(51 days)
The Adagio™ Retracting ECG patient lead wires are used to connect electrodes and/or sensors placed at the appropriate sites on the patient to a monitoring device for general monitoring and/or diagnostic evaluation by a health care professional.
The Adagio™ Retracting ECG Lead Wires are standard five lead wire set that incorporate retractors to facilitate the handling of the lead wires and are:
• ANSI/AAMI EC 53: 1995 (R) 2001 Compliant
• AAMI EC 13: 2002 (R) 2007 Color Code compliant
The provided document K093657 describes the Adagio™ Retracting ECG Lead Wires. Here's an analysis of its acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Acceptance Criteria (Standards/Tests) | Reported Device Performance (Compliance/Results) |
|---|---|---|
| Electrical Safety | 21 CFR 898.12IEC 60601-1, Sub clause 56.3 (c)ANSI/AAMI EC 53: 1995 (R) 2001 | Tested and found to comply with all required patient safety testing, including the listed applicable standards. "Test results confirm that the Adagio is safe and effective for its intended use." |
| Performance - Bench | Established protocols for bench testing. | "Bench testing was conducted on the Adagio™ Retracting ECG Lead Wires according with established protocols and test results confirm that the final product met the requirements for the safety and performance standards and its intended use." |
| Biocompatibility | Based on patient contact. | Not Applicable: "The Adagio™ Retracting ECG Lead Wires do not have patient contact. Therefore they do not require biocompatibility testing." |
| Sterilization | Sterility requirements. | Not Applicable: "are not provided sterile." |
| Shelf Life | Expected lifespan/usability. | Not Applicable: "The Adagio™ Retracting ECG Lead Wires; are intended to be reusable." |
| Substantial Equivalence | Comparison to predicate device (K942321). | "The Adagio™ Retracting ECG Lead Wires has identical performance and technological characteristics of common non retractable ECG patient lead wires used extensively in the medical industry as well as the legally marketed predicate, cleared under 510(k) K942321." |
| "The Adagio™ Retracting ECG Lead Wires are equivalent to the predicate lead wire devices cleared to market under 510(k) K942341." |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes bench testing and electrical safety testing as the primary means to demonstrate safety and effectiveness.
- Sample Size for Test Set: The document does not specify a numerical sample size for the devices tested in electrical safety or bench testing. It generally states that the "Adagio™ Retracting ECG Lead Wires" (plural) were tested.
- Data Provenance: The data is from prospective testing conducted by the manufacturer (ACIST Medical Systems, Inc.) to evaluate the device against specified standards and internal protocols. No information is provided regarding the country of origin of the data beyond the manufacturer's location in Eden Prairie, MN, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This question is not applicable in this context. The "ground truth" for the performance of an ECG lead wire is based on objective measurements against established engineering and safety standards, not on expert interpretation of medical images or clinical outcomes. The device's function is to transmit electrical signals reliably and safely, which is assessed through bench and electrical tests.
4. Adjudication Method for the Test Set:
- This question is not applicable. Adjudication methods like "2+1" are typically used in clinical studies where multiple experts evaluate ambiguous cases. For bench and electrical safety testing, results are typically objective measurements against pass/fail criteria from 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 question is not applicable. The device is an ECG lead wire, a hardware component for signal transmission, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and AI assistance improvement are irrelevant to its evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- This question is not applicable. This device is a passive hardware component (lead wire) and does not involve an algorithm or AI operating in a standalone capacity. Its performance is evaluated on its ability to meet electrical and mechanical standards.
7. The Type of Ground Truth Used:
The "ground truth" for this device's performance is established by:
- Objective measurements and compliance with recognized industry standards: Specifically, electrical safety standards (21 CFR 898.12, IEC 60601-1, ANSI/AAMI EC 53: 1995 (R) 2001) and internal bench testing protocols.
- Demonstration of "identical performance and technological characteristics" to a legally marketed predicate device (K942321). This establishes a comparative "ground truth" based on the predicate's known safe and effective performance.
There is no mention of expert consensus, pathology, or outcomes data being used to establish the ground truth for this type of device.
8. The Sample Size for the Training Set:
- This question is not applicable. There is no "training set" as this device is a hardware component and does not employ machine learning or AI that would require a training phase.
9. How the Ground Truth for the Training Set Was Established:
- This question is not applicable for the same reasons as 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).