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The tenso-comfort BPM 105 /BPM 205 is a wrist non-invasive blood pressure device which is intended for use in measuring blood pressure and pulse rate in adult patient population. The measuring method is an oscillometric blood pressure measurement with automatic sequence and refers to the auscultatory method as the reference standard. The model version BPM 105 is equipped with a radio module to transmit the measurement data to a PC. The device is not intended for neonatal use.

The non-invasive wrist blood pressure meter BPM105 and BPM205 determine the arterial blood pressure by means of the oscillometric blood pressure measuring method. With this method the pressure fluctuations are measured, which develop when depressing pulse-cyclic blood pulses in the compressed arteria under the blood pressure cuff put on. The blood pressure apparatus in the model variant BPM105 is equipped with a radio module, with which the transmission of the stored measured values on a PC is optionally possible (radio interface for PC and software is offered as accessory).

Here's a summary of the acceptance criteria and the study information for the tenso-comfort BPM 105 / 205 device, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The acceptance criteria for the tenso-comfort BPM 105 / 205 focus on its measurement accuracy compared to established standards for non-invasive blood pressure devices.

Note: The document explicitly states "The measuring method is an oscillometric blood pressure measurement with automatic sequence and refers to the auscultatory method as the reference standard." This implies that the device's accuracy was compared against auscultatory measurements, which is a standard method for validating blood pressure monitors.

Study Information

The provided 510(k) summary does not include a detailed report of a specific clinical study proving the device meets the acceptance criteria. Instead, it relies on demonstrating substantial equivalence to a predicate device, the TaiDoc Clever TD-3018A (K051703), which presumably has already undergone such validation.

The substantial equivalence discussion indicates that the measurement accuracy of the tenso-comfort BPM 105 / 205 is claimed to be equivalent to that of the predicate device.

Given the information provided, many of the requested details about a specific validation study are absent. However, based on what is available, we can infer the following:

2. Sample size used for the test set and the data provenance: Not explicitly stated in the provided text. The document refers to the oscillometric method referring to the auscultatory method as the reference standard, implying such testing would have been done.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated. For validation against an auscultatory method, it would typically involve trained medical professionals taking blood pressure measurements.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not explicitly stated.
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 a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, implicitly. The listed accuracy metrics for Pressure and Pulse are for the device's performance directly, without human intervention in the measurement process (beyond operating the device). The device's oscillometric method is an algorithm that directly provides the blood pressure and pulse readings.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for blood pressure measurement is stated as the "auscultatory method as the reference standard." This typically involves measurements taken by trained healthcare professionals using a stethoscope and sphygmomanometer.
8. The sample size for the training set: Not applicable and not mentioned. This is a measurement device, not an AI model that requires a training set in the conventional sense. The "training" of such a device refers to its design and calibration processes.
9. How the ground truth for the training set was established: Not applicable for a training set in the context of an AI model. For the device's design and calibration, the reference standard would be the auscultatory method.

In summary, the 510(k) summary primarily demonstrates substantial equivalence to a predicate device by comparing technical specifications and intended use. While it states the device operates under the oscillometric method with reference to the auscultatory standard for accuracy, the specific details of a dedicated clinical validation study for this device (tenso-comfort BPM 105 / 205) are not provided in this document. Such studies would have been performed for the predicate device and the new device would be expected to perform similarly given the equivalence argument.

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Innocor is indicated for the determination of a number of hemodynamic parameters. Cardiac Output (CO) is the principal measured parameter. Utilizing inert gas rebreathing, Innocor measures the relative levels of two inhaled gases of differing blood solubility over approximately 3-4 respirations and calculates pulmonary blood flow (PBF). In the absence of a significant intrapulmonary shunt (arterial oxygen saturation ≤ 95% as measured by a pulse oximeter incorporated in the Innocor), PBF is equal to CC. As an optional accessory, Innocor includes a noninvasive Blood Pressure (NIBP) monitoring system. This option provides systolic, diastolic and mean arterial pressures. With the NIBP option, Innocor provides values for the following measured and calculated hemodynamic parameters: Cardiac Output, Arterial Oxygen Saturation, Heart Rate, Stroke Volume, Lung Volume, Cardiac Index, troke Index, Blood Pressures (Systolic, Diastolic, Mean Arterial), ystemic Vascular Resistance, Systemic Vascular Resistance Index.

Innocor is a compact point-of-care device intended to be used for measurement of a) cardiac output (CO) utilizing inert gas rebreathing (IGR) technology and b) other hemodynamic parameters. Two Models will be made available initially in the U.S: Innocor, Innocor with NIBP option. With the NIBP module option, the device will provide values for the hemodynamic parameters included in the Indications for Use below.

The provided text for K051907 describes the Innocor device and its substantial equivalence to predicate devices, focusing on its ability to measure cardiac output and other hemodynamic parameters. However, it does not contain the detailed information required to fill out the table and answer the study-related questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement in a clinical study for the Innocor device itself.

The document primarily focuses on establishing substantial equivalence for regulatory purposes by comparing the Innocor's intended use and components (inert gas rebreathing for cardiac output, pulse oximeter, NIBP) to already cleared predicate devices. It lists the predicate devices and the parameters Innocor measures but does not include a specific study design with acceptance criteria and performance metrics for the Innocor.

Therefore, I cannot provide the requested table and detailed study information based solely on the provided text. The output below reflects the information that is not present in the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

3. Number of Experts and Qualifications for Ground Truth Establishment

• Number of Experts: Not specified in the provided text.
• Qualifications of Experts: Not specified in the provided text.

4. Adjudication Method for Test Set

• Adjudication Method: Not specified in the provided text.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? Not specified in the provided text. The document focuses on device equivalence, not human reader performance with or without AI assistance.
• Effect Size of Human Reader Improvement: Not applicable, as an MRMC study is not mentioned.

6. Standalone (Algorithm Only) Performance Study

• Was a standalone study done? The document describes the device's functionality for measuring various parameters. While it performs these measurements, a formal "standalone study" with specific performance metrics against an established ground truth (as typically reported for AI/algorithm performance) is not detailed. The text implies a comparison to methods like Thermodilution and Direct Fick for cardiac output, but not in the format of a standalone performance study with defined criteria and results.

7. Type of Ground Truth Used

• Type of Ground Truth: For the cardiac output measurement, the document mentions substantial equivalence to "Thermodilution Cardiac Output Computers" and the "Direct Fick Method preamendment calculation method." These predicate methods serve as a comparative basis for the Innocor's measurements, implying they represent the "truth" against which the new device is compared. However, a specific ground truth dataset and its source (e.g., pathology, outcomes data, expert consensus on a test set) for Innocor's own validation is not described.

8. Sample Size for Training Set

• Sample Size: Not applicable. The Innocor is described as a device utilizing inert gas rebreathing technology and other measurement components, not an AI/machine learning algorithm that requires a training set in the conventional sense.

9. How Ground Truth for Training Set Was Established

• How Established: Not applicable, as there is no mention of a training set for an AI/machine learning component.

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