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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.

Device Description

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.

AI/ML Overview

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.

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K Number

K023559

Device Name

FISHER & PAYKEL HEALTHECARE ORACLE ORAL MASK

Manufacturer

FISHER & PAYKEL HEALTHCARE, LTD.

Date Cleared

2003-06-12

(232 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K003894

Intended Use

The Fisher & Paykel Healthcare Oracle Oral Mask is an accessory to a Noncontinuous ventilator (IPPB) as per 73 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 environments for the treatment of Obstructive Sleep Apnea (OSA). It constitutes the patient to ventilator interface in a noncontinuous ventilator system. The device administers positive airway pressure orally. The Oral Mask is a reusable device for use on the prescription of a suitably qualified physician. The Oral Mask may be reprocessed for multi-patient use.

Device Description

The Oracle Oral Mask is an accessory to a Noncontinuous ventilator (IPPB) according to 21 CFR §868.5905. It constitutes the patient to ventilator interface in a noncontinuous ventilator system.

The Oracle Oral Mask consists of a mouthpiece and flexible breathing tube. The flexible breathing tube is connected to the output breathing tube of the ventilator. The ventilator supplies air at CPAP or Bilevel pressures (typically in the range 3 - 19 cm H2O) which is available at the Oral Mask mouthpiece.

The mouthpiece is positioned in the patient's mouth during CPAP or Bilevel 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 flexible breathing tube provides a transition between the more rigid output tube of the ventilator and the mouthpiece, facilitating freedom of movement while maintaining circuit integrity. An exhaust port adjacent to the mouthpiece provides a means to purge exhaled gases from the breathing circuit.

AI/ML Overview

This document describes a 510(k) submission for the Fisher & Paykel Healthcare Oracle Oral Mask, an accessory to a noncontinuous ventilator. The submission aims to demonstrate substantial equivalence to a predicate device (Fisher & Paykel Healthcare, LTD., Oracle Oral Mask, Model 900HC451. K003894). As such, the "acceptance criteria" are implicitly met by demonstrating this substantial equivalence through non-clinical testing.

Here's a breakdown based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied from Equivalence Claim)	Reported Device Performance (Summary of Non-Clinical Tests)
Safe for patient-to-ventilator interface	Demonstrated effective performance in terms of strength, durability, and biocompatibility.
Effective in delivering positive airway pressure for OSA treatment	Effective performance demonstrated through testing.
Reliable device when used and maintained as specified	Effective performance demonstrated through testing.
Reprocessable to achieve a sterile product for multi-patient use	Testing showed the Oral Mask can be effectively sterilized and this process does not adversely affect function, durability, or safety.
Unobstructed access to the patient's airway	Mouthpiece designed to assure unobstructed access.
Creation of an air-seal around the patient's mouth for sustained positive airway pressure	Mouthpiece designed to create an air-seal.
Retention of mouthpiece in the mouth during sleep (minimal leakage)	SnapFlap™ rests against the patient's cheeks to retain the mouthpiece, with adjustable positions for improved fit.
Means to purge exhaled gases (exhaust port)	Elbow incorporates a pattern of holes for an exhaust port. Labeling states it must be connected to a ventilator with sufficient bias airflow to guarantee minimal re-breathing.
Freedom of movement for the patient (flexible breathing tube)	Flexible breathing tube with elbow and swivel joint rotation, and tubing flexure provides freedom of movement.
Connector to industry-standard breathing tubes	Swivel joint is a press fit to industry standard breathing tube (ISO 5356-1, ASTM F1054: 22mm conical fitting).
Biocompatible materials	Manufactured from materials that meet appropriate requirements of ISO 10993-1.
Functional for up to 12 months of daily use	Designed to function as intended for up to 12 months. (Performance based on design, not explicitly tested for this duration in the summary).
Reprocessable up to 20 times	Designed to be reprocessed up to 20 times. (Performance based on design and reprocessing test, not explicitly for 20 cycles in the summary).

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

The document does not explicitly state a specific "test set" sample size in terms of patient numbers or the number of masks tested for each non-clinical test. The testing mentioned refers to "tests, relevant to the modifications, were performed on the new Oral Mask."

Sample Size: Not specified. It generally refers to samples of the device itself rather than patient data in this context.
Data Provenance: The document does not specify the country of origin of the data. It's a submission from Fisher & Paykel Healthcare Ltd, based in New Zealand. The tests are non-clinical, likely performed in-house or by a third-party lab. The data is retrospective in the sense that the tests were performed to support the 510(k) submission, not as a prospective clinical trial.

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

Not applicable. This is a 510(k) submission for a Class II medical device (accessory to a non-continuous ventilator) demonstrating substantial equivalence based on non-clinical tests (strength, durability, biocompatibility, sterilization effectiveness). It does not involve human users or a "ground truth" derived from expert interpretation of medical images or patient outcomes in the way an AI/ML device would.

4. Adjudication Method for the Test Set

Not applicable. As this involves non-clinical testing of physical and material properties, there would be no adjudication method in the context of expert consensus found in clinical or AI/ML studies. Test results would be objectively measured against predefined specifications.

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. This is not an AI/ML device. It's a physical medical device.

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

No. This is not an AI/ML device.