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AC Cream - Conductive paste is intended for use in clinical and research EEG/EP recordings from humans. It is used with external electrodes as the conductor between the scalp and recessed electrodes to reduce impedance between the electrode surface and the skin.

AC Cream - Conductive paste is intended for use in clinical and research EEG/EP recordings from humans. It is used with external electrodes as the conductor between the scalp and recessed electrodes to reduce impedance between the electrode surface and the skin.
It's characterized by pale yellow colour, no crystallization, no flocculation, bright.
AC Cream - Conductive paste function is of conductor between the electrode used and the patient's skin and of getting the impedance lower for a better recording of the signal. AC Cream - Conductive paste is for external use with recording electrodes only.
AC Cream - Conductive paste is made of powders, Potassium Chloride and Sodium Chloride as conductors, combined with thickening agents and humectants, all in an aqueous solvent.
The composition is the following: Water, Ceteareth-20, Glycerol, Propylene Glycol, Bentonite, Sodium chloride, Potassium chloride, Calcium carbonate, Polysorbate 20, Phenoxyethanol, Ethylhexylglycerin
The pH range is 6÷8, and Impedance at 10Hz is 120± 25 Ohm.
The mean impedance after 7 days use, considering the worst values detected, is around 480 ± 10 Ohm.
The Conductivity is 20 mS/cm
Shelf life of AC Cream - Conductive paste is 3 years if stored properly in the closed packaging, kept away from the sunlight and within the limit temperature

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for AC Cream - Conductive paste:

1. Table of Acceptance Criteria and Reported Device Performance:

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SAC2 is intended for use in clinical and research EEG/EP recordings from humans. It is used with external electrodes as the conductor between the scalp and recessed electrodes to reduce impedance between the electrode surface and the skin.

SAC2 is intended for use in clinical and research EEG/EP recordings from humans. It is used with external electrodes as the conductor between the scalp and recessed electrodes to reduce impedance between the electrode surface and the skin. SAC2 is provided in an aluminum tube of 100g. It's characterized by light grey colour, no crystallization, no flocculation, no adverse smell, opaque. SAC2 function is of conductor between the electrode used and the patient's skin and of getting the impedance lower for a better recording of the signal. SAC2 is for external use with recording electrodes only. SAC2 is made of powders, Potassium Chloride and Sodium Chloride as conductors, combined with thickening agents and humectants, all in an aqueous solvent. The composition is the following: Water, Talc, Celite, Glycerol, CarboxyMethylCellulose, Sodium chloride, Potassium chloride, Phenoxyethanol, Ehylhexylglycerin The pH range is 8÷10, and Impedance at 10Hz is 50 ± 10 Ohm. The Conductivity is 20 mS/cm Shelf life of SAC2 is 3 years if stored properly in the closed aluminum tube kept away from the sunlight.

The provided text describes the 510(k) summary for the SAC2 - Electrode cream. It does not contain information about a study involving human readers or AI assistance. The performance testing section focuses on bench tests (aging, long-term conductivity) and biocompatibility, not on a clinical effectiveness study with human subjects.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

Not applicable for this type of product/study. The performance tests described are bench tests on the product itself, not on data from human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth for biocompatibility and bench testing is established through standardized laboratory procedures and instrument readings, not expert consensus.

4. Adjudication method for the test set

Not applicable. Adjudication is typically used in studies involving subjective interpretation (e.g., medical imaging), which is not the case for these performance tests.

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

No, an MRMC comparative effectiveness study was not done. The document pertains to an electrode cream, not an AI software or system that assists human readers.

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

No, a standalone algorithm performance study was not done. The device is a physical electrode cream, not an algorithm.

7. The type of ground truth used

The ground truth for the performance tests (aging, long-term conductivity) was established by objective measurements against defined parameters (e.g., color, pH, impedance, DC offset voltage) and the biological responses observed in standardized biocompatibility tests (cytotoxicity, irritation, sensitization). This is based on established industry standards like ASTM F1980-16, ANSI/AAMIEC12:2000, ISO 10993-5, and ISO 10993-10.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable. As noted above, this device does not involve a training set.

