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The Commander III device is for use by patients to collect and transmit general health questions and patient vital sign data (such as weight, blood pressure, glucose, pulse oximetry, peak flow) between the patient, typically at home, and a health care professional at a remote site.
Contraindications, Precautions and Warnings: The Commander III device makes no interpretation, evaluation, medical judgments or recommendations for treatment. Clinical judgment and experience are required to check and interpret the information transmitted. The Commander III is not intended as a substitute for medical care.

Commander III is similar to a simple personal computer with a modem that stores and transmits data. Commander III connects to a user's telephone line at home. It has a display that asks health related questions to which the user can respond 'Yes', 'No', or select from a list. It also has inputs for devices such as weight scales, blood pressure meters, glucometers, peak flow meters and pulse oximeters. These devices download data through a RS232 connection. The functionality of these devices has not been modified; they are used as supplied from the manufacturer.

Here's an analysis of the provided text regarding the Cardiocom Commander III, broken down by your requested categories.

Important Note: The provided document is a 510(k) summary for a medical device seeking clearance based on substantial equivalence. This type of submission relies on showing that a new device is as safe and effective as a legally marketed predicate device (K982481 A&D Medical UA-767PC Digital Blood Pressure Monitor in this case), rather than requiring extensive de novo clinical trials to prove efficacy from scratch. Therefore, many of the typical acceptance criteria and study details for AI/ML devices, such as multi-reader multi-case studies or detailed ground truth establishment, are not present in this type of submission. The focus is on demonstrating comparability to the predicate device, particularly in areas like accuracy and safety standards.

Acceptance Criteria and Device Performance

Study Proving Acceptance Criteria:

The document states, "The results of bench, laboratory, and clinical testing indicates that the new device is as safe and effective as the predicate device." And in the conclusion: "After analyzing bench, test laboratory, and clinical testing data, it is the conclusion of Cardiocom that the Cardiocom Commander III is as safe and effective as the predicate device, has essentially no significant technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device."

This indicates that studies were performed to demonstrate that the Commander III meets the same performance and safety standards as the predicate device, specifically ANSI/AAMI SP10: 1992+A1 for blood pressure accuracy.

Additional Information Not Extensively Detailed in the Provided Text:

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

   • The document mentions "clinical testing data" but does not specify the sample size for a test set or the data provenance (e.g., country of origin, retrospective/prospective). As a 510(k) based on substantial equivalence, the clinical testing would likely be focused on demonstrating comparable performance to the predicate against established standards (like AAMI SP10), which often involves a specific number of subjects. However, these specifics are not in the provided summary.

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

   • Not applicable/Not specified in this type of submission. For blood pressure monitors, accuracy is typically assessed against a reference standard (e.g., a mercury sphygmomanometer used by trained clinicians) rather than "expert consensus" in the way it applies to diagnostic image interpretation. The AAMI SP10 standard outlines the methodology for such validation tests.

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

   • Not applicable/Not specified. "Adjudication" typically refers to resolving discrepancies in expert interpretations, which isn't the primary method for validating blood pressure device accuracy.

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. This device is a measurement system, not an AI diagnostic tool that assists human readers/interpreters. There is no mention of AI or human-in-the-loop performance measurement in the provided text.

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

   • Yes, in the sense that the device's ability to measure blood pressure, pulse, etc., is evaluated as a standalone function primarily against established standards (like AAMI SP10). The device itself is a standalone measurement system for collecting vital signs.

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

   • For blood pressure accuracy, the ground truth would typically be established by a reference method, such as a mercury sphygmomanometer, performed by trained observers according to standard protocols (e.g., specified in AAMI SP10). The document refers to "clinical testing data" which would be based on this type of ground truth.

7. The sample size for the training set:

   • Not applicable/Not specified. This device is not described as using machine learning or AI that would require a distinct "training set." It is a hardware and software system for data collection and transmission.

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

   • Not applicable, as a training set, as typically understood for AI/ML, is not described for this device.

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The Commander III device is for use by patients to collect and transmit general health questions and patient vital sign data (such as weight, blood pressure, glucose, pulse oximetry, peak flow) between the patient, typically at home, and a health care professional at a remote site.

Commander III is similar to a simple personal computer with a modem that stores and transmits data. Commender III connects to a user's telephone line at home. It has a display that asks health related questions to which the user can respond 'Yes', 'No', or select from a list. It contains an integrated blood pressure meter. It also has inputs for devices such as weight scales, glucometers, peak flow meters and pulse oximeters. These devices download data through a RS232 connection. The functionality of these devices has not been modified; they are used as supplied from the manufacturer.

