(107 days)
The Fisher & Paykel Healthcare Oracle Oral Mask is an accessory to a Noncontinuous ventilator (IPPB) as per BZD, 21 CFR §868.5905.
The Oral Mask is indicated for use by adults requiring CPAP or Bilevel ventilator treatment in home, hospital and laboratory for the treatment of Obstructive Sleep Apnea (OSA). The Oral Mask is a ventilator interface in a non-continuous ventilator system. The device administers positive airway pressure orally. The Oral Mask is a reusable device for use under the direct supervision of a suitably qualified physician. The Oral Mask may be reprocessed for multi-patient use.
The Oracle Oral Mask provides a patient to ventilator oral interface in a noncontinuous ventilator system. The mouthpiece is positioned in the patient's mouth during CPAP or Bileyel treatment. Features of the mouthpiece ensure the desired positive airway pressure is delivered to the patient with minimal leakage and that the mouthpiece is retained in the mouth while asleep.
The Oracle Oral Mask is supplied with an accessory kit for optional use, consisting of nasal plugs and a non-rebreathing valve, which may be used to reduce oral dryness as a result of nasal leak.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Fisher & Paykel Healthcare Oracle Oral Mask (K033087):
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (K033087) does not explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it focuses on demonstrating substantial equivalence to a predicate device.
| Acceptance Criteria Category | Acceptance Criteria (as implied/inferred from the document) | Reported Device Performance and Evidence in Study (from the document) |
|---|---|---|
| Intended Use | Must align with the predicate device's intended use. | "Both masks have the same intended use..." (Section 1a(6)). The Oracle Oral Mask is intended for adult patient use by individuals diagnosed with requiring CPAP or Bilevel ventilator treatment, typically for Obstructive Sleep Apnea (OSA), for use in home, hospital, or laboratory settings. |
| Operating Principle | Must align with the predicate device's operating principle. | "Both masks have the same... operating principle..." (Section 1a(6)). The mouthpiece is positioned in the patient’s mouth to deliver positive airway pressure for CPAP or Bilevel treatment, minimizing leakage, and ensuring retention during sleep. |
| Technological Characteristics | Must demonstrate similar technological characteristics to the predicate device, especially in pressure-flow, dead space CO2, and flow impedance. | "The Oracle Oral Mask outlined in this submission is equivalent to the predicate mask with respect to pressure-flow characteristics, dead space CO2, and flow impedance." (Section 1a(6)). Minor modifications (alternative silicone for SnapFlap™, inclusion of accessory kit) are noted but not considered to alter fundamental equivalence. |
| Biocompatibility | Materials must be biocompatible and suitable for intended use. | "The Oral Mask is manufactured from materials that have either been previously cleared for the same intended use, or are compliant with the requirements of ISO 10993-1." (Section 1a(6)). Tests performed demonstrated biocompatibility (Section 1b(1)). |
| Strength and Durability | Must withstand normal use and reprocessing procedures, demonstrating effective performance in terms of strength and durability. | "Tests, relevant to the modifications, were performed on the Oracle Oral Mask to demonstrate substantial equivalence to the predicate device. These demonstrated effective performance in terms of strength, durability..." (Section 1b(1)). The device is reusable and may be reprocessed for multi-patient use. |
| Safety and Effectiveness | Must be as safe and effective as the predicate device when used as intended. | "When used as intended, the Oracle Oral Mask has been shown to be as safe and effective as the predicate device." (Section 1b(3)). This is a general conclusion based on the equivalence demonstrated through various tests and comparisons. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for any clinical or non-clinical tests. It refers generally to "tests pertinent to the modifications" (Section 1b(1)). Similarly, there is no information on data provenance (e.g., country of origin, retrospective/prospective). The studies are non-clinical, focusing on material and design characteristics rather than patient outcomes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not mentioned in the provided document. The studies described are non-clinical and focus on engineering and material properties, not clinical ground truth established by medical experts.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not mentioned. The document describes non-clinical engineering and material tests, not clinical evaluations requiring adjudication of subjective expert opinions.
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
An MRMC study was not done. The submission is for a medical device (oral mask), not an AI-powered diagnostic tool, so this type of study is not relevant or included.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical mask, not an algorithm.
7. The Type of Ground Truth Used
For the non-clinical tests described:
- Engineering specifications/standards: For strength, durability, pressure-flow characteristics, dead space CO2, and flow impedance.
- ISO 10993-1 standards: For biocompatibility.
- Material specifications: For the silicone used in the SnapFlap™.
No "expert consensus," "pathology," or "outcomes data" in the medical sense of establishing ground truth for a diagnostic algorithm is mentioned or required here.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical oral mask, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for this type of device.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).