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The FloSure Ventilation Patch is intended to be used in conjunction with NPWT Dressing Kits compatible with the SIMEX NPWT Systems EX200 and EX300 for the application of negative pressure wound therapy to the wound. The FloSure Ventilation Patch is to be applied to the occlusive wound dressing. When used in conjunction with the Simex NPWT EX200 and EX300 pumps and dressing kits, the FloSure Ventilation Patch is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of wound exudates, infectious material and tissue debris.

The FloSure Ventilation Patch is appropriate for use on the following wounds:

• · Pressure Ulcers
• · Diabetic/Neuropathic Ulcers
• · Venous Insufficiency Ulcers
• · Traumatic Wounds
• · Post-Operative and Dehisced Surgical Wounds
• · Skin Flap and Grafts

The FloSure Ventilation Patch is used with the NPWT wound dressings to improve air-flow through the dressing when desired. The FloSure Ventilation Patch augments the transparent dressing by providing additional gas permeability to the wound dressing site through its proprietary hydrophobic and micro-porous filter membrane. The access to additional air-flow can aid in keeping the vacuum in balance resulting in a continuous flow of exudate. Stagnation in the flow of exudate can cause pooling at the wound site and result in blockage alarms.

The provided text describes a 510(k) premarket notification for the "FloSure Ventilation Patch." This device is a medical accessory intended for use with Negative Pressure Wound Therapy (NPWT) systems. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for a novel functionality.

Therefore, the study described is a non-clinical bench testing and biocompatibility assessment for substantial equivalence, not a study to prove acceptance criteria for a new functional performance or algorithm.

Here's a breakdown of the requested information based on the provided text, with significant portions noted as "Not Applicable" or "Not Provided" due to the nature of the submission (510(k) for an accessory, not an AI device or a novel functional device requiring extensive performance metrics):

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not explicitly stated for each test. The non-clinical testing refers to "comparative performance bench testing" and standard biocompatibility assessments. These typically involve a sufficient number of samples to ensure statistical validity for the specific test, but the exact count is not provided in this summary.
• Data Provenance: The tests are "non-clinical testing" and "comparative performance bench testing," implying laboratory-based testing conducted by or for the manufacturer. There is no mention of country of origin for data or whether it's retrospective or prospective, as it's not patient-level data.

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

• Not Applicable. This device is an accessory to a medical device, and the evaluation is for substantial equivalence to a predicate, based on bench testing and biocompatibility, not on interpretation of complex medical data requiring expert consensus or ground truth in the context of diagnostic accuracy.

4. Adjudication Method for the Test Set

• Not Applicable. See point 3.

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. This submission is for a physical medical device accessory (a ventilation patch), not an AI-powered diagnostic or interpretive device. No MRMC study was conducted or relevant.

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

• Not Applicable. This is not an algorithmic or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Bench Test Results and Biocompatibility Standards: The "ground truth" or reference for performance was industrial standards for biocompatibility (e.g., ISO standards usually underlie cytotoxicity, sensitization tests) and functional performance metrics of the predicate device (UNI NPWT Foam Wound Dressing Kit) when assessed with SIMEX NPWT Systems EX200 and EX300.

8. The sample size for the training set

• Not Applicable. This is not a machine learning or AI device that requires a training set.

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

• Not Applicable. See point 8.

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