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The disposable rectal temperature probes are intended to be used for continually monitoring temperature for up to 10 minutes from the rectum of adults, the probes may be used for up to 24 hours.

The temperature probes are non-sterile and designed for single patient use with monitors of EDAN model iM50. These devices are indicated for use by qualified medical personnel in hospital environment.

Disposable temperature probe is used during patient temperature measurement. The probe consists of a phone plug connector on the adapter cable end and a thermistor on the patient end. The probe measures temperature by a resistor that is sensitive to temperature changes. The probe is connected to the patient monitor by using an interconnect cable.

The probe is used with legacy Edan Instruments, Inc. patient monitors iM50, which was cleared under K113623.

The probe is packed individually into a plastic bag in non-sterile condition. The package label describes product LOT codes, CE-mark, legal entity information and a caution "Rx Only ".

The provided text is a 510(k) Summary for a disposable temperature probe. Based on the content, the acceptance criteria and the study proving the device meets these criteria can be described as follows:

Acceptance Criteria and Device Performance Study for a Disposable Temperature Probe

This medical device is a Disposable Temperature Probe. The acceptance criteria and the performance study were conducted to demonstrate substantial equivalence to a predicate device (Caremed Disposable Temperature Probe K182755).

1. Table of Acceptance Criteria and Reported Device Performance

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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 Reusable SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult (> 40 kg) and pediatric (10-50 kg) patients.

The proposed device, Reusable SpO2 Sensors are accessories to patient monitors, which are intended for continuous non-invasive monitoring of functional arterial oxygen saturation and pulse rate. The compatible patient monitor is EDAN iM50 with Nellcor SpO2 module (K113623).

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 pulse rate conditions.

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).

Here's a breakdown of the acceptance criteria and study details for the Reusable SpO2 Sensor, based on the provided FDA 510(k) summary:

This device is a Reusable SpO2 Sensor, an accessory to patient monitors used for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult (> 40 kg) and pediatric (10-50 kg) patients.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document specifically details performance criteria and claims for SpO2 and PR accuracy compared to a legally marketed predicate device.

Note: The document emphasizes substantial equivalence to the predicate device, meaning the new device's performance is demonstrated to be equivalent to a device already cleared by the FDA. The performance data presented are in direct comparison to the predicate's stated specifications.

Study Details Proving Device Meets Acceptance Criteria:

The information provided is typical for a 510(k) submission, focusing on demonstrating substantial equivalence rather than a detailed standalone clinical study report.

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

• Test Set Sample Size: The document states that "Clinical hypoxia test results were obtained in human adult volunteers." However, the specific number of adult volunteers (sample size) used for the clinical accuracy testing is not provided in this summary.
• Data Provenance: The data appears to be prospective clinical data gathered specifically for this submission, as indicated by "Clinical testing has been performed under an approved protocol with subject informed consent." The country of origin for the data is not explicitly stated, but the submitting company and correspondent are based in Shenzhen, China.

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

• This information is not provided in the document. For pulse oximetry clinical studies, ground truth is typically established by arterial blood gas analysis (co-oximetry), not by expert consensus on visual assessment or interpretation.

4. Adjudication Method for the Test Set:

• Adjudication methods (like 2+1, 3+1) are typically relevant for studies involving human interpretation of medical images or data where subjective decisions are made. For a pulse oximetry study where ground truth is established by a quantitative measurement (co-oximetry), traditional adjudication methods as described are not applicable.

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

• No, an MRMC study was not done. MRMC studies are designed to compare the performance of human readers, often with and without AI assistance, especially in diagnostic imaging. This device is a sensor, and its accuracy is assessed quantitatively against a gold standard (co-oximetry), not through human reader interpretation. Therefore, questions about an effect size of human readers improving with AI assistance are not applicable to this type of device and study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done:

• Yes, in essence. The clinical accuracy study ("Clinical hypoxia test results were obtained in human adult volunteers to validate the accuracy of Changke Reusable SpO2 Sensors versus arterial oxygen saturation (SaO2) as determined by co-oximetry") assesses the performance of the device (including its internal algorithm for calculating SpO2 and PR) against a gold standard. While the device outputs data for human use, the accuracy assessment itself is effectively a standalone performance evaluation of the sensor and its processing capabilities.

7. The Type of Ground Truth Used:

• The ground truth used for the clinical accuracy testing was arterial oxygen saturation (SaO2) as determined by co-oximetry. Co-oximetry is considered the gold standard for measuring arterial oxygen saturation.

