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The Silent Night V is indicated for use in the diagnostic evaluation of adults with possible sleep disorders. The Silent Night V can score obstructive apneas, which includes mixed apneas.

The Silent Night V is a portable, line-powered ventilatory effort recorder for use in the home for the diagnostic evaluation of the patient. The device consists of a bedside unit which is positioned on the patient and the sensors are placed on the patient's body and connect into the patient module. The Silent Night V contains the same functions as its predecessor, Silent Night II, with the addition of two other functions. The functionality of Silent Night V has been expanded from the previous estimation device, (Silent Night II K973902) to include ventilatory effort monitoring. The Silent Night V provides the following data:

• Arterial oxygen saturation level (SP02)
• Pulse rate
• Respiration effort signal
• Respiration sound corrected for ambient room noise.
  Throughout a typical sleep study, sleep-disordered breathing information and statistics are stored into the memory. The stored information includes time and duration of apneas and hypopneas, block apneas, number of apneas and hypopneas, number of central apneas, number of mixed apneas, number of obstructive apneas, number of desaturation events, number of pulse events, number of respiratory effort events, number of sound events, minimum saturation levels, pulse rate, respiratory effort level, sound measurement level, open in intervals, pulse rate, respiratory effort level, sound measurement level, open in intervals. Current storage capacity is 512 Kbytes, which is sufficient to retain three 8-hour studies. Software has been developed to retrieve, score, display and print the collected data on a personal computer. The collected data is provided to the physician to view the sleep data.

Here's a summary of the acceptance criteria and the study proving the Silent Night V device meets those criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document doesn't explicitly state "acceptance criteria" but rather presents performance metrics from the clinical study as evidence of equivalence to the predicate device. Therefore, the "acceptance criteria" column is populated with implied targets based on the documented performance.

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

• Sample Size: The document does not explicitly state the total number of patients/studies in the clinical test set. It mentions "using the overall number of patients as the basis of calculation" for RDI, but a specific number is not provided.
• Data Provenance: Prospective. The study involved patients undergoing a sleep laboratory evaluation with a standard polysomnograph, and the Silent Night V was used "concomitantly for a side-by-side comparison." This indicates a prospective collection of data in a clinical setting. The country of origin is not explicitly stated, but the company address is Palo Alto, CA, USA, suggesting the study was conducted in the US.

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

The document does not provide details on the number of experts or their qualifications used to establish the ground truth. It states that the ground truth was derived from "a standard polysomnograph" and that "The data were compared on an event-by-event basis." This implies that the PSG data was expertly scored, but no specifics about the scorers are given.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method. It states, "The data were compared on an event-by-event basis." This suggests a direct comparison, likely by an expert, between the PSG and Silent Night V outputs. However, specific methods like 2+1 or 3+1 for resolving discrepancies are not mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described. The study compared the device against a standard polysomnograph (PSG), not an AI-assisted human reader vs. a human reader without AI assistance. Therefore, there is no effect size reported for human readers improving with AI.

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

Yes, a standalone study was performed. The reported performance metrics (sensitivity, false positives, correlation) represent the performance of the Silent Night V device itself in detecting and classifying respiratory events, directly compared to the PSG. This is "algorithm only without human-in-the-loop performance" for the device under evaluation.

7. The Type of Ground Truth Used

The ground truth used was expertly interpreted polysomnography (PSG) data. This is considered a gold standard for sleep disorder diagnosis. The document states, "Patients underwent a sleep laboratory evaluation with a standard polysomnograph." The Silent Night V's data was then compared directly to this PSG data.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. This suggests that if the device utilizes a machine learning algorithm, the training data details were not included in this 510(k) summary. Alternatively, the device may be based on traditional signal processing rather than machine learning, eliminating the need for a "training set" in that context.

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

Since no information about a training set is provided, there is no information on how its ground truth was established.

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The Silent Night II is indicated for use in the diagnostic evaluation of adults with possible Obstructive Sleep Apnea. It is intended to record a patient's respiratory pattern during sleep. The device is designed for prescription use in home screening of adults with possible sleep disorders. Information provided by the device includes the numbers of apneic and hypopneic events and the proportion of these events to the total sleep duration; and snoring levels (in decibels). The device is capable of recording four nights or up to 40 hours for an individual patient, after which time the sleep data are downloaded for provision to the prescribing physician.

