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Intended for use on adult patients only as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's score. The ECG recording may be obtained at any location specified by a physician including home, hospital, or clinic. Subjects screened for sleep apnea should have periods of sleep of at least 4 hours duration during which the ECG is receiled to sinus rhythm in nature.

Holter LX Analysis is a software option to the Holter for Windows software (K930564). The software has been designed to detect sleep disordered breathing due to obstructive apneas or hyponneas. The software uses 2 channel ECG and oximetry data collected via the DR180+ Holter Recorder to calculate the patient's Apnea-Hypopnea Index (AHI). The Holter and Oxymetry ECG data obtained by monitoring is not analyzed at the time of recording is complete, the data must be downloaded to a compatible NorthEast Monitoring Holter LX Analysis with sleep apnea software system to be analyzed by a healthcare professional. The sleep apnea monitoring algorithm used in the subject device is the exact algorithm already cleared by FDA. The Sleep Technician or Physician will utilize standard Holter procedure to hook up the recorder to the patient. The patient will sleep with the recorder for one night in order to collect data. Either the patient or a sleep clinician will note the time that the patient falls asleep and awakens. The sampling rate is 180 samples/second. The Holter LX Analysis software detects each R-wave. The calculations of AHI are performed. The Holter LX Analysis software can only be used in conjunction with North East Monitoring Holter recorders.

Here's an analysis of the provided text regarding the Holter LX Analysis device, focusing on its acceptance criteria and the study used for validation:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria (e.g., minimum sensitivity, specificity) for the Holter LX Analysis software. Instead, it relies on demonstrating substantial equivalence to a predicate device.

Explanation: The filing states, "Comparison of test data between the Holter LX Analysis software and the LifeScreeen Apnea device found equivalent results for sensitivity, specificity, accuracy, and positive predictivity. We believe the subject device is substantially equivalent to the predicate device." This implies that the acceptance criteria were met by showing performance equivalent to the predicate, K042745 (LifeScreen Apnea).

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

The document does not specify the sample size used for the comparative test set.

• Sample Size: Not specified.
• Data Provenance: The text states, "The underlying algorithm remains the same, but the AHI is calculated using oximetry data from a study conducted by Biancamed." This suggests the test data (or at least the oximetry data used for AHI calculation) came from a prospective or retrospective study conducted by Biancamed. The country of origin is not mentioned.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set. Given that the algorithm itself is the exact same as the predicate and the study focuses on the incorporation of oximetry, it's possible the original predicate study established a ground truth against which the algorithm was initially validated, and this submission leverages that, with a focus on verifying the oximetry data integration.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method for the test set.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or reported in this submission. The study described is a comparison of the new device's computational output (Holter LX Analysis with oximetry) to a predicate device's computational output (LifeScreen Apnea, which used the same base algorithm). There is no mention of human readers.

6. Standalone Performance Study

Yes, a standalone (algorithm only) performance study was implicitly done. The "comparison of test data between the Holter LX Analysis software and the LifeScreeen Apnea device" constitutes a standalone performance comparison between two algorithms (one with an oximetry enhancement). However, it's a comparison between algorithms, not against an independent "gold standard" in this specific submission. The original validation of the algorithm (when used in LifeScreen Apnea) would have been the standalone validation.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for the comparison study or the original algorithm validation. However, as it is a device to determine the "need for clinical diagnosis and evaluation by polysomnography," it is highly probable that the original algorithm's ground truth was established by polysomnography (PSG), which is the gold standard for sleep disorder diagnosis. The current submission focuses on equating results with the predicate device, not re-validating against the ultimate clinical ground truth itself.

8. Sample Size for the Training Set

The document does not specify the sample size for the training set. It mentions the algorithm is "the exact algorithm already cleared by FDA" and sourced from Biancamed. This implies the training (if any was needed for the base algorithm) occurred prior to its use in the predicate device. For the oximetry enhancement, it's unclear if new training was involved or if it was a direct application of existing scientific principles.

9. How the Ground Truth for the Training Set Was Established

The document does not specify how the ground truth for the training set was established. Similar to the test set, it's highly probable that the original algorithm (developed by Biancamed) was trained and validated against polysomnography (PSG) as the ultimate ground truth for sleep apnea events. This submission focuses on the application of that already cleared algorithm, with the added oximetry data.

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