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The TONOPORT VI is a small-size, lightweight, portable, non-invasive blood pressure (NIBP) monitor for ambulatory measurement of the blood pressure by the oscillometric method. The cuff is borne on the upper arm and an electrical pump in the device generates the pressure in the cuff. The TONOPRT VI is powered by two AA size batteries (alkaline or rechargeable NiMH batteries). The device records up to 400 blood pressurements at predefined intervals. In order to assess the measurements, the stored data can be transmitted via a RS-232. USB 1.1 or USB 2.0 interface to a PC for further evaluation or archiving purposes by analysis software.

TONOPORT VI is intended to be used for measuring the systolic, diastolic, mean arterial blood pressure and the heart rate of human beings.

The intended paient populations are adults and children (but not neonates) with a circumference of the upper arm in the range of 17 to 42 cm.

TONOPORT VI is a prescription device in health care medicine and is intended for use following consultation and instruction by a physician (family doctor, specialist or hospital). It can be used, if the physical condition of the patient allows an automatic, non-invasive blood pressurement. Preparation and application of the TONOPORT VI is done by medically trained staff. The patient does not operate with the TONOPORT VI by himself. TONOPORT VI is not intended to be used in intensive care medicine or for alarming of life-threatening conditions.

A measurement with TONOPORT VI can be combined with other measurements and medical examinations at the patient that a diagnosis about the patient's health condition depends not alone from the measurement of the TONOPORT VI.

The TONOPORT VI measures the blood pressure non-invasively and provides the systolic, diastolic, mean arterial blood pressure and the heart rate of human beings. The cuff is borne on the upper arm of the patient and an electrical pump in the device generates the pressure in the cuff. The TONOPRT VI is powered by two AA size batteries (alkaline or rechargeable NiMH batteries). The device records up to 400 blood pressure measurements at predefined intervals. In order to assess the measurements, the stored data can be transmitted via a RS-232, USB 1.1 or USB 2.0 interface to a PC for further evaluation or archiving purposes by analysis software. It is intended to get used by physicians (primary care physician, specialists and hospitals).

The provided document is a 510(k) premarket notification for a medical device called TONOPORT VI, a non-invasive blood pressure (NIBP) monitor. It primarily focuses on demonstrating substantial equivalence to a predicate device, TONOPORT V, rather than providing a detailed clinical study for novel performance claims.

Therefore, the specific information requested about acceptance criteria and a study proving the device meets those criteria, especially in the context of AI/human reader performance, MRMC studies, or training/test set ground truth establishment, is not present in this document. This device is a traditional medical device (NIBP monitor) and not an AI/ML-driven device or an imaging device that would typically undergo such studies.

However, based on the provided document, here's what can be inferred about acceptance criteria for this type of device and the performance demonstrated:

Acceptance Criteria and Reported Device Performance (Inferred from Substantial Equivalence and Standards Compliance)

Given that this is a 510(k) submission for a non-invasive blood pressure monitor, the primary acceptance criteria revolve around the device's ability to accurately measure blood pressure and heart rate, meet safety standards, and demonstrate equivalence to a legally marketed predicate device. While explicit "acceptance criteria" tables with numerical targets are not provided in this regulatory letter, they are implicitly met by demonstrating compliance with recognized standards.

Regarding the other specific questions, based on the provided document:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • The document does not describe a specific clinical "test set" or study with human subjects for performance evaluation (other than, presumably, tests required by the listed standards).
   • It explicitly states: "An assessment of clinical data to show safety and performance of the device was not made, because the TONOPORT VI uses identical algorithms for the blood pressure measurement like the predicate device TONOPORT V." This indicates the submission relies on the predicate's established clinical performance and the new device's compliance with electrical and performance standards.

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 applicable. No expert ground truth establishment for a test set is described, as it's not a diagnostic imaging device or an AI/ML device requiring human expert review for performance evaluation.

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

   • Not applicable. No such adjudication method is described.

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

   • No such study was done or described. This device is an NIBP monitor, not an AI-assisted diagnostic tool that would typically undergo MRMC studies.

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

   • While the device's core function is an "algorithm only" (oscillometric method), the document describes it as a physical device that functions to measure BP. It doesn't detail a "standalone" algorithmic performance study in the context of an AI/ML submission where such a study would test the algorithm's output against ground truth. Its performance is implicitly deemed acceptable by meeting the industry standards (IEC 80601-2-30) for blood pressure measuring systems, which ensures accuracy.

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

   • For blood pressure monitors, accuracy is typically validated against a reference standard (e.g., invasive arterial blood pressure measurement or auscultation with a trained observer) as part of the standards compliance (IEC 80601-2-30). However, the document does not detail these specific ground truth methodologies or study results, instead relying on compliance with the standard which dictates these.

