(80 days)
The Respire Pink Series intraoral appliances are intended to treat snoring and mild to moderate Obstructive Sleep Apnea (OSA) in adult patients 18 years of age or older.
Optionally, the DentiTrac® micro-recorder may be incorporated into a Respire Pink Series device. The micro-recorder is intended to measure patient compliance to oral appliance therapy in combination with the DentiTrac® system.
The Respire Pink Series with DentiTrac® refers to two devices: Respire Pink Series-Herbst and the Respire Pink Series-Herbst-EF, herein referred to collectively as Respire Pink Series. These devices function as mandibular advancement splints which hold the jaw in a forward position. The forward jaw placement moves the tongue and pharyngeal tissue into a position to help maintain an open airway, which allows the passage of more air per breath and helps in the treatment of snoring and mild to moderate Obstructive Sleep Apnea (OSA). Respire Pink Series appliances are customizable devices which are produced according to the individual patient anatomy and prescription.
The Respire Pink Series-Herbst consists of full hard acrylic upper and lower fitting surfaces, and the Respire Pink Series-Herbst-EF consists of hard acrylic fitting side plates and chrome (BEGO Wironit®) upper palatal and lower lingual plates. The Herbst hardware on the side of the device allows for forward and lateral jaw movement while restricting backward jaw movement, and allows the patient to open and close the mouth. The Herbst hardware contains an expansion screw for mandibular position adjustment, and is attached to the appliance using medical grade stainless steel fixing elements and screws.
This submission is to provide clinicians the option to incorporate a Braebon DentiTrac® micro-recorder into a Respire Pink Series device. The micro-recorder is encapsulated in Loctite epoxy and fully encased into the device acrylic, and is not patient contacting. The micro-recorder is utilized to track patient compliance to prescribed oral appliance therapy by collecting data for wear-time through oral temperature, movement tracking, and head position. The data can be uploaded to a cloud-based web application using the DeniTrac® system which allows clinicians to review the patient data. The inclusion of the microrecorder provides additional treatment information to clinicians without effecting the operating principles of the Respire Pink Series devices.
The provided document is a 510(k) summary for the Respire Pink Series with DentiTrac®, a medical device intended to treat snoring and mild to moderate Obstructive Sleep Apnea (OSA). The document describes the device, its intended use, comparison to predicate devices, and performance testing. However, it does not contain detailed acceptance criteria and a study proving the device meets those criteria in the typical format of a diagnostic performance study.
Instead, the document details a substantial equivalence determination, which is a different type of regulatory submission. In this context, "acceptance criteria" are related to demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than meeting specific quantifiable performance metrics against a defined ground truth in a clinical study.
Here's an analysis based on the information provided, highlighting what is and is not present:
Key Findings from the Document:
- Device Type: Intraoral appliance for snoring and OSA, with an optional micro-recorder for compliance tracking.
- Regulatory Pathway: 510(k) Premarket Notification, seeking substantial equivalence to predicate devices.
- Predicates:
- Key Difference of the New Device: The addition of the DentiTrac® micro-recorder to the Respire Pink Series (which previously existed without it).
- Performance Testing Focus: Non-clinical. The document explicitly states: "The addition of the DentiTrac® micro-recorder does not adversely affect the original design, therefore, not introducing any new issues of concern. A risk assessment shows that risks are mitigated to acceptable levels, and performance testing related to the DentiTrac® micro-recorder confirms that EMC and electrical safety, biocompatibility, and software elements were evaluated."
Addressing Your Specific Questions:
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A table of acceptance criteria and the reported device performance:
No explicit table of quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity for OSA efficacy) is provided. The "performance" described is largely non-clinical, focusing on safety, electrical compatibility, biocompatibility, and software aspects, evaluated against standards or risk assessments. The goal of a 510(k) is to show substantial equivalence, not to re-prove clinical efficacy against new, explicit performance targets if the predicate device's efficacy is already established.
The "performance" aspect for the DentiTrac® micro-recorder relates to its ability to accurately measure compliance. The document states: "DentiTrac® performance testing is located in the Braebon DentiTrac® Master File MAF 2557. Process validation concerning the incorporation and functionality of the DentiTrac® micro-recorder is certified by Braebon." This implies performance testing for the micro-recorder itself occurred, but the details (acceptance criteria, results) are not in this document.
