Search Results

Urological catheter is intended for drainary tract. Catheterization is accomplished by inserting the catheter through the urethra and into the bladder. Intended population is adults and pediatrics.

The Subject Device is a single-use, 2-way Foley catheter that is constructed of medical grade silicone. It incorporates two (2) lumens, one for inflation/deflation of the other for drainage of the urinary tract. The balloon, at the distal end of the catheter, is inflated to the labeled fill volume and remains inflated via the incorporated two-way valve in the connector at the proximal end of the inflation lumen. The connector engages with slip/taper luer connection that is standard on syringes. With the balloon inflated, the catheter maintains position in the urinary tract for the duration of the clinical application. Prior to removal, the balloon is deflated via the 2-way valve connection. The drainage inlet is located distal to the catheter's balloon. The urinary bag is a standard non-interconnectable connector. The Subject Device is packaged inside a perforated plastic sleeve that is inserted into a sterile barrier pouch. Ten (10) units are packaged into a carton, which is the saleable unit. The Subject Device is terminally sterilized via Ethylene Oxide (EO). The Subject Device will be initially offered in 14. 16. 18Fr sizes. The entire length of the Subject Device is disposable. The Subject Device is not sold as a set, there are no accessories or components included.

This document is a 510(k) premarket notification for a urological catheter. It describes the device, its intended use, and compares it to a predicate device. It also summarizes the evaluations performed to demonstrate substantial equivalence.

Based on the provided text, the questions regarding acceptance criteria and study proving device performance (specifically for an AI/ML medical device, as implied by the detailed questions about data, ground truth, experts, and MRMC studies) cannot be fully answered. The document describes a traditional medical device (Foley catheter) and its clearance process, which relies on physical and functional performance testing, rather than an AI/ML algorithm requiring large datasets and expert ground truth.

Here's why many of your questions are not applicable to this specific submission and what information is available:

This document describes a physical medical device (Foley Catheter), not an AI/ML medical device. Therefore, many of your questions related to AI/ML specific evaluations (such as data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable.

However, I can extract information relevant to the type of device discussed.

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

The document states that "The test program was performed in accordance to FDA guidance and recognized performance states, which includes the following: Biocompatibility, Sterilization, Packaging Integrity (i.e., Sterile Barrier), Transportation, Performance/Functionality." It then concludes, "Successful results were achieved with all evaluations conducted."

While specific numerical acceptance criteria (e.g., "burst pressure > X psi") and detailed performance data (e.g., "average burst pressure = Y psi") are not explicitly listed in this summary, the general categories of testing and the affirmation of "successful results" serve as the summary of performance meeting acceptance criteria.

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

The document does not specify the sample sizes for the performance testing (e.g., number of catheters tested for burst strength, or number of sterility tests). It also does not discuss data provenance in terms of country of origin or retrospective/prospective, as these are typically considerations for clinical data in software/AI submissions, not physical device performance testing.

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

Not applicable. Ground truth as typically understood in AI/ML (e.g., expert labels on images) is not relevant to the physical performance testing of a Foley catheter. Performance tests are typically conducted according to standardized engineering protocols (e.g., ASTM F623).

4. Adjudication method for the test set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements among multiple human readers/experts in AI/ML ground truth establishment. This is not relevant for physical device testing.

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 is a physical medical device, not an AI-assisted diagnostic tool.

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 a standalone algorithm.

7. The type of ground truth used

For physical devices, "ground truth" refers to established physical, chemical, and biological performance standards and validated test methodologies (e.g., ASTM F623 for performance, ISO standards for biocompatibility/sterilization). The document states: "The test program was performed in accordance to FDA guidance and recognized performance states." This implies compliance with such standards.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. As above, this is a physical medical device, and the concept of "ground truth for a training set" (in the context of AI/ML) does not apply.

Ask a specific question about this device

Urological catheter intended for drainage/irrigation of the urinary tract. Catheterization is accomplished through the urinary tract, but also suprapubic placement or by nephrostomy. Intended population is adults and pediatrics.

The subject device is a single-use, latex-free, 3-way Foley catheter that is constructed of medical grade silicone. It incorporates three (3) lumens, one for inflation/deflation of the balloon, another for drainage, and the remainder for irrigation of the urinary tract. The balloon, at the distal end of the catheter, is inflated to fill volume between 10-30 ml and remains inflated via the incorporated two-way valve in the connector at the proximal end of the inflation lumen. The connector engages with slip/taper luer connection that is standard on syringes. With the balloon inflated, the catheter maintains position in the urinary tract for the duration of the clinical application. Prior to removal, the balloon is deflated via the two-way valve connection. The drainage inlet is located distal to the catheter's balloon. The urinary bag is a standard non-interconnectable connector. The irrigation outlet is located just proximal of the catheter's balloon. It is positioned underneath a sleeve, which directs fluid in the proximal direction towards the 3-way connection. The purpose of the sleeve is to disperse the irrigation fluids gently down the urinary tract. The connector for the irrigation lumen is a standard non-interconnectable connector.

The provided document is a 510(k) Premarket Notification for a medical device, specifically a PSM 3-Way Silicone Foley Catheter. As such, it is not a study proving the device meets acceptance criteria in the context of an AI/ML medical device. Instead, it demonstrates substantial equivalence to a predicate device based on similar technological characteristics and performance standards.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, sample size for training set) are not applicable to this type of regulatory submission for a traditional medical device (not an AI/ML device).

However, I can extract the acceptance criteria and reported device performance related to the physical and functional attributes of the Foley catheter based on the provided text.

Here's a breakdown of what can be extracted and what cannot:

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

The document doesn't explicitly state "acceptance criteria" values in a table format with corresponding "reported performance." Instead, it highlights that testing was performed "in accordance to FDA guidance and recognized performance states" and that "Successful results were achieved with all evaluations conducted." This implies that the device met the standards for these tests. The "performance standards" column in the comparison table indirectly serves as acceptance criteria.

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

• Sample Size: Not specified for any of the tests.
• Data Provenance: Not specified. This is a regulatory submission, not a clinical study report. The tests are likely performed by the manufacturer or their contracted labs.

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. This is not an AI/ML device. "Ground truth" in this context would refer to the standards applied in the physical and functional tests, not expert interpretation of medical images or data. Testing is based on established engineering and material standards.

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

• Not Applicable. Not an AI/ML device.

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 is not an AI/ML device, so no MRMC study would be performed.

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

• Not Applicable. This is not an AI/ML device, so no algorithm standalone performance would be done.

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

• The "ground truth" for this medical device would be adherence to recognized engineering and material standards (e.g., ASTM F623 for catheters, ISO standards for biocompatibility and sterilization), and the device's functional performance against its design specifications. It's based on objective measurements and established scientific test methods, not expert consensus in a diagnostic sense.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device.

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

• Not Applicable. This is not an AI/ML device.

Ask a specific question about this device