(181 days)
The Lifeclinic 2400 is intended to be used by the general public so that a user can measure his/her own blood pressure and pulse rate. It is not a diagnostic device, and only furnishes data so that users can consult their personal physicians.
The Lifeclinic LC500 is indicated for the measurement of blood pressure and heart rate by members of the general public. The device does not perform any diagnoses; it only provides pressure and rate data to the users, who are advised to consult a physician.
The Lifeclinic 2400 is an automated system for measuring blood pressure and pulse rate designed to be used by the general public in stores and other places. It is completely automatic, and measures blood pressure by the oscillometric method. The user is guided by a series of interactive screens and voice instructions.
The Lifeclinic 2400 consists of a fixed cuff into which the user inserts an arm. The cuff automatically inflates and then deflates after the user presses a button. The device measures blood pressure using the oscillometric method.
The provided document is limited in detail regarding acceptance criteria and a definitive study proving the device meets said criteria. However, based on the available information, here's an attempt to answer the questions:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| All required AAMI tests for such devices | The unit meets all required AAMI tests for such devices. |
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 for the test set: Not specified.
- Data provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as the document states "Clinical tests: Not required" and the non-clinical tests likely refer to AAMI standards which do not typically involve expert-established ground truth in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no clinical test set or expert adjudication is mentioned.
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
- This is not applicable since the device is an automated blood pressure measurement system, not an AI-assisted diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, a standalone evaluation was done. The document states: "The Lifeclinic 2400 is a completely automatic, and measures blood pressure by the oscillometric method... The unit meets all required AAMI tests for such devices." This implies the device's performance was evaluated based on its automated measurement capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth for the non-clinical tests (AAMI standards) would likely be established in accordance with the specific AAMI protocol for blood pressure monitors, which typically involves comparing the device's measurements against a reference standard (e.g., a mercury sphygmomanometer reading by trained observers). The document doesn't specify the exact ground truth used within the AAMI tests, but it would be a standardized, objective measurement.
8. The sample size for the training set
- Not applicable. The document describes a medical device, not an AI/ML model that would require a distinct training set. The term "training set" is usually relevant for machine learning algorithms.
9. How the ground truth for the training set was established
- Not applicable (see point 8).
§ 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).