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The Disposable and Reusable SPO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 40 kg at hospital facilities.

The proposed device, Disposable and Reusable SpO2 Sensors are accessories to the oximeters, which are intended for spot checking or continuous monitoring of functional arterial oxygen saturation and pulse rate in non-invasive with U.S. legally marketed oximeters or patient monitors. The SSD-001-W09AN sensors is disposable while the SS-010-AF10 and SS-018-AF10 sensors are reusable. They are only intended for adult.

The sensor shall be connected with its corresponding monitor. Oxygenation of blood is measured by detecting the infrared and red light absorption characteristics of deoxygenated hemoglobin and oxygenated hemoglobin, which consists of a probe attached to the patient's finger. The sensor is connected to a data acquisition system which is used to calculate and display oxygen saturation levels and heart rate conditions.

Each sensor has two LEDs, emitting both red and infrared light, and a photodiode. Red and infrared light lit alternately according to certain sequence, when the fingertips of capillary repeatedly with the heart pumps blood congestion, light emitting diode after blood vessels and projected onto a photodiode, photodiode can be induced to change with pulse light intensity, the electrical signals in the form of change. Then the received signal is forwarded to the corresponding oximeter that amplifies the signal and an algorithm that calculates the ratio. By measuring the wave crest of the pulse wave and the absorbance of the trough, SpO2 is calculated to obtain the correct oxygen saturation value. The saturation value is determined by the percentage ratio of the oxygenated hemoglobin (HbO2) to the total amount of hemoglobin (Hb).

Here's an analysis of the provided information regarding the acceptance criteria and study for the Disposable SpO2 Sensors and Reusable SpO2 Sensors:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states the acceptance criteria for SpO2 and Pulse Rate (PR) accuracy, and it reports that the device meets these requirements.

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

• Sample Size: 12 human adult volunteers were used for each clinical study (there were two studies). This means a total of 24 human adult volunteers were used for the two studies combined.
• Data Provenance: The studies were described as "Clinical hypoxia test results obtained in human adult volunteers." The document doesn't specify the country of origin, but it implies a prospective clinical study using induced hypoxia.

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

The document does not specify the number of experts or their qualifications for establishing the ground truth. It only states that the ground truth for arterial oxygen saturation (SaO2) was "determined by co-oximetry."

4. Adjudication Method for the Test Set

The document does not provide details on any adjudication method used for the test set.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a sensor, and the clinical study focuses on its accuracy against a gold standard (co-oximetry) rather than a comparison of human reader performance with and without AI assistance.

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

Yes, the accuracy tests described are effectively a standalone performance evaluation of the device. The device itself (sensor and its internal algorithms for calculating SpO2 and PR) is directly compared against the ground truth (co-oximetry) measurements. There's no human 'reading' or interpretation of the sensor's output being evaluated in this context, other than potentially reading the numerical display that the device provides.

7. The Type of Ground Truth Used

The ground truth used was arterial oxygen saturation (SaO2) as determined by co-oximetry. This is a recognized gold standard for measuring oxygen saturation in blood.

8. The Sample Size for the Training Set

The document does not mention the sample size for any training set. Given that this is a sensor (hardware with embedded algorithms) rather than a software-as-a-medical-device (SaMD) based on AI/Machine Learning that typically requires extensive re-training, it's possible that a distinct "training set" as understood in deep learning contexts was not highly relevant or explicitly documented. The development process likely involved calibration and verification, which might use internal datasets not explicitly labeled as "training."

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

Since a "training set" is not explicitly mentioned, the method for establishing its ground truth is also not provided.

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Medke Oximetry Finger Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate(PR) for adult patients weighing greater than 40kg,

The Medke Oximetry Finger Sensors are compatible sensor for use with major types of patient monitors and oximeter devices of Original Equipment Manufacturer (OEM). The sensors are made up of connector, cable, two specific wavelength LEDs & a photo detector assembled into the sensor housing. The sensors use optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The Medke Oximetry Finger Sensors contain finger clip type and soft tip type. The finger clip sensor is comprised of a plastic shell with silicone pads which position the optical components, and a cable with OEM compatible connector. The soft finger sensor consists of an integrated silicone rubber tip which is installed the optical components, and a cable with OEM compatible connector. The Medke Oximetry Finger Sensors have unique labeling and specifications designed for compatibility with Nellcor patient monitor(NPB40) cleared in K963707.

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

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document states the predicate device has a SpO2 Accuracy of "±2%(70-100%)" and Pulse Rate Accuracy of "±2(30-250bpm)". While the Medke device reports RMS values (Arms), the conclusion states they "meets the requirements of ISO80601-2-61," implying these results fall within acceptable limits based on that standard, and are presented as meeting the predicate's performance or being substantially equivalent.

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

• Sample Size for Test Set (SpO2 Accuracy): 12 healthy adults were selected as subjects. Each subject provided 25 data samples, resulting in a total of 300 data pairs (SpO2 vs. SaO2).
• Data Provenance: The study involved an "invasive 'breathe-down' test" on "healthy adult volunteers." The location or country of origin for these volunteers is not explicitly stated, but the company is based in Shenzhen, China. The study appears to be prospective as it involves active testing on human subjects.
• Sample Size for Test Set (PR Accuracy): Not explicitly stated, but tested using a "simulator."

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

• Number of Experts: Not applicable. The ground truth for SpO2 accuracy was established through direct measurement of arterial blood SaO2 using a CO-Oximeter, which is a clinical reference method, not through expert interpretation of images or other subjective data.
• Qualifications of Experts: Not applicable for establishing ground truth as it was based on objective measurements.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The SpO2 accuracy was determined by comparing the device's SpO2 readings directly with SaO2 measured by a CO-Oximeter from arterial blood samples. There was no mention of multiple reviewers or adjudication of subjective data.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This study focuses on device accuracy against a reference standard in controlled conditions, not on how human readers perform with or without AI assistance. The device is an oximetry sensor, not an AI diagnostic tool that assists human readers.

