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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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