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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.

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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 when used as an accessory to a flexible 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.

The provided text describes a 510(k) summary for the K122593 device. Based on this document, here's an analysis of the acceptance criteria and study information:

Key Takeaways:

• This 510(k) submission is for a device that is essentially identical to a previously cleared predicate device (K083275).
• The nature of the submission is a "design and labeling change" that does not alter intended use, indications for use, or performance specifications.
• Therefore, the primary study to demonstrate substantial equivalence was verification testing and bench testing to confirm that the changes did not negatively impact safety or effectiveness, essentially showing it still performs like the predicate. There were no clinical studies (e.g., studies involving human subjects, AI performance, or even animal studies) required or discussed for this specific 510(k).

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)

• Sample Size for Test Set: Not applicable in the context of clinical data. The "test set" here refers to the specific units or components of the device undergoing verification/bench testing. The document does not specify the number of units tested.
• Data Provenance: Not applicable for design verification and bench testing. These are laboratory-based tests performed by the manufacturer.

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 ground truth for this submission was based on engineering specifications and the functional performance of the device against established benchmarks (i.e., its predicate). No expert human readers or clinicians were involved in establishing "ground truth" for a test set in the traditional sense of a diagnostic device study.

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

• Not applicable. No clinical test set requiring adjudication was used.

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. This device is an electrosurgical unit, not an AI-assisted diagnostic tool. An MRMC study is not relevant to this type of device.

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

• Not applicable. This is not an AI algorithm; it's a medical device for coagulation.

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

• The "ground truth" for this submission was the established performance characteristics and safety profile of the legally marketed predicate device (K083275). The verification and bench testing aimed to prove the new device performs identically to the predicate and that the minor changes did not introduce new safety or effectiveness concerns.

8. The sample size for the training set

• Not applicable. No training set was used as this is not an AI or machine learning device.

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

• Not applicable. No training set was used.

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