(58 days)
The Kepler MedTec Single Patient Use ECG Lead Wire is a electrode cable system used to transmit signals from patient electrodes to various electrocardiograph recorders / monitors for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment. The Single Patient Use ECG Lead Wire Set is intended to be used by trained operators in a medical professional's environment.
The Single Patient Use ECG Lead Wire is a single patient, electrode cable system used to transmit signals from patient surface electrodes to various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. This type of device is 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.
Here's a breakdown of the acceptance criteria and study information based on the provided 510(k) summary for the Single Patient Use ECG Lead Wire Set:
This submission is for an ECG Lead Wire Set, which is a fairly straightforward electromechanical device. Unlike AI/ML-driven software, its performance is primarily evaluated through adherence to established engineering standards and physical testing, not through clinical efficacy studies involving human readers or extensive AI model training. Therefore, many of the requested elements (like sample sizes for test/training sets, expert ground truth, MRMC studies, and standalone AI performance) are not applicable in the context of this device and typical regulatory submissions for such products.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Connector Retention Force | Meets ANSI/AMMI EC 53A standard. The device design for connector retention force is comparable to the predicate devices, which also meet this standard. |
| Electrical Performance | Meets ANSI/AMMI EC 53A standard. The device's electrical performance is comparable to the predicate devices, which also meet this standard. |
| Biological Evaluation | Meets EN/ISO 10993-1:2003 (Part I: Guidance on selection of tests). This standard addresses biocompatibility, indicating the materials used are safe for patient contact. |
| General Safety (Electrical) | Meets IEC 601-1 (1998) subclause 56.3(c). This standard pertains to general requirements for safety of medical electrical equipment. |
| Product Markings | Meets ANSI/AAMI EC13:2002 (chapter 4.1.1.5). This standard covers product markings for cardiac monitors, heart rate meters, and alarms, ensuring appropriate labeling for the lead wire set. |
| Quality Systems | Complies with Good Manufacturing Practice (GMP) requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). (Implied by FDA's substantial equivalence determination, as compliance with general controls is a prerequisite for marketing). |
| Registration and Listing | Complies with annual registration and listing requirements (21 CFR Part 807). (Implied by FDA's substantial equivalence determination). |
| Labeling | Complies with labeling requirements (21 CFR Part 801) and "Misbranding by reference to premarket notification" (21CFR Part 807.97). (Implied by FDA's substantial equivalence determination, and explicit mention of labeling in FDA letter). |
| Medical Device Reporting | Complies with medical device reporting (MDR) (21 CFR 803). (Implied by FDA's substantial equivalence determination). |
| Intended Use Match | Intended use is substantially equivalent to predicate devices. The device's intended use ("transmit signals from patient electrodes to various electrocardiograph recorders / monitors for both diagnostic and monitoring purposes") is the same as the predicate devices. This is a functional rather than a performative acceptance criterion in this context. |
Note: The document primarily outlines the standards met rather than providing specific raw performance data. The "reported device performance" is the statement of compliance with these standards, implying that the device successfully passed the tests required by each standard.
Study Details (Applicability for ECG Lead Wires)
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Sample Size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the summary. For electrical and mechanical performance testing (e.g., connector retention force, electrical integrity, biocompatibility), sample sizes are typically determined by the respective standards (e.g., ANSI/AAMI EC53A, ISO 10993). These are usually small, representative batches or a statistically significant number of units to ensure consistency.
- Data Provenance: Not explicitly stated. Such testing is typically conducted in designated test laboratories, either in-house or by third-party contractors. The location (country) of these labs is not specified. The testing is prospective for the device under review.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For an ECG lead wire set, "ground truth" as it relates to clinical diagnosis or interpretation by experts (e.g., radiologists) is not relevant. The device's performance is objectively measured against engineering specifications and physical standards. Expert consensus would not be used to assess, for example, connector retention force.
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Adjudication method for the test set:
- Not Applicable. Adjudication methods (like 2+1 or 3+1) are for resolving discrepancies in expert interpretations, typically in clinical studies or image analysis. This is not how an ECG lead wire's compliance with engineering standards is assessed. Compliance is determined by objective measurements meeting predefined thresholds.
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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, not applicable. MRMC studies are designed for assessing the impact of diagnostic aids (often AI-powered) on human reader performance. An ECG lead wire is a passive component for signal transmission, not a diagnostic aid that assists a human reader in interpretation. Therefore, such a study would not be performed.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, not applicable. "Standalone performance" refers to the performance of an algorithm without human intervention, typically for AI/ML software. An ECG lead wire is a physical device that transmits electrical signals, not an algorithm.
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The type of ground truth used:
- Objective Engineering Standards / Physical Measurements: The "ground truth" for this device's performance relies entirely on objective measurements against established engineering standards (e.g., force in Newtons for retention, electrical resistance/impedance values, biocompatibility profiles) and visual inspection where applicable. There is no subjective ground truth or clinical outcome data used directly for this type of device's regulatory review in this context.
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The sample size for the training set:
- Not Applicable. "Training set" refers to data used to train an AI/ML model. This device is not an AI/ML product; it is an electromechanical accessory.
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How the ground truth for the training set was established:
- Not Applicable. As there is no AI/ML model, there is no training set or ground truth establishment for a training set. The device's "ground truth" for its design and manufacturing is based on adherence to the listed industry standards and specifications.
§ 870.2900 Patient transducer and electrode cable (including connector).
(a)
Identification. A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.(b)
Classification. Class II (performance standards).