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The Respire Clear is indicated to treat mild to moderate Obstructive Sleep Apnea (OSA) in patients, 18 years of age or older.

The Respire Clear is an oral appliance used in the treatment of mild to moderate obstructive sleep apnea. This device helps move a patient's jaw forward, thus opening their airways, and allowing them to breathe more easily throughout the night. The Respire Clear is made out of dental industry standard 3D printed resins & metals, and is custom designed to fit each patients' unique oral anatomy.

The provided document is a 510(k) Premarket Notification for the Respire Clear device, an intraoral device for mild to moderate obstructive sleep apnea. It describes the device, its intended use, and comparative information with predicate devices, but it does not contain details about acceptance criteria, device performance results against specific criteria, or a comprehensive study report as requested in the prompt.

The document states:

• "bench testing was conducted on the device in order to ensure that it safely & effectively performs as intended. This testing included mechanical safety & performance validation, biocompatibility tests, and shipping validation tests. The results indicated that the Respire Clear performs as well as the predicate device." (page 8, section b(1)).
• "The mechanical safety, performance validation, and biocompatibility tests criteria were all evaluated thoroughly, and passed successfully." (page 9, section b(3)).
• Clinical testing was "not required" per FDA guidance because the device does not use dissimilar designs, new technology, or changes in indication for use compared to previously cleared devices (page 8, section b(2)).

Therefore, I cannot create the requested table of acceptance criteria and reported device performance, nor can I provide information about the specifics of the study (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, or training set details) because these details are not present in the provided text.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on design, materials, and intended use, rather than presenting a detailed performance study against explicit acceptance criteria.

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Our devices are indicated to treat mild to moderate Obstructive Sleep Apnea (OSA) in patients, 18 years of age or older.

The Respire Pink AT (Hard, Hard/Soft, EF) is an oral appliance used in the treatment of mild to moderate obstructive sleep apnea. This device helps move a patient's jaw forward, thus opening their airways, and allowing them to breathe more easily throughout the night. The Respire Pink AT (Hard, Hard/Soft, EF) is made out of dental industry standard acrylic resins & metals, and is custom designed to comfortably fit each patients' unique oral anatomy.

The provided FDA 510(k) summary for the “Respire Pink AT (Hard, Hard/Soft, EF)” device focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study report for the device's performance against specific clinical or technical metrics for disease treatment. This summary primarily relies on bench testing and a comparison to its predicate device to show safety and effectiveness.

Therefore, many of the requested details, such as specific acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert qualifications for ground truth, adjudication methods, or results from MRMC or standalone studies, are not available in the provided text. The device is an oral appliance for treating Obstructive Sleep Apnea (OSA), not a diagnostic tool where "acceptance criteria and reported device performance" as typically understood in AI/imaging devices would apply.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria for device performance in treating OSA (e.g., AHI reduction, oxygen saturation). Instead, it relies on demonstrating substantial equivalence to a predicate device and successful completion of non-clinical tests.

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

• Sample size for test set: Not applicable/not provided. The "testing" mentioned is non-clinical bench testing.
• Data provenance: Not applicable. The testing is laboratory-based, not patient data.

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

• Not applicable/not provided. Ground truth in the context of diagnostic performance (e.g., expert consensus on images) is not relevant to this type of device and testing. The "ground truth" for the non-clinical tests would be the established engineering and safety standards.

4. Adjudication method for the test set:

• Not applicable/not provided. Adjudication typically applies to multi-reader studies for diagnostic devices.

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 not an AI-assisted diagnostic device, and no MRMC study was performed.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• For the non-clinical tests (mechanical, biocompatibility, shipping validation), the "ground truth" implicitly refers to established engineering standards, material safety specifications (e.g., ISO 10993), and regulatory requirements for medical devices. The device was assessed against these benchmarks.

8. The sample size for the training set:

• Not applicable. This is not an AI device that uses a training set of data.

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

• Not applicable.

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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:
  • Primary: SomnoDent® with Micro-Recorder (K150369)
  • Reference: Respire Pink Series-Herbst (K131138), Respire Pink Series-Herbst-EF (K150572)
• 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:

1. 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).

2. 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.

3. 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.

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

   Not applicable. No clinical "test set" or adjudication method is described.

