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The WoundPro Negative Pressure Wound Therapy System may promote wound healing, through the drainage and removal of infectious material and other fluids from the wound site, with continuous and/or, intermittent negative pressure. Patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts may benefit from the use of this device. The WoundPro is intended for use in a healthcare facility only.

Additional Wounds Indicated are:

• · Diabetic/Neuropathic ulcers
• · Pressure ulcers
• · Chronic wounds
• · Acute wounds
• · Dehisced wounds

The WoundPro is part of a family of products offered by Pensar Medical LLC. The WoundPro is a powered suction pump that uses controlled negative pressure to a dressing and flange assembly through tubing.

The control unit incorporates a maintenance free brushless DC motor and is powered by a rechargeable battery power source. Optionally the unit can be connected to mains power using the included Medical Grade Switching power converter. The device is monitored by software and contains an alarm function with audio and visual prompts.

The WoundPro has a negative pressure setting range of 20mm to 200mmHg which is electronically monitored and controlled. The pump includes push button user interface controls and an electronic display with audible and visual alarm indicators.

The device can accommodate 300cc and 800cc canister sizes.

The unit can be operated on a countertop and has provisions for connection to IV poles, bedside rails, or footboard mounting.

The provided text is a 510(k) summary for the Pensar WoundPro Negative Pressure Wound Therapy System. It describes the device, its intended use, and a comparison to predicate devices to establish substantial equivalence. However, the document does not contain a study that proves the device meets specific device performance acceptance criteria in terms of clinical or analytical efficacy for wound healing.

Instead, the summary focuses on demonstrating equivalence through:

• Identical Indications for Use: The WoundPro has the same indications as the predicate.
• Similar technological characteristics: Comparisons of product type, product code, therapy unit, housing, modes, weight, dimensions, external power supply, electrical battery powered, power source, expected useful life, collection canisters, filter, dressing system, gauze dressing kit assembly, drape, dome/exudates line assembly, method of sterilization, single-use packaging for dressings, biocompatibility, and accessories.
• Performance Testing: It mentions various performance tests but does not provide details on specific acceptance criteria or the numerical results of these tests relating to wound healing outcomes.

Therefore, I cannot populate the table or answer most of your detailed questions directly from the provided text as the information is not present. The document focuses on demonstrating substantial equivalence based on comparability to predicate devices rather than independent, quantitative performance criteria for clinical outcomes.

Here's what I can provide based on the document:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria for clinical performance (e.g., wound healing rates, reduction in infection). Instead, it relies on the device having "SMILARITY or DIFFERENCE" to the predicate. The "performance" mentioned refers to engineering and safety characteristics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to engineering and software tests, not clinical studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The document discusses engineering and safety assessments, not clinical interpretation or ground truth establishment by medical experts for patient outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

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 as the device is a Negative Pressure Wound Therapy System, not an AI-powered diagnostic or interpretive device that would involve "human readers" or "AI assistance" in the sense of image interpretation. No MRMC study was mentioned or performed for this type of device.

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, and its function involves direct interaction with a wound.

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

This is not applicable in the context of clinical "ground truth" for wound therapy efficacy in this document. The "ground truth" for the engineering performance tests would be based on established engineering standards and specifications.

8. The sample size for the training set

This information is not provided. The document details hardware and software testing, not machine learning model training.

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

This information is not provided.

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