(232 days)
A custom-fitted mandibular repositioning device intended to reduce or alleviate nighttimc snoring and obstructive slocp apnca.
The SUAD™ Device is a custom-fitted mandibular device that allows patients to move their jaw laterally and vertically without disengaging the appliance. The device is adjusted to provide the anticipated relief of the condition by moving the mandible forward in 1mm increments by adding advancement shims onto the posts. The SUAD™ Device has modifications in the combination of materials used, the assembly, and the fabrication technique compared to the predicate device. The casted framework is substantially equivalent to casted frameworks used in dentures prior to 1976. The "tube and rod" assembly of the pivot and tube is substantially equivalent to the Herbst appliance, with a changed angle of the connecting tube to the pivot for greater stability. The framework strengthens the device. Smooth "buttons," frames covering all occlusal and incisal surfaces, and the use of vacuum-formed thermo-plastic result in less exposed wires.
Here's a summary of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document for the SUAD™ Device (K023836) does not present traditional acceptance criteria in terms of specific performance metrics (like accuracy, sensitivity, specificity) for a device that provides an automated output or diagnostic assessment. Instead, the "acceptance criteria" are implied by its substantial equivalence comparison to predicate devices, focusing on functional characteristics and intended use. The "device performance" is therefore described in terms of its ability to perform these functions and address identified risks, similar to its predicates.
| Acceptance Criteria Category (Implied by Substantial Equivalence) | Reported Device Performance (SUAD™ Device) |
|---|---|
| Intended Use Equivalence: | |
| - Intraoral device | Yes |
| - Reduce snoring | Yes |
| - Reduce obstructive sleep apnea | Yes |
| Design Equivalence: | |
| - Removable device | Yes |
| - Custom fit | Yes |
| - Adjustable | Yes |
| - Allows lateral and vertical movement | Yes |
| - Frames cover all occlusal and incisal surfaces | Yes |
| Material Equivalence: | |
| - Base material, vinyl | Yes |
| - Ethylene acrylic overlay | Yes |
| - Steel metal components | Yes |
| Risk Mitigation (Implied by Special Controls): | |
| - Intraoral gingival, palatal, or dental soreness | The internal framework and specific materials used provide for a comfortable fit. |
| - Obstruction of oral breathing | The angle of the upper connecting tube has been redirected, allowing for greater stability of the upper form. With the retruded force of the mandible, the new direction of the tube forces the upper frame to stay in a properly seated position. |
| - Loosening or flaring of lower anterior teeth/general tooth movement | The frames are designed to cover all the occlusal and incisal surfaces. |
Study Details:
The provided document (510(k) K023836) does not detail a study involving quantitative performance metrics for the SUAD™ Device itself. Instead, it relies on demonstrating substantial equivalence to existing legally marketed predicate devices, particularly the Removable Herbst Appliance (K955822).
The 'study' presented is a comparison table (Table 1 - Substantial Equivalence Comparison) that outlines the attributes of the SUAD™ Device against several predicate devices (Herbst, Klearway, Silencer, TAP). This table serves as the primary evidence to "prove" the device meets the acceptance criteria, by showing it shares the same intended use, fundamental design characteristics, and materials.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not applicable. There is no specific "test set" of patients or data mentioned in the context of performance evaluation for this 510(k). The evaluation is based on a comparison of device characteristics and design.
- Data Provenance: Not applicable. The document focuses on declarative statements about device features and a comparison to predicate devices, rather than data collected from a study.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. As no human-in-the-loop performance measurement or diagnostic assessment is described for the device, there is no mention of experts establishing a ground truth for a test set. The designers and manufacturers are the experts cited for the device's characteristics.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There is no test set or human interpretation requiring adjudication.
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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 MRMC study was done. This device is a physical mandibular appliance, not an AI or diagnostic imaging device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm-only performance study was done. This is a physical medical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" implicitly used for the substantial equivalence claim is the established performance and safety profile of the predicate devices. The SUAD™ Device is considered safe and effective because its characteristics are similar to those already proven safe and effective. Risk mitigation strategies (Table 2) are described for potential risks, but these are design features rather than outcomes data from a specific study.
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The sample size for the training set:
- Not applicable. This document does not describe a training set as would be relevant for an AI/algorithm-based device.
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How the ground truth for the training set was established:
- Not applicable. There is no training set for this type of device.
In summary, the K023836 submission for the SUAD™ Device primarily demonstrates acceptance by proving substantial equivalence to predicate devices already on the market, rather than through a new clinical performance study with specific quantitative acceptance criteria or a "test set" in the context of an AI/diagnostic device. The "proof" is in the detailed comparison of design, materials, and intended use, along with a discussion of how the device addresses potential risks through its design modifications.
§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
(a)
Identification. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.(b)
Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”