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 device is an intraoral appliance, not an AI-powered diagnostic tool that assists human readers. Therefore, an MRMC study is irrelevant to this submission.

6. 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.

7. 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).

8. 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."

9. 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.

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The Respire Blue Scries - EF is indicated to treat mild to moderate OSA (Obstructive Sleep Apnea)

The Respire Blue Series – EF (Endurance Frameworks) – is available with a hard device fitting surface. The hard surface consists of Acrylic (side plates / trays) and chrome - Wironit material (upper / Palatal and lower / Lingual plates / trays). Refer to Figure 1 Representative Drawing. The device is retained with ball and clasps which are used to hold elastic bands which guide the jaw to the desired position. In addition there are expansion screws inside the Acrylic side plates / trays that allows for device expansion based on patient needs.

The upper and lower components are connected by an adjustable hinge, thus the patient can open and close the mouth while wearing the appliances

The provided text describes the Respire Blue Series - EF intraoral device, indicated for treating mild to moderate Obstructive Sleep Apnea (OSA). The 510(k) submission (K152292) is for a modification to a previously cleared device (K111207), specifically the material used for the top and bottom plates/trays.

Based on the provided text, the acceptance criteria and study information can be summarized as follows:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: For the Material Integrity testing, five (5) sample devices were used.
• Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective. It is assumed to be part of the manufacturer's internal testing as described in the 510(k) submission.

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

• The document does not mention the use of experts to establish ground truth for the non-clinical tests described. The tests appear to be laboratory-based material science tests.

4. Adjudication Method for the Test Set

• This information is not applicable as the described tests are laboratory-based material science tests, not clinical studies involving interpretation by multiple experts.

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 MRMC comparative effectiveness study was done. This device is a physical intraoral device, not an AI-assisted diagnostic tool.

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

• No standalone algorithm performance study was done. This device is a physical intraoral device.

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

• For biocompatibility and cytotoxicity, the "ground truth" is defined by the ISO 10993 standards and the specific reactivity thresholds of the MEM Elution test.
• For material integrity, the "ground truth" is established by the mechanical properties (elongation, load-bearing force) of the material compared to a benchmark (the predicate device and the force exerted by a human bite).

8. The sample size for the training set

• A "training set" is not applicable for the type of non-clinical tests described for this physical device. These are material characterization and performance validation tests, not machine learning model training.

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

• This information is not applicable as there is no training set for a machine learning model.

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The Respire Pink Series - Herbst - EF is indicated to treat mild to moderate OSA.

The Respire Pink Series - Herbst - EF (Endurance Frameworks) - is available with a hard device fitting surface. The hard surface consists of Acrylic (side plates) and chrome - Wironit material ( upper / Palatal and lower / Lingual plates). Refer to Figure 1 Representative Drawing. The device is retained with ball and clasps which allows the device to be tightened if it becomes loose. The device is a mandibular advancement splint that holds the jaw in a forward position to help keep the tongue and supporting tissues in a position to help maintain an open airway, which helps in the treatment of snoring and mild to moderate obstructive sleep apnea. The Herbst hardware on the side of the device allows the patient to move forward and left and right, but not backwards. These movements give the patient some freedom to move which is important for their comfort and overall success of the device. The upper and lower components are connected by an adjustable hinge, thus patient can open and close while wearing the appliances.

{
  "acceptance_criteria_and_study": {
    "acceptance_criteria_table": [
      {
        "criterion": "Biocompatibility and cytotoxicity",
        "reported_performance": "Demonstrated via biocompatibility and cytotoxicity testing for Wironit material."
      },
      {
        "criterion": "Material integrity (specimen elongation and load bearing force to break)",
        "reported_performance": "Points of failure were identified at the same location for both Wironit/Acrylic and Acrylic-only (predicate) devices. The amount of energy to cause failure was less for Wironit/Acrylic but still far exceeded the amount of energy required by an oral cavity to create such a failure (average of 275.6 lbf)."
      }
    ],
    "sample_size_test_set": "Five (5) sample devices for material integrity testing.",
    "data_provenance": "Not specified (implied in-house testing by the submitter or a contracted lab).",
    "number_of_experts_ground_truth": "Not applicable, as the evaluation involves material testing rather than expert-derived ground truth for clinical outcomes.",
    "qualifications_experts": "Not applicable.",
    "adjudication_method": "Not applicable.",
    "mrmc_comparative_effectiveness_study": false,
    "standalone_performance_study": true,
    "type_of_ground_truth": "Laboratory testing data (biocompatibility, cytotoxicity, material integrity).",
    "sample_size_training_set": "Not applicable, as this is a device modification evaluation with laboratory testing, not an AI/algorithm study requiring a training set.",
    "ground_truth_training_set_establishment": "Not applicable."
  }
}

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The Respire Pink Series - Herbst is indicated to treat mild to moderate OSA.

