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The Pulse Oximeter is a non-invasive device indicated for use in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult patients. It is intended for spot- check and/or continuous data collection, and not continuous monitoring. It can be used in sleep labs, long-term care, hospitals and home use.

The Pulse Oximeter is a lightweight, portable health finger ring oximeter for home or healthcare facilities. SpO2 measurement technology is based on the developed photoelectron method and circuit design, and Shenzhen Viatom Technology Co., Ltd. developed calculation software. The SpO2 sensor receives the optical signal from the red light and infrared light through the finger into the oximeter. Two emitting tubes (red light diodes and infrared diodes) are located on the inner right side of the sensor, and they can emit red light and infrared. The receiving end is located on the inner left side of the sensor, and it can receive the red light and infrared through the finger. The MCU receives the pulse signal, gets the frequency signal by counting, processes its digital signal, and finally gets the measured SpO2 value. The PR is calculated on average by the above peak intervals of the PR waveform.

The provided text is a 510(k) summary for a Pulse Oximeter (Models PO2, PO2A, PO2B) and does not contain information about an AI/ML-driven device. Therefore, it is not possible to describe acceptance criteria or a study related to an AI/ML device based on this document.

The document primarily focuses on demonstrating the substantial equivalence of the subject pulse oximeter to a predicate pulse oximeter (K191088 Checkme O2 Pulse Oximeter) by meeting established performance standards for pulse oximeters, such as ISO 80601-2-61.

Here's an analysis based on the information available in the document, demonstrating why it doesn't fit the AI/ML framework you've described:

General Device Performance (Pulse Oximeter):

1. A table of acceptance criteria and the reported device performance:
   The document does not present a formal "acceptance criteria table" in the context of an AI/ML model. Instead, it provides a comparison table of the subject device's specifications and performance metrics against a predicate device.

   Characteristic	Acceptance Criteria (Implicit from Predicate & Standards)	Reported Device Performance (Subject Device)
   SpO2 Accuracy (70-100%)	±2%	1.77% ARMS
   Pulse Rate Accuracy	±2bpm or ±2% (whichever is greater)	±2bpm or ±2% (whichever is greater)
   SpO2 Measurement Accuracy (ARMS)	≤ 2% (from ISO 80601-2-61)	1.77%
   Work Mode	Spot-check and continuous data collection (not continuous monitoring)	Spot-check and continuous data collection (not continuous monitoring)
   Intended Application Site	Finger	Finger

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

   • Test Set Description: The "clinical validation testing of the SpO2 performance" was conducted on "healthy adult volunteers."
   • Sample Size: The exact number of healthy adult volunteers is not specified in the document.
   • Data Provenance: The document states "Measured values are from a controlled lab study in healthy volunteers." It does not specify the country of origin. The study appears to be prospective, as it involved actively testing subjects with the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This question is not applicable to this device. For a pulse oximeter, "ground truth" for SpO2 and pulse rate is established using a co-oximeter and ECG (or similar reference standard) on induced hypoxia studies, as per ISO 80601-2-61. There are no "experts" in the AI/ML sense establishing ground truth labels for images or other complex data. The "ground truth" clinical values are collected by qualified personnel trained in conducting such studies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., radiology reads) to resolve discrepancies and establish a consensus ground truth. For a pulse oximeter, the reference measurements from the co-oximeter are the ground truth, and human adjudication is not part of the process.

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:
   This question is not applicable. The device is not an AI-assisted diagnostic tool. No MRMC study was performed or is relevant for this type of device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   This question is not applicable in the context of an AI/ML algorithm. The performance of the pulse oximeter itself (which contains an algorithm to calculate SpO2 and PR from optical signals) was evaluated in a standalone manner against reference standards in the clinical study. The device's performance is inherently "standalone" in its measurement function, as it provides direct numerical outputs.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For SpO2 accuracy, the ground truth was arterial oxygen saturation measured by a co-oximeter (from blood samples) during induced hypoxia, as per ISO 80601-2-61. For pulse rate, the ground truth would typically be derived from an electrocardiogram (ECG) monitor. This is a physiological reference standard, not expert consensus or pathology.

