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The SunTech Medical Cycle BP monitor and Pulse Oximeter is indicated for use in measuring and displaying systolic and diastolic blood pressures, heart rate, and functional saturation of arterial hemoglobin (SpO2) of adult and pediatric patients in hospitals, medical facilities and subacute environments.

Device Description

The Cycle BP Monitor and Pulse Oximeter, a microprocessor based ambulatory blood pressure monitor and oxygen saturation measurement system compatible with ergometer stress-test systems, uses Korotkoff sounds to determine blood pressure and an optical finger sensor for oxygen saturation. An internal electric pump is used to inflate the cuff, and deflation is controlled by two valves. The Cycle has the ability to make blood pressure at predetermined intervals (normally from a schedule determined by the physician), or on demand. Saturation measurements are updated once per second.

AI/ML Overview

The provided text describes the SunTech Medical Cycle BP Monitor and Pulse Oximeter, its intended use, and its equivalence to a predicate device. It references several standards and tests, but it does not provide explicit acceptance criteria or detailed study results for device performance against those criteria.

Therefore, I cannot populate the table with acceptance criteria and reported device performance directly from the given text.

Here's what I can infer and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Metric	Acceptance Criteria (from AAMI SP10: 2002, IEC, etc.)	Device Performance
Blood Pressure Measurement Accuracy (Mean Difference)	Not explicitly stated in the document, but typically defined by AAMI SP10. Usually, mean difference ± 5 mmHg and standard deviation ≤ 8 mmHg are acceptance criteria.	Not reported in the document. The document only states "These tests have indicated passing results."
Blood Pressure Measurement Accuracy (Standard Deviation)	Not explicitly stated in the document, but typically defined by AAMI SP10.	Not reported in the document.
Pulse Oximetry Accuracy (SpO2)	Not explicitly stated in the document, but typically defined by ISO 9919. Usually, a root mean square deviation (ARMS) of less than 3% in the range of 70-100% SpO2 is expected.	Not reported in the document. The document only states "These tests have indicated passing results."
Heart Rate Accuracy	Not explicitly stated in the document, but often covered by the same standards as BP.	Not reported in the document.
Safety (Electrical, EMC, etc.)	Compliance with IEC 60601-1, IEC 60601-1-2, etc.	"These tests have indicated passing results."
Functional Specification (SunTech document # 99-0049-XX-FS)	Not detailed in this submission.	"These tests have indicated passing results."

Study that proves the device meets the acceptance criteria:

The document broadly states that "The Cycle BP Monitor has been tested to the applicable requirements of the following standards and requirements. These tests have indicated passing results." The specific standards listed are:

AAMI SP10: 2002 (American Association for Medical Instrumentation, standard for sphygmomanometers)
IEC 60601-1:1996 (Medical electrical equipment – Part 1: General requirements for safety)
IEC 60601-2-30:1999 (Medical electrical equipment – Part 2-30: Particular requirements for the safety of automatic electronic sphygmomanometers)
ISO 9919:1992 (Pulse oximetry equipment – Particular requirements for safety and essential performance)
IEC 60601-1-2:2001 (Medical electrical equipment – Part 1-2: General requirements for safety – Collateral standard: Electromagnetic compatibility – Requirements and tests)
IEC 60601-1-4:2000 (Medical electrical equipment – Part 1-4: General requirements for safety – Collateral standard: Programmable electrical medical systems)
IEC 60601-2-49:2001 (Medical electrical equipment – Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment)
Functional Specification, (SunTech document # 99-0049-XX-FS)

The document claims that the device "indicated passing results" for these tests, implying that the studies conducted in accordance with these standards demonstrated compliance with their respective criteria. However, no specific data or methodology details of these studies are provided in this extract.

Missing Information from the provided text:

Due to the nature of this submission (abbreviated 510(k) summary), the detailed information about the studies is not included. The following points cannot be answered from the provided text:

Sample size used for the test set and the data provenance: Not available in the document. For AAMI SP10, there are specific requirements for subject demographics (e.g., age, blood pressure range, gender distribution) and a minimum number of subjects (typically 85 for clinical validation).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in the document. For AAMI SP10, ground truth (reference blood pressure) is typically established by at least two trained observers taking simultaneous auscultatory measurements.
Adjudication method for the test set: Not available in the document.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a standalone blood pressure and pulse oximeter, not an AI-assisted diagnostic tool for interpretation by human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, the device itself performs the measurements. The "tests have indicated passing results" for standalone performance according to the listed standards.
The type of ground truth used: For Blood Pressure, it's highly likely to be expert auscultation as per AAMI SP10. For SpO2, it would be co-oximetry (invasive blood gas analysis).
The sample size for the training set: Not applicable/Not available. This device (from 2006) would likely use a deterministic algorithm or a simpler calibration model rather than a machine learning model that requires a "training set" in the modern AI sense. Even if it involved some algorithm development, the specifics are not disclosed.
How the ground truth for the training set was established: Not applicable/Not available.

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