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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.

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:

• 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:

• 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).

• 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.

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The Masimo SET" Rad-57 cm and m Pulse CO-Oximeters and accessories are indivated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO), pulse rate (measured by an SpOn sensor), carboxyhemoglobin, and/or methemoglobin saturation (measured by an SpCO/SpMet sensor) for adult, pediative, and neonaal patients in hospitals, hospital-type facilities, mobile, and home environments.

The Masimo SET® Rad-57 cm and m Pulse CO-Oximeters and accessories are indicated for the continuous noninvasive montoring of functional oxygen saturation of arterial hemoglobin (SpO-) and pulse rate (measured by an SpO-sensor) and carboxyhenoglobin and methemoglobin saturation or methemoglobin (measured by an SpCO/SoMet sepsor). The Masimo SFFT Rad-57 cm and m Pulse CO-Oximeters and accessories are indicated for use with adult, pediatric, and neouatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.

The Rad-57 cm and m Handheld Pulse CO-Oximetesr with Rainbow technology are noninvasive, arterial oxygen saturation and pulse rate monitor that also measure Carboxyhemoglobin. The Rad-ST featurena multicologies and Indicelosmallion display that continuously displays numeric values for SpO2 and pulse rate, a Low Signal (Q Indicator (Low SIQ) included LED) indicator bars for Perfusion Index (PI) and Carboxyhemoglobin saturation (%SpCO) and/or Methemoglobin saturation(%21). alarm status, alarm silence, battery life and SpCO/SpMet sensor connected. The Masino SET Rad-57 cm and and Photo (10-Oximeters are intended to be used with Masimo's LNOP and LNCS series of oximelery sensors and patient ables and Masimo is Rainbow SpCO/SpMet sensors and Rainbow cables.

Here's the breakdown of the acceptance criteria and the study details for the Masimo Rainbow SET® Rad-57 cm and m Pulse CO-Oximeters, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

2. Sample Size Used for the Test Set and Data Provenance:

• SpO2 (No Motion & Motion): Healthy adult volunteers. The number of subjects is not explicitly stated, but the studies were "human blood studies."
• Neonatal SpO2 (Motion): Healthy adult volunteers. The number of subjects is not explicitly stated.
• SpCO & SpMet: Healthy adult volunteers. The number of subjects is not explicitly stated.
• Low Perfusion: Benchtop testing using a Biotek Index 2 simulator and Masimo's simulator. Not applicable for human subjects.
• Data Provenance: The studies were conducted on "human blood" studies, implying prospective data collection in a controlled environment (induced hypoxia). The country of origin is not specified but is implicitly in the context of FDA submission, likely the US.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

• SpO2, SpCO, SpMet: The ground truth was established using a laboratory CO-oximeter and, for SpO2 studies, an ECG monitor. No human experts were involved in establishing the primary ground truth for these physiological measurements. The reference standard itself (the laboratory CO-oximeter) is the "expert" here.

4. Adjudication Method for the Test Set:

• Not applicable as the ground truth was derived from objective laboratory instruments (CO-oximeter and ECG monitor), not from human expert consensus requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC comparative effectiveness study was not done. This study focused on the standalone performance of the device against objective reference standards, not on the improvement of human readers with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Yes, a standalone performance study was done. The described clinical and bench tests evaluate the device's accuracy in measuring SpO2, SpCO, SpMet, and pulse rate against reference standards, without human interpretation influencing the primary measurements.

7. The Type of Ground Truth Used:

• Instrumental Ground Truth / Reference Standard:
  • For SpO2, SpCO, and SpMet: A laboratory CO-oximeter was used to determine arterial blood gas values.
  • For SpO2 and Pulse Rate: An ECG monitor was also used in the SpO2 studies.
  • For Low Perfusion: Benchtop simulators (Biotek Index 2 and Masimo's simulator) were used.

8. The Sample Size for the Training Set:

• The document does not explicitly state the sample size for a training set. The described studies are for validation/testing, not for training the algorithm. The device "Masimo SET Technology" is mentioned as having "validated for no motion accuracy" and "validated for motion accuracy," implying prior development and internal validation. The current document focuses on the performance of the Rainbow SET® Rad-57 cm and m Pulse CO-Oximeters.

9. How the Ground Truth for the Training Set was Established:

• The document does not provide details on how the ground truth for an internal training set (if one existed) was established. The information focuses on the validation studies against a laboratory CO-oximeter and ECG monitor for the listed performance criteria.

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