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The Nasal-Aire II Pediatric interface is an accessory to positive pressure ventilation devices (i.e. CPAP, Bi-Level) for both adult and pediatric patients aged seven and older or weighing more than 40 lbs, in the hospital, clinic or home environments.

The Nasal-Aire II Pediatric is intended for single-patient re-use in the home environment and multiple-patient re-use in the hospital / institutional environment.

The Nasal-Aire II Pediatric has been modified from the Nasal-Aire II to meet the requirements of the pediatric population and adults requiring smaller sizes to achieve the proper fit and comfort. The Nasal-Aire II Pediatric provides therapy through the nose only.

The Nasal-Aire II Pediatric interface is an accessory to positive pressure ventilation devices (i.e. CPAP, Bi-Level) for both adult and pediatric patients aged seven and older or weighing more than 40 lbs, in hospital, clinic, or home environments.

For homecare applications, the Nasal-Aire II Pediatric may be reused multiple times by a single patient. For institutional applications (i.e. sleep lab, other clinical settings), the interface may be reused multiple times by multiple patients.

The Nasal-Aire II Pediatric interface has a soft nasal cannula to form a seal with the nasal openings. The nasal cannula has two nasal inserts and has integrated exhalation ports. The interface also has tubing, connectors to attach the tubing to the nasal cannula, and a swivel coupling that allows the interface to connect to the ventilation device. Headgear is attached to the device to secure the interface on the patient.

There are five nasal cannula sizes available, ranging from A (largest) to E (smallest).

The device is available by prescription only.

This document is a 510(k) summary for the Nasal-Aire II Pediatric device, which is an accessory to positive pressure ventilation devices. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study of the device's performance against specific acceptance criteria.

Therefore, many of the requested items related to acceptance criteria and specific study details (like sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not present in the provided text for the Nasal-Aire II Pediatric device.

The document states that "functional testing relative to the intended use of the Nasal-Aire II Pediatric show that it is as safe and effective as the predicate devices." However, it does not detail what specific functional tests were performed, what the acceptance criteria for those tests were, or what the reported performance was.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Cannot provide. The document does not specify quantitative acceptance criteria or report specific performance metrics for the Nasal-Aire II Pediatric. It broadly claims "functional testing" shows it is "as safe and effective as the predicate devices," but no details are given.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Cannot provide. No information about a specific test set, its sample size, or data provenance is mentioned.

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)

• Cannot provide. No ground truth establishment for a test set is discussed.

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

• Cannot provide. No information on adjudication methods is present.

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

• Cannot provide. This is a medical device (nasal cannula), not an AI/imaging device that would typically involve human readers or MRMC studies.

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

• Cannot provide. This device is a passive accessory and does not involve an algorithm.

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

• Cannot provide. No ground truth is discussed beyond the general assertion that functional testing supports safety and effectiveness.

8. The sample size for the training set

• Cannot provide. No training set is mentioned as this is not an AI/machine learning device.

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

• Cannot provide. No training set or ground truth establishment for a training set is mentioned.

Summary of available information related to equivalence:

• Device Trade Name: Nasal-Aire II Pediatric
• Common/Usual Name: Accessory to Non-Continuous Ventilator
• Predicate Devices:
  • K060105: Kidsta Mask System (ResMed)
  • K022465: Nasal-Aire II (Innomed Technologies Inc. - likely the original version from which this pediatric version was modified)
  • K002001: Breeze Sleepgear with Nasal Pillows (Puritan Bennett Corp.)
  • K072993: Reusable Headrest® with Nasal Seal (AEIOMed, Inc.)
  • Unknown K number: Infant Nasal CPAP Set (Hudson RCI)
• Conclusion on Equivalence (from the submission): The Nasal-Aire II Pediatric device is substantially equivalent to the predicate devices in intended use, environment of use, patient population, and frequency of use. Its basic method of operation and design are also substantially equivalent to the predicates. Materials information and functional testing relative to the intended use of the Nasal-Aire II Pediatric show that it is as safe and effective as the predicate devices.
• Intended Use (as stated by FDA in the letter): The Nasal-Aire II Pediatric interface is an accessory to positive pressure ventilation devices (i.e. CPAP, Bi-Level) for both adult and pediatric patients aged seven and older or weighing more than 40 lbs, in the hospital, clinic or home environments. Intended for single-patient re-use in the home environment and multiple-patient re-use in the hospital / institutional environment.

