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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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The PVC Urinary Catheter is launched for clean intermittent catheterization (CIC) treatment. It is intended for use in the drainage of fluid from the urinary tract. It is indicated for use in male, female, and pediatric patients 2-12 years old.

The Silicone Urinary Catheter is intended to be placed in the urethra, to drain urine into a collection device. Two-way catheters are intended for urological bladder drainage only. Three-way catheters are intended for urological bladder drainage and bladder irrigation. It is indicated for use in male, female, and pediatric patients 2-12 years old.

The Latex Urinary Catheter is intended to be placed in the bladder, through the urethra, to drain urine into a collection device. Neleton catheters are launched for clean internittent catheterization (CIC). Two-way catheters are intended for urological bladder drainage only. Three-way catheters are intended for urological bladder irrigation. It is indicated for use in male, female, and pediatric patients 2-12 years old.

Disposable urinary catheter is a kind of disposable product which is used for draining the bladder, for temporary or short term. Based on the materials, the disposable urinary catheter includes PVC Urinary Catheter, Silicone Urinary Catheter and Latex Urinary Catheter.

PVC Urinary Catheter only has nelaton type structure, which is made of PVC and is intended for draining the bladder for short term. PVC Urinary Catheter consists of drainage funnel, drainage lumen, eyelets and tip. It is supplied in French size ranging from 8 to 20F. The catheters come in sizes from 12Fr-20Fr for adults and 8Fr-10Fr for pediatrics 2 -12 years old.

Silicone Urinary Catheter is made of pure silicone. It is intended to be placed in the bladder, through the urethra, to drain urine into a collection device and has two-way type and three-way type. The two-way type consists of funnel, drainage lumen, drainage eyes, balloon, inflating connector and valve. The three-way type consists of Funnel, Drainage lumen, Injection connector, injection lumen, drainage eyes, balloon, inflating connector and valve. Both of them are supplied in French size ranging from 8 to 24F. The catheters come in sizes from 12Fr-24Fr for adults and 8Fr-10Fr for pediatrics 2 -12 years old.

Latex Foley Catheter is made of nature latex, which has nelaton type, two-way type and three-type.

The nelaton Latex Urinary Catheter is intended for draining the bladder for short term and consists of drainage funnel, drainage lumen, eyelets and tip. The nelaton catheters come in sizes from 12Fr-20Fr for adults and 8Fr-10Fr for pediatrics 2-12 years old.

The two-way type and three-way type are intended to be placed in the bladder, through the urethra, to drain urine into a collection device. The two-way type consists of funnel, drainage lumen, drainage eyes, balloon, inflating connector and valve. The three-way type consists of Funnel, Drainage lumen, Injection connector, injection lumen, drainage eye. Both of them are supplied in French size ranging from 8 to 24F. The catheters come in sizes from 12Fr-24Fr for adults and 8Fr-10Fr for pediatrics 2 -12 years old.

This document describes a 510(k) premarket notification for Disposable Urinary Catheters (PVC, Silicone, and Latex). It focuses on demonstrating substantial equivalence to predicate devices, rather than a de novo evaluation of clinical effectiveness with an AI component. Therefore, much of the requested information regarding AI-specific studies (e.g., sample sizes for test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, training set details) is not applicable or present in this document.

Here's an analysis of the provided information, addressing the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally based on meeting specified performance standards. The reported device performance is that the device "Passed" all tests against these requirements.

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

This document describes non-clinical "bench testing" and "biocompatibility tests" performed in accordance with standards like EN 1616, ASTM F623, and ISO 10993. These types of tests do not typically involve patient-specific data or test sets in the context of AI. The sample sizes for these bench tests are not specified in this document, nor is the data provenance in terms of country of origin or retrospective/prospective status as it would be for a clinical study. The device manufacturer is Zhanjiang Star Enterprise Co., Ltd based in China.

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

Not applicable. This is a non-clinical, bench testing submission. No "ground truth" established by experts in a clinical context (e.g., radiologists) is mentioned or required for this type of submission.

4. Adjudication method for the test set

Not applicable. There are no clinical test sets or expert evaluations requiring adjudication in this submission.

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 urinary catheter, not an AI-powered diagnostic or assistive technology. No MRMC studies were conducted or described.

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

Not applicable. This device is a physical medical device (urinary catheter) and does not involve an algorithm or AI.

7. The type of ground truth used

For the performance tests, the "ground truth" is defined by the technical specifications and requirements outlined in the referenced international standards (e.g., EN 1616, ASTM F623). For biocompatibility, the "ground truth" is adherence to the criteria set forth in the ISO 10993 series of standards. This is not clinical "ground truth" such as pathology or outcomes data.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI, and therefore, no training set.

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

Not applicable. No training set exists for this device.

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