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The SML OSA2 Appliances are intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea in adults. The SML-OSA2 appliances are worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The customized appliance is inserted and removed by the patient and adjusted by the prescribing dentist.

The SML-OSA2 APPLIANCES include five device models: Adjustable Sleep Appliance (ASA), Clear Sleep Adjustable Dorsal, Clear Sleep Adjustable Anterior, Quiet Night Appliance (QNA) and V-force.

The SML-OSA2 Appliances are customized, intraoral dental devices designed to reduce snoring and mild to moderate obstructive sleep apnea in adults. The devices fit over the dentition and reposition the mandible in a slightly protrusive position. The SML-OSA2 APPLIANCES consist of 2 arch forms that are linked to advance the mandible, and are worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The customized appliance is inserted and removed by the patient and adjusted by the prescribing dentist.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the SML-OSA2 Appliances device:

This document is a 510(k) Premarket Notification for the SML-OSA2 Appliances. In the context of 510(k) submissions, the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through de novo performance studies. Therefore, the information provided focuses on comparability and known safety/effectiveness of materials and design.

Acceptance Criteria and Reported Device Performance

The document doesn't present a table of numerical acceptance criteria and a corresponding table of the device's measured performance in the typical sense of a diagnostic or therapeutic device undergoing a detailed performance study. Instead, substantial equivalence to a predicate device (ATG/SM-OSA Appliances, K130130) is the overarching "acceptance criterion" being met.

Here's how the "acceptance criteria" (implicitly, the characteristics of the predicate) and "reported device performance" (characteristics of the subject device) are presented:

Study Information & Data Provenance

1. Sample size used for the test set and the data provenance:

   • No specific test set or associated sample size is mentioned. This is a 510(k) submission primarily relying on substantial equivalence to a predicate device, not de novo performance testing.
   • The document implies that the "data provenance" for the predicate device's effectiveness would be from its own clearance, but no specific study details are given here for either device.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. There was no specific test set or ground truth established for the SML-OSA2 Appliances regarding clinical performance, as no clinical testing was required or performed for this 510(k). The ground truth for the predicate's effectiveness would have been established during its own clearance.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable, as no specific test set or clinical study requiring adjudication was performed for the SML-OSA2 Appliances.

4. 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:

   • Not applicable. This device is a physical intraoral appliance, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

   • Not applicable. This device is a physical intraoral appliance.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the purposes of this 510(k) submission, the "ground truth" for the device's safety and effectiveness relies on the established safety and effectiveness of the predicate device (K130130) for its specified indications for use.
   • The "ground truth" for the materials used in SML-OSA2 Appliances (including new ones like POM and latex elastomers) is established by their prior use in cleared dental/intraoral devices or their inclusion in the FDA Biomaterials Compendium.

7. The sample size for the training set:

   • Not applicable. This is not an algorithm or AI device that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for this type of device.

In summary: The document from the FDA acknowledges a 510(k) premarket notification for the SML-OSA2 Appliances. It concludes that the device is substantially equivalent to a predicate device (ATG/SM-OSA Appliances, K130130), meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. This determination is made based on comparing the indications for use, technological characteristics (design, materials, scientific principle), and performance standards, primarily relying on existing data and prior clearances rather than new, extensive performance studies for the subject device. "No clinical testing is required for these devices."

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The ATG/SM-OSA appliances are intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea in adults. The ATG/SM-OSA appliances are worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The customized appliance is inserted and removed by the patient and adjusted by the prescribing dentist.

The ATG/SM-OSA APPLIANCES are primarily polymer trays that are used intraorally over the dentition to make the mandible protrude. Three designs are included: Adjustable Herbst, Adjustable Dorsal, and MIRS. The mandible protrusion is controlled by stainless steel tubes & rods or screws for the Herbst and Dorsal designs. The MIRS single-piece construction has a lingual rest to set the mandibular protrusion. Each device is fabricated to the prescription of a dentist.

The provided text describes a 510(k) premarket notification for the ATG/SM-OSA APPLIANCES. This submission is for a medical device that does not require a clinical study with acceptance criteria and performance data in the typical sense of an AI/ML device.

The basis for this 510(k) submission is substantial equivalence to a predicate device, meaning the new device (ATG/SM-OSA APPLIANCES) is essentially identical in intended use, design, function, and materials to an already legally marketed device (DynaFlex® Anti-snoring and Sleep Apnea Devices).

Therefore, many of the requested elements for an AI/ML device study (like sample size, ground truth, expert consensus, MRMC studies, standalone performance, etc.) are not applicable to this type of submission.

Here's a breakdown of the relevant information provided and why other sections are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

No formal clinical study with acceptance criteria and a specific performance measurement was conducted or described in this document for the ATG/SM-OSA APPLIANCES. Instead, the "study" proving the device meets the acceptance criteria is a comparison and analysis of the new device against its predicate device to demonstrate substantial equivalence.

The manufacturer, Selane Products Inc., performed:

• An FMEA (Failure Mode and Effects Analysis) risk analysis.
• Evaluation of the materials of construction.
• Evaluation of the design.

2. Sample size used for the test set and the data provenance

• Not Applicable. No test set, clinical data, or performance data from human subjects was used for this 510(k) submission. The submission relies on demonstrating similarity to a previously cleared predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. No ground truth for a test set was established as no clinical study or test set was mentioned.

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

• Not Applicable. This is a physical medical device, not an AI/ML diagnostic or assistive tool.

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

• Not Applicable. This is a physical medical device.

7. The type of ground truth used

• Not Applicable. No ground truth was established for a performance study. The "ground truth" for this submission is the established safety and effectiveness of the predicate device.

8. The sample size for the training set

• Not Applicable. No training set was used. This is not an AI/ML device.

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

• Not Applicable. No training set was used.

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