Respire Pink Series - Herbst is a customized device for each patient which consists of two dental plates, upper and lower, made of Acrylic.

The Respire Pink Series – Herbst is a mandibular advancement splint that holds the jaw in a forward position to help keep the tongue and supporting tissues in a position to help maintain an open airway, which in turn helps in the treatment of snoring and mild to moderate obstructive sleep apnea.

The Herbst hardware on the side of the devices allow the patient to move forward and left and right, but not backwards. These movements give the patient some freedom to move which is important for their comfort and overall success of the device.

The upper and lower components are connected by an adjustable hinge, thus patient can open and close while wearing the appliances.

Respire Pink Series - Herbst are offered in two options: {1) Hard/Soft which has a dual laminate layer that provides a soft layer on the tooth surface (2) Hard devices which are all acrylic and retained with ball clasps, this allows the device to be tightened if it it becomes loose.

The provided document is a 510(k) summary for the Respire Pink Series-Herbst device. It assesses the device's substantial equivalence to predicate devices, rather than presenting a standalone study with specific acceptance criteria and performance metrics for the novel device.

The summary states that the Respire Pink Series - Herbst is considered substantially equivalent to the Respire Blue Series (K111207) and SUAD (K023836) in terms of intended use, indication for use, technological characteristics, performance, and user interface.

Therefore, the information you've requested regarding acceptance criteria, a specific study proving it meets those criteria, sample sizes, expert qualifications, etc., is not explicitly available in this document for the Respire Pink Series-Herbst device itself, as the submission focuses on demonstrating equivalence to previously cleared devices.

However, based on the information provided, here's what can be extracted and inferred regarding the basis for the substantial equivalence claim, which implicitly serves as the "study" proving the device meets the criteria by comparing it to established devices:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission, the "acceptance criteria" are not quantitative performance targets for the new device but rather a demonstration that its characteristics are similar enough to predicate devices to not raise new questions of safety or effectiveness. The "reported device performance" is a comparative assessment.

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

The document does not specify a distinct "test set" sample size for the Respire Pink Series - Herbst in the context of an independent clinical trial to establish its performance. Rather, it refers to:

• Bench testing: Performed to demonstrate equivalence to predicate devices. No sample sizes are given for this testing.
• Clinical evaluation and observation: Results mentioned generally for "reduction of snoring and reduction of apneic events measured by polysomnograms." This implies existing clinical data or clinical observations related to the type of device or predicate devices, rather than a specific prospective study with a defined sample size for the Respire Pink Series - Herbst.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The clinical evaluation mentioned seems to be a summary of existing knowledge or observations, not a new clinical trial for this specific device.

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

This information is not provided in the document. As the submission relies on demonstrating substantial equivalence, it does not detail a process for establishing ground truth for a novel "test set" in the way a de novo device would. The clinical evaluation mentioned is referenced generally, without detailing expert involvement or qualifications.

4. Adjudication Method

This information is not provided. The document does not describe the methodology of any specific clinical study that would require an adjudication method.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study is not mentioned or implied. The document focuses on demonstrating substantial equivalence through component and functional similarity, as well as general performance statements (bench testing and clinical evaluation), not a human reader improvement study.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

This device is a physical intraoral device, not an algorithm or software. Therefore, the concept of a "standalone" algorithmic performance study does not apply.

7. Type of Ground Truth Used

For the clinical evaluation and observation mentioned:

• The "ground truth" for effectiveness appears to be based on polysomnograms measuring apneic events and observed reduction of snoring. This is a standard objective and subjective measurement for sleep apnea devices.
• For the equivalence claim, the ground truth is essentially the established safety and effectiveness of the predicate devices (Respire Blue Series and SUAD) as cleared by the FDA.

