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Disposable Non-invasive EEG Sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals.

Disposable Non-invasive EEG Sensor is a sensor assembly with pre-gelled electroencephalogram (EEG) electrodes. The Sensor is applied to the skin of the patient to record electrophysiological (such as EEG) signals. It is a low impedance, single patient use, non-sterile disposable electrode sensor that is designed for application to areas including forehead, temporal, above eyebrow and mastoid process. The Sensor is designed to provide ease of use and electrode placement accuracy. It is used in conjunction with a monitor with an EEG module.

The sensor design is constructed using FPC (Flexible Printed Circuit Board) and medical foam. Place the foam plate and conductive gel on the FPC board. The bottom of the foam is covered with medical grade pressure sensitive adhesive for skin adhesion. A printed circuit board, which is part of the FPC board and printed with conductive silver chloride, is pasted on the other side of the foam. The flexible foam wrapped with conductive gel is used to contact the skin. When the flexible foam contacts the skin, the conductive gel will connect the skin with the FPC board to form a conductive bridge. The silver/silver chloride circuit provides signal continuity from each electrode to the monitor. The FPC board is attached to site like forehead and transmits EEG signals.

The company, Shenzhen Med-link Electronics Tech Co., Ltd., is seeking 510(k) clearance for their Disposable Non-invasive EEG Sensor. The device is a non-sterile, single-patient use electrode sensor designed to record electrophysiological (EEG) signals. The indications for use state that the sensor is "applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals."

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document mentions "bench testing," "electrical safety and performance tests," "biocompatibility tests," and "package integrity and functional performance testing." However, specific sample sizes for these tests are not provided in the summary. The provenance of the data (country of origin, retrospective/prospective) is also not explicitly stated beyond the manufacturer being in China.

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

This information is not applicable to the data provided. The studies described are bench tests and engineering performance evaluations of a physical medical device (EEG sensor), not studies that require expert-established ground truth for diagnostic accuracy or clinical outcomes.

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

This information is not applicable as the described tests are technical performance evaluations, not studies involving 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:

This is not applicable. The device is an EEG sensor, a hardware component for recording signals, not an AI-powered diagnostic tool requiring human reader studies.

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

This is not applicable. The device is a sensor, not an algorithm. The performance tests are focused on the hardware's ability to accurately record signals and meet safety standards.

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

The "ground truth" for the tests performed is based on established industry standards and regulatory requirements for electrical safety, performance, biocompatibility, and material properties. For example, ANSI/AAMI ES60601-1 for electrical safety, ANSI/AAMI EC12 for EEG electrode performance, and ISO10993 series for biocompatibility.

8. The sample size for the training set:

This is not applicable. The device is a hardware sensor, not a machine learning algorithm that requires a training set.

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

This is not applicable as there is no training set for this device.

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Disposable ECG Cable and Leadwires are intended to be used with ECG monitoring devices to measure a patient's ECG for general monitoring and/or diagnostic evaluation by heath care professional.

Disposable ECG Cable and Leadwires meets the requirements of the standard ANSI/AAMI EC53, ECG TRUNK CABLES and PATIENT LEADWIRES. This leadwire set is intended for single-patient use.

Disposable ECG Cable and Leadwires with specific various lengths are the replacements for similar cables manufactured by Original Equipment Manufacturers (OEM) and other third party after market manufacturers for their respective monitors.

These devices consist of connectors on each cable end and a shielded bulk cables are used to transfer the signals from the electrodes to the patient monitor.

These devices use the same type of constructions and have the same technological characteristics as the predicate devices. They use a medical grade PVC and TPU cable jacket with medical grade PVC and ABS over molded connectors with integral relief.

The provided text describes the regulatory clearance of a medical device, the "Med-link Disposable ECG Cable and Leadwires," but it does not contain information about a study proving the device meets acceptance criteria in the way you've outlined.

The document is a 510(k) premarket notification summary, which aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through clinical or detailed standalone studies.

