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The ECG Cables and Leadwires is intended to be used with ECG. The ECG Cables and Leadwires 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 Cables and Leadwire 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 describes a 510(k) premarket notification for "ECG Cables and Leadwires" by Xinkang Medical Instrument Co., Ltd. This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving novel effectiveness.

Therefore, the document does not contain the kind of information requested for many of your points, as it pertains to a device whose function is to transmit signals, not to generate diagnostic outputs that would require extensive clinical studies with ground truth, expert adjudication, or MRMC studies.

Here's a breakdown based on the provided text, addressing what is available and noting what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily based on adherence to recognized electrical and biocompatibility standards, and demonstrating substantial equivalence to a predicate device. Performance is framed in terms of meeting these standards.

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

• Not Applicable. The submission is for ECG cables and leadwires, which are accessories for ECG devices. The evaluation here is based on engineering and biocompatibility standards rather than a clinical "test set" of patient data for diagnostic accuracy. No human subject data (e.g., retrospective or prospective) is described for a "test set" of performance.

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

• Not Applicable. As per point 2, there is no "test set" in the context of diagnostic performance that would require ground truth established by experts.

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

• Not Applicable. There is no "test set" as defined in the context of diagnostic accuracy assessment.

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 device is ECG cables and leadwires, not an AI-powered diagnostic tool. MRMC studies for AI assistance are not relevant to this submission.

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 (expert consensus, pathology, outcomes data, etc.):

• Not Applicable. The "ground truth" for this device's acceptance is its adherence to established electrical, safety, and biocompatibility standards, and its functional equivalence to a legally marketed predicate device. This is determined through laboratory testing and engineering analysis, not medical ground truth from patient data.

8. The sample size for the training set:

• Not Applicable. This is not an AI/machine learning device that requires a training set.

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

• Not Applicable. Not an AI/machine learning device.

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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 ECG Cable/Leadwires is intended to be used with ECG. The ECG Cable/Leadwires 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/Leadwires is comprised of Plug, cable/leadwires and connector. The device is used to transmit ECG signals from electrodes which are affixed to the patient's body for both diagnostic and monitoring purposes. Each lead wire is attached to ECG patient electrodes. The leadwires connector plugs into one end of the external trunk cable which is plug into an ECG monitor.

This is a 510(k) premarket notification for an ECG Cable/Leadwires device. The document states that no clinical tests were performed, which means no studies were done to establish the acceptance criteria for device performance or to prove the device meets those criteria in a clinical setting.

The provided information focuses on demonstrating substantial equivalence to a predicate device (K120010) through nonclinical testing.

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

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

   Acceptance Criterion (Standard)	Reported Device Performance
   Electrical Performance and Safety:
   IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+AM1:2012 (Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance)	Comply
   AAMI/ANSI EC53:2013 (ECG Trunk Cables and Patient Leadwires)	Comply
   Biocompatibility:
   ISO 10993-1:2009 (Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process)	No cytotoxicity, No irritation, No sensitization (Implied)

   Note: The document states that the device "Comply with" these standards for electrical performance and safety, and lists biocompatibility results for "No cytotoxicity, No irritation, No sensitization," implying these are the acceptance criteria met through testing following ISO 10993-1.

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

   • Sample Size: Not specified for non-clinical tests.
   • Data Provenance: Not specified, but generally, bench testing (non-clinical) is conducted by the manufacturer or a contracted lab. The manufacturer is Shenzhen Coreray Technology Co., Ltd. in P.R China. The testing would be prospective in nature for device validation.

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 as this is a medical device (ECG Cable/Leadwires) undergoing non-clinical bench testing for electrical safety, performance, and biocompatibility, not an AI/diagnostic software that requires expert ground truth for interpretation.

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

   • Not applicable for non-clinical bench testing. Adjudication methods are typically used in clinical studies or for establishing ground truth in diagnostic accuracy studies.

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

   • No. A MRMC comparative effectiveness study was not done. This device is an ECG cable/leadwire, which is a hardware component for signal transmission, not an AI-powered diagnostic tool for interpretation.

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

   • No. This device is an ECG cable/leadwire, a hardware component for signal transmission. It is not an algorithm or AI.

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

   • For the non-clinical tests, the "ground truth" is defined by the technical specifications and requirements outlined in the referenced international and national standards (IEC 60601-1, AAMI/ANSI EC53, ISO 10993-1). Compliance with these standards indicates the device adequately performs its intended function and is safe.

8. The sample size for the training set

   • Not applicable. This is a hardware medical device; there is no "training set" in the context of machine learning or AI.

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

   • Not applicable for the same reason as above.

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These devices are intended to be used with various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. They are solely intended to be used between the electrode in contact with the patient's skin and the recording/monitoring device. This cabling facilitates the conduction of signals between the patient and the monitoring device. AIV cables are limited by the Indications for Use of the connected recording/monitoring device.

AlV's Electrocardioaraph (ECG) cables (also sometimes referred to as trunk or leadwires) are replacements for similar cables manufactured by the Original Equipment Manufacturers (OEM) and other third party after market manufacturers for their respective monitors. The Trunk Cables connect the OEM patient monitor to the patient leadwires connect the trunk cable to the skin mounted ECG electrodes.

These cables consist of connectors on each cable end and a shielded bulk cable. The cables are used to transfer the signals from the electrodes to the patient monitor. The Trunk Cables have limited skin contact with the patient, while the Leadwires attached on the patient's chest have more continuous skin contact.

The AIV cables use the same type of construction and have the same technological characteristics as the predicate devices. They use a medical grade PVC cable jacket with medical grade PVC overmolded connectors with an integral strain relief.

The provided document describes the 510(k) summary for AIV's ECG Cables, Trunk and Patient Lead Wires, seeking substantial equivalence to existing devices. As such, the study described here is NOT an AI/ML device study. The acceptance criteria and "device performance" in this context refer to engineering specifications and compliance with recognized standards for medical devices, rather than an AI model's predictive accuracy.

Here's the information extracted and formatted according to your request, with clarifications due to the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a "test set" in the context of an AI/ML study. The evaluation was based on bench testing of the AIV cables. The sample size for these physical tests is not specified in the provided summary.
• Data Provenance: Not applicable in the sense of data origin for an AI model. This is a physical device and the "data" comes from bench testing of the manufactured cables.

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

• Not applicable. This is not an AI/ML device requiring expert ground truth for image interpretation or similar. The "ground truth" for these cables is compliance with engineering standards (ANSI/AAMI EC53 and EC53A) and functional equivalence to legally marketed predicate devices, assessed through bench testing. The evaluation was done by the manufacturer (AIV) and reviewed by the FDA.

4. Adjudication method for the test set

• Not applicable. There was no "test set" requiring adjudication in the AI/ML sense. Compliance was determined by meeting consensus standards and demonstrating equivalence to predicate devices through bench 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

• No. This is not an AI/ML device. Therefore, no MRMC study with human readers or AI assistance was performed.

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

• Not applicable. This is not an algorithm. The "standalone performance" for this device would be its ability to physically and electrically perform its intended function (signal conduction) when bench tested, which was stated to be "as intended."

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

• The "ground truth" for this device is based on compliance with recognized consensus standards (ANSI/AAMI EC53 and EC53A) for electrical and mechanical performance, and demonstrated functional and technological equivalence to legally marketed predicate devices.

8. The sample size for the training set

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

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

• Not applicable. There is no training set for this device.

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