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Actreen® Hi-Lite Intermittent Urinary Catheters are indicated for intermittent urinary catheterization by adult and pediatric patients with chronic urine retention or voiding dysfunction.

The proposed B. Braun Actreen® Hi-Lite Intermittent Urinary Catheter devices are flexible tubular devices that are inserted through the urethra and used to pass fluids from the urinary tract. These Actreen® Hi-Lite Intermittent Urinary Catheters are offered in a 7.5 inch length with a variety of French gauge sizes ranging from 6-16 with a straight tip. The outer packaging was designed to facilitate easier, no touch access for those with limited dexterity, while the hydrophilic lubrication makes this single use catheter ready to use.

The provided text is a 510(k) Pre-market Notification for a medical device, the Actreen® Hi-Lite Intermittent Urinary Catheters. This document details the process for obtaining FDA clearance for a device by demonstrating its "substantial equivalence" to a predicate device already on the market.

It's important to understand that a 510(k) summary does not contain the detailed clinical study results or statistical analyses that would typically be required to answer your specific questions about acceptance criteria for an AI/ML medical device, especially regarding aspects like MRMC studies, human-in-the-loop performance, or the nuances of ground truth establishment for complex image analysis.

The "studies" described in this document are primarily non-clinical performance tests demonstrating the physical, chemical, and biological safety and functionality of a physical medical device (a catheter) compared to an existing, similar catheter.

Therefore, many of your questions are not applicable to the information provided in this 510(k) summary. I can, however, extract the relevant "acceptance criteria" and "performance data" as presented for this specific type of device.

Here's an attempt to answer your questions based on the provided document, acknowledging the limitations for an AI/ML context:

Acceptance Criteria and Device Performance (for a physical medical device, not AI/ML)

The "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to its predicate device (K180801) through various non-clinical tests. The "performance" is the successful outcome of these tests, confirming that the new device performs similarly and safely to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria here are for a physical urinary catheter, not an AI/ML device. They relate to material compatibility, physical properties, and sterility, as outlined in the referenced standards. The "performance" is the successful meeting of these standards, which is stated as a conclusion rather than detailed results.

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

• Sample Size: Not specified in the 510(k) summary for the biocompatibility or design verification tests. These tests are typically conducted on a representative number of samples to ensure statistical validity, but the exact count isn't disclosed in this public summary.
• Data Provenance: Not specified. Testing would typically be conducted at the manufacturer's facilities or a certified testing lab. The country of origin of the data is not mentioned, nor is whether the data is retrospective or prospective, as these are lab-based performance tests, not clinical studies in the typical sense.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable. This document describes the performance testing of a physical medical device (catheter) against engineering and biocompatibility standards, not the evaluation of an AI algorithm requiring expert ground truth for image interpretation.

4. Adjudication Method for the Test Set

• Not Applicable. No expert adjudication method is described as this is not an AI/ML or clinical diagnostic study. The "adjudication" is essentially the successful completion and interpretation of the standard-based tests by qualified lab personnel.

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

• No. An MRMC study is specifically designed for evaluating the impact of an AI diagnostic aid on human reader performance, typically in diagnostic imaging. This document pertains to the
  510(k) clearance of a physical medical device (a urinary catheter) and does not involve diagnostic imaging or AI assistance.

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

• Not Applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• Not Applicable in the AI/ML sense. The "ground truth" for this device's performance is defined by the established and validated methodologies within the referenced international standards (ISO 10993-1 for biocompatibility, EN 1616 for physical performance). For example, a successful biocompatibility test result is "ground truth" that the materials are non-toxic and compatible with the human body under specified conditions.

8. The Sample Size for the Training Set

• Not Applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."

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

• Not Applicable. As above, no training set or AI algorithm is involved.

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