Here's a breakdown of why this document doesn't fit your request and what information it does provide:

• Type of Device: The device is a Disposable ECG Cable and Leadwires, which is an accessory to ECG monitoring devices, not a diagnostic algorithm or AI system. Therefore, the concepts of "sensitivity," "specificity," "AI improvement," "training sets," "test sets," "ground truth," or "expert adjudication" as typically applied to AI/ML medical devices are not relevant here.
• Purpose of 510(k): The primary goal of a 510(k) submission is to show that a new device is "substantially equivalent" to a predicate device already on the market, meaning it has the same intended use and technological characteristics, or if there are differences, those differences do not raise new questions of safety and effectiveness.

Given this context, I cannot fill out your requested table and information points as they pertain to a different type of device evaluation (e.g., for an AI/ML diagnostic software).

However, I can extract the information that is relevant to the document provided:

Summary of Device Evaluation (as per the 510(k) Summary):

Acceptance Criteria and Device Performance (based on regulatory standards rather than clinical endpoints):

Here's why the other points you requested are not available in this document:

1. Sample size used for the test set and data provenance: Not applicable. This device is an accessory (cable/leadwire) and its performance is evaluated against engineering/safety standards (IEC, AAMI, ISO), not clinical data sets with "test sets" or "data provenance" in the context of an algorithm. The testing involves bench and type testing of the physical device according to standards.
2. Number of experts used to establish the ground truth... and their qualifications: Not applicable. There is no "ground truth" to establish through experts for an ECG cable's performance in the way a diagnostic algorithm requires. Compliance to standards is verified through laboratory testing.
3. Adjudication method: Not applicable. No human adjudication is mentioned or relevant for electrical and biocompatibility testing of a cable.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is not an AI/ML diagnostic device, so MRMC studies are irrelevant.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
6. The type of ground truth used: Not applicable. The "ground truth" here is compliance with established engineering and safety standards, verified through bench testing.
7. The sample size for the training set: Not applicable. There is no "training set" for an ECG cable.
8. How the ground truth for the training set was established: Not applicable.

In conclusion, the provided document details the "substantial equivalence" of an ECG cable to a predicate device by demonstrating compliance with relevant international and national standards for electrical safety, performance, and biocompatibility through non-clinical (bench and type) testing, not through a clinical study with acceptance criteria for diagnostic accuracy metrics.

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Med-link Pulse Oximeter is intended for spot checking in measuring and displaying functional arterial oxygen saturation (SpO2) and pulse rate of patients in hospitals, physician's office, clinical settings and home care environment. It's a reusable device intended for adults and pediatrics who are well or poorly perfused.

Med-Link Pulse Oximeter is to spot-check oxygen saturation in blood (SpO2) and pulse oximeter is used on adults and pediatrics at hospital, clinics, and/or home. The device mainly consists of power supply module, detector and emitter LED, signal collection and processor module, user interface and button control. There is no visual or audio alarm. The device is reusable and non-sterile. The device has AM801. The device contains a dual light source (Red LED and Infrared red LED) and a photo detector. Bone, tissue, pigmentation, and venous vessels normally absorb a constant amount of light over time. The arteriolar bed normally pulsates and absorbs variable amounts of light during the pulsations. The ratio of light absorbed in an oxygen saturation measurement (SpO2). Because a measurement of SpO2 is dependent on light from the device, excessive ambient light can interfere with this measurement. The wavelength of red LED is 660mm and infrated LED is 905nm with maximum optical output power of 15mW.

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

1. Table of Acceptance Criteria and Reported Device Performance

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Med-link Reusable Temperature Probes:

Med-link Temperature Probes are intended to be used for monitoring temperature for multi-patient use. The temperature probes are reusable and designed for use with monitors of Philips Model IntelliVueMP50, Mindray Model PM-9000 and Drager Model Infinity Gamma XL.

These devices are used by qualified medical professional only.

Med-link Disposable Temperature Probes:

Med-link Disposable Temperature Probes are intended to be used for monitoring temperature for single patient use. The temperature probes are non-sterile and designed for use with monitors of GE Model B20 and Philips Model IntelliVueMP50.

These devices are used by qualified medical professional only.

The proposed devices are used for patient temperature measurement. The probes are reusable depending on models. These probes consist of a connector on the monitor end and a thermistor on the patient end. The working principle is resistance based on the metal conductor increases with temperature decrease, and the linear changes to the characteristics of the temperature measurement. The proposed devices are designed to be used in healthcare facilities like hospital.

