(211 days)
The Multi-Link™ X2 ECG Adapter and Direct Connect Lead Wire System are used in telemetry to transmit ECG signals from the electrodes to the transmitters on ambulatory patients within a defined coverage area for monitoring purposes. The Multi-Link Direct Connect Lead Wires are single-patient-use, non-sterile and cannot be reprocessed. The Multi-Link Adapters are reusable, non-sterile and can be reprocessed. The Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System are used with any patient population requiring ambulatory ECG, and are compatible with Philips, Mindray and Nihon Kohden electrocardiograph monitors.
The Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System is a combination of reusable adapters, already cleared lead wires (reusable K980582 and disposable single patient use K101660) and direct connect disposable single patient use lead wires, used to transmit signals from patient electrodes to the transmitters on ambulatory patients within a defined coverage area for monitoring purposes. This type of device is common to both the industry and to most medical establishments. The Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System are not stand alone devices, but are accessories to the host monitoring devices. The adapters and lead wires are conductors carrying the signal from the patient to the monitor.
This document is a 510(k) Premarket Notification from the FDA for a device called "Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System" (K163316). It primarily focuses on demonstrating substantial equivalence to predicate devices through performance and biocompatibility testing against international standards.
Given the nature of the device (ECG adapters and lead wires), the acceptance criteria are based on meeting specified performance standards rather than measures like accuracy, sensitivity, or specificity often associated with diagnostic AI tools. Therefore, information related to AI-specific elements such as training/test sets, ground truth establishment, expert adjudication, or MRMC studies for improved human reader performance will not be relevant.
Here's the breakdown of the acceptance criteria and study information provided:
1. A table of acceptance criteria and the reported device performance
| Performance Characteristic (Acceptance Criteria - Standard/Section) | Reported Device Performance |
|---|---|
| Non-clinical Performance Testing | |
| Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (AAMI ANSI ES60601-1:2005/(R):2012 and A1:200012) | Pass |
| Medical electrical equipment – Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment (AAMI ANSI IEC 60601-2-27:2011) | Pass |
| ECG trunk cables and patient leadwires (AAMI ANSI EC53: 2013) | Pass |
| Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (IEC 60601-1-6 Edition 3.1 2013-10) | Not explicitly detailed but implied by "Pass" for all relevant tests. |
| Specific Performance Tests (derived from the above standards): | |
| Compatibility Testing | Pass |
| Lifecycle and Contact Resistance | Pass |
| Inspection of Air Clearance | Pass |
| Defibrillation Protection and Energy Reduction | Pass |
| Dielectric Withstand Testing | Pass |
| Storage Conditioning and Drop Test | Pass |
| Cable and Lead wire Noise | Pass |
| Flex Life Test | Pass |
| Tensile Strength | Pass |
| Connector mating/unmating | Pass |
| Retention force test | Pass |
| Contact Resistance Test | Pass |
| Lead wire Resistance | Pass |
| Material Resistance for Cleaning and Disinfection Stress | Pass |
| Wiping Durability Test | Pass |
| Biocompatibility Testing | |
| Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (AAMI ANSI ISO 10993-1:2009/(R)2013) | Implied "Pass" by completing the subsequent tests. |
| Biological Evaluation of Medical Devices-Part 5: Tests for In Vitro Cytotoxicity (AAMI ANSI ISO 10993-5:2009/(R2014)) | Pass |
| Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization (AAMI ANSI ISO 10993-10:2010/(R2014)) | Pass |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document describes performance testing of physical components (adaptors and lead wires) against established engineering and safety standards. It does not refer to a "test set" in the context of clinical data or patient records. Therefore, information about sample size for a test set or data provenance (country of origin, retrospective/prospective) is not applicable or provided. The testing is likely conducted in a laboratory setting on a sample of manufactured devices.
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)
This information is not applicable. The device is a medical accessory, and its performance is evaluated against engineering and safety standards, not against "ground truth" established by clinical experts for diagnostic accuracy.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable, as the testing involves meeting pre-defined objective engineering standards, not subjective clinical evaluations requiring adjudication.
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
An MRMC study is not relevant to this device. This device is an ECG adapter and lead wire system, which transmits ECG signals. It is not an AI-powered diagnostic tool, and therefore, there is no human reader "improvement with AI vs without AI assistance" to measure.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical accessory and does not contain an "algorithm" for standalone performance evaluation in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is defined by the objective pass/fail criteria outlined in the referenced international engineering and safety standards (e.g., AAMI ANSI ES60601-1, AAMI ANSI IEC 60601-2-27, AAMI ANSI EC53, ISO 10993 series). There is no clinical "ground truth" like expert consensus or pathology involved in evaluating these performance characteristics.
8. The sample size for the training set
This information is not applicable. The device is a physical accessory and does not involve training data or algorithms in the way an AI-driven diagnostic device would.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated above.
§ 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).