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The V-TRUST Handheld Pulse Oximeter is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adults.

This device with reusable SpO2 sensor accessories is indicated for non-invasive spot checking or continuous monitoring.

The V-TRUST Handheld Pulse Oximeter is a light weight, portable and non-invasive pulse oximeter designed for use in measuring and displaying functional arterial oxygen saturation and pulse rate for adults during no motion based on the principle of spectrophotometry.

The V-TRUST Handheld Pulse Oximeter uses the same fundamental technology with the predicate device, 503 Pulse Oximeter. The SpO₂ and pulse rate software algorithms, interference-filtering software, and alarming system are identical to the software in the legally marketed predicate device cleared under K911124, with minor changes that do not raise new questions of safety or efficacy.

The V-TRUST Handheld Pulse Oximeter is allowed to link individual Solaris Compatible Reusable Adult SpO2 Finger Sensor (K061931) only. Solaris finger sensors are electro-optical sensors which function without skin penetration, electrical contact, or heat transfer. The sensors use optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter device.

Here's a breakdown of the acceptance criteria and study information for the V-TRUST Handheld Pulse Oximeter:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 10 healthy subjects (5 males and 5 females).
• Data Provenance: Not explicitly stated (e.g., country of origin), but the study was a "hypoxia study" conducted in adherence to ISO 9919:2005, implying a controlled clinical environment. It is a prospective study because subjects were tested during no motion to determine accuracy against an ABG analyzer.

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

The document does not explicitly state the number of experts used or their qualifications for establishing the ground truth. It mentions that the ground truth for SpO2 and heart rate was determined "against the artery blood gas (ABG) analyzer in hospital," implying a gold standard measurement rather than expert consensus on visual interpretation.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by an objective medical device (ABG analyzer) rather than expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This device is a standalone pulse oximeter, not an AI-assisted diagnostic tool that would typically involve human readers. The study compared the device's performance against a gold standard and a predicate device.

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

Yes, a standalone performance study was done. The study evaluated the accuracy of the V-TRUST Handheld Pulse Oximeter's measurements (SpO2 and heart rate) directly against a clinical gold standard (ABG analyzer) and a predicate device, without involving human interpretation of the device's output.

7. The Type of Ground Truth Used

The ground truth used for SpO2 was established by an artery blood gas (ABG) analyzer in a hospital setting. For heart rate, the ground truth was also established through comparison against the ABG analyzer and the predicate device. This represents an objective, clinically accepted gold standard.

8. The Sample Size for the Training Set

The document does not provide information on a training set or its sample size. This is typical for a device like a pulse oximeter, where the fundamental technology (spectrophotometry) and algorithms are well-established and not based on a machine learning model that requires explicit "training data" in the same sense as an AI diagnostic tool. The software algorithms are stated to be "identical to the software in the legally marketed predicate device cleared under K911124."

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

Not applicable, as no specific training set for a machine learning model is mentioned or implied. The device's software algorithms are inherited from the predicate device.

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The TD-8002 Multi-Parameter Spot-Check Monitor measures systolic and diastolic pressure, pulse rate, ear temperature, blood glucose and oxygen saturation of arterial hemoglobin (SpO2).
The device is intended to be used by clinicians and medically qualified personnel.
For glucose measurements, it quantitatively determines glucose levels using capillary and venous whole blood.
For blood pressure measurements, it is intended to be used to measure noninvasively the systolic and diastolic blood pressure and pulse rate of adults.
For pulse oximeter measurements, is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2 ) and pulse rate for adults.
For ear thermometer, it is intended for the intermittent measurement and monitoring human body temperature.

