of why the information is not present based on the nature of the device:

• 1. A table of acceptance criteria and the reported device performance: Not applicable. Performance for a surgical instrument is assessed through comparisons of its technological characteristics (e.g., design, materials, principle of operation) to predicate devices, and potentially through bench testing for safety and functional specifications, not a performance table against clinical acceptance criteria as would be seen for a diagnostic or AI device.
• 2. Sample sized used for the test set and the data provenance: Not applicable. There is no "test set" in the context of clinical performance data for this type of surgical instrument in this document.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth or expert review process of clinical data is described in this 510(k) summary for the device's performance.
• 4. Adjudication method for the test set: Not applicable.
• 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-assisted diagnostic device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
• 8. The sample size for the training set: Not applicable. This is not a machine learning device.
• 9. How the ground truth for the training set was established: Not applicable.

Summary of Relevant Information from the Document:

• Device Type: Cardiovascular Surgical Instrument/Heart Stabilizer.
• Regulatory Pathway: 510(k) Premarket Notification, indicating substantial equivalence to predicate devices.
• Predicate Devices: Medtronic Octopus Tissue Stabilizer (K964445) and the CTS (Guidant) Vacuum Assist Stabilizer (K992833).
• Basis of Equivalence: Patient population, intended use, function, basic system components, device design, and principal of operation were found to be substantially equivalent to the predicate devices.
• Study Described: The document refers to "Comparisons between the new and predicate devices shows that technological characteristics (i.e. device design and principal of operation) are substantially equivalent." This implies an engineering and design comparison rather than a clinical study with performance metrics in the typical sense.

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