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The BSC Removable Patient Leads ECG Cable is used to transmit signals from patient-connected electrodes or transducers to electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. ECG cables are supplied non-sterile and are not sterilizable; they are reusable devices and are recommended to be used by trained operators in a medical environment. Use is limited by the indications for use of the connected monitoring or diagnostic equipment.

The BSC ECG cable, model 6750 is an external device used to transmit ECG signals from electrodes which are affixed to the patient's body to an external BSC programming system that includes an ECG display monitor. Each leadwire clip is attached to ECG patient electrodes. The other end of the leadwire plugs into one end of the trunk cable. The trunk cable then plugs into the BSC programming system.

Here's an analysis of the provided text regarding the Boston Scientific Removable Patient Leads ECG Cable:

This document is a 510(k) premarket notification for a medical device. For such devices, particularly those like an ECG cable, the acceptance criteria and supporting studies are primarily focused on bench testing and demonstrating substantial equivalence to a legally marketed predicate device, rather than clinical efficacy studies often seen with diagnostic AI algorithms.

Therefore, many of the requested categories (e.g., sample size for test/training set, number of experts, adjudication methods, MRMC studies, standalone performance with metrics like AUC, sensitivity, specificity) are not applicable in this context as they pertain to performance claims that involve analysis of patient data, not the functional performance of a cable.

Here's a breakdown based on the available information:

Acceptance Criteria and Device Performance

Study Details (for predicate comparison and bench testing)

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

   • Test Set Sample Size: Not applicable in the context of clinical performance data. The "test set" here refers to the specific units of the ECG cable that underwent bench testing. The document does not specify the number of individual cables tested.
   • Data Provenance: The testing was conducted by Boston Scientific Corporation (or its manufacturing facility, TSE) as part of the 510(k) submission process. This implies testing was done in a controlled environment as an internal validation. No country of origin is specified for the data itself beyond the location of the manufacturing facility (Taiwan) and the applicant (USA). The testing is prospective for the purpose of the 510(k) submission.

2. 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 diagnostic performance (e.g., presence/absence of disease) is not relevant for an ECG cable. The "ground truth" for this device's performance would be engineering specifications and international standards (e.g., for electromagnetic compatibility, electrical safety). Experts involved would be engineers and regulatory specialists, but their role is to ensure compliance with standards, not diagnose using the device.

3. Adjudication method for the test set:

   • Not applicable. Adjudication methods (like 2+1) are used for resolving disagreements in expert interpretations of patient data, which is not relevant here. The testing involves objective measurements against predefined engineering standards.

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:

   • No. This is not applicable. MRMC studies are associated with evaluating diagnostic AI devices where human performance is part of the outcome. This document is for a medical cable, not an AI diagnostic tool.

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

   • In a broad sense, yes, for bench tests. The "standalone" performance here refers to the physical and electrical characteristics of the cable itself, independent of human interpretation of ECG data. The document states "bench testing were performed to support a determination of substantial equivalence." This includes tests like electromagnetic compatibility, electrical safety, and biocompatibility, which are conducted on the device itself against established standards. The performance metrics are direct measurements of compliance with these standards (e.g., signal integrity, insulation resistance, etc.), rather than diagnostic metrics like AUC.

6. The type of ground truth used:

   • Engineering Specifications and Regulatory Standards. The "ground truth" for this device is its adherence to established electrical, mechanical, and biocompatibility standards (e.g., ISO, ANSI, AAMI, IEC 60601-2-27 related to leadwire colors, etc.) and its functional equivalence to the predicate device. These standards define acceptable ranges for performance characteristics.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of an ECG cable. This term is used for machine learning models.

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

   • Not applicable. (See point 7).

Summary of the Study:

The "study" described in the 510(k) summary is not a clinical trial or an AI performance study, but rather a set of bench tests and a comparison to a predicate device to demonstrate "substantial equivalence."

The acceptance criteria are implicitly met through:

• Demonstration of similar Indications for Use, Patient Usage, Sterility, Anatomical Sites, and Functionality as the predicate device (Tyco K771645).
• Compliance with design specifications (e.g., number of leadwires, cable lengths, connector types, leadwire colors, materials) that are either identical or considered equivalent to the predicate.
• Successful completion of Electromagnetic Compatibility, Electrical Safety, and Biocompatibility testing, ensuring the device performs as intended and introduces no new safety concerns.

The study proving the device meets the acceptance criteria consists of:

• Bench Testing: Internal testing conducted by the manufacturer (Boston Scientific) on the device itself (the ECG cable model 6750). The results confirmed that the "device design meets the performance requirements and performs as intended" and that "no new safety or performance issues were found."
• Predicate Device Comparison: A detailed characteristic-by-characteristic comparison (Table 2-1) between the Boston Scientific ECG cable and the Tyco predicate device (K771645) to demonstrate substantial equivalence in design, technology, and intended use.

This approach is standard for 510(k) submissions of Class II devices like ECG cables, where the primary regulatory hurdle is to show that the new device is as safe and effective as a legally marketed one, without necessarily requiring new, extensive clinical studies.

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