Acceptance Criterion (Implicit/General for 510(k)) Reported Device Performance (from document) Safety & Efficacy (Overall) Device is substantially equivalent to predicate devices (SomnoDent® with Micro-Recorder and Respire Pink Series-Herbst/Herbst-EF). The addition of the DentiTrac® micro-recorder does not adversely affect the original design or introduce new issues of concern. The new device utilizes the same materials, manufacturing procedures, principles of operation, and overall design as existing Respire Pink Series devices, with the DentiTrac® micro-recorder being identical to that used in the SomnoDent® predicate. Risk Mitigation A risk assessment showed that risks are mitigated to acceptable levels. EMC and Electrical Safety Evaluated (related to DentiTrac® micro-recorder). Specific data not in this document, but implied to meet standards. Biocompatibility Evaluated (related to DentiTrac® micro-recorder). Specific data not in this document, but implied to meet standards based on substantial equivalence claim and previous assessments of the Respire Pink Series. Software Elements Evaluated (related to DentiTrac® micro-recorder). Specific data not in this document. Micro-Recorder Functionality "Process validation concerning the incorporation and functionality of the DentiTrac® micro-recorder is certified by Braebon." Intended to measure patient compliance to oral appliance therapy by collecting data for wear-time through oral temperature, movement tracking, and head position. (Details of validation in Braebon DentiTrac® Master File MAF 2557, not in this document). Respire Medical performs 100% visual and functional inspections. Mechanical Integrity/Manufacturing Respire Medical performs 100% visual and functional inspections throughout the production process to ensure that the device meets manufacturing specifications for the Respire Pink Series device and specifications for the incorporation of the DentiTrac® micro-recorder. The device allows for forward and lateral jaw movement while restricting backward jaw movement, and allows the patient to open and close the mouth. The Herbst hardware contains an expansion screw for mandibular position adjustment. (These are design features, not "performance" in the sense of a clinical outcome metric). -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable/Not provided in this document. This document focuses on substantial equivalence based on technical and non-clinical testing, particularly regarding the addition of the DentiTrac® micro-recorder. It does not describe a clinical performance study with a distinct "test set" of patients or data in the way a diagnostic AI device would. The performance testing for the DentiTrac® micro-recorder itself (which is embedded) is referenced to a Master File (MAF 2557), so details about its own test set would be there, but are not in this 510(k) summary.
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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 there is no clinical "test set" in this document for evaluating the device's diagnostic or clinical efficacy, there's no mention of experts establishing a ground truth.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No clinical "test set" or adjudication method is described.
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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:
Not applicable. This device is an intraoral appliance, not an AI-powered diagnostic tool that assists human readers. Therefore, an MRMC study is irrelevant to this submission.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a physical medical device (intraoral appliance), not an algorithm. The DentiTrac® micro-recorder tracks compliance data, which is then uploaded to a web application for clinicians to review. It is a data collection tool, not a standalone diagnostic algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable for clinical efficacy in this document. The "ground truth" for the non-clinical testing would be engineering specifications, material standards, electrical safety standards, and risk assessment thresholds. For instance, the "ground truth" for biocompatibility is successful adherence to ISO 10993 standards. For micro-recorder functionality, it would be the accuracy and reliability of its compliance tracking features (details in MAF 2557).
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The sample size for the training set:
Not applicable. This is a physical medical device, not a machine learning algorithm that requires a "training set."
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How the ground truth for the training set was established:
Not applicable. As above, no training set for an algorithm is involved.
Conclusion based on the provided text:
The document describes a 510(k) submission for a physical medical device (intraoral appliance) that has incorporated a compliance tracking micro-recorder (DentiTrac®). The "acceptance criteria" and "studies" are framed within the context of demonstrating substantial equivalence to existing predicate devices, focusing on non-clinical aspects like materials, manufacturing, design, principles of operation, electrical safety, biocompatibility, and software evaluation of the embedded micro-recorder. This is distinct from a clinical performance study with quantitative diagnostic metrics and explicit acceptance criteria against a defined ground truth, which is typically seen for new diagnostic or AI-driven medical devices. The document references a Master File (MAF 2557) for detailed performance testing of the DentiTrac® micro-recorder, suggesting that more specific performance data for that component exists elsewhere.
§ 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.”