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The Disposable EEG cable is intended for non-invasive use with recording and monitoring equipment, active and reference), of Electroencephalograph (EEG), electromyography (EMG), and Evoked Potentials (EP).

The Disposable EEG cable, which is cutaneous electrodes connected to lead wires, is noninvasive, single use electrodes intended to be used on normal, healthy, clean, intact skin for recording purposes. In other words, the Disposable EEG cable is used in the acquisition of signals for the purpose of monitoring and recording Electroencephalograph(EEG), Electromyograph(EMG), and Evoked Potentials(EP). The Disposable EEG cable is delivered non - sterile and are available in disposable version.

The request asks for specific details about the acceptance criteria and study proving a device meets them. However, the provided text is an FDA 510(k) clearance letter for a "Disposable EEG cable", which is a Class II device.

The document states that a clinical study was not required for this device, and the evaluation for substantial equivalence was based on bench performance testing and biocompatibility testing. This type of device (a cable and electrode) does not involve complex algorithms or AI assistance, which are the typical contexts for the detailed performance studies outlined in the prompt (e.g., MRMC studies, training/test sets, expert adjudication, effect sizes).

Therefore, I cannot provide the requested information regarding:

• Acceptance criteria table and device performance: The document only refers to compliance with standards for electrical safety and biocompatibility, not specific performance metrics in the context of an AI/algorithm-based device.
• Sample size for test set and data provenance: No test set in the sense of an algorithm evaluation.
• Number of experts and qualifications: No expert review panels for ground truth establishment.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not applicable as there's no AI component or human reader interpretation being improved.
• Standalone performance: Not applicable.
• Type of ground truth: Not applicable.
• Sample size for training set: No training set as there's no AI/algorithm.
• Ground truth for training set: Not applicable.

The document confirms that this device is a simple medical device (a cable with electrodes) and not a software/AI-based medical device.

What the document does provide regarding performance:

• Biocompatibility testing: Conducted using ISO 10993-1, including Cytotoxicity, Sensitization, and Irritation tests.
• Electrical safety: Conformance with AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (consolidated text) Medical electrical equipment -Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, mod).
• Performance test: Carried out according to "" and ANSI AAMI EC12:2000/(R)2015 Disposable ECG electrodes.

In summary, the provided text does not contain the information required to answer the prompt, as the device in question is a simple medical cable and not an AI/algorithm-driven device evaluated through the types of studies described in the prompt.

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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 ECG cable is intended to be used with ECG. The device is used to connect electrodes placed at appropriate sites on the patient to ECG for general monitoring and/or diagnostic evaluation by health care professional.

The device is an external device used to transmit ECG signals from electrodes that are affixed to the patient's body for both diagnostic and monitoring purposes. One end of each leadwire is attached to ECG patient electrodes; the other end is affixed / molded into one end of the trunk cable which are plug into an ECG monitor. The proposed device is disposable.

The provided text describes a 510(k) premarket notification for a "Disposable ECG Cable" (K200026) and a comparison with a predicate device. This submission focuses on establishing substantial equivalence to a legally marketed predicate device, rather than providing a detailed study proving the device meets acceptance criteria in the way this request envisions (e.g., performance metrics like sensitivity/specificity for an AI algorithm).

Medical devices like ECG cables are typically evaluated against established technical standards and for safety and effectiveness, rather than having acceptance criteria and performance reported in terms of diagnostic accuracy metrics.

Therefore, many of the requested points are not applicable to this type of device submission. However, I can extract the relevant information.

Acceptance Criteria and Device Performance for Disposable ECG Cable (K200026)

Based on the provided document, the "acceptance criteria" are derived from compliance with recognized international and national standards for medical electrical equipment and biocompatibility. The "reported device performance" is demonstrated through successful adherence to these standards.

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

For a device like an ECG cable, the "study" is typically a series of non-clinical bench tests and biocompatibility assessments demonstrating compliance with the aforementioned standards.

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

• Test Set Sample Size: Not specified in terms of distinct units. The testing is performed on samples of the device as required by the standards (e.g., number of units necessary to perform electrical safety tests, or for biocompatibility tests).
• Data Provenance: The document does not explicitly state the country of origin for the non-clinical test data. It indicates the manufacturer is in Shenzhen, China. The studies are prospective (tests performed specifically for this submission).