8. The Sample Size for the Training Set:

• This information is not provided in the 510(k) summary. For medical devices, particularly sensors, "training set" is often interpreted as the data used during the development and calibration of the device's algorithms. The summary focuses on the validation data (clinical studies) rather than internal R&D or algorithm training data.

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

• As the sample size and specific details of a "training set" (in an AI/ML context) are not explicitly mentioned for this device's development, the method for establishing ground truth for any such internal data is not provided. However, it is inferred that similar, highly accurate methods (like co-oximetry) would have been used during the sensor's design and calibration phases to ensure its foundational accuracy.

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MFM-CMS is a software application that is intended for use as a clinical data managing system (also referred to as a clinical information system - CIS).The MFM-CMS Central Monitoring System offers centralized physiological information management of adult, pediatric and neonatal patients which is automatically acquired from multiple bedside monitors. The MFM-CMS provides: collection, display and documentation of data from bedside monitors, viewing of patient physiologic data at remote locations and alarms when the results of the physiologic parameters exceed the user defined limit. It operates with off-the-shelf software. The system is intended for use in a hospital/clinical environment.

The MFM-CMS Central Monitoring System is a software production which runs on PC platform with Microsoft Windows XP or Microsoft Windows 7 operating system. Through specified EDAN protocol, one MFM-CMS can connect with multi-monitor manufactured by EDAN to collect patients' information and monitoring data such as physiological waveforms, physiological parameters and alarms. The MFM-CMS can also send bidirectional control instructions to bedside monitors to change patients' information, alarm limits, and conduct NIBP measurements. The bedside Patient Physiological Monitors have been cleared by FDA under K101539, K120144, K110922, K113623, K113653 and K120173 separately. The monitoring information collect by the MFM-CMS can be saved and printed. At the same time, the old records can be searched conveniently and quickly.

Here's an analysis of the provided text regarding the acceptance criteria and study for the EDAN Instruments MFM-CMS Central Monitoring System:

This device documentation does not contain the level of detail typically found in a study demonstrating performance against specific acceptance criteria for an AI/CADe device. The 510(k) summary focuses more on the software's functionality, its classification, and its substantial equivalence to a predicate device. It lacks quantifiable performance metrics against acceptance criteria.

Therefore, for many of your requested points, the answer will be "Not provided in the text."

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

Explanation: The document describes the system's features and intended use but does not define specific performance acceptance criteria (e.g., accuracy, sensitivity, specificity for particular physiological events like arrhythmia detection, or data display latency). Consequently, no reported device performance metrics against such criteria are provided.

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 provided in the text.
• Data Provenance: Not provided in the text.

Explanation: The document mentions "Verification and validation testing was done on MFM-CMS" and lists "Software testing," "Risk analysis," "Safety testing," and "Performance test" as quality assurance measures. However, it does not detail the nature of these "tests," nor does it specify any test datasets, their sizes, or their origin.

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)

• Number of Experts: Not provided in the text.
• Qualifications of Experts: Not provided in the text.

Explanation: Since no detailed performance study or test set is described, there's no mention of experts or their role in establishing ground truth.

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

• Adjudication Method: Not provided in the text.

Explanation: As no test set with expert ground truth is described, there's no mention of an adjudication method.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not conducted or described.
• Effect Size of Human Improvement: Not applicable, as no such study was performed.

Explanation: The MFM-CMS is a central monitoring system for displaying physiological data and alarms from bedside monitors, not a diagnostic AI/CADe device designed to assist human readers in interpreting images or signals more effectively. Its primary function is data aggregation and display. Therefore, an MRMC study comparing human performance with and without AI assistance is not relevant to this type of device and was not conducted.

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

• Standalone Performance Study: Not described in the text in terms of quantifiable metrics.

Explanation: The "Performance test" mentioned is too vague to determine if it constituted a standalone performance study with specific metrics. The device's primary function is to process and display data, not necessarily to perform standalone diagnostic calculations that would have defined standalone accuracy metrics. It is a "software production" that runs on a PC and monitors data, and connectivity/display functionality would be the main "performance" aspects.

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

• Type of Ground Truth: Not provided in the text.

Explanation: Without details on any specific performance tests, the method for establishing ground truth is not described.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable / Not provided in the text.

Explanation: This device is a software application for data collection, display, and alarm management. It is not an AI/Machine Learning device in the sense that it requires a "training set" to learn to perform a diagnostic task. It relies on predefined protocols and inputs from connected monitors.

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

• How Ground Truth for Training Set was Established: Not applicable / Not provided in the text.

Explanation: As it's not an AI/ML device requiring a training set, the concept of establishing ground truth for training is not relevant here.

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