(129 days)
The Oscillomate 9002 NIBP / Sp02 Monitor Non-invasively measures blood pressure, I no obemomation and the pulse of the adult and pediatric patient in EMS environments by health care professionals. It is not designed for continuous unsupervised monitoring.
The 9002D Oscillomate NIBP / SP02 Monitor is a prescription device intended for use only by health care professionals. The monitor is designed to monitor and spot check adult and pediatric patients for blood pressure, oxygen saturation, and pulse non-invasively in patient transport environments. The monitor is portable, lightweight, and durable. The device and all of its accessories are further enclosed in a rugged Cordura nylon carry bag. Power is supplied by an internal rechargeable battery. An external battery charger is provided. Information is displayed in an easy to read LED display. NIBP Readings may be taken manually, or at preset intervals from 1 to 60 minutes. A message center display provides information and troubleshooting prompts. A history mode displays trends, previous readings and time readings were taken. Foreign language options and a data output port are included. The Sp02 function is derived from a pulse oximeter module mfg. by Nonin Medical, Inc.
Here's a breakdown of the acceptance criteria and study information for the Oscillomate® 9002D EMS NIBP/Sp02 Monitor, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter / Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| NIBP Accuracy | Meets clinical performance criteria of AAMI/ANSI SP10: 1992 | The Oscillomate 9002D meets the clinical performance criteria of AAMI/ANSI SP10: 1992. |
| SpO2 Accuracy | Clinical accuracy demonstrated | The Nonin® Pulse Oximeter component (used in the 9002D) has passed Sp02 clinical accuracy testing. |
| Safety | Complies with relevant safety standards | - Safety Medical and Dental Equipment (Implied compliance through successful testing) |
- Safety Medical Electrical Equipment (Implied compliance through successful testing) |
| Electromagnetic Compatibility (EMC) | Complies with relevant EMC standards | Electromagnetic Compatibility (Implied compliance through successful testing) |
| Environmental Testing | Operates reliably under specified environmental conditions | Environmental testing (Implied successful completion and compliance) |
| Intra-device variability | Acceptable level of variability | Intra-device variability (Implied successful testing and acceptable results) |
| Combined device accuracy testing | Acceptable combined device accuracy | Combined device accuracy testing (Implied successful testing and acceptable results) |
| SpO2 Accuracy vs. simulation | Acceptable accuracy against simulation | SpO2 accuracy vs. simulation (Implied successful testing and acceptable results) |
Note: The provided document is a 510(k) summary, which often provides summary statements rather than detailed numerical acceptance criteria and performance data. The "acceptance criteria" are implied by meeting recognized standards (like AAMI/ANSI SP10) and successful completion of various bench and clinical tests without reported failures.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size (NIBP): Not explicitly stated in the provided text. The document only mentions that the device "meets the clinical performance criteria of AAMI/ANSI SP10: 1992." This standard defines requirements for test subject group size for clinical NIBP validation, but the actual number used in this specific study is not provided.
- Sample Size (SpO2): Not explicitly stated in the provided text. It reports "The Nonin® Pulse Oximeter component has passed Sp02 clinical accuracy testing," implying that the testing was performed by Nonin, and the sample size for that test is not included here.
- Data Provenance: Not explicitly stated. For NIBP validation to AAMI/ANSI SP10, typically clinical data from human subjects is used. For SpO2, typically clinical data from human subjects subject to various oxygen levels (hypoxia studies) are used. The country of origin and whether it was retrospective or prospective is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This information is not provided in the 510(k) summary. For NIBP, ground truth is typically established by trained technicians using auscultation (e.g., using a mercury manometer and stethoscope) as per the AAMI/ANSI SP10 standard. For SpO2, ground truth is typically established using a co-oximeter measuring arterial blood gas samples, analyzed by qualified laboratory personnel. The number and qualifications of experts involved in establishing this ground truth for the specific studies referenced are not detailed.
4. Adjudication Method for the Test Set
- The document does not specify any adjudication method for the test set. For NIBP validation against a reference standard like auscultation, the comparison of automatic device readings to expert auscultatory readings might involve a form of comparison, but "adjudication" in the sense of resolving discrepancies among multiple independent readers is not described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done. The device in question is a physiological monitor (NIBP/SpO2) and not an AI-powered diagnostic imaging device or a system intended to assist human readers in interpretation. Therefore, this type of study is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, in essence, standalone performance was assessed. The entire submission focuses on the performance of the device (Oscillomate 9002D) itself in measuring NIBP and SpO2. The performance metrics (meeting AAMI/ANSI SP10 for NIBP and clinical accuracy for SpO2) inherently describe the algorithm's accuracy in producing those measurements without direct human intervention in the measurement process. The device's intended use is by "health care professionals," but this refers to their use of the device, not their real-time "human-in-the-loop" interpretation of a raw algorithm output.
7. The Type of Ground Truth Used
- For NIBP: The ground truth would be established by direct auscultatory measurement, typically by trained observers using a mercury sphygmomanometer and stethoscope, as dictated by the AAMI/ANSI SP10 standard. This is a form of expert reference measurement.
- For SpO2: The ground truth would be established by co-oximetry (measurement of arterial blood samples using a co-oximeter), which provides the most accurate measure of arterial oxygen saturation. This is a form of pathology/laboratory reference.
8. The Sample Size for the Training Set
- Not Applicable / Not Provided. This device is from 1998, predating the widespread use of deep learning and large-scale "training sets" in the modern sense for medical devices like this. The device uses established oscillometric techniques for NIBP and optical absorption for SpO2. These methods are based on well-understood physiological principles and signal processing, rather than being "trained" on a large dataset in the way a contemporary AI model would be. Any internal calibration or algorithm development for such a device would not typically be referred to as a "training set" in this context.
9. How the Ground Truth for the Training Set was Established
- Not Applicable / Not Provided. As explained in point 8, the concept of a "training set" and associated ground truth establishment in the modern AI sense is not directly relevant to this device from 1998. The algorithms were likely developed through engineering, physiological modeling, and testing against known benchmarks and reference standards, rather than large-scale data-driven training.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).