This 510(k) summary focuses on demonstrating that the new pediatric version of the Nasal-Aire II maintains the same safety and effectiveness as already cleared predicate devices through design similarity and general functional testing, rather than presenting a performance study against specific, novel acceptance criteria.

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Nasal-Aire is intended for use as an accessory to respiratory ventilators. Ventilation is indicated for patients who require mechanical assistance with breathing.

Nasal Aire is an accessory to positive pressure ventilation devices (e.g. CPAP, Bi-level). It may also be used in respiratory insufficiencies if the patient can tolerate the excess dead space.

The Nasal-Aire cannot exhaust exhaled air therefore this device must be used with a ventilator that contains an active exhalation valve or with an intentional leak port added into the breathing circuit

Nasal-Aire is a nasal insert with attached tubing for connection with non-continuous ventilation devices. The simplicity of the Nasal-Aire design allows easy manipulation of the device. Soft, pliable silicone is used for the nasal insert portion of the device facilitates a comfortable fit of the device when in use.

The Nasal-Aire accessory and associated tubing is intended for use in delivering ventilation to patients. The device consists of a hollow silicone elastomer under nose strip with molded nasal insert sleeves made from silicone elastomer. The under nose strip is fitted bilaterally with 3/8" Tygon® tubing which serves as conduits for ventilation. The tubing is joined to form a single ventilation conduit by a silicone elastomer "Y" coupling. The system is completed by the "Y" coupling connected to an adapter for connection to the main ventilators supply line. When the device is worn by the patient the under nose strip is positioned across the patient's upper lip and the silicone nasal inserts are inserted in the patient's nares. The tubing drapes over the patient's ears in the manner of standard nasal cannulae used for administering oxygen with the "Y" coupling positioned in front of the patient.

This document describes the Nasal-Aire™ ventilator accessory and its clearance through the 510(k) process, which relies on demonstrating substantial equivalence to a predicate device. It does not contain an acceptance criteria table with reported device performance in the way one would typically see for an AI/ML device or a device requiring specific performance metrics against a defined standard.

Instead, the performance evaluation for this medical device focuses on safety and functionality sufficient to demonstrate equivalence for its intended use as a ventilator accessory.

Here's an attempt to extract and infer the requested information based on the provided text, acknowledging that many fields will be "Not Applicable" or "Not Provided" given the nature of a 1999 510(k) summary for a ventilator accessory.

Acceptance Criteria and Study for Nasal-Aire™ Ventilator Accessory

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The text states "A limited clinical study was conducted using the device to assess unintended leakage of respiratory gases during clinical use. In vivo tests with healthy subjects..." The exact number of healthy subjects is not specified.
• Data Provenance: The study was "in vivo" (on living subjects). The location or country of origin is not specified, but it's likely in the USA given the FDA application. The study appears to be prospective as it involved testing the device on subjects.

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

• Not Applicable. This type of device evaluation (for a physical medical accessory) does not typically involve expert consensus for "ground truth" in the same way an AI/ML diagnostic device would. Performance was directly measured (e.g., leakage).

4. Adjudication Method for the Test Set:

• Not Applicable. As there's no "ground truth" established by experts or human readers to adjudicate, this concept does not apply to this device's testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:

• No. An MRMC study is relevant for diagnostic or interpretive devices involving human readers. This is a ventilator accessory, and its effectiveness was evaluated based on physical performance parameters like leakage and biocompatibility.

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 or software.

7. The type of ground truth used:

• For the leakage study, the "ground truth" was the direct measurement of unintended leakage during ventilation.
• For biocompatibility, the "ground truth" was compliance with established material safety standards (FDA Blue Book Memorandum G95-1 and ANSI/AAMI/ISO Standard 10993 (Part 1)).

8. The sample size for the training set:

• Not Applicable. This device does not use machine learning or AI, so there is no training set.

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

• Not Applicable. This device does not use machine learning or AI, so there is no training set or ground truth for it.

Summary Context:

This 510(k) summary (from 1999) describes a physical medical device. The "acceptance criteria" are implicitly met by demonstrating that the device functions as intended (minimal leakage, comfortable fit), uses safe and compatible materials, and is substantially equivalent to a legally marketed predicate device (The Monarch® Mini Mask). The studies mentioned are primarily focused on physical performance and material safety, not on diagnostic accuracy or AI performance.

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