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Biasurge Advanced Surgical Solution is indicated for use in mechanical cleansing and removal of debris, including microorganisms from wounds.

BIASURGE Advanced Surgical Solution is a clear, colorless solution intended for cleansing and removal of debris, including microorganisms, from wounds. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of debris, including microorganism, from wounds. BIASURGE Solution is provided in a soft polypropylene 1000mL container with a spikeable port. BIASURGE Solution is composed of Purified Water, Poloxamer 407, Sodium Chloride, Ethylhexylglycerin, Hypromellose, Octane-1,2-diol, Polyaminopropyl Biguanide [PHMB; a preservative], EDTA Disodium, EDTA Trisodium.

The provided text describes the 510(k) premarket notification for the BIASURGE Advanced Surgical Solution. However, it does not contain the detailed information necessary to fully address all aspects of the request, especially regarding specific acceptance criteria for performance, test set sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies of an AI-powered device.

This document describes a medical device that is a wound cleanser/irrigation solution, not an AI-powered diagnostic or assistive device that would typically have the kind of performance data (e.g., sensitivity, specificity, reader studies) requested in the prompt. The performance testing mentioned is related to biocompatibility, preservative effectiveness, and shelf-life, which are chemical and physical properties, not diagnostic accuracy.

Therefore, many sections of your request cannot be fulfilled from the provided text. I will address what information is available and explicitly state when information is missing.

This document describes the 510(k) submission for the BIASURGE Advanced Surgical Solution, a wound cleanser. The submission focuses on demonstrating substantial equivalence to a predicate device based on similar indications for use, product form, function, and safety evaluations. The device's performance testing primarily pertains to its chemical and physical properties, not diagnostic accuracy or AI-driven tasks.

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" and "reported device performance" as typically applied to AI/diagnostic devices (e.g., sensitivity, specificity, AUC) is not directly applicable to this wound cleanser. The performance testing detailed here is for safety and stability.

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

This information is not provided in the document. The performance testing described (biocompatibility, USP , aging study) would involve specific sample sizes relevant to those types of chemical/material tests, but these are not disclosed. The data provenance (e.g., country of origin, retrospective/prospective) is also not stated as it's not relevant for this type of device and submission.

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

This information is not applicable and therefore not provided. This device is a wound cleanser, not an imaging or diagnostic device where expert ground truth establishment for a test set would be required. The "ground truth" here relates to chemical/physical properties and safety validated by standard laboratory methods and ISO guidelines, not clinical expert consensus on images or diagnoses.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving expert readers for diagnostic accuracy assessments, which is not the case for this device.

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

No, an MRMC comparative effectiveness study was not done. This type of study is for evaluating the impact of an AI system on human reader performance, which is irrelevant for a wound cleansing solution.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The device is a physical solution, not an algorithm. Therefore, no standalone algorithm performance was assessed.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is based on:

• Standardized laboratory testing results (e.g., ISO 10993 for biocompatibility, USP for preservative effectiveness, aging studies for stability).
• Chemical composition analysis comparing it to the predicate device.
• The fundamental mechanism of action: mechanical cleansing and removal of debris via hydrodynamic shear, which is a known physical principle.

There is no "expert consensus," "pathology," or "outcomes data" ground truth in the context of diagnostic accuracy for this device.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. This device is a chemical solution, not an AI model that requires a training set.

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

This information is not applicable and therefore not provided, as there is no training set for this type of medical device.

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