(220 days)
PerioStom™ Dental Dressing is an oral wound dressing intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief.
PerioStom™ Dental Dressing can be utilized for the pain relief and protection of oral mucosa due to irritation, trauma, or following iatrogenic procedures such as scaling and root planing.
PerioStom™ Dental Dressing is a powder based wound dressing comprised entirely of spray-dried chitosan. PerioStom™ Dental Dressing is provided to the clinician in a stainless steel container and can be applied to the tissue via a dental instrument of their choice (e.g. a Prichard or Howard Periosteal Elevator) or a dry gloved finger. PerioStom™ Dental Dressing is also supplied in preloaded cartridges for application to harder to reach areas of the oral mucosa via the FS Dispenser™.
This FDA submission describes a medical device, the PerioStom™ Dental Dressing, and seeks substantial equivalence to a predicate device. However, this submission does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML medical device.
The provided document describes a dental dressing, which is a physical barrier intended for temporary protection of oral mucosal tissue and to provide pain relief. This is a traditional medical device, not an AI/ML-driven device. Therefore, the requested information pertaining to AI/ML device testing (such as performance metrics like sensitivity/specificity, sample sizes for test/training sets, expert qualifications for ground truth, MRMC studies, standalone performance, etc.) is not applicable to this submission.
The document focuses on demonstrating substantial equivalence to a predicate device (HemCon® Dental Bandage K060363) through:
- Comparison of technological characteristics: Both are spray-dried chitosan-based dressings that form a bioadherent gel.
- Non-clinical performance testing: Viscosity, pH, microbial testing, and wound barrier testing. The results were found to be "substantially equivalent" for the subject and predicate devices.
- Biocompatibility testing: According to ISO 10993 standards (Cytotoxicity, Sensitization, and Irritation/Intracutaneous Reactivity). The device met these requirements.
No clinical performance testing was conducted or deemed necessary for this type of device and submission.
Therefore, I cannot provide the requested table and information as it pertains to AI/ML device performance and testing. This document describes a non-AI physical medical device.
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