(24 days)
The Irrigation Set is indicated for people with a stoma who want to irrigate.
The Irrigation Set is a Class II device, consisting of a single-use sleeve; a water bag (500-2000 ml) to hold water, a regulator where the paddle wheel that is integrated in the regulator gives visual assurance that water is entering the colon, a tube with a cone-shaped tip, a press plate and belt which are reusable devices. The Irrigation Set is provided with a nylon storage case.
The provided text describes the 510(k) summary for the Irrigation Set, a Class II medical device. It focuses on demonstrating substantial equivalence to a predicate device (K840268) based on design, intended use, and functional performance.
Here's an analysis of the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, the acceptance criteria and performance are listed as "functional performance and biocompatibility testing" with "acceptable results". More specific details are provided for the bench tests.
| Acceptance Criteria Category | Specific Test / Performance Metric | Reported Device Performance |
|---|---|---|
| Functional Performance | Accuracy of Volume Indicator | Acceptable results |
| Freedom from Leakage | Acceptable results | |
| Flow Controller | Acceptable results | |
| Hanging Strength | Acceptable results | |
| Biocompatibility | Biocompatibility testing | Acceptable results |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the test set (bench tests). It also does not mention the country of origin of the data or whether the tests were retrospective or prospective.
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)
This information is not applicable and not provided. The testing involved in-vitro (bench) tests, not clinical evaluations that would require expert ground truth assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are typically used in clinical studies involving interpretation by multiple experts, which is not the case for these bench tests.
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
There is no mention of an MRMC comparative effectiveness study, AI, or human readers in the provided text. The device is an "Irrigation Set" and the tests are non-clinical in nature.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
There is no mention of any algorithm or AI in the provided text. The device is a physical medical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The concept of "ground truth" as typically used in AI/diagnostic studies is not applicable here. The "ground truth" for these non-clinical tests would be the established engineering specifications and scientific principles governing the performance of the device's components (e.g., a volume indicator's accuracy is measured against a known standard, leakage is determined by the absence of fluid escape, etc.). The study relies on objective physical measurements and established biocompatibility testing protocols.
8. The sample size for the training set
There is no mention of a "training set" in the provided text. This concept is relevant to machine learning or AI device development, which is not described here.
9. How the ground truth for the training set was established
Not applicable, as no training set is mentioned or relevant to the described device and testing.
§ 876.5895 Ostomy irrigator.
(a)
Identification. An ostomy irrigator is a device that consists of a container for fluid, tubing with a cone-shaped tip or a soft and flexible catheter with a retention shield and that is used to wash out the colon through a colostomy, a surgically created opening of the colon on the surface of the body.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.