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Recording muscle activity for Electromyography (EMG) applications. For single patient use only.

The disposable hypodermic needle is inteded to be used for iniection of the Botulinum Toxin into a muscle. while recording electromyography activity. The electrode has an open lumen and is designed for muscle stimulation, motor unit action, potential recording and Botulinum Toxin injection.

A diagnostic electromyography 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). The needle electrodes are for single patient only.

This 510(k) premarket notification is for a Disposable EMG Needle Electrode, a Class II medical device. The submission focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than proving novel performance against acceptance criteria through a clinical study. As such, the information typically found in acceptance criteria and efficacy studies is not present in this document.

Here's an analysis based on the provided text, addressing your questions where possible:

1. A table of acceptance criteria and the reported device performance

The provided document does not contain a table of acceptance criteria or reported device performance in the way you might expect for a new, performance-based device. This 510(k) summary is for a device seeking substantial equivalence, meaning its safety and effectiveness are established by showing it is as safe and effective as a legally marketed predicate device. The focus is on demonstrating similar design, materials, packaging, and technological characteristics.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not describe a specific test set, sample size, or data provenance because it is a 510(k) submission based on substantial equivalence. It does not present results from a clinical trial or performance study that would typically involve a test set.

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)

This information is not applicable and not provided. No "ground truth" was established for a test set as there was no study comparing the device's performance to a known truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. There was no adjudication method as there was no performance study involving a test set and human readers.

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

An MRMC comparative effectiveness study was not performed and is not described in this document. The device is an electrode, not an AI-assisted diagnostic tool.

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

A standalone performance study was not performed and is not described. The device is a physical electrode, not a standalone algorithm.

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

This information is not applicable and not provided. No "ground truth" was used in a performance study.

8. The sample size for the training set

This information is not applicable and not provided. This document does not describe the development of an algorithm or AI model that would require a training set.

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

This information is not applicable and not provided. There was no training set for which a ground truth needed to be established.

Summary of the K091410 Submission:

This 510(k) premarket notification by Spes Medica s.r.l. for their "Disposable EMG Needle Electrodes" is a Class II medical device submission seeking substantial equivalence. The core argument for safety and effectiveness is that the device is "similar in design, materials, packaging and other technological characteristics" to several legally marketed predicate devices (e.g., MEDICOTEST A/S Neuroline, AMBU A/S Neuroline, MEDELEC Disposable Needle Electrode, etc.).

The document describes the device's intended use: "Recording muscle activity for Electromyography (EMG) applications. For single patient use only." It also notes a specific use case for the hypodermic version: "injection of the Botulinum Toxin into a muscle, while recording electromyography activity."

The FDA's letter (AUG 11 2009) confirms that they have reviewed the submission and determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use. This means that, in the context of this 510(k), the device indirectly meets "acceptance criteria" by being deemed as safe and effective as existing products, without requiring independent performance studies with acceptance criteria or ground truth.

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