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Spes Medica Subdermal Needle Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals. Examples include: Electromyography (EMG), Electroencephalography (EEG) and Nerve potential signals. The electrodes are sterile and for single patient use only.

Spes Medica Subdermal Needle Electrodes are monopolar needles intented to use for Electromyography (EMG), Electroencephalograph (EEG) and Nerve potential signals in example and they are intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals. The Subdermal Needle Electrodes are used for recording and stimulation (micro stimulation), this stimulation has no therapeutic purpose but has the purpose of activating an electrical response.

The provided text describes the acceptance criteria and performance testing of the Spes Medica Subdermal Needle Electrodes, but it largely focuses on biocompatibility, sterilization/packaging, and electrical safety standards rather than a comparative effectiveness study involving human readers or AI.

Therefore, many of the requested fields related to AI performance, human reader studies, and large-scale clinical data will not be present in this document.

Here's a breakdown of the available information based on your request:

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

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

The document does not specify general "test sets" or data provenance in the way one would for an AI or clinical study. The performance tests are laboratory-based and conducted on the device components or prototypes. The sample sizes for each specific test (e.g., number of units tested for tensile strength, number of samples for biocompatibility) are not explicitly stated, nor is the country of origin or whether they were retrospective/prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This document describes performance testing for a medical device to establish its safety and effectiveness based on international standards, not the establishment of ground truth by clinical experts for diagnostic accuracy.

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

Not applicable. This is not a diagnostic study requiring expert adjudication.

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

Not applicable. This document does not describe an AI device or an MRMC study.

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

Not applicable. This is not an AI device.

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

For the various performance tests, the "ground truth" is defined by the requirements of the international standards (e.g., ISO, ASTM, IEC) that the device must meet. For biocompatibility tests, it's the biological response against established thresholds; for electrical safety, it's adherence to voltage and isolation limits; for mechanical tests, it's resistance to forces.

8. The sample size for the training set

Not applicable. This is not an AI device.

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

Not applicable. This is not an AI device.

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Tech Dots are intended for use in clinical and research EEG/EP recordings from humans. They are used with external electrodes as the conductor between the scalp and recessed electrodes to reduce impedance between the electrode surface and the skin

Tech Dots are conductive gel dots to be used with external electrodes as the conductor between skin and electrode and to reduce impedance between the electrode surface and the skin. A single Tech Dot has a 11 ± 1 mm diameter, 2.5 ± 0.5 mm high, and weights 0.14 ± 0.01 g. It's characterized by clear colour, no crystallization, no flocculation, no adverse smell, brightness. Tech Dots function is of conductor between the electrode used and the patient's skin and of getting the impedance lower for a better recording of the signal. Tech Dots are for use with external electrodes only. Tech Dot is made of Potassium Chloride as conductor, combined with thickening agents and humectants, all in an aqueous solvent. The composition is the following: Water, Glycerol (vegetable origin), Polyacrylate co-polymer (proprietary), Potassium chloride. The pH range is 4.1 ± 0.1, and Impedance at 10Hz is 80 ± 10 Ohm. The Conductivity is 2 mS/cm. Shelf life of TechDots is 3 years if stored properly in sealed aluminum pouch and at the limits of temperature indicated on the labeling.

This document is a 510(k) premarket notification for a medical device called "Tech Dots - Conductive gel," submitted by Spes Medica S.r.l. to the FDA. The submission aims to demonstrate that Tech Dots are substantially equivalent to a legally marketed predicate device (Electro-Gel, K111717).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for "Tech Dots - Conductive gel" are primarily established through demonstrating substantial equivalence to the predicate device and meeting relevant performance standards for electroconductive media. The reported performance is based on internal testing.

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

The document details performance testing (Biocompatibility and Bench Testing) for the Tech Dots device itself, rather than a clinical study involving human subjects or image data for AI.

