Search Results

The Defogging and Cleaning Solution is a single-use laparoscopic accessory device intended to facilitate intra-operative defogging and cleaning of the laparoscope lens thereby maintaining visualization of the surgical site.

The Minimally Invasive Defogging and Cleaning Solution is a biocompatible surfactant (Docusate Sodium) when used as indicated. It functions in the same manner as the predicate devices. It is intended to be used to prevent fogging of the lens of devices (laparoscope) that provide visualization during minimally invasive surgeries. Additionally, the solution can be used to clean the end of the lens of devices (laparoscope) that provide visualization during minimally invasive surgeries (i.e. to rinse lens intra-operatively by rinsing any debris from the lens which becomes attached to the lens as a result of the procedure.)

The provided text describes the Minimally Invasive Devices Defogging and Cleaning Solution (Flo-X) and its equivalence to predicate devices. It includes a summary of performance testing, which serves as the data to prove the device meets certain criteria.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" with numerical targets in a formal table like sensitivity/specificity. Instead, it describes performance goals as "effectiveness" and "equivalence" to predicate devices. Since specific criteria are not quantified, I will present the test title as the implicit criterion and the summarized results as the reported performance.

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

• Sample Size: The document does not specify exact numerical sample sizes for most tests.
  • For the acute systemic toxicity test, it mentions "mice" but not the number of mice.
  • For other bench and animal (porcine peritoneal cavity) studies, the sample sizes are not explicitly stated.
• Data Provenance:
  • Country of Origin: Not specified.
  • Retrospective or Prospective: Not specified, but the descriptions of "testing performed" and "studies" imply these were prospective studies designed to evaluate the device.

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

This information is not provided in the document. The tests seem to be primarily objective (e.g., measuring defogging, cleaning efficacy against a known contaminant like grease, stability analysis) rather than relying on expert subjective evaluation for "ground truth."

4. Adjudication Method for the Test Set:

This information is not provided. Given the nature of the tests (bench and animal, with objective metrics like clearing grease or defogging), it's unlikely that a human adjudication method in the context of clinical image assessment would be relevant or used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

An MRMC study is not applicable and was not done. The device is a "Defogging and Cleaning Solution" for a laparoscope lens, not an AI or diagnostic imaging tool that would assist human readers interpreting medical images.

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

This question is not applicable. The device is a physical solution, not an algorithm. Its performance is inherent to its physical and chemical properties and is evaluated in its intended use environment.

7. The Type of Ground Truth Used:

The "ground truth" for the performance tests appears to be:

• Objective measures of function: E.g., the visible absence of fog, the visible removal of grease, the stability of chemical properties (pH, concentration, HPLC).
• Comparison to controls/predicates: Water, saline, and legally marketed predicate defogging devices serve as benchmarks for effectiveness and equivalence.
• Biological outcomes: For the toxicity study, "no mortality or evidence of systemic toxicity" in mice served as the outcome/ground truth for safety.

8. The Sample Size for the Training Set:

This question is not applicable. The device is a physical product, not a machine learning algorithm that requires a training set.

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

This question is not applicable for the same reason as #8.

Ask a specific question about this device

The Clear-Vu System is a single-use, disposable laparoscopic accessory device intended to facilitate intra-operative defogging and cleaning of the lens of a laparoscope during minimally-invasive surgery while maintaining visualization of the surgical site.

The Clear-Vu System consists of a multi-lumen sheath assembly mounted on the shaft of the laparoscope, which connects to the existing CO₂ insufflation circuit to defog the laparoscope lens and divert surgical debris, and connects to the existing surgical irrigation system to clean the lens via saline flush.

The provided text describes the Clear-Vu™ System, an endoscope lens cleaning and defogging device. However, it does not contain the specific details required to fully answer your request, such as a table of acceptance criteria, reported device performance figures, sample sizes for test sets, expert qualifications, or details about MRMC studies.

Based on the information available in the document, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated in the provided text. The document indicates that the device was subjected to simulated use testing and preclinical animal testing to "demonstrate its effectiveness." However, the specific metrics or thresholds that would define "effectiveness" (i.e., the acceptance criteria) are not provided.
• Reported Device Performance: Not explicitly stated in the provided text. The document claims the device demonstrated "effectiveness" in simulated use and animal testing, but no quantitative performance results (e.g., success rates, time to clear, optical clarity improvements) are given.

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

• Test Set Sample Size: Not provided. The text mentions "simulated use testing" and "preclinical animal testing in a porcine model" but does not specify the number of simulated cases or the number of animals used.
• Data Provenance: The preclinical animal testing was conducted in a porcine model. For the simulated use testing, the provenance is a "surgical environment simulation chamber," implying a controlled laboratory setting. It is retrospective in the sense that the testing was completed before the 510(k) submission.

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

• Not provided. The document does not mention the use of experts to establish ground truth for performance testing. Given the nature of the device (cleaning and defogging), "ground truth" during testing would likely be assessed through objective measures of lens clarity or subjective assessment by observers, rather than a diagnostic 'truth' established by experts.

4. Adjudication Method for the Test Set

• Not provided. Since the document doesn't detail how the effectiveness was measured, it also doesn't specify any adjudication method for those measurements.

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

• Not performed/reported. The document makes no mention of a human-in-the-loop study or an MRMC comparative effectiveness study involving human readers with or without AI assistance. The device is an accessory, not an AI diagnostic tool.

6. Standalone Performance Study

• Yes, a standalone study was done, but details are limited. The performance testing described (simulated use and preclinical animal testing) evaluates the algorithm/device's functionality in isolation, without direct human intervention as part of the performance measurement. The device "facilitates" cleaning and defogging, implying it performs this function on its own, and the tests were to demonstrate its effectiveness in performing this function. However, the specific metrics and results of this standalone performance are not provided.

7. Type of Ground Truth Used

• Observational effectiveness. For the simulated use and animal testing, the "ground truth" would be established by observing whether the device successfully defogged and cleaned the laparoscope lens as intended. This is an objective assessment of function rather than a diagnostic truth. For example, measures of visibility before and after cleaning, or the absence of fog/debris.

8. Sample Size for the Training Set

• Not applicable / Not provided. The Clear-Vu System is a mechanical accessory device, not an AI/ML algorithm that requires a "training set." Therefore, this question is not relevant to the described device.

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

• Not applicable. As the device is not an AI/ML algorithm, there is no training set and no ground truth establishment for it.

Summary of Missing Information:

The most significant missing information for a complete answer includes:

• Specific quantitative acceptance criteria for device effectiveness.
• Quantitative results of the device's performance in simulated use and animal studies.
• Actual sample sizes for the testing.

Ask a specific question about this device