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The DS7A and DS7AH are stimulators intended for use during neurological monitoring and assessment in a clinical environment. They are intended for use by trained personnel either competent to apply appropriate stimuli or under the supervision and instruction of one who is.

The Digitimer DS7A Stimulator provides constant current high voltage pulses of brief duration for percutancous stimulation during investigation of the electrical activity of nerve and muscle tissue. The output current is continuously variable over the range 0 to 100 milliamps, from a source voltage continuously variable from less than 100 volts to 400 volts, to meet the requirements of human pathological cases. Short pulse durations have been made available to minimise any discomfort to the subject. The pulse width range can be varied from 50 microsconds to 2 milliscconds in six steps. A specially designed isolated output stage maintains a square (current) pulse shape while minimising stimulus artefacts. The Digitimer DS7AH Stimulator is a variant of the DS7A providing a higher maximum current at reduced pulse width. This option is offered to overcome the difficulty of stimulating deep peripheral nerves with large area electrode pads. The DS7AH option will provide a maximum stimulus current of 1 amp at up to 400 volts compliance at pulse widths up to 200 us.

The provided 510(k) summary for the DIGITIMER Ltd DS7A/DS7AH Constant Current High Voltage Stimulators does not contain the kind of performance data, study details, or acceptance criteria typically associated with AI/ML-driven medical devices that would require such granular information.

This device is a physical stimulator and its approval is based on substantial equivalence to a predicate device (Digitimer D185 Multipulse Cortical Stimulator, K020400), rather than a clinical study demonstrating AI model performance against acceptance criteria. The application focuses on technical specifications and safety standards directly comparable between the new device and its predicate.

Therefore, most of the requested information cannot be extracted from this document, as it describes a different type of regulatory submission and device.

Here's a breakdown of why and what little can be inferred:

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

• Acceptance Criteria: Not explicitly stated as performance metrics with thresholds in the context of an AI/ML model. For this type of device, acceptance criteria are generally related to electrical performance specifications, safety standards (e.g., EN 60601-1, EN 60601-1-2), and demonstrating that these meet or exceed the predicate device's capabilities without introducing new safety or effectiveness concerns. These are essentially the technical specifications and safety compliance.
• Reported Device Performance: The document provides a "Substantial Equivalence Comparison" table that lists parameters for the Predicate Device D185, DS7A, and DS7AH. The "performance" here is described by these specifications, such as stimulus output range, pulse width, compliance voltage, and safety features.

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

• Not applicable. This device is a hardware stimulator. Its performance is characterized by engineering and electrical testing, not by evaluating an algorithm on a dataset.

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)

• Not applicable. No ground truth in the context of expert review of data is established for this type of device. Performance is verified through technical compliance and physical testing.

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

• Not applicable.

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/ML device, and no MRMC study was conducted.

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

• Not applicable. This is a standalone hardware device, not an algorithm.

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

• The "ground truth" for this device's approval is its adherence to specified electrical
  parameters, safety standards (e.g., EN 60601-1 series), and a demonstration of substantial equivalence to a legally marketed predicate device (K020400). This involves engineering measurements and compliance testing, not clinical "ground truth" data for an algorithm.

8. The sample size for the training set

• Not applicable. There is no training set for a hardware stimulator.

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

• Not applicable.

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