(105 days)
Recording muscle activity for Electromyography (EMG) applications. For single patient use only. Patient population: Adults.
Bi-polar/multi-polar disposable concentric needles for recording muscle activity. The needles consist of a stainless steel hypodermic outer shell with a centered platinum/iridium inner recording core with a trocar sharpencd tip. An electrically insulated molded handle incorporates the contact points allowing electrical continuity through the connecting cable, which is sold separately.
The Rochester Electro-Medical, Inc. Ultra Sharp Concentric Needles are diagnostic electromyograph needle electrodes. The acceptance criteria and the study proving the device meets these criteria are detailed in the "Non-clinical Testing" section of the 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Characteristic | Reported Device Performance |
|---|---|
| Core Centering & Size | Verified through microscopic visual examination. |
| Microscopic Visual Examination | Conducted to assess overall quality. |
| Sharpening | Microscopic visual examination with special attention to bevel convergence, burrs, and point. Also includes a foam test. |
| Electrical Continuity of all poles | Verified using an audible ohmmeter. |
| Electrical Isolation of all poles | Verified using an audible ohmmeter. |
| Needle hypodermic shell examination | Assessed for straightness and stated length. |
| Handle Mold Design | Visual and audible ohmmeter for electrical aspects. |
| Connector Interface | Visual and audible ohmmeter for electrical aspects. |
| Sterility | Achieved through Gamma Irradiation. |
| Biocompatibility | Materials (Stainless Steel & Platinum) are biocompatible. |
| Mechanical Safety | Packaged needle covered with a needle cover. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a separate "test set" sample size in the traditional sense for a clinical study. The device performance was evaluated through a series of internal "Non-clinical Testing" procedures, which include:
- Process Control: Verification of manufacturing processes.
- Process Verification: Done according to established control processes.
- Design Verification: Performed using samples from the first production run, with methods identical to the Process Approval phase.
The "samples from the first production run" serve as the test set for design verification. The exact number of samples tested at each stage (Process Control, Process Verification, Design Verification) is not specified.
Data Provenance: The data appears to be retrospective and internal, derived from the manufacturer's own quality control and design verification processes conducted in the U.S. (Lutz, FL).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of external experts or a formal ground truth establishment process involving experts for the "Non-clinical Testing." The assessments were primarily based on internal quality control and manufacturing process verification, likely performed by manufacturing and quality control personnel. Their specific qualifications are not detailed.
4. Adjudication Method for the Test Set
No formal adjudication method (e.g., 2+1, 3+1) is described. The "Non-clinical Testing" relies on direct measurements, visual inspections, and functional tests (like ohmmeter readings) against predefined specifications. Discrepancies would likely be addressed through internal quality control protocols.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on the safety and effectiveness of the device itself through non-clinical bench testing, not on the improvement of human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
The device is a physical medical instrument (a needle electrode), not an algorithm or an AI-powered system. Therefore, the concept of "standalone (algorithm only)" performance is not applicable. The performance described relates to the physical and electrical characteristics of the needle.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical testing appears to be based on:
- Engineering Specifications/Design Parameters: For characteristics like core centering, size, length, and straightness.
- Established Quality Control Standards: For visual examinations (burrs, bevel convergence, point) and functional tests (electrical continuity, isolation).
- Industry Standards: Compliance with various ISO and AAMI/ANSI standards (e.g., ISO 13485, ISO 14971, ISO 10993-1, ISO 9626, ISO 7864).
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable as this is a physical medical device, not an AI/ML algorithm. The document describes manufacturing processes and design verification, not algorithm development.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set mentioned in the context of this device.
§ 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).