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PocketDoc Micro Wound Therapy System is indicated for patients who may benefit from a suction device as it may promote wound healing through the removal of low to moderate levels of exudate and infectious material.

Appropriate wound types include:

• · Chronic
• Acute
• · Traumatic
• Subacute and dehisced wounds
• · Partial-thickness burns
• · Ulcers (such as diabetic or pressure)
• · Flaps and grafts
• · Closed surgical incisions

PocketDoc Micro Wound Therapy System is suitable for use in both a healthcare and homecare setting.

The PocketDoc" Micro Wound Therapy System (PocketDoc) is a negative pressure wound therapy (NPWT) system that is specifically designed for shallow wounds with low to moderate amounts of exudate (*10 ml/day) that no longer or never required a collection canister. The system consists of a disposable, small, lightweight, battery operated, portable suction device (pump control unit) containing an electric motor driven vacuum pump, Enluxtra Humifiber Wound Dressings made of a hydrophilic gelling fiber (K122297), adhesive polyurethane drapes and StingRay TPE flanges with PVC tubing to connect the dressing/drape to the suction device. The dressing is applied over the wound and the drape is applied over the dressing to hold it in place. The flange on top of the drape is connected to the pump control unit via the tubing. The dressings, drapes, flanges and tubing are supplied sterile and are for single use. The pump control unit is for single patient use and is provided nonsterile. The PocketDoc" Micro Wound Therapy System is suitable for use in both a healthcare and homecare setting. The portable suction device can be placed in a pocket, a carrier or attached to the body with an arm/leg Velcro strap which is provided.

The provided text describes the 510(k) premarket notification for the PocketDoc™ Micro Wound Therapy System. However, it does not contain the level of detail required to answer all aspects of your request regarding acceptance criteria and the study proving the device meets those criteria for complex AI/ML-based diagnostic devices.

The document focuses on demonstrating substantial equivalence to a predicate device, which is a different regulatory pathway than proving meeting acceptance criteria for an AI/ML diagnostic system through rigorous performance studies.

Specifically, the document lacks:

• A table of specific numerical acceptance criteria (e.g., sensitivity, specificity, AUC thresholds).
• Reported device performance against such numerical criteria.
• Details on sample size, provenance, and ground truth establishment for a diagnostic AI model's test set.
• Information on expert adjudication for ground truth, MRMC studies, or standalone algorithm performance metrics.
• Details on the training set size or how its ground truth was established, as would be relevant for an AI model.

The "Summary of Non-Clinical Testing" section outlines bench testing for the device's physical and functional properties (pressure accuracy, low-pressure indicator, exudate collection, battery life, safety limits), as well as general medical device testing (sterilization, biocompatibility, software validation, electrical safety, EMC, human factors). These are typical for powered medical devices, not for diagnostic algorithms or AI.

Therefore, based only on the provided text, I cannot describe the acceptance criteria and the study that proves an AI/ML diagnostic device meets them. The provided text relates to a negative pressure wound therapy system, which is a therapeutic device, not an AI/ML diagnostic device.

If you mistakenly provided text for a non-AI/ML device, please clarify. If the "PocketDoc™ Micro Wound Therapy System" is an AI/ML device and these details are missing, then the provided documentation does not sufficiently describe its AI/ML performance evaluation in the way you've requested.

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