(115 days)
The intended use of the Apieron INSIGHT™ eNO System is to quantitatively measure exhaled nitric oxide (eNO) in expired human breath as a marker of inflammation in persons with asthma. Measurement of eNO in expired human breath by the Apieron INSIGHT eNO System is a non-invasive, simple and safe method to measure a decrease in eNO in asthma patients that often occurs after treatment with anti-inflammatory pharmacological therapy as an indication of the therapeutic effects in patients with elevated eNO levels. The Apieron INSIGHT eNO System is suitable for use in children ages 8 to 17 years of age, and in adults 18 years of age and older. eNO measurements, as an adjunct to established clinical assessments, provide the physician an objective marker to evaluate the patient's response to anti-inflammatory therapy. The Apieron INSIGHT eNO System can be used by trained operators in a physician's office laboratory setting. The Apieron INSIGHT eNO System should not be used in critical care, emergency care or in anesthesiology.
The Apieron INSIGHT™ eNO System consists of a Monitor, a single-use disposable Sensor Cartridge and other disposable test supplies. The Monitor contains the measurement and breath sampling hardware and provides a user-friendly interface to guide the operator through the test sequence and guide the patient through the breath sampling maneuver. The disposable Sensor Cartridge contains a Biosensor that changes its optical transmission properties when it reacts with the nitric oxide in the breath sample. The Apieron INSIGHT eNO System is transportable, operated by an AC outlet and designed for use with the disposable Sensor Cartridge.
The provided text does not contain detailed information regarding specific acceptance criteria, performance metrics, or the study design with the level of detail requested for each point. The document is a 510(k) summary, which generally focuses on establishing substantial equivalence to a predicate device rather than providing exhaustive clinical study results.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states: "All necessary bench and clinical testing was conducted on the Apieron eNO System to support a determination of substantial equivalence to the predicate device." However, specific quantitative acceptance criteria (e.g., accuracy, precision limits) or the detailed reported performance values for these criteria are not provided in the given text.
2. Sample size used for the test set and the data provenance:
This information is not provided in the document. The text mentions "clinical testing" but does not specify the sample size, country of origin, or if the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. The device measures exhaled nitric oxide (eNO) as a marker of inflammation in asthma. Ground truth in this context would likely refer to a reference method for eNO measurement or clinical diagnosis of asthma/inflammation. The number and qualifications of experts for establishing such ground truth are not mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided.
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:
This device is not an AI-assisted diagnostic imaging tool that would typically involve human readers interpreting images. It is a system for quantitatively measuring exhaled nitric oxide. Therefore, an MRMC comparative effectiveness study in the context of human readers improving with AI assistance is not applicable and not mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The Apieron INSIGHT™ eNO System is described as a "Breath Nitric Oxide Test System" that measures eNO. This implies a "standalone" performance in terms of the device's ability to accurately quantify eNO from a breath sample. However, specific standalone performance metrics (e.g., accuracy against a reference standard) and the study details for this are not provided. The text states it "quantitatively measure exhaled nitric oxide (eNO)," which implies a standalone function.
7. The type of ground truth used:
The ground truth for a device measuring eNO would typically be a reference method for nitric oxide measurement. While the text refers to the device measuring a "decrease in eNO...as an indication of the therapeutic effects," the specific ground truth used for validating the device's measurement accuracy is not explicitly stated. It can be inferred that the device's measurements would be compared against a recognized standard for eNO measurement.
8. The sample size for the training set:
As this is a 510(k) for a medical device that quantifies a biomarker, it is unlikely to involve a "training set" in the machine learning sense. The device has a "Biosensor that changes its optical transmission properties when it reacts with the nitric oxide." The performance evaluation would likely focus on the accuracy and precision of this sensor and the overall system. Therefore, a "training set" as commonly understood in AI/ML is not applicable and not mentioned.
9. How the ground truth for the training set was established:
Given that there is no mention of a training set in the AI/ML context, this question is not applicable.
§ 862.3080 Breath nitric oxide test system.
(a)
Identification. A breath nitric oxide test system is a device intended to measure fractional nitric oxide in human breath. Measurement of changes in fractional nitric oxide concentration in expired breath aids in evaluating an asthma patient's response to anti-inflammatory therapy, as an adjunct to established clinical and laboratory assessments of asthma. A breath nitric oxide test system combines chemiluminescence detection of nitric oxide with a pneumotachograph, display, and dedicated software.(b)
Classification. Class II (special controls). The special control is FDA's guidance entitled “Class II Special Controls Guidance Document: Breath Nitric Oxide Test System.” See § 862.1(d) for the availability of this guidance document.