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The intended use of the New Device is to establish a path of entry for minimally invasive instruments. Instruments provided with a stopcock are intended for insufflation of the operative space when the trocar is in place.

The ENDOPATH® Dilating Tip Trocar has application in general, thoracic, gynecologic, or other minimally invasive surgical procedures to establish a path of entry for minimally invasive instruments.

The ENDOPATH® Dilating Tip Trocar has application in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for minimally invasive instruments.

The ENDOPATH® Dilating Tip Trocar consists of two main sub-assemblies: an obturator sub-assembly and a sleeve sub-assembly.

The obturator consists of a sharp flat blade tip or pyramidal tip and a spring loaded shield. The shield is designed to cover the flat blade or pyramidal tip to protect internal structures from puncture or laceration once the abdominal or thoracic cavity has been entered.

The sleeve subassembly has an inner gasket seal or flapper door seal and an outer gasket seal to maintain pneumoperitoneum when instrumentation is inserted and withdrawn through the cannula during a surgical procedure. Some instruments are provided with a stopcock for insufflating the operative space and a flapper door lever to allow quick desufflation. Integral threads along the outside diameter of the cannula portion of the sleeve provide a retention mechanism to stabilize the sleeve in tissue.

The ENDOPATH® Dilating Tip Trocar shall be provided in a variety of sizes from 3mm to 12mm in diameter and 65mm to 150mm in length.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ENDOPATH® Dilating Tip Trocar:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document explicitly states "Pre-clinical laboratory evaluations were performed to ensure that the device can be used as designed. The studies demonstrated acceptable performance to the Predicate Device..." The acceptance criteria are not quantified with specific thresholds (e.g., "no more than X force required for insertion," "no leaks exceeding Y ml/min"). Instead, the performance is reported as "acceptable" in comparison to a predicate device.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not specified.
• Data Provenance: The studies were "Pre-clinical laboratory evaluations." This suggests the tests were conducted in a laboratory setting, likely in the US (given the submission to the FDA in Cincinnati, Ohio). It is a prospective study as newly manufactured devices were tested.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not applicable/Not specified. The "ground truth" for this type of device (a surgical trocar) would be based on engineering specifications and functional testing, not expert consensus on medical images or clinical outcomes in the same way an AI diagnostic tool would.

4. Adjudication Method for the Test Set:

• Not applicable/Not specified. As noted above, the testing is functional and engineering-based, not reliant on human interpretation or adjudication in the medical sense.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation tools, not for a physical surgical device like a trocar.

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

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

7. The Type of Ground Truth Used:

• The ground truth (or more appropriately, the standard) for evaluation was likely established through engineering specifications for the device's functional components and comparative performance against a predicate device. The studies "demonstrated acceptable performance to the Predicate Device." This implies the predicate device's established performance served as the benchmark.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI-based device, so there is no "training set."

9. How the Ground Truth for the Training Set was Established:

• Not applicable. As above, there is no "training set."

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To establish a path of entry for minimally invasive instruments. The instrument is intended for creating secondary ports under direct visualization.

The (TRADE NAME) Non-shielded Surgical Trocar with Threaded Sleeve has application in thoracic, general, gynecologic, or other minimally invasive surgical procedures to establish a path of entry for minimally invasive instruments. The instrument is intended for insertion under direct visualization for secondary port locations.

The (TRADE NAME) Non-shielded Surgical Trocar consists of two main subassemblies: a non-shielded obturator sub-assembly and the sleeve sub-assembly.

The non-shielded obturator sub-assembly is designed with a protective sheath to cover the flat blade. This protective sheath protects the gaskets on the sleeve assembly when the obturator and sleeve are mated together for insertion into the operative cavity. When the sleeve and obturator are properly engaged, the protective sheath is retracted so that the blade is exposed when it extends from the trocar sleeve.

An inner and outer gasket seals to maintain pneumoperitoneum when instrumentation is inserted and withdrawn through cannula during a surgical procedure. Integral threads along the outside diameter of the cannula portion of the sleeve provide a retention mechanism to stabilize the sleeve in tissue

The (TRADE NAME) Non-shielded Surgical Trocar shall be provided in a variety of sizes from 3mm to 12mm in diameter and 75mm to 150mm in length.

This device is designed to create secondary trocar sites and is labeled to be used only under direct visualization of the insertion site.

This document is a 510(k) Summary of Safety and Effectiveness for a surgical trocar, not a study evaluating an AI device or algorithm. Therefore, the requested information about acceptance criteria, study design for AI evaluation, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone performance of an AI is not available in the provided text.

The document describes a medical device (a non-shielded surgical trocar) and its equivalence to a predicate device, based on pre-clinical laboratory evaluations for its physical performance.

Here's a breakdown of what can be extracted from the provided text, recognizing it doesn't fit the AI/algorithm evaluation paradigm:

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

The document does not provide a table with specific quantitative acceptance criteria or detailed reported performance values. Instead, it states that "The studies demonstrated acceptable performance to the Predicate Device" for specific functionalities. This implies that the acceptance criteria were likely functional and comparative to the predicate device, although the numerical benchmarks are not listed.

2. Sample sized 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 were performed." The number of devices tested or the conditions under which they were tested are not detailed.
• Data Provenance: Not specified, but given it's pre-clinical laboratory evaluations, it would be internal testing.
• Retrospective or Prospective: These were likely prospective tests conducted on the newly designed 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 is not applicable as the "ground truth" here pertains to physical device performance (e.g., maintaining seals, insertion functionality), not interpretation of medical data by experts. The "truth" would be determined by the objective success or failure of the device during the specified pre-clinical tests, as assessed by engineering or testing personnel.

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

Not applicable. This concept is relevant for expert review of medical data, not for the physical performance testing of a medical device.

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 device.

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

Not applicable. This is not an AI algorithm.

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

The "ground truth" for this device's performance would be objective measurements and observations from the pre-clinical laboratory evaluations (e.g., successful insertion, no leakage, proper mating of components). It is not based on medical diagnoses or outcomes data in humans, as these are pre-clinical tests.

8. The sample size for the training set

Not applicable. This is not an AI model requiring a training set.

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

Not applicable. This is not an AI model.

In summary, the provided text describes a traditional medical device (surgical trocar) and its regulatory submission. It does not pertain to the evaluation of an AI-powered device or algorithm, and therefore the specific questions tailored to AI evaluation cannot be answered from this document.

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