Here's the analysis of the provided text regarding the Cardiocom Commander III device, focusing on its acceptance criteria and the study used to prove it meets them:

Disclaimer: The provided document is a 510(k) summary, which is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. It is not generally a detailed clinical study report and thus may not contain all the specific metrics and methodologies typically found in such a report. Many of the requested details (like specific statistical measures for performance, sample sizes for training data, expert qualifications, etc.) are not explicitly stated in this type of regulatory submission and would be found in the actual studies conducted by the manufacturer, which are summarized or referenced here.

Acceptance Criteria and Reported Device Performance

The provided 510(k) summary for the Cardiocom Commander III does not define explicit, quantitative acceptance criteria for its performance. Instead, the core of this submission is a demonstration of substantial equivalence to a predicate device (Cardiocom LLC Commander II). This means the acceptance criterion is implicitly that the new device is "as safe and effective" as the predicate device.

The reported device performance, in this context, is that the new device maintains the same functionalities and performance characteristics as the predicate, especially regarding its core function of oscillometric automated blood pressure monitoring.

Study Details

The submission refers to "bench, laboratory, and clinical testing data" to support its claim of substantial equivalence. However, the details of these studies are very brief, which is typical for a 510(k) summary.

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

   • Test Set Sample Size: Not explicitly stated. The document simply mentions "clinical testing data."
   • Data Provenance: Not specified (e.g., country of origin). The document does not indicate if the data was retrospective or prospective.

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

   • Number of Experts: Not mentioned.
   • Qualifications of Experts: Not mentioned.

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

   • Not mentioned.

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:

   • This is not applicable to this device. The Cardiocom Commander III is a non-invasive automated blood pressure monitor and a data collection/transmission system. It does not involve human "readers" interpreting medical images or data in a way that an AI would assist.

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

   • Yes, for the blood pressure measurement component, the device would have undergone standalone performance testing against reference standards, as required for blood pressure devices. The submission states, "The Commander III has a built in NIBP meter," and this component's accuracy would have been validated. However, the specific results of this standalone performance (e.g., mean difference, standard deviation compared to a reference sphygmomanometer as per ISO standards) are not provided in this summary. The summary broadly states "bench, laboratory, and clinical testing data."

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

   • For the blood pressure meter component, the ground truth would typically be a simultaneous measurement by a trained observer using a calibrated mercury sphygmomanometer or an equivalent reference standard, adhering to recognized protocols for blood pressure device validation (e.g., ANSI/AAMI/ISO 81060-2). For the other vital sign inputs (glucometers, pulse oximeters, peak flow meters), the ground truth would be established by the respective reference devices' measurements, as the Commander III acts as a data collector and transmitter for these, not the primary measurement device (except for the built-in NIBP).

7. The sample size for the training set:

   • Not applicable/Not mentioned. This device does not appear to employ a machine learning or AI model that requires a "training set" in the conventional sense of AI algorithms that learn from data. It's a hardware device with embedded firmware for data collection and transmission.

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

   • Not applicable. As above, there's no indication of a machine learning "training set" being used for this device.

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The Commander II device is for use by patients to collect and transmit general health questions and patient vital sign data (such as weight, blood pressure, glucose, pulse oximetry, peak flow) between the patient, typically at home, and a health care professional at a remote site.

The Commander II is an automated device that connects to the user's telephone system at home. It has a display that asks the user health related questions and has inputs for devices such as weight scales, blood pressure meters, and other vital sign measurement devices.

The provided text is a 510(k) premarket notification for the Commander II device, which is an automated system for collecting and transmitting patient health data. This document does not contain the detailed study information or acceptance criteria typically found for studies evaluating the performance of a medical device against specific metrics, especially not for AI-enabled devices or clinical efficacy studies.

Instead, the document focuses on:

• Device Description and Intended Use: Explaining what the Commander II is and what it does.
• Substantial Equivalence to a Predicate Device: Arguing that the Commander II is similar enough to an already approved device (Home Care Monitoring System, AvidCare Corp., K010029) to be cleared for market.
• Safety and Functional Testing: Mentioning compliance with general electrical safety, emissions, and telephone network standards (EN60601-1-2, EN61000-3-2, FCC Part 68, UL/C-UL). It states "Verification and validation testing was conducted to establish performance and reliability characteristics of the device," but does not provide details of these tests, their acceptance criteria, or their results in a quantifiable manner.

Therefore, I cannot fulfill the request for a table of acceptance criteria, reported device performance, sample sizes, ground truth establishment, or specific study details like MRMC or standalone performance, as this information is not present in the provided text.

The document essentially states that the device was tested to general safety and operational standards and that these tests, along with the low-risk device type, led Cardiocom to conclude there are "no significant concerns about safety and effectiveness." It does not provide the kind of performance data (e.g., sensitivity, specificity, accuracy for a specific task) that would typically be associated with acceptance criteria for a diagnostic or AI-powered medical device.

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