(32 days)
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
| Acceptance Criteria Category | Specific Criteria (from predicate) | Reported Device Performance (Commander III) |
|---|---|---|
| Blood Pressure Measurement Accuracy | Pressure: ±3 mmHg or ±2%, whichever is greater | SAME (from AAMI) - Implied to meet this |
| Pulse Rate Accuracy | Pulse: ±5% | SAME (from AAMI) - Implied to meet this |
| Measurement Range (Pressure) | 20 mmHg to 280 mmHg | SAME (from AAMI) - Implied to meet this |
| Measurement Range (Pulse) | 40 to 200 pulses/minute | SAME (from AAMI) - Implied to meet this |
| Operating Principle | Oscillometric automated blood pressure monitoring | SAME |
| Display | LCD: Systolic, Diastolic, Pulse | SAME |
| Standards Compliance | ANSI/AAMI SP10: 1992+A1 (Blood Pressure Sphygmomanometers) | SAME |
| Electrical Safety | UL/IEC 60601-1 | UL/IEC 60601-1 |
| Electromagnetic Compatibility | IEC 60601-1-2 | IEC 60601-1-2 |
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:
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).