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

The proposed device, Disposable SpO2 Sensors are accessories to the patient monitors, which are intended for continuous non-invasive monitoring of functional arterial oxygen saturation and pulse rate. The compatible patient monitor is Nihon Kohden BSM-5135A. The sensor shall be connected to its corresponding monitor through Caremed adapter cable model SZ30-36. Oxygenation of blood is measured by detecting the infrared and red-light absorption characteristics of deoxygenated hemoglobin and oxygenated hemoglobin, which consists of a probe attached to the patient's finger. The sensor is connected to a data acquisition system which is used to calculate and display oxygen saturation levels and heart rate conditions. Each sensor has two LEDs, emitting both red and infrared light, and a photodiode. Red and infrared light lit alternately according to certain sequence, when the fingertips of capillary repeatedly with the heart pumps blood congestion, light emitting diode after blood vessels and projected onto a photodiode, photodiode can be induced to change with pulse light intensity, the electrical signals in the form of change. Then the received signal is forwarded to the corresponding oximeter that amplifies the signal and an algorithm that calculates the ratio. By measuring the wave crest of the pulse wave and the absorbance of the trough, SpO2 is calculated to obtain the correct oxygen saturation value. The saturation value is determined by the percentage ratio of the oxygenated hemoglobin (HbO2) to the total amount of hemoglobin (Hb).

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document states that "Clinical hypoxia test results were obtained in human adult volunteers to validate the accuracy of Caremed Disposable SpO2 Sensors versus arterial oxygen saturation (SaO2) as determined by co-oximetry."
For the expanded indication to include infants (3 kg < weight < 15 kg), the document states, "This specification has been verified and validated according to ISO 80601-2-61: 2017 clause 201.12.1.101 SpO2 accuracy of pulse oximeter equipment."

• Sample Size: The exact number of human adult volunteers used for the clinical hypoxia test is not explicitly stated. Similarly, the sample size for the infant validation is not provided.
• Data Provenance: The general nature of the clinical hypoxia test in "human adult volunteers" suggests prospective data collection for the purpose of the study. The document does not specify the country of origin, but the submission sponsor is Shenzhen Caremed Medical Technology Co., Ltd. in China.

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

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

• Number of Experts: The document does not specify the number of experts used.
• Qualifications of Experts: The document does not specify the qualifications of the experts, other than implying they would be qualified to perform arterial blood gas measurements and co-oximetry.

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

The document does not provide information regarding any adjudication method used for the clinical test set data. The ground truth was established by co-oximetry.

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 device is a Disposable SpO2 Sensor, a medical device for physiological monitoring, not an AI-powered diagnostic imaging tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this submission.

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

The device itself is a sensor that generates measurements (SpO2 and pulse rate) which are then processed by an oximeter (patient monitor). The clinical testing assessed the accuracy of these measurements against a gold standard (co-oximetry), which effectively evaluates the "standalone" performance of the sensor's ability to accurately measure physiological parameters. There is no explicit mention of a "human-in-the-loop" component for interpretation of the SpO2 values that would differ from standard clinical practice with such devices.

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

The ground truth for the clinical accuracy study was established by arterial oxygen saturation (SaO2) as determined by co-oximetry. This is considered a gold standard for measuring blood oxygen levels.

8. The sample size for the training set:

Pulse oximetry devices typically do not have a "training set" in the context of machine learning algorithms for image interpretation or complex diagnostic tasks. Their performance is primarily based on the physical principles of light absorption by hemoglobin. While there might be internal calibration data or historical performance data used in the development of the device's signal processing algorithms, the document does not specify a training set sample size in the way it would be defined for AI/ML models.

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

As noted above, a distinct "training set" in the AI/ML sense is not applicable to traditional pulse oximetry devices. The ground truth for developing and calibrating the device's underlying principles and algorithms would be based on controlled experiments and physiological models that relate light absorption to blood oxygen saturation, typically validated against gold standard measurements like co-oximetry in a laboratory or controlled clinical setting. The document does not provide details on how this early-stage ground truth was established for the development of the device's core technology. The clinical studies mentioned are for validation of the final product.

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The Reusable Temperature Probes are intended to be used for monitoring temperature. The temperature probes are reusable and designed for use with monitors of Nihon Kohden model BSM-5135A. These devices are indicated for used by qualified medical personnel only.

