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The Wesper Lab is a digital recording device designed to be used under the direction of a physician or trained technician but may be applied by a layperson. Wesper Lab records multiple physiological parameters from a sleeping patient for the purpose of simultaneous or subsequent display of the parameters. The displayed data assists in the identification of sleep apnea by trained personnel. Wesper Lab is intended to be used for adult sleep studies at home or clinical environment. The body-worn component of the system is single-use, to be discarded nightly application. The device does not monitor or diagnose the patient and does not issue any alarms.

Wesper Lab ("the device") is indicated as a digital recording device designed to be used under the direction of a physician or trained technician but may be applied by a layperson. Wesper Lab records multiple physiological parameters from a sleeping patient for the purpose of simultaneous or subsequent display of the parameters. The device consists of an abdominal patch, a thoracic patch and a mobile application. The patches are single-use wearable, flexible, thin, and wireless, and are designed to record sleep data in adult patients. Both patches are identical and differ only in their anatomical designation at test setup time. The flexible fabric allows the patch to retract and expand as the patient breathes and moves during sleep. The mobile application ("the app") resides on the patient's personal mobile device, relaying sleep data wirelessly to a secure remote storage location ("the cloud") for subsequent analysis by a healthcare professional. The patches collect multiple physiological parameters related to sleep to be used by a healthcare professional. Specifically, the patches measure sleep position, respiratory effort, and Wesper-Sum- Flow / Wesper-Sum-Pressure. Data from the patches is transmitted via Bluetooth low energy (BLE) throughout the night to the app, which uploads the data to the cloud. A third BLE port on the app connects to an FDA cleared pulse oximeter, which provides pulse rate and blood oxygen saturation measurements. The data recorded by the patches is relayed to a remote secure storage, where it will be downloaded to a local PC. Then, Wesper staff will execute the Study Output Module (SOM) and save the data locally on the desktop computer. The data is then ready for interpretation by a healthcare provider.

Based on the provided text, the Wesper Lab is a digital recording device used for sleep studies to assist in the identification of sleep apnea. The performance data section describes the studies undertaken to demonstrate its safety and effectiveness.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

For the specific aspect of sleep apnea identification, the key performance metric is the correlation with Polysomnography (PSG) AHI (Apnea-Hypopnea Index), which is the gold standard.

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

• Sample Size for Clinical Test Set: 45 patients
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the study was described as "multi-center," suggesting it was conducted across different sites. Given the FDA submission, it's highly likely to be within the United States.
  • Retrospective or Prospective: Prospective. The text states, "Wesper has conducted a prospective, multi-center clinical study for Wesper Lab..."

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

The text states that the "gold standard - in-lab, polysomnographic (PSG) tests" were used to establish ground truth. PSG tests are typically interpreted by trained personnel, often registered polysomnographic technologists (RPSGTs) and sleep physicians (e.g., neurologists or pulmonologists with sleep medicine board certification). The number of experts is not specified, nor are their exact qualifications beyond "trained personnel."

4. Adjudication Method for the Test Set

The text does not explicitly describe an adjudication method for the PSG ground truth. It implies that standard PSG interpretation procedures were followed to derive the AHI, which serves as the ground truth. There is no mention of multiple independent expert interpretations followed by an adjudication process (e.g., 2+1, 3+1).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done and Effect Size

No, an MRMC comparative effectiveness study involving human readers assisting with or without AI was not reported for the sleep apnea identification aspect. The study evaluated the device's standalone performance in correlating with PSG AHI.

The study did involve, "The displayed data assists in the identification of sleep apnea by trained personnel," which implies human interpretation. However, the study's focus was on the Wesper Lab's ability to record and display data that could achieve a high correlation with the gold standard AHI, not on how human readers' diagnostic accuracy changed with AI assistance.

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

Yes, the clinical study's primary objective, as described by the 95.1% correlation with PSG AHI, appears to be a standalone (device only) performance evaluation because it compares the device's output (presumably, its calculated AHI or raw data leading to AHI) directly against the PSG AHI ground truth. While the device's purpose is to provide data for interpretation by "trained personnel," the reported correlation is a measure of the device's accuracy in capturing the necessary physiological parameters that align with PSG-derived AHI.