8. The sample size for the training set:
   This question is not applicable. The document describes a traditional medical device (pulse oximeter) that uses a pre-defined algorithm based on physical principles (absorption of red and infrared light). It does not mention any "training set" for an AI/ML model. The "algorithm" for SpO2 calculation is based on principles of spectroscopy and physiological models, not machine learning from a dataset in the way a deep learning model would be trained.

9. How the ground truth for the training set was established:
   This question is not applicable for the same reasons as #8. There is no training set for an AI/ML model described.

In summary, the provided document details the regulatory clearance for a traditional medical device (pulse oximeter) based on established performance standards, and therefore, the questions tailored for AI/ML device evaluations are generally not relevant.

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The Pulse Oximeter is a non-invasive device intended for spot checking and/or continuous data collection of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in home environments and clinical institutions except acute clinical environment.

The Pulse Oximeter is a non-invasive device intended for spot checking and/or continuous data collection of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in home environments and clinical institutions except acute clinical environment. The Pulse Oximeter has two models, PO6 and PO6A, which are almost the same (include principle, structure, material, production process, performance) except appearance color. The device consists of main unit, SpO2 sensor and charging cable. The main unit is mainly composed of MCU, power management circuit, SpO2 measurement circuit, display control circuit, etc. The device is powered by internal battery. The device is not for life supporting or life-sustaining, not for implant. The device or sensor is not sterile, the sensor does not need sterilization, and the sensor is reusable but does not need re-sterilization since it is not sterile. The device is for prescription. The device does not contain drug or biological products.

The provided text describes the 510(k) submission for the Oxyfit Pulse Oximeter, which is a medical device for measuring oxygen saturation (SpO2) and pulse rate (PR). The key study proving the device meets acceptance criteria is a clinical test, specifically a controlled desaturation study.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states the SpO2 accuracy meets the requirement of "less than or equal to 2% under no motion condition" with an Arms value of 1.57%. For other parameters like pulse rate accuracy and display ranges, the document primarily compares them to the predicate devices, implying that meeting or being comparable to the predicate's performance serves as an implicit acceptance criterion.

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

• Sample Size: 12 healthy adult subjects.
• Data Provenance: The study was conducted in an "independent research laboratory." While the specific country of origin is not explicitly stated, the manufacturer is Shenzhen Viatom Technology Co., Ltd. in China. The study was a prospective controlled desaturation study where subjects were induced into hypoxia.

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

• The document states "The measured arterial hemoglobin saturation value (SpO2) of the subject device was compared with arterial hemoglobin oxygen (SaO2) value, determined from blood samples with a CO-oximeter (control device)."
• The ground truth (SaO2) was established by a CO-oximeter, a laboratory instrument considered highly accurate for measuring blood oxygen. The text does not mention the involvement of human experts for establishing the ground truth, as it relies on the direct comparison with an objective measurement obtained from a CO-oximeter.

4. Adjudication Method for the Test Set

• There was no mention of an adjudication method as the ground truth was established by direct comparison with a CO-oximeter measurement from blood samples. This is an objective measurement, not requiring human interpretation or adjudication.

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 a pulse oximeter, which directly measures physiological parameters (SpO2 and PR). It is not an AI-assisted diagnostic tool that would typically involve human readers or image interpretation.

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

• Yes, the performance stated (SpO2 accuracy of 1.57% Arms) is representative of the standalone performance of the pulse oximeter device itself, as it directly measures SpO2 and PR without human intervention for its core function. The study compares the device's readings to reference measurements (CO-oximeter).

7. The Type of Ground Truth Used

• The primary ground truth used for SpO2 accuracy was outcomes data / objective measurement which is the arterial hemoglobin oxygen (SaO2) value determined from blood samples with a CO-oximeter.

