NOGA AUTOMATED SLEEP STUDY SCORING AND DATA MANAGEMENT SYSTEM

• K Number: K070326
• Device Name: NOGA AUTOMATED SLEEP STUDY SCORING AND DATA MANAGEMENT SYSTEM
• Manufacturer: WIDEMED LTD
• Date Cleared: 2007-05-05 ( 89 days)
• Product Code: MNR , VEN
• Regulation Number: 868.2375
• Type: Traditional
• Panel: AN
• Reference & Predicate Devices: K022506 , K000253 , K040595

Intended Use

The Noga Automated Sleep Study Scoring and Data Management System is a computer program (software) intended for use as an aid for the diagnosis of respiratory related sleep disorders.

The Noga System is intended to be used for analysis, display, redisplay (retrieve), summarize, reports generation and networking of physiological data received from a physiological activity monitoring device.

Physiological data includes: ECG, SpO2, EtCO2 and Impedance respiration.

Device Description

The Noga Automated Study Scoring and Data Management System (Noga System) is a Web-based computer program (software), intended for use as an aid to the diagnosis of respiratory-related sleep disorders.

The Noga System is designed to process the raw signal data acquired by a third party physiological activity monitoring device in standard medical download format, analyze them, obtain the study's analysis results, generate summary reports, and display the signals' data and reports on a personal computer, using a standard Internet Explorer Browser.

Signals from the physiological activity monitoring device include the following:

• ECG
• Impedance respiration
• EtCO2
• SpO2

Scoring Analysis includes:

• Apnea/Hypopnea Index (AHI)
• Sleep Staging (Sleep - Wake stages, and Total Sleep Time)
• Respiratory Events Detection (Apnea and Hypopnea)

AI/ML Overview

Here's a summary of the acceptance criteria and the study details for the Noga Automated Sleep Study Scoring and Data Management System, based on the provided text:

Acceptance Criteria and Device Performance

Metric	Acceptance Criteria (Implicit)	Reported Device Performance
AHI Correlation	High correlation with gold-standard PSG and predicate device	Statistical analysis indicated high correlation of AHI across devices.
Sensitivity (AHI ≥15)	High sensitivity for detecting AHI ≥15	100% (vs. gold-standard)
92.8% (vs. Morpheus predicate)
Specificity (AHI ≥15)	High specificity for detecting AHI ≥15	92.7% (vs. gold-standard)
94.8% (vs. Morpheus predicate)

Study Details

1. Sample size used for the test set and the data provenance:

   • The document states that "A clinical study was conducted," but it does not explicitly state the sample size (number of patients or studies) used for the test set.
   • Data provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document does not explicitly state the number of experts used to establish the ground truth for the test set.
   • Qualifications of experts: The ground truth was established against "gold-standard PSG manual scoring." This implies human experts (sleep technologists or physicians) performed the manual scoring, but their specific qualifications (e.g., years of experience, board certification) are not provided.

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

   • The document does not specify an adjudication method. It simply refers to "gold-standard PSG manual scoring."

4. 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:

   • The document does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The study focused on the standalone performance of the Noga system compared to gold-standard and a predicate device.

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

   • Yes, a standalone performance study was done. The clinical study validated "the accuracy of the Noga System to detect respiratory related sleep disorders against both a gold-standard PSG and the Morpheus predicate device." This assesses the algorithm's performance directly.

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

   • The primary ground truth used was expert consensus / manual scoring, specifically "gold-standard PSG manual scoring". It was also compared against the performance of a predicate device (Morpheus).

7. The sample size for the training set:

   • The document does not provide information on the sample size used for the training set. It only mentions that the Noga software program is "based on the Morpheus software program."

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

   • The document does not explicitly state how the ground truth for the training set was established. Given that the Noga software is based on Morpheus, it is likely that Morpheus's training data and ground truth establishment methods would be relevant, but this is not detailed for Noga itself.

Regulation Number and Section

§ 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).