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The Reusable and Disposable 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 40kg. The sensors are intended to be used in hospital settings where patient care is offered by qualified healthcare personnel.

The proposed device, Reusable and Disposable SpO2 sensors are the accessory of the patient monitors, which are intended for continuous monitoring of functional arterial oxygen saturation and pulse rate in non-invasive way with legally marketed devices.

The sensor shall be connected to its corresponding monitor (Nellcor, N-600x cleared in K060576), and it is used to attach the patient's finger and measure oxygenation of blood from detecting the infrared-light and red-light absorption characteristics of deoxygenated hemoglobin and oxygenated hemoglobin. The sensor is connected to a data acquisition system which is used to calculate and display oxygen saturation values and heart rate conditions.

The Reusable and Disposable SpO2 sensors consist of compatible connectors, cable, and patient sensor terminal. And the optical components of sensor are designed to a light emitting diode and a light detector. Red and Infrared lights are shone through the terminal tissues. Then parts of the emitting lights are absorbed by blood and tissues. The light absorbed by the blood varies with the oxygen saturation of haemoglobin. The light detector detects the light volume transmitted through the tissues on the basis of blood pulse, then the microprocessor calculates a value for the oxygen saturation by measuring the absorbance of the wave peak and the wave trough. The saturation values are determined by the percentage ratio of the oxygenated hemoglobin (HbO2) to the total amount of hemoglobin (Hb).

This document describes a 510(k) premarket notification for reusable and disposable SpO2 sensors. It details performance data, including biocompatibility, electrical safety, EMC, and clinical studies. However, the document does NOT contain information about AI/ML models or their performance, nor does it specify acceptance criteria for such models, or the details of ground truth establishment by experts for AI/ML development.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of AI/ML, as the provided text pertains to a standard medical device (SpO2 sensor) without any indication of AI components.

To answer your question accurately, I would need a document that describes the performance of an AI-powered medical device.

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The Disposable SpO2 Sensor is indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adults in hospital environment.

The proposed device, Disposable SpO2 Sensor is an accessory to the patient monitors, which are intended for continuous monitoring of functional arterial oxygen saturation and pulse rate. The compatible patient monitor is EDAN iM50 cleared in K113623. The sensor shall be connected to its corresponding monitor through adapter cable model CK-03-452. 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 are emitted through fingertips and received by a 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).

The provided text is a 510(k) Summary for a Disposable SpO2 Sensor (K200069). It details the device's technical specifications, intended use, and comparison to a predicate device (K191279). The document also outlines the performance data submitted to support the substantial equivalence determination, including biocompatibility, non-clinical, and clinical studies.

Based on the provided text, here's the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a clinical hypoxia test conducted on human adult volunteers to validate the accuracy of the Disposable SpO2 Sensor against arterial oxygen saturation (SaO2) determined by co-oximetry. This clinical study was performed according to ISO 80601-2-61:2017 and FDA guidance for Pulse Oximeters - Premarket Notification Submissions.

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

• Sample Size: The document states "human adult volunteers" but does not specify the exact number of subjects used in the clinical hypoxia test.
• Data Provenance: The data is prospective clinical data obtained from human adult volunteers. The country of origin is not explicitly stated, but the applicant and correspondent are based in Shenzhen, China.

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 about the number or qualifications of experts used to establish the ground truth. It states that arterial oxygen saturation (SaO2) was "determined by co-oximetry," which is a laboratory method, not typically an expert consensus per se.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method for the test set. The ground truth was established by co-oximetry.

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

No, an MRMC comparative effectiveness study was not conducted. This is a medical device, specifically a sensor, that provides a direct measurement, rather than an interpretation requiring multiple readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the clinical hypoxia test evaluated the standalone performance of the device's ability to measure SpO2. The device functions as a sensor with an algorithm to calculate SpO2 and PR, and the clinical study validated this algorithm's accuracy without a human explicitly "in the loop" for interpretation.

7. The Type of Ground Truth Used

The type of ground truth used was outcomes data / reference standard measurement, specifically arterial oxygen saturation (SaO2) as determined by co-oximetry. Co-oximetry is a highly accurate laboratory method for measuring various hemoglobin species, including SaO2.

8. The Sample Size for the Training Set

The document does not specify a sample size for a training set. This device is a sensor and likely uses empirically derived algorithms and calibration, rather than a machine learning model that requires a distinct training set. The clinical study mentioned is for validation/testing.