Reusable temperature probes are used during patient temperature measurement for multi-patient use. These probes consist of a phone plug connector on the monitor end and a thermistor on the patient end. Temperature probes measure temperature by a resistor that is sensitive to temperature changes. These probes are connected to the patient monitor either directly by using a phono plug or by an interconnect cable. These probes have a skin or core contact with a patient.

These temperature probes are typically used with legacy Nihon Kohden monitors BSM-5135A.

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

The provided text describes the performance data for the Reusable Temperature Probe (Models: TRAG-2252, TRAS-2252, TRCG-2252 and TRCS-2252) in support of its substantial equivalence determination.

Here's a breakdown of the requested information based on the text:

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

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

The document does not explicitly state the sample size used for performance testing (e.g., how many probes were tested) nor does it specify the provenance (e.g., country of origin) of the data. It indicates that "All subject devices were conducted performance testing according to ISO 80601-2-56" and references "Laboratory accuracy" and "Time response" results as well as biocompatibility testing. The nature of these tests (e.g. for electrical safety and accuracy) suggests they are conducted in a laboratory setting, not on patient data.

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

This section is not applicable as the device is a temperature probe, and the performance testing described is objective measurement against standards and physical characteristics, not expert interpretation of diagnostic images or clinical scenarios requiring ground truth establishment by experts.

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

This section is not applicable for the reasons stated above. Adjudication methods are typically relevant for studies involving human interpretation (e.g., radiologists reading images) where disagreement among experts needs resolution.

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 section is not applicable. The device is a Reusable Temperature Probe, which is a physical measurement device, not an AI-assisted diagnostic tool.

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

This section is not applicable, as the device is a temperature probe and does not involve an algorithm for diagnostic interpretation. Its performance is inherent in its design and manufacturing.

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

For the performance metrics (accuracy, time response, safety, EMC) of the temperature probe, the "ground truth" is established by objective measurement against the specified international standards (e.g., ISO 80601-2-56 for accuracy and time response, IEC 60601-1 for electrical safety, ISO 10993 series for biocompatibility). There is no "expert consensus" or "pathology" involved in determining if a physical temperature measurement falls within a specified range.

8. The sample size for the training set

This section is not applicable. The device is a Reusable Temperature Probe, which is a hardware medical device, not an AI algorithm that requires a training set.

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

This section is not applicable, as there is no training set for this type of device.

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Rectal Temperature Probe:

The Disposable Rectal Temperature Probes are intended to be used for monitoring temperature from the rectum. The temperature probes are non-sterile and designed for single patient use with monitors of Nihon Kohden model BSM-5135A. These devices are indicated for use by qualified medical personnel only.

Skin Temperature Probe:

The Disposable Skin Temperature Probes are intended to be used for monitoring temperature from skin. The temperature probes are non-sterile and designed for single patient use with monitors of Nihon Kohden model BSM-5135A. These devices are indicated for use by qualified medical personnel only.

Disposable temperature probes are used during patient temperature measurement. These probes consist of a plug connector on the adapter cable end and a thermistor on the patient end. Temperature probes measure temperature by a resistor that is sensitive to temperature changes. These probes are connected to the patient monitor by using an interconnect cable. These probes have a skin or rectal contact with adult patients. Both the skin and rectal probe are single use and provided non-sterile.

These temperature probes are typically used with legacy Nihon Kohden monitors BSM-5135A.

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

Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance, formatted to address your specific questions.

Based on the provided document, the device in question is a "Disposable Temperature Probe" (Rectal and Skin types). This is a 510(k) submission, meaning the manufacturer is demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness from scratch. Therefore, the "acceptance criteria" and "study" are primarily focused on showing that the new device performs comparably to the predicate and meets relevant safety and performance standards for its intended use.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission for a temperature probe, the "acceptance criteria" are intrinsically tied to the performance standards for clinical electronic thermometers and the performance of the predicate device. The document explicitly states the criteria and the results obtained for the subject device.

Notes on the Table:

• The document doesn't explicitly state "acceptance criteria" as a separate list, but rather "Performance Data" which includes the tests conducted and their "Pass" results, demonstrating compliance with established standards and equivalence to the predicate.
• The "Accuracy" value listed under "Features" in the comparison table (±0.1°C) is more stringent than the general laboratory accuracy acceptance criterion (Not greater than 0.3 °C). However, the document states Pass for the laboratory accuracy test, implying it met the more stringent ±0.1°C as well, given the direct comparison to the predicate.

