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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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The SiOxD Wound Matrix is intended for use in the management of wounds. Wound types include: Partial and fullthickness wounds, pressure ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, first degree and partial thickness burns, skin tears) and draining wounds.

The SiOxD Wound Matrix is a non-pyrogenic, sterile, single use device intended for use in local management of wounds. The SiOxD Wound Matrix is a soft, white, conformable, non-woven, absorbent, biocompatible fiber matrix made from synthetic biomaterials. The SiOxD Wound Matrix conforms in the defect space / wound bed and includes a fibrous, porous structure that allows for fluid absorption. The SiOxD Wound Matrix is structurally similar to collagen, a key component of the native extracellular matrix, and serves as a scaffold for cellular infiltration and vascularization. SiOxD Wound Matrix promotes a moist environment for the body's natural healing process.

The SiOxD Wound Matrix is not designed to be held in place with compression bandages or tapes. Only light pressure without mechanical compression or secondary bandaging is required for proper device function. The matrix applied to the wound bed naturally sloughs off during wound healing and does not require manual removal.

The provided document K232847, a 510(k) summary for the SiOxD Wound Matrix, does not contain information on an AI/ML-based medical device. Therefore, it does not include details on acceptance criteria, study methodologies for AI performance, sample sizes for training/test sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

The document describes a medical device, the SiOxD Wound Matrix, which is a non-pyrogenic, sterile, single-use wound dressing made from hydrated amorphous silica in fibrous form. The submission is for a line extension of an already cleared device (K222189). The new submission adds new intermediate size offerings and single barrier packaging configurations.

Since this is a submission for a physical medical device (wound dressing) and not a software/AI device, the information requested in your prompt regarding AI/ML performance, acceptance criteria, and specific study details (like sample size for test/training sets, expert ground truth) is not applicable to this document. The "study that proves the device meets the acceptance criteria" in this context refers to standard medical device testing (e.g., sterilization, packaging integrity, biocompatibility), not AI model validation.

If you have a document pertaining to an AI/ML medical device, please provide it, and I will be happy to extract the relevant information.

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