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

As no training set is explicitly mentioned or implied for a machine learning model, the method for establishing its ground truth is not applicable in this context. The core algorithm for pulse oximetry is based on known physical principles of light absorption by blood components.

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The Disposable SPO2 Sensor is 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 SpO2 Sensor is accessory to the oximeter, which is intended for continuous monitoring of functional arterial oxygen saturation and pulse rate in non-invasive with U.S. legally marketed oximeter. It is only intended for adult. The sensor shall be connected with the corresponding monitor (Nellcor N-600). 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).

The provided text describes a 510(k) premarket notification for a Disposable SpO2 Sensor and includes information about its performance data. However, it does not contain a detailed study proving the device meets specific acceptance criteria in the format requested. While it states that clinical studies were conducted to verify accuracy and that the device complies with ISO 80601-2-61:2017, the specifics of those studies (sample size, ground truth methodology, expert qualifications, etc.) are lacking.

Therefore, I will extract what is available and indicate where information is not provided in the document.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states: "Clinical hypoxia test results were obtained in human adult volunteers to validate the accuracy of disposable SpO2 Sensor versus arterial oxygen saturation (SaO2) as determined by co-oximetry."

• Sample Size (Test Set): Not specified.
• Data Provenance: Human adult volunteers, prospective study (clinical hypoxia test). Country of origin is not specified, but the submission sponsor and correspondent are based in Shenzhen, China.

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

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

4. Adjudication method for the test set

• Adjudication Method: Not specified. The ground truth was established by "co-oximetry," which is an objective measurement rather than expert consensus on images.

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 is an accessory device (SpO2 sensor) for an oximeter, not an AI-powered diagnostic system involving human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

Yes, the performance evaluation of the Disposable SpO2 Sensor for SpO2 accuracy and PR accuracy is a standalone assessment of the device's measurement capabilities. The clinical hypoxia test specifically aims to validate the accuracy of the device against a reference standard (co-oximetry). There is no "human-in-the-loop" component in the performance of the sensor itself, as it is a measurement device.

7. The type of ground truth used

• Type of Ground Truth: Arterial oxygen saturation (SaO2) as determined by co-oximetry, which is considered an objective, established medical measurement for blood oxygen levels.

8. The sample size for the training set

The document does not mention a "training set" in the context of machine learning. The device's performance is verified through clinical testing against a reference standard rather than through algorithm training on a dataset.

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

Not applicable as no training set for a machine learning algorithm is discussed. The device is a direct measurement sensor.

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Caremed Disposable SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult, pediatric and infant patient populations.

The proposed device, Disposable SpO2 Sensors are accessories to the patient monitors, which are intended for continuous non-invasive monitoring of functional arterial oxygen saturation and pulse rate. The compatible patient monitor is Nihon Kohden BSM-5135A. The sensor shall be connected to its corresponding monitor through Caremed adapter cable model SZ30-36. 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).

This document describes the performance data and acceptance criteria for the Disposable SpO2 Sensor (K191279).

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document states that "Clinical hypoxia test results were obtained in human adult volunteers to validate the accuracy of Caremed Disposable SpO2 Sensors versus arterial oxygen saturation (SaO2) as determined by co-oximetry."
For the expanded indication to include infants (3 kg

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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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Coreray Reusable SPO2 Sensor is intended to be used in hospital settings where patient care is offered by qualified healthcare personnel. The Reusable SPO2 Sensor is intended 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 Reusable SPO2 Sensor is comprised of a connector and a cable which terminates into sensor housing. The sensor contains two specific wavelength LEDs and a photo detector assembled into the sensor housing which separate by one housing half and the other half. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. One type of sensor housing is described in this submission: Reusable finger clip sensor. The sensor has a labeling and specifications designed for compatibility with a specific monitor.

The provided text is a 510(k) Premarket Notification for a Reusable SpO2 Sensor. It outlines the device's characteristics, intended use, and a comparison to predicate devices to demonstrate substantial equivalence. The document includes information on the non-clinical and clinical tests performed.

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

Acceptance Criteria and Reported Device Performance

Study Details:

1. Table of Acceptance Criteria and Reported Device Performance: See table above. The acceptance criteria for SpO2 and Pulse Rate accuracy are directly compared to the predicate device's performance, specifically K153184 for SpO2 accuracy. The document states "compliance with the ISO80601-2-61" standard, which the SpO2 accuracy of ±3% (70-100%) meets.

