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The Oral Device-OA is intended to reduce night-time snoring and / or mild to moderate obstructive sleep apnea (OSA) for adults 18 and older.
The Oral Device-S is intended to reduce night time snoring for adults 18 and older.

Passion for Life Healthcare UK Limited is offering two devices: 1) the Oral Device-S is an OTC device intended as an aid for the reduction of snoring; and 2) the Oral Device-OA is a Rx device intended as an aid for the reduction of mild to moderate obstructive sleep apnea, and/or snoring.
Both the Oral Device-S and Oral Device-OA are an oral appliance design concept based upon the use of a standard set of upper and lower trays of one size.
The Oral Device-OA is fitted by a dentist to act as a Mandibular Repositioning Device (MRD).
Whereas the Oral Device-S, an OTC device, is fitted by the user at home and any adjustments can be made without clinician interaction.

The provided text describes a 510(k) summary for two oral devices, the Oral Device-OA and Oral Device-S, and their substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study that proves the device meets specific performance acceptance criteria for an AI/ML powered medical device.

The document focuses on demonstrating substantial equivalence to existing medical devices based on:

• Indications for Use: Both the proposed devices and predicates are for reducing snoring and/or mild to moderate obstructive sleep apnea (Oral Device-OA) or just snoring (Oral Device-S).
• Technology/Principle of Operation: Both types of devices use upper and lower trays to advance the mandible.
• Environment of Use: Home and clinical settings for OA; Home for S.
• Patient Population: Adults 18 years and older.
• Non-clinical performance testing: This includes durability (180 days), flexural strength/fracture toughness, water absorption/solubility, mechanical/tensile testing, and drop testing.
• Biocompatibility of Materials: Adherence to ISO 10993 standards (cytotoxicity, sensitization, irritation).

Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML powered device, a study proving it meets those criteria, sample sizes, expert ground truth, or MRMC studies, as none of this information is present in the provided text.

The document details the device's physical and functional equivalency to its predicates, not its performance in an AI/ML context.

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