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)

• This question is Not Applicable (N/A) for this type of device. There's no "ground truth" to be established by clinical experts in this context. The performance is determined by meeting engineering and biological safety standards.

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

• N/A: No adjudication method is used as there is no subjective assessment of clinical data or diagnoses involved. Compliance is determined by objective measurements against standard requirements.

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

• N/A: This is not an AI-enabled diagnostic device. No MRMC study was performed.

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

• N/A: This is not an algorithm-based device. No standalone algorithm performance study was done.

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

• N/A: For this device, "ground truth" is established by the specifications and measurable parameters defined in the referenced industry standards (e.g., electrical resistance limits, insulation integrity, biological response to materials).

8. The sample size for the training set

• N/A: This device does not involve machine learning or AI algorithms requiring a training set.

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

• N/A: This device does not involve machine learning or AI algorithms.

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The 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 neonate, infant, child and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.

The subject device is an accessory used in conjunction with noninvasive blood pressure measurement systems. It is available in neonatal, infant, child and adult sizes. The subject device includes disposable blood pressure cuff. All the disposable blood pressure cuff has same structure, which contains Cuff and single tube. The disposable blood pressure cuff is single use device, and which is made of non-woven fabrics (Cuff) and PVC (Air tube), thereinto, the non-woven fabrics (Cuff) is the material used to contacting with the patient. The disposable blood pressure cuff has 6 models with different population with different circumference size.

I am sorry, but the provided text does not contain the detailed information needed to fully answer your request regarding the acceptance criteria, study details, and sample sizes for the medical device described. The document is a 510(k) summary for a Disposable NIBP Cuff, which primarily focuses on establishing substantial equivalence to a predicate device.

Here's a breakdown of what is and is not in the text, relative to your request:

What is present in the document:

• Acceptance Criteria (Indirectly): The document states that "Non-clinical tests were conducted to verify that the subject device met all design specifications" and that it complies with "ISO 81060-1, Non-Invasive Sphygmomanometers - Part 1: Requirements and Test Methods for Non-Automated Measurement Type, First Edition 2007." This standard would implicitly define the performance acceptance criteria for blood pressure cuffs. However, the specific numerical acceptance criteria (e.g., maximum allowable error in mmHg) are not explicitly listed in the provided text. The "Max. Leakage" of "

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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 ECG Cable is intended to be used with ECG. The ECG Cable is used to connect electrodes placed at appropriate sites on the patient to ECG for general monitoring and/or diagnostic evaluation by health care professional.

The ECG Cable is an external device used to transmit ECG signals from electrodes that are affixed to the patient's body for both diagnostic and monitoring purposes. One end of each leadwire is attached to ECG patient electrodes; the other end is affixed / molded into one end of the trunk cable which are plug into an ECG monitor.

The provided text is a 510(k) summary for an ECG Cable and does not contain information about an AI-powered device or software. Therefore, I cannot extract acceptance criteria, study details, or ground truth information relevant to AI/ML device performance.

The document primarily focuses on demonstrating substantial equivalence of the ECG Cable to a predicate device based on:

• Intended Use/Indications for Use: The ECG Cable connects electrodes to an ECG for monitoring/diagnostic evaluation by healthcare professionals.
• Technological Characteristics: Comparison of features like reusability, anatomical sites, patient end termination, material, electrical safety, and biocompatibility.
• Performance Data:
  • Biocompatibility testing: Cytotoxicity, Sensitization, and Irritation tests conducted in accordance with ISO 10993-1.
  • Non-clinical data: Compliance with IEC 60601-1 and ANSI/AAMI EC53 standards for electrical safety.
  • Clinical data: No clinical study was included as performance was demonstrated through non-clinical and biocompatibility testing.

Since this submission is for a physical medical device (an ECG cable) and not an AI/ML diagnostic or measurement software, the concepts of "acceptance criteria for AI performance," "test set sample size," "expert ground truth," "adjudication," "MRMC study," or "standalone algorithm performance" are not applicable here.

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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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The 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 neonate, infant, child and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.