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

   • Sample Size for Test Set: The document states, "Clinical testing is conducted for validation of SoO2 the Coreray Reusable & Disposable SpO2 Sensor." However, the exact number of subjects or data points for the clinical test is NOT explicitly stated in the provided text.
   • Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. It only mentions "Clinical testing is conducted for validation."

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

   • The document does not specify the number of experts used or their qualifications for establishing ground truth in the clinical testing.

4. Adjudication Method for the Test Set:

   • The document does not describe any adjudication method used for the clinical test set.

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. The device in question is a SpO2 sensor, which provides direct physiological measurements, not an AI-based diagnostic tool requiring human reader interpretation or MRMC studies. Therefore, this type of study is not applicable and was not performed.

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

   • Yes, effectively. For a device like an SpO2 sensor, the "standalone performance" refers to its ability to accurately measure SpO2 and pulse rate. The clinical testing mentioned ("Clinical testing is conducted for validation of SoO2 the Coreray Reusable & Disposable SpO2 Sensor") serves as the standalone performance evaluation, confirming the device's accuracy without requiring human interpretation of its output beyond standard clinical use. The reported accuracies (±3% for SpO2) are the standalone performance metrics.

7. The Type of Ground Truth Used:

   • For SpO2 sensors, the gold standard (or "ground truth") for SaO2 (arterial oxygen saturation) measurement in clinical studies is typically arterial blood gas (ABG) analysis (Co-oximetry). While the document doesn't explicitly state "ABG," the mention of "Clinical testing is conducted for validation of SoO2" implies comparison against such a reference method as per ISO 80601-2-61, which requires induced hypoxia studies with arterial blood sampling.

8. The Sample Size for the Training Set:

   • This question applies to machine learning models. The device in question is a physiological sensor, not an AI/ML model that requires a "training set" in the computational sense. Therefore, N/A.

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

   • As this is not an AI/ML device, the concept of "ground truth for the training set" does not apply. N/A.

In summary, the document primarily focuses on demonstrating substantial equivalence through comparison of technical characteristics and adherence to relevant standards for a medical device. While it mentions clinical testing for validation of SpO2, it lacks detailed specifics regarding sample size, expert involvement, or adjudication methods for this clinical study, which are more commonly detailed for AI/ML device submissions.

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The devices are intended for spot checking or continuous monitoring of functional arterial oxygen saturation and pulse rate in non-invasive oximeter equipment. The sensors are reusable depending on models, and are intended for adult, pediatric or infant, depending on models. They shall be used in healthcare settings.

The proposed device, 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 noninvasive U.S. legally marketed oximeters or patient monitors. The sensors are reusable or disposable depending on models, and are intended for adult, pediatric or infant, depending on models.

The proposed devices measure, along with the corresponding oximeters, non-invasively, the arterial oxygen saturation of blood. The measurement method is based on the red and infrared light absorption of hemoglobin and oxyhemoglobin. Each sensor has two LEDs, emitting both red and infrared light, and a photodiode. The light is emitted through human finger and received by a photodiode. Then the received signal is forwarded to the corresponding oximeter that amplifies the signal and an algorithm that calculates the ratio. The saturation value is determined by the percentage ratio of the oxygenated hemoglobin (HbO2) to the total amount of hemoglobin (Hb).

The patient contact components include cable and sensor. The contact level is surface device and contact duration is limited contact (less than 24h).

This document describes the validation of SpO2 Sensors. Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document states that "Clinical hypoxia test results were obtained in human adult volunteers." While the specific number of volunteers is not explicitly stated in this summary, it is implied that a sufficient number participated to "validate the accuracy."
• Data Provenance: The data was obtained from clinical hypoxia tests conducted in human adult volunteers. The document does not specify the country of origin, but the submitting company is based in China. The study appears to be prospective as it involves active testing on human subjects.

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

The document does not provide details on the number or qualifications of experts involved in establishing the ground truth. It states that "arterial oxygen saturation (SaO2) as determined by co-oximetry" was used as the ground truth. This suggests that the ground truth was established through a gold standard measurement technique rather than human expert interpretation of images or other data.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by co-oximetry, which is a direct measurement, not an interpretation requiring adjudication.

