(48 days)
The Medi-Trace® 1610C Combination Defibrillation, Monitoring and Pacing Electrode is intended for use in defibrillation procedures, cardioversion, pacing and ECG monitoring on adults.
A pre-gelled conductive electrode consisting of a pre-attached leadwire, and insulating layer of a vinyl substrate, a secondary vinyl piece covering the crimped wire connector, a layer of metal foil, a conductive adhesive hydrogel, a pressure sensitive adhesive (PSA) ring and a release liner. Device is packaged in pairs in a heat sealed pouch; 10 pouches are packaged into one shelf box shipper.
This document describes the performance summary for the Medi-Trace® 1610C Combination Defibrillation, Monitoring and Pacing Electrode.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Set by AAMI DF-39) | Reported Device Performance |
|---|---|
| AAMI DF-39 Electrical Tests (Paragraph 3.3.19): Specifications for self-adhesive electrodes for monitoring and defibrillation and pacing. This likely includes parameters such as impedance, current distribution, and other electrical safety and performance metrics relevant to the intended functions. | The device and predicate device were both subjected to AAMI electrical tests as described in DF-39, 3.3.19. Test results for both the device and the predicate meet the specifications as established in DF-39 for self-adhesive electrodes for monitoring and defibrillation and pacing. |
| Energy Throughput Testing: Assessment of the electrode's ability to efficiently deliver and sustain the energy required for defibrillation procedures. | Both the device and the predicate device underwent energy throughput testing. Test results for both the device and the predicate meet the specifications as established in DF-39 for self-adhesive electrodes for monitoring and defibrillation and pacing. |
| Simulated Use Testing (per DF-39 specifications): This includes evaluation of performance during: | The device was subjected to simulated use testing. Test results for the device met the specifications as established in DF-39 for self-adhesive electrodes for monitoring, defibrillation and pacing. |
| * Multiple Defibrillation Shocks: Ability to withstand and perform effectively after repeated high-energy electrical discharges. | |
| * Maximum Current Pacing: Capability to deliver and maintain maximum pacing currents. | |
| * ECG Monitoring: Performance in accurately acquiring and transmitting electrocardiogram signals. | |
| Biocompatibility Testing (per ISO-10993, Part I): Evaluation for biological effects such as irritation, cytotoxicity, and sensitization. The criteria would be to show no adverse biological responses. | The device was subjected to biocompatibility testing as recommended in ISO-10993, Biological Evaluation of Medical Devices Part I: "Evaluation and Testing." The device was found to be non-irritating, non-cytotoxic and non-sensitizing. |
| Shelf Life: Data to substantiate the claimed shelf life of the device under specified storage conditions. | Data obtained in accelerated shelf life studies were reviewed and found to substantiate our claimed shelf life. |
2. Sample Size Used for the Test Set and Data Provenance
The provided summary does not explicitly state the numerical sample size for the test set used in the performance studies. It mentions "the device and the predicate device" were subjected to AAMI electrical tests and energy throughput testing, and "the device" was subjected to simulated use testing. This implies a comparative study against a predicate device and then simulated usage for the new device.
The data provenance (country of origin, retrospective/prospective) is not specified. However, given that this is a 510(k) submission to the FDA, the testing would have been conducted to meet US regulatory requirements, likely by the manufacturer, Graphic Controls Corporation, based in Buffalo, NY, USA. The studies would be considered prospective for the purpose of demonstrating substantial equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This type of device (defibrillation, monitoring, and pacing electrode) typically does not involve human expert interpretation for "ground truth" in the same way an imaging or diagnostic AI device does. The "ground truth" here is defined by the technical specifications and performance standards outlined in AAMI DF-39. The validation involves objective measurements against these predefined engineering and safety standards. Therefore, no "experts" with specific clinical qualifications like radiologists would be used to establish a ground truth for interpretation.
4. Adjudication Method for the Test Set
Not applicable for this type of device and study. The testing involves direct measurement against specified performance criteria as outlined by AAMI DF-39. There is no human interpretation or subjective assessment that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document does not describe an MRMC comparative effectiveness study. The device is a medical electrode, and its performance is evaluated based on technical specifications and functional testing, not on human reader performance with or without AI assistance. There is no AI component mentioned in the context of improving human reader performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, in essence. The performance studies described (electrical tests, energy throughput, simulated use, biocompatibility, shelf life) are all evaluating the device itself, functioning independently, against pre-defined technical and safety standards. There is no "human-in-the-loop" component in assessing the intrinsic performance of the electrode. These are tests of the physical device's characteristics and functionality.
7. Type of Ground Truth Used
The ground truth for this device's performance evaluation is based on:
- Established Technical Specifications and Standards: Primarily the requirements outlined in AAMI DF-39 for self-adhesive electrodes for monitoring and defibrillation and pacing.
- Biocompatibility Standards: ISO-10993, Part I.
- Functional Performance Benchmarks: The ability to perform its intended functions (defibrillation, pacing, ECG monitoring) within acceptable parameters during simulated use.
8. Sample Size for the Training Set
Not applicable. This device is a physical electrode, not a software algorithm or AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 870.5310 Automated external defibrillator system.
(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.