Search Results

Two-Way Catheter - Urethral catheterization for bladder drainage for Urological use only

Three Way Catheters - Urethral catheterization for bladder drainage and bladder irrigation for urological use only

The Well Lead Latex and Silicone Foley catheters are two-way Foley catheters which are placed in the bladder throught the urethra. The urine drains out through the catheter into a collection device attached to the catheter.

Based on the provided text, here's a detailed analysis of the acceptance criteria and the study performed for the Well Lead Silicone and Latex Foley Catheters:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided text does not specify a sample size used for a test set. It mentions conformance to an ASTM standard, which implies testing was conducted, but the details of that testing, including sample specifics, are not present. The data provenance (country of origin, retrospective/prospective) is also not mentioned.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The document does not mention the use of experts to establish a "ground truth" in the context of typical diagnostic device studies. The performance is assessed against an engineering standard (ASTM F 623-99), not through expert consensus on medical images or diagnoses.

4. Adjudication Method:

Not applicable. This device is a medical catheter, and its performance is evaluated against engineering and manufacturing standards, not through adjudication of diagnostic outputs.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. The provided text does not describe an MRMC comparative effectiveness study. This type of study is relevant for diagnostic AI devices where human readers interpret medical data.

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

Not applicable. This device is a physical medical instrument (catheter), not an algorithm or AI system.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is adherence to the specifications outlined in the ASTM F 623-99 standard. This standard likely covers physical dimensions, material properties, sterility, and packaging integrity. It's an engineering/manufacturing standard, not clinical pathology or outcomes data.

8. The Sample Size for the Training Set:

Not applicable. This section is relevant for AI/ML devices that require training data. The Well Lead Foley Catheters are physical medical devices.

9. How the Ground Truth for the Training Set was Established:

Not applicable. This section is relevant for AI/ML devices.

Summary of Device Performance Study:

The "study" cited in the document is the claim that the device "conform[s] to ASTM F 623-99." This indicates that the manufacturer has performed internal testing and quality control procedures to ensure their Foley catheters meet the established specifications of this American Society for Testing and Materials (ASTM) standard. ASTM F 623-99, titled "Standard Specification for Foley Catheter," would define the precise requirements for aspects like catheter diameter, balloon volume, material strength, leakage, and other critical performance characteristics. The document does not provide a detailed report of the specific tests conducted, the sample sizes for those tests, or the raw data, but rather states the conclusion of conformance to the standard.

Ask a specific question about this device