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Delphi MCS Electrode Cap is an EEG electrode set intended for routine clinical settings where rapid placement of large number of EEG electrodes is desired.

The Delphi MCS Electrode Cap is made of elastic textile material, preserving the shape and size. The cap provides the exact position of the electrodes on the head without the need for additional measurements and adjustments. Large holes are provided for ventilation and access to the electrodes and patient's skin. The cap is fixed to the head with a chinstrap. The Cap is available in the following sizes: XL 60-66cm, XL/L 57-63cm, L 54-60cm, L/M 51-57cm, M 48-54cm. The textile caps sizes are identifiable by the color material or seam and marking according to international system 10-20.

The Ag/AgCl electrodes are designed to provide minimal polarization and long-term stability of the signal. The conductive surface of the electrodes which is housed inside the electrode base does not have direct skin contact; an electrically conductive substance (hydrogel) is used inside the electrode base for improved conductivity.

Delphi Cap electrodes are thin cup Ag/AgCl sintered electrode for EEG recording. The electrodes are designed for maximum comfort while the patient in a supine position. The design of this electrode is suitable for conducting combined TMS-EEG studies. The Ag/AgCl sintered electrode material guarantees minimum polarization and long-term signal stability, as well as an increased electrode life.

The provided text does not contain information about acceptance criteria for a device's performance, nor does it detail a study that proves a device meets such criteria in terms of clinical effectiveness or diagnostic accuracy. Instead, the document describes the substantial equivalence claim for a new medical device, the "Delphi MCS Electrode Cap," in comparison to a predicate device, the "Electro-Cap System."

The document primarily focuses on demonstrating that the new device shares the same intended use and similar technological characteristics as the predicate device, and that any differences do not raise new safety or effectiveness concerns.

Here's a breakdown of what is provided, and what is missing based on your request:

Information Present (related to device evaluation):

• Device Name: Delphi MCS Electrode Cap
• Intended Use: "Delphi MCS Electrode Cap is an EEG electrode set intended for routine clinical settings where rapid placement of large number of EEG electrodes is desired."
• Performance Data (Non-Clinical Bench Tests):
  • Biocompatibility: Cytotoxicity, Sensitization, Irritation (per ISO 10993 standards)
  • Electrical safety (per IEC 60601-1)
  • Use cycle reliability and durability testing (resistance, noise, impedance, durability, repeated cleaning cycles)
  • AC Impedance
  • Offset Voltage
  • Combined offset instability and internal noise
  • Bias current tolerance
  • Shelf Life
  • Conductive connection compliance
• Conclusion of Performance Tests: "The results of the performance bench testing support the safety profile of the device and demonstrate that the device functions as intended." (This indicates the device met some internal performance objectives for these bench tests, but specific acceptance criteria and detailed quantitative results are not provided.)

Missing Information (as per your request):

1. A table of acceptance criteria and the reported device performance: While non-clinical tests are listed, the specific acceptance criteria for each test (e.g., maximum allowed impedance, specific thresholds for cytotoxicity) and the quantitative reported performance of the Delphi MCS Electrode Cap against these criteria are not provided in this document. The document only states that the tests were "successful" and "support the safety profile" and "demonstrate that the device functions as intended."
2. Sample sized used for the test set and the data provenance: Not applicable to the type of non-clinical bench testing reported.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is bench testing, not a clinical study requiring expert ground truth for interpretation.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not mentioned. This type of study would be relevant for devices that involve human interpretation of output (e.g., AI for image diagnosis), which is not the primary function of an EEG electrode cap.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this device is an electrode cap, not an algorithm.
7. The type of ground truth used: Not explicitly stated for each bench test, but implied to be based on established standards and physical/electrical measurements.
8. The sample size for the training set: Not applicable, as this is a physical medical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided FDA 510(k) clearance letter and summary primarily address the safety and technical similarity of the Delphi MCS Electrode Cap to a predicate device through non-clinical bench testing. It does not detail specific acceptance criteria for clinical performance or diagnostic accuracy, nor does it describe a clinical study comparing its effectiveness or AI-assisted performance against human readers.

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The Delphi Stimulator is intended to be used for stimulation of peripheral nerves for diagnostic purposes.

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).

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:

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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