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The indication for use of this device must be restricted to colon cleansing when medically indicated, such as before radiological or endoscopic examination.

This device is not a kit. This device is an instrument for hydrotherapy of the colon. It introduces filtered water at a confortable temperature into the large intestine. It is an automatic system for filling and emptying water into and out of the colon and thus cleansing the colon of its contents when medically indicated such as before radiological or endoscopic examination. It is hygienic, painless and odorless. The instrument has an automatic pressure safety system; automatic disinfection; a system for collection of samples for analysis; remote and frontal panel control; a counter for the number of liters of water used; a three-way faucet; flow regulator; thermostatic mixer and an automatic temperature safety feature. It contains disposable components for use only once in the therapy

The provided document is a 510(k) Premarket Notification summary for the TRANSCOM Colon Hydrotherapy Model HC-2000. It focuses on demonstrating substantial equivalence to already marketed predicate devices rather than providing detailed acceptance criteria and a study proving performance against those criteria in the context of a new, quantifiable performance claim.

Here's a breakdown based on the request:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not define specific "acceptance criteria" in terms of measurable performance thresholds. Instead, it relies on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use. The table provided (pages 2-3) compares various parameters of the TRANSCOM device with three predicate devices.

Table: Comparative Technological Characteristics (as a proxy for acceptance and performance based on equivalence)

2. Sample size used for the test set and the data provenance

The document explicitly states:

• "Substantial equivalence is not based on an assessment of non-clinical performance data." (page 5, Section 7)
• "Substantial equivalence is not based on an assessment of clinical performance data." (page 5, Section 8)

Therefore, no test set was used as no particular performance study was conducted to prove the device met acceptance criteria beyond demonstrating similar technological characteristics and intended use to predicate devices already on the market. There is no information on data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as no test set or clinical/non-clinical performance data was used in the assessment for substantial equivalence.

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

Not applicable, as no test set or performance evaluation requiring ground truth adjudication was conducted.

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 a medical device (colonic irrigation system), not an AI-assisted diagnostic tool. No MRMC study was conducted.

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

Not applicable. This is a medical device, not an algorithm.

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

Not applicable, as no specific performance evaluation requiring ground truth was conducted. The ground for equivalence is the functional and technological similarity to legally marketed predicate devices.

8. The sample size for the training set

Not applicable, as this is a medical device for hydrotherapy, not a machine learning algorithm.

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

Not applicable, as this is a medical device for hydrotherapy, not a machine learning algorithm.

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