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Sleeved IC 2 SWT (16" and 8"), Sleeved IC 2 Plus (16" and 8"), Sleeved IC 2 Pocket (16"), & Sleeved IC 2 Plus Pocket (16" and 8"): This 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.
Sleeved IC 2 Pocket (8"): This intermittent catheter is a flexible tubular device that is inserted through the urethra by female and female paediatric (pediatric) patients who need to drain urine from the bladder.

The Sleeved IC 2 (not finalized) catheters are:

• E-beam sterilized.
• Hydrophilic-coated, single use catheter.
• Have two drainage eyelets that is used to manage urinary incontinence.
• The Sleeved IC is inserted into the urethra to drain urine from the bladder.
• Available in 16 inch and 8 inch lengths.
• Available in various Fr sizes ranging from Fr 08 through Fr 16.
• Are made from Thermo-plastic Elastomer (TPE); not made with phthalates and not made with PVC.
• Packaged in a foil which was designed to be easy to open and to facilitate access to the catheter.
• Lubricated by direct contact with the hydration fluid.
• Available with and without integrated urine collection bag.
• Available in pocket and straight packaging configurations.
• Environment of use: hospital, home setting, public places.

The provided document describes the FDA clearance for the "Sleeved IC 2 Family" of intermittent catheters (K233524). It details the device's characteristics, indications for use, and a comparison to a predicate device ("Sleeved IC" K220667). It also summarizes the non-clinical testing conducted to support the substantial equivalence claim.

However, the document does not contain the specific information required to complete a table of acceptance criteria with reported device performance from a clinical study, nor does it detail a study that demonstrates the device meets specific acceptance criteria in the way described in the prompt.

Here's an explanation of why the requested information cannot be fully provided based on the input:

• Type of Submission: This is a 510(k) premarket notification, which establishes substantial equivalence to a legally marketed predicate device. For many moderate-risk devices (Class II), clinical studies are not always required if non-clinical performance testing can demonstrate substantial equivalence.
• Focus of the Document: The document focuses primarily on the technical characteristics and non-clinical testing (e.g., physical performance, biocompatibility, sterilization, packaging) to show that the new device performs as safely and effectively as the predicate device. It explicitly states, "Brief Description of Non-Clinical Testing".

Therefore, I cannot provide the requested information regarding acceptance criteria, sample sizes for test sets (as no clinical test set is described), number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for a clinical study because this information is not present in the provided text.

The document does include details on the non-clinical testing performed, which serves as the "study" demonstrating the device meets the requirements for clearance.

Below is a partial response based on the information available, noting where specific requested details are absent:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes non-clinical performance testing against recognized standards rather than specific acceptance criteria from a clinical study. The "reported device performance" is that the device "met all applicable requirements" of these standards.

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

• Sample Size: Not specified for any of the non-clinical tests. Non-clinical bench testing often uses small, representative samples.
• Data Provenance: Not specified, but generally, such testing is conducted in controlled laboratory environments by the manufacturer or contract labs. It is non-clinical (i.e., not from human subjects).

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

• Not applicable. The testing described is non-clinical and does not involve expert review or "ground truth" establishment in the context of clinical expert consensus. Performance is measured against engineering and biological standards.

4. Adjudication method for the test set

• Not applicable. This is not a clinical study involving human interpretation or adjudication.

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 urological catheter, not an AI-powered diagnostic or assistive device that would involve human readers or AI assistance.

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

• Not applicable. This device does not incorporate an algorithm.

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

• For non-clinical performance, the "ground truth" is established by the specifications and measurable parameters defined in the referenced international and national standards (e.g., ISO 20696 for physical properties, ISO 10993 for biocompatibility).

8. The sample size for the training set

• Not applicable. This device does not use machine learning or AI, so there is no training set.

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

• Not applicable. (See #8)

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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 Sleeved IC (final name to be determined) is a sterile, hydrophilic-coated, single use catheter with drainage eyelets that is used to manage urinary incontinence. The Sleeved IC is inserted into the urethra to drain urine from the bladder. The catheter is available in 16in length. The catheter is available in 12 and 14 Fr sizes. The catheter is provided in a sterile manner, utilization method. The device is made from Thermo-plastic Elastomer (TPE) and is phthalate free and PVC free. This directly hydrated catheter is packaged in a foil pouch which was designed to be easy to open and to facilitate access to the catheter. The primary pack contains both the catheter assembly and the hydration fluid. This means that the coated catheter surface is lubricated by direct contact with the hydration fluid.

