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The Zest™ Nasal Mask is intended for single patient adult use by individuals who have been diagnosed by a physician as requiring CPAP or Bi-level ventilator treatment in the home, hospital or other clinical setting.

The Zest™ Nasal Mask is a respiratory mask which is non invasive, the Silicone Seal is positioned over the nose, and it seals on the area around the nose, and the upper lip. The mask is held on the face with headgear straps. It connects to a single breathing tube via a swivel adaptor, to receive pressurized gases. On the mask base are exhalation vents (bias holes) that allow exhaled gases to be continually flushed and removed to room air. The silicone seal is contoured for comfort and to reduce leakage.

The provided text describes a 510(k) premarket notification for the Zest™ Nasal Mask. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a de novo clinical trial with explicit acceptance criteria and a detailed study design. Therefore, much of the requested information regarding acceptance criteria, sample sizes for training/test sets, ground truth establishment, expert adjudication, and MRMC studies is not applicable to this type of regulatory submission and is not present in the provided document.

The document primarily relies on non-clinical comparative testing to establish substantial equivalence.

Here's a breakdown of the information that can be extracted or inferred from the provided text, along with explanations for the missing information:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: The document does not explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., leakage rate, pressure drop limits). Instead, the acceptance criterion for regulatory approval is "substantial equivalence" to the predicate device. This is demonstrated through comparative testing rather than meeting pre-defined numerical thresholds for new performance.
• Reported Device Performance: The document states that "Testing of the Zest™ Nasal Mask was compared to the predicate Fisher & Paykel Healthcare Opus HC482 Direct Nasal Mask for performance... These tests demonstrate substantial equivalence of the Zest™ Nasal Mask to the predicate mask." The specifics of the performance results are summarized as demonstrating equivalence, but no raw data or numerical outcomes are provided in this summary.

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

• Sample Size for Test Set: Not applicable/Not provided. The "test set" in this context refers to non-clinical comparative testing (e.g., bench tests, materials testing), not a clinical study involving human subjects or a large dataset in the way AI/ML models are evaluated. The document references "test reports included in Appendix B," but the details of these tests (e.g., number of masks tested, number of cycles) are not in the provided summary.
• Data Provenance: Not applicable/Not provided. As it's non-clinical testing, there's no data provenance in terms of country of origin for patient data. The testing would have been conducted by the manufacturer or a contracted lab. It's retrospective in the sense that the test results are reviewed after completion.

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

• Number of Experts: Not applicable. For non-clinical validation of medical devices like a nasal mask, "ground truth" is typically established by engineering specifications, international standards, or physical measurements, not expert clinician consensus on a dataset.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no human interpretation or adjudication of test results in the way it's done for diagnostic AI algorithms. Test results are compared against engineering/performance specifications or directly against the predicate device's performance.

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

• MRMC Study: No. This type of study is not relevant for the regulatory clearance of a physical medical device like a nasal mask. MRMC studies are typically used for evaluating the performance of diagnostic imaging devices or AI algorithms where human readers interpret cases.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study: No. The device is a physical nasal mask, not an algorithm. Therefore, "standalone algorithm performance" is not applicable.

7. Type of Ground Truth Used

• Type of Ground Truth: For the performance testing, the "ground truth" would be established by:
  • Engineering Specifications: Adherence to design specifications and relevant industry standards (e.g., for airflow, pressure integrity, dead space).
  • Predicate Device Performance: Direct comparison of the Zest™ Nasal Mask's measured performance characteristics against those of the K063036 Fisher & Paykel Healthcare Opus HC482 Direct Nasal Mask.
  • Biocompatibility Standards: Compliance with recognized standards for material safety, likely demonstrated by reference to the K061236 Fisher & Paykel Healthcare Flexifit HC432 Full Face Mask, which was also found to be substantially equivalent for biocompatibility.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set. The design of the mask is based on engineering principles and potentially anthropometric data, not machine learning from a "training set."

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this device.

Summary of the Study:

The study proving the device meets its "acceptance criteria" (i.e., substantial equivalence) was a series of non-clinical comparative tests.

• Purpose: To demonstrate that the Zest™ Nasal Mask is substantially equivalent in terms of safety and effectiveness to its predicate devices.
• Comparison for Performance: The Fisher & Paykel Healthcare Opus HC482 Direct Nasal Mask (K063036).
• Comparison for Biocompatibility: The Fisher & Paykel Healthcare Flexifit HC432 Full Face Mask (K061236).
• Methodology: The document states "Testing... was compared to the predicate... for performance and... for biocompatibility." This implies bench testing and material analyses were conducted, and the results were evaluated against the predicate's known characteristics. The specifics are in "Appendix B" which is not provided.
• Conclusion: The manufacturer concluded, and the FDA agreed, that "The comparison of features, performance, and intended use demonstrate that the Zest™ Nasal Mask is substantially equivalent to the predicate Fisher & Paykel Healthcare Opus HC482 Direct Nasal Mask for performance and the HC432 Full Face Mask for biocompatibility."

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