(77 days)
The UrAssist system is intended for the non-invasive, non-sterile collection of urine.
UrAssist is a portable urine collection unit which utilizes a battery-operated pump-assisted technology to drain the urine from a collection cup through a plastic tube and into a collection bag that stores a day's amount of urine.
The provided text describes the UrAssist system, a urine collection unit. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way one might expect for a typical medical device with quantitative performance metrics.
Instead, the document is a 510(k) summary for a Class I device, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than rigorous performance goal attainment through clinical studies with defined endpoints.
Here's a breakdown of what is and is not in the document, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly provided in the document as quantitative acceptance criteria with corresponding performance metrics. The document states compliance with general safety and electrical standards and non-clinical testing.
| Acceptance Criteria Category | Specific Acceptance Criteria (as implied/stated) | Reported Device Performance (as implied/stated) |
|---|---|---|
| Safety | Compliance with IEC 60601-1 (electrical safety) | "in-house testing verify or will verify that UrAssist meets the requirements specified for a urine collection unit", "safe, clean, concealed method to store" |
| EMC | Compliance with IEC 60601-1-2 (EMC) | "in-house testing verify or will verify that UrAssist meets the requirements specified for a urine collection unit" |
| Biocompatibility | Biocompatibility requirements for urine collection unit | "Biocompatibility...testing verify or will verify that UrAssist meets the requirements specified for a urine collection unit" |
| Functionality | Urine collection ability | "portable urine collection unit which utilizes a battery-operated pump-assisted technology to drain the urine from a collection cup through a plastic tube and into a collection bag" |
2. Sample Size Used for the Test Set and Data Provenance
- Not specified. The document mentions "in-house testing" and non-clinical studies (biocompatibility, EMC, electrical safety) but does not provide details on sample sizes, methodologies, or data provenance for any specific test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not applicable/Not specified. This document describes a 510(k) submission for a urine collection device, not an imaging or diagnostic AI device where expert ground truth for test sets is typically established. The "testing" referred to is about engineering and material safety, not diagnostic accuracy.
4. Adjudication Method for the Test Set
- Not applicable/Not specified. See point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study is not mentioned as this device is a physical urine collection unit, not a diagnostic imaging or AI-assisted interpretation tool where reader performance is evaluated.
6. Standalone (Algorithm Only) Performance Study
- No. This is not an algorithm-based device.
7. Type of Ground Truth Used
- Given the nature of the device (a urine collector), the "ground truth" for the tests mentioned (biocompatibility, EMC, electrical safety) would likely be engineering specifications, material standards, and regulatory compliance requirements rather than expert consensus, pathology, or outcomes data in a clinical sense.
8. Sample Size for the Training Set
- Not applicable/Not specified. This is not an AI or machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 8.
In summary: The provided document is a 510(k) summary for a Class I medical device (urine collector). Its purpose is to demonstrate substantial equivalence to a predicate device, primarily through non-clinical testing for safety, EMC, and biocompatibility, as well as describing its functional characteristics. It does not include the detailed performance study information with explicit acceptance criteria, sample sizes, and expert review often associated with more complex medical devices, especially those incorporating AI or diagnostic functions.
§ 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.