Search Results

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.

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.

Ask a specific question about this device

EasyCare Online is a web based solution for healthcare specialists intended to:
• assist in the diagnosis of sleep disordered breathing in adult patients through analysis of data recorded by an EasyCare Online compatible home sleep test device.
• transfer and display, usage and therapeutic information that has been transmitted remotely from the patient's therapy device located in the home. It is intended to support the standard follow-up care of patients that have been prescribed a compatible ResMed therapy device for the treatment of obstructive sleep apnea or respiratory insufficiency. EasyCare Online also provides remote settings capabilities

EasyCare Online is a web application that can transfer, store, manage and display usage and therapy data from (ResMed compatible flow generators) and diagnostic data from (ResMed compatible sleep study devices). The data is transferred from the device either wirelessly through a communications module, or with the aid of an SD card and internet technology, to a central database and then displayed on the clinician's/DME's computer, through a web based application such as internet Explorer.

EasyCare Online is used to monitor and optimize the therapy of patients diagnosed with sleep apnea or respiratory insufficiency, who are using a ResMed therapy device or home sleep test study device. The application enables patient usage data to be shared across several different user groups for the primary purpose of monitoring patient compliance and home sleep studies. Clinical users. Home Medical Equipment (DME) providers and other healthcare specialists can access data with ResMed approved user accounts. Also, clinical users and DMEs are able to address any clinical issues in a timely manner and provide the necessary patient support, including the modification of device settings. EasyCare Online supports physicians in the diagnosis Sleep Disordered Breathing, by reviewing home sleep test results via their web browser or download the clinical data to their PC for further analysis.

Here's an analysis of the provided text regarding the acceptance criteria and study for the EasyCare Online device:

This 510(k) submission is for an expanded intended use of an existing device (EasyCare Online, K123557) by integrating functionality from another predicate device (ApneaLink Plus, K083575). Therefore, the "study" primarily focuses on demonstrating that the new integration does not negatively impact the existing functionality and accurately displays data from the newly integrated device. It does not involve a traditional clinical study for the diagnostic accuracy of the device itself.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the comparison to the predicate devices and the successful completion of non-clinical testing. The "reported device performance" is essentially the successful completion of verification activities.

Study Details

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

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

• Test Set Sample Size: "Three patient breathing pattern scripts" were used for the side-by-side testing.
• Data Provenance: Not explicitly stated. The scripts likely represent simulated or standardized data rather than individual patient data from a specific country or collected prospectively/retrospectively in a clinical setting.

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):

• This submission does not involve human expert adjudication of diagnostic outcomes. The "ground truth" for the side-by-side testing was the output of the predicate ApneaLink Plus PC software. The study's goal was to ensure the modified EasyCare Online replicated this known output accurately. Therefore, no external experts were used to establish ground truth in the traditional sense of a clinical diagnostic study.

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

• None (in the context of human adjudication). The "adjudication" was a direct comparison of output data between the modified device and the predicate device's software.

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 was not an MRMC study. The device is a data management and display system, not a diagnostic AI system intended for direct human assistance in interpretation in the way a typical diagnostic image analysis AI would be.

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

• Yes, in spirit. The core of the "testing" was comparing the data processing and display capabilities of the modified EasyCare Online (algorithm/software only) against the known output of the predicate ApneaLink Plus PC software (also algorithm/software only). The "standalone" performance here refers to the software's ability to process and present data identically to an established, cleared device.

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

• The "ground truth" for the side-by-side testing was the output of the predicate ApneaLink Plus PC software (K083575). This means the existing, cleared device's performance served as the benchmark for accuracy for the data processing and display component. This is often referred to as "reference standard" or "comparator device" in such equivalence studies.

8. The sample size for the training set:

• Not applicable / Not explicitly stated. This submission does not describe the development of a novel algorithm that requires a "training set" in the machine learning sense. The changes primarily involved integrating existing functionalities and ensuring data integrity.

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

• Not applicable. As no training set for a novel algorithm was described, this question is not relevant to this submission. The "ground truth" for the device's expanded functionality was anchored to the performance of its predicate devices.

Ask a specific question about this device

The ApneaLink™ Pro 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 Pro records the following data: patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse and respiratory effort 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 Pro recorder is a 4-channel battery-powered respiratory pressure sensor and oximetry system. ApneaLink Pro provides recordings of respiratory pressure, respiratory effort, pulse rate and oxygen saturation during sleep. The physician prescribed device will help to recognize sleep-related respiratory disorders. The patient may perform the recording at home by himself. The Apnealink Pro recorder and the respiratory effort sensor must be fastened with the re-usable belt on the patient's chest. 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 Pro 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 Pro recorder. The respiratory effort sensor is connected to the ApneaLink Pro 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 Pro recorder must be returned to the physician. With the ApneaLink Software installed on a personal computer the physician can generate a report with the recorded and analyzed data to aid in diagnosis. The recordings and the report can be sent via email to further clinical investigation.

