(269 days)
The HEM-9000AI is intended to measure systolic and diastolic blood pressure, and pulse rate in adults with an arm circumference of 17-50 cm (7-20 inches) and to measure/calculate radial augmentation index (AI). The HEM-9000AI is intended for use in physician's offices, hospitals, clinics and other medical facilities where non-invasive blood pressure and radial augmentation index measurements/calculations are performed on patients and invasive measurement is contraindicated.
The augmentation index (AI) function of the HEM-9000AI has not been evaluated on patients who have inter-ventricular conduction delays (IVCD).
The HEM-9000AI is an oscillometric NIBP measurement and applanation tonometry augmentation index (AI) measurement/calculation device. The HEM-9000AI utilizes both an oscillometric blood pressure detection technology via a cuff wrap at upper arm as well as a tonometry measurement at the radial artery at the HEM-9000AI measures the oscillometric signal for NIBP measurement and processes the data through its CPU and algorithm within the device. It provides measurements of systolic and diastolic blood pressures, as well as pulse rate for adult patients with upper arm circumference in the range of 7 - 20 inches (17 -- 50 cm). AI information is collected via tonometry by the placement of a set of sensors over the radial artery at the wrist. The tonometer applies pressure and compresses the radial artery until sensors detect the pulse wave (PW). The signal is sent back to the central processor, which separates the superimposed waveform into the eiected wave and the reflected wave components. AI is derived from the pulse wave by calculating the amplitude-ratio of "reflected wave" to "ejected wave" at the radial artery. All information appears on the device display and can be printed. The device is self-contained, single unit with both oscillsometric and tonometry signal detection built in.
Here's a breakdown of the acceptance criteria and study information for the HEM-9000AI, based on the provided 510(k) summary:
Acceptance Criteria and Reported Device Performance
The provided document specifically mentions two key performance aspects: Non-Invasive Blood Pressure (NIBP) measurement and Augmentation Index (AI) measurement/calculation.
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance | Comments |
|---|---|---|---|
| NIBP Measurement | ANSI/AAMI SP-10:2002 | Validated by adhering to the tests in ANSI/AAMI SP-10:2002. | The device's NIBP algorithm and hardware are stated to be the same as the predicate device HEM-907XL, which was likely also validated to this standard. |
| Augmentation Index (AI) | Conformance to "device specification for this aspect" and "accuracy." | Clinical studies demonstrated that the calculation of Augmentation Index is highly reproducible. A direct comparison with the predicate SphygmoCor Px on 162 patients showed similar results for displayed radial AI. | While "highly reproducible" and "similar results" are reported, specific quantitative metrics (e.g., mean difference, standard deviation of differences) are not detailed in this summary. |
Study Details
Here's a summary of the study details based on the provided text:
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Sample Size used for the test set and the data provenance:
- Augmentation Index (AI) Comparison: 162 patients.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "sequential order" measurements on patients, suggesting a prospective design for this particular comparison.
- NIBP Testing: The document mentions "Clinical testing for the NIBP aspect was performed in accordance with the specific requirements established within ANSI/AAMI SP-10:2002." ANSI/AAMI SP-10 typically requires a certain number of subjects (e.g., 85 adult subjects) for clinical validation, but the exact count isn't specified here for the HEM-9000AI's NIBP component.
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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 the provided summary. For NIBP validation against AAMI SP-10, the "ground truth" would typically be invasive arterial pressure measurements, not expert consensus. For AI, the "ground truth" was essentially the measurement from the predicate device (SphygmoCor Px).
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. The clinical testing described does not involve subjective interpretations requiring adjudication.
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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 device, not an AI-assisted diagnostic imaging or interpretation system that would typically involve human readers.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, implicitly. The performance evaluation for both NIBP and AI describes the device's measurements/calculations as standalone outputs, without human interpretation of the algorithm's direct output being part of the primary evaluation. The comparison to the predicate device is a standalone performance metric.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- NIBP: Conformance to ANSI/AAMI SP-10:2002 typically implies comparison against invasive arterial blood pressure measurements as the reference standard (ground truth). This is not explicitly stated but is the common practice for such standards.
- Augmentation Index (AI): The "ground truth" for the AI comparison was the measurement obtained from the predicate device, SphygmoCor Px, on the left radial artery. The study aimed to show "similar results" to this established device.
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The sample size for the training set:
- Not specified. The document primarily discusses performance testing (validation) rather than explicit details about the development or training of the AI algorithms. The NIBP algorithm is stated to be the "same" as the HEM-907XL, suggesting it was already established. The AI calculation is mentioned, but its development process or training data size is not detailed.
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How the ground truth for the training set was established:
- Not specified. As noted above, details about algorithm development or training ground truth are not provided in this summary.
§ 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).