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The JS Dental Lab Mouth Guard is intended for protection against bruxism and teeth grinding. They create a barrier between the upper and lower dentition to protect the patient's overall occlusion.

The JS Dental Lab Mouth Guard (herein referred to as Subject Device) is a patient contact protective custom-fit mouth guard that covers the upper teeth and lower teeth to prevent premature tooth wear and noise caused due to bruxism and teeth grinding. It fits over upper teeth or lower teeth during sleep. The Subject Device can offset the effects of bruxing or teeth grinding while protecting teeth from daily wear and tear. The Subject Device is created based on the user's teeth impression and manufactured using the biocompatible material, equivalent to the Thermoformed Mouthguards/Nightguards (herein referred to as Predicate Device, K121365). The Subject Device contains biocompatible materials, namely, Erkodur or Splint Biocryl, Erkoloc-Pro, Erkoflex-95, EVA Based Clear Mouthguard Material and BIOPLAST and is available in four different variations. All the biocompatible materials used are ISO-certified, BPA-free, and are cleared for dental use in humans.

The provided document is a 510(k) premarket notification for a medical device, the "JS Dental Lab Mouth Guard." This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria for AI performance.

Therefore, this document does not contain the information requested in your prompt regarding acceptance criteria and a study that proves the device meets those criteria for an AI-powered device.

The JS Dental Lab Mouth Guard is a physical dental device (a mouthguard), not an AI-powered software or algorithm. The review process for such a device focuses on material biocompatibility, physical properties, and a comparison of its technological characteristics and indications for use to an existing predicate device.

Specifically, the document focuses on:

• Device Description: A custom-fit mouth guard for bruxism and teeth grinding.
• Materials: Biocompatible materials like Erkodur, Splint Biocryl, Erkoloc-Pro, Erkoflex-95, EVA-based clear mouthguard material, and BIOPLAST.
• Comparison to Predicate: Demonstrating substantial equivalence to "Thermoformed Mouthguards/Nightguards (K121365)" in terms of indications for use, design, materials (with some minor differences noted as not raising new questions of safety and efficacy), reusability, single-patient use, manufacturing method, and sterility.
• Biocompatibility Testing: Confirmation of material biocompatibility according to ISO 10993-1:2018.
• Bench Performance Testing: Stating that physical properties for the materials have been provided by the material manufacturer.

There is no mention of any AI component, algorithm, or software in this submission. Consequently, there are no "acceptance criteria" related to AI performance, no "test set" for AI, no "ground truth" establishment by experts, and no "MRMC comparative effectiveness study" for AI assistance.

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