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The Optical Separator System is a sterile single use device, intended for use in conjunction with Applied's currently marketed Trocar products to establish a path of entry for endoscopic instruments for use during general, abdominal, gynecological and thoracic minimally invasive procedures or to gain access through tissue planes and/or potential spaces for endoscopic instruments. The Optical Separator System may be used with or without visualization for primary and secondary insertions, and as a means of insufflating the peritoneum prior to laparoscopic procedures.

The Optical Separator System is indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments, and as a means of insufflating the peritoneum prior to laparoscopic procedures.

The Optical Separator System is a sterile single use device, intended for use in conjunction with Applied's currently marketed Trocar products. A standard trocar assembly consists of an obturator, a seal and a cannula system. Traditional obturators use a blade for cutting to establish a path of entry through the several layers of tissue. The Dilating Tip Trocar dilates and separates tissue along its natural fiber lines in its path of entry.

The Optical Separator System will be available in sizes of 5mm, 11mm and 12mm diameter in lengths ranging from 55mm to 150mm.

The provided document is a 510(k) summary for the Optical Separator System. It describes the device, its intended use, and states that performance testing demonstrated substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria or a detailed study description with performance metrics that would allow for a comprehensive table as requested.

The document states: "The performance and functional testing of the Optical Separator System included tests to verify the insertion force and tests to verify its reliability and visualization during use. The performance and functional testing demonstrated that the Optical Separator System is substantially equivalent to its predicate devices and it introduces no new safety and effectiveness issues when used as instructed." This is a general statement and does not provide quantifiable acceptance criteria or detailed results.

Therefore, many of the requested fields cannot be filled from the provided text.

Here’s what information can be extracted/inferred:

1. 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.
• Data Provenance: Not specified (likely internal company testing, but no details on country or whether it was retrospective/prospective).

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. This device is a surgical instrument, not an AI/diagnostic tool requiring expert ground truth for image interpretation or diagnosis. The "performance data" refers to functional and reliability testing.

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

• Not applicable for this type of device and testing.

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/diagnostic device.

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

• Not applicable. This is a physical surgical instrument.

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

• Not applicable. Performance testing for this device would involve engineering benchmarks, material specifications, and functional testing rather than clinical ground truth for diagnosis/interpretation.

8. The sample size for the training set

• Not applicable. This is a physical surgical instrument, not an AI model requiring a training set.

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

• Not applicable.

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The Optical Separator is a sterile single use device, intended for use in conjunction with Applied's currently marketed Trocar products to establish a path of entry for endoscopic instruments for use during general, abdominal, gynecological and thoracic minimally invasive procedures or to gain access through tissue planes and/or potential spaces for endoscopic instruments. The Optical Separator may be used with or without visualization for primary and secondary insertions.

The Optical Separator is indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.

The Optical Separator is a sterile single use device, intended for use in conjunction with Applied's currently marketed Trocar products. A standard trocar assembly consists of an obturator, a seal and a cannula system. Traditional obturators use a blade for cutting to establish a path of entry through the several layers of tissue. The Optical Separator dilates and separates tissue along its natural fiber lines in its path of entry.

The Optical Separator will be available in sizes of 5mm, 8mm, 11mm and 12mm diameter and in lengths ranging from 55mm to 150mm.

The use of the Optical Separator, which separates tissue along its natural fibers versus cutting of tissue by traditional bladed trocars is expected to reduce trauma to vessels and the abdominal wall and minimize the risk of organ puncture. Upon removal of the trocar at the end of the procedure the separated tissue is expected to reapproximate, leaving a smaller, linear defect.

This document describes the Optical Separator, a sterile, single-use device designed to establish a path of entry for endoscopic instruments in various minimally invasive surgical procedures. The device aims to reduce trauma by dilating and separating tissue along natural fiber lines instead of cutting.

Here's an analysis of the acceptance criteria and the study performed, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The testing described is general "performance and functional testing" rather than a clinical study with a defined test set of patient data.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth as this was not a study involving diagnostic interpretation or subjective assessment. The testing described focuses on mechanical and functional performance characteristics of the device.

4. Adjudication Method for Test Set

No adjudication method is mentioned as there was no test set requiring expert adjudication.

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

No MRMC comparative effectiveness study was performed or mentioned. This device is a surgical instrument, not a diagnostic imaging aid that would typically involve human readers.

6. Standalone (Algorithm Only) Performance Study

No standalone performance study was performed or mentioned. This is a physical medical device, not a software algorithm.

7. Type of Ground Truth Used

The ground truth used for assessing the device's performance was based on:

• Engineering specifications and standards: Implicit in the "tests to verify insertion force," "reliability," and "visualization."
• Comparison to predicate devices: The primary ground truth for regulatory approval was demonstrating "substantial equivalence" to existing, legally marketed predicate devices (EndoPath Optiview Optical Surgical Obturator and Applied Medical Dilating Tip Obturator). This implies that the performance of the predicate devices served as a benchmark for safety and effectiveness.

8. Sample Size for Training Set

The concept of a "training set" is not applicable here as this is a physical medical device undergoing performance and functional testing, not a machine learning algorithm.

9. How Ground Truth for Training Set Was Established

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

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