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Intermittent urinary catheterization.

LoFric® Sense™ is a single-use catheter designed as an intermittent pathway for drainage of the bladder. The catheters are available in one length with a Nelaton (straight) tip and a variety of diameters to accommodate individual anatomy. Each catheter is packaged with a water packet that is to be broken immediately before use in order to soak the tubing.

Here's an analysis of the provided information, focusing on acceptance criteria and the supporting study details:

Device: LoFric® Sense™ (Urological catheter and accessories)
Submission Number: K123751
Date: February 28, 2013

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

Based on the provided document, the acceptance criteria are not explicitly stated as numerical targets. Instead, the study's primary goal was to demonstrate substantial equivalence to a predicate device. This means the acceptance criteria are implicitly met if the device shows comparable performance characteristics to the predicate device.

Acceptance Criteria (Implicit for Substantial Equivalence):

• Safety: The device should not raise new issues of safety compared to the predicate.
• Efficacy/Performance: The device should have similar performance characteristics to the predicate.
• Biocompatibility: The device should be biocompatible.
• Dimensional Integrity: The device must meet specified dimensional requirements.

Reported Device Performance:
The document states that the LoFric® Sense™:

• "has the same intended use" as the predicate.
• "uses the same operating principle" as the predicate.
• "incorporates the same basic design" as the predicate.
• "incorporates the same or very similar materials" as the predicate.
• "has similar packaging and is sterilized using the same materials and processes" as the predicate.
• "Performance testing and biocompatibility testing were submitted to address efficacy and safety of the device and to show substantial equivalence to the predicate device."
• "Non-clinical testing data that was submitted, referenced, or relied upon to demonstrate substantial equivalence included: dimensional analysis, biocompatibility testing and modified performance testing according to ASTM F623."
• "Any differences in the technological characteristics between the subject and predicate device do not raise new issues of safety or efficacy."

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

The document does not specify a "test set" in the context of human subject testing or a clinical trial. The evaluation primarily relies on non-clinical testing data.

• Sample Size: Not explicitly stated for specific non-clinical tests (e.g., how many catheters were dimensionally analyzed or used for performance testing).
• Data Provenance: The manufacturer, Wellspect HealthCare, is based in Mölndal, Sweden. It is highly probable the non-clinical testing was conducted in Sweden or by contracted labs. The document does not specify if any data originates from other countries.
• Retrospective/Prospective: Non-clinical testing (dimensional analysis, biocompatibility, performance testing) is inherently prospective as it's conducted specifically for the submission.

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)

This information is not applicable as the study described is a non-clinical, substantial equivalence comparison to a predicate device, not a diagnostic accuracy study relying on expert-established ground truth.

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

This information is not applicable as the study described is a non-clinical, substantial equivalence comparison to a predicate device. There is no mention of a "test set" requiring adjudication by human readers/experts.

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

This information is not applicable. The submission is for a urological catheter (medical device), not an Artificial Intelligence (AI) enabled diagnostic or assistive tool.

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

This information is not applicable. The submission is for a physical medical device, not an algorithm or AI system.

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

For the non-clinical testing, the "ground truth" for demonstrating substantial equivalence is based on:

• Industry Standards and Regulations: Adherence to standards like ASTM F623 for performance testing.
• Reference Materials/Specifications: For dimensional analysis, the ground truth would be the defined design specifications of the device.
• Established Methods: For biocompatibility, validated biological test methods determine the ground truth regarding material safety.
• Predicate Device Data: The performance and characteristics of the legally marketed predicate device (Astra Tech, LoFric® Primo™ - K122078) serve as a crucial comparative "ground truth."

8- The sample size for the training set

This information is not applicable. The submission is for a physical medical device, not an AI or machine learning model that requires a training set.

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

This information is not applicable. There is no training set involved in this medical device submission.

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