Search Results

BresoDX1 is indicated for use as an aid in the diagnosis of moderate to severe sleep apnea in adult patients. BresoDX1 records a patient's physiological signals during sleep and scores apneas and hypopneas. BresoDX1 is intended to be used in the home and clinic settings.

BresoDX1 is a lightweight data acquisition system intended for use by Health Care Professional (HCP) as an aid in the diagnosis of moderate to severe sleep apnea for adults. It is suitable for independent use in unattended settings, like in the home, or with minimal assistance in clinic settings.

BresoDX1 is to be worn while sleeping and consists of: (1) a BresoSensor which is placed on the patient's suprasternal notch with a disposable BresoSensor Frame (2) a BresoHub, which is located at the bedside; (3) a Nonin WristOx2® pulse oximeter, which is worn on the patient's wrist, where the oximeter sensor is to be placed on the patient's finger; and (4) BresoDX1 software.

The BresoSensor and the Nonin WristOx2® pulse oximeter sensor will record patient's tracheal breathing sounds, neck/body position and movement, tracheo-sternal movement, arterial oxyhemoglobin saturation and heart rate overnight during sleep. Recorded data on the BresoSensor and oximeter will be sent to the BresoHub wirelessly via Wi-Fi and Bluetooth for pre-processing and storing. When the patient returns the BresoDX1 system to the health care professional, stored data that had been uploaded will be processed for analysis and sleep study report generation. The generated report will show the following channels: heart rate, SpO2, airflow, respiratory effort, and body position. The health care professional will be able to use the software to review data, edit automated scoring, and re-generate a sleep study report based on the edited scoring for further interpretation. The health care professional will reprocess the device after each use.

Here's a breakdown of the acceptance criteria and the study proving the BresoDX1 device meets them, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

The core acceptance criteria for the BresoDX1 device revolve around its diagnostic accuracy for moderate to severe sleep apnea when compared to Polysomnography (PSG), which serves as the gold standard.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the clinical study results, particularly for sensitivity, specificity, positive predictive value, negative predictive value, and correlation with PSG metrics. The document explicitly states "All tests confirmed that the subject device meets the pre-determined acceptance criteria and the requirements of the relevant standards" but does not enumerate the numerical acceptance values beforehand. Therefore, the reported performance is the demonstration of meeting acceptance.

Note on REIb: REIb is the total number of respiratory events scored by BresoDX1 x 60 divided by monitoring time (in minutes).

Beyond clinical performance, other acceptance criteria implicitly include:

• Electrical Safety: Compliance with IEC 60601-1:2005+A1:2012, CAN/CSA-C22.2 No. 60601-1:2014, ANSI/AAMI ES60601-1:2005/A1:2012. (Achieved)
• Home Healthcare Environment: Compliance with IEC 60601-1-11:2015. (Achieved)
• Usability: Compliance with IEC60601-1-6:2010+A1:2013 and IEC 62366-1:2015/COR1:2016. (Achieved)
• EMC Testing: Compliance with IEC 60601-1-2:2014, FCC part 15. (Achieved)
• Biocompatibility: Compliance with ISO10993-1, ISO 10993-5 (2009), ISO 10993-10 (2010). (Achieved)
• Device Precision & Repeatability: Demonstrated via bench performance tests. (Achieved)
• Oximetry Integration Accuracy: Validated against ISO 80601-2-61:2017 Sub-clauses 201.12.1.103 & 201.12.1.104. SpO2 accuracy of ±2% (non-motion, low perfusion) / ±3% (motion) and pulse rate accuracy of ±3% (motion, non-motion, low perfusion). (Achieved)

Study Proving Device Meets Acceptance Criteria

2. Sample Size and Data Provenance

• Test Set Sample Size: 164 subjects.
• Data Provenance: Prospective, single-arm, multiple-site, blinded study. The document does not explicitly state the country of origin, but generally, FDA submissions involve studies conducted in the US or Canada, as Bresotec Inc. is based in Canada.

3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly state the number of experts used to establish the ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). However, it mentions "in-laboratory polysomnography (PSG)" and "AHI(PSG)" and "ODI(PSG)", which strongly implies that board-certified sleep physicians or registered polysomnography technologists, typically under the supervision of a sleep physician, established the ground truth according to standard clinical practice.

4. Adjudication Method for the Test Set
The document does not specify an explicit adjudication method (e.g., 2+1, 3+1). The nature of PSG scoring usually involves a single trained technologist scoring and a sleep physician reviewing and finalizing the report. If discrepancies arose between multiple scorers (though not explicitly mentioned as being present for ground truth establishment), standard practice would involve a consensus process, but this is not detailed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on the device's performance against PSG, not on how human readers' performance with or without AI assistance changes. The BresoDX1 is presented as an "aid in the diagnosis," and its software processes data to generate reports for a Health Care Professional (HCP) to review and interpret. The study appears to validate the automated scoring capabilities of the device as accurate for diagnosis.

6. Standalone (Algorithm Only) Performance
Yes, a standalone performance study was done. The clinical study directly compares the BresoDX1 device's automated scoring (REIb) and other metrics (ODI) against the concurrently recorded and independently scored "gold standard" in-laboratory PSG. The results presented for sensitivity, specificity, PPV, NPV, and correlations are measures of this standalone algorithm's performance.

7. Type of Ground Truth Used
The type of ground truth used was expert consensus / clinical standard, specifically in-laboratory Polysomnography (PSG). PSG is widely considered the gold standard for diagnosing sleep apnea.

8. Sample Size for the Training Set
The document does not specify the sample size for the training set. The clinical study described (164 subjects) is presented as the validation or test set for performance evaluation.

9. How the Ground Truth for the Training Set Was Established
The document does not provide details on how the ground truth for the training set (if a separate training set was used for the algorithm's development) was established. It only describes the methodology for the reported pivotal clinical validation study's ground truth (PSG). It's common practice for algorithm development to use retrospective datasets, where PSG would also be the ground truth.

Ask a specific question about this device