FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Here's an analysis of the provided text regarding the Amsure™ Foley Catheter (K030120) and the request for information on acceptance criteria and a supporting study.

Based on the provided FDA 510(k) clearance letter (K030120), no information is available about specific acceptance criteria or an associated study proving the device meets those criteria.

The 510(k) clearance process does not typically require clinical trials or performance studies with acceptance criteria in the same way a PMA (Pre-Market Approval) does. Instead, a 510(k) submission demonstrates "substantial equivalence" to a legally marketed predicate device. This means the new device has the same intended use and the same technological characteristics as the predicate, or has different technological characteristics but does not raise different questions of safety and effectiveness, and the information submitted demonstrates that the device is as safe and effective as the legally marketed device.

Therefore, the document does not contain the information you've requested regarding acceptance criteria and a study to prove they are met. The FDA letter is a confirmation of clearance based on the substantial equivalence determination.

To answer your questions as best as possible given the provided limitations:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria for Substantial Equivalence (General, not specific to device performance):
- Same intended use as predicate: Yes, stated as "drainage of fluids to, and from, the urinary tract," which is a common intended use for Foley catheters.
- Same technological characteristics as predicate, or different technological characteristics that do not raise different questions of safety and effectiveness: This would have been demonstrated in the 510(k) submission, but the letter does not detail these characteristics or how they compare.
- As safe and effective as predicate: Assumed to be met through comparison of technological characteristics and any performance data submitted.
Reported Device Performance: Not detailed in this document. The 510(k) summary (not provided here) would likely contain this information, referring to performance data (e.g., biocompatibility testing, sterility, dimensional conformity, mechanical integrity) submitted to demonstrate equivalence to the predicate.

2. Sample size used for the test set and the data provenance

Not applicable for this 510(k) clearance. The letter indicates clearance based on substantial equivalence to a predicate, not on a specific clinical performance study with a test set. Design validation and verification testing (e.g., bench testing) would have been performed, but details are not in this FDA letter.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable for this 510(k) clearance. No clinical test set with expert-established ground truth is mentioned.

4. Adjudication method for the test set

Not applicable for this 510(k) clearance.

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 for this 510(k) clearance. This device is a Foley catheter, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable for this 510(k) clearance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable for this 510(k) clearance. The "ground truth" for a 510(k) device generally refers to its ability to meet design specifications and perform reliably for its intended use, typically assessed through engineering and bench testing, and comparison to a predicate, rather than clinical ground truth from patient data.

8. The sample size for the training set

Not applicable for this 510(k) clearance. There is no mention of a "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable for this 510(k) clearance.

In summary: The provided document is an FDA 510(k) clearance letter for a medical device (Foley catheter). This type of clearance primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing details of independent clinical studies with specific acceptance criteria, ground truth, or statistical analyses of AI performance. Such detailed performance data and acceptance criteria would typically be found in the 510(k) summary document from the manufacturer or within the comprehensive submission provided to the FDA, neither of which is present here.

Summary

Regulation Number and Section

§ 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.