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Spes Medica Disposable Adhesive Surface Electrodes are intended for use with electrodiagnostic or neurological monitoring equipment for the recording of electrophysiological activity and for electrical stimulation. The electrodes are non-sterile and for single patient use only.

Spes Medica Disposable Adhesive Surface Electrodes are single patient use, disposable devices. Electrodes are non-invasive as they are applied to the patient's skin using a selfadhesive solid-gel surface. The electrodes consist of 3 different layers of materials.

The upper layer consists in a cotton non-woven pad, the second layer is the sensor and consists in a conductive layer. The lower layer, then the material in direct contact with the patient's skin consist in a solid Hydro-gel adhesive layer.

Spes Medica Disposable Adhesive Surface Electrodes are supplied with leads or with snap connector.

The electrodes which are attached to a lead wire terminate at the opposite end using different type of connectors such us:

• DIN 42802 "touch proof" safety connectors; .
• 0,7 mm "touch proof" pin; .
• Concentric "touch proof" bipolar socket; .
• 2 mm "touch proof" socket; .

The snap connector electrode uses Ag/AgCl pellet(s) as the conductive element. The active surface of the pellet is comprised between the cotton non-woven pad and the Hydro-gel adhesive layer. The pellet is attached to a stainless steel male snap connector which is used as connection.

The provided text is a 510(k) summary for Disposable Adhesive Surface Electrodes by Spes Medica s.r.l. It asserts that the device is substantially equivalent to legally marketed predicate devices. However, it does not include a study that proves the device meets specific acceptance criteria in the manner requested.

Instead, the document details a technological comparison to establish substantial equivalence, which is a regulatory pathway to market a device based on its similarity to existing, legally marketed devices (predicates). This pathway typically relies on demonstrating that the new device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, and MRMC studies are not present in the provided document, as these are typically part of a de novo classification or premarket approval (PMA) application, not a 510(k) for substantial equivalence based on technological comparison.

Here's a breakdown of what can be extracted and what cannot:

Acceptance Criteria and Device Performance (Not Applicable - Substantial Equivalence Claim)

The document does not define specific performance acceptance criteria for the new device or present a study comparing its performance against such criteria. Instead, it states:

"Spes Medica Disposable Adhesive Surface Electrodes are similar in intended use, design, materials, packaging and other technological characteristics to the predicate devices. After analyzing performance and safety testing, it is the conclusion of Spes Medica s.r.I. that the Disposable Adhesive Surface Electrodes are safe and effective as the predicate devices and introduce no new questions concerning safety and effectiveness."

This suggests that the "acceptance criteria" were implied to be "as safe and effective as the predicate devices," and the "study" was an analysis of the device's characteristics against those of the predicates.

Other Requested Information (Not Present in the Document)

The document does not contain information regarding:

• Sample sizes used for the test set and the data provenance: No test set is described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment for a test set is described.
• Adjudication method for the test set: No adjudication method is described.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: No MRMC study is mentioned.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device is a physical electrode, not software with an algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no performance study against a ground truth is described.
• The sample size for the training set: No training set is described.
• How the ground truth for the training set was established: Not applicable.

Device Description and Basis for Substantial Equivalence:

The document's "study" consists of a comparison to the following predicate devices:

The conclusion is based on the new device being similar in:

• Intended use
• Design
• Materials
• Packaging
• Other technological characteristics

The document explicitly states: "No new technology or basic materials are used in these designs."

In summary, the provided text is a 510(k) premarket notification for a Class II medical device, seeking clearance based on substantial equivalence to existing devices. It does not present a study with quantitative acceptance criteria and performance data as would be found in different types of regulatory submissions for novel devices or significant modifications.

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