(125 days)
As a disposable, single use Female External Urinary Collection Pouch, it is intended to collect urine and assist in directing it away from the body.
Mediquest, Inc.'s Female External Urinary Collection Pouch
This set of documents describes an FDA clearance for a "Female External Urinary Collection Pouch" manufactured by Mediquest, Inc. The documents are from 1997. Due to the age of the document and the nature of the device (a simple collection pouch), the level of detail regarding device performance studies is very limited and does not align with the typical requirements for describing AI-powered medical devices as outlined in your prompt.
Based on the provided text, I can extract the following:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria or specific performance metrics. The FDA clearance is based on a determination of "substantial equivalence" to a predicate device. This implies that the device meets the same performance and safety standards as the predicate, but those specific standards are not detailed here.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not specified) | "Substantially equivalent" to predicate device |
| (Not specified) | Intended to collect urine and assist in directing it away from the body. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. For a device like a urinary collection pouch from 1997, a formal "test set" in the context of an AI study would not have been conducted. The substantial equivalence determination likely relied on existing data for the predicate device and potentially limited in-house testing by the manufacturer.
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 provided. Ground truth establishment for a simple, non-AI device is not relevant in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as it's not applicable to this type of device and submission.
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
No such study was conducted or mentioned. This device is not AI-powered.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable, as the device is not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This is not applicable. The device is a physical product, and its effectiveness is determined by its ability to collect urine, likely evaluated through basic functional testing or comparison to similar existing products.
8. The sample size for the training set
This information is not provided and is not applicable, as this is not an AI device.
9. How the ground truth for the training set was established
This information is not provided and is not applicable, as this is not an AI device.
In summary: The provided documents pertain to a pre-AI era medical device (a female external urinary collection pouch) that received FDA clearance based on "substantial equivalence" to a predicate device. Therefore, the detailed requirements for AI device studies (acceptance criteria, test sets, ground truth, expert involvement, etc.) are entirely absent from these brief regulatory letters.
§ 876.5250 Urine collector and accessories.
(a)
Identification. A urine collector and accessories is a device intended to collect urine. The device and accessories consist of tubing, a suitable receptacle, connectors, mechanical supports, and may include a means to prevent the backflow of urine or ascent of infection. The two kinds of urine collectors are:(1) A urine collector and accessories intended to be connected to an indwelling catheter, which includes the urinary drainage collection kit and the closed urine drainage system and drainage bag; and
(2) A urine collector and accessories not intended to be connected to an indwelling catheter, which includes the corrugated rubber sheath, pediatric urine collector, leg bag for external use, urosheath type incontinence device, and the paste-on device for incontinence.
(b)
Classification —(1)Class II (special controls) for a urine collector and accessories intended to be connected to an indwelling catheter. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.(2)
Class I (general controls). For a urine collector and accessories not intended to be connected to an indwelling catheter, 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. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.