The ApneaLink Pro is a ventilatory effort recorder intended to aid healthcare professionals in diagnosing sleep-disordered breathing in adult patients.

Here's an analysis of the acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a "side-by-side testing of the detection of respiratory events and reported indices" to demonstrate substantial equivalence to the predicate device, ApneaLink Plus (K083575). The "acceptance criteria" appear to be that the ApneaLink Pro's performance for detecting and classifying respiratory events is substantially equivalent to that of the predicate device.

• Pulse/saturation detection
• Apnea/hypopnea according to classic definition
• Snoring detection
• Cheyne-Stokes breathing detection
• Hypopnea detection
• Apnea classification (obstructive, mixed, central)
• Central apnea determination according to threshold apnea/effort pause | Confirmed Substantially Equivalent to ApneaLink Plus (K083575): "side-by-side testing... used to demonstrate that the ApneaLink Pro is Substantially Equivalent to the ApneaLink Plus (K083575). In the side-by-side testing, the detection of all respiratory events is compared. The recorded, analyzed, displayed values and reported apnea classification... are compared to those of the ApneaLink Plus." |
  | Recorded, analyzed, displayed values | Substantially Equivalent to ApneaLink Plus (K083575) | Confirmed Substantially Equivalent to ApneaLink Plus (K083575): "The recorded, analyzed, displayed values... of Apneal.ink Pro are compared to those of the ApneaLink Plus." |
  | Reported apnea classification (obstructive/mixed/central) | Substantially Equivalent to ApneaLink Plus (K083575) | Confirmed Substantially Equivalent to ApneaLink Plus (K083575): "reported apnea classification of obstructive/mixed/central apneas of Apneal.ink Pro are compared to those of the ApneaLink Plus." |
  | Meeting predetermined acceptance criteria and relevant standards | All internal and external tests confirm compliance with predetermined acceptance criteria and requirements of relevant standards. (This is a broader statement, encompassing electrical safety, EMC, mechanical, and environmental tests, in addition to the clinical performance comparison). This implies numerical or qualitative thresholds for each specific test, though these are not detailed in the provided text. | Confirmed: "All internal and external tests confirmed that the product meets the predetermined acceptance criteria and the requirements of the relevant standards." |
  | Biocompatibility | No additional testing required as no changes from the predicate device in patient-contacting components. | Confirmed: "No additional biocompatibility testing was required as none of the components in contact with patients have changed from the predicate." |

2. Sample Size and Data Provenance for the Test Set

• Sample Size: The document does not explicitly state the sample size (number of patients or recordings) used for the side-by-side testing. It simply refers to "side-by-side testing... of the detection of all respiratory events."
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

• The document does not mention the number of experts used to establish ground truth or their specific qualifications. The study methodology described as "side-by-side testing" against a predicate device suggests that the predicate device's output itself served as a reference point for comparison, rather than an independent expert-established ground truth.

4. Adjudication Method for the Test Set

• The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none). Given that the comparison is "side-by-side" against a predicate device, it's likely that the predicate's output was considered the de facto reference, and no separate human adjudication process is detailed for this comparison.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC study described: The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. The study focuses on comparing the new device (ApneaLink Pro) to an existing device (ApneaLink Plus) in terms of its ability to detect and report physiological events. The ApneaLink Pro is a recording and analysis device, not an AI-assisted diagnostic tool for human readers in the context of improving their performance.

6. Standalone (Algorithm Only) Performance

• Standalone performance was the focus: The primary study described is a "side-by-side testing of the detection of respiratory events and reported indices" where the ApneaLink Pro's analytical software output is compared directly to the ApneaLink Plus's output. This is a form of standalone performance evaluation for the device's analytical capabilities, as it does not involve human interpretation of the raw data from the new device beyond what the predicate already provided. The device aids in diagnosis by producing a report; the reported performance is of the device's ability to generate this report.

7. Type of Ground Truth Used

• Predicate Device Output: The ground truth for this comparison study was effectively the performance and outputs ("recorded, analyzed, displayed values and reported apnea classification") of the legally marketed predicate device, ApneaLink Plus (K083575). The goal was to establish "substantial equivalence," not necessarily absolute accuracy against a gold standard like polysomnography or pathology, within the scope of this particular submission.

8. Sample Size for the Training Set

• The document does not mention a "training set" in the context of device development or performance evaluation. The ApneaLink Pro is described as a successor model with hardware and software changes, and the testing described is a comparison to a predicate, not a machine learning model requiring a training set.

9. How Ground Truth for the Training Set Was Established

• Since no training set is described for a machine learning algorithm, there is no information on how ground truth for a training set was established. The device's "technology" section implies updates to a microprocessor and software for data handling, not necessarily a learning algorithm.

Ask a specific question about this device