Search Results

The Oscar 2, Model 250 system is a non-invasive oscillometric ambulatory blood pressure monitor that is intended to be used with AccuWin Pro, a PC-based computer program for the recording of up to 250 measurements of systolic and diastolic blood pressure and heart rate. It is intended for use as an aid or adjunct to diagnosis and treatment when it is necessary to measure an adult and pediatric (> 3yrs.) patient's systolic and diastolic blood pressures over an extended period of time. The system is only for measurement, recording, and display. It makes no diagnoses.

Optionally, The Model 250 will provide a derived ascending aortic blood pressure waveform and a range of central arterial indices. These measurements are provided non-invasively through the use of a brachial cuff.

It is to be used on those patients where information related to ascending aortic blood pressure is desired but the risks of cardiac catheterization procedure or other invasive monitoring may outweigh (excludes pediatic subjects).

BlueTooth, wireless connectivity will be offered as an option.

Device Description

The Oscar 2 monitor is worn by the patient on a waist belt and is connected to an ABPM blood pressure cuff around the non-dominant upper arm. The cuff is inflated automatically at intervals which can be programmed during setup. Blood pressure is measured by the oscillometric method which senses pressure waves in the artery when occluded by pressure in the cuff. Measurement of the frequency of the pressure waves enables heart rate to also be measured.

The Oscar 2 is a small hand-held or portable device, approximately 120 x 72 x 32 mm in size and weighs approximately 284 g including batteries. For convenience during a 24 hour study, the device can be worn with an optional pouch on a belt shoulder strap. The ABPM cuff is connected to the device, and the control buttons provide stop/start, day/night switch, event marking and dosage response capabilities. The LCD graphic screen allows for function monitoring and appropriate icon display. The device uses a microprocessor with software, which is not accessible to the user. The unit is powered by two (2) "AA" batteries located at the rear of the device. A USB port connection is used to download the patient information into the AccuWin Pro™ v4 software located on a separate PC. The AccuWin components include a flash drive and a USB cable.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the SunTech Medical Oscar 2, Model 250, based on the provided text:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, not typically a comprehensive clinical trial report with detailed acceptance criteria and performance metrics for the new device. Therefore, much of the requested information regarding specific performance numbers, sample sizes for test/training sets, expert qualifications, and adjudication methods for the new device's own performance studies is not directly present in this document. The document primarily states that the device was tested to applicable standards and demonstrated substantial equivalence to predicates.

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with reported numerical performance for the Oscar 2, Model 250 itself. Instead, it states that the device was tested to harmonized standards, implying that it met the requirements of those standards relevant to non-invasive blood pressure measurement. The key standard referenced for clinical investigation is ISO 81060-2:2013, Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type.

Likely Implied Acceptance Criteria (from ISO 81060-2:2013, general for NIBP devices):

While not explicitly stated in the document with actual results, conformance to ISO 81060-2:2013 typically requires the following for blood pressure measurement accuracy:

Metric (Implied by ISO 81060-2:2013)	Acceptance Criteria (General)	Reported Device Performance (Not in document, implied by passing standard)
Mean Difference (Device vs. Reference)	≤ ±5 mmHg for Systolic and Diastolic BP	Implied to meet this criterion by passing the standard.
Standard Deviation of Differences	≤ 8 mmHg for Systolic and Diastolic BP	Implied to meet this criterion by passing the standard.
Individual Differences	For 80% or more of readings,	Implied to meet this criterion by passing the standard.
		device and reference readings differ by ≤ ±5 mmHg.
	For 90% or more of readings,	device and reference readings differ by ≤ ±10 mmHg.
	For 95% or more of readings,	device and reference readings differ by ≤ ±15 mmHg.

For Central Blood Pressure (CBP) Algorithm: The document states the device derives CBP and that the SphygmoCor® XCEL (a predicate device) also provides derived ascending aortic BP and central arterial indices. The acceptance criteria for the accuracy of a derived central blood pressure waveform and parameters are not detailed in this 510(k) summary. Given its reliance on the SphygmoCor® XCEL algorithm, it's likely they would have aimed to demonstrate comparable performance to that predicate, which itself would have had its own validation studies.

Study Details for the SunTech Medical Oscar 2, Model 250:

Sample size used for the test set and the data provenance:
- The document states that the device was tested to ISO 81060-2:2013. This standard generally requires a minimum of 85 participants for clinical investigation of automated non-invasive sphygmomanometers. However, the exact sample size used for this specific device's test set (Oscar 2, Model 250) is not specified in the provided text.
- Data Provenance: Not specified. Typically, such studies are prospective, but this document does not state it. The country of origin of the data is also not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. For NIBP validation under ISO 81060-2, manual reference blood pressure measurements are typically taken by a minimum of two trained observers (experts) following a specific protocol (e.g., auscultatory method). Their qualifications would typically involve being trained and validated against a mercury sphygmomanometer, but the exact information for this study is not provided.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified. For NIBP validation, the "2+1" method (two observers, with a third if their readings differ significantly) or similar expert consensus is standard for establishing reference blood pressure. However, the document does not detail the method used.
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. This device is an automated non-invasive blood pressure monitor and does not involve human "readers" interacting with an AI to interpret images or data in a diagnostic context that would necessitate an MRMC study.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, a standalone performance study was conducted implicitly. The statement that the device was "tested to the applicable requirements of the following standards and requirements" including ISO 81060-2:2013 indicates that the device's algorithmic performance in measuring blood pressure was assessed independently against a reference standard. The nature of an automated sphygmomanometer being a measurement device means its primary function is standalone measurement. While human operators apply the cuff and initiate measurements, the core blood pressure calculation is algorithmic (standalone).
- The Central Blood Pressure (CBP) algorithm's performance is also implicitly standalone, deriving the waveform and parameters from the brachial cuff measurements.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For brachial blood pressure measurement validation (per ISO 81060-2), the ground truth is typically established by simultaneous, direct arterial measurement using an invasive catheter (less common in routine validation) or, more commonly, manual auscultatory measurements obtained by trained observers using a mercury sphygmomanometer (or equivalent validated reference cuff device) on the contralateral arm or sequentially. The document implies the latter through its reference to ISO 81060-2.
- For the derived central blood pressure, the ground truth would typically be invasive central blood pressure measurements, though the document relies on substantial equivalence to a predicate that also derives this non-invasively. The validation of the derivation itself would typically involve comparison to invasive central measurements.
The sample size for the training set:
- Not specified. This document does not provide details about a training set for the NIBP or CBP algorithms. For a device like this, the algorithms would typically be developed and potentially refined using various datasets, but a distinct "training set" for regulatory submission is not usually detailed in this type of 510(k) summary unless the AI component is novel and centrally a "machine learning" algorithm in the modern sense. Given the age of the submission (2016) and the nature of an oscillometric algorithm, it's more likely based on established physiological models and signal processing rather than deep learning requiring large, explicitly defined training sets.
How the ground truth for the training set was established:
- Not applicable/Not specified, as no specific "training set" details are provided. If implicitly part of algorithm development, the ground truth would be established similarly to the test set (e.g., expert-referenced blood pressure values).