• Sample Size for Testing: The specific sample sizes for tests like aging, pH, impedance, and long-term conductivity are not explicitly stated in the provided text (e.g., "how many units were tested"). It mentions "Spes Medica Tech Dots are tested internally for pH, impedance on a regular basis," implying ongoing quality control, but not a specific sample size for a formal study dataset. For biocompatibility, it indicates the gel "Gel" as 'Component Name' being tested.
• Data Provenance: The studies are described as "Performance Testing was performed on device characteristics of Spes Medica Tech Dots," and "Spes Medica Tech Dots are tested internally." This implies the data is prospective (generated for this submission/validation) and produced by the manufacturer (Spes Medica S.r.l.) in Italy.

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

This document describes the validation of a conductive gel, not an AI-powered diagnostic device that requires expert-established ground truth from medical images. Therefore, the concept of "experts" establishing "ground truth" for a test set (e.g., radiologists for disease presence) is not applicable here. The "ground truth" for the device's performance is established by technical specifications and recognized industry standards (e.g., ISO 10993, ANSI/AAMIEC12). The "experts" involved would be the engineers and quality assurance personnel at Spes Medica S.r.l. who conducted the tests and verified compliance with these standards. Their specific qualifications are not detailed beyond "Quality Assurance and Regulatory Affairs" for the Official Correspondent.

4. Adjudication Method for the Test Set

Not applicable. As this is not an AI device or a clinical study requiring human interpretation of medical data, there is no need for an adjudication method. The test results are objective measurements against defined standards.

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

Not applicable. This is not an AI device, and therefore no MRMC study or assessment of human reader improvement with AI assistance was conducted or needed.

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

Not applicable. This is not an algorithm or software device. Its performance is inherent to its physical and chemical properties as a conductive gel.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth used for validating "Tech Dots - Conductive gel" is based on:

• Performance Standards: Recognized international and national standards for medical devices and electroconductive media (e.g., ISO 10993 for biocompatibility, ANSI/AAMIEC12 for electrical performance/impedance).
• Predicate Device Characteristics: The established characteristics and cleared performance of the legally marketed predicate device (Electro-Gel, K111717) serve as a comparative ground truth for demonstrating substantial equivalence of intended use and technological characteristics.
• Defined Chemical and Physical Specifications: Internal specifications for pH, conductivity, viscosity, appearance, etc., which are then verified through laboratory testing.

8. The Sample Size for the Training Set

Not applicable. This is not an AI device that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI model, there is no ground truth established for it.

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IOM Stimulator Probes are used by the surgeon as the medium to deliver electrical stimulation to tissue during intraoperative neurological monitoring, to identify nerves and spinal nerve roots and to assess nerve function. IOM Stimulator Probes disposable surgical stimulators are indicated for tissue dissection and stimulation of cranial and peripheral nerves for location and identification during surgery, including spinal nerve roots.

IOM Stimulator Probes are used by the surgeon as the medium to deliver electrical stimulation to tissue during intraoperative neurological monitoring, to identify nerves and spinal nerve roots and to assess nerve function. The probes are supplied sterile and are for single use only. The probes are connected to an electrical stimulator using a flexible lead wire(s) and a 'touch-proof' safety connector(s) on the distal end.

All IOM Stimulator Probes are sterilized by Ethylene Oxide and single use only.

The IOM Stimulator Probes are composed by the part in contact with the patient that is medical grade stainless steels, then there is the handle part and cable in biocompatible plastic; finally the cable has a 'touch-proof' safety connectors.

The provided document is a 510(k) summary for the "IOM Stimulator Probes" and describes a comparison study against predicate devices to establish substantial equivalence. It does not contain information about a study that proves the device meets specific acceptance criteria in the manner typically associated with clinical performance or algorithm evaluation (e.g., sensitivity, specificity, accuracy). Instead, it focuses on demonstrating that the device has similar technological characteristics to legally marketed predicate devices, and that differences do not raise new questions of safety or effectiveness.

