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The Spacelabs Model OnTrak (9027) Ambulatory Blood Pressure (ABP) Monitor is a small, lightweight unit designed to take blood pressure and heart rate measurements for a 24 hour, or longer period. These measurements are recorded in the monitor and may be transferred to Spacelabs ABP analysis systems.

The Spacelabs Model OnTrak (90227) Ambulatory Blood Pressure (ABP) Monitor (Spacelabs OnTrak) is a small, lightweight unit designed to take non-invasive blood pressure (NIBP) and heart rate (HR) measurements for a 24 hour, 48 hour, or longer period. These The Spacelabs OnTrak does not have any physiological alarms, but does have an audible low battery indicator. The Spacelabs OnTrak utilizes the same NIBP cuffs as the predicate device.

The provided document details the 510(k) premarket notification for the Spacelabs Model OnTrak (90227) Ambulatory Blood Pressure Monitor. This document does not contain information about an AI-powered device, nor does it conduct a study comparing human readers with and without AI assistance. Instead, it focuses on the substantial equivalence of a new medical device to a legally marketed predicate device.

However, I can extract the acceptance criteria and performance information as presented for this device, and infer what would typically be considered "acceptance criteria" based on the standards cited for medical device performance.

Acceptance Criteria and Reported Device Performance

For a blood pressure monitor, the primary acceptance criteria revolve around accuracy of blood pressure measurement. The document refers to ISO 81060-2: 2009 for "Clinical investigation of automated measurement type," which sets the standard for blood pressure monitor accuracy. While the document doesn't explicitly list the detailed clauses of ISO 81060-2 as "acceptance criteria" tables, the "Manometer Accuracy" under the technology comparison section provides a direct performance metric.

Study Information (Based on the provided document):

1. Sample size used for the test set and the data provenance:
   The document does not explicitly state the sample size for the clinical testing (if a specific clinical test was conducted beyond meeting the standard's criteria implicitly) or for the various bench tests. It refers to "Test results" which "indicate that the Spacelabs OnTrak complies with its predetermined specifications and the applicable standards."
   Data provenance is not mentioned. Given the regulatory nature of the submission (510(k)), it would typically be prospective clinical study data if a new clinical trial was undertaken, or extensive bench testing. The primary comparator is the predicate device, implying testing was done to show equivalence.

2. 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 document. For a blood pressure monitor clinical validation (as per ISO 81060-2), ground truth is typically established by trained observers using a mercury sphygmomanometer or highly accurate reference methods, often with multiple observers following a specific protocol. The qualifications would be highly trained technicians or clinicians.

3. Adjudication method for the test set:
   This information is not provided. In clinical validation studies of blood pressure monitors, an adjudication method (such as an averaged reading from two trained observers, or a third observer for discrepancy) is commonly used to establish the reference blood pressure.

4. 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 Ambulatory Blood Pressure Monitor, which is a standalone measurement device, not an AI-powered diagnostic tool requiring human interpretation. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   Yes, the performance testing described is for the standalone device. The Spacelabs OnTrak is an automated system designed to measure blood pressure independently. The "Summary of Performance Testing" for Software, Electrical Safety, EMC, and Bench performance refers to the device's inherent functionality without human intervention for the measurement process itself. The user interaction relates to operating the device (usability standard), not interpreting its output.

6. The type of ground truth used:
   For the blood pressure measurements, the ground truth for clinical validation (if detailed data were provided, which they are not) would typically be established by simultaneous measurements using a reference method, such as a mercury sphygmomanometer operated by trained personnel, per the requirements of ISO 81060-2. For other aspects like software, electrical safety, etc., the "ground truth" is adherence to the specified technical standards.

7. The sample size for the training set:
   This device does not utilize a "training set" in the context of machine learning, as it is not an AI/ML-powered device. Its operation is based on established oscillometric principles rather than learned algorithms from a dataset.

8. How the ground truth for the training set was established:
   Not applicable, as there is no "training set" for this type of device.

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