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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 System is indicated for use in both open and percutaneous (MIS) surgical approaches to the spine. PediGuard is also indicated for use with fluoroscopic guidance in percutaneous (MIS) surgical approaches to the spine.

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® modular and single-piece devices are single use, devices composed of stainless steel and plastic, and are provided sterile. The PediGuard devices consist of a handle containing the electronics and a stainless steel shaft with distal sensor for measuring electrical impedance of the tissues immediately in contact with the sensor during use. The devices produce visual and audible signals to indicate changes in impedance associated with possible vertebral perforation.

All PediGuard® models provide real-time visual and auditory feedback to the surgeon during the preparation of the pedicle screw pilot holes, sounding an alert when the tip of the sensor senses a change in the impedance of the surrounding tissues, which may indicate that the tip is in contact with soft tissues and a possible vertebral cortex perforation.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the PediGuard device:

Important Note: The provided document is a 510(k) summary for a medical device (PediGuard). 510(k) submissions typically focus on demonstrating "substantial equivalence" to a predicate device, rather than strictly defining and proving specific acceptance criteria in the same way a de novo or PMA submission might. Therefore, the "acceptance criteria" here are largely implied by the performance of the predicate device and the new device's ability to achieve similar or improved results in specific tests. Direct, quantified "acceptance criteria" for each performance metric are not explicitly stated in a dedicated table format within this document.

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, explicit quantitative acceptance criteria are not presented in a table. However, we can infer the targets based on the comparison to the predicate device and the results of the cadaver and clinical studies.

• No new issues of safety compared to the predicate device.
• Device cannot be turned off until battery exhausted (safety feature).
• Single-use. | - Conforms to ASTM F138-08, ASTM F899-1, IEC 60601-1, IEC 60601-1-4, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 11135-1, ISO 10993-7, ISO 11737-1, ISO 11737-2, ISO 11607-1, ISO 11607-2, ASTM F88, ASTM F1929, ASTM F1980, ASTM D4169.
• The 120mm length device is identical in all aspects (materials, electronics, connectors and dimensions) to the cleared 160mm Cannulated PediGuard, with the exception of being shorter. These minor technological changes raise no new issues of safety or effectiveness.
• Device cannot be turned off until battery exhausted. Prevents reuse of device.
• Single-use. |
  | Effectiveness (Screw Breach) | Improved or equivalent performance in reducing pedicle screw breach compared to Jamshidi needle (cadaver study). | 60% reduction in screw breach when using the Cannulated PediGuard over use of the Jamshidi needle (cadaver study). |
  | Effectiveness (Fluoroscopy Use) | Improved or equivalent performance in reducing fluoroscopy shots compared to Jamshidi needle (cadaver study). | 86.8% reduction of total fluoroscopy shots when using the Cannulated PediGuard over use of the Jamshidi needle (cadaver study). |
  | Effectiveness (Optimal Placement) | No difference or improved optimal screw placement when using PediGuard in both open and MIS surgery compared to predicate (clinical study - implied, or standard of care if predicate wasn't directly compared). | No difference in optimal screw placement when using the PediGuard in either open or MIS surgery (clinical study). This suggests it is at least equivalent to standard practice. |
  | Functional Equivalence/Features | Same intended use, similar indications for use, and technological characteristics as the predicate PediGuard. | The PediGuard is identical with the corresponding predicate models, with one technological difference: introduction of a shorter 120mm Cannulated PediGuard (otherwise identical). The device provides real-time visual and auditory feedback to the surgeon, indicating impedance changes for possible vertebral cortex perforation and EMG surveillance for spinal nerves. |

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

• Cadaver Trial:
  • Sample Size: Not explicitly stated as a number of cadavers or pedicle screws. It states "a cadaver trial in which thoracolumbar pedicle screws were placed at T10-L5 level in cadavers." This implies multiple screws per cadaver.
  • Data Provenance: Not explicitly stated (e.g., country of origin). The study is retrospective in method as the data was collected after the procedures, but the experiment itself (placing screws) would be prospective/controlled.
• Clinical Study:
  • Sample Size: Not explicitly stated. It mentions "a clinical study of PediGuard in both open posterior pedicle screw fixation (PPSF) procedures and MIS posterior spine arthrodesis procedures."
  • Data Provenance: Not explicitly stated (e.g., country of origin, specific institutions). The nature of a "clinical study" implies human subjects in a real-world surgical setting. It's likely prospective if designed to assess the PediGuard's performance.

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

The document does not provide details on the number or qualifications of experts used to establish ground truth for either the cadaver or clinical studies. In spine screw placement studies, "ground truth" for screw breach is typically established by post-placement imaging (e.g., CT scan) reviewed by a radiologist or surgeon, or direct dissection in cadaver studies. For optimal screw placement, similar methods or direct surgical assessment could be used.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, as typically applied to image reading algorithms, was not done. This device is an intraoperative tool providing real-time feedback, not an imaging diagnostic tool where multiple readers interpret cases.

However, a comparative effectiveness study was done in the sense that the PediGuard's performance was compared against a traditional method (Jamshidi needle) in one outcome (reduction in screw breach and fluoroscopy shots).

• Effect Size of human readers improvement with AI (PediGuard) vs without AI assistance: Not applicable in the typical MRMC sense. The PediGuard is the "AI assistance" (or rather, the intelligent feedback system) for the surgeon.
  • Effect vs. Jamshidi Needle:
    • Reduction in screw breach: 60%
    • Reduction in total fluoroscopy shots: 86.8%

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

The device's function is inherently "human-in-the-loop." It provides visual and audible alerts to the surgeon who then uses this information to guide their actions. Therefore, a standalone (algorithm only) performance study would not be relevant or possible given the device's intended use. The performance data is the human-in-the-loop performance.

7. The Type of Ground Truth Used

• Cadaver Trial: "Screw breach" and "total fluoroscopy shots." The ground truth for screw breach would typically be determined by post-insertion CT imaging or direct dissection, and fluoroscopy shots are objective counts.
• Clinical Study: "Optimal screw placement." The ground truth for "optimal screw placement" would likely be determined by post-operative imaging (e.g., CT scans) interpreted against established criteria, possibly with expert consensus.

8. The Sample Size for the Training Set

The document does not mention any "training set." This type of device relies on established physical principles (electrical impedance changes) and real-time sensing, not on a machine learning model that requires a distinct training set in the typical AI/ML sense. The feedback system is presumably pre-calibrated and validated based on biophysical properties, not trained on a dataset of cases.

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

Since no training set is mentioned or implied for this device, this question is not applicable.

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