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The Colorado Catheter iCath™ and SterileSure™ are intended for use in adult male and adult female patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals who are unable to promote natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode.

The iCath" and SterileSure™ are intended to be disposable medical devices that offer a pre-lubricated self catheterization alternative that does not require the application of lubricant prior to use to facilitate the insertion of a urinary catheter. Although nearly identical, the iCath™ is designed and intended for outpatient use, and the SterileSure™ is designed and intended for inpatient use administered to a patient under the care of medical personnel.

The iCath" and SterileSure™ are intended to be used to drain urine from the bladder. The devices are provided sterile and for single-use only. Both consist of a catheter assembled within a thin, flexible sheath to minimize patient contact and reduce contamination. The sheath is connected to an introducer tip that is inserted into the urethra to facilitate advancement of the catheter into the urethra. The introducer tip of the iCath™ contains a lubricant reservoir feature in which the catheter is lubricated prior to insertion with a watcr-soluble hydrophilic water-based lubricant. The SterileSure™ is prelubricated with the water-soluble hydrophilic waterbased lubricant.

The devices are packaged singly with a urine drainage bag, or in a kit with accessories including benzalkonium chloride swabsticks or provodine iodine swabsticks, gauze pad, and urine collection container or urine drainage bag, and non-latex, powder-free gloves

The provided text describes the 510(k) submission for the Colorado Catheter iCath™ and SterileSure™ urinary catheterization devices. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/ML performance. The document focuses on regulatory approval, substantial equivalence to a predicate device, basic biocompatibility testing, and general performance requirements for a medical device of this type.

Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and AI/ML specific performance metrics cannot be extracted from this document.

Here's a breakdown of what can be inferred or is explicitly stated, alongside what is missing:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: Not specified for any of the biocompatibility or performance tests.
• Data Provenance: Not specified, but likely from testing labs rather than clinical data. Given the nature of these tests, they are typically conducted on material samples or animal models, not human patients. The tests are focused on material safety and basic functionality.

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)

• Not applicable to the presented data. The tests are laboratory-based assays (e.g., cell culture, animal studies) or engineering performance assessments, not clinical studies requiring expert ground truth in the context of diagnostic interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable to the presented data. This method is typically used for clinical study and image interpretation where expert consensus is needed. The tests described are objective, laboratory-based results.

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

• No. This is a urinary catheter, a physical medical device, not an AI/ML diagnostic tool. Therefore, an MRMC study related to AI assistance for human readers is not relevant and was not performed.

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

• No. This is a physical medical device. There is no AI algorithm to test in a standalone manner.

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

• Ground Truth for Biocompatibility Tests: Established by specific biological reactions (e.g., cell reactivity, animal responses to extracts) as per ISO or similar standard methods.
• Ground Truth for Performance Testing: Likely based on engineering specifications and functional requirements (e.g., flow rates, material strength, lubricity), but these are not detailed in the provided text.

8. The sample size for the training set

• Not applicable. There is no AI/ML algorithm requiring a training set mentioned in this 510(k) submission.

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

• Not applicable. As there is no AI/ML component, there is no training set or associated ground truth.

Summary of AI/ML Relevance:

This 510(k) summary is for a traditional physical medical device (urinary catheters) and therefore does not include any information pertinent to AI/ML device performance, acceptance criteria, or studies. The questions posed are highly relevant for AI/ML-powered medical devices, but not for this specific submission.

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