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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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