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Under the supervision of a healthcare professional, Microlyte® Ag/Lidocaine Wound Dressing may be used for the management of partial and full thickness wounds including diabetic foot ulcers, venous stasis ulcers, ischemic ulcers, surgical wounds, post-surgical incisions, donor sites, debrided partial thickness wounds, first degree burns, partial thickness burns, abrasions and lacerations.

Microlyte® Ag/Lidocaine Wound Dressing is a sterile, single use absorbent polymeric matrix composed primarily of synthetic polyvinyl alcohol with 2.5 mg/in² of lidocaine hydrochloride USP, with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.1 mg/in² of silver.

The provided text describes the regulatory filing for a medical device (Microlyte® Ag/Lidocaine Wound Dressing) and extensively discusses its comparison to predicate devices, performance, and safety data. However, it does not contain information about the acceptance criteria or a study that uses a designated test set with ground truth established by experts for evaluating a classification or detection algorithm's performance.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than proving performance against specific acceptance criteria for an AI/ML-based device.

Therefore, I cannot provide the requested information, which would typically be found in a clinical study report or a detailed performance validation report for an AI/ML device.

Here's why the information is not present:

• Device Type: Microlyte® Ag/Lidocaine Wound Dressing is a physical wound dressing containing lidocaine and silver, not a software or AI/ML-based diagnostic or therapeutic device.
• Regulatory Pathway: The 510(k) pathway for this device emphasizes comparison to predicates to establish safety and effectiveness, not direct performance against algorithmic metrics.
• Performance Data: The "Performance and Safety Data" section lists physical performance, antimicrobial performance, biocompatibility, animal studies, and pyrogenicity testing. These are typical tests for a physical wound dressing and do not involve AI/ML algorithm evaluation.

To directly answer your request based on the provided text, the answer is that this document does not contain the information needed to fill out the table regarding AI/ML acceptance criteria and study details.

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Rx

Management of partial and full thickness wounds including stage I - IV pressure ulcers, ulcers caused by mixed vascular etiologies, Diabetic skin ulcers, 1st and 2nd degree burns, post-surgical incisions, graft sites, lacerations, skin tears, cuts and abrasions.

OTC

Management of minor wounds including minor cuts, abrasions, lacerations and burns.

The Field Shield Wound Dressing is a spray on hydrogel wound dressing that hydrates, seals and protects dermal injuries to create and maintain a moist wound environment. A moist wound environment is known to be conducive to the wound healing process. It is a hydrophilic system containing a polyacrylate polymer matrix with silver hydrosol and lidocaine. The dressing donates moisture to a wound and maintains a moist environment. When applied to the liquid device donates moisture to the wound then sets into a thin, pliable, transparent film barrier over the surface of the wound. The film is capable of setting over intact and compromised skin surfaces. The device is intended for use for up to 30 days. with reapplication recommended every 24 to 72 hours. The device contains silver hydrosol that may inhibit the growth of microorganisms such as Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, antibiotic resistant strains of MRSA and VRE, as well as fungi such as Candida albicans and Candida auris within the dressing. Additionally, the dressing contains lidocaine as a topical anesthetic. Clinical evaluation showed that the Lidocaine can reduce pain within 30 minutes after application; long-term pain reduction has not been evaluated. Field Shield® Wound Dressing is intended for both Prescription and over the counter (OTC) indications for use.

The provided document describes the KeriCure Inc.'s Field Shield Wound Dressing, an unclassified device. The information focuses on demonstrating its substantial equivalence to predicate devices, particularly regarding safety and effectiveness.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as quantitative thresholds for the Field Shield Wound Dressing. Instead, the document focuses on demonstrating that the device meets safety and performance standards equivalent to predicate devices, particularly through various types of testing. The reported device performance is outlined in the "Summary of Performance Testing" table.

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