8. The Sample Size for the Training Set

• The document describes a clinical validation study and does not provide information about a "training set" in the context of machine learning model development. This is typical for a traditional medical device like a pulse oximeter, which relies on established physical principles for its operation rather than machine learning algorithms trained on large datasets.

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

• Not applicable, as no training set for an AI/ML model is mentioned in the document. The device's operation is based on optoelectronic principles for measuring oxygen saturation and pulse rate.

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The Blood Pressure Monitor is indented to measure or electrocardiogram (ECG) in home or healthcare facilities environment. The device is a blood pressure monitor intended for use in measuring blood pressure and pulse rate in adult population. The device is intended to measure, display, store and review adults' single-channel ECG rhythms and gives some suggested symptoms such as regular beat, low HR and high HR. The ECG part of the device is for Rx only, and the blood pressure part is for OTC.

Viatom Blood Pressure Monitor are designed to measure the systolic and diastolic blood pressure, pulse rate and ECG of an individual intended for home use. By using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm, the device inflates the arm cuff with an integral pump, then deflates the cuff via an electric valve. During inflation, the arm cuff pressure is monitored, and pulse waveform data is extracted. The extracted pulse waveform data is then analyzed by software which deternines pulse rate, as well as systolic and diastolic blood pressure, which is a well-known technique in the market called the "oscillometric method". In addition to the BP measurement, the device also incorporates electrodes capable of gathering ECG data from the user. This can be done as a separate function. To initiate the ECG, the user places one or more fingers in contact with the electrodes on the right and left side of the device. The electrodes measure a single-lead ECG between left and right fingers. The single-lead ECG data is displayed on the LCD. The main components of the Blood Pressure Monitor are the main unit, cuff unit and ECG unit (only for BP2). The preformed cuff unit, which is applicable to arm circumference approximately between 220 and 420 mm, includes the inflatable bladder and Nylon and polyester shell. All models of the arm blood pressure monitor use a single size of cuff. The device consists of the microprocessor, the pressure sensor, the power on/off key, the pump, exhaust valve, bluetooth transmission, cuff and ECG circuit including the electrodes. The subiect devices are powered by Li-ion Polymer Battery. The device has Irreqular beat: If the change speed of heart rate exceeds a certain threshold during measurement, is judged as irreqular heartbeat. The subject device includes bluetooth transmission which can transfer data to other device through the bluetooth connection such as smart phone.

Here's a breakdown of the acceptance criteria and study information for the Shenzhen Viatom Technology Co., Ltd. Blood Pressure Monitor (K193348), based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

Blood Pressure Measurement (based on ISO 81060-2)

ECG Measurement (based on IEC 60601-2-47)

Specific Accuracy Parameters (from Comparison Table)

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

• Blood Pressure Clinical Investigation:

  • Sample Size: 85 patients (39 males and 46 females).
  • Data Provenance: Not explicitly stated (e.g., country of origin), but implies a prospective clinical study conducted by the manufacturer for this submission. The "same arm sequential method" was adopted.

• ECG Clinical Investigation:

  • Sample Size: 35 patients (24 males and 11 females).
  • Data Provenance: Not explicitly stated (e.g., country of origin), but implies a prospective clinical study conducted by the manufacturer for this submission. "Comprising with the cleared device" was adopted during the clinical testing.

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

The document does not explicitly state the number of experts or their qualifications for establishing the ground truth for either the blood pressure or ECG test sets.

• Blood Pressure: The ground truth was established using a "manual Mercury Sphygmomanometer" as a reference device. It's implied that trained personnel would operate this for comparison, but their specific qualifications are not detailed.
• ECG: The ground truth for the ECG investigation was established by "comprising with the cleared device," suggesting comparison against an existing, cleared ECG device. There is no mention of expert review of the ECG waveforms themselves for ground truth.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for resolving discrepancies in either the blood pressure or ECG test sets.

