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The PediGuard is indicated for use during pedicle screw pilot hole drilling to provide feedback to the surgeon via visual and audible alerts that indicate a change in impedance at the tip of the probe and may indicate contact of the tip with soft tissues and possible vertebral cortex perforation. The PediGuard also is specifically indicated for use in intraoperative electromyographic ("EMG") surveillance to assist in the location and evaluation of spinal nerves during surgery of the spine, by administration of low voltage electrical energy to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves.

The PediGuard System is a hand held, battery operated bi-polar probe that is comprised of the following components: (1) a stainless steel shaft; (2) a hollow plastic handle; and (3) an electronic cartridge. Its components are manufactured from stainless steel and plastics according to ASTM and USP requirements.

The provided 510(k) summary for the PediGuard™ Nerve Detector System does not contain the detailed information necessary to complete most of the requested sections regarding acceptance criteria and study design.

Here's a breakdown of what can be inferred and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

• Specific numerical or statistical acceptance criteria (e.g., sensitivity, specificity, accuracy, signal-to-noise ratio, response time, threshold values for impedance change).
• Quantifiable results of the device's performance against any established criteria.

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

Missing Information:

• Sample Size: The document does not mention any specific test set, number of cases, or even the type of study (e.g., animal, cadaver, human).
• Data Provenance: Not mentioned. It's unclear if any data used for "testing" was retrospective or prospective, or the country of origin.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Missing Information:

• No mention of a "test set" in the context of expert review or ground truth establishment. Therefore, no information on the number or qualifications of experts.

4. Adjudication Method for the Test Set

Missing Information:

• Given the absence of a described test set with expert review, there is no information on any adjudication method.

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

Missing Information:

• The document does not indicate that an MRMC comparative effectiveness study was performed. It focuses on substantial equivalence to predicate devices, but not on human reader improvement with or without AI assistance. This device is a nerve stimulator, not an AI-powered diagnostic tool, so such a study would not typically be applicable.

6. Standalone Performance Study (Algorithm Only)

Missing Information:

• This device is a hardware probe with electronics for impedance sensing and electrical stimulation. It is not an "algorithm-only" device that would typically have a standalone performance study in the AI/software context. The "testing" mentioned is likely related to its functional performance and material equivalence, not an algorithm's diagnostic accuracy. No specific standalone performance study results are provided.

7. Type of Ground Truth Used

Missing Information:

• No specific ground truth establishment method (e.g., pathology, outcomes data, expert consensus) is described, as the detailed testing methodology is absent. The "testing for equivalence" likely relied on comparing electrical outputs or functional behaviors to predicate devices, rather than a diagnostic ground truth.

8. Sample Size for the Training Set

Missing Information:

• This device is not described as an AI/machine learning device that would typically have a "training set." Therefore, no information on training set sample size is provided.

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

Missing Information:

• As no training set is mentioned (see point 8), there is no information on how its ground truth was established.

Summary of what can be gleaned from the document:

The 510(k) summary focuses on establishing substantial equivalence to predicate devices based on:

• Similar design and materials: "components of the PediGuard Nerve Monitoring System are similar in design, material, and intended use to other nerve monitoring systems..."
• Intended use: The indications for use are similar to predicate devices.
• Functional testing for equivalence: "Testing was performed to demonstrate the equivalence of the construct design to currently marketed spinal systems." (No details about this testing are provided).
• Compliance with material standards: "Its components are manufactured from stainless steel and plastics according to ASTM and USP requirements."

The provided text is a high-level summary for regulatory filing, not a detailed scientific study report. It demonstrates that the device's fundamental design, materials, and intended functions are comparable to existing cleared devices, which is the cornerstone for 510(k) clearance.

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