Search Results

The PRECISION Endoscopic Infrared Coagulator with single-use disposable MAXiguide flexible light guide is intended for treatment of hemorrhoids and other lesions in the colon and rectum by the transmission of infrared energy when used as an accessory to a colonoscope, flexible sigmoidoscope, or other flexible gastrointestinal endoscope.

This device is designed to coagulate blood and tissue, specifically for treatment of hemorrhoids and small lesions in the colon and rectum, when used as an accessory to a flexible endoscope.

This 510(k) submission (K130489) is for a design and labeling change to an existing device, the PRECISION Endoscopic Infrared Coagulator™ with SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE. The submission explicitly states that there are no technology differences between the submission device and its predicate devices, and no changes to the intended use or indications for use.

Therefore, the study performed is focused on demonstrating that the design changes do not affect the safety and effectiveness of the device, rather than proving performance against new acceptance criteria for a novel technology.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a design change with no technological differences or changes to intended use, the acceptance criteria are implicitly that the device continues to meet the safety and effectiveness profile of the predicate devices. The reported performance is verification that these standards are maintained.

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

The document does not specify a quantitative sample size for the "bench testing" performed. It generally states that "Verification testing results for the design changes were completed and all tests passed."

• Sample Size: Not explicitly stated (likely refers to a number of test articles/units for bench testing).
• Data Provenance: The testing was "Bench testing," implying it was conducted in a laboratory or engineering setting by the manufacturer (Optim LLC in Sturbridge, MA). It is retrospective in the sense that it's verifying changes to an existing design, not gathering new clinical data on patients.

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

This type of information is not applicable to this 510(k) submission.

• This submission is not for an AI/ML device, diagnostic device, or a device that requires human interpretation of outputs to establish ground truth.
• The "verification testing" described is bench testing, which assesses engineering and functional performance against defined specifications, not against expert-established ground truth related to clinical outcomes or interpretations.

4. Adjudication Method for the Test Set

Not applicable for the reasons stated above. There's no interpretive test set requiring adjudication.

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 device is an infrared coagulator, not an AI-assisted diagnostic or therapeutic tool that would involve human readers or image interpretation.

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

Not applicable. This device does not involve an algorithm with standalone performance.

7. The Type of Ground Truth Used

The "ground truth" for this type of submission is typically defined by engineering specifications, established performance parameters of the predicate device, and compliance with relevant consensus standards. For example, ground truth for power output might be a specific wattage as measured by calibrated equipment, or ground truth for light guide flexibility might be its ability to withstand a certain bend radius without damage. The document indicates verification was against the safety and effectiveness of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

Ask a specific question about this device