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

No, an MRMC comparative effectiveness study involving human readers and AI assistance was not mentioned or described in the provided document. The clinical studies focused on comparing the device to a reference (for BP) or a cleared device (for ECG).

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

Yes, standalone performance (algorithm only) was evaluated for both the blood pressure and ECG functionalities.

• Blood Pressure: The device's automated oscillometric method was compared directly to a manual mercury sphygmomanometer.
• ECG: The device's ability to measure, display, store, and detect suggested symptoms (regular beat, irregular beat, low HR, high HR) was tested against a cleared device and bench tests for accuracy. The note states, "The ECG performance of the subject device is tested by bench test including the irregular beat High HR and Low HR and has been verified by the required accuracy." This indicates standalone algorithmic evaluation.

7. The Type of Ground Truth Used

• Blood Pressure: The ground truth used was comparison to a manual Mercury Sphygmomanometer.
• ECG: The ground truth used was comparison to a cleared device and bench test verification for specific parameters like irregular beat, high HR, and low HR.

8. The Sample Size for the Training Set

The document does not provide any information about a training set or its sample size. This submission focuses on the performance evaluation of the final product, implying that any internal development/training would have occurred prior to these validation studies.

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

Since no information on a training set is provided, there is no information on how its ground truth would have been established.

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The Oxiband Pulse Oximeter is a wrist pulse oximeter indicated for use in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult patients. It is intended for spot-check and/ or continuous data collection, and not continuous monitoring. It can be used in sleep labs, long-term care, hospitals and home use.

The Oxiband (Checkme) O2 Pulse Oximter is a lightweight, portable health wrist oximeter for use in sleep labs, long-term care, hospitals and home use. The device indicated for use in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult patients. It is intended for spot-check and/ or continuous data collection, and not continuous monitoring. The data and results provided by this device are for pre-check screening purpose only and cannot be directly used for diagnostic or treatment. The device consists of main unit, SpO2 sensor, wristband and charging cable. The main unit is mainly composed of MCU, power management circuit, SpO2 measurement circuit, display control circuit, etc. The device is powered by an internal battery. The device is not for life supporting or life sustaining, not for implant. The device or sensor is not sterile, the sensor does not need sterilization, and the sensor is reusable but does not need re-sterilization since it is not sterile. The device is for prescription. The device does not contain drug or biological products.

I am unable to answer this question. The provided text does not contain detailed information about the acceptance criteria for the Oxiband (Checkme) O2 Pulse Oximeter, nor does it describe a specific study proving the device meets these criteria in the structured format requested (e.g., test set sample size, expert qualifications, adjudication method, MRMC study, standalone performance, training set details).

While the document mentions non-clinical and clinical tests were performed and standards were met (e.g., ISO 80601-2-61 for SpO2 accuracy), it does not provide the granular details necessary to fill out all the requested fields. For example, it states "The SpO2 accuracy performance results showed the Checkme Pro Health Monitor with external SpO2 sensor to have an ARMS of 1.88 during steady state conditions over the range of 70%-100%", but it does not specify the sample size of subjects in this study, the provenance of the data, the methodology for establishing ground truth, or details about any human-in-the-loop studies.

Therefore, I cannot extract the requested information from the provided text.

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The subject device intended to measure the diastolic, systolic blood pressures and pulse rate for adult population in home and hospital facilities by using a non-invasive oscillometric technique with a single upper arm cuff (22-42 cm). The device detects the appearance of irregular heats during measurement and gives a warning signal with readings.

Viatom Blood Pressure Monitor are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a noninvasive technique in which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method".

