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The Versatile 1 EZCare™ Wound Vacuum System is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing.

The product is a portable suction pump that may promote wound healing when used with accessory wound sealing kits.

This 510(k) summary describes a device that is a Versatile 1 EZCare™ Wound Vacuum System, a portable suction pump intended to promote wound healing. The submission focuses on demonstrating substantial equivalence to a predicate device (Versatile 1™ Wound Vacuum System, K042134 and K052456) rather than clinical performance against specific acceptance criteria for a new clinical claim. Therefore, the provided document does not contain the requested detailed information about acceptance criteria and a study proving the device meets those criteria in a clinical context.

Here's what can be extracted based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly define quantitative acceptance criteria for clinical performance that would typically be seen in a study proving a device meets a specific efficacy threshold. Instead, it relies on demonstrating substantial equivalence to a predicate device.

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

The document does not mention a "test set" in the context of clinical performance data. The "performance testing" referred to is likely engineering and bench testing to demonstrate the device functions as intended and is comparable to the predicate. There is no information on sample size or data provenance (country of origin, retrospective/prospective) for clinical data.

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

Not applicable. The document does not describe a clinical study requiring expert-established ground truth.

4. Adjudication Method for the Test Set:

Not applicable.

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

No, the document does not mention an MRMC study or any study comparing human readers with and without AI assistance. This device is a wound vacuum system, not an AI-powered diagnostic tool, so such a study would not be relevant.

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

Not applicable. This device is a physical medical device (a wound vacuum system), not an algorithm or AI system.

7. The Type of Ground Truth Used:

Not applicable, as no clinical study with ground truth establishment is described. The "ground truth" for this type of submission is typically based on the predicate device's established safety and effectiveness.

8. The Sample Size for the Training Set:

Not applicable. The document does not describe a training set for an algorithm or AI model.

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

Not applicable.

Summary of what the document does communicate regarding evidence for the device:

The document is a 510(k) Summary for a Class II medical device (Powered Suction Pump). The primary method of demonstrating approval is through substantial equivalence to a legally marketed predicate device (Versatile 1™ Wound Vacuum System).

• Evidence for Equivalence: BlueSky Medical states they "evaluated the indications for use, materials, technology, product specifications, and energy requirements of the system."
• Performance Testing: "Performance testing has been completed to demonstrate the safe and effective use of the Versatile 1 EZCare™ Wound Vacuum System for the intended use." This likely refers to bench testing, engineering verification, and validation to ensure the device meets its design specifications and operates safely and effectively, consistent with the predicate device.
• Conclusion: "Performance testing and device comparison demonstrates that the subject device is substantially equivalent to the predicate device, and is safe and effective for the intended use."

The provided information is typical for a 510(k) submission where the device is not novel in its mechanism or intended use, but rather a modification or new version of an existing cleared device. It relies on a comparison to a predicate device rather than de novo clinical trial data establishing new efficacy claims against specific, quantitative acceptance criteria.

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