The V-TRUST TD-8002 Multi-Parameter Spot-Check Monitor, Model TD-8002 (TD-8002) is a patient monitor that measures and displays real time physiological data of the patient, including blood glucose measurement. The TD-8002 can be used to monitor one or more of the following parameters: Noninvasive blood pressure (NIBP), blood oxygen saturation (SpO2), pulse rate, body temperature, and blood glucose. For all these vital parameters, the TD-8002 will be capable of limit alarms for SpO2, and storing monitoring data for retrospective review.
The TD-8002 has two monitoring devices built in the main unit: oximeter and NIBP monitor. The other two monitoring devices, infra-red ear thermometer and blood glucose meter are connected to the main unit via USB cable. All of the devices for monitoring vital signs are cleared by the FDA.
The oximeter sensor connected to the main unit of TD-8002 is the same as the Solaris Compatible Reusable Adult SpO2 Finger Sensor (Model S100A-090103 or Model S100A-300103) cleared under K061931.

The provided text is a 510(k) summary for the V-TRUST TD-8002 Multi-Parameter Spot Check Monitor. It does not contain specific acceptance criteria, detailed study designs, or performance metrics beyond a general statement that the device "meets its intended use and is equivalent to the predicate devices." The document primarily focuses on establishing substantial equivalence to previously cleared devices.

Therefore, many of the requested details about acceptance criteria, study specifics, and performance data cannot be extracted from this summary.

Here's a breakdown of what can be inferred or directly stated, and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• Blood Pressure Accuracy
• Pulse Rate Accuracy
• Ear Temperature Accuracy
• Blood Glucose Accuracy
• SpO2 Accuracy
• Pulse Rate (from SpO2) Accuracy | "The laboratory and clinical studies for the performance of V-TRUST TD-8002 Multi-Parameter Spot-Check Monitor demonstrate that the performance of this system meets its intended use and is equivalent to the predicate devices."
  (No specific performance metrics like mean absolute difference (MAD), bias, or limits of agreement are reported in this summary.) |

Explanation of Inferred Criteria: The 510(k) process relies on demonstrating substantial equivalence to predicate devices. This implicitly means that the new device must perform at least as well as, or within acceptable tolerances compared to, the predicates for each parameter it measures. However, the exact quantitative acceptance criteria (e.g., specific AAMI standards for NIBP, ISO standards for glucose, or specific SpO2 accuracy limits) are not detailed in this summary.

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

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified, beyond general "laboratory and clinical studies." It does not mention country of origin or whether studies were retrospective or 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 provided in the 510(k) summary. Given the nature of the device (physiological measurements), ground truth would likely be established using highly accurate reference methods (e.g., arterial line for NIBP, CO-oximeter for SpO2, laboratory analyzer for glucose). The expertise of individuals involved in operating these reference methods would be relevant, but "experts to establish ground truth" in the AI/image analysis sense is not applicable here.

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

• Not applicable/not specified. This type of adjudication is typically relevant for subjective assessments, particularly in imaging studies involving AI. For objective physiological measurements, the ground truth is established by a reference device, not by expert consensus.

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. This device is a multi-parameter spot-check monitor, not an AI-assisted diagnostic tool for human readers. Its function is to directly measure physiological parameters.

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

• Yes, the performance referenced ("laboratory and clinical studies for the performance of V-TRUST TD-8002 Multi-Parameter Spot-Check Monitor") would inherently be a standalone performance assessment of the device's accuracy in measuring each parameter. The device itself is designed to provide direct measurements, not to assist a human in interpreting something.

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

• While not explicitly stated, for each parameter, the ground truth would be established by a highly accurate reference method or device. For example:
  • Blood Pressure: Likely invasive arterial line measurements or a highly calibrated reference NIBP device.
  • Pulse Rate: Could be derived from ECG or a highly accurate reference pulse oximeter/NIBP device.
  • Ear Temperature: A highly accurate reference thermometer (e.g., rectal probe, calibrated oral thermometer).
  • Blood Glucose: A laboratory-grade glucose analyzer using plasma or serum separated from the same blood sample.
  • SpO2: A CO-oximeter measurement from arterial blood gas.

8. The sample size for the training set

• This information is not applicable and not provided. The V-TRUST TD-8002 is a device that uses established measurement principles (e.g., oscillometric for NIBP, spectrophotometry for SpO2, enzymatic for glucose). It does not employ machine learning algorithms in the sense that would require a "training set" for an AI model.

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

• This information is not applicable and not provided, as there is no "training set" in the context of this device's technology.

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