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The intended use of the ENDOPATH® OPTIVIEW® Optical Surgical Obturator and Sleeve is to establish a path of entry for endoscopic instruments.

The ENDOPATH® OPTIVIEW® Optical Surgical Obturator and Sleeve has applications in abdominal, gynecologic, and thoracic minimally invasive surgical procedures as well as endoscopic surgery of superficial veins and fascia of the lower extremities to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments. The trocar may be used without visualization for primary and secondary insertions.

The ENDOPATH® OPTIVIEW® Optical Surgical Obturator and Sleeve consists of an obturator and a 5mm, 11mm, or 12mm sleeve.

The clear, tapered optical element, when used with an endoscope, provides visibility of individual tissue layers during insertion. The blunt tip maysupplied, is compatible with standard luer lock fittings and provides for insufflation of the abdominal cavity. The ENDOPATH® OPTIVIEW® Optical Surgical Obturator and Sleeve has a sealing range that accommodates appropriately sized instruments. The obturator accommodates an appropriately sized zero degree endoscope. There are two obturator ergonomic options: O designated codes without a handle, and H designated codes with an integral pistol grip handle which aids in the insertion of the device.

The provided text describes a 510(k) summary for the ENDOPATH® OPTIVIEW® Optical Surgical Obturator and Sleeve. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving performance against specific acceptance criteria for a novel device.

Therefore, many of the requested categories for a study proving device acceptance criteria cannot be extracted from this document, as the document's purpose is different.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Reasoning: The "Performance data" section states, "Pre-clinical laboratory evaluations were performed to ensure that the device can be used as designed. These studies demonstrated acceptable performance to the predicate device in mating the obturator with the sleeve, insertion into the operative cavity with or without visualization, removal of the obturator from the sleeve, security of the sleeve in tissue, and maintenance of pneumoperitoneum of the operative space." This implies that the 'acceptable performance to the predicate device' for these specific functions served as the acceptance criteria for those tests.

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 used for the test set: Not specified.
• Data provenance: "Pre-clinical laboratory evaluations." The country of origin and whether it was retrospective or prospective is not mentioned.

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)

• Not applicable. The document does not describe studies involving expert-established ground truth. The "performance data" describes pre-clinical laboratory evaluations against a predicate device, which typically involves engineering or technical assessment rather than expert evaluation of diagnostic accuracy.

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

• Not applicable. No adjudication method is mentioned as it relates to expert review.

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

• This is not an AI device. No MRMC study was performed or mentioned.

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

• This is not an AI device. No standalone algorithm performance was assessed.

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

• The "ground truth" implicitly used was the performance of the legally marketed predicate device. The study aimed to show "acceptable performance to the predicate device" across several functional aspects.

8. The sample size for the training set

• Not applicable. This is not an AI device, so there is no concept of a training set as would be used in machine learning. If this refers to samples used in general pre-clinical testing, it is not specified.

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

• Not applicable. This is not an AI device.

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The intended use of the New Device is to establish a path of entry for minimally invasive instruments.
The ENDOPATH® OPTIVIEW™ Optical Surgical Obturator and Sleeve has applications in abdominal, thoracic and gynecological minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The obturator can be used without visualization for primary and secondary insertions.

The ENDOPATH® OPTIVIEW™ Optical Obturator and Sleeve consists of two main components: an obturator with an optical element and a trocar sleeve.
The optical obturator provides visualization of tissue as it passes through each layer by dilating and separating the tissue along its path of entry.
The sleeve component has sealing capability to maintain pneumoperitoneum when instrumentation is inserted and withdrawn through the trocar sleeve during a surgical procedure
The ENDOPATH® OPTIVIEW™ Optical Surgical Obturator and Sleeve shall be provided in a variety of size sleeves from 3mm to 12mm in diameter and 65mm to 155mm in length.
The sleeve component of the device will be supplied with or without a stopcock for insufflation, with seals to maintain pneumoperitoneum as instruments are passed through the trocar sleeve, with or without a desufflation lever, and with or without stability threads for additional retention of the sleeve while it is in tissue.

The provided document describes the acceptance criteria and study for the ENDOPATH® OPTIVIEW™ Optical Surgical Obturator and Sleeve.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states, "Pre-clinical laboratory evaluations were performed to ensure that the device can be used as designed." It does not specify a numerical sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The evaluations are described as "pre-clinical laboratory evaluations," suggesting they were conducted in a controlled lab setting rather than with human patients.

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

The document does not mention the use of experts to establish a ground truth or their qualifications for the pre-clinical laboratory evaluations. The evaluations focused on objective device performance metrics rather than subjective assessment requiring expert consensus.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method for the test set. Given the pre-clinical laboratory nature of the evaluations, an adjudication process involving multiple human observers would typically not be required for the specified performance metrics.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No multi-reader multi-case (MRMC) comparative effectiveness study was done. The document describes pre-clinical laboratory evaluations of the device's functional performance, not a study comparing human readers' performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was done in the sense that the evaluations focused solely on the device's functional performance in a laboratory setting. There is no mention of an algorithm, as this is a physical surgical device, not a software or AI product. The "pre-clinical laboratory evaluations" represent this standalone assessment of the device's capabilities.

7. Type of Ground Truth Used

The ground truth used was based on the designed functionality and expected physical performance of the device in pre-clinical laboratory settings. This would involve quantifiable measurements and observations of the device's mechanical integrity (mating, removal), interaction with mock tissue (insertion, security of sleeve), and maintenance of a sealed environment (pneumoperitoneum). It is not expert consensus, pathology, or outcomes data in the traditional sense, but rather adherence to engineering and functional specifications.

8. Sample Size for the Training Set

The document does not mention a training set sample size. This is a physical medical device, not an AI or machine learning model that requires a training set. The "pre-clinical laboratory evaluations" are for testing the device, not for training it.

9. How the Ground Truth for the Training Set Was Established

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

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