8. Sample Size for the Training Set

This device is not an AI/ML algorithm that requires a training set. This information does not apply.

9. How the Ground Truth for the Training Set Was Established

This device is not an AI/ML algorithm that requires a training set. This information does not apply.

In summary: The provided document is a 510(k) summary demonstrating substantial equivalence. It does not contain the details of a specific clinical trial with defined acceptance criteria, sample sizes, expert involvement, or adjudication methods for the novel device, as it leverages the clearance of predicate devices to establish its safety and effectiveness. The "study" here is the comparative analysis against the predicate devices, supported by bench testing and general clinical evaluation, confirming that no new safety or effectiveness concerns are raised.

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The Respire Blue Series is indicated to treat mild to moderate OSA. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea (OSA).

Respire Blue Series is a patented, custom made device for each patient which consists of two dental plates, upper and lower, made of Acrylic. The attachment is at a 65 degree angle to enable movement of the appliances, thus patient can open and close while wearing the appliances. The appliance is open in the front to add comfort by allowing the patient to inhale and exhale more air per breath. Respire Blue Series are offered in two options: (1) Hard/Soft which has a dual laminate layer that provides a soft layer on the tooth surface (2) Hard devices which are all acrylic and retained with ball clasps, this allows the device to be tightened if it becomes loose.

The provided document is a 510(k) premarket notification for the Respire Blue Series device, an intraoral device for snoring and obstructive sleep apnea (OSA). The document focuses on demonstrating substantial equivalence to already marketed predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with detailed performance metrics.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, and standalone performance studies is not explicitly available in the provided text in the typical format of a clinical trial or performance study report.

Instead, the submission relies on demonstrating substantial equivalence to predicate devices. This means that if the predicate devices were accepted based on certain performance, and the new device is sufficiently similar and raises no new safety or effectiveness concerns, it can also be accepted.

Here's a breakdown of what can be extracted and what is not available based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Strict acceptance criteria and their corresponding reported device performance metrics (e.g., sensitivity, specificity, accuracy, AHI reduction percentage) are not defined or explicitly presented in the document for the Respire Blue Series itself.

Instead, the acceptance for market clearance is based on demonstrating substantial equivalence to predicate devices in terms of:

The document states: "Bench testing results have demonstrated that all test method acceptance criteria were met and demonstrated equivalent results to the predicated devices." This implies that physical and mechanical properties were tested against benchmarks established by the predicate devices, but the specific numerical acceptance criteria and results are not provided.

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

Not explicitly provided. The document refers to "Clinical evaluation and observation results" demonstrating the success rate, but it does not specify the sample size, data provenance (e.g., country of origin), or whether the data was retrospective or prospective for the Respire Blue Series. This information would typically be detailed in a separate clinical study report, which is not part of this 510(k) summary. Given the emphasis on substantial equivalence, a full-scale clinical trial might not have been required if adequate existing data supported the predicate devices and the new device's similarity.

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

Not applicable/not provided. Since a specific "test set" with ground truth established by experts is not detailed for the Respire Blue Series itself in this document, this information is not available. The "clinical evaluation and observation results" mentioned are not described in enough detail to ascertain how ground truth was established by experts.

4. Adjudication Method for the Test Set

Not applicable/not provided. As there is no detailed description of a test set and associated ground truth establishment, there is no mention of an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on the device's functional equivalence and safety, not on human reader performance with or without AI assistance. This device is a physical intraoral appliance, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The Respire Blue Series is a physical medical device (an intraoral appliance), not an algorithm or AI system. Therefore, a "standalone algorithm performance" study is not relevant.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the Respire Blue Series itself, the document states "clinical evaluation and observation results have demonstrated the success rate of reduction of snoring and the success rate of reduction of apneic events measured by polysomnograms."

Therefore, for the "clinical evaluation" mentioned, the ground truth for "reduction of apneic events" would have been established by polysomnography (PSG), which is the gold standard for diagnosing sleep apnea.

8. The Sample Size for the Training Set

Not applicable/not provided. As this is a physical medical device and not an AI/ML algorithm requiring a "training set," this information is not relevant or provided.

9. How the Ground Truth for the Training Set Was Established

Not applicable/not provided. This question pertains to AI/ML models, which is not the nature of the Respire Blue Series device.

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