Search Results

PediGuard and PediGuard Cannulated systems:

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 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.

PediGuard Threaded System:

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

DSG Zavation screw system:

The Zavation Screw System is indicated for use with the Zavation Spinal System during pedicle screw insertion to provide feedback to the surgeon via visual and audible alerts that indicate a change in impedance at the tip of the pedicle screw and may indicate contact of the tip with soft tissues and possible vertebral cortex perforation. The Zavation Screw System is indicated for use in both open and percutaneous (MIS) surgical approaches to the spine, with options of direct insertion of the screw in bone or after a step of preparation of the pilot hole with sensor equipped instruments.

The DSG Connect technology is a pedicle screw system used for bone drilling procedure during open or minimally invasive spinal fusion. The devices provide visual and audible alerts to a surgeon to indicate a change in electrical conductivity at the tip of the probe that may indicate contact of the tip with soft tissues. The DSG Connect Technology provides the user with an optional visual graphical presentation of the electrical conductivity information communicated by the DSG Connect devices to a tablet, with the App providing a visual representation of the audio signal emitted by the device handle. The App allows for display and recording of the signal, including graphing of changes in the audio signal over time.

The DSG Connect technology is incorporated in to the handles of the Cannulated PediGuard Threaded system, and DSG Zavation screw system.

The provided text describes the 510(k) submission for the "DSG Connect Technology" and details its performance evaluation. However, it does not contain a table of acceptance criteria or specific detailed reported device performance against those criteria in a quantitative manner. Instead, it lists various tests performed to demonstrate safety and effectiveness for a device that provides visual and audible alerts based on impedance changes during pedicle screw insertion, and optionally displays this data on a tablet.

Therefore, for the aspects that require specific quantitative acceptance criteria or detailed study results (points 1, 5), the information is not present in the provided document. For other points, I will extract what is available.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance

1. A table of acceptance criteria and the reported device performance

Information Not Provided: The document does not present a table with quantitative acceptance criteria (e.g., specific thresholds for accuracy, sensitivity, specificity) and corresponding numerical performance results. Instead, it lists categories of tests performed and their general purpose ("Verify that X is Y" or "Ensure Z").

Based on the "Performance Data" section (Page 6-7), here's a summary of the types of tests mentioned, which implies the acceptance criteria would be for the device to meet these verified specifications:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: The document does not specify a numerical sample size for the "test set" in the context of clinical performance. The "System Evaluation" mentions "surgeon in a pig lab," which indicates animal testing, but not a human clinical test set.
• Data Provenance: The "pig lab" study details are not provided, so country of origin or retrospective/prospective nature is unknown. Given it's a 510(k) for a device already on the market (with previous versions), the focus seems to be on demonstrating equivalence through non-clinical performance and a limited system validation. This is typical for a 510(k) for a modified device.

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)

Information Not Provided: The text mentions "System design validation by surgeon in a pig lab" but does not specify the number of surgeons or their qualifications for establishing any "ground truth" for a test set. This device relies on real-time impedance feedback, not pre-existing data (like images) that would require expert annotation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Information Not Provided: No adjudication method is mentioned, which aligns with the absence of specific clinical "test set" ground truth establishment by multiple experts.

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

Information Not Provided: The device, "DSG Connect Technology," is a nerve stimulator/locator that provides real-time feedback (visual and audible alerts, and optional graphical display on a tablet) during pedicle screw insertion. It is not an AI-assisted diagnostic imaging device that would typically undergo an MRMC study for human reader performance improvement. Its function is to provide direct intraoperative guidance, not to assist in interpreting complex medical images.

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

Information Provided (Implicitly): The device functions primarily as a standalone measurement tool, providing real-time electrical conductivity information. The "Output signal evaluation" test ("Verify that the output signal of the modified device... is equivalent to the predicate device for similar conductivity levels") suggests a standalone evaluation of its core electrical performance. The wireless communication and app display are enhancements for presenting this standalone data. The device's "alerts" are an automated output of its algorithm.

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

For a device that measures impedance to indicate potential contact with soft tissues or cortex perforation during surgery, the "ground truth" would generally be:

• Physical measurement/calibration: For tests like "Pulse output" and "Output signal evaluation," the ground truth is often established by known electrical properties of test media or by comparison to a validated predicate device.
• Direct observation during animal/cadaveric studies: For tests like "System Evaluation (surgeon in a pig lab)," the "ground truth" for successful or problematic screw placement would be based on direct anatomical observation, post-procedure imaging, or direct nerve stimulation responses.
• Design specifications/standards: For safety, mechanical, and software verification tests, the "ground truth" is adherence to predefined engineering specifications, regulatory standards (like IEC 60601-1/-2), and functional requirements.

The document does not explicitly state the ground truth establishment method for each test, but inferring from the test descriptions, it would be a combination of these.

8. The sample size for the training set

Information Not Applicable/Provided: This device does not appear to be based on a machine learning model that would require a "training set" in the typical sense of AI/ML software (i.e., learning from vast amounts of data). It is a device that provides feedback based on direct electrical impedance measurements and established physiological responses to electrical stimulation.

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

Information Not Applicable/Provided: As this is not an AI/ML device requiring a training set, this question is not relevant.

Ask a specific question about this device

The DSG™ Zavation Screw System is indicated for use with the Zavation Spinal System during pedicle screw insertion to provide feedback to the surgeon via visual and audible alerts that indicate a change in impedance at the tip of the pedicle screw and may indicate contact of the tip with soft tissues and possible vertebral cortex perforation. The DSG™ Zavation Screw System is indicated for use in both open and percutaneous (MIS) surgical approaches to the spine, with options of direct insertion of the screw in bone or after a step of preparation of the pilot hole with sensor equipped instruments.

