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The Model 960 Series is a desktop monitor intended for use as a continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, non invasive blood pressure and temperature. The intended patient population comprises adult, and pediatric weighing more than 5Kg. The intended environment of use is hospital environment. Hospital use typically covers areas such as general care floors, operating rooms, special procedure areas, intensive and critical care areas within the hospital plus hospital-type facilities such as surgical centers, sub-acute centers, special nursing facilities and sleep labs. The Model 900 is an Pulse Oximeter only.

WARNING: The Model 900 and 960 Series is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms.

The Mediaid Vital Signs monitor Pulse Oximeter Model M960P provides real time monitoring and display of ox vgen saturation of arteriolar hemoglobin (SpO2), Non Invasive Blood Pressure, pulse rate and body temperature. Where as the Mediaid Pulse Oximeter Model M900 provides real time monitoring and display of oxygen saturation of arteriolar hemoglobin (SpO2) and pulse rate only.

Noninvasive arterial oxygen saturation measurement is obtained by directing red and infra red light through a pulsating vascular bed. The pulsating arterioles in the path of the light beam cause a change in the amount of light detected by a photodiode. The pulse oximeter determines the oxygen saturation of arterial blood by measuring the ratio of transmitted red to infrared light within the pulse waveform. The non-pulsatile signal is removed electronically for the purpose of calculation. Therefore, skin, bone, and other non-pulsating substances do not interfere with the measurement of arterial oxygen saturation.

Non invasive blood pressure is intended to non invasively measure systolic, diastolic and mean arterial pressures (MAP).

Temperature- Thermometer takes patient temperature in oral, axillary or rectal mode.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Mediaid M960/M900 series devices:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Pulse Oximeter (SpO2): The document states "clinical hypoxia studies conducted in an independent research lab." It does not specify the sample size for the patients involved in these studies. The data provenance is described as "independent research lab," implying a controlled clinical environment, likely prospective for the specific hypoxia challenge. No country of origin is explicitly mentioned.
• NIBP Monitor: No specific sample size is provided. The study was conducted by "Suntech Medical Inc on their OEM module." This suggests the test data was generated by the OEM, not Mediaid directly. The provenance would be wherever Suntech Medical Inc. conducted their studies.
• Clinical Thermometer: No specific sample size is provided. The clinical tests were "conducted on an external hospital." The provenance would be the location of that hospital.

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

This information is not explicitly provided in the document for any of the components.

• Pulse Oximeter (SpO2): Ground truth was established by "arterial blood samples analyzed on a laboratory co-oximeter." This implies the co-oximeter is the "expert" or standard reference, not human experts.
• NIBP Monitor: Ground truth would be derived from the reference method used in compliance with IEC 60601-2-30 and AAMI SP10 (e.g., intra-arterial measurement or a highly accurate sphygmomanometer with expert oversight), but the document does not elaborate on the specific experts or their qualifications.
• Clinical Thermometer: Ground truth would be derived from a highly accurate reference thermometer in the hospital setting, but the document does not elaborate on specific experts or their qualifications for establishing this ground truth.

4. Adjudication Method for the Test Set

This information is not provided for any of the tests. The measurements are compared against reference standards rather than subject to adjudication by multiple human experts.

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 involving human readers and AI assistance was not performed and is not applicable to this type of device (vital signs monitor). This document describes the performance of a medical device itself, not an AI or imaging diagnostic tool that would typically involve human reader performance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Yes, the studies described are essentially standalone performance evaluations. The devices (pulse oximeter, NIBP, thermometer) are designed to provide direct measurements, and their accuracy is assessed against reference standards without a human interpreting an image or output that then needs to be compared to a human baseline. The "human-in-the-loop" here is the clinician using the device for patient assessment, but the device's accuracy is evaluated independently of that use.

7. The Type of Ground Truth Used

• Pulse Oximeter (SpO2): "Arterial blood samples analyzed on a laboratory co-oximeter." This is a high-precision, gold-standard laboratory reference.
• NIBP Monitor: Based on compliance with IEC 60601-2-30 and AAMI SP10, the ground truth would be established through defined reference methods within those standards (e.g., invasive arterial pressure measurement or a validated oscillometric reference).
• Clinical Thermometer: Based on compliance with ASTM E 1112:00 and EN 12470-4, the ground truth would be established using a calibrated reference thermometer in a clinical setting.

