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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.

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