(350 days)
Model EW243 and model EW254 are intended to be used for the oscillometric PRECISE LOGIC™ measurement of systolic and diastolic blood pressure and pulse rate using a pressurized cuff.
These devices are designed for use by adults. These devices should not be used on infants or toddlers, for continuous monitoring medical emergencies or operations, or for any other purpose other than measuring blood pressure.
Blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultation method, within the limits prescribed by the American National Standard, Electronic or Automated Sphygmomanometers.
MECA intends to market two battery-operated, non-invasive, digital, electronic, arm blood pressure monitors, model EW243 and model EW254.
Here's a breakdown of the acceptance criteria and study information for the Matsushita Electric Corporation of America's Blood Pressure Monitors, Model EW243 and Model EW254, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state numerical acceptance criteria in a table format. However, it does state the overall performance claim for the device.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Blood pressure measurements are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultation method, within the limits prescribed by the American National Standard, Electronic or Automated Sphygmomanometers. | "This study demonstrates that MECA's arm blood pressure monitors can accurately measure blood pressure." |
Important Note: The document refers to meeting the "limits prescribed by the American National Standard, Electronic or Automated Sphygmomanometers" as the benchmark for equivalence. The specific numerical limits of this standard are not detailed in the provided text.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the provided text. The text only mentions "a clinical study was conducted using model EW254."
- Data Provenance: Not explicitly stated. There is no mention of the country of origin or whether the study was retrospective or prospective. Given the nature of a clinical study for device approval, it is highly likely to be prospective, but this is an inference, not a direct statement.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not explicitly stated. The text refers to "a trained observer using the cuff/stethoscope auscultation method" for ground truth establishment. It does not quantify how many such observers were used, nor does it specify their qualifications (e.g., years of experience).
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated. Given that the ground truth is established by a "trained observer using the cuff/stethoscope auscultation method," it implies a comparison to a widely accepted clinical standard. There is no mention of multiple observers or any specific adjudication process like 2+1 or 3+1.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, there is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The study described focuses on the device's accuracy against a standard human measurement, not on human readers improving with AI assistance.
- Effect Size of Human Readers with AI: Not applicable, as no MRMC study involving AI assistance was mentioned.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Performance Study: Yes, a standalone performance study was done. The clinical study specifically evaluated the "arm blood pressure monitors" (EW254) to demonstrate their accuracy in measuring blood pressure independently. While "algorithm only" is a modern term, the described clinical study directly assesses the device's measurement capability without human intervention in the measurement process (beyond applying the cuff and starting the device). It states: "This study demonstrates that MECA's arm blood pressure monitors can accurately measure blood pressure."
7. Type of Ground Truth Used
- Ground Truth Type: Expert consensus/clinical standard. The ground truth was established by "a trained observer using the cuff/stethoscope auscultation method." This is a widely accepted clinical standard for blood pressure measurement.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not explicitly stated. The document mentions that the devices "use the same blood pressure measurement algorithm" as the predicate device (EW277), but "the values for the matrix table and constants have been modified to account for differences in the volume and pressure in the arm." It does not provide details on a specific training set size for these modifications.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not explicitly detailed. While the underlying algorithm is shared with the predicate device, it's inferred that the modifications to the "matrix table and constants" would have been informed by data reflecting arm measurements. However, the specific method for establishing ground truth for this "training" or adjustment phase is not described in the provided text.
§ 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).