8. The Sample Size for the Training Set

This information is not provided. Since these are vital signs monitors and not AI/machine learning algorithms that are "trained," the concept of a "training set" as typically understood in AI development does not directly apply here. The devices are based on established physiological principles and calibrated during manufacturing.

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

As noted in point 8, the concept of a training set in the AI sense is not applicable. The devices are calibrated based on physical principles and validated against reference standards.

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Non-invasive measurement of arterial oxygen saturation and pulse rate in hospitals, physician's office, emergency medical facilities, or at home. The model 34 can store data in memory for later review and documentation and also features a sleep mode for basic patient sleep screening.

The Mediaid Pulse Oximeter Model 34 is designed to measure the percentage of functional oxygenated hemoglobin to total hemoglobin. Noninvasive arterial oxygen saturation measurement is obtained by directing red and infra red light through a pulsating vascular bed. The pulsating arterioles in the path of the light beam cause a change in the amount of light detected by a photodiode. The pulse oximeter determines the oxygen saturation of arterial blood by measuring the ratio of transmitted red to infrared light within the pulse waveform. The non-pulsatile signal is removed electronically for the purpose of calculation. Therefore, skin, bone, and other non-pulsating substances do not interfere with the measurement of arterial oxygen saturation.

The provided text describes a 510(k) summary for the Mediaid Pulse Oximeter Models M30 and M34. However, it does not contain specific acceptance criteria or detailed results of a study that directly compare the device's performance against predefined criteria in a quantifiable table format.

The document generally states that "Performance testing was conducted during clinical hypoxia studies conducted in an independent research lab. Mediaid Pulse Oximeter Model 34 were compared to arterial blood samples analyzed on a laboratory cooximeter and found to be equivalent to predicate device accuracy claims." It also notes "Bench testing was performed to verify pulse rate accuracy."

Given the limitations of the provided text, I will construct a response based on the information available and indicate where specific details are missing.

Acceptance Criteria and Device Performance for Mediaid Pulse Oximeter Models M30 and M34

The provided 510(k) summary indicates that the Mediaid Pulse Oximeter Models M30 and M34 underwent performance testing to establish substantial equivalence to predicate devices. While specific numerical acceptance criteria and a detailed table of results are not included in the provided text, the summary states that the device was found to be "equivalent to predicate device accuracy claims" based on clinical hypoxia studies and bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document does not explicitly state the numerical acceptance criteria for SpO2 accuracy (e.g., RMS difference within a certain percentage) or pulse rate accuracy. It relies on the assertion of equivalence to predicate device claims.

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated for either the clinical hypoxia study or the bench testing. The document refers to "clinical hypoxia studies" without specifying the number of subjects or data points.
• Data Provenance:
  • Clinical Hypoxia Studies: Conducted in an "independent research lab." The country of origin of the data is not specified.
  • Study Type: These appear to be prospective studies, as they involved testing the device against arterial blood samples.

3. Number of Experts and Qualifications for Ground Truth

This information is not provided in the document. For the SpO2 accuracy, the ground truth was established by "arterial blood samples analyzed on a laboratory cooximeter." While the cooximeter itself is an objective measurement tool, the expertise of the individuals operating and interpreting the cooximeter data is not mentioned.

4. Adjudication Method

This information is not applicable/not provided for the types of tests described. The primary ground truth for SpO2 was objective (laboratory cooximeter readings from arterial blood samples).

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

• No, an MRMC comparative effectiveness study was not done according to this document. The testing focused on the standalone performance and accuracy of the device against objective measurements, rather than evaluating the improvement of human readers with AI assistance. Pulse oximeters typically provide direct measurements and are not systems designed for human interpretation of complex images or signals requiring subjective reader analysis and subsequent adjudication.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone study was done. The clinical hypoxia studies and bench testing directly assessed the performance of the Mediaid Pulse Oximeter Model 34 itself, independent of human interpretation or intervention beyond standard device operation. The device's SpO2 readings were compared to the "ground truth" established by the laboratory cooximeter, representing its standalone accuracy.

