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Intended for use in Colon Irrigation with any colon irrigation system.

Class II - These devices are intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.

JIMMY JOHN III RECTAL NOZZLE

The provided documents are a 510(k) clearance letter and an "Indications For Use" form for the "JIMMY JOHN III RECTAL NOZZLE". These documents are from 1997 and pertain to a medical device for colon irrigation.

Based on the content of these documents, it is not possible to provide the requested information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications.

Here's why:

• Age of Documents: These documents are from 1997, which predates the common practices and requirements for detailed performance study reporting as outlined in your request.
• Type of Device: A "rectal nozzle" for colon irrigation is a relatively simple device compared to complex algorithms or imaging devices that would typically undergo rigorous performance studies with specific statistical metrics.
• "Substantially Equivalent" Clearance: The 510(k) clearance process, especially in 1997, largely relied on demonstrating "substantial equivalence" to a predicate device already on the market, rather than requiring extensive de novo clinical performance studies with specific acceptance criteria as would be expected for novel or high-risk devices.
• "Indications For Use" Form: This form only defines the intended use of the device, not its performance metrics or how those metrics were validated.

Specifically addressing your points, based only on the provided text:

1. A table of acceptance criteria and the reported device performance: Not available. The documents do not contain any performance metrics or acceptance criteria for the device beyond its intended use for colon cleansing.
2. Sample sized used for the test set and the data provenance: Not available. No a clinical study is described that would have a test set and associated data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available. No ground truth establishment is mentioned.
4. Adjudication method for the test set: Not available. No adjudication method is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This type of study is not mentioned as it's typically for diagnostic or imaging devices, not a physical medical device for irrigation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This device is a physical nozzle, not an algorithm.
7. The type of ground truth used: Not applicable/Not available. For a device like this, the "ground truth" would likely relate to the effectiveness of colon cleansing, which would be evaluated clinically, but no such study is described.
8. The sample size for the training set: Not applicable/Not available. There is no "training set" for this type of device.
9. How the ground truth for the training set was established: Not applicable/Not available.

In summary, the provided documents are regulatory clearance papers for a physical medical device from 1997. They do not contain the type of detailed performance study information, acceptance criteria, or statistical results that you are asking for, which are more commonly associated with modern submissions for diagnostic algorithms, imaging devices, or novel therapeutic devices.

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Intended for use in Colon Irrigation with any colon irrigation system.

Class II - These devices are intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.

JIMMY JOHN III RECTAL NOZZLE MODEL CIT

The provided document is an FDA 510(k) clearance letter for the "JIMMY JOHN III RECTAL NOZZLE MODEL CIT." This document does not contain information about acceptance criteria or a study proving that a device meets those criteria, as it pertains to a physical medical device (rectal nozzle) rather than a software-based AI/ML device.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study details from these documents.

Ask a specific question about this device