(35 days)
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:
- 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.
- 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.
- 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.
- Adjudication method for the test set: Not available. No adjudication method is mentioned.
- 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.
- 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.
- 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.
- The sample size for the training set: Not applicable/Not available. There is no "training set" for this type of device.
- 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.
§ 876.5220 Colonic irrigation system.
(a)
Identification. A colonic irrigation system is a device intended to instill water into the colon through a nozzle inserted into the rectum to cleanse (evacuate) the contents of the lower colon. The system is designed to allow evacuation of the contents of the colon during the administration of the colonic irrigation. The device consists of a container for fluid connected to the nozzle via tubing and includes a system which enables the pressure, temperature, or flow of water through the nozzle to be controlled. The device may include a console-type toilet and necessary fittings to allow the device to be connected to water and sewer pipes. The device may use electrical power to heat the water. The device does not include the enema kit (§ 876.5210).(b)
Classification. (1) Class II (performance standards) when the device is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.(2) Class III (premarket approval) when the device is intended for other uses, including colon cleansing routinely for general well being.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any colonic irrigation system described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a colonic irrigation system described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other colonic irrigation system shall have an approved PMA in effect before being placed in commercial distribution.