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The ENDOPATH® Ultra-Retractor and Vessel Dissector are intended for use in dissecting and retracting in all types of surgical procedures requiring dissection and retraction of tissue.

The ENDOPATH™ Ultra-Retractor has application for the creation and maintenance of an operative cavity in the extraperitoneal spaces such as the retroperitoneal, preperitoneal, and subcutaneous areas. The device may be used in all types of surgical procedures, requiring dissection and retraction of tissue.

The Vessel Dissector has application for use in the blunt dissection of tubular structures such as veins, arteries, nerves, and ducts. The device may also be used in all types of surgical procedures requiring dissection of tissue.

The ENDOPATH® Ultra-Retractor consists of a handle, a wide shaft, and a transparent blunt tip dissector (two instruments are available with a variation in the tip size). The blunt tip dissects tissue and creates a cavity that allows instrument passage. The wide shaft maintains the space created by the transparent tip. The tip is transparent to allow visualization during insertion, tunneling, and dissection. Also, the device is provided with a luer lock, located on the handle, for the attachment of suction or gas, such as CO2, nitrogen, or air, as an aid for the removal of mist or smoke when used in combination with electrosurgery or ultrasonic devices and/or clearing the endoscope lens.

The instrument is compatible with a rigid endoscope that has maximum diameter of 5.5mm and is 290mm to 300mm in length.

This document is a 510(k) summary for the ENDOPATH® Ultra-Retractor and Vessel Dissector. It does not contain the level of detail typically found in a study description that would allow for a comprehensive answer to all parts of your request. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed outcomes from a large-scale clinical study with specific performance metrics and ground truth establishment.

Here's what can be extracted and what cannot:

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

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

• Sample Size: Not specified. The document only mentions "Pre-clinical laboratory evaluations." These are likely benchtop tests or potentially animal studies, not human clinical trials with a defined test set sample size.
• Data Provenance: Not specified. Given it's pre-clinical lab evaluation, it would likely be internal testing data, not country-specific patient data.
• Retrospective/Prospective: Not specified, but "Pre-clinical laboratory evaluations" often imply prospective testing designed to evaluate specific aspects of the device.

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)

• This information is not provided. Pre-clinical evaluations typically rely on engineering specifications, design verification, and internal expert judgment regarding mechanical and functional performance, rather than a formal "ground truth" established by external medical experts in the way clinical studies do.

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

• Not applicable/not specified. Adjudication methods are typically used in clinical studies where interpretation of results (e.g., image readings) by multiple human experts is involved. Pre-clinical lab evaluations generally do not involve this process.

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

• No, an MRMC comparative effectiveness study was not done. This document predates widespread AI in medical devices and focuses on mechanical and functional equivalence for a surgical instrument. An MRMC study is relevant for diagnostic imaging AI algorithms, not for surgical retractors.

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

• No, this is not an AI/algorithm-based device. It is a physical surgical instrument. Therefore, a standalone algorithm performance study is not applicable.

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

• The document refers to "pre-clinical laboratory evaluations." For a surgical instrument like this, the "ground truth" would likely be adherence to engineering specifications, successful performance of intended functions (e.g., retraction strength, dissection ability, ability to maintain space), material compatibility, and sterile barrier integrity. This would be verified through a combination of physical and mechanical testing, not expert consensus on medical images or pathology.

8. The sample size for the training set

• Not applicable. This device does not use a training set as it is not an AI/machine learning device.

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

• Not applicable, as there is no training set for this device.

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