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SpeediCath Flex Set is indicated for use by patients with urine retention and patients with 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 urine to drain.

The product is for male patients only.

The SpeediCath Flex Set is a sterile, single use hydrophilic coated polyurethane catheter for men with an integrated collection bag (urine bag) which provides ease of use during collection and emptying of urine. The catheter is to be used for intermittent drainage of the bladder through the urethra by adult males with missing or reduced bladder control. The catheter has a protective sleeve which serves as protection from the user's touch and aids the user during insertion of the catheter into the urethra. The device is intended for use by prescription only. The device comes in FR size 10, 12, 14, and 16; corresponding to model numbers 28931, 28932, 28934, and 28936 respectively.

The provided text describes the regulatory clearance for the SpeediCath Flex Set, a urological catheter. It does not contain information about an AI/ML powered device, therefore no information regarding acceptance criteria or performance of such a device can be extracted.

The document discusses the device's indications for use, technological characteristics, and non-clinical testing performed to demonstrate its safety and effectiveness compared to predicate devices. The listed tests are standard for medical devices like catheters and include standards for urine collection bags, sterile urinary catheters, material properties (coefficient of friction), usability, biocompatibility, packaging performance, and shelf life.

Here's the information that can be extracted, based on the provided text, heavily inferring from the context of a medical device submission:

1. A table of acceptance criteria and the reported device performance
   The document states: "All tests met the pre-determined acceptance criteria." It lists the standards and internal requirements against which the device was tested, but does not provide specific numerical acceptance criteria or reported performance values for each test. For example, it lists "ISO 8669-2:1996 Urine collection bags - Part 2: Requirements and test methods" as a fulfilled requirement, but doesn't detail what those requirements are or the specific results.

   Acceptance Criteria (Inferred from standards and internal requirements)	Reported Device Performance
   Requirements of ISO 8669-2:1996 (Urine collection bags)	Met all requirements
   Requirements of ISO 20696:2018 (Sterile urinary catheters and accessory devices)	Met all requirements
   Requirements of ASTM F623-99:2013 (Foley Catheters - Flow rate only)	Met all requirements
   Requirements of D1894:2014 (Coefficient of friction)	Met all requirements
   Requirements of ISO 62366-1:2015, AAMI HE 75:2009, and FDA Guidance (Usability)	Met all requirements
   Requirements of ISO 10993-1 (2018) and FDA Guidance (Biocompatibility)	Met all requirements
   Requirements of ASTM D4169 (Performance Testing of Shipping Containers)	Met all requirements
   Requirements of ASTM F1980-16 (Real Time and Accelerated Aging shelf life)	Met all requirements
   Internal requirements for break-off tap force	Met all requirements
   Internal requirements for cap/handle opening torque	Met all requirements
   Internal requirements for drip-tight closure of handle and cap	Met all requirements
   Internal requirements for pH and Osmolality of the wetting agent/hydrophilic coating	Met all requirements
   Internal requirements for protective sleeve welding strength	Met all requirements

2. Sample size used for the test set and the data provenance
   The document does not specify the sample sizes used for the non-clinical tests. It states "Performance testing for SpeediCath Flex Set was conducted..." but gives no details on the number of units tested. The data provenance is internal testing by Coloplast A/S. The text does not mention patient data, so neither retrospective nor prospective patient data is referenced.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
   Not applicable, as this is a non-clinical testing report for a physical medical device. Ground truth, in the context of expert review, is not relevant here. The "truth" is established by adherence to specified testing standards and internal requirements.

4. Adjudication method for the test set
   Not applicable for non-clinical device performance 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. The device is a urological catheter, not an AI/ML-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
   Not applicable. The device is a urological catheter, not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
   Not applicable in the sense of clinical "ground truth." The "ground truth" for the non-clinical tests is defined by the requirements outlined in the referenced international standards, ASTM standards, relevant FDA guidances, and Coloplast's internal specifications.

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.

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