Search Results

The PVDF Effort Sensor is intended to measure and output respiratory effort signals from a patient for archival in a sleep study. The sensor is an accessory to a polysomnography system which records and conditions the physiological signals for analysis and display, such that the data may be analyzed by a qualified sleep clinician to aid in the diagnosis of sleep disorders.

The PVDF Effort Sensor is intended for use on both adults and children by healthcare professionals within a hospital, laboratory, clinic, or nursing home, or outside of a medical facility under the direction of a medical professional.

The PVDF Effort Sensor does not include or trigger alarms, and is not intended to be used alone as, or a critical component of,

• an alarm or alarm system;
• an apnea monitor or apnea monitoring system; or
• life monitor or life monitoring system.

The PV01 PVDF Effort Sensor is a respiratory effort monitoring accessory designed for use during sleep studies to assess breathing patterns by measuring chest and abdominal wall movement. The device functions as an accessory to polysomnography (PSG) systems, enabling qualified sleep clinicians to analyze respiratory data for the diagnosis of sleep disorders.

The sensor consists of two main components: a PVDF (polyvinylidene fluoride) sensor module and an elastic belt. The sensor module contains two plastic enclosures connected by a piezoelectric PVDF sensing element encased in a silicone laminate. The PVDF material generates a tiny voltage that is output through the lead wire to the sleep amplifier. The change in voltage as the tension on the PVDF film fluctuates corresponds to the breathing of the patient. Since the PVDF material generates voltage, the sensor does not require a battery or power from the amplifier. The output signal is processed by the sleep recording system for monitoring and post-study analysis.

The PV01 PVDF Effort Sensor is intended for prescription use only by healthcare professionals in hospitals, sleep laboratories, clinics, nursing homes, or in home environments under medical professional direction. The device is designed for use on both adult and children participating in sleep disorder studies. The sensor is intended to be worn over clothes and not directly on the patient's skin.

The 510(k) clearance letter for the PV01 PVDF Effort Sensor does not contain the specific details required to fully address all aspects of your request regarding acceptance criteria and the study proving the device meets them. This document is a regulatory approval letter, summarizing the basis for clearance, not a detailed study report.

However, based on the provided text, here's an attempt to extract and infer the information:

Overview of Device Performance Study

The PV01 PVDF Effort Sensor underwent "comprehensive verification and validation testing" including "functional and performance evaluations" and "validation studies" to confirm it meets design specifications and is safe and effective. Additionally, "comparative testing against the Reference Device" was performed.

This suggests that the performance evaluation primarily focused on:

1. Safety Tests: Compliance with UL 60601-1 standards to ensure electrical and liquid ingress safety.
2. Usability and Validation Test: Assessment of user experience and comfort during a simulated sleep study.
3. Performance Comparison Test: Electrical signal output comparison to a legally marketed predicate device under simulated breathing conditions.
4. Temperature Range Test: Verification of signal output performance at extreme operating temperatures.

Acceptance Criteria and Reported Device Performance

Based on the "Summary of Tests Performed" section, the following can be inferred:

Missing Information and Limitations:

The provided FDA 510(k) clearance letter is a high-level summary and does not contain the granular details typically found in a full study report. Therefore, most of the following requested information cannot be extracted directly from this document.

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

   • Test Set Size: Not specified for any of the performance tests. For the usability test, it mentions "Participants" (plural), but no number. For the performance comparison test, it states "Both devices were placed on a rig," implying a comparison, but no human subject or case count.
   • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The usability test mentions "participants," potentially implying prospective data collection, but this is a broad inference.

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

   • Not Applicable/Not Specified: The device is a "PVDF Effort Sensor" that measures and outputs respiratory effort signals. Its purpose is to provide raw physiological data for a "qualified sleep clinician to aid in the diagnosis of sleep disorders." The device itself does not provide a diagnosis or interpretation that would require expert ground truth labeling in the traditional sense of an AI diagnostic device (e.g., image-based AI). The performance assessment appears to be against expected signal characteristics and comparison to a known device, not against clinical ground truth established by experts.

3. Adjudication method for the test set:

   • Not Applicable/Not Specified: Given the nature of the device (a sensor outputting physiological signals) and the described tests, a formal adjudication process (like for interpreting medical images) is not mentioned or implied.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:

   • No: This type of study (MRMC for AI assistance) is not mentioned. The device is a sensor, not an AI interpretative tool designed to assist human readers directly. It provides raw data for clinicians to analyze.

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

   • Partially Yes (for the sensor itself): The "Performance Comparison Test" and "Temperature Range Test" assess the device's signal output performance independently without a human in the loop for interpretation. The "Safety Tests" are also standalone tests on the device's physical and electrical properties.

6. The type of ground truth used:

   • Physiological Simulation / Device Output Comparison: For the "Performance Comparison Test," the ground truth was essentially the simulated breathing patterns produced by a "rig" and the expected output signals of a known predicate/reference device.
   • User Feedback / Self-Reported Metrics: For the "Usability and Validation Test," the ground truth was the participants' subjective feedback on comfort and ease-of-use, and the absence of reported use errors or adverse events.
   • Compliance with Standards: For "Safety Tests," the ground truth was compliance with the specified clauses of the UL 60601-1 standard.

7. The sample size for the training set:

   • Not Applicable/Not Specified: The PV01 PVDF Effort Sensor is described as a passive hardware sensor ("generates a tiny voltage," "does not require a battery or power from the amplifier") that measures physical movement. It is not an AI/ML algorithm that requires a "training set" in the computational sense.

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

   • Not Applicable: As stated above, there is no mention or implication of a training set as this is a hardware sensor, not an AI/ML algorithm.

In summary, the provided document gives a high-level overview of the acceptance criteria met for regulatory clearance, primarily focusing on safety, basic functional performance relative to another device, and usability. It does not delve into the detailed statistical methodology and independent ground truth establishment typical of AI/ML device studies.

Ask a specific question about this device

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.

Ask a specific question about this device