K Number
K173196
Date Cleared
2018-01-24

(114 days)

Product Code
Regulation Number
N/A
Panel
SU
Reference & Predicate Devices
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

SUNTOUCH® Dental Dressing is intended for use as a wound dressing in extraction sites, and may be used as a wound dressing for the temporary management of oral surgical wounds, such as operative, postoperative and traumatic injuries.

Device Description

SUNTOUCH® Dental Dressing is made from biocompatible regenerated cellulose, chemically treated to become water-soluble, contains no chemical additives. Upon contact with moist oral wound, the material dissolves and transforms into a gelatinous material. By applying gentle pressure at this time, the material will adhere to the wound and form a barrier, protecting the wound from further irritation. SUNTOUCH® Dental Dressing dissolves in a few days and is safe if swallowed. Excess dressing material may be removed by rinsing with sterile water or saline solution. The dressings are sterilized with Sterility Assurance Level (SAL) of 10-6.

AI/ML Overview

The provided text is a 510(k) summary for the SUNTOUCH® Dental Dressing. It details the device's characteristics and compares it to a predicate device to establish substantial equivalence. However, the document does not describe acceptance criteria and a study proving the device meets those criteria in the context of an AI/algorithm-based medical device.

The SUNTOUCH® Dental Dressing is a physical product (a wound dressing) made of regenerated cellulose. The studies described are for the performance and biocompatibility of this physical material. The questions in the prompt (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details) are specifically relevant to AI/Machine Learning medical devices, which process data to provide diagnostic, prognostic, or treatment-related insights.

Since the SUNTOUCH® Dental Dressing is not an AI/algorithm-based device, these types of studies and acceptance criteria are not applicable or described in this 510(k) summary.

Therefore, I cannot provide the requested information based on the input text because it does not pertain to an AI/algorithm medical device.

N/A