(128 days)
These devices are indicated for use by incontinent persons with other medical conditions that warrant the use of a leg bag and are intended to collect urine. They may be connected to either an indwelling or non-indwelling catheter.
Medline Leo Bags are vinyl pouches with sterile fluid paths and adjustable comfort straps. This device is attached to the leg of an incontinent person and used to collect urine. This device may be used with an indwelling catheter or an external catheter. A leg bag provides the catheterized person with greater mobility and are usually worn during the day and are replaced at night with a standard urinary drainage bag.
The provided document is a 510(k) summary for a medical device: "Urine Collection Leg Bag for External Use Premium Leg Bag, Fabric-Bac Leg Bag, Urinary Leg Bag" by Medline Industries, Inc.
This document explicitly states: "There are no clinical studies that have been performed on these devices, both for the predicate and the new devices."
Therefore, based on the provided text, there is no study described that proves the device meets specific acceptance criteria as it relates to clinical performance. The submission rather relies on substantial equivalence to a predicate device already on the market, and the only difference noted is in the labeling.
Given this information, it is not possible to fill out the requested table and answer the study-related questions.
However, I can extract the information explicitly available:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Clinical Performance: | No clinical studies performed. The device is substantially equivalent to Medline's Urine Collector Leg Bag and Bard's Leg Bags (K780032). The only difference is in labeling. |
| Technological Characteristics: | No new technological characteristics. Identical to existing devices, with only a labeling change. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable, as no clinical studies were performed.
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, as no clinical studies were performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical studies were performed.
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, as no clinical studies were performed, and the device is a urine collection bag, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable, as no clinical studies were performed, and the device is a urine collection bag, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable, as no clinical studies were performed. The basis for approval is substantial equivalence to legally marketed predicate devices.
8. The sample size for the training set:
Not applicable, as no clinical studies were performed.
9. How the ground truth for the training set was established:
Not applicable, as no clinical studies were performed.
§ 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.