The provided text describes the 510(k) summary for Med-link Reusable and Disposable Temperature Probes. While it outlines the device's characteristics and comparison to predicate devices, it does not contain information about acceptance criteria or a study that proves the device meets specific performance acceptance criteria in the context of AI/ML algorithm evaluation.

The document states:

• "No clinical studies were performed to demonstrate substantial equivalence." (Section 10)
• The non-clinical tests focused on safety, essential performance, and biocompatibility in accordance with relevant IEC and ISO standards for medical electrical equipment and biocompatibility. The performance standard cited is ISO 80601-2-56 for body temperature measurement.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/ML algorithm's performance, as this document is for a traditional medical device (temperature probes) and does not involve AI/ML.

However, I can extract the reported device performance and testing information that is present in the document for the temperature probes themselves, which is related to the accuracy of the temperature measurement.

Reported Device Performance (for the temperature probes, not an AI/ML algorithm):

Regarding the other requested information for AI/ML algorithms:

1. Sample size used for the test set and the data provenance: Not applicable, as this is not an AI/ML algorithm. Non-clinical tests were performed to assess safety and effectiveness against standards.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Device calibration and accuracy testing typically refer to established laboratory methods and reference standards, rather than expert interpretation.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device itself is standalone in its function as a temperature probe; there is no AI algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For temperature accuracy, the ground truth would typically be established by calibrated reference thermometers in a controlled environment, adhering to the requirements of the relevant performance standards (e.g., ISO 80601-2-56).
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

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Med-link Temperature Probes are intended to be used for monitoring temperature for multi-patient use. The temperature probes are reusable and designed for use with monitors of Philips Model Intelli Vue MP50, Mindray Model PM-9000, Datex-Ohmeda Model Cardiocap II, Drager Model Infinity Gamma XL.

These devices are used by qualified medical professional only.

The proposed devices are used for patient temperature measurement for multi-patient use. The temperature probes are reusable and consist of a connector on the monitor end and a thermistor on the patient end. The working principle is resistance based on the metal conductor increases with temperature decrease, and the linear changes to the characteristics of the temperature measurement.

The Med-link Temperature Probes are intended for monitoring temperature for multi-patient use. They are reusable and designed for use with specific monitors (Philips Model IntelliVue MP50, Mindray Model PM-9000, Datex-Ohmeda Model Cardiocap II, Drager Model Infinity Gamma XL).

Here's an analysis of the acceptance criteria and supporting study information:

1. Acceptance Criteria and Reported Device Performance

The core performance acceptance criterion for the Med-link Temperature Probes appears to be accuracy.

Other relevant criteria and performance:

• Type of Use: Prescription Use
• Operating Principle: Resistance of thermistor based on the metal conductor increases with temperature decrease, and the linear changes to the characteristics of the temperature measurement.
• Measurement Site: Skin, Esophageal, and Rectal
• Component: Reusable
• Thermistor Resistance: 2.25K@25°C
• Sterilization: Non-sterile
• Electrical Safety: Comply with IEC 60601-1
• Performance Standard Compliance: ISO 80601-2-56

2. Sample Size and Data Provenance for Test Set

The document does not explicitly state the specific sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for any clinical studies.

The document mentions "performance bench testing in accordance with ISO 80601-2-56 for all models of the subject device with compatible monitors was conducted and the results met the requirements." This indicates that the testing was likely laboratory-based bench testing rather than clinical trials with human subjects.

3. Number of Experts and their Qualifications for Ground Truth

The document does not indicate the involvement of experts in establishing ground truth for a test set, as the testing described is primarily bench testing against recognized standards rather than clinical validation requiring expert interpretation or diagnosis.

4. Adjudication Method for the Test Set

Not applicable, as the document describes bench testing against technical standards, not a study requiring adjudication of expert interpretations.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on device equivalence based on technical standards and performance specifications, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study in the form of bench testing was conducted. The document states: "performance bench testing in accordance with ISO 80601-2-56 for all models of the subject device with compatible monitors was conducted and the results met the requirements." This testing evaluates the device's technical performance against a recognized standard without human interpretation in the measurement process.

