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The Digitimer DS7AP Constant Current Stimulator is indicated for use as an adjunct in the treatment of high and low anorectal malformations by helping in the identification of the striated muscles to be used in anal reconstructions.

The DS7AP Constant Current Stimulator has been specially designed to meet the requirements of pediatric surgeons who need a reliable and easy to use muscle locating stimulator when carrying out the Peña, "Pull-through" or posterior sagittal anorectoplasty (PSARP) anorectal reconstruction technique.

The Digitimer DS7AP Constant Current Stimulator is indicated for use as an adjunct in the treatment of high and low anorectal malformations by helping in the identification of the striated muscles to be used in anal reconstructions.

Here's a breakdown of the acceptance criteria and supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance:

Notes on Acceptance and Performance:

The primary acceptance criteria for the DS7AP were related to demonstrating substantial equivalence to the predicate device (Radionics Pena Muscle Stimulator PS-1 - K980448) in terms of intended use, indications for use, and technological characteristics.

While there are differences in specific electrical output values (e.g., maximum output voltage and current, pulse width, pulse frequency), power source, and some safety features (automatic overload trip, compliance with 21 CFR 898), the manufacturer argued and the FDA determined that these differences do not raise different questions of safety or effectiveness. For instance, regarding the power source difference, the subject device's power supply is "identical to that of the Digitimer DS7A/AH Constant Current Stimulators, which are approved for marketing under number K051357."

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

• Sample Size: Not applicable. The submission states that no clinical tests were required for this submission. The evaluation was based on non-clinical testing and comparison of technological characteristics to a predicate device.
• Data Provenance: Not applicable for a test set as no clinical tests were performed.

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

• Not applicable as no clinical tests were conducted and thus no expert-established ground truth for a test set was established.

4. Adjudication method for the test set:

• Not applicable as no clinical tests were conducted.

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 constant current stimulator, not an AI-assisted diagnostic tool for human readers. No MRMC study was performed.

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

• Not applicable. This is a medical device (constant current stimulator), not an algorithm. Its function is to directly stimulate muscles, not to provide an output that requires standalone evaluation against a ground truth in the way an algorithm would.

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

• Not applicable. The substantial equivalence determination was based on non-clinical testing to national and international standards (e.g., EN 60601-1, IEC 60601-1-2, IEC 62366-1, ISO 14971, EN 60601-2-10) and a comparison of technological characteristics to a legally marketed predicate device.

8. The sample size for the training set:

• Not applicable as this is a medical device, not an AI/machine learning model that requires a training set.

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

• Not applicable as no training set was used.

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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.

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