Search Results

Urinary catheter for intermittent use.
The catheter is indicated for use by patients with chronic urine retention and patients with a post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing the urine to drain.

The SpeediCath Standard is a sterile single use hydrophilic coated polyurethane catheter. The catheter is placed in a swelling media, packed and sealed in a foil pouch and sterilized.

The provided text is a 510(k) summary for the SpeediCath Standard urological catheter. It outlines the device's characteristics, indications for use, and a summary of non-clinical testing conducted to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

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

The document does not explicitly state numerical acceptance criteria in a table format for specific performance metrics. Instead, it indicates that "All tests met the pre-determined acceptance criteria." It lists the types of performance tests conducted.

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

The document does not specify the sample size used for any of the tests. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) as the tests are non-clinical, benchtop, and accelerated aged studies.

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

This information is not applicable and not provided in the document. The studies described are non-clinical (biocompatibility, bench testing, shelf life, sterilization dose confirmation), which do not typically involve human expert interpretation for "ground truth" in the way clinical studies or AI algorithm evaluations do.

4. Adjudication method for the test set

This information is not applicable and not provided in the document. As mentioned in point 3, the studies are non-clinical and do not involve human adjudication processes for a test set.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. This device is a urological catheter, and the studies described are non-clinical; thus, an MRMC study related to AI assistance for human readers would not be relevant.

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

This information is not applicable and not provided. The device is a physical medical device (catheter) and does not involve an algorithm or AI.

7. The type of ground truth used

The concept of "ground truth" as typically defined in AI/clinical studies (e.g., expert consensus, pathology, outcomes data) is not directly applicable to physical device performance testing as described. For the non-clinical tests, the "ground truth" would be established by the specifications and validated methodologies of the referenced standards (e.g., ISO, ASTM). For example:

• Biocompatibility: Ground truth is defined by the criteria within ISO 10993-1 and FDA guidance.
• Bench Testing: Ground truth is defined by the specified parameters and ranges within ASTM D1894 and internal test methods.
• Shelf Life: Ground truth is established by the specified degradation limits and stability parameters within ASTM F1980-16.
• Sterilization: Ground truth is defined by the validated sterilization dose (e.g., sterility assurance level) according to ISO 11137-2.

8. The sample size for the training set

This information is not applicable and not provided. As the device is a physical medical product and not an AI/software product, there is no "training set."

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

This information is not applicable and not provided. There is no training set for this type of device submission.

Ask a specific question about this device