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Delphi stimulator is a Magnetic stimulator used for Magnetic stimulation of peripheral nerves for diagnostic purposes. Magnetic stimulation is a non-invasive technique for stimulating neural tissue. Application areas of magnetic stimulation are a sub-set of the application areas for current stimulation. The Delphi stimulator is connected to a Magnetic Coil which transfers the magnetic stimulation to the tissue.

The stimulator consists of power electronics to generate the magnetic field in the Magnetic Coil. It is controlled via a user interface installed on a PC workstation connected to the stimulator. enabling the operator to overview all functions, stimulus sequences, controls, status and measured data. The magnetic pulse is Biphasic waveform and the stimulator can stimulate with a frequency of up to 3 pulses per second (pps).

AI/ML Overview

The provided text does not contain information about acceptance criteria and a study that proves the device meets those criteria in the format requested. The document is an FDA 510(k) summary for the "Delphi Stimulator," which focuses on demonstrating substantial equivalence to a predicate device.

The "Performance Data" section (Section 10) lists various tests performed, but these are primarily bench tests for substantial equivalence, electrical safety, EMC, and software validation. It does not present specific acceptance criteria (e.g., minimum sensitivity or specificity targets) or a clinical study with human subjects to evaluate the device's diagnostic performance against such criteria.

The information provided is as follows:

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

No explicit table of acceptance criteria with corresponding device performance for diagnostic accuracy (e.g., sensitivity, specificity) is provided.
The document mentions "Stimulation output comparison to Predicate" where the results "demonstrated substantial equivalency." This is a comparison for substantial equivalence, not a performance metric against a set acceptance criterion.

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

Not applicable. No clinical test set involving patient data is described. The performance data refers to nonclinical bench tests.

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

Not applicable. No clinical test set requiring expert-established ground truth is described.

4. Adjudication method for the test set:

Not applicable. No clinical test set requiring adjudication is described.

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 device is a stimulator for diagnostic purposes, not an AI-powered diagnostic system that assists human readers.

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

Not applicable. This device is a stimulator, not an algorithm.

7. The type of ground truth used:

Not applicable. For the bench tests performed, the "ground truth" would be the expected electrical and magnetic outputs, and adherence to safety and software standards, which were verified directly rather than against a clinical ground truth.

8. The sample size for the training set:

Not applicable. This document describes a medical device, a stimulator, not a machine learning or AI model that requires a training set.

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

Not applicable. As above, this document does not refer to a machine learning or AI model.

Summary of available "Performance Data" from the document:

Test	Test Method Summary	Results
Stimulator Output Comparison to Predicate	Stimulation output was measured in SMT units (Electrical field) and compared to the predicate (per FDA Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems)	The obtained results demonstrated substantial equivalency
System verification testing	The device was operated at various intensities to verify it functions as intended	No failures were observed; test passed.
ASCA test for basic safety and essential performance	Testing per IEC 60601-1 and IEC 60601-1-2	Pass
Software testing	Software testing per the requirement of the software life cycle as defined in IEC 62304:2006 Amendment 2015 - Medical device software - Software life cycle processes.	Pass
Cybersecurity assessment	Evaluation of threat per: - FDA Guidance, Post-market Management of Cybersecurity in Medical Devices - FDA Guidance, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. - AAMI TIR57:2016 Principles for Medical Device Security-Risk Management - FDA Guidance, Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act	No vulnerabilities were found; labeling includes all required elements addressing cybersecurity

In conclusion, the document describes non-clinical bench tests and adherence to safety and software standards to support the substantial equivalence claim, rather than a clinical study evaluating diagnostic performance against specific acceptance criteria.

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