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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

4. Adjudication Method for the Test Set

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

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret results, often with and without AI assistance. This submission describes an ECG/EKG/SpO2/IBP cable and lead-wire device, which does not involve human interpretation of diagnostic images or AI assistance in that context.

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

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

7. The Type of Ground Truth Used

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

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

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

8. The Sample Size for the Training Set

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

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

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

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