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The Ambulo 2400 Ambulatory Blood Pressure Monitor is indicated for use in adult & pediatric patient populations; it is not indicated for use with neonates.

The Ambulo 2400 Ambulatory Blood Pressure Monitor is designed to measure systolic and diastolic blood pressure and pulse rate of adults and pediatric patients, using the oscillometric method on a cuffed arm.

The Ambulo 2400 is a compact, lightweight, non-invasive ambulatory blood monitoring system. The Ambulo 2400 can measure systolic and diastolic blood pressure and pulse rate over and pulse rate over a 24 hour period. It is easily configured and individually-fitted for each patient by a physician or health care professional. Measurements are automatically captured, without medical supervision, by the Ambulo 2400 and later downloaded to a computer for analysis and interpretation by a physician.

The provided text is a 510(k) premarket notification for the Ambulo 2400 Ambulatory Blood Pressure Monitoring System. It describes the device, its intended use, and the testing performed to demonstrate its safety and effectiveness.

However, the document does not contain specific acceptance criteria or detailed results of a study proving the device meets those criteria in the format requested. It mentions performance testing and compliance with various standards but lacks the quantitative data needed to complete the requested table and detailed study information.

Therefore, I cannot provide a complete answer to your request based on the provided text. The document refers to "predetermined requirements" and "predetermined specification" for performance and software testing but does not explicitly state what these are in numerical terms or provide the specific results that would fill out your table.

Based on the available information, here's what can be inferred and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in the provided text in a quantifiable manner (e.g., specific accuracy ranges for blood pressure). The document mentions compliance with standards like IEC 80601-2-30:2009+A1:2013 for automated non-invasive sphygmomanometers, which would contain the acceptance criteria.
• Reported Device Performance: Not numerically reported in the provided text. The document states that "Test results indicated that the Mortara Ambulo 2400 complies with its predetermined specification" and that it "performs as well as or better than the predicate device," but no actual performance numbers are given.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified. The document only states "Performance Testing - Clinical: The Ambulo 2400 was evaluated for clinical performance to demonstrate safety and effectiveness."
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not available in the provided text.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• This information is not available in the provided text.

5. 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:

• The Ambulo 2400 is an automated blood pressure monitor, not an AI assistance tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this device type.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Yes, implicitly. The device is an automated blood pressure monitor. Its primary function is to measure blood pressure without continuous human intervention during the measurement period. The "Performance Testing - Clinical" would evaluate this standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For an automated blood pressure monitor, the "ground truth" in clinical performance testing would typically be reference measurements taken simultaneously by a validated, highly accurate manual method (e.g., auscultation by trained observers) or another highly accurate automated device. The document does not specify the ground truth methodology used for its clinical testing.

8. The sample size for the training set:

• Not applicable as this is not an AI/machine learning device that requires a training set in the conventional sense. The device measures physical parameters.

9. How the ground truth for the training set was established:

• Not applicable as this is not an AI/machine learning device.

In summary, while the document confirms that clinical performance testing was conducted and that the device complies with predetermined specifications and relevant standards, it lacks the specific quantitative data and detailed methodology to answer most of your detailed questions regarding acceptance criteria and study particulars.

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The Ambulo 2400 Ambulatory Blood Pressure Monitor is designed to measure systolic and diastolic blood pressure and pulse rate of adults who are eighteen (18) years and older, using the oscillometric method on a cuffed arm.

The Ambulo 2400 is a compact, lightweight, non-invasive ambulatory blood monitoring system. The Ambulo 2400 can measure systolic and diastolic blood pressure, mean arterial pressure and pulse rate over a 24 hour period. It is easily configured and individually-fitted for each patient by a physician or health care professional. Measurements are automatically captured, without medical supervision, by the Ambulo 2400 and later downloaded to a computer for analysis and interpretation by a physician.

The provided text describes the Ambulo 2400 Ambulatory Blood Pressure Monitoring System and lists several standards it complies with. However, it does not contain:

• A table of acceptance criteria and reported device performance.
• Details of a specific study to prove the device meets acceptance criteria, including sample sizes, data provenance, ground truth establishment, or expert involvement.
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.

The document primarily focuses on regulatory compliance (510(k) summary) rather than detailing a specific performance validation study.

Therefore, for the requested information, the answer is:

• 1. A table of acceptance criteria and the reported device performance: This information is not provided in the document. The document lists several standards (e.g., AAMI/ANSI SP10;2002) that the device complies with, but it does not present the specific acceptance criteria derived from these standards alongside the device's measured performance for blood pressure accuracy. Compliance with AAMI/ANSI SP10 suggests the device would meet its accuracy requirements, which typically involve mean difference and standard deviation between the device and a reference measurement, but these specific values are absent.
• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided in the document.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not provided in the document.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided in the document.
• 5. 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: Not applicable. This device is an automated blood pressure monitor, not an AI-assisted diagnostic imaging device that involves human readers.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is a standalone automated blood pressure monitor. Its performance would inherently be "standalone" in how it measures blood pressure. However, specific details of a standalone algorithm validation study with accuracy metrics are not presented.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated in the document. For blood pressure monitors complying with standards like AAMI/ANSI SP10, the ground truth is typically established using simultaneous measurements by trained observers using a mercury sphygmomanometer or another validated reference method.
• 8. The sample size for the training set: Not provided in the document. (This is an established device, not undergoing AI model training as discussed in typical AI/ML submissions).
• 9. How the ground truth for the training set was established: Not provided in the document.

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