(337 days)
The Oscillomate 9001D monitor non-invasively measures the blood pressure of adult and pediatric patients primarily in the emergency care environment. The monitor automatically inflates an occluding cuff and, using the Oscillometric measurement technique, determines systolic, diastolic and pulse rate.
The 9001D monitor is compact, lightweight, and durable. The device is housed in and ABS enclosure. 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. 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 previous readings and time readings were taken.
The Oscillometric technique monitors the changes of pressure caused by the flow of blood through the artery. The monitor will inflate the cuff around the patients arm to a value that occludes the artery. The monitor then deflates the cuff in steps. As the cuff pressure goes down, blood continues to flow through the artery. The increasing blood flow causes the amplitude of the pressure pulses in the cuff to increase. As the monitor steps down further, the pulses will reach a peak amplitude and then start to decrease with additional pressure steps. The rising and falling of the amplitude of these pressure pulses as the cuff pressure is stepped down, creates a curve that is used to find the systolic pressure and diastolic pressure. Counting the pulses over a time period will give a pulse rate. Motion artifact rejection techniques are used to provide accurate results under most operating conditions.
Here's a breakdown of the acceptance criteria and study information for the Oscillomate 9001D Non-invasive Blood Pressure Monitor, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Device Performance (Oscillomate 9001D) |
|---|---|
| AAMI/ANSI SP10: 1992 Clinical Accuracy (Mean difference in Systolic/Diastolic pressure: ±5 mmHg or less with a standard deviation of 8 mmHg or less) | Meets ANSI/AAMI SP-10, 1992. Mean difference in Systolic (and Diastolic) pressure comparison: ±5 mmHg or less with a standard deviation of 8 mmHg or less. |
| Equivalent performance in patient motion, road noise, and vibration conditions in a vehicular transport environment (compared to predicate device) | Provides equivalent performance when encountering patient motion, road noise and vibration conditions in a vehicular transport environment. |
| Outperforms predicate device in patient simulation accuracy over a range of input conditions. | Met the conditions for acceptance and outperformed the predicate device in patient simulation. |
| UL544 Safety Requirements | Passed |
| IEC 601-1 Safety Requirements | Passed |
| IEC 601-1-2 Safety Requirements | Passed |
| IEC 601-2-30 Safety Requirements | Passed |
| BS EN 1060-1 Safety Requirements | Passed |
| ISTA Packaging Shipping Testing | Passed |
| IEC 68 (series) Environmental Shock and Vibration Testing | Passed |
| EN 60601-1-2 Electromagnetic Compatibility | Passed |
| IEC 801-1-2; IEC 801-1-3; IEC 801-1-4; IEC 801-1-5 Electromagnetic Compatibility | Passed |
| CISPR - 11 Electromagnetic Compatibility | Passed |
| IEC 68-2-27 (SHOCK) Shock & Vibration Resistance | Passed |
| IEC 68-2-6 (Sin. VIBRATION) Shock & Vibration Resistance | Passed |
| IEC 68-2-34 (RANDOM VIBRATION, wide band) Shock & Vibration Resistance | Passed |
| Cuff Over-Pressurization limits (Software Limit) | 290 mmHg (Meets IEC 601-2-30, AAMI SP-10) |
| Cuff Over-Pressurization limits (Redundant switch) | 330 mmHg (Meets IEC 601-2-30, AAMI SP-10) |
| Prolonged Cuff Inflation time-out | Up to 120 seconds (Meets IEC 601-2-30, AAMI SP-10) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify the exact sample size for either the clinical or non-clinical studies. It mentions "measured subjects" for the transport environment study and "patient simulation device" for the accuracy comparison. For the clinical study, it states it was "conducted in accordance with AAMI SP10:1992," which implies they followed the standard's recommended subject count (typically a minimum of 85 subjects for AAMI SP10). However, the precise number is not given here.
- Data Provenance: Not explicitly stated (e.g., country of origin). The document implies a prospective nature for the comparative and clinical studies ("A comparative study was made to evaluate both monitors...").
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- The document does not explicitly state the number of experts or their qualifications used to establish ground truth.
- For the clinical accuracy testing, adherence to AAMI/ANSI SP10: 1992 suggests that the ground truth would have been established by trained observers taking reference blood pressure measurements (e.g., auscultatory measurements using a sphygmomanometer) as per the standard's methodology. The qualifications of these observers are not detailed here but would typically involve individuals trained in the accurate manual measurement of blood pressure according to the standard.
4. Adjudication Method for the Test Set
- The document does not specify an adjudication method like 2+1 or 3+1. For AAMI/ANSI SP10, typically multiple observers take simultaneous manual measurements, and the average or a specific method (e.g., discarding outliers) is used to establish the reference.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study typically involves multiple human readers interpreting medical images or data with and without AI assistance to measure improvement. The Oscillomate 9001D is a non-invasive blood pressure monitor, not an imaging device, and the studies described are focused on device performance against a standard and a predicate device, not human interpretation improvement.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
- Yes, a standalone performance study was done.
- The "patient simulation device" study evaluated the Oscillomate 9001D's accuracy over a range of input conditions in a controlled, artificial environment, essentially testing the algorithm's performance independent of human error in measurement.
- The "AAMI/ANSI SP10: 1992 clinical accuracy testing" also evaluated the device's standalone performance by comparing its automated readings to manually obtained reference blood pressure measurements.
7. Type of Ground Truth Used
- Expert Consensus/Reference Standard: For the clinical accuracy testing conforming to AAMI/ANSI SP10: 1992, the ground truth would be established by simultaneous, independent auscultatory measurements performed by trained observers. This effectively represents an "expert reference standard."
- Patient Simulation: For the non-clinical accuracy comparison, the ground truth was derived from the controlled inputs of a "patient simulation device."
8. Sample Size for the Training Set
- The document does not specify a separate training set or its sample size. This type of device's algorithm is typically developed and validated using engineering principles and controlled test data rather than a machine learning training/test split model. The clinical and non-clinical tests described serve as validation, not training.
9. How the Ground Truth for the Training Set Was Established
- As no specific "training set" in the context of machine learning is described, the method for establishing its ground truth is not applicable or provided. The device's underlying algorithm for oscillometric blood pressure measurement would be based on established physiological models and empirical data from general research and development, not a specific "training set" as understood in modern AI/ML contexts.
§ 870.1270 Intracavitary phonocatheter system.
(a)
Identification. An intracavitary phonocatheter system is a system that includes a catheter with an acoustic transducer and the associated device that processes the signal from the transducer; this device records bioacoustic phenomena from a transducer placed within the heart, blood vessels, or body cavities.(b)
Classification. Class II (performance standards).