The provided text describes a 510(k) premarket notification for a medical device called "Sleeved IC," which is an intermittent catheter. The submission aims to demonstrate substantial equivalence to a predicate device, the "VaPro2 Intermittent Catheter" by Hollister Incorporated (K180824).

The document details the device's characteristics and compares them to the predicate device, along with the non-clinical testing performed. However, it does not provide explicit acceptance criteria in the form of numerical performance thresholds or a specific study that measures device performance against these criteria as typically seen for AI/ML devices.

Instead, the document focuses on demonstrating substantial equivalence through a series of engineering, biocompatibility, and sterilization tests. The "acceptance criteria" are implied to be the successful completion of these standard tests and conformity to relevant ISO and industry standards for medical devices of this type. The "study" proving acceptance criteria is the sum of these non-clinical tests.

Let's break down the information based on your requested points, highlighting what is present and what is absent in the document regarding performance criteria specific to an AI/ML device.

Missing Information/Not Applicable for this Device Type:

This device is a physical medical device (intermittent catheter), not an AI/ML device. Therefore, many of your specific questions related to AI/ML performance, such as sensitivity, specificity, AUC, human reader improvement with AI assistance, standalone algorithm performance, training set details, and adjudication methods for ground truth in an AI context, are not applicable to this 510(k) submission.

Information Extracted from the Document:

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

   The document does not present a table of acceptance criteria and device performance in the format typically used for AI/ML devices (e.g., sensitivity, specificity, F1-score). Instead, the "acceptance criteria" are implied by successful completion of various non-clinical tests and conformity to standards. The "reported device performance" is that it met all applicable requirements.

   Acceptance Criteria (Implied)	Reported Device Performance
   Conformity to BS EN ISO 20696:2018 (Sterile urethral catheters for single use)	Met all applicable requirements.
   Equivalence of lubricity to predicate device	Substantial equivalency of catheter lubricity demonstrated via testing.
   Catheter strength and security of drainage funnel fit	Testing conducted showed it met requirements.
   Flow rate through catheter	Testing conducted showed it met requirements.
   Catheter kink stability and peak tensile force	Testing conducted showed it met requirements.
   Biocompatibility (ISO 10993 series)	All requirements met for biological endpoints (cytotoxicity, irritation, sensitization, systemic toxicity).
   Sterilization (ISO 11137 series, ANSI/AAMI/ISO 11737 series)	Met all requirements of the listed FDA recognized standards. The required Sterility Assurance Level (SAL) has been validated.
   Packaging integrity (maintenance of sterile barrier)	Verified through shelf life.
   Transportation testing (no impact on safety/efficacy)	Verified no impact from transportation hazards.

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

   This information is not provided for the non-clinical tests. Medical device performance testing often uses a statistically relevant number of samples for each specific test (e.g., a batch of catheters for tensile strength, a certain number of test animals for biocompatibility), but these specific sample sizes and data provenance (e.g., country of origin, retrospective/prospective) are not detailed in this 510(k) summary.

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

   This is not applicable as this is a physical medical device, not an AI/ML diagnostic system requiring expert interpretation as ground truth.

4. Adjudication method for the test set

   This is not applicable for the same reasons as above.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance

   This is not applicable as this is a physical medical device, not an AI-assisted diagnostic system.

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

   This is not applicable as this is a physical medical device.

7. The type of ground truth used

   The "ground truth" for this device's non-clinical testing refers to established scientific principles, physical measurements (e.g., force, flow rate), chemical analysis, and biological responses as defined by the referenced ISO standards and industry best practices. It's not "expert consensus" or "pathology" in the context of diagnostic performance.

8. The sample size for the training set

   This is not applicable as this is a physical medical device and does not involve AI/ML training.

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

   This is not applicable for the same reasons as above.

In summary, the provided document describes a traditional medical device 510(k) submission, not an AI/ML device. Therefore, the questions tailored to AI/ML device performance validation are not addressed, as they are not relevant to this type of product. The "acceptance criteria" are implied by regulatory compliance and successful completion of standard non-clinical tests demonstrating substantial equivalence to a predicate device.

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