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OxiScan II Oximetry Data Management Software (OxiScan II) is a central server based software system that uses a personal computer based application written in Microsoft Dot Net protocol to capture oximetry data from an oximeter, and then transmit this data, in a secure encrypted file, via internet, to the central server. At the central server the data is used to render a standard report that is then transmitted via fax and/or email to the prescribing physician. The intended use of the report is to provide a physician with information to help determine the best pulmonary treatment.

The OxiScan II Oximetry Data Management Software is intended to collect, report and archive oximetry trend data to provide information to a medical professional, as a supplemental tool to assist in the timely identification of pulmonary needs.

The OxiScan II Oximetry Data Management Software is intended to (1) transfer oximetry data from a pulse oximeter to a central server data base in order to maintain unique records per patient and test of this pulse oximetry data, and (2) to generate and archive standard reports drawn from this data. A list of approved oximeters appears in the Capture software.

The OxiScan II Oximetry Data Management Software is not a diagnosis tool. It is a decision management support tool that allows medical personnel to securely and accurately upload and view data related to pulse oximetry and to provide output reports as feedback which may be used by a Heathcare professional to form a patient history.

OxiScan II Oximetry Data Management Software is an accessory for use with compatible pulse oximeters. OxiScan II Oximetry Data Management Software collects and stores patient information containing raw oximetery data captured by a pulse oximeter. This information is transferred by a personal computer to an internet Web server where a report which summarizes and graphically presents the data is prepared. This report is delivered to a Healthcare Professional who then uses it along with other information to determine a course of pulmonary treatment. The report may be retrieved, reviewed, and retransmitted via the OxiScan II Oximetry Data Management Software web site.

The OxiScan II Oximetry Data Management Software is a software system intended to collect, report, and archive oximetry trend data from compatible pulse oximeters to provide information to a medical professional. It acts as a supplemental tool for timely identification of pulmonary needs and to form a patient history, but it is not a diagnostic tool.

The acceptance criteria for the OxiScan II Oximetry Data Management Software are primarily focused on its functional characteristics, safety, and effectiveness in meeting its stated intended use, and its substantial equivalence to a predicate device. The study demonstrating that the device meets these criteria is described as "Functional and Safety Testing."

Here's the breakdown of the information requested, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a numerical sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states that "Representative samples of OxiScan II Oximetry Data Management Software were successfully performance tested."

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The testing mentioned appears to be software performance testing rather than clinical validation with expert review.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

The document does not describe any adjudication method for a test set. The validation described focuses on functional, safety, and effectiveness testing of the software itself and its equivalence to a predicate device.

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

No, an MRMC comparative effectiveness study was not done. The device is data management software, not an AI-assisted diagnostic tool. Its purpose is to collect, report, and archive oximetry data for review by healthcare professionals, not to provide interpretations or assist human readers in making diagnoses in the way an AI algorithm might.

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

The device, OxiScan II, is described as "Oximetry Data Management Software." Its standalone performance would relate to its ability to accurately capture, transmit, process, and report oximetry data as per its specifications. The document states that "Representative samples of OxiScan II Oximetry Data Management Software were successfully performance tested to verify compliance to appropriate functional characteristics." This implies standalone testing of the software's data management capabilities. However, it explicitly states it is "not a diagnosis tool" and relies on a "Healthcare Professional" for interpretation, meaning its intended use always involves human-in-the-loop for clinical decision-making.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document does not detail the type of "ground truth" in the sense of clinical diagnoses or outcomes. Given the nature of the device as data management software, the "ground truth" for its performance testing would likely involve:

• Expected data values/formats: Verifying that captured oximetry data matches the source.
• Report accuracy: Confirming that generated reports correctly reflect the stored data.
• System functionality: Ensuring features like secure transmission, archiving, and retrieval work as designed.
• Compliance with specifications: Testing against pre-defined functional and technical requirements.

8. The Sample Size for the Training Set

The document does not mention a training set, as the device is not described as utilizing machine learning or artificial intelligence that would typically require a training set. The "Functional and Safety Testing" refers to performance verification, not an AI model's training.

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

As no training set is mentioned or applicable to this type of software, this information is not provided.

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Mediaid's compatible sensors are indicated as accessories to pulse oximeters used on Pulse Oximeters manufactured by Nonin Inc for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in infant, pediatric, and adult patients.

Mediaid SpO2 sensors are electro-optical sensors that function without skin penetration, electrical contact, or heat transfer. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The sensor contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The optical components are housed in adhesive film, rigid spring-loaded clip, or foam and Velcro wrap. The sensor cable is terminated in a DB-9 connector.

The Mediaid SpO2 Sensors are intended for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring. The device's performance was evaluated through clinical hypoxia studies and bench testing.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "equivalent to predicate device accuracy claims" for SpO2 accuracy, but it does not explicitly state numerical acceptance criteria for SpO2 or pulse rate. It implies that the predicate device's accuracy claims serve as the benchmark.