The main components of the Blood Pressure Monitor are the main unit and cuff unit. The preformed cuff unit, which is applicable to arm circumference approximately between 220 and 420 mm, includes the inflatable bladder and Polyester shell. All models of the arm blood pressure monitor use a single size of cuff. The device consists of the microprocessor, the pressure sensor, the power on/off key, the rubber bulb, exhaust valve, bluetooth tranismision and cuff. The subject devices are powered by Li-ion Polymer Battery.

The device has irregulae heart beat (IHB) indicator which is defined as a rhythm that is 25% less or 25% more than the average rhythm detected while the monitor is measuring the systolic and diastolic blood pressure.

The subject device includes bluetooth tranismision which can tranfer data to APP installed in smart phone. The APP can display, store and review the measurement data including the systolic and diastolic blood pressure and pulse rate.

The provided document is a 510(k) summary for a Blood Pressure Monitor, seeking clearance from the FDA. It compares the device to a predicate device and outlines the testing performed to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The core acceptance criterion for this blood pressure monitor is its accuracy. The standard referenced is ISO 81060-2:2013, which specifies requirements for the clinical validation of automated non-invasive sphygmomanometers.

The document states the following for the subject device:

Note: The document only provides a high-level statement for clinical accuracy (meeting ISO 81060-2 requirements). It does not provide the specific numerical results of the clinical endpoints for systolic and diastolic blood pressure differences required by ISO 81060-2 (e.g., mean difference and standard deviation, or cumulative percentages within 5, 10, 15 mmHg for individual differences). It only indicates that the device passed the tests.

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

• Sample Size for Clinical Test Set: 85 patients (38 males and 47 females) (Page 7)
• Data Provenance: The document does not explicitly state the country of origin for the clinical data. However, given the manufacturer's location (Shenzhen, China) and the consultants' locations (Shenzen, China), it is highly probable the study was conducted in China. The study was a prospective clinical investigation as it involved patients participating in a study to collect data for the device's validation.

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

The provided document does not explicitly state the number or qualifications of experts involved in establishing the ground truth for the clinical test set.

For ISO 81060-2 validation: "The manual Mercury Sphygmomanometer was used as a reference device." This implies measurements were taken by trained operators, but their specific qualifications (e.g., physicians, nurses, technicians) and their adjudication process (if any, beyond simultaneous measurement) are not detailed.

4. Adjudication Method for the Test Set

The document states: "Same arm sequential method was adopted during the clinical testing. The manual Mercury Sphygmomanometer was used as a reference device." (Page 7)

This describes a direct comparative measurement method for ground truth, where the device under test and the reference manual sphygmomanometer are used on the same arm, sequentially. This method inherently reduces inter-arm variability but relies on the accuracy of the sequential measurements and the operator's technique. There is no indication of an "adjudication method" in the sense of multiple independent expert readers reviewing data and resolving discrepancies (e.g., 2+1 or 3+1 consensus), as this typically applies to image-based diagnostic systems, not direct physiological measurement devices like blood pressure monitors.

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

No, an MRMC comparative effectiveness study was not done. This type of study is primarily relevant for diagnostic devices where human readers interpret medical images or data, and AI assistance might improve their performance. A blood pressure monitor is a direct measurement device; its performance is validated against a reference standard, not against human reader interpretation.

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

Yes, the core of the clinical validation (ISO 81060-2) is a standalone performance test for the device's accuracy. The device (algorithm) measures blood pressure, and this measurement is directly compared to a reference standard (manual mercury sphygmomanometer). This is an "algorithm only" performance, as the human interaction is primarily in operating the device and the reference, not in interpreting the device's output and making a diagnosis.

7. The Type of Ground Truth Used

The ground truth used was comparative measurements against a validated reference device: "The manual Mercury Sphygmomanometer was used as a reference device." (Page 7). This method is specified by the ISO 81060-2 standard for clinical validation of automated blood pressure devices, which compares the device's readings to those obtained by a "gold standard" auscultatory method.

