(61 days)
The Unimed Disposable ECG Lead Wires are indicated for use in the monitoring of cardiac signals for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment.
The unimed disposable 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.
The provided document is a 510(k) premarket notification for the "Unimed Disposable ECG Lead Wires". It describes the device, its intended use, a comparison to a predicate device, and performance data from adherence to recognized standards. However, it does not contain the specific information required to answer the prompt in detail, such as acceptance criteria in a table format, specific details of a study (sample size, data provenance, ground truth establishment, expert roles, adjudication methods), or any MRMC comparative effectiveness study results.
This document describes a device used to transmit cardiac signals, not an AI or imaging device, so many of the requested criteria (like multi-reader multi-case studies, ground truth establishment for algorithms, training sets, etc.) are not applicable to this type of medical device submission.
Based only on the provided text, here is what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with specific numerical targets and corresponding device performance results. Instead, it states that the device "meets the requirements of EC53 and IEC60601-1" and "meets the following the recognized standards." This indicates compliance with the standards are the acceptance criteria for performance, but the specific metrics and values are not detailed in this submission.
| Acceptance Criteria (Standards Adhered To) | Reported Device Performance |
|---|---|
| ANSI/ANMM EC53-1995 (R)2001, R(2008) ECG Cables and Leadwires (except4.3.1) | Device meets requirements of this standard. |
| ANSI/AAMI EC13 Cardiac monitors, heart rate meters and alarms (only product markings, chapter 4.1.1.5),2002 | Device meets requirements of this standard. |
| FR 898: Guidance Document on the Performance Standard for Electrode Lead Wires and Patient Cables, May 11, 1998 | Device meets requirements of this standard. |
| IEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements for Safety, 1988+A1:1991+A2:1995 | Device meets requirements of this standard. |
| ISO 10993-5, Biological evaluation of medical devices-Part 5: Tests for In Vitro cytotoxicity, 2009 | Device meets requirements of this standard. |
| ISO 10993-10, Biological evaluation of medical devices-Part 10: Tests for irritation and delayed-type hypersensitivity, 2010 | Device meets requirements of this standard. |
Regarding the study that proves the device meets the acceptance criteria:
The document states that "performance data" was submitted to demonstrate substantial equivalence and adherence to the listed standards. However, it does not describe a "study" in the typical clinical trial sense with the requested details. The performance data seems to refer to engineering testing and biocompatibility assessments to confirm compliance with the technical standards.
Due to the nature of this device (an ECG lead wire, essentially a cable), many of the questions are not directly applicable. I will answer the remaining questions with "Not Applicable" or "Not Provided" where the information is not present in the given text.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not provided. This would typically refer to the number of devices tested to meet the standards, or potentially the number of subjects if clinical performance was explicitly tested beyond standard adherence, but such detail is absent.
- Data Provenance: Not provided. The manufacturing country is China, but the origin of any test data is not specified.
- Retrospective or Prospective: Not provided.
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)
- Not Applicable. This is not an AI or diagnostic imaging device that requires expert interpretation for ground truth establishment. Device performance is assessed against technical standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No human adjudication is mentioned or implied for the performance testing of an ECG lead wire 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
- Not Applicable. This is an ECG lead wire, not an AI-powered diagnostic system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. The "ground truth" for this device's performance is adherence to the specifications and performance requirements outlined in the cited engineering and biocompatibility standards.
8. The sample size for the training set
- Not Applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI device that requires a training set.
§ 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).