(1212 days)
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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