(201 days)
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with arm circumference ranging from 7 inches to 20 inches (from 17 cm to 50 cm).
The device is a digital monitor intended for use in measuring blood pressure and pulse rate.
The provided text is a 510(k) premarket notification approval letter for the Omron Intellisense™ Digital Blood Pressure Monitor, Model HEM-907XL. It largely focuses on regulatory approval and does not contain detailed information about specific acceptance criteria or the study that proves the device meets them. Therefore, I cannot fully answer your request based solely on the provided input.
However, I can interpret what would typically be required for such a device and infer some information based on the device type and regulatory context. I will highlight what is directly available and what is inferred/typical.
Here's an attempt to answer your questions based on the provided text and general knowledge of medical device approvals for non-invasive blood pressure monitors:
1. Table of acceptance criteria and the reported device performance
The provided document does not explicitly state specific acceptance criteria or report device performance in a table format. For a blood pressure monitor, typical acceptance criteria would be based on recognized standards (e.g., AAMI, ISO 81060-2). These standards usually quantify accuracy as the mean difference and standard deviation between the device's readings and a reference method (like a sphygmomanometer used by trained observers).
Inferred/Typical Acceptance Criteria (based on standards like AAMI/ISO 81060-2):
| Parameter | Acceptance Criteria (Inferred/Typical) | Reported Device Performance (Not in document) |
|---|---|---|
| Mean Absolute Difference (all) | ≤ 5 mmHg | Not reported |
| Mean Difference (systolic) | ≤ ± 5 mmHg | Not reported |
| Mean Difference (diastolic) | ≤ ± 5 mmHg | Not reported |
| Standard Deviation (systolic) | ≤ 8 mmHg | Not reported |
| Standard Deviation (diastolic) | ≤ 8 mmHg | Not reported |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided text. For blood pressure monitors, clinical validation studies typically involve a minimum of 85 subjects (per AAMI/ISO standards) to ensure sufficient data points across various blood pressure ranges.
- Data Provenance: Not specified in the provided text. Such studies are typically prospective clinical trials. The country of origin is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified in the provided text. For blood pressure monitor validation, ground truth is established by multiple trained observers (typically 2 or 3) using a reference sphygmomanometer, often auscultatory.
- Qualifications of Experts: Not specified. They would typically be trained medical professionals or technicians highly proficient in manual blood pressure measurement using auscultation, with their performance regularly checked for inter-observer variability.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified in the provided text. If multiple observers are used, a common method involves two independent observers taking readings, and if their readings differ by more than a pre-defined threshold (e.g., 4 mmHg), a third independent observer would take an additional reading, or the measurements would be discarded/repeated. This is often referred to as a "double-observer" or "co-observer" method.
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
- MRMC Study: No, this device (a digital blood pressure monitor) is not an AI-assisted diagnostic tool that involves radiologists or "human readers" in the sense of image interpretation. Therefore, an MRMC comparative effectiveness study where human readers improve with or without AI assistance is not applicable to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Yes, the fundamental performance assessment of a digital blood pressure monitor is inherently a standalone performance evaluation. The device's algorithm measures blood pressure and pulse rate automatically and independently, without direct human influence on the measurement process itself, aside from proper cuff placement and activation. The accuracy is then compared against a human-obtained reference standard.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: For a blood pressure monitor, the ground truth would be established through expert consensus (or comparison) against a reference standard method, typically auscultatory measurement by trained observers using a mercury or an adequately validated aneroid sphygmomanometer.
8. The sample size for the training set
- Training Set Sample Size: This information is not applicable in the traditional sense of machine learning model training sets, as the Omron Intellisense™ Digital Blood Pressure Monitor is a hardware device with an embedded algorithm, not a machine learning model that undergoes continuous training with new data. Its calibration and core algorithm were developed and validated in a more traditional engineering sense. The closest equivalents would be the data used during initial algorithm development and internal testing, which is separate from the clinical validation (test set). This information is not typically disclosed in an FDA approval letter.
9. How the ground truth for the training set was established
- Training Set Ground Truth Establishment: Similar to point 8, this is not applicable as a "training set" in the modern AI/ML context. The ground truth for developing the device's algorithms and calibration would have been established through controlled experimental settings using reference blood pressure measurement techniques (e.g., invasive arterial lines for initial validation, or highly controlled auscultatory measurements) to optimize the device's measurement accuracy. This developmental information is proprietary and not part of the public 510(k) summary.
Summary of Limitations:
The provided FDA letter is a regulatory approval document and focuses on demonstrating substantial equivalence to a predicate device. It does not contain the detailed technical and clinical study report information that would typically include the specific data requested in your prompt. This type of detailed data would be found in the device's 510(k) submission, specifically the clinical validation study report, which is usually not included in the public-facing approval letter.
§ 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).