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The LoFric® Hydro-Kit II Single Use Urinary Catheter is intended for intermittent catheterization of the urethra.

The LoFric® Hydro-Kit II Single Use Urinary Catheter is designed as an intermittent pathway for drainage of the bladder. The device consists of a catheter, coated with a hydrophilic low-friction coating. The surface is hydrophilic and when the catheter is immersed in water or physiological saline solution for 30 seconds, it becomes slippery and ready to use. The catheter is provided in a variety of lengths and sizes. The catheter is packed within a bag for urine collection. The urine collection bag is used as a wetting container prior to catheterization. Inside the closed urinary bag, a water sachet is placed. By holding the product upright and exerting a light pressure on the folded water sachet, the water will activate the hydrophilic catheter surface.

The Astra Tech AB LoFric® Hydro-Kit II Single Use Urinary Catheter, as described in the provided 510(k) summary, underwent performance testing to establish its safety and effectiveness. However, the document does not present detailed acceptance criteria in a quantitative table or the specific results against such criteria. Instead, it broadly states that "Laboratory testing and biocompatibility testing was conducted to determine device functionality and conformance to design input requirements."

Here's an analysis based on the information provided and what can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain a specific table of acceptance criteria or detailed reported device performance metrics/results. The submission focuses on demonstrating substantial equivalence to a predicate device (LoFric® Single Use Urinary Catheter, K896750) rather than presenting a de novo performance study against explicit criteria.

The 510(k) summary states:

• "Laboratory testing and biocompatibility testing was conducted to determine device functionality and conformance to design input requirements."
• "The difference between the LoFric® Hydro-Kit II Single Use Urinary Catheter and the predicate is the packaging concept and addition of accessories as urine collection bag and water sachet. The method of sterilization is changed. This difference does not raise new questions of safety and effectiveness. Laboratory data demonstrates this."

This indicates that internal performance testing was conducted, likely focusing on aspects such as:

• Functionality: Ensuring the hydrophilic coating activates correctly, the catheter remains slippery for the intended duration, and the urine collection bag and water sachet function as designed.
• Biocompatibility: To confirm the materials are safe for patient contact.
• Sterilization Effectiveness: To validate the new sterilization method.
• Physical Integrity: Ensuring the catheter and packaging maintain integrity during handling and use.

Without specific numerical acceptance criteria (e.g., "slipperyness duration ≥ X minutes," "tensile strength ≥ Y N," "sterility assurance level = Z"), a detailed table of objective results cannot be constructed from this document. The "reported device performance" is summarized as the device meeting "design input requirements" and demonstrating that changes "do not raise new questions of safety and effectiveness."

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

The document does not specify the sample size used for the laboratory testing.
The data provenance is internal laboratory data, suggesting it was conducted by the manufacturer, Astra Tech, Inc. The document does not mention the country of origin of the data beyond the manufacturer's location. The testing is implicitly prospective in nature, as it was conducted to validate the new design changes.

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

This type of information is not applicable in this context. The study described is laboratory-based performance testing of a medical device (catheter), not a diagnostic or imaging device where expert interpretation of clinical data would be required to establish ground truth.

4. Adjudication method for the test set

This is not applicable as the study is laboratory performance testing, not a clinical study requiring expert adjudication of patient outcomes or interpretations.

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 is not applicable. The device is a physical medical device (urinary catheter), not an AI-powered diagnostic tool. Therefore, an MRMC study and AI performance metrics are irrelevant to this submission.

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

This is not applicable as the device is a physical medical device, not an algorithm or AI system.

7. The type of ground truth used

For the laboratory performance testing mentioned, the "ground truth" would be established by objective engineering and material science standards and specifications. This could include:

• Reference standards: Established methods and instruments for measuring physical properties (e.g., friction, tensile strength, sterility).
• Biocompatibility standards: ISO or ASTM standards for material safety.
• Design specifications: Internal requirements set by Astra Tech for the performance of the catheter and its components.

It is not based on expert consensus, pathology, or outcomes data in the clinical sense directly, but rather on whether the device performs according to its predetermined engineering and safety parameters.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical medical device. There is no "training set" in the context of machine learning or AI development.

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

This is not applicable as there is no training set for this type of device.

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