7. Type of Ground Truth Used

• For SpO2 Accuracy: The ground truth used was objective laboratory measurements from arterial blood samples analyzed on a laboratory cooximeter (gold standard for arterial oxygen saturation measurement).
• For Pulse Rate Accuracy: The ground truth method is not explicitly detailed beyond "bench testing," but it would typically involve comparison to a known, accurately generated pulse signal.

8. Sample Size for the Training Set

• This information is not applicable and not provided for this device. Pulse oximeters are typically developed using established physiological principles and calibration, not through machine learning models that require training sets with ground truth labels.

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

• This information is not applicable and not provided for this device, as it does not rely on a training set in the context of machine learning.

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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 Mediaid SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring.

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 style connector, with an adapter cable for Datex-compatible models.

The provided document describes the Mediaid SpO2 Sensor and its clearance. However, it does not include detailed acceptance criteria or a comprehensive study report with all the requested information. The document focuses on demonstrating substantial equivalence to predicate devices based on a clinical hypoxia study and other tests.

Here's the information that can be extracted and a summary of what is not present:

Missing Information:

• Specific numerical acceptance criteria for SpO2 accuracy (e.g., A_rms value, range of acceptable deviation).
• Specific numerical acceptance criteria for pulse rate accuracy.
• The exact "reported device performance" against those criteria.
• Sample size used for the test set beyond "2 or subjects" which is likely a typo for "20 subjects".
• Data provenance details like country of origin for the clinical hypoxia study.
• Number of experts, their qualifications, or adjudication methods for ground truth, especially for the clinical hypoxia study.
• Whether an MRMC comparative effectiveness study was done, or its effect size.
• Sample size for the training set or how its ground truth was established, as this is a standalone device without an explicit AI/ML component described for training.

Available Information from the Document:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not explicitly provided in a table format with numerical criteria and corresponding reported performance. The document generally states that the device was "found to be equivalent to predicate sensors" and "2 or [likely "20"] subjects" were tested.

2. Sample sized used for the test set and the data provenance:

   • Sample Size (Test Set): "2 or subjects" (likely a typo, intended to be "20 subjects")
   • Data Provenance: Clinical hypoxia studies conducted in an "independent research lab." The country of origin is not specified, but the submission is to the US FDA. The study was retrospective or prospective is not stated, but clinical hypoxia studies are typically prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not specified. The ground truth was established by an "arterial blood co-oximeter." Experts might have been involved in the operation or interpretation, but their role in establishing "ground truth" (beyond operating the co-oximeter) is not detailed.

4. Adjudication method for the test set: This information is not specified.

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: An MRMC comparative effectiveness study was not done, and there is no mention of AI assistance in this context, as the device is an SpO2 sensor, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device's performance was evaluated in a standalone manner as an SpO2 sensor. The "clinical hypoxia studies" compared the sensor's readings to arterial blood co-oximetry. It's an algorithm-only performance in the sense that the sensor produces a reading directly.

7. The type of ground truth used:

   • For oxygen saturation (SpO2): Arterial blood co-oximeter
   • For pulse rate: Samples were analyzed on a "facorater J ou vi [likely a typo for a type of device or method] performed to verify pulse rate accuracy." Further details on this are not provided.

8. The sample size for the training set: This is a physical sensor, not an AI/ML model that typically requires a "training set" in the computational sense. Therefore, this concept does not apply directly to the information provided. The development process would involve calibration and internal testing, but not a "training set" as understood in a machine learning context.

9. How the ground truth for the training set was established: See point 8. Not applicable in the context of this device and information provided.

Summary of Device Performance Study (as described):

The Mediaid SpO2 Sensors were evaluated through "clinical hypoxia studies" conducted in an "independent research lab."

• Methodology: The SpO2 sensors were compared directly to an "arterial blood co-oximeter," which served as the ground truth.
• Outcome: The sensors were "found to be equivalent to predicate sensors" based on this comparison.
• Pulse Rate: "Samples analyzed on a facorater J ou vi performed to verify pulse rate accuracy."
• Other Tests: Biocompatibility, electrical safety, and EMC testing were also performed to demonstrate conformance with established industry standards.

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