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

• Sample Size: Not explicitly stated. The document mentions "clinical hypoxia studies" without providing the number of subjects.
• Data Provenance: Clinical hypoxia studies were conducted in an "independent research lab." The country of origin is not specified, but the submission is to the US FDA. The studies appear to be prospective, as they are described as "conducted" for the purpose of the device's evaluation.

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

Not explicitly stated. The ground truth for SpO2 measurements was established using "arterial blood samples analyzed on a laboratory co-oximeter." The expertise of those analyzing the co-oximeter results is not detailed.

4. Adjudication Method for the Test Set

Not applicable. The ground truth for SpO2 was derived from objective measurements (laboratory co-oximetry of arterial blood samples), not from expert consensus requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The evaluation focuses on the device's performance against a reference standard (co-oximetry) and predicate device equivalence, not on human reader performance with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was done for the SpO2 sensor. The "clinical hypoxia studies" evaluated the Mediaid SpO2 sensors against arterial blood samples analyzed on a laboratory co-oximeter, demonstrating the algorithm's (sensor's) ability to measure SpO2 directly. Bench testing was also performed solely on the device to verify pulse rate accuracy.

7. Type of Ground Truth Used

• SpO2: Objective measurement from "arterial blood samples analyzed on a laboratory co-oximeter."
• Pulse Rate: Not explicitly stated, but likely derived from a validated reference method during bench testing.

8. Sample Size for the Training Set

Not applicable. The document describes a medical device (SpO2 sensor) rather than an AI-powered diagnostic algorithm that typically requires a distinct training set. The device's operation is based on established electro-optical principles, not on machine learning requiring a training phase with labeled data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no specific training set for an AI/ML algorithm described.

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The Masimo SET® Rad-5v Pulse Oximeter is intended for non-continuous noninvasive monitoring of finctional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO3 sensor) for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, and mobile environments.

The Rad-5v Handheld Pulse Oximeter is indicated for the non-continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, and neonatal patients during both motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, and mobile environments.

The Masimo SET® Rad5v Pulse Oximeter is indicated for the non-continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, and neonatal 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 Masimo SET® Rad-Sv Handheld Pulse Oxineter is noninvasive, arterial oxygen saturation and pulse rate monitor. The Rad-ITIC Mannin SEE - Not of Principely that continuously displays numeric values for SpO2 and pulse rate, as well as LED indicator bars for Pulse Amplitude Index (PAI) and Signal Quality (SQ).

Here's an analysis of the acceptance criteria and the studies that prove the Masimo SET® Rad-5v Pulse Oximeter meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" presented above are directly derived from the device's stated "Specifications and Operating Ranges" and the accompanying notes, which describe the validation methods and expected accuracy.

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

The document does not explicitly state a numerical "sample size" for the test set in terms of the number of subjects or data points. However, it mentions:

• Human Blood Studies on Healthy Adult Volunteers: Used for no motion and motion accuracy (induced hypoxia).
• Clinical Studies on Neonates: Used for no motion conditions and low perfusion.
• Bench Top Testing: Used for low perfusion accuracy against simulators.

The data provenance is prospective human studies conducted as "clinical studies" and "human blood studies" as well as bench testing. The country of origin is not explicitly stated, but the company address is in Irvine, CA, USA, and the submission is to the US FDA, implying testing was likely conducted in the USA or under US regulations.

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

The document does not specify the number of experts used to establish ground truth or their qualifications.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study and therefore no effect size for human readers with and without AI assistance can be determined. Pulse oximetry is a direct measurement device, not typically requiring human interpretation of complex images or data in an MRMC study context.

6. Standalone (Algorithm Only) Performance

Yes, standalone performance was done. The entire testing described (bench testing and clinical studies against co-oximeters and ECG) establishes the algorithm's performance without specific human interpretation or intervention in the measurement process, other than device operation. The device continuously displays numeric values, implying an algorithmic output.

7. Type of Ground Truth Used

The ground truth used for the clinical and human blood studies was:

• Arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter: For SpO2 accuracy.
• ECG monitor: For pulse rate accuracy.

For bench testing, the ground truth was provided by:

• Brotek Index 2 simulator and Masimo's simulator: For low perfusion accuracy.

8. Sample Size for the Training Set

The document does not provide a sample size for the training set. It states that the "values in the look-up table are based upon human blood studies against a laboratory co-oximeters in induced hypoxia states during motion and non-motion conditions." This implies that data from human studies was used to develop or calibrate the device's algorithms (the look-up table), but the specifics of that dataset size are not detailed.

9. How the Ground Truth for the Training Set Was Established

The ground truth for the look-up table (which serves as the basis for the algorithm's calculation) was established by:

• Human blood studies against a laboratory co-oximeter in induced hypoxia states during motion and non-motion conditions. The document indicates that the device's fundamental conversion algorithm from absorbance signals to SpO2 values is derived from these studies.

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