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The TrueFunction® Adjustable Herbst Appliance is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

The TrueFunction® Adjustable Herbst Appliance is a prescription only appliance that is customized by True Function Laboratory to dentist specific instructions.

TrueFunction® - Adjustable Herbst Appliances are primarily polymer trays that are used intraorally over the dentition to make the mandible protrude. Material composition of the proposed devices include acrylic PMMA, dual laminate polymers, stainless steel ball clasps, exing elements and adjustment key and colorant. Also provided with the device is a stainless steel key used to make necessary mandibular protrusion adjustments by turning the screws as needed.

They are available in three mandibular advancement models: The Dual Laminate, the Acrylic with Clasp, and the Acrylic without Clasp model.

The Dual Laminate - this model has a soft, rubbery surface on the inside of each piece and a hard acrylic surface on the outside without metal clasps for retention. The appliance is held in place by the soft, rubbery liner. Patients must have adequate natural undercuts for retention of the Dual Laminate model, because retention cannot be increased during treatment, and the appliance cannot be modified to accommodate new tooth restorations or the loss of posterior teeth.

The Acrylic with Clasp and Acrylic without Clasp - the acrylic with clasp model has several metal ball clasps, which can be adjusted to increase retention on teeth that have insufficient undercuts. The ball clasps can often be modified, should further dental work be performed and adjustments required. For the non-clasp model, the patient must have adequate natural undercuts because retention cannot be increased during treatment, and the appliance cannot be modified to accommodate new tooth restorations or the loss of posterior teeth.

TrueFunction® - Adjustable Herbst Appliances mandible protrusion is controlled by stainless steel tubes & rods or screws for all three mandibular advancement designs. Each device is fabricated to the prescription of a dentist.

TrueFunction® - Adjustable Herbst Appliances device components comes in contact with the patient's gum (please reference the diagram below), and are composed of Methyl Methacrylate, Thermoplastic Polyurethane and high grade Chromium-nickel steel.

Here's a breakdown of the requested information based on the provided text, focusing on the TrueFunction Adjustable Herbst Appliances:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance for the TrueFunction Adjustable Herbst Appliances is based on substantial equivalence to predicate devices, not on specific performance metrics with acceptance criteria like a diagnostic algorithm would have. Therefore, there's no table of numerical acceptance criteria or performance values provided for this type of device.

Instead, the acceptance criteria are met by demonstrating that the device has:

• Same intended use: "The reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA)" in adults, prescribed by a dentist, and customized by True Function Laboratory.
• Technological characteristics that do not raise new questions of safety and effectiveness: This is assessed by comparing design, function, and materials to previously cleared predicate devices.
• Compliance with relevant standards: ISO 7405 and ISO 10993 part 5 and part 10 for biocompatibility, as referenced in 21 CFR 872.5570.

Reported Device Performance:

The document states:

• "The TrueFunction® - Adjustable Herbst Appliances are essentially identical in indications for use to the predicate devices..."
• "Technological characteristics which do not raise new questions of safety and effectiveness."
• "The material composition... to comply with the Standard ISO 7405 and ISO 10993 part 5 and part 10..."
• "The material characteristic... meeting ASTM standards, have been found to be substantially equivalent to the predicate device material characteristics."
• "No new materials are used... all materials are already used in dental laboratories for previously cleared devices..."
• "No new concerns are introduced with the new TrueFunction® - Adjustable Herbst Appliances that are not present in the predicate devices."

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This is a medical device clearance based on substantial equivalence, not a study involving a test set of data points as would be typical for an AI/algorithm-based device. No patient data (test set) was used for this clearance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. No ground truth for a test set was established as no clinical study was performed.

4. Adjudication Method for the Test Set

Not applicable. No test set was used.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This document does not mention any MRMC comparative effectiveness study or AI assistance. The device is a physical intraoral appliance, not an AI software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This is a physical device, not an algorithm.

7. The type of ground truth used

Not applicable. No clinical data or ground truth in the context of diagnostic performance was used for this 510(k) clearance. The "ground truth" for clearance is the established safety and effectiveness of the predicate devices and the demonstration that the new device is substantially equivalent to them.

8. The sample size for the training set

Not applicable. No training set was used.

9. How the ground truth for the training set was established

Not applicable. No training set was used.

Summary of the K170578 Clearance for TrueFunction Adjustable Herbst Appliances:

This 510(k) clearance is for a physical medical device (intraoral appliance) and not for an AI diagnostic algorithm. Therefore, many of the questions related to clinical study design, test sets, training sets, ground truth, and expert adjudication are not applicable. The clearance is based on demonstrating substantial equivalence to already legally marketed predicate devices through a comparison of intended use, technological characteristics (design, function, materials), and compliance with relevant performance standards (biocompatibility). No new clinical data or human performance studies were required or submitted, leveraging the "least burdensome provisions" of the FDA Modernization Act of 1997.

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