The Silent Night™ II is a modified version of the legally marketed Silent Night I. The device is a portable, line-powered ventilatory effort recorder intended for use in the home screening of possible sleep disorders. The metal box has two receptacle connectors: one for input power and another for the microphone cable. The sensing microphone and the ambient noise microphone are located at the distal end of the cable, and are attached to the user by means of a modified conventional plastic oxygen cannula. The sensing microphone, located directly beneath the patient's nose, senses respiratory sounds during sleep. The ambient microphone, angled to the side of the patient's nose, senses room ambient noise and measures snoring levels. The Silent Night II is capable of recording up to four nights of sleep study data. The beginning and end of the sleep study are controlled by the use of the START and STOP buttons, located on the front of the unit. An LCD indicates operational status and has a sound level bar, used by the patient at the beginning of the study to verify adequate sensing of breathing sounds by the device.

The device operates by sensing the sound field (breathing sounds + room ambient noise) via the two microphones. Breathing sounds are extracted from all sounds received. The signals are filtered, analyzed, and processed to differentiate between types of sounds and to classify sounds as regular snoring or breathing, hypopnea, or annes. When beep study is completed, the cumulatively logged data are downloaded by Local Site a personal computer. Specialized software and provides, for each night of the sleep study, information about apneas, hypopneas, and snoring levels.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Silent Night™ II device, formatted to include the requested information:

Acceptance Criteria and Device Performance Study for Silent Night™ II

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the clinical evaluation of the Silent Night™ II by comparing it to a predicate device, the Sensormedics Model 4100 Somnostar system, for detecting sleep disordered breathing events. The acceptance criteria are implicitly derived from the "high positive correlation" and "strong positive linear association" stated. Specific numeric thresholds for sensitivity and specificity are not precisely defined in the text, but the study indicates the device met these criteria.

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

• Test Set Sample Size: The document does not explicitly state the number of patients or the exact sample size used for the clinical evaluation. It only mentions "Patients were subjected to sleep laboratory evaluation."
• Data Provenance: The study appears to be prospective as patients were "subjected to sleep laboratory evaluation" where both the Silent Night II and the Sensormedics system were used simultaneously. The country of origin of the data is not specified, but given the submitter is based in San José, CA, USA, and the FDA review, it is highly likely the study was conducted in the USA.

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

• Number of Experts: The document does not specify the number of experts used.
• Qualifications of Experts: The document does not explicitly state the qualifications of the experts. However, given that the ground truth was established by a "standard polysomnograph (the Sensormedics Model 4100 Somnostar system)" and involved simultaneous data gathering, it can be inferred that medical professionals trained in polysomnography and sleep disorder diagnosis (e.g., sleep physicians, registered polysomnographic technologists) would have been involved in interpreting and scoring the Sensormedics data.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1). The ground truth was established by the Sensormedics Model 4100 Somnostar system, which is a standard polysomnograph. This implies that the output of this established device served as the reference standard.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done or described in the provided text. The study compares the device's measurements directly against those of a gold-standard polysomnograph, not against human readers using or not using AI.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done. The clinical evaluation directly compared the measurements (number of Apneas and Respiratory Disturbance Index - RDI) calculated by the Silent Night II device to those gathered simultaneously by the Sensormedics standard polysomnograph. This assesses the algorithm's performance without direct human interaction for interpretation of the Silent Night II's raw data, although human expertise would be involved in interpreting the Sensormedics output (ground truth).

7. Type of Ground Truth Used

The ground truth used was polysomnography data, specifically from the "Sensormedics Model 4100 Somnostar system," which is described as a "standard polysomnograph." This is a highly accepted clinical standard for diagnosing sleep disorders.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. This suggests that if machine learning was involved in the device's development (which is not explicitly clear from the description of signal processing and classification), the details of its training were not part of this 510(k) summary. Given the date of the document (1998), early machine learning techniques might have been used, but explicit "training set" reporting was less common compared to modern AI/ML device submissions.

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

As no training set is mentioned, no information is provided on how its ground truth would have been established.

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