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AC Wound Management System is indicated for patients who would benefit from a suction device (negative pressure) to help promote wound healing by removing fluids, including irrigation and body fluids, wound exudates, and infectious materials. Examples of appropriate wound types include: Diabetic/Neuropathic ulcers, Pressure ulcers, Chronic wounds, Acute wounds, Dehisced wound, Partial-thickness burns, and Flaps and Grafts.

The AC Wound Management System is a powered suction pump that utilizes a pump drive to generate light negative pressure. The pump drive is powered by a rechargeable battery. Optionally the unit can be connected to mains power using an included power converter. AC Wound Management System has a negative pressure setting range of -50 mmHg to -175 mmHg which is electronically monitored and controlled. The system includes a keyboard for user interface as well as audible and visual alarm indicators. The system includes a 300cc canister. The system can be set on a countertop, carried using a shoulder bag or mounted to an IV pole or bedside rail using the AC Wound Management System's mount. The AC Wound Management System includes the following three components: The pump drive, The waste canister, with its suction tube (the two are connected permanently), FDA cleared generic NPWT dressing, which will be distributed by NanoVibronix. The pump drive is a non-disposable unit which contains a motor, a battery and a user interface. The drive has a piston which protrudes the drive and reciprocates to activate the suction pump, which is integral to the canister. In the drive there is also a vacuum level monitor which monitors the vacuum at all times and maintains the required set therapy. The waste canister attaches to the drive. The pump creates vacuum within the waste canister for the purpose of suctioning exudates from the wound and collecting them in the canister. The canister has a hydrophobic filter. The suction tube connects the waste canister to the wound dressing applying the vacuum generated within the waste canister to the wound site. The tube also transfers the exudates from the wound to the waste canister by maintaining flow from the wound site towards the waste canister at all times.

Here's a breakdown of the acceptance criteria and study information for the AC Wound Management System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document indicates that the comparative bench tests were performed for "three negative pressure levels: -50mmHg, -100mmHg and -175mmHg." For each level, the test duration was 72 hours. This suggests a sample size related to the number of pressure levels tested and the duration of the testing rather than a patient count. The specific number of devices tested is not explicitly stated, but it was a comparative test against one predicate device.
• Data Provenance: The data provenance is from bench testing, meaning it's laboratory-generated data, not from human or animal subjects. There is no information regarding the country of origin of this data, but it's presumed to be from the manufacturer's testing facilities or a contracted testing lab. The study is a prospective test in the sense that the new device was evaluated against defined criteria and a predicate.

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

• This device approval is based on bench testing for substantial equivalence to a predicate device, not on clinical performance requiring human expert judgment (like image interpretation). Therefore, no human experts were involved in establishing the "ground truth" for the test set in the traditional sense. The "ground truth" was based on objective measurements against the predicate device and established engineering standards.

4. Adjudication Method for the Test Set

• Not applicable. Since the evaluation was based on objective bench tests and engineering measurements, there was no need for an adjudication method by human experts.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No clinical studies were conducted."

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

• Yes, in a metaphorical sense. The "algorithm" here is the device's mechanical and electronic function. The bench tests evaluated the AC Wound Management System's performance in a standalone capacity against its specifications and the predicate device, without human intervention in the operation being evaluated (other than setting it up).

7. The Type of Ground Truth Used

• The ground truth used was based on objective engineering measurements and comparison to a legally marketed predicate device's performance and compliance with international standards (IEC 60601-1, IEC 60601-1-2) and the device's own labeling specifications.

8. The Sample Size for the Training Set

• This information is not applicable as this device approval is based on demonstrating substantial equivalence through bench testing, not on a machine learning model that requires a training set.

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

• This information is not applicable as no training set was used for this type of device approval.

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