7. Type of Ground Truth Used

The ground truth used was established by recognized international technical standards and specifications. Specifically, the device's performance was compared against the requirements of:

• ISO 80601-2-56: Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement.
• The stated accuracy of ±0.1°C and measurement range of 25-45°C are the "ground truth" against which the device's measured performance was assessed during bench testing.

8. Sample Size for the Training Set

The document does not describe any machine learning or AI components that would require a "training set." Therefore, this question is not applicable. The device is a traditional electronic thermometer.

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

Not applicable, as there is no mention of a training set for machine learning or AI.

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Med-link Reusable Blood Pressure Cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in neonatal, pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.

The proposed device, Med-link Reusable Blood Pressure Cuffs is rectangle soft inelastic sleeve with bladder, to which a single-tube or twin-tube is connected. It is wrapped around the patient's limb and secured by hook and loop closure. The device tubing is connected to a non-invasive blood pressure measurement system. It is available in various sizes for different limb range. It is provided non-sterile.

The Med-link Reusable Blood Pressure Cuff underwent non-clinical testing to assess its safety and essential performance. The acceptance criteria and reported device performance are based on compliance with specific ISO and IEC standards.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample sizes used for each specific non-clinical test (ISO 81060-1, IEC 80601-2-30, biocompatibility tests). It indicates that "A series of safety, essential performance and biocompatibility tests were performed."
The provenance of the data is not specified in terms of country of origin or whether the tests were retrospective or prospective. It states the tests were "conducted in accordance with" the listed standards, implying a controlled testing environment.

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

This information is not provided in the document. The non-clinical testing primarily focuses on objective measurements against international standards rather than expert-derived ground truth as might be seen in diagnostic imaging studies.

4. Adjudication Method for the Test Set:

This information is not applicable and is not provided. The testing involves standardized laboratory and performance tests, not a judgmental adjudication 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 information is not applicable and is not provided. The device is a blood pressure cuff, not an AI-assisted diagnostic tool for which MRMC studies would typically be conducted.

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

This information is not applicable and is not provided. The device is not an algorithm, so standalone algorithm performance is not relevant. The performance of the cuff is evaluated as a physical accessory for blood pressure measurement systems.

7. The Type of Ground Truth Used:

The ground truth for the performance claims relies on:

• International Standards: Compliance with ISO 81060-1, IEC 80601-2-30, ISO 10993-5, and ISO 10993-10. These standards establish the acceptable technical performance and safety criteria for such devices.
• Biocompatibility Testing: Objective laboratory tests (cytotoxicity, skin irritation, skin sensitization) directly measure the device's interaction with biological systems against established thresholds.
• Predicate Device Comparison: The inherent assumption is that if the device performs equivalently to legally marketed predicate devices that have already met regulatory requirements, then it is safe and effective.

8. The Sample Size for the Training Set:

This information is not applicable to this type of medical device. Blood pressure cuffs are mechanical devices, and their performance is established through physical and biological testing, not machine learning models that require training sets.

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

This information is not applicable for the reasons stated in item 8.

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Med-link Disposable Blood Pressure Cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in neonatal, pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.

The proposed device, Med-link Disposable Blood Pressure Cuff is rectangle soft inelastic sleeve. There is a single-tube or twin-tube connected to a sealed gas chamber. It is wrapped around the patient's limb/thigh and secured by hook and loop closure. The device tubing is connected to a non-invasive blood pressure measurement system. It is available in various sizes for different limb range. It is provided non-sterile.

This document is a 510(k) premarket notification for the Med-link Disposable Blood Pressure Cuff. It aims to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on the FDA recognized consensus standard ISO 81060-1:2007/ AAMI/ANSI/ISO81060-1:2007/(R)2013 Non-Invasive Sphygmomanometers -Part 1: Requirements And Test Methods For Non-Automated Measurement Type, and ISO 10993 (Biological evaluation of medical devices) series for biocompatibility.

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

The document does not explicitly state the sample size used for the performance testing. It mentions "Performance testing was performed on the subject device," but does not specify the number of devices or measurements.