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

• Standalone Performance: Yes, in essence, the accuracy studies for both SpO2 and Pulse Rate represent the standalone performance of the device. The device's output (SpO2 and PR) was directly compared against established ground truth (CO-Oximeter for SpO2, simulator for PR). There is no "human-in-the-loop" interaction described that would affect the device's measurement performance for these parameters.

7. The Type of Ground Truth Used

• SpO2 Accuracy: The ground truth was outcomes data/physiological measurement (SaO2 measured directly from arterial blood samples using a CO-Oximeter). This is an objective, gold-standard method for determining true oxygen saturation.
• PR Accuracy: The ground truth was established by using a simulator with known pulse rates (30-250 BPM). This is also an objective, controlled method.

8. The Sample Size for the Training Set

• Training Set Sample Size: The document does not provide information about a "training set" or "training data." This type of device (oximetry sensor) is based on fundamental biophysical principles and calibrated during manufacturing. It does not typically involve machine learning or AI models that require a separate training dataset for algorithm development in the way a diagnostic AI would. The studies described are for verification/validation of the finished product's performance.

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

• Ground Truth for Training Set: Not applicable, as there is no mention of a training set for an AI/ML model for this device. The device's underlying measurement principles are well-established for pulse oximetry.

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The EnviteC OxiPen Pulse Oximeter is intended for noninvasive spot-check measurement of functional oxygen saturation of arterial hemoglobin (SpO2), and pulse rate (measured by SpO2 sensor accessories).

The monitor is intended for use on adult and pediatric patients in hospitals, hospital-type facilities, mobile, and home environments.

The OxiPen Pulse Oximeter is a compact battery-powered handheld monitor designed for simplicity and portability for spot checking applications. It does not provide alarms or settable alarm limits.

The OxiPen features large readable numeric displays for SpO2 and pulse rate and a pulse bar indicator for visual assessment of pulsation. Additional indicators include a signal quality LED and heart symbol which show pulsation, a sensor symbol for disconnection alert, and a battery capacity symbol.

Like the referenced predicate device, the OxiPen provides an audible pulse tone which varies with saturation level, as well as audible and visual alerts for conditions like sensor disconnect and power-off. The LCD display may be backlit by briefly pressing any key.

The OxiPen is provided with sensors specifically designed for use with the device, and features a compact connector with EnviteC proprietary pinout.

The EnviteC OxiPen Pulse Oximeter and accessory sensors employ the same technological characteristics as the predicate device and other oximeters to determine functional arterial oxygen saturation - arterially perfused tissue is illuminated sequentially by two wavelengths of light emitted by light emitting diodes (LED's), and the time varying absorbance of the tissue is measured from a photodiode light sensor. The resultant electrical signal is amplified, digitized, and analyzed to determine the functional oxygen saturation and pulse rate. The information is displayed on a liquid crystal display with pulse bar graph and audible pulse tone.

The OxiPen utilizes a two-layer architecture in which the oximeter-specific functions are managed by a dedicated subsystem (ChipOx) and the monitor functions including power management, display, and user interface are controlled separately.

Here's a summary of the acceptance criteria and study information based on the provided document:

Acceptance Criteria and Device Performance Study for EnviteC OxiPen Pulse Oximeter

The document primarily focuses on demonstrating substantial equivalence to a predicate device and fulfilling regulatory requirements for safety and efficacy. While it states that clinical tests were performed to validate accuracy claims, it does not explicitly list specific numerical acceptance criteria for performance metrics (e.g., accuracy range for SpO2 or pulse rate) in a table format. Instead, it broadly states that the device "passed all of the tests" and "Clinical test results support the stated accuracy claims for the specified range of 70% to 100% SaO2."

Therefore, the table below reflects what can be inferred or directly stated from the provided text regarding performance. Specific numerical acceptance criteria are not available in this document.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify the exact number of subjects or cases used in the clinical testing. It only states, "Clinical testing was performed... All testing was performed under an institutionally approved protocol with subject confidentiality and informed consent."
• Data Provenance: The document does not explicitly state the country of origin of the clinical data. It is a submission by a German company, so it is plausible it could be European or international.
• Retrospective or Prospective: Not explicitly stated, but the phrase "Clinical testing was performed... under an institutionally approved protocol with subject confidentiality and informed consent" strongly suggests a prospective study.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• No adjudication method is described in the provided text.

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

• No MRMC comparative effectiveness study is mentioned. The study described focuses on standalone device performance against cooximetry.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone performance study was conducted. The clinical testing "validated the performance and accuracy of the EnviteC OxiPen Pulse Oximeter and accessory sensors under controlled hypoxia versus arterial oxygen saturation as determined by cooximetry." This is a direct measure of the device's accuracy without human interpretation influencing the measurement itself.

7. Type of Ground Truth Used

• Expert Consensus: Not explicitly stated.
• Pathology: Not applicable for SpO2 measurement.
• Outcomes Data: Not applicable for SpO2 measurement.
• Other: Cooximetry was used as the ground truth for arterial oxygen saturation (SaO2). The document states, "...versus arterial oxygen saturation as determined by cooximetry."

8. Sample Size for the Training Set

• The document does not describe a machine learning model or a training set. It refers to "Embedded software in the device," but this would typically involve traditional software development and verification/validation, not a machine learning training process.

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

• Not applicable, as no machine learning training set is described.

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