8. The sample size for the training set

   • Not applicable. This document describes a traditional NIBP device, not an AI/ML device that undergoes "training." The "algorithms" mentioned are established signal processing and measurement algorithms, not machine learning algorithms requiring a distinct training set.

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

   • Not applicable. See explanation for point 8.

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The Tonoport V is intended to be used for measuring the systolic, diastolic, mean blood pressure and the heart rate of human beings for periods up to 30 hours. The intended patient populations are adults and children (but not neonates) with a circumference of the upper arm in the range of 17 cm to 42 cm. Tonoport V is a prescription device in health care medicine. It can be used, if the physical condition of the patient allows an automatic, non-invasive blood pressure measuring under his observation. Medically trained staff like a doctor or nurse, etc should do this judgment as well as the accommodation of the patients and the preparation and application of the Tonoport. The patient does not operate with the Tonoport V by himself. A measurement with Tonoport V is combined with other measurements and medical examinations at the patient, so that a diagnosis about the patient's health condition depends not alone from the measurement of the Tonoport V. Tonoport V is not intended to be used in home care medicine or in intensive care medicine or for alarming of life-threatening conditions.

The Tonoport V is a compact, lightweight, patient-borne, non-invasive blood pressure (NIBP) holter using the oscillometric method. The cuff is borne on the upper arm and an electrical pump inside the device generates the pressure in the cuff. The Tonoport V is powered from two AA size batteries (alkaline or rechargeable NiMH batteries). For periods of up to 30 hours it records the patient's blood pressure at predefined intervals and save the results. In order to assess the measurements, the stored data can be transmitted via a RS-232 interface to a 9-needle dot-matrix printer with serial interface (EPSON LX-300+) or to another medical device for further evaluation or archiving purposes.

The provided 510(k) summary for the Tonoport V device does not contain the specific details required to fully answer all aspects of your request regarding acceptance criteria and a study proving those criteria were met.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions compliance with "voluntary and mandatory standards" and "performance standards" but does not explicitly state quantitative acceptance criteria (e.g., specific accuracy ranges for blood pressure measurements) or numerical results of device performance against such criteria.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the given text. There is no mention of a specific test set, its size, or the geographic origin (country of origin) or temporal nature (retrospective/prospective) of the data used for testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the given text. There's no mention of a test set, let alone experts establishing ground truth for it.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This information is not provided in the given text. The document focuses on the device's technical aspects and equivalence to a predicate, not on its impact on human reader performance.

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

The Tonoport V is described as a "patient-borne, non-invasive blood pressure (NIBP) holter using the oscillometric method." It is a standalone device that records blood pressure at predefined intervals. The "algorithm only" performance would refer to the device's inherent ability to measure blood pressure, which is central to its function. The document states: "The results of these measurements demonstrated that the Tonoport V is as safe, as effective, and performs as well as the predicate device." This implies standalone performance testing was conducted, but specific metrics are not detailed.

7. The Type of Ground Truth Used

Given that the device measures blood pressure, the ground truth for an NIBP device is typically established through comparison with a validated reference standard blood pressure measurement method, such as auscultatory blood pressure measurement by trained observers or an invasive arterial line. However, the document does not specify the exact type of ground truth used in its testing. It only states "The Tonoport V complies with the voluntary and mandatory standards as detailed in Section 12 of this submission," which would presumably dictate or reference methods for establishing ground truth for NIBP devices.

8. The Sample Size for the Training Set

This information is not provided in the given text. Being a device from 2001, the concept of "training set" for AI/machine learning models as we understand it today might not have been applicable in the same way. The device relies on the oscillometric method, which is a well-established physiological principle rather than a machine learning algorithm requiring a "training set" in the modern sense.

9. How the Ground Truth for the Training Set Was Established

As above, this information is not provided and the concept of a "training set" for this type of device from this era is likely not directly applicable. The device's calibration and accuracy would be established through a different validation process against reference standards.

Summary of Study Context from the Document:

The 510(k) submission highlights several quality assurance measures applied to the development of the Tonoport V, including:

• Requirements specification review
• Software and hardware testing
• Safety testing
• Environmental testing
• Final verification and validation
• Compliance with performance standards

The overarching conclusion of the "Test Summary" is: "The results of these measurements demonstrated that the Tonoport V is as safe, as effective, and performs as well as the predicate device."

This indicates that internal testing was conducted to ensure the device met its design specifications and performed comparably to the predicate device (ABPM Mobil-o-Graph Blood Pressure Monitor, Model ABP Control K964235). However, the specific details of these tests (acceptance criteria, sample sizes, ground truth methods, expert involvement, etc.) are not included in this 510(k) summary.

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