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

The document does not specify the sample size used for the performance tests (e.g., how many probes were tested for accuracy, biocompatibility, etc.).

• Data Provenance: Not explicitly stated as "country of origin" for the test data itself (e.g., where the lab tests were conducted). However, the manufacturer is Shenzhen Caremed Medical Technology Co., Ltd. in China, and the correspondent is also in China, suggesting the testing likely occurred there or was overseen by the Chinese entity preparing the submission.
• Retrospective or Prospective: The testing described (biocompatibility, electrical safety, EMC, laboratory accuracy, time response) appears to be prospective testing conducted specifically for the purpose of this 510(k) submission, rather than retrospective analysis of existing data.

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

This type of information is not provided in the document. For a temperature probe, "ground truth" for performance would typically be established by calibrated laboratory equipment and standard test methods (e.g., temperature baths, reference thermometers) rather than human experts. Biocompatibility testing follows laboratory protocols and analysis by qualified lab personnel.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. "Adjudication" usually refers to a process where multiple human readers or experts review data and resolve discrepancies to establish a consensus ground truth. This is not how performance data for a temperature probe is typically validated; it relies on objective physical measurements and standardized test procedures.

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

No, an MRMC comparative effectiveness study was not done. Such studies are typically performed for diagnostic imaging AI devices where human interpretation is a critical component, to assess how AI assistance impacts human reader performance. This device is a measurement tool, not an AI diagnostic tool.

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

This question is not applicable in the context of this device. The disposable temperature probe is a physical measuring device, not an AI algorithm. Its performance is inherent in its design and manufacturing, not an algorithm that operates independently. The device's performance characteristics (accuracy, time response) are "standalone" in that they are measured directly from the device's output.

7. The Type of Ground Truth Used

The ground truth for this device's performance was established through:

• Standardized laboratory measurements: Using calibrated equipment and following established international standards (e.g.,
  • ASTM E1112 for "Standard Specification for Electronic Thermometers for Intermittent Determination of Patient Temperature" (implied for accuracy)
  • ISO 80601-2-56 for "Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement" (referenced for EMC and time response)
  • IEC 60601-1 for "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance" (referenced for electrical safety)
• Biocompatibility testing: Following ISO 10993 series standards, which involve in-vitro and/or in-vivo tests to assess biological responses.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. This device is a physical medical instrument, not a machine learning model. Therefore, there is no "training set."

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

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

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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 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 proposed device is an accessory used in conjunction with noninvasive blood pressure measurement systems. It is available in neonatal, infant, child and adult sizes.

The proposed device includes disposable blood pressure cuff and reusable blood pressure cuff, both disposable and reusable blood pressure cuff has same structure, which contains Cuff with bladder and Air Hose. Air hose has single tube and double tube.

The disposable blood pressure cuff is single use device, and which is made of non-woven fabrics & PVC (Cuff) and PVC (Air Hose), the non-woven fabrics & PVC (Cuff) is the material used to contacting with the patient.

The disposable blood pressure cuff has 24 models with different population with different arm size, and the 12 models of 24 are use single tube of air hose and other 12 models are use double tube of air hose, which is used for different noninvasive blood pressure measurement system.

The reusable blood pressure cuff is reusable device, and which is made of PU & PVC (Cuff) and PVC (Air Hose), thereinto, the PU & PVC (Cuff) is the material used to contacting with the patient.

The reusable blood pressure cuff has 16 models with different population with different arm size, and the 8 models of 16 are use single tube of air hose and other 8 models are use double tube of air hose, which is used for different noninvasive blood pressure measurement system.

The provided document is a 510(k) summary for the Caremed Reusable Blood Pressure Cuff and Caremed Disposable Blood Pressure Cuff. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study for a new medical AI or advanced diagnostic device. Therefore, much of the requested information (e.g., sample size for test sets and training sets, number of experts, adjudication methods, MRMC studies, ground truth types) is not directly applicable or available in this type of submission for a blood pressure cuff.

However, I can extract information related to the performance data provided within the context of a 510(k) submission for this device.

1. Table of Acceptance Criteria and Reported Device Performance

For a blood pressure cuff, the "acceptance criteria" and "reported device performance" are primarily related to safety, material biocompatibility, and functional performance (e.g., pressure range, leakage, and compliance with recognized standards).

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

This information is typically not provided in a 510(k) summary for a blood pressure cuff. The "test set" here refers to samples of the device materials tested for biocompatibility and the device itself for functional performance.

