(16 days)
management of urinary incontinence.
ProSys™ Custom Fit Leg Bag with Preattached Adjustable Inlet Tube for Patient Sizing which is available in a volume capacity of 500ml. Each non-sterile bag is fitted with a permanently welded adjustable inlet tube with a self-packaged connector which connects to an external catheter. The inlet tube is available in one (1) size, 600mm to accommodate patient preference. Fabric straps are used to secure the leg bag in place. The leg bag has a T-tap drainage valve. The inlet tube contains an anti-reflux valve to reduce the risk of urine backflow and infection and a sample port used for urine sampling is integrated into the universal connector.
This document is a 510(k) Premarket Notification for a medical device (ProSys™ Custom Fit Leg Bag). It describes the device, its intended use, and claims substantial equivalence to an existing device.
However, the provided text does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of algorithm performance or diagnostic accuracy. The "study" mentioned consists of bench testing (for connector strength, impact, leakage, and anti-reflux valve) and biocompatibility testing. These are not the types of studies that would involve "test sets," "ground truth," "expert consensus," "MRMC," or "standalone performance" in the way typically associated with AI/algorithm-based medical devices or diagnostic tools.
Therefore, I cannot populate the table or answer most of your specific questions. The device described is a physical medical device (a leg bag for urinary incontinence), not a software or AI-driven diagnostic tool.
I can, however, provide information based on what is present in the text regarding the types of testing performed for this physical device.
Information Available from the Text (for a physical medical device, not an algorithm):
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (What was tested) | Reported Device Performance (Outcome) |
|---|---|
| Connector strength of attachment | Performed at an acceptable level |
| Resistance to impact | Performed at an acceptable level |
| Leakage | Performed at an acceptable level |
| Anti-reflux valve function | Performed at an acceptable level |
| Biocompatibility (Cytotoxicity, Irritation, Sensitization) | Components are acceptable for use (one cytotoxic result for fabric straps, explained in Item 5b; all others non-irritating or negligibly irritating, non-sensitizing, non-cytotoxic) |
Regarding the remaining points (2-9), there is no relevant information in the provided text as these questions pertain to studies of AI/algorithm performance, which is not applicable to this device description:
- Sample sized used for the test set and the data provenance: Not applicable (no data-driven test set for a diagnostic algorithm)
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable
- Adjudication method for the test set: Not applicable
- 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
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable
- The type of ground truth used: Not applicable
- The sample size for the training set: Not applicable
- How the ground truth for the training set was established: Not applicable
§ 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.