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ICU Medical Graduated Adapter with Clave® is indicated as an accessory to a urinary catheter which facilitates the transfer of fluids into or out of the bladder via connection to the graduated adapter. This device for single procedure use only. Connection to catheter not to exceed 30 days.

The Clave with Graduated Adapter is a device that allows the Urologist a device that can "slip-fit" on a urology catheter. This is then used to infuse fluids into the bladder for procedures as the physician determines. The Clave can connect to a threaded device or any ISO 594-1 & -2 compliant luer device. When the Clave is activated, fluid may then pass through the graduated adapter. When the syringe or luer is disconnected, the Clave can withstand back pressures as much as 45 psi and thereby preclude fluid leakage coming from the bladder via the catheter and attachment.

The submitted device consists of a Clave which has a spike, stepped silicone plug and body that is then solvent-bonded to a graduated adapter using cyclohexanone, dichloride or validated equivalent.

This document describes a 510(k) premarket notification for a medical device called the "Graduated Adapter with Clave®" by ICU Medical, Inc. This submission focuses on establishing substantial equivalence to previously marketed predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria through standalone performance or comparative effectiveness studies.

Here's an analysis based on the provided text, addressing your questions where information is available:

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

The document does not explicitly present a table of quantitative acceptance criteria with corresponding device performance results. Instead, it relies on demonstrating substantial equivalence to predicate devices. This means that the new device shares similar technological characteristics and is as safe and effective as a legally marketed device that does not require premarket approval.

The primary "acceptance criteria" appear to be:

• Substantial Equivalence: The device must be deemed substantially equivalent to predicate devices in terms of materials, performance, and operational features.
• Safety and Effectiveness: The device must be safe and effective for its intended use.
• Compliance with Standards: The device complies with published international standards for connecting components, ISO 10993-1 for biocompatible materials, and ISO 11137-1 for sterilization by radiation.
• Sterility Assurance Level (SAL): The SAL has an established and validated history of meeting the 10⁻⁶ level.

The document reports the following as evidence of meeting these general 'criteria':

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

This document does not describe a clinical study with a "test set" in the sense of patient data. The evaluation is primarily based on bench testing, material characterization, and comparison to predicate devices. Therefore, there is no sample size of patients or data provenance related to human subjects from a test set.

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 is not applicable as there was no test set of human data requiring ground truth established by experts. The "ground truth" for this type of submission is typically adherence to engineering standards, material specifications, and functional bench test results. The experts involved would likely be engineers and quality control personnel within ICU Medical, along with FDA reviewers.

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

Not applicable. There was no test set requiring adjudication in this context.

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. This device is a mechanical connector/adapter accessory, not an AI-powered diagnostic or therapeutic tool. There are no "human readers" to improve with or without AI assistance.

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

Not applicable. This is a physical medical device, not an algorithm. Bench tests would have been performed on the device in a "standalone" manner to confirm its physical properties and fluid handling capabilities, as indicated by the mention of "45 psi" back pressure resistance.

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

The "ground truth" for this 510(k) submission is primarily derived from:

• Engineering Specifications and Standards: Compliance with ISO standards (10993-1, 11137-1) and internal design specifications.
• Bench Test Results: Functional tests (e.g., pressure resistance, fluid flow) conducted on the device.
• Material Characterization: Verification that the materials used (ABS, Cyrex, LSR, Polyester, Polycarbonate) meet their specified properties and are suitable for the intended use and biocompatibility.
• Predicate Device Equivalence: The performance and safety profile of already legally marketed devices serve as a benchmark.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable, as there is no training set for this type of device.

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