• Sample Size for Test Set: Not specified in the document. Standard practice would involve testing a representative number of samples to demonstrate compliance with standards for biocompatibility and functional performance.
• Data Provenance: Not explicitly stated as country of origin but likely conducted by testing laboratories in China, given the manufacturer's location. The studies are "non-clinical" and likely retrospective in that they characterize the manufactured product.

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

Not applicable in this context. The "ground truth" for a blood pressure cuff's performance is typically established by objective physical and chemical testing against established international standards (e.g., ISO for biocompatibility and sphygmomanometers), not by expert consensus or readings.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for evaluating human reader performance in diagnostic studies, which is not relevant for a blood pressure cuff's mechanical and material performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a blood pressure cuff, not an AI-powered diagnostic device. No human-in-the-loop performance or MRMC study was conducted or is relevant.

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

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims of these blood pressure cuffs is based on objective measurement against established international standards (e.g., ISO 81060-1 for non-invasive sphygmomanometers, ISO 10993 for biocompatibility) and direct physical/chemical testing.

8. The Sample Size for the Training Set

Not applicable. This is not an AI device that requires a training set.

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

Not applicable.

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Caremed Reusable & Disposable SPO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate(PR) for adult patients weighing greater than 40 kg and pediatric patients weighing 10 -50 kg at hospital facilities

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

8. The sample size for the training set

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

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

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

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The subject device is intended for use only by trained healthcare professionals for measurement of a patient's ECG for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment.

The Caremed patient cable and lead wires including trunk cable and leadwires, are intended use for transmitting signals from patient surface electrodes to various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. The type of devices are common to both industry and to most medical establishments. The system is designed to provide a family of lead wires that will link the patient and the compatible patient trunk cable system.

The provided text does not describe acceptance criteria for a medical device in the typical sense of performance metrics for an AI/ML model, nor does it detail a study proving such criteria are met. Instead, it is a 510(k) Premarket Notification summary for "Caremed Patient Cable and Leadwires."

This document focuses on establishing substantial equivalence to a previously cleared predicate device, rather than defining and proving performance against specific quantitative acceptance criteria of an AI/ML system.

However, I can extract the relevant information from the document that pertains to the device's characteristics and the standards it meets, which serve as its "acceptance criteria" in the context of a 510(k) submission for a non-AI medical device.

Here's an interpretation based on the provided text, recognizing it's not about AI performance metrics:

The "acceptance criteria" for this device are its compliance with recognized industry standards and its substantial equivalence to a predicate device. The "study" proving this involves a comparison to the predicate device and demonstration of compliance with relevant safety and performance standards through testing (though detailed test results are not provided in this summary).

Here's the information formatted as requested, with explanations where the categories don't directly apply to this type of medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. For this type of device (patient cables and leadwires), the "test set" for substantial equivalence is primarily a comparison against technical specifications and performance standards, not a clinical data set in the way an AI/ML model would be evaluated. The text indicates "Not applied" for clinical test data.
• Data Provenance: Not applicable. The "data" are technical specifications, material properties, and compliance test results (which are not detailed in this summary).

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

• Not applicable. "Ground truth" in the context of an AI/ML model evaluation does not apply to this device. The "ground truth" here is the established safety and performance requirements set by industry standards and regulatory bodies, along with the characteristics of the predicate device.

4. Adjudication method for the test set

• Not applicable. There's no "adjudication method" described as would be used for expert consensus on AI outputs. The evaluation is based on technical specifications and compliance with standards.

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

• Not applicable. This is not an AI/ML device; therefore, an MRMC study related to AI assistance is irrelevant.

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

• Not applicable. This is not an AI/ML device.

7. The type of ground truth used

• Ground Truth: For this type of device, the "ground truth" is defined by:
  • Regulatory Standards: Specifically, ANSI/AAMI EC53, ANSI/AAMI EC13, 21 CFR Part 898, IEC 60601-1, ISO 10993-5, and ISO 10993-10.
  • Predicate Device Characteristics: The characteristics, indications for use, and performance of the Unimed Disposable ECG lead wires (K142489).

8. The sample size for the training set

• Not applicable. This is not an AI/ML device, so there is no concept of a "training set."

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

• Not applicable. As above, no training set for an AI/ML model; the "ground truth" for compliance testing is established by recognized standards and the clear specifications of the predicate device.

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