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The Disposable Pre-gelled Surface Electrodes are intended for recording/stimulation and monitoring of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potential (EP) signals.

The Rochester Electro-Medical Disposable Pre-gelled Surface Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of stimulating/recording of biopotential signals. Electrodes are applied in the study of biopotentials such as Electroencephalograph (EEG), surface Electromyography (EMG) and Evoked Potential signals (EP). Electrodes are non-invasive as they are applied to the patient's skin using a self-adhesive solid-gel surface. The electrodes are non-sterile and for single use only.

A conductive solid gel electrode consisting of a conductive adhesive gel, a silver/silver chloride plated eyelet, an adhesive cloth substrate, label, lead wire with a 0.60" diameter touch-proof female socket per DIN 42802 and polystyrene release liner. These are available in various lead lengths, lead configurations, electrode styles/sizes, and wire colors.

This document is a 510(k) Summary for the Rochester Electro-Medical Disposable Pre-gelled Surface Electrode, demonstrating its substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly enumerated with numerical targets in this summary. Instead, the document states that the physical and electrical characteristics of the subject device (Rochester Disposable Adhesive Surface Electrodes) were evaluated against those of the predicate device (Xian Friendship Medical K110289). The overarching acceptance criterion is "substantially equivalent" to the predicate device, meaning there are no new concerns regarding safety or effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

The document refers to "bench testing" that included electrode impedance measurements and gel uniformity inspection. However, the specific sample size used for these tests is not provided in this 510(k) summary. The data provenance is implied to be from internal laboratory testing conducted by Rochester Electro-Medical, Inc. or an affiliated testing facility. It is prospective testing, performed specifically for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to this submission. The device is a physical electrode, and its performance is evaluated against engineering specifications and comparison to a predicate device, not through expert-labeled data for a diagnostic algorithm.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation is based on bench testing of physical and electrical properties, not on expert review of ambiguous cases.

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 information is not applicable. The device is a physical electrode, not an AI-powered diagnostic tool, so an MRMC study is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is a physical electrode, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the device's performance is established by engineering measurements (e.g., electrode impedance, physical dimensions, material composition) and biocompatibility testing standards (ISO 10993 series). The ultimate "ground truth" for regulatory approval relies on demonstrating substantial equivalence to a predicate device that has already been deemed safe and effective based on similar scientific and engineering principles.

8. The sample size for the training set

This information is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI algorithms.

9. How the ground truth for the training set was established

This information is not applicable for the same reason as in point 8.

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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

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.

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