(225 days)
The Prizma device is indicated to measure, record and transmit ECG one-lead data, and to measure, record, display and transmit heart rate, peripheral oxygen saturation and skin temperature data. The device utilizes a mobile platform to initiate user actions (test, display and data transfer by email) through the mobile application. The device does not perform diagnostic functions.
Intended population: adult patients.
The Prizma is designed in the form of a Mobile Device jacket. The device consists of:
- A sensor unit (Prizma device) embedded with electronics and physiological sensors, in . polycarbonate housing.
- A silicone cover to mechanically receive the sensor unit and form a "Jacket" that is attached to the ● back of the smartphone. Cover design can be modified from one smartphone to another to fit the different dimensions.
- Prizma mobile App, installed on a smartphone, for operating the Prizma device.
- A medical power adapter
The physiological sensors housed in the Medical Capsule are as follows
- One lead ECG sensor, recording + heart rate measurement, derived out of ECG data; ●
- Photo-plethysmography, Peripheral capillary Oxygen Saturation (SPO2) measurement; .
- Skin temperature thermometer using IR; .
Here's a breakdown of the acceptance criteria and study information for the Prizma device, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document details the performance of the SpO2 function against the ISO 80601-2-61 standard. Performance data for ECG and Temperature are described in relation to standards and predicate devices, but specific acceptance criteria and detailed quantitative results beyond comparative statements are not explicitly provided in a tabular format within this document.
| Parameter | Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|---|
| SpO2 | ISO 80601-2-61: a-rms ≤ 3.5% SpO2 over the range of 70% to 100% SpO2 | a-rms = 2.33% over the range of 70% to 100% SpO2 |
Note: For ECG and Temperature, the document primarily makes comparative statements to predicates and compliance with standards rather than numerical acceptance criteria and specific performance metrics in this section.
2. Sample Size Used for the Test Set and Data Provenance:
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SpO2 Clinical Validation:
- Sample Size: 12 subjects (including dark skin).
- Data Provenance: Prospective clinical study conducted at the Bickler Ye Hypoxia Research Laboratory, Shenzhen Medical University, China.
-
Other Tests (ECG, Temperature, Usability): The document mentions various other tests (e.g., QRS detection, HR measurement, usability per IEC 62366-1:2015) but does not specify the sample sizes or data provenance for these particular tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not explicitly stated in the provided document for any of the tests. The SpO2 clinical validation used blood gas analysis as the reference, which implies laboratory personnel expertise in obtaining and interpreting these measurements, but specific details about "experts" determining primary ground truth for the device's output are not given.
4. Adjudication Method for the Test Set:
This information is not explicitly stated in the provided document. The SpO2 clinical validation involved comparing the device's readings to a reference device (OSM-3R multi-wavelength oximeter) and blood gas analysis, but details on how discrepancies or disagreements, if any, were adjudicated are not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned for this device. The device does not perform diagnostic functions and is not an AI-assisted diagnostic tool that would typically involve human reader performance studies. The improvements mentioned for the Prizma (e.g., larger screen, animations, simplified use via mobile app) are related to usability and user interaction rather than direct AI assistance to human diagnostic interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Yes, the performance data presented (e.g., SpO2 a-rms) reflects the standalone performance of the device's sensing and processing capabilities without human diagnostic intervention. The device's indications specifically state it "does not perform diagnostic functions," implying its role is to measure, record, and transmit data.
7. Type of Ground Truth Used:
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SpO2: The ground truth for the SpO2 clinical validation was established using blood gas analysis and a reference device (OSM-3R multi-wavelength oximeter). The blood gas analysis serves as the more direct physiological ground truth.
-
ECG (QRS detection and HR measurement): Ground truth was established by means of a signal simulator (Prizma QRS Detection Validation by means of a Signal Simulator).
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Temperature: While not explicitly detailed as "ground truth" for a specific test, the comparison to the predicate (Health-ePod) and its reliance on a "look-up table which was developed based on a clinical trial to convert the skin temperature to body temperature" suggests that reference measurements from clinical scenarios were used to validate the predicate, which the Prizma then references.
8. Sample Size for the Training Set:
The document does not provide information regarding the sample size for a training set. This is consistent with the device's stated function as a measurement and data transmission device rather than a diagnostic AI algorithm that typically undergoes distinct training and test phases with large datasets.
9. How the Ground Truth for the Training Set Was Established:
Since no information on a training set is provided, the method for establishing its ground truth is also not available in this document.
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).