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EndoClear™ Laparoscopes Accessory is intended to be used by qualified physicians to provide endoscope lens cleaning for uninterrupted visualization of internal structures in a wide variety of diagnostic and therapeutic laparoscopic procedures.

The Virtual Ports EndoClear™ system is an accessory tool for laparoscopic procedures that consists of the EndoClear™ Lens Cleaner and the Virtual Ports Applier. The EndoClear™ Lens Cleaner is an internally anchored, hands-free, laparoscope lens cleaning device that is attached to the internal operating cavity wall and remains in position until completion of the surgery, enabling the surgeon to effectively clean the laparoscope lens of blood, fat, fog, and secretions without removing it from the cavity. The EndoClear™ Lens Cleaner is introduced via a cannula using the Virtual Ports Applier, which introduces the EndoClear™ Sens Cleaner into the cavity, enables positioning of the device under endoscopic guidance, anchors it to the internal cavity wall, and removes the EndoClear™ Lens Cleaner at the end of the surgical procedure.

The provided document is a 510(k) summary for the Virtual Ports Ltd. EndoClear™ System. It focuses on demonstrating substantial equivalence to a predicate device through technical characteristics and bench testing. Crucially, this document does not contain information about a study proving the device meets specific acceptance criteria in the context of AI performance or clinical efficacy.

Instead, it states that "Bench tests were performed to ensure that the device performs as intended. All testing results demonstrated satisfactory performance." This suggests a verification of engineering specifications rather than a comparative study for acceptance criteria related to clinical outcomes or AI performance, as the original request implies.

Therefore, many of the requested categories cannot be populated from the provided text.

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

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):

• Cannot be determined from the provided text. The document only mentions "bench tests."

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):

• Cannot be determined from the provided text. This information is typically relevant for studies involving human interpretation or clinical data.

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

• Cannot be determined from the provided text.

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 study was not described. The device is a physical accessory for laparoscopic procedures, not an AI-powered diagnostic or assistive tool for human readers.

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

• No, a standalone AI algorithm performance study was not described. The device is a physical accessory.

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

• For the "bench tests," the ground truth would likely be engineering specifications and test protocols designed to verify the device's mechanical, material, and functional performance as intended. The document states "device performs as intended," indicating adherence to pre-defined functional requirements.

8. The sample size for the training set:

• Not applicable / Cannot be determined. This device is hardware, not an AI algorithm requiring a training set.

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

• Not applicable / Cannot be determined. This device is hardware, not an AI algorithm.

Summary of Device and Performance Information Available from the Text:

The EndoClear™ System is an accessory for laparoscopic procedures designed to clean endoscope lenses internally. The performance validation cited in this 510(k) summary relies on:

• Bench tests: These tests were performed to ensure the device performs "as intended," and all results were "satisfactory." The specific criteria for "satisfactory performance" in these bench tests are not detailed.
• Biocompatibility testing: The materials in contact with the human body were confirmed to be biocompatible in accordance with ISO 10993-1.

The document's primary purpose is to demonstrate substantial equivalence to a previously cleared predicate device (K080051) based on having the "same intended use" and incorporating the "same technology," despite some engineering and material changes, and a labeling change. The "performance validation" described serves to support this claim of substantial equivalence for mechanical and material aspects, not a clinical effectiveness study or AI performance evaluation.

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EndoClear™ Laparoscopes Accessory is intended to be used by qualified physicians to provide endoscope lens cleaning for uninterrupted visualization of internal structures in a wide variety of diagnostic and therapeutic laparoscopic procedures.

The Virtual Ports EndoClear™ system is a sterile, single patient use system consisting of: EndoClear™ Lens Cleaner and the EndoClear™ Introducer. The EndoClear Lens Cleaner is an internally anchored hands-free, laparoscope lens cleaning device which is attached to the internal abdominal cavity wall and remains in position until completion of the surgery, enabling the surgeon to effectively clean the lens of blood, fat, fog, and secretions without removing it from the cavity. The Virtual Ports EndoClear™ Lens Cleaner is introduced via a cannula using the EndoClear™ Introducer, which also removes the EndoClear™ Lens Cleaner at the end of the surgical procedure.

The Virtual Ports EndoClear™ system is a sterile, single-patient use system designed to clean the lens of a laparoscope internally during surgery without removing it from the abdominal cavity. This allows for uninterrupted visualization of internal structures during diagnostic and therapeutic laparoscopic procedures.

Here's an analysis of the acceptance criteria and study data based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size:
  • Bench Tests: The document does not specify a numerical sample size for the bench tests. It states "Series of bench tests were performed."
  • Animal Study: The document does not specify a numerical sample size (e.g., number of animals) for the animal study. It just states "An animal study was performed."
• Data Provenance: The document does not explicitly state the country of origin for the studies. Given the applicant's address (Israel), it's highly probable the studies were conducted in Israel or a location collaborating with the applicant. The studies described are prospective in nature, as they involve testing the device to evaluate its performance.

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

The document does not provide information regarding the number of experts, their qualifications, or the method used to establish ground truth for the test set in either the bench tests or the animal study. The evaluation of performance in the animal study would typically involve veterinary surgeons or researchers, but this is not detailed.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test set.

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

No multi-reader multi-case (MRMC) comparative effectiveness study was mentioned or conducted, as this device is a physical tool for cleaning a laparoscope lens, not an imaging or diagnostic algorithm used by multiple human readers.

6. Standalone (Algorithm Only) Performance Study

No standalone (algorithm only) performance study was conducted. The EndoClear™ system is a physical medical device, not an algorithm, and it is intended for human-in-the-loop use by a surgeon during laparoscopic procedures.

7. Type of Ground Truth Used

• Bench Tests: The ground truth for bench tests would be defined by pre-established engineering specifications or performance metrics for lens cleaning effectiveness (e.g., clarity measurements after cleaning, removal of specific contaminants).
• Animal Study: The ground truth for the animal study would likely be a combination of direct observation by the surgical team/researchers on the safety (e.g., lack of device-related injury) and effectiveness (e.g., visual clarity through the endoscope, ability to complete the intended surgical task). The document implies a qualitative assessment ("performs as intended," "no safety and effectiveness questions were raised").

8. Sample Size for the Training Set

This information is not applicable as the EndoClear™ system is a physical device and does not involve a "training set" in the context of machine learning algorithms.

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

This information is not applicable for the same reason as point 8.

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