7. The Type of Ground Truth Used

The primary ground truth used for the clinical study was gold standard in-lab Polysomnography (PSG) tests, specifically their derived Apnea-Hypopnea Index (AHI).

8. The Sample Size for the Training Set

The text does not explicitly state the sample size used for the training set. The clinical study described with 45 patients is clearly identified as a test set for performance evaluation.

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

Since the training set size and details are not provided, it is unclear how ground truth for the training set was established. However, given the nature of the device and the eventual performance evaluation against PSG, it's highly probable that any training data would also have been validated against PSG or similarly reliable methods for sleep data.

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Universal XactTrace is intended to measure respiratory effort to assist in the diagnosis of sleep disorders or sleep related respiratory disorders. The respiratory effort signals measured are processed to provide electrical signals suitable for connection to the inputs of physiological recording equipment.

The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments.

Universal XactTrace is intended for diagnostics purposes only and is not intended to be used as an apnea monitor.

The Universal XactTrace is a small battery powered reusable respiratory effort sensor. It incorporates electronics to measure and process a respiratory effort signal to provide an electrical signal suitable for connection to the inputs of a physiological recorder.

The Universal XactTrace is composed of a sensor belt and a belt cable. The sensor belt has two types: abdomen belt that is applied around the patient's abdomen and thorax belt that is applied around the patient's thorax. The sensor belts are intended to be worn over clothing. The belt cable is used to connect the belt sensor to a physiological recorder.

The Universal XactTrace is powered by a non replaceable battery that is built in the buckle of the sensor belt and switches on/off when the buckle is connected/unconnected.

The Universal XactTrace is based on Respiratory Inductive Plethysmograph (RIP) technique.

Here's a breakdown of the acceptance criteria and the study information for the Universal XactTrace Ventilatory Effort Recorder, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to predicate devices through technological characteristic comparison and compliance with regulatory standards, rather than defining specific numerical performance acceptance criteria (e.g., sensitivity, specificity) for a clinical outcome.

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

• Sample Size: Not explicitly stated. The document mentions "the signals detected with the Universal XactTrace were compared to signals detected with the predicate devices." This implies a comparison study, but the number of subjects or recordings used for this comparison is not provided.
• Data Provenance: Not explicitly stated. The context suggests that the testing was performed internally ("internal testing and verification") and externally by SEMKO. It does not specify the country of origin of the data or whether the study was retrospective or prospective.

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

• Not applicable. The study described is a comparison of instrument signals, not a clinical study requiring expert ground truth for disease diagnosis. The ground truth for signal comparison would be the signals produced by the predicate devices themselves.

4. Adjudication Method for the Test Set:

• Not applicable. As described, the study is a technical comparison of signals rather than a diagnostic performance study requiring adjudication of clinical outcomes by experts.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The document describes a comparison of device signals to those of predicate devices, not an assessment of human reader performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Yes, a standalone study was performed in the sense that the device's signal output was directly compared to the predicate devices. The "algorithm" in this context refers to the device's internal processing of respiratory effort signals. The performance discussed is about the output signal's characteristics, not an AI-driven diagnostic interpretation.

7. Type of Ground Truth Used:

• The ground truth used for performance assessment was the signals generated by the predicate devices (Crystal Trace Piezo Respiratory Effort Sensor and Summit IP). The study aimed to show that the Universal XactTrace produced comparable respiratory effort signals.

8. Sample Size for the Training Set:

• Not applicable. This device is a sensor and signal processor, not an AI/machine learning algorithm that requires a training set in the conventional sense for diagnostic classification. The embedded software implies some signal processing logic, but this is likely rule-based or engineered, not a trained model.

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

• Not applicable. See point 8. The device's functionality is based on Respiratory Inductive Plethysmography (RIP) technique and standard signal processing, not on a machine learning model trained with a ground truth dataset.

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