Therefore, many of the requested details, such as sample size for test sets, data provenance, expert ground truth, MRMC studies, standalone performance, and training set information, are not applicable to the type of study presented in this document.

Here's an analysis of what is available in the document related to acceptance criteria and the "study" (which is a comparison for substantial equivalence):

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

The document doesn't explicitly state "acceptance criteria" for performance metrics like sensitivity or specificity. Instead, the acceptance criterion for regulatory clearance is establishing substantial equivalence to predicate devices in terms of intended use, technological characteristics, and safety/effectiveness. The "reported device performance" is demonstrated through a comparison of technological characteristics with predicate devices.

The document provides multiple comparison tables, one for each type of IOM Stimulator Probe. Below is a summarized example for one probe type, to illustrate how the comparison functions as "performance" in this context.

Table: Comparison of IOM Stimulator Probes (Example for Neural stimulator probe insulated monopolar)

The document includes similar comparison tables for:

• Neural stimulator probe bipolar hook (compared to Xian Friendship Medical Electronics)
• Neural stimulator probe tripolar hook (compared to Xian Friendship Medical Electronics)
• Neural stimulator probe monopolar ball (compared to Xian Friendship Medical Electronics)
• Neural stimulator probe bipolar balls (compared to Xian Friendship Medical Electronics)
• Neural stimulator probe bipolar concentric (compared to Xian Friendship Medical Electronics)
• Neural stimulator probe bipolar minifork (compared to Medtronic)

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

This information is not applicable and not provided. The "study" here is a comparison of product specifications and characteristics against predicate devices, not a clinical study involving patients or a performance evaluation against a labeled dataset. There is no "test set" in the context of clinical data or algorithm performance.

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. As above, there is no "test set" requiring expert ground truth in this type of submission.

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

This information is not applicable and not provided.

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 and not provided. This device is a surgical stimulator probe, not an AI-powered diagnostic or assistive tool.

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

This information is not applicable and not provided. This device is a passive surgical instrument.

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

This information is not applicable and not provided. The "ground truth" equivalent would be the established specifications and performance of the legally marketed predicate devices, against which the new device's specifications are compared.

8. The sample size for the training set

This information is not applicable and not provided. This device does not involve machine learning or a "training set."

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

This information is not applicable and not provided.

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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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The Dragonfly Laryngeal Surface Electrode is intended to be used as disposable, self-adhesive electrode attached to an endotracheal tube and positioned for continuous EMG monitoring of the larynx during surgical procedures. It is intended for use only by a licensed physician and in conjunction with these listed below medical grade electromyographic monitors: Neurovision Medical Products Nerveana Axon Eclipse Medtronic - NIM XLTEK EP Works Nicolet Viking Cadwell Cascade Neurosign Avalanche

Spes Medica Dragonfly Laryngeal Surface Electrode are single used electrodes for evoked EMG monitoring of the larynx and it to be inserted and retained in position against the larvngeal muscle by use of an endotracheal tube. The Electrodes are intended to be used as disposable, self-adhesive electrodes attached to an endotracheal tube and positioned for continuous EMG monitoring of the larynx during surgical procedures. Spes Medica produces two different families of electrodes: Family A and Family B. The family A and B mentioned above are the same product because, have been developed with same intended use, design, materials, packaging and other technological characteristics. The manufacturing processes are the same for both configurations (Family A and Family B) but the substrates and the shape of the electrodes are different. Indeed, for the family A the substrate for the Silver ink is a polyester film and for the family B the substrate for the Silver ink is carbon loaded vinyl. Furthermore, both families use the same connection to the EMG unit.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) premarket notification for the "Dragonfly Laryngeal Surface Electrodes," focusing on demonstrating substantial equivalence to previously marketed devices. It describes the device, its intended use, and compares it to predicate devices but does not include details on specific performance metrics, clinical study designs, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot fulfill your request to provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance for the test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance study details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How training set ground truth was established.

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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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