(57 days)
TECA™ elite Disposable Monopolar Needles are intended for use with recording, monitoring and stimulation/recording equipment for the stimulation/recording of biopotential signals including electromyograph (EMG) and nerve potential signals.
CareFusion TECAT™ elite Disposable Monopolar Needles (TECATM elite Needles) are disposable, single use, sterile products intended to sense subcutaneous bioelectrical activity, or to stimulate nerve or muscular response by insertion into the patients muscle(s) through the skin where the recording area can differentiate between individual motor units. TECATM elite Needles are connected to an electromyographic (EMG) device through a cable. The EMG device detects and displays the biopotential information to the user. TECAT™ elite Needles are stainless steel, platinum alloy, and/or gold plated stainless steel, and coated with a polytetrafluoroethylene (PTFE) insulator. A low-friction lubricant is applied to the exterior surface of the needle. TECAT™ elite Needles are passive devices, and do not contain electrical hardware components or software. The following device modifications were made to the TECAT™ elite Needles: Reformulation of the PTFE exterior needle coating; Addition of a low friction lubricant to the exterior surface of the needle; and Modification of the needle tip geometry.
The provided text describes the 510(k) Premarket Notification for CareFusion's TECA™ elite Disposable Monopolar Needles. This document focuses on demonstrating substantial equivalence to a predicate device, rather than a clinical study establishing the performance of a novel AI/ML device against specific acceptance criteria. Therefore, most of the requested information regarding AI/ML device performance, sample sizes, expert ground truthing, MRMC studies, or training sets is not applicable here.
However, I can extract information related to the device's characteristics and the testing performed to show its compliance.
Here's the relevant information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document primarily focuses on verifying that the modified TECA™ elite Needles comply with predetermined specifications and applicable standards, specifically referencing ISO 10993-1 for biocompatibility and ISO 7864 for performance. The "acceptance criteria" here are implied by these standards and the internal requirements, and the "reported device performance" is a general statement of compliance.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Meet biological evaluation requirements. | "Biocompatibility verification was performed on direct patient contact materials... in accordance with... ISO 10993-1: 2009... Verification results and device material comparisons indicated that the TECAT™ elite Needles comply with their predetermined specifications, and with the applicable portions of the Standard." |
| Performance - Coating: Coating performance | "Verification of coating performance... indicated that the TECAT™ elite Needles comply with their predetermined specification and with the applicable Standard." |
| Performance - Tip Geometry: Tip geometry | "Verification of tip geometry... indicated that the TECAT™ elite Needles comply with their predetermined specification and with the applicable Standard." |
| Performance - Insertion Force: Validated insertion force | "Validation of insertion force... indicated that the TECAT™ elite Needles comply with their predetermined specification and with the applicable Standard." |
| Performance - Recording Characteristics: Noise and impedance testing | "Validation of recording characteristics including noise and impedance testing... indicated that the TECAT™ elite Needles comply with their predetermined specification and with the applicable Standard." |
| Overall Safety and Effectiveness | "Verification and validation activities were conducted to establish the performance and safety characteristics of the device modifications... The results... demonstrate that the TECA™ elite Needles are safe and effective when used in accordance with the intended use and labeling." |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as the study described is a device modification verification, not a clinical study with a specific test set of patient data. The testing involved bench performance and biocompatibility assessments of the physical device and its materials.
3. Number of Experts Used to Establish the Ground Truth and Qualifications of Those Experts
This information is not provided and is not applicable to the type of device verification described. Ground truth for clinical outcomes or diagnostic accuracy by experts is not relevant here.
4. Adjudication Method for the Test Set
Not applicable. The testing described involves bench tests and biocompatibility assessments, not clinical data requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This device is a passive, disposable electromyograph needle, not an AI-powered diagnostic tool that would typically undergo such a study to evaluate human reader improvement with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, this is not an AI/ML algorithm. It's a physical medical device.
7. The Type of Ground Truth Used
For biocompatibility, the "ground truth" was established by compliance with the ISO 10993-1 standard and comparison of direct patient contact materials. For performance testing, the "ground truth" was established by compliance with internal requirements and the ISO 7864 standard for sterile hypodermic needles.
8. The Sample Size for the Training Set
Not applicable. There is no training set mentioned as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set.
§ 890.1385 Diagnostic electromyograph needle electrode.
(a)
Identification. A diagnostic electromyograph needle electrode is a monopolar or bipolar needle intended to be inserted into muscle or nerve tissue to sense bioelectrical signals. The device is intended for medical purposes for use in connection with electromyography (recording the intrinsic electrical properties of skeletal muscle).(b)
Classification. Class II (performance standards).