(28 days)
CompactCath is indicated for use in male, female, and pediatric patients (adolescents and transitional adolescents) with chronic urine retention and patients with post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain.
The CompactCath Intermittent Urinary Catheter is a sterile, single use urine drainage catheter for use in draining urine from the bladder in subjects with urine drainage problems.
The provided text is a 510(k) summary for the CompactCath Intermittent Urinary Catheter. This document primarily focuses on establishing substantial equivalence to a predicate device and does not contain detailed information about acceptance criteria and a study proving a device meets them in the context of an Artificial Intelligence (AI) device.
However, based on the information provided, here's what can be extracted and what cannot be answered concerning acceptance criteria and a study:
1. A table of acceptance criteria and the reported device performance
The document states: "Product testing was completed and met the acceptance criteria. Testing included flow measurements, bond strength, deployment, and insertion force using anatomical models to simulate clinical use for both the CompactCath device and the predicate device. Test results show the products are equivalent."
While acceptance criteria were met, the specific numerical criteria and the reported performance values are not provided in this summary. The word "equivalent" is used to describe the results compared to the predicate device, but no quantitative data for either the criteria or the performance is given.
2. Sample size 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 in the document. The testing involved "anatomical models to simulate clinical use," but the number of models/tests, their origin, or whether the study was retrospective or prospective (which isn't directly applicable as it's not a clinical study on human subjects) is not detailed.
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/provided. The testing described involves physical measurements on a medical device (flow, bond strength, deployment, insertion force) using anatomical models. Establishing "ground truth" through expert consensus is typically relevant for diagnostic imaging or AI devices that interpret data, where human experts label or interpret cases. Here, the "ground truth" would be the direct physical measurements themselves (e.g., actual flow rates, actual insertion force).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods like "2+1" or "3+1" are used in studies where multiple human readers or AI systems interpret data, and discrepancies need to be resolved to establish a consensus ground truth. This is not relevant to the type of physical performance testing described for a urinary catheter.
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
This information is not applicable. The device described is a physical medical device (an intermittent urinary catheter), not an AI diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. As stated above, this is a physical medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance testing, the "ground truth" would be the physical measurements themselves (e.g., direct measurements of flow rates, bond strength, deployment characteristics, and insertion force). These are objective measurements rather than interpretations requiring expert consensus or pathology.
8. The sample size for the training set
This information is not applicable/provided. As this is not an AI device, there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable/provided.
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.