The subject device is an accessory used in conjunction with noninvasive blood pressure measurement systems. It is available in neonatal, infant, child and adult sizes. The subject device includes reusable blood pressure cuff. All the reusable blood pressure cuff has same structure, which contains Cuff with bladder and Air Hose. Air hose has single tube. The reusable blood pressure cuff is reusable device, Model CK-XT-78211-XXX series are made of PU synthetic leather (Cuff) and TPU (Air Hose), and the PU synthetic leather (Cuff) is the material used to contacting with the patient's intact skin. Model CK-XT-78243-XXX series are made of Nylon (Cuff) and silica gel (Air Hose), and the Nylon (Cuff) is the material used to contacting with the patient's intact skin.

The provided text describes a 510(k) submission for a Reusable NIBP Cuff, demonstrating its substantial equivalence to a predicate device. However, it does not include detailed acceptance criteria and a study proving the device meets those criteria in the format requested.

The document focuses on non-clinical data and biocompatibility testing, primarily to show compliance with international standards and substantial equivalence, rather than a direct comparison against specific performance acceptance criteria for the blood pressure measurement accuracy itself (which is typically addressed by standards like ISO 81060-2).

Therefore, it is not possible to fully answer the request based on the provided text. I will extract the available information and explicitly state what is missing.

Missing Information from the Provided Document:

• A table of specific acceptance criteria for blood pressure measurement accuracy and corresponding device performance data against these criteria. The document mentions compliance with ISO 81060-1 but does not provide the specific performance results or acceptance limits for accuracy from this standard.
• The exact sample size used for any performance testing related to blood pressure measurement accuracy.
• Data provenance (country of origin, retrospective/prospective) for any detailed performance study.
• Number and qualifications of experts for ground truth establishment.
• Adjudication method for a test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
• Whether a standalone (algorithm only) performance study was done.
• The specific type of ground truth used for performance validation (e.g., direct arterial measurement, oscillometric reference).
• Sample size for the training set (no training set mentioned as this is a physical medical device, not an AI/software device).
• How ground truth for the training set was established (not applicable).

Based on the provided text, here is the information available:

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

The document states that non-clinical tests were conducted to verify that the subject device met all design specifications and complied with specific standards, implying these standards define the acceptance criteria. However, explicit numerical acceptance criteria and the device's reported performance against them are not provided in a detailed table as requested.

The relevant standards mentioned are:

• ISO 81060-1: Non-Invasive Sphygmomanometers - Part 1: Requirements and Test Methods for Non-Automated Measurement Type, First Edition 2007.
• ISO 10993-5: Biological Evaluation of Medical Devices Part 5: Tests for In Vitro Cytotoxicity.
• ISO 10993-10: Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.

For biocompatibility testing, the acceptance criteria are generally "no sensitization observed" and "Negligible (no observed primary irritation)" and passing cytotoxicity tests, which the device reportedly met. These are general statements rather than specific numerical criteria.

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

• Sample Size: Not specified for any performance testing related to NIBP accuracy. For biocompatibility, "the battery of testing" was mentioned, but specific sample sizes of biological material or animals are not detailed.
• Data Provenance: Not specified. The submission sponsor and correspondent are based in China (Shenzhen, P.R. 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 provided as the device is a physical NIBP cuff, not an AI/software device usually requiring expert ground truth in this context. The performance verification likely involved physical laboratory testing and possibly clinical studies, not expert review of images or data.

4. Adjudication method for the test set

• Not applicable/Not provided. This usually pertains to studies involving expert review for AI/image analysis.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable/Not provided. This pertains to AI-assisted diagnostic devices.

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

• Not applicable/Not provided. This pertains to AI/software performance. The device is a physical medical accessory.

7. The type of ground truth used

• For NIBP cuff performance (ISO 81060-1): The standard typically describes methods for validating the accuracy of non-invasive blood pressure measurements, often against a reference method (e.g., intra-arterial pressure measurement) or a validated simulator. The exact ground truth method used in their specific tests is not detailed in this summary.
• For Biocompatibility (ISO 10993-5, -10): The ground truth is established through standardized laboratory assays for cytotoxicity, sensitization, and irritation using accepted biological models (e.g., cell cultures, animal models, or human patch tests).

8. The sample size for the training set

• Not applicable. This device is a physical NIBP cuff, not a software or AI algorithm that requires a training set.

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

• Not applicable. As above, no training set is relevant for this type of device.

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