The data provenance is not specified regarding country of origin or specific study design (retrospective or prospective). The tests are described as "non-clinical testing," which suggests laboratory-based evaluations rather than human subject trials for the core performance and biocompatibility aspects.

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

This document describes the testing of a basic medical accessory (blood pressure cuff). The "ground truth" for its performance is established by objective measurements against a recognized standard (ISO 81060-1). There is no mention of experts establishing a "ground truth" in the way one might for diagnostic imaging or a subjective clinical assessment. The ground truth for biocompatibility is established through standardized laboratory tests.

4. Adjudication Method for the Test Set

Not applicable. The performance and biocompatibility tests are objective measurements against established standards, not subjective assessments requiring adjudication by multiple experts.

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

No. This is a 510(k) submission for a blood pressure cuff, which is a physical accessory, not an AI or imaging-based diagnostic device. Therefore, an MRMC comparative effectiveness study, which typically evaluates human readers' performance with and without AI assistance, is not relevant or applicable here.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a passive accessory and does not involve an algorithm. Its function is to interface with a blood pressure measurement system.

7. Type of Ground Truth Used

The ground truth used for performance testing (accuracy and reliability of pressure transmission, cuff inflation/deflation, etc.) is the adherence to the ISO 81060-1 standard's objective requirements and test methods.

For biocompatibility testing, the ground truth is established by the results of standardized laboratory tests (Cytotoxicity, Skin Irritation, Skin Sensitization) as defined by the ISO 10993 series.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning algorithm and therefore does not have a "training set."

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

Not applicable, as there is no training set for this device.

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Shenzhen Med-link disposable probe, model S0136J-L, is indicated for single patient use when continuous, non-invasive arterial oxygen saturation and pulse rate monitoring are required for adult patients or pediatric patients weighing more than 30 kg. The S0136J-L is contraindicated for use with patients during motion condition.

Shenzhen Med-link Pulse Oximeter Probes are electro-optical probes which function without skin penetration, electrical contact, or heat transfer. The probes 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 silicon rubber pads. These SpO2 probes not made with natural rubber latex.

The Shenzhen Med-Link Pulse Oximeter Probe, model S0136J-L, was tested to ensure its performance and safety, primarily focusing on SpO2 accuracy and pulse rate accuracy.

1. Acceptance Criteria and Reported Device Performance:

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

The document mentions "clinical testing to validate the performance and accuracy of the probes under controlled hypoxia versus arterial oxygen saturation as determined by co-oximetry." However, it does not specify the exact sample size of subjects used for this clinical test set.

The data provenance is prospective, as indicated by the description of the clinical study, which involved "all testing performed under an institutionally approved protocol with subject informed consent." The country of origin of the data is not explicitly stated, but it can be inferred to be from the location where the clinical study was conducted.

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 used or their qualifications for establishing the ground truth. The ground truth for SpO2 accuracy was determined by "arterial oxygen saturation as determined by co-oximetry." This implies instrumental measurement as the "ground truth" rather than expert consensus on interpretation.

4. Adjudication Method for the Test Set:

The document does not describe an adjudication method for the test set, as the ground truth was established by co-oximetry, which is an objective measurement rather than a subjective interpretation requiring adjudication among experts.

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:

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed as this device is a pulse oximeter probe, not an AI-assisted diagnostic tool that requires human interpretation of images or data. Therefore, the concept of human reader improvement with AI assistance is not applicable.

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

Yes, a standalone performance assessment was conducted for the device. The clinical study evaluated the performance of the Shenzhen Med-link Probe itself in determining SpO2 accuracy under controlled hypoxia, compared to co-oximetry as the reference standard. This is a direct measure of the device's algorithmic performance.

7. The Type of Ground Truth Used:

The ground truth for SpO2 accuracy was arterial oxygen saturation as determined by co-oximetry. This is an objective, instrumental measurement of the true physiological value.

8. The Sample Size for the Training Set:

The document does not specify a separate training set or its sample size. For a medical device like a pulse oximeter, the "training" typically refers to the development and calibration of the internal algorithms based on physiological principles and empirical data, rather than a distinct machine learning training set in the conventional sense. The "clinical testing" described serves as the validation or test set against which the device's performance is measured.

