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Latex Foley Catheter is inserted into the bladder through urethra and are indicated for routine urine drainage or for routine post-operative drainage and bladder irrigation.

The Latex Foley Catheter is inserted through the urethra during urinary catheterization and goes into the bladder for urine drainage or irrigation. It consists of a shaft, a drainage funnel, an inflation funnel, an irrigation funnel (if present), a balloon and a valve. The device is made from latex with silicone coating and available in different types (e.g., straight, Tiemann, female etc.) and sizes for adult and pediatric use.

This document is a 510(k) premarket notification for a medical device: the Wellead® Latex Foley Catheter. It is not an AI/ML device, therefore, the information requested in your prompt regarding AI/ML acceptance criteria and studies (e.g., sample sizes for test and training sets, number of experts for ground truth, MRMC studies, standalone performance) is not applicable.

The document focuses on demonstrating substantial equivalence to a legally marketed predicate device (K082815, also a Well Lead Latex Foley Catheter) through nonclinical testing.

Here's an analysis of the provided text in the context of your request, highlighting what is and isn't present:

Not Applicable for this document: The device in question is a physical medical device (Foley catheter), not an AI/ML software or a device that uses AI/ML. Therefore, criteria and studies related to AI/ML device performance (like the number of experts for ground truth, MRMC studies, standalone algorithm performance, training set details, or effect size of AI assistance) are not found in this type of 510(k) submission.

Here's what can be extracted from the document regarding acceptance criteria and performance for this physical device:

1. Acceptance Criteria and Reported Device Performance

The document states that all pre-determined acceptance criteria were met for the nonclinical tests. While specific numerical acceptance criteria (e.g., "flow rate must be >X mL/min") are not explicitly listed in this summary, the types of tests conducted and their successful completion imply meeting such criteria.

Note: The document only states that the acceptance criteria were "met" for all tests. It does not provide the specific numerical results or the exact numerical thresholds for each acceptance criterion. This is typical for a 510(k) summary, as detailed test reports are part of the full submission but not usually included in the public summary.

2. Sample Size Used for the Test Set and Data Provenance

The document describes nonclinical bench testing. It does not specify sample sizes for these tests, nor does it refer to "test sets" in the context of patient data for AI/ML validation.

• Test Set Sample Size: Not specified. (The tests are done on physical catheter samples, not on a dataset of patient images/records.)
• Data Provenance: Not applicable in the context of patient data for AI/ML. The "data" are measurements from bench testing of the physical device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not applicable. Ground truth for a physical device's performance (e.g., flow rate, balloon integrity) is established through standardized engineering and laboratory testing protocols, not through expert human review of data.
• Qualifications of Experts: Not applicable. The validation relies on the expertise of engineers and lab technicians performing tests according to recognized standards (ASTM, ISO, BS EN).

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no human subjective assessment of "truth" that requires adjudication for these nonclinical performance tests.

5. Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No. This is a physical device, not an AI-assisted diagnostic tool for which MRMC studies would be relevant.

6. Standalone Performance

• Standalone Performance: Yes, in a sense. The "standalone" performance here refers to the physical device's performance determined through bench testing (e.g., flow rate, balloon integrity) without human intervention in the device's function or the test outcome. It is not "standalone algorithm performance" as it would be for an AI device.

7. Type of Ground Truth Used

• Ground Truth Type:
  • Engineering/Physical Measurements: The ground truth for the device's performance characteristics (e.g., flow rate, balloon volume, resistance to rupture) is established by using calibrated instruments and standardized methods to measure these physical properties.
  • Compliance with Standards: The "ground truth" for regulatory acceptance is that the device's performance measurements fall within the specified limits defined by international standards (e.g., ASTM F623-19, BS EN 1616:1997) and the manufacturer's own pre-determined acceptance criteria.
  • Biocompatibility: Demonstrated through specific assays and tests as per ISO 10993-1.
  • Sterilization: Validated against a standard (ANSI/AAMI/ISO 11135:2014) to confirm sterility.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable.

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