(73 days)
The intermittent catheter is a flexible tubular device that is inserted through the urethra by male, female and pediatric patients who need to drain urine from the bladder.
The Onli intermittent catheter is a single use catheter to be used as a means of managing urinary incontinence by draining urine from the bladder. The catheter has the following elements:
Σ Ready to use, single use intermittent catheter
Σ Hydrophilic-coated, phthalate free catheter
Σ Two smooth catheter eyelets
Σ Color coded funnel
Σ Not made with natural rubber latex
Σ Gripper on the16-in. catheter to aid with insertion
The packaging contains a sealed water compartment chamber of which the water migrates to the catheter compartment and lubricates the catheter. The outer packaging was designed to be easy to open and facilitate access to the catheter.
The provided document is a 510(k) summary for the Onli Intermittent Catheter. It is a submission to the FDA demonstrating substantial equivalence to a predicate device, not a study proving the device meets specific acceptance criteria in the context of an AI/ML medical device.
Therefore, most of the requested information (acceptance criteria for an algorithm, study design for AI/ML performance, ground truth, sample sizes for AI/ML training/test sets, expert qualifications, adjudication, MRMC studies, standalone performance) is not applicable to this document. This document describes a medical device, a urological catheter, and its performance characteristics, which are mainly mechanical and biological, not algorithmic.
Here's what can be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify "acceptance criteria" in the sense of predefined thresholds for an AI/ML algorithm's performance (e.g., sensitivity, specificity). Instead, it describes performance testing conducted to demonstrate safety and effectiveness for a physical medical device. The "reported device performance" is a statement of compliance or satisfactory results rather than specific numerical metrics.
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with G95-1 and ISO 10993 standards | Results indicate compliance to the standard. |
| Sterility | Sterility achieved via Gamma Irradiation per ANSI/AAMI/ISO 11137 | All results were satisfactory. |
| Packaging Integrity | Maintain sterile barrier through shelf life | Capable of maintaining a sterile barrier for at least two years. |
| Transportation | No impact to safety or efficacy due to transport hazards | The test produced successful results. |
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 present in the document. The tests performed are for a physical medical device (catheter), not an AI/ML algorithm.
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 and not present in the document. Ground truth, in the context of AI/ML, refers to labels for training or testing data, which is not relevant for a physical catheter.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not present in the document.
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 and not present in the document. An MRMC study is relevant for diagnostic imaging devices often involving AI, not for a urological catheter.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not present in the document. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable and not present in the document.
8. The sample size for the training set
This information is not applicable and not present in the document. There is no AI/ML algorithm with a training set for this device.
9. How the ground truth for the training set was established
This information is not applicable and not present in the document.
In summary: The provided document describes the regulatory submission for a physical medical device, the Onli Intermittent Catheter, demonstrating its substantial equivalence to a predicate device based on various physical and biological performance tests. It does not contain any information related to the development, testing, or performance of an AI/ML algorithm.
§ 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.