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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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Cadwell Disposable Stimulator Probe is used to perform localized stimulation of neural tissue and to locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery. The Cadwell Disposable Stimulator Probe is a single patient use device.

Cadwell Disposable Stimulator Probes come sterilized in three electrical configurations and multiple lengths to accommodate stimulating through cannulas during minimally invasive surgeries: Disposable Concentric Probes -Localized stimulation due to coaxial nature of active and reference electrodes. Tip diameter approx 1mm. Particularly useful when working with a microscope. Disposable Concentric Probes may be bent by user to facilitate viewing access under a microscope. Disposable Bipolar Probes -Both active and return electrode are built into the probe. Both tips of the Disposable Bipolar Probe must be in contact with tissue for stimulation current to flow. The Bipolar Probe will stimulate a small amount of tissue, more than Concentric Probes, but less than Monopolar probes. Disposable Bipolar Probes may be bent to facilitate viewing access under a microscope. Disposable Monopolar Probe -The Monopolar Probe has a single active electrode and must be used in conjunction with a remote return electrode connected to the patient. The Monopolar probe is insulated to the tip with only a stimulating "ball" or "tip" exposed. Disposable Monopolar Probes may be bent to facilitate viewing access under a microscope.

The information primarily discusses the substantial equivalence of Cadwell Disposable Stimulator Probes to predicate devices. It provides detailed comparisons of physical characteristics.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for a device that provides an output like a diagnostic algorithm. Instead, it defines "substantial equivalence" as the acceptance criterion, which is met by demonstrating that the Cadwell probes have similar physical and material characteristics to existing predicate devices.

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

The study is not a clinical trial or algorithm performance study with a "test set" in the traditional sense of AI/diagnostic device evaluation. It is a comparison of physical device specifications. Therefore, information about "sample size for the test set" and "data provenance" (country of origin, retrospective/prospective) is not applicable in this context. The "test" involved bench testing of the Cadwell probes themselves against the specifications of the predicate devices.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Ground truth in this context means the established specifications of the predicate devices. These specifications are likely derived from engineering designs and regulatory approvals, not from expert consensus on medical images or patient outcomes. Therefore, information about "number of experts" and their "qualifications" for establishing ground truth is not applicable.

4. Adjudication Method:

Since the study is a comparison of physical specifications rather than an interpretation task, an "adjudication method" (like 2+1 or 3+1) is not applicable. The comparison is against objective measurements and declared specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This study is focused on the physical characteristics and materials of a stimulator probe, not on the interpretative performance of human readers or AI algorithms. As such, there is no "effect size of how much human readers improve with AI vs without AI assistance" to report.

6. Standalone (Algorithm Only) Performance Study:

No, a standalone performance study was not done. This device is a physical medical instrument (a stimulator probe), not an AI algorithm or software device.

7. Type of Ground Truth Used:

The "ground truth" for this study is the established specifications and characteristics of legally marketed predicate devices as declared in their 510(k) notifications or product documentation, combined with bench testing measurements of the Cadwell device's physical attributes and functionality (like sterility). It is not expert consensus, pathology, or outcomes data, as this is a device for stimulation, not diagnosis.

8. Sample Size for the Training Set:

This concept is not applicable as the document describes the substantial equivalence of a physical medical device, not an AI model or algorithm that requires a training set.

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

This concept is not applicable for the same reason as point 8.

In summary, the provided document describes a 510(k) submission for substantial equivalence based on a comparison of physical device characteristics and materials, supported by bench testing and sterilization validation, rather than a performance study of a diagnostic algorithm or AI system.

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To locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery.

Stimulator probes are used as the medium to deliver electrical stimulation to tissue during intraoperative neurological monitoring. The probes are available in various monopolar and bipolar configurations according to the required application. 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. Monopolar electrodes require a separate stimulator return electrode. Stimulator probes are used by the surgeon to locate and identify motor nerves and spinal nerve roots and to assess nerve function. Bipolar probes may also be used to record nerve action potentials directly from the nerve. The probes are designed with a plastic handle and stainless steel active electrode shaft insulated to the tip. The probe shaft may be bent to allow viewing access under a microscope.

This submission pertains to Axon Systems' Disposable Stimulator Probes, which are devices used to deliver electrical stimulation to tissue during intraoperative neurological monitoring. The document provided is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance study results. As such, the requested information (acceptance criteria, specific performance metrics, sample sizes, expert qualifications, etc.) is not present in the provided text.

The 510(k) summary only states the following:

1. A table of acceptance criteria and the reported device performance: This information is not provided. The summary focuses on technological characteristics and substantial equivalence, not specific performance metrics against pre-defined acceptance criteria.

2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): No information on test set sample sizes or data provenance is available.

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 provided.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable and not mentioned, as there is no test set or ground truth establishment process 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: This is not applicable. The device described is a medical instrument (stimulator probe), not an AI diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, as there isn't a diagnostic algorithm undergoing validation against a ground truth.

8. The sample size for the training set: Not applicable and not mentioned.

9. How the ground truth for the training set was established: Not applicable and not mentioned.

Summary of the 510(k) Conclusion:

The document concludes that "Axon Systems' Disposable Stimulator Probes are substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised or evident." This equivalence is based on the description of technological characteristics, such as:

• Identical materials: "Materials used are the same as in the predicate devices."
• Similar design: Insulated probe shaft of various lengths mounted to a plastic handle, electrically connected to a "touch-proof" safety connector.
• Intended Use: "To locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery," which is presumably consistent with the predicate devices.

The predicate devices mentioned are:

• Technomed Europe - Disposable Probes (K050325)
• Xomed Surgical Products - Ball Tip Monopolar stimulating probe (K992869)

In essence, the "study" proving the device meets acceptance criteria in a 510(k) submission like this is primarily a demonstration of substantial equivalence to already cleared devices, rather than a de novo clinical trial with defined acceptance criteria and performance outcomes.

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