8. The Sample Size for the Training Set

The document does not mention any training set or its sample size. This is typical for direct measurement devices validated against a known standard. AI/ML-based diagnostic devices often have explicit training sets, but this device appears to rely on a traditional oscillometric method and its validation is based on direct clinical comparison, not a machine learning model developed with a large training dataset.

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

As no training set is discussed or mentioned, the method for establishing its ground truth is not applicable or detailed in this document.

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The Checkme Pro Health Monitor is intended to be used for measuring, reviewing and storing of ECG (adults only), oxygen saturation and pulse rate (adults only for continuous data collection and recording, adults and pediatrics for spot checking) and temperature in the home or in healthcare facilities.

This device is not intended to subspital diagnostic ECG device and also not to be used on patients with implanted cardiac devices, such as pacemakers and/or implanted cardio-defibrillators (ICDs).

The Checkme Pro Health Monitor is a lightweight, portable health monitor for use in the home or health care facility. The Checkme Pro Health Monitor is used for measuring, displaying, reviewing and storing of multiple physiological parameters including ECG, pulse oxygen saturation (SpO2), pulse rate and temperature. This device is not intended to substitute for a hospital diagnostic ECG device. The device is capable of measuring and storing data for up to twelve users.

The provided text describes the regulatory clearance for the Viatom Checkme Pro Health Monitor, which includes functionalities for ECG, oxygen saturation (SpO2), pulse rate, and temperature measurement. The document details performance testing for each function against recognized standards.

Here's a breakdown of the requested information based on the provided text, focusing on the ECG, SpO2, and Thermometer functionalities as these are the core medical measurements. The Pedometer function is also listed but does not have detailed acceptance criteria or performance study information similar to the medical functions within this document.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not provide specific sample sizes (number of patients/cases) for the clinical performance tests (ECG, SpO2, Temperature). It only states that the device was tested according to relevant IEC and ISO standards. These standards typically involve specific test methodologies, which may include human subjects or simulations, but the details of the sample size or whether the data was retrospective or prospective, or country of origin are not disclosed in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The performance claims are based on compliance with international standards, which would outline how ground truth is established within their testing protocols, but the specifics (e.g., number of expert clinicians, their qualifications) are not detailed here.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

The adjudication method for establishing ground truth within the test sets is not specified in this document.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor any evaluation of human reader improvement with AI assistance. The device is a monitor that provides measurements and waveforms, not an AI-assisted diagnostic tool that interprets complex medical images or data requiring human reader assessment of improvement.

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

The performance testing described (ECG algorithm testing, SpO2 compliance, Thermometer compliance) assesses the device's inherent function, which is a standalone performance of the algorithms and sensors. For instance, the ECG algorithm's compliance with IEC 60601-2-47 means its performance in calculating heart rate and waveform display meets the standard without human intervention for results generation. Similarly for SpO2 and temperature, the listed accuracies are for the device's direct measurements.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly state the type of ground truth used for each test. However, for devices like these, ground truth would typically be established by:

• ECG: Reference highly accurate diagnostic ECG devices or expert interpretation of standard 12-lead ECGs for heart rate and morphology analysis (as per IEC 60601-2-47).
• SpO2: Co-oximetry for blood oxygen saturation levels for absolute accuracy, or a calibrated reference pulse oximeter for comparative accuracy (as per ISO 80601-2-61).
• Temperature: Calibrated reference thermometers (e.g., rectal thermometers for core body temperature, as per ISO 80601-2-56).

8. The sample size for the training set

The document does not mention any training set size. This device appears to be primarily a physiological monitor with direct measurement capabilities rather than a complex machine learning model that requires explicit training data in the context of this regulatory submission. The "ECG algorithm" mentioned would likely refer to signal processing algorithms for heart rate detection and waveform filtering, which are typically designed and validated through engineering methods rather than machine learning training sets in the same sense.

9. How the ground truth for the training set was established

Since no training set is mentioned in the context of machine learning, this information is not applicable and therefore not provided in the document.

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