(18 days)
The CSI Model 5K Managed Health System Kiosk is intended for use by the general public to measure blood pressure, pulse and weight. It is not intended to be a diagnostic device; it only provides data on blood pressure, heart rate and weight and users are advised to consult a physician.
The CSI Model 5K Managed Health System Kiosk provides an unsupervised means for measuring and tracking an individual's blood pressure (both systolic and diastolic) and pulse rate. The kiosk can typically be installed in retail establishments and drug stores and may or may not be part of the pharmacy. The device has push buttons for user interface. Such buttons include "Start" button to start the test after the user has inserted the arm into the cuff mechanism, a "Release" button to deflate the cuff mechanism in the event of an emergency, a "Weight" button to start the process of measuring the weight of the user. The output of the machine includes displays to indicate the blood pressure (systolic and diastolic), heart rate and weight. To start the process, the user inserts her arm into the cuff and pushes a button. The machine then proceeds to inflate the cuff and measure the blood pressure using oscillometric method. Once measured, the blood pressure (both systolic and diastolic) and the heart rate are output to the display mounted on the front of the device.
This looks like a 510(k) summary for a medical device called the CSI Model 5K Managed Health System Kiosk, which is an automated noninvasive blood pressure monitor. However, the provided text does not contain a detailed study report with specific acceptance criteria, device performance, sample sizes, or ground truth information in the format requested.
The document discusses that the device has been "subjected to clinical evaluation and bench testing" and "meets the requirements of AAMI/ANSI SP10:2002," along with other IEC standards. AAMI/ANSI SP10:2002 is a standard that outlines requirements for automated sphygmomanometers, including accuracy specifications. Therefore, the acceptance criteria are implicitly those defined by AAMI/ANSI SP10:2002.
Since the detailed study information is missing, I cannot fill in most of the requested table and sections. I will indicate where the information is not provided in the document.
Here's an attempt to answer based only on the provided text, with clear indications of missing information:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from AAMI/ANSI SP10:2002) | Reported Device Performance |
|---|---|---|
| Blood Pressure Accuracy | Mean Difference: ≤ ±5 mmHg | Not specified in provided text; device "meets the requirements of AAMI/ANSI SP10:2002" |
| Standard Deviation | ≤ 8 mmHg | Not specified in provided text; device "meets the requirements of AAMI/ANSI SP10:2002" |
| Pulse Rate Accuracy | Not explicitly stated in AAMI/ANSI SP10 for automated devices, but typically within ±5% or 5 bpm. | Not specified in provided text; device "meets the requirements of AAMI/ANSI SP10:2002" |
| IEC 60601-1 (Safety) | Compliance with general safety requirements for medical electrical equipment. | Device "meets the requirements of IEC 60601-1" |
| IEC 60601-2-30 (Safety) | Compliance with particular safety requirements for automated non-invasive sphygmomanometers. | Device "meets the requirements of ... 60601-2-30" |
| IEC 60601-1-2 (EMC) | Compliance with general requirements for safety, electromagnetic compatibility. | Device "meets the requirements of ... 60601-1-2" |
Explanation of AAMI/ANSI SP10:2002 (Implicit Acceptance Criteria):
The AAMI/ANSI SP10:2002 standard for automated sphygmomanometers typically requires the following for blood pressure accuracy validation in clinical studies:
- Mean Difference (Device vs. Reference): The mean difference between the test device readings and reference (auscultatory) readings should be within ±5 mmHg.
- Standard Deviation (Difference): The standard deviation of the differences should be 8 mmHg or less.
- A minimum of 85 subjects is usually recommended for the validation study, balanced across age and blood pressure ranges.
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective). The text only states "CSI Model 5K Managed Health System Kiosk has been subjected to clinical evaluation and bench testing."
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.
- Qualifications of Experts: Not specified. For blood pressure device validation, the "experts" typically refer to trained observers using a reference auscultatory method (e.g., two trained observers blinded to each other's readings, using a mercury sphygmomanometer or validated equivalent).
4. Adjudication method for the test set
- Adjudication Method: Not specified. For blood pressure device validation, and specifically for ground truth establishment, the method often involves two trained observers taking readings and a third adjudicator if their readings differ significantly. This is typically part of the AAMI/ANSI SP10 validation protocol, but the specifics are not in the provided text.
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 is not applicable. The device is an automated blood pressure monitor, not an AI-assisted diagnostic imaging or interpretation system that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, the entire device (CSI Model 5K Kiosk) operates as a standalone system. Its performance, as implicitly indicated by "meets the requirements of AAMI/ANSI SP10:2002," refers to its automated measurement capability without human intervention for the measurement itself.
7. The type of ground truth used
- Type of Ground Truth: For blood pressure measurement device validation according to standards like AAMI/ANSI SP10, the ground truth is typically established by simultaneous or
sequential auscultatory measurements performed by trained observers using a calibrated reference sphygmomanometer (e.g., mercury sphygmomanometer).
8. The sample size for the training set
- Training Set Sample Size: Not applicable/Not specified. For a purely oscillometric blood pressure device, the "training set" doesn't typically exist in the same way it would for a machine learning model. The device's algorithm is based on physiological principles and calibrated, rather than "trained" on a large dataset in the AI sense. If there was an internal dataset used during algorithm development, it is not mentioned.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable/Not specified, for the reasons mentioned above.
§ 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).