(140 days)
The Multi-Link Cable and Lead Wire System is intended to transmit ECG signals from patient monitors for monitoring purposes. The Multi-Link Cable and Lead Wire System is limited to indications for use of the connected monitoring equipment. The Multi-Link trunk cables) are reusable, nonsterile and can be reprocessed. The Multi-Link lead wires are available reusable (single patient use). The Multi-Link Cable and Lead Wire System is compatible with GE Healthcare, Philips, Mindray, Spacelabs and Nihon Kohden electrocardiograph monitors.
The Multi-Link X2 ECG Cable and Lead Wire Systems are a combination of reusable ECG trunk cables and single-patient use lead wires (SPUL) used to transmit signals from patient electrodes to various electrocardiograph monitors for monitoring purposes. This type of device is common to both the industry and to most medical establishments. The Multi-Link X2 ECG Cable and Lead Wire Systems are not stand alone devices but are accessories to the host monitoring devices.
The provided text is a 510(k) premarket notification for a medical device called the "Multi-Link X2 ECG Cable and Lead Wire System." This document aims to demonstrate that the new device is substantially equivalent to legally marketed predicate devices. It covers the device's indications for use, technological characteristics, and performance data, primarily focusing on compliance with established medical device standards.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative manner for specific diagnostic performance metrics (e.g., sensitivity, specificity, AUC). Instead, the device performance is demonstrated through adherence to recognized medical device standards. The "Performance Data" section lists the standards the device was tested against and states that the tests were performed to support substantial equivalence.
| Performance Characteristic | Standard | Reported Device Performance |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity | AAMI ANSI ISO 10993-5:2009/ (R2014) | The lead wire is considered to be a skin contact with prolonged duration. Tests for Cytotoxicity, Sensitization, and Irritation were performed (implied successful by submission). |
| Sensitization | AAMI ANSI ISO 10993-10:2010/ (R2014) | The lead wire is considered to be a skin contact with prolonged duration. Tests for Cytotoxicity, Sensitization, and Irritation were performed (implied successful by submission). |
| Irritation | AAMI ANSI ISO 10993-10:2010/ (R2014) | The lead wire is considered to be a skin contact with prolonged duration. Tests for Cytotoxicity, Sensitization, and Irritation were performed (implied successful by submission). |
| General Biocompatibility | AAMI ANSI ISO 10993-1:2009/ (R) 2013 | Biological evaluation performed within a risk management process (implied successful by submission). |
| Electrical Performance | ||
| Compatibility Testing with Bedside Monitors | 60601-2-27:2011 | Tests performed to ensure compatibility (implied successful by submission). |
| Lifecycle and Contact Resistance (Instrument Connectors) | EC53:2013 (Section 5.3.5 and 5.3.7) | Tests performed (implied successful by submission). |
| Grabber and Snap Lifecycle (Long SPUL and Direct Connect Lead wires) | EC53:2013 (Section 5.3.5 and 5.3.7) | Tests performed (implied successful by submission). |
| Multi-Link Yoke and Long Lead wires | EC53:2013 (Section 5.3.5, 5.3.6 and 5.3.7) | Tests performed (implied successful by submission). |
| Inspection of Air Clearance | 60601-1:2012 and 60601-2-27:2011 | Tests performed (implied successful by submission). |
| Defibrillation Protection and Energy Reduction | 60601-1 | Tests performed (implied successful by submission). |
| Leakage Current Test | 60601-1:2012 | Tests performed (implied successful by submission). |
The document states, "Successful verification test results ensured that the proposed device does not raise any different question of safety and effectiveness." This indicates that the device met the requirements of the listed standards, and this compliance serves as the "acceptance criteria" for demonstrating substantial equivalence for this type of device (ECG cables and lead wires).
For a device like an ECG cable and lead wire system, performance is primarily assessed through its ability to safely and effectively transmit ECG signals, which is verified through compliance with electrical safety, biocompatibility, and functional standards, rather than diagnostic accuracy metrics typically associated with AI-driven diagnostic devices.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a "test set" in the context of clinical data, as it describes a hardware device that transmits signals rather than a diagnostic algorithm. The testing described refers to engineering verification and validation of the device's physical and electrical characteristics against recognized safety and performance standards. Therefore, information about "sample size" for a clinical test set or "data provenance" (country of origin, retrospective/prospective) is not applicable here. The testing would involve a sufficient number of device units or components to demonstrate compliance with the specified standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable to the presented device and study. The "ground truth" for an ECG cable and lead wire system is its adherence to electrical and material safety standards, which is assessed through laboratory testing and engineering analysis, not through expert clinical consensus on diagnostic findings.
4. Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, often with AI systems. The studies here involve objective measurements against technical standards.
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:
This information is not applicable. The device is an ECG cable and lead wire system, which are hardware accessories for patient monitoring. It does not incorporate AI technology, nor is it a diagnostic tool that assists human readers in interpreting results. Therefore, an MRMC comparative effectiveness study with AI assistance is not relevant.
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 hardware component; it is not an algorithm and does not operate in a standalone algorithmic capacity.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device is compliance with established international and national medical device standards for electrical safety, biocompatibility, and functional performance (e.g., "60601-2-27:2011," "EC53:2013," "AAMI ANSI ISO 10993"). This is determined through objective engineering tests and material analyses.
8. The Sample Size for the Training Set:
This information is not applicable. The device is an ECG cable and lead wire system, which undergoes engineering verification and validation. It is not an AI algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable, as there is no "training set" for this hardware device.
§ 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).