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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

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.

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The intended use of the ABP-lite is to detect, diagnose, and monitor hypertension.

The ABP-lite is a 24-hour Ambulatory Blood Pressure Monitoring System (ABPMS) which obtains and stores the results of repeated determinations of blood pressure and heart rate during the activities of ordinary daily living. The ABP-lite system also manages a patient data base. The ABP-lite ABPMS includes a pneumatic cuff (worn by the patient), Data Recorder Unit (worn by the patient -- collects blood pressure ("BP") and heart rate ("HR") data), Remote Control Unit (LCD display of BP and HR data as well as error codes, patient control functions of event button and stop ongoing test). Interface Unit (interface between Remote Control Unit and PC), and ABPM-Soft Analyzer (proprietary custom software used for initial setup of Data Recorder, plus download, processing and printing of collected data).

The ABP-lite system weighs 13 ounces and is 21 cubic inches in size. The ABP-lite system uses the Korotkoff and oscillometric methods of blood pressure measurement with blood pressure cuff and microphone technology. Safety systems include an emergency pressure release system and watchdog timer.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the NewMed ABP-lite, structured to answer your specific questions.

Important Note: The provided document is a 510(k) summary from 1996. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report with extensive statistical analysis and specific performance metrics against pre-defined acceptance criteria, as would be expected for modern medical device submissions. Therefore, many of your requested details may not be explicitly available in this type of document.

Acceptance Criteria and Device Performance

Based on the provided text, the acceptance criteria are not explicitly stated with numerical thresholds (e.g., "accuracy of +/- 5 mmHg"). Instead, the document relies on demonstrating substantial equivalence to a predicate device (NewMed ABP 1000i). The "performance" is therefore implied to be similar to or within acceptable limits of the predicate device.

Table of Acceptance Criteria and Reported Device Performance

Study Details

Due to the nature of a 1996 510(k) summary, which emphasizes substantial equivalence, the "study" referred to is primarily non-clinical testing to demonstrate this equivalence rather than a detailed, standalone clinical trial designed to prove specific numerical acceptance criteria.

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: Not specified. The document only mentions "non-clinical testing performed on the ABP-lite blood pressure monitor." There is no mention of a human subject test set.
   • Data Provenance: Not specified. Given it's non-clinical testing, it likely refers to bench testing, engineering verification, and perhaps internal comparative measurements rather than clinical data from a specific country.
   • Retrospective/Prospective: Not specified, but likely refers to a series of internal verification and validation activities conducted as part of the device development.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

   • Not applicable/Not specified. The "ground truth" in this context would likely be reference measurements from a calibrated standard or the predicate device itself during comparative testing. No human experts are mentioned for establishing ground truth for this non-clinical testing.

3. Adjudication Method for the Test Set:

   • Not applicable/Not specified. This typically applies to clinical studies involving human interpretation or expert review, which is not described.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

   • No, an MRMC study was not done. The document describes a comparison to a predicate device, but this is a device-to-device comparison, not a study evaluating human reader performance with and without AI assistance.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

   • Yes, implicitly. The "non-clinical testing" and the statement that the devices "perform identically" refer to the automated measurement capabilities of the ABP-lite itself in comparison to the predicate, without human intervention in the measurement process. The device's algorithm performs the blood pressure and heart rate measurements independently.

6. The Type of Ground Truth Used:

   • For this 510(k) submission, the "ground truth" for demonstrating performance was the performance of the predicate device (Nissei/NewMed ABP 1000i) as established through prior regulatory clearance, and presumably, calibrated measurement standards for bench testing. The primary claim is substantial equivalence to this predicate.

7. Sample Size for the Training Set:

   • Not applicable. The ABP-lite is an ambulatory blood pressure monitor that uses established Korotkoff and oscillometric methods. It does not appear to employ machine learning or AI algorithms requiring a training set in the modern sense. The "software in the data recorder unit was designed using off-the-shelf software programs" and "custom configured," suggesting standard programming rather than a data-driven training approach.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as there's no indication of a training set for an AI/ML model.

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