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510(k) Data Aggregation
(191 days)
QDC-PRO, AND NOX-RIP
The QDC-PRO device is a sensor unit intended for measuring of physiological signals during sleep. The signals measured are processed in the QDC-PRO device and the resulting signals made available at the output connector for acquisition by a 3rd party polysomnography (PSG)/sleep recorder.
The QDC-PRO device is indicated for use in patients greater than 2 years of age.
The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments.
The ODC-PRO device is intended to function as an accessory for 3rd party PSG systems, delivering the respiratory signals needed in PSG studies along with position/activity signals.
Polysomnography (PSG) is a multi-parametric sleep study indicated for diagnosis of various sleep disorders. The ODC-PRO is therefore a part of a full PSG, the gold standard sleep study, and its main objectives is to provide signals used for diagnoses of sleep disordered breathing (SDB).
The signals measured by the ODC-PRO are provided as analog signals to a general 3rd party PSG amplifier that has DC inputs with characteristics matching the QDC-PRO device signal output specifications.
The output signals include:
- Abdomen respiratory effort (RIP) .
- . Thorax respiratory effort (RIP)
- . SUM of abdomen and thorax respiratory effort (RIP)
- Nasal pressure from nasal cannula .
- Snore signal from nasal cannula .
- . Body position
- . Activity
- Audio .
The respiratory effort is measured by the use of respiratory inductive plethysmography (RIP).
The QDC-PRO device provides calibration for the RIP signals by the use of Quantitative Diagnostic Calibration (QDC) technique. The calibrated RIP signals (Sum) represents the tidal volume of the respiration better than un-calibrated RIP signals.
The QDC-PRO contains a sensor unit, respiratory effort sensors (RIP belts) and cables. The QDC-PRO is worn by the patient. It measures signals from two respiratory effort sensors, audio via an inbuilt microphone, nasal pressure and snoring via a nasal cannula and patient 's position/activity data. The signals are processed within the device and the resulting signals made available at the output connector for acquisition by a 3rd party polysomnography (PSG)/sleep recorder.
The QDC-PRO is powered with one AA (1.5V) battery and has a display for status indication, signal integrity, and buttons for control.
The provided 510(k) summary for the QDC-PRO device does not contain a specific table of acceptance criteria with reported device performance metrics in the format usually associated with clinical performance studies. Instead, it focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and a general summary of performance testing.
However, based on the provided text, we can infer the acceptance criteria for signal quality and the overall conclusion regarding device performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic / Acceptance Criteria | Reported Device Performance |
|---|---|
| Signal Quality (General) | "Signal comparison tests conducted for the QDC-PRO device confirm the quality of the signals being measured by the device. The results demonstrate that the QDC-PRO signals may be regarded as clinically equivalent to that of the predicates Respitrace QDC and NOX T3." |
| Quantitative Diagnostic Calibration (QDC) Function Performance | "Quantitative Diagnostic Calibration (QDC) function comparison tests conclude that the QDC-PRO performance may be regarded as clinically equivalent to that of the predicate Respitrace QDC." |
| Safety and Effectiveness | "Thorough internal and external testing has demonstrated that the QDC-PRO device is effective and safe for its intended use." |
| "Based on the testing, risk analysis, verification and validation activates described above and Besed on the essang, how analysis) - chivices provided in Table 1 above, it is the conclusion of Nox Medical that the QDC-PRO device is substantially equivalent to the predicates NOX T3 from Nox Medical (K082113) and Respitrace QDC from SensorMedics Corporation (K903011) and presents no new concerns about safety and effectiveness." (FDA's substantial equivalence finding supports this.) | |
| Compliance with Standards | "The ODC-PRO device complies with the applicable EMC and patient safety standards: IEC60601-1:2007 (Basic safety and essential performance), AAMI/ ANSI ES60601-1:2005 (Basic safety and essential performance), IEC62304 (Medical Device Software), ISO14971 (Risk Management), IEC 62366 (Usability Engineering)." |
| Usability | "Usability testing compliant with the standard: IEC 62366 - Medical devices - Application of usability engineering to medical devices, demonstrates that the QDC-PRO device is simple and safe to operate and minimizes the likelihood of errors and lapses." |
2. Sample Size Used for the Test Set and Data Provenance
The summary states that "Signal comparison tests" and "Quantitative Diagnostic Calibration (QDC) function comparison tests" were conducted, as well as "Clinical evaluation". However, it does not specify the sample size used for these test sets (e.g., number of patients, number of studies).
The data provenance is not explicitly stated as retrospective or prospective, nor are the specific countries of origin for the data provided. The overall context suggests internal testing and evaluation conducted by Nox Medical, with clinical evaluation comparing to publicly available data from predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts or their qualifications used to establish ground truth for any test sets. The "clinical evaluation" mentions that signals were "comparable to the already validated and publicly available Respitrace QDC and Nox T3 device, respectively," implying a comparison to established performance of predicate devices rather than independent expert ground truth for novel data.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method (e.g., 2+1, 3+1, none) for a test set.
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 done with human readers. The clinical evaluation focused on comparing the device's signals to those of predicate devices, not on assessing human reader performance with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the studies described are analogous to standalone performance studies for the device's signal acquisition and processing capabilities. The signal comparison and QDC function comparison tests assess the direct output of the QDC-PRO device against established benchmarks (predicate devices), without involving human interpretation as part of the core performance measurement against a ground truth. The device is a "sensor unit" providing output signals for a 3rd party PSG system, so its primary performance is in accurate signal generation.
7. The Type of Ground Truth Used
The ground truth used for performance validation was primarily:
- Established performance of predicate devices: The QDC-PRO's signals and QDC function were deemed "clinically equivalent" to those of the Respitace QDC and NOX T3. This implies that the performance of these legally marketed predicate devices serves as the benchmark or "ground truth" for comparison.
- Compliance with recognized standards: The device's safety, software development, risk management, and usability were validated against relevant IEC, AAMI/ANSI, and ISO standards.
8. The Sample Size for the Training Set
The document does not provide any information regarding a training set sample size. Given that this is a sensor unit that produces physiological signals, it is unlikely to involve "training" in the machine learning sense that would require a distinct training set (beyond perhaps internal calibration data or development data which are not specified). The focus is on the accuracy of the physical measurements and signal processing.
9. How the Ground Truth for the Training Set was Established
As no training set is mentioned or implied in the context of machine learning, there is no information on how ground truth for a training set was established.
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