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

No. This study is for an SpO2 sensor, not an AI or imaging device where human readers would interpret results. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

6. Standalone (Algorithm Only) Performance

Yes, in a sense. The primary performance evaluation (SpO2 and Pulse Accuracy) is an assessment of the device's ability to measure these parameters against a known ground truth (arterial oxygen saturation by co-oximetry). While the sensor is an accessory to an oximeter, its accuracy is evaluated inherently as a standalone measurement component interacting with the human body to produce data.

7. Type of Ground Truth Used

The ground truth used was outcomes data/physiological measurement. Specifically, "arterial oxygen saturation (SaO2) as determined by co-oximetry." Co-oximetry is a laboratory method considered a gold standard for measuring oxygen saturation in arterial blood.

8. Sample Size for the Training Set

Not applicable. This document describes the validation of a medical device (SpO2 sensor), not an AI algorithm that requires a separate training set. The device's underlying principles are based on established physics (red and infrared light absorption of hemoglobin), not machine learning from a large dataset.

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

Not applicable, as there is no training set mentioned or implied for this type of medical device.

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Caremed Reusable & Disposable 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 and pediatric patients weighing 10 -50 kg at hospital facilities

Caremed Reusable & Disposable SPO2 Sensors use optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the patient monitor or oximeter device. The probe contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The LED and photodiode are contained in sensor housing.

This document is a 510(k) premarket notification for the Caremed Reusable & Disposable SpO2 Sensors. It states that the device is substantially equivalent to a legally marketed predicate device. The information provided is primarily focused on demonstrating this substantial equivalence through comparisons of technical properties and adherence to standards, rather than providing a detailed clinical study report with specific acceptance criteria and detailed performance of the new device.

Here's an attempt to answer your questions based on the provided text, recognizing that some information is implicit or not fully detailed:

1. A table of acceptance criteria and the reported device performance

The document mentions that the subject device's SpO2 and Pulse Rate accuracy meet the requirements of ISO80601-2-61. However, it only provides the SpO2 Accuracy and Pulse Rate Accuracy of the predicate device (K100077 and K111888) as a comparison point in Table 1. It also states the subject device's accuracy has a "slight difference" from the predicate. Without the explicit values for the subject device's SpO2 and Pulse Rate accuracy and the specific ISO80601-2-61 requirements, a direct "acceptance criteria vs. reported performance" table cannot be fully constructed for the subject device.

However, based on the predicate device's performance as a proxy for expected accuracy and the statement that the subject device meets ISO80601-2-61 standards, we can infer some criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not explicitly stated. The document mentions "human adult volunteers" but does not specify the number.
• Data Provenance: Not explicitly stated for the clinical trial. The company is based in Shenzhen, China.
• Retrospective or Prospective: "Clinical hypoxia test results were obtained in human adult volunteers" typically implies a prospective study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable or not mentioned. For SpO2 sensor accuracy testing, the ground truth (arterial oxygen saturation, SaO2) is typically established by laboratory methods such as co-oximetry of arterial blood samples, not by expert consensus.

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

Not applicable or not mentioned. As the ground truth is established by co-oximetry, there's no need for an adjudication method involving human experts for the primary endpoints.

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

Not applicable. This is a medical device for directly measuring physiological parameters (SpO2 and pulse rate), not an AI-assisted diagnostic imaging device that involves human readers.

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

Yes, a standalone performance test was done. The document states: "Clinical hypoxia test results were obtained in human adult volunteers to validate the accuracy of Caremed Reusable & Disposable SPO2 Sensors versus arterial oxygen saturation (SaO2) as determined by co-oximetry." This is a direct measurement of the device's accuracy against a gold standard, which is a standalone performance assessment.

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

The ground truth used was arterial oxygen saturation (SaO2) as determined by co-oximetry from arterial blood samples. This is considered a gold standard laboratory method.

8. The sample size for the training set

Not explicitly stated. For SpO2 sensors, "training data" often refers to data used to derive or refine the oximetry algorithm. If this refers to the data used for the algorithm, its size is not mentioned. If it refers to clinical data, the document mainly references the clinical performance study (test set).

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

Not explicitly stated. Assuming a similar methodology to the test set, the ground truth for any algorithm development or training would likely have been established using co-oximetry from arterial blood samples.

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The Philips disposable SpO2 sensor M1134A is indicated for use by health care professionals whenever there is a need for acquiring non-invasively the arterial oxygen sturation a support the measurement of oxygen saturation. Intended for monitoring, recording, and alarming of the physiological parameters arterial oxygen saturation (SpO2) and pulse rate of adults, infants, and neonates in a healthcare environment and during transport inside and outside of healthcare environments.

