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

The HC-1 and HC-1 Classic proposed device is a device for colon cleaning. It introduces water at a comfortable temperature into the large intestine. It automatically fills and empties water into and out of the colon thus cleansing it of its contents when medically indicated such as before radiological or endoscopic examination. It is hygienic, painless and odorless. The device is equipped with an automatic pressure safety system; integrated disinfectant container, flow regulator and a 3-way manifold. It is supplied with disposable probe/hose assemblies for single-use during colonic hydrotherapy.

The HYDROKIT is a colonic irrigation system intended to instill water into the colon through a nozzle inserted into the rectum to evacuate the contents of the lower colon.

Here's an analysis of the provided documentation regarding the acceptance criteria and study for the TRANSCOM COLON HYDROTHERAPY MODELS HC-1 and HC-1 Classic, and HYDROKITS:

This device did not undergo a study to prove it met specific quantitative acceptance criteria related to its clinical efficacy or performance in a traditional sense. Instead, the FDA clearance via a 510(k) pathway was based on demonstrating substantial equivalence to a predicate device. This means the manufacturer argued the new device is as safe and effective as a legally marketed device (the predicate).

Therefore, many of the typical study-related questions (sample size, ground truth, MRMC, etc.) are not applicable in this context.

Here's the information based on your request:

1. A table of acceptance criteria and the reported device performance

Since this was a substantial equivalence submission, there aren't explicit quantitative "acceptance criteria" for clinical performance in the document beyond meeting the functional specifications of a colon irrigation system comparable to the predicate. The "performance" is implicitly deemed equivalent to the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: Not applicable. No clinical test set data was provided.
• Data Provenance: Not applicable for clinical testing. Bench testing was performed but details on sample size for components or systems are not specified in this summary.

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. No establishment of ground truth by experts in a clinical study was performed or documented here.

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

Not applicable. No clinical test set.

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. No MRMC study was performed as this is a medical device (colon irrigation system), not an AI diagnostic tool involving human readers.

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

Not applicable. This is not an algorithm-based device. Functional laboratory bench testing was performed to ensure correct operation of the device.

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

Not applicable for clinical ground truth. For the device itself, the "ground truth" for demonstrating substantial equivalence rested on:

• Bench testing: Verifying electrical safety, electromagnetic compatibility, and delivery of colon hydrotherapy according to specifications.
• Biocompatibility testing: For the Hydrokits (cytotoxicity, sensitization, irritation/intracutaneous toxicity).
• Mechanical testing: For the Hydrokits (tensile, compression).
• Comparison to Predicate Device: Architectural and functional similarities to the legally marketed predicates.

8. The sample size for the training set

Not applicable. This device does not use an "algorithm" in a machine learning sense, so there is no training set.

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

Not applicable. See above.

Summary of the Study:

The "study" presented here is a pre-market notification (510(k)) for substantial equivalence.

• For the HC-1 and HC-1 Classic colon hydrotherapy units: The study primarily involved a comparison of technological characteristics and features to a previously cleared predicate device (TRANSCOM COLON HYDROTHERAPY MODEL HC-2000, K970482). Bench testing confirmed basic functional aspects like electrical safety, EMC, and operational specifications. No animal or clinical testing was performed. The conclusion was that the new devices' intended use, indications for use, functionality, and operation are essentially the same as the predicate, making them substantially equivalent.
• For the HYDROKITS (disposable speculums and associated components): The study involved a comparison to a predicate device (SPO1 and SP02 disposable speculums, K000388). Bench testing included biocompatibility tests (cytotoxicity, sensitization, irritation or intracutaneous toxicity) and mechanical tests (tensile, compression) of the material (SASOL HNR100 polypropylene copolymer). No clinical data was submitted. The conclusion was substantial equivalence to the predicate disposable speculums.

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