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

As no distinct training set for an AI/ML algorithm is described in the context of this traditional medical device, the concept of establishing ground truth for a training set in that manner is not applicable. The device's internal algorithms would have been developed based on established physiological models of light absorption by oxygenated and deoxygenated hemoglobin, and calibrated using data that correlates pulse oximetry readings with gold standard co-oximetry measurements during the device's development process. Details of this development process are not provided in the summary.

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Shenzhen Med-link Cable / lead-wire are intended to be used with ECG, EKG, SpO2 and Invasive Blood Pressure monitoring devices. The Cable / lead-wire are used to connect electrodes, catheters, and/or sensors placed at appropriate sites on the patient to a monitoring device for general monitoring and/or diagnostic evaluation by heath care professional.

Med-link Cable / Lead-wire with specific various lengths are the replacements for similar cables manufactured by Original Equipment Manufacturers (OEM) and other third party after market manufacturers for their respective monitors. These cables consist of connectors on each cable end and a shielded bulk cable. The cables are used to transfer the signals from the electrodes to the patient monitor. The Med-link cables use the same type of constructions and have the same technological characteristics as the predicate devices. They use a medical grade PVC and TPU cable jacket with medical grade PVC and ABS over molded connectors with integral relief.

Here's the analysis of the provided text regarding acceptance criteria and the supporting study for the medical device:

Device: Cable / lead-wire (ECG, EKG, SpO2 and Invasive Blood Pressure) manufactured by Shenzhen Med-link Electronics Tech Co., Ltd.

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating substantial equivalence to predicate devices through various safety and performance standards. The acceptance criteria are defined by compliance with these standards, and the reported performance confirms this compliance.

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

• Sample Size for Test Set: The document does not specify a numerical sample size for the test set. It states that "Med-Link Cable / Lead-wire" were tested according to various standards and "Performance Bench testing was conducted on the Shenzhen Med-link cable / lead-wire according with established protocols." This implies testing of a representative number of cable/lead-wire units to ensure compliance with each standard.
• Data Provenance: The data is internally generated by the manufacturer (Shenzhen Med-link Electronics Tech Co., Ltd.) through "Performance Bench testing." No information about the country of origin of the data itself (beyond the manufacturer's location in China) or whether it's retrospective or prospective is explicitly stated. However, given it's bench testing for a premarket submission, it would be prospective data generated for the purpose of demonstrating compliance.

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

This section is not applicable to this submission. The "ground truth" here is defined by compliance with established international and national medical device standards (ISO, IEC, ANSI/AAMI, FDA regulations). The testing involves objective measurements against these predefined criteria, not subjective expert judgment that would require establishing a ground truth via consensus.

4. Adjudication Method for the Test Set

This section is not applicable. As the testing involves objective measurements against predefined standards, there is no need for an adjudication method by experts. The results are either compliant or non-compliant with the specified technical requirements.

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 type of study is typically used for diagnostic imaging devices where human readers interpret results, often with and without AI assistance. This submission describes an ECG/EKG/SpO2/IBP cable and lead-wire device, which does not involve human interpretation of diagnostic images or AI assistance in that context.

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

This section is not applicable. The device is a passive accessory (cable/lead-wire) for monitoring devices, not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only)" performance does not apply. The tests performed (biocompatibility, electrical safety, bench testing) assess the device's inherent physical and electrical properties.

7. The Type of Ground Truth Used

The "ground truth" used for this device is compliance with established international and national medical device standards and regulations. These include:

• ISO 10993-5:1999 (Cytotoxicity)
• ISO 10993-10:2002/Amd1:2006 (Irritation & Delayed-Type Hypersensitivity)
• IEC 60601-1:1998; Am1; A2:1995 (Medical electrical equipment - General requirements for safety)
• ANSI/AAMI EC53:1995/(R) 2001 (ECG cables and leadwires)
• FDA 21CFR Part 898 Final rule
• DIN 42-802 (for specific interconnection requirements)

These standards define the objective performance and safety benchmarks that the device must meet.

8. The Sample Size for the Training Set

This section is not applicable. The device is a hardware component (cable/lead-wire), not an AI/ML algorithm that requires a "training set."

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

This section is not applicable for the same reason as point 8.

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