The modified device uses adhesive-free material (adhesive-free skins) which covers the optical parts of the sensor and which comes into contact with the patient. Such a modified SpO2 sensor can be applied to patients whenever skin sensitivity is a concern. The new disposable SpO2 sensors M1134A are for single use, when continuous non-invasive arterial oxygen saturation and pulse rate monitoring are required. The measurement method is based on the absorption of light, which is sent through human tissue (for example through the index finger). The light is emitted from two sources with different wavelengths and is received by a photodiode. Through interference with the human tissue the two distinct wavelengths will be differently absorbed. Out of this different absorption behavior a so-called Ratio can be calculated. Based on calibration curves, the Ratio can be related to a SpO2 value.

Here's a breakdown of the acceptance criteria and the study details for the Philips disposable SpO2 sensor M1134A, based on the provided text:

1. A table of acceptance criteria and the reported device performance

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

• Test Set Sample Size: 12 volunteers (6 male, 6 female).
• Data Provenance: The study was conducted in a controlled environment as a "desaturation study." The country of origin is not explicitly stated, but the manufacturer is based in Germany, and the submission is to the FDA in the USA. This was a prospective study, as it involved actively collecting new data from volunteers.

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

The document does not explicitly state the number of experts used or their qualifications for establishing ground truth. The primary ground truth for SpO2 accuracy was established by a CO-Oximeter as a reference, which is a gold standard for blood oxygen measurement.

4. Adjudication method for the test set

The document does not describe an adjudication method involving multiple human readers for the test set. The validation appears to rely on a direct comparison between the device's readings and the reference CO-Oximeter.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a sensor for direct physiological measurement, and the study focuses on its accuracy against a reference device, not on diagnostic image interpretation by humans with or without AI assistance.

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

Yes, the study described is a standalone performance study of the sensor. The device itself (the SpO2 sensor) is an "algorithm only" in the sense that it mechanically measures and calculates SpO2 and pulse rate. The study assesses the accuracy of these measurements against a gold standard (CO-Oximeter) without human interpretation being the primary variable.

7. The type of ground truth used

The type of ground truth used was CO-Oximeter measurements. This is a highly accurate, direct measurement of arterial oxygen saturation and serves as the reference standard to which the SpO2 sensor's readings were compared.

8. The sample size for the training set

The document does not mention a separate "training set" in the context of machine learning. The device's accuracy is based on its fundamental measurement principle and calibration curves, which would have been developed during the device's design phase. The mentioned "more than 300 blood samples" were part of the validation study (test set) to confirm the accuracy, not for training a model.

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

As there's no explicitly mentioned "training set" in the context of machine learning, the establishment of "ground truth for the training set" is not applicable in this document. The device's underlying principle relies on light absorption and pre-established calibration curves, which would have been developed using known SpO2 values and corresponding light absorption ratios during the initial design and development of oximetry technology. The presented study focuses on validating the final device's performance.

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The Philips reusable and disposable SpO2 Sensors are intended for non-invasive measurement of oxygen saturation (SpO2) and pulse rate.

Philips Reusable SpO2 Sensors M1191T, M1192T, and M1193T: M1191T is indicated for adult patients, M1192T is indicated for pediatric patients, and M1193T is indicated for neonatal patients.

Philips SpO2 Reusable Clip Sensor Model M1196T: M1196A and M1196T are indicated for patients > 40 kg (typically adult patients).

Philips Disposable SpO2 Sensor M1131A: M1131A is indicated for adult patients/pediatric patients

Philips Disposable SpO2 Sensors M1132A and M1133A: M1132A is indicated for infant patients, and M1133A for adult/infant/neonatal patients.

Not Found

The provided text discusses regulatory approval for Philips SpO2 sensors but does not contain information about acceptance criteria or a study proving device performance against specific criteria. The document describes a 510(k) submission for a labeling change to add compatibility with non-Philips monitors. The testing mentioned in the document states "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved system level tests, integration tests, environmental tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. The results demonstrate that the pulse oximetry sensors functionality meets all reliability requirements and performance claims." However, it does not provide details on specific acceptance criteria values, reported device performance metrics, sample sizes, data provenance, ground truth establishment, or any comparative effectiveness studies.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the provided text.

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