PHARMASMART PUBLIC USE BLOOD PRESSURE MONITOR, MODELS PS-1000/PS-1500/PS-2000

• K Number: K063137
• Device Name: PHARMASMART PUBLIC USE BLOOD PRESSURE MONITOR, MODELS PS-1000/PS-1500/PS-2000
• Manufacturer: PHARMASMART, INC.
• Date Cleared: 2007-05-01 ( 197 days)
• Product Code: DXN
• Regulation Number: 870.1130
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: K040562 , K982776

Intended Use

The PharmaSmart Models PS-1000, PS-1500 and PS-2000 are indicated for use for non-invasive oscillometric blood pressure and pulse rate monitoring by the general public in a sit down kiosk form. The device does not perform any diagnoses; it only provides pressure and rate data to the users, who are advised to consult a physician.

Device Description

The PharmaSmart Blood Pressure kiosks Models PS-1000, PS-1500 and PS-2000 provide a self service means for measuring and tracking an individual's blood pressure (both diastolic and systolic) and pulse rate. The unattended kiosk can be installed in retail locations and is typically associated with pharmacy operations. Blood pressure readings are taken automatically by the customer with no operator assistance required. Readings are reported on the LCD display, printed on an optional thermal printer, or stored on an optional smart card for long term tracking. The PharmaSmart Blood Pressure kiosk provides a self-contained system for measuring and reporting blood pressure and pulse. The user interface consists of a simple membrane keypad with 3 buttons (4 buttons for some language translations) for user control, an LCD monitor for feedback, an automatically inflating blood pressure cuff to take readings and an optional thermal printer for hard copy output. The core functionality of the system is to take and record blood pressure readings. This is accomplished by the user with no assistance required. When seated at the kiosk the user's arm is comfortably inserted into the automatically inflating blood pressure cuff. When the reading is initiated using the membrane keyboard the cuff automatically inflates and deflates and records the systolic and diastolic blood pressure readings along with the user's pulse.

AI/ML Overview

Here's a summary of the acceptance criteria and the study details for the PharmaSmart Blood Pressure Monitor, based on the provided text:

Acceptance Criteria and Reported Device Performance

The device claims to meet the requirements of AAMI SP10:2002. While the specific numerical acceptance criteria (e.g., mean difference, standard deviation) from AAMI SP10 are not explicitly stated in the provided text, the document indicates compliance with this standard for performance.

Acceptance Criteria (AAMI SP10:2002)	Reported Device Performance
Specific AAMI SP10:2002 criteria not explicitly detailed in the provided text.	Device meets the requirements of AAMI SP10:2002.

Study Details

1. Sample Size and Data Provenance:

   • Test Set Sample Size: Not specified.
   • Data Provenance: Not specified. The document only mentions "clinical evaluation."

2. Number of Experts and Qualifications for Ground Truth (Test Set):

   • Number of Experts: Not specified.
   • Qualifications of Experts: Not specified.

3. Adjudication Method (Test Set):

   • Not specified.

4. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

   • No MRMC comparative effectiveness study is mentioned. The study focuses on the device's accuracy against a standard (AAMI SP10).

5. Standalone Performance Study:

   • Yes, a standalone study was conducted. The "clinical evaluation" and "bench testing" mentioned are for the device's performance itself, not in conjunction with human readers.

6. Type of Ground Truth Used:

   • The ground truth used for the clinical evaluation would be reference blood pressure measurements obtained through a validated method (typically auscultation by trained observers) as stipulated by AAMI SP10:2002 for comparison with the device's readings.

7. Training Set Sample Size:

   • Not applicable/Not specified. The device is a physical blood pressure monitor, not an AI/machine learning algorithm requiring a separate training set in the typical sense. Its performance is evaluated against a standard, not by being "trained" on data.

8. How Ground Truth for Training Set was Established:

   • Not applicable. (See point 7).

Summary of Key Information Not Provided in the Document:

• Specific numerical acceptance criteria from AAMI SP10:2002.
• Detailed breakdown of the clinical study, including sample size, demographics of participants, and the number/qualifications of individuals who established the ground truth.
• The exact methodology of the "clinical evaluation."

Regulation Number and Section

§ 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).