(167 days)
The ApneaLink™ Air device is indicated for use by Health Care Professionals (HCP), where it may aid in the diagnosis of sleep disordered breathing for adult patients. ApneaLink Air records the following data: patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse, respiratory effort and body position during sleep. The device uses these recordings to produce a report for the HCP that may aid in the diagnosis of sleep disordered breathing or for further clinical investigation. The device is intended for home and hospital use under the direction of a HCP.
The ApneaLink Air recorder is a 5-channel battery-powered respiratory pressure sensor and oximetry system. ApneaLink Air provides recordings of respiratory pressure, respiratory effort, pulse rate, oxygen saturation and body position during sleep. The physician prescribed device will help to recognize sleep-related respiratory disorders. The ApneaLink Air recorder and the respiratory effort sensor must be fastened with the re-usable belt on the patient's chest parallel to the spine. All relevant respiratory information during sleep will be collected via nasal cannula, pulse oximetry module and respiratory effort sensor. The disposable plastic nasal cannula is connected to the ApneaLink Air recorder and fixed at the patient's nose. The oximetry sensor is connected to the Xpod and fixed at the patient's finger. The Xpod is connected to the ApneaLink Air recorder. The respiratory effort sensor is connected to the ApneaLink Air recorder and held in place by the belt. LED's indicate if the sensors are attached correctly. A Test complete light advises at the end of a recording if sufficient data for analysis was recorded during the night. After recording, the ApneaLink Air recorder must be returned to the physician. With the ApneaLink Software the physician can generate a report with the recorded and analyzed data (respiratory pressure, respiratory effort, pulse rate, oxygen saturation) to aid in diagnosis. The body position data is stored as an EDF+ file on the recorder. It is accessible on a computer via USB connection using an EDF viewer.
The provided text describes the ApneaLink Air device, its indications for use, and a comparison to predicate devices, but it contains limited details regarding acceptance criteria for clinical performance and specific studies proving those acceptance criteria for the diagnosis of sleep-disordered breathing. The document focuses more on demonstrating substantial equivalence based on technical specifications and mechanical/electrical safety testing, particularly highlighting the addition of body position recording.
Here's an analysis based on the information provided in the text, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the device's clinical performance acceptance criteria and reported performance for aiding in the diagnosis of sleep-disordered breathing are not explicitly stated as quantitative metrics (e.g., sensitivity, specificity, accuracy).
The document states:
- "Detection of respiratory events and reported indices was cleared under K083575 (ApneaLink Plus) and remained unchanged in ApneaLink Pro (K131932) and ApneaLink Air." This implies that the clinical performance related to detecting respiratory events (and thus deriving indices like AHI) is considered equivalent to the predicate ApneaLink Plus (K083575). However, the specific acceptance criteria and performance data for ApneaLink Plus are not detailed in this document.
- Regarding the new feature, body position recording: "Clinical data with regard to body position recording are not required as the body position data do not alter or influence any of the indices (like e.g. AHI or Apnea Index) or data generated by the testing and bench testing is sufficient to prove that body position recording results are as accurate as specified." And "Additional side by side testing has been performed by using a protractor to show the defined position around the body axis for ApneaLink Air and Nox T3."
Given this, a table summarizing explicitly stated acceptance criteria and performance for the diagnostic aid function cannot be fully constructed from the provided text. The document infers equivalence to predicate devices for its core diagnostic function and relies on bench testing for the new body position feature.
| Acceptance Criterion (Clinical Performance for Sleep Disordered Breathing Diagnosis) | Reported Device Performance |
|---|---|
| Not explicitly stated in this document for the ApneaLink Air itself. The document relies on equivalence to predicate devices (ApneaLink Plus K083575 and ApneaLink Pro K131932) for "Detection of respiratory events and reported indices." | Not explicitly stated for the ApneaLink Air itself. Performance is assumed to be equivalent to predicate devices. |
| For Body Position Recording (new feature): Accuracy of recording body position. | "bench testing is sufficient to prove that body position recording results are as accurate as specified." (Specific accuracy metrics not provided). Tested "using a protractor to show the defined position around the body axis for ApneaLink Air and Nox T3." |
2. Sample Size for the Test Set and Data Provenance
- Sample Size (Test Set): Not specified for clinical performance related to sleep-disordered breathing diagnosis. For the new body position recording feature, "Additional side by side testing has been performed by using a protractor" suggests direct comparison, but no specific number of subjects or samples is given.
- Data Provenance: Not explicitly stated for any clinical data mentioned or inferred. The document refers to "bench testing" and "side by side testing" without specifying if these involved human subjects or geographical origin. The device manufacturer is ResMed Germany Inc.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. This information would typically be part of a clinical study report, which is not fully provided here.
4. Adjudication Method
- Adjudication Method: Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study evaluating human readers' improvement with AI vs. without AI assistance was not mentioned in this document. The device itself is an assessment tool, not an AI-assisted diagnostic aid for human readers in the context of this submission.
- Effect Size: Not applicable, as no such study was described.
6. Standalone (Algorithm Only) Performance Study
- Standalone Performance Study: The document states, "Detection of respiratory events and reported indices was cleared under K083575 (ApneaLink Plus) and remained unchanged in ApneaLink Pro (K131932) and ApneaLink Air." This implies that the algorithm's performance for detecting respiratory events and generating indices was established in prior submissions (K083575), and its performance remains unchanged. However, no specific details of that standalone study (e.g., metrics, study design) are provided in this document.
7. Type of Ground Truth Used
- For Detection of Respiratory Events and Indices (inherited from predicates): Not explicitly stated in this document. Typically, full polysomnography (PSG) interpreted by sleep specialists is considered the gold standard for ground truth in sleep-disordered breathing diagnosis.
- For Body Position Recording (new feature): The new body position feature relies on "bench testing" and "using a protractor to show the defined position around the body axis." This indicates a physical measurement/reference standard for ground truth for the sensor's accuracy, not a clinical ground truth like pathology or outcomes data.
8. Sample Size for the Training Set
- Sample Size (Training Set): Not specified. This document pertains to regulatory submission for a device, not the development or training of an algorithm. The core functionality and algorithms are "unchanged" from a prior cleared device (K083575), so any training data for those algorithms would have been part of that earlier submission.
9. How Ground Truth for Training Set Was Established
- Ground Truth for Training Set: Not specified in this document. As above, any ground truth establishment for algorithm training would have been part of the previous K083575 submission.
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).