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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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The Incontinence Probes are intended to provide electromyographic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.

The Incontinence Probe models PE0001, PE0002, PE0004, PE0005, PE0006, PE0007 , PE0008, PE0009, and PE0010 are stand-alone probes/electrodes, which can be placed inside the adult rectum or female vagina to transmit electrical stimulation signals or pelvic floor EMG signals when connected to pelvic electrical stimulators or EMG biofeedback devices during the treatment of urinary incontinence . All the models are reusable for a single patient except PE0003, which is a disposable vaginal probe. The probes are not packaged with specific floor muscle stimulators and EMG/biofeedback equipment but are compatible with low-frequency (less than 1000Hz working frequency) stimulators or EMG/biofeedback devices that meet the standards of IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-10 and use 2.0 DIN connection. The probes are made of S304 stainless steel and Acrylonitrile-Butadiene-Styrene (ABS). The probes are designed for use in home or clinic by a single user. The probes do not require sterilization but need cleaning for reuse according to the cleaning instructions provided in the instructions for use manual.

The provided text is related to the 510(k) premarket notification for the "Incontinence Probe" by Shenzhen Med-link Electronics Tech Co., Ltd. It details the device description, indications for use, comparison with a predicate device, and non-clinical testing conducted to demonstrate substantial equivalence.

However, the provided text does not contain information about acceptance criteria or a study proving that a device meets specific acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, accuracy) typically associated with AI/ML devices.

Instead, the acceptance criteria and testing described are focused on device safety and performance characteristics for a physical medical device (an incontinence probe), not an AI/ML diagnostic tool.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device diagnostic performance, as the document is about a different type of device and testing.

The document covers:

• Non-clinical testing for a physical device (Incontinence Probe).
• Tests performed include: Biocompatibility (cytotoxicity, sensitization, irritation), Shelf-life validation, Electrical Safety (IEC 60601-1), and Performance Bench Testing (visual testing, electrical output verification, cable dielectric strength, lead wire contact resistance, ANSI/AAMI EC53).
• The "acceptance criteria" here are implicitly tied to the standards cited (e.g., ISO 10993 for biocompatibility, IEC 60601-1 for electrical safety, ANSI/AAMI EC53 for lead wires), meaning the device passed these standard tests as acceptable.

If the request was based on a misunderstanding of the device type, and the intent was to find information on a diagnostic AI device, this document does not contain that information.

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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 Wrist Digital Blood Pressure Monitor is non-invasive blood measurement of arterial blood pressure values in adults. It is intended to measure the diastolic, systolic blood presures and pulse rate through an inflatable cuff wrapped around the wrist. It can be used by medical professionals or at home. The cuff circumference is limited to 13.5-19.5 cm.

Med-link Upper Arm Digital Blood Pressure Monitor is non-invasive measurement of arterial blood pressure values in adults. It is intended to measure the diastolic, systolic blood presures and pulse rate through an inflatable cuff wrapped around the upper arm. It can be used by medical professionals or at home. The cuff circumference is limited to 22-32cm.

The proposed devices are battery driven automatic non-invasive blood pressure Monitor. It is used for automatically conduct the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult at wrist or upper arm within its claimed range and accuracy by oscillometry technique. Devices are consisted of three main parts: external hardwares (such as cuff), analog circuit, and MCU. The devices have the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time.

The proposed devices are intended to be used in medical facilities or at home and provided non-sterile. The proposed devices have 2 models:

Med-link Wrist Digital Blood Pressure Monitor Model:ESM101
Med-link Upper Arm Digital Blood Pressure Monitor Model:ESM201

Here's an analysis of the provided text regarding the acceptance criteria and study for the Med-link Wrist Digital Blood Pressure Monitor Model: ESM101 and Med-link Upper Arm Digital Blood Pressure Monitor Model: ESM201.

1. Table of Acceptance Criteria & Reported Device Performance

Study That Proves the Device Meets Acceptance Criteria:

The document states that a series of tests were performed in accordance with several standards to assess the safety and effectiveness of the Med-link Digital Blood Pressure Monitor. Specifically for performance, the standard cited is ISO 81060-2 Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type. This standard outlines the requirements for clinical validation of automated non-invasive sphygmomanometers.

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

The document does not explicitly state the specific sample size used for the clinical validation described by ISO 81060-2. However, the ISO 81060-2 standard itself mandates a minimum number of subjects for clinical validation. This information would typically be found in the full clinical study report, which is not included in this 510(k) summary.

The document does not explicitly state the country of origin of the data nor whether the study was retrospective or prospective. It just mentions "a series of safety, essential performance and biocompatibility tests were performed."

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

The document does not specify the number of experts or their qualifications for establishing the ground truth during the clinical validation tests (ISO 81060-2). Clinical validation per ISO 81060-2 typically involves simultaneous auscultatory measurements by trained observers (experts) that serve as the reference standard against which the automated device's measurements are compared.

4. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method used. In the context of ISO 81060-2, the reference standard for blood pressure measurements is typically established by two trained observers performing auscultatory measurements. Discrepancies between these observers would then usually be handled by a predefined adjudication process (e.g., a third observer). However, this specific detail is not provided.

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

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned in the provided text. The evaluation focuses on the standalone performance of the device against a reference standard.

6. Standalone Performance Study

Yes, a standalone performance study was done. The document states that "a series of safety, essential performance and biocompatibility tests were performed" and explicitly mentions ISO 81060-2, Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers and ISO 81060-2 Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type. These standards are used to establish the standalone performance of the device (algorithm only, as applied in an automated device like this blood pressure monitor).

7. Type of Ground Truth Used

Based on the reference to ISO 81060-2, the ground truth for the test set would be expert auscultatory measurements (the "reference sphygmomanometer"). This involves trained human observers using mercury or aneroid sphygmomanometers to manually measure blood pressure, which is then compared to the automated device's readings.

8. Sample Size for the Training Set

The document does not provide any information regarding a "training set" or its sample size. This type of device (a deterministic blood pressure monitor based on oscillometry) typically does not involve machine learning models that require a separate "training set" in the same way an AI/ML-based diagnostic device would. The internal algorithms are typically calibrated and validated, but not "trained" on a large dataset in the sense of deep learning.

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

As no training set is indicated for this type of device, this question is not applicable based on the provided information.

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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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