The DSG™ Zavation Screw System is a modification to the cleared DSG™ Threaded Drill System and consists of the DSG™ Electronic T-handle, Ratcheting Handle, DSG™ Pin (active stylet), and the previously cleared Zavation Spinal System (K153404). These components are purchased and shipped as a complete system from Zavation, with the DSG™ Threaded Drill System components and Zavation Spinal System components individually packaged. The complete system is provided with the modified instructions for use of the DSG™ Zavation Screw System.

All of the patient-contacting materials are categorized per FDA's guidance on ISO 10993-1 as externally communicating materials that are in contact with the body for a limited duration, and are unchanged from the prior clearance. Certain components of the device are single-use while others are re-usable; certain components are provided sterile while others are sterilized by the end user.

The device is intended for use by surgeons in a professional healthcare environment, and utilizes sensing technology to detect the impediately surrounding tissues while inserting pedicle screws either through a previously drilled pilot hole or directly into bone. The surgeon can either drill and/or tap the screw hole prior to inserting the pedicle screw, or can use the system to directly insert the screw into the bone without a pilot hole. As the screw is manually advanced into the bone, the distal sensor measures the electrical impedance of the immediately surrounding tissues. The device produces real-time visual and audible signals to indicate changes in impedance associated with possible vertebral perforation.

The provided text describes the 510(k) summary for the SpineGuard DSG™ Zavation Screw System. It outlines the device, its intended use, and comparative information with a predicate device. However, it does not detail specific acceptance criteria with numerical targets or a comprehensive study plan with the level of detail requested for AI/device performance.

Based on the information provided, here's what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance:

The document describes "performance testing" but does not define explicit acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy, or a specific range of values for mechanical properties). Instead, it states that "All tests were passed, demonstrating equivalent performance according to device specifications and thus supporting substantial equivalence." The tests are:

Missing Information: Specific quantitative acceptance criteria (e.g., "placement accuracy within X mm" for cadaver testing, or specific thresholds for mechanical integrity). The "Pass" result indicates that the device met internal specifications, but these specifications are not detailed in the provided text.

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

• Test Set Sample Size: Not specified for any of the performance tests. For "Cadaver Testing," the sample size (number of cadavers, or number of pedicle screws inserted) is not mentioned. For "Mechanical Testing," the number of units tested is also not specified.
• Data Provenance: Not specified. It's unclear if the cadaver testing was performed in the US or another country. The document notes the sponsor is in France.
• Retrospective or Prospective: Not explicitly stated, though cadaver testing would typically be considered prospective for the device evaluation.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. For cadaver testing, it would likely involve surgeons, but their number and experience are not mentioned.

4. Adjudication method for the test set:

• Adjudication Method: Not specified. If multiple experts were involved (which is not stated), the method for resolving discrepancies (e.g., 2+1, 3+1, none) is not 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 device is not an AI/ML-driven diagnostic or image analysis tool for "human readers." It's a surgical guidance system providing real-time feedback (visual and audible alerts) based on impedance measurements during pedicle screw insertion. Therefore, an MRMC study related to human readers improving with AI assistance is not applicable to this device. The "feedback to the surgeon" is a direct function for intraoperative guidance, not a tool for interpreting images or data that human "readers" would then review.

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" as it provides feedback to the surgeon. It's not a standalone diagnostic algorithm. The "performance data" describes the device's accuracy and integrity when used by a human. So, a standalone algorithm performance without human involvement is not applicable in the AI sense. Its "standalone" performance would be about the accuracy of its impedance detection, which is implicitly covered by the "Pass" results in the cadaver and mechanical testing.

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

• Cadaver Testing: The "placement accuracy" implies that the true anatomical position and any perforations would be verified (e.g., radiography, CT scan, or direct visual inspection post-dissection), which would serve as the ground truth. However, the specific method for establishing this ground truth is not detailed.
• Mechanical Testing: Ground truth would be based on engineering specifications and measurements (e.g., force, torque, displacement thresholds).

8. The sample size for the training set:

This device does not appear to be an AI/ML device that requires a distinct "training set" in the context of machine learning. Its operation is based on pre-programmed impedance thresholds for tissue differentiation. Therefore, this question is not applicable in the context of the provided information.

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

As there's no mention of a "training set" in the context of an AI/ML algorithm, this question is also not applicable. The device's impedance thresholds would likely be established through prior research and experimentation on tissue types, rather than a "training set" with established ground truth labels in the machine learning sense.

Ask a specific question about this device

The DSG™ Threaded Drill System is intended to be used for the preparation of pedicle screw holes. The DSG™ Threaded Drill System 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 DSG™ Threaded Drill System is indicated for use in both open and percutaneous (MIS) surgical approaches to the spine. The DSG™ Threaded Drill System is also indicated for use with fluoroscopic guidance in percutaneous (MIS) surgical approaches to the spine.

The DSG™ Threaded Drill System 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 DSG™ Threaded Drill System is designed to prepare pedicle screw holes. The sensor at the distal 3mm of the shaft detects the electrical impedance of the tissue immediately surrounding the sensor and provides real-time audio and visual information to the surgeon to assist the surgeon to determine the relative density of the tissue at the tip of the shaft. A skilled surgeon can interpret the varying pitch and cadence of the feedback to determine potential breaches of the cortical wall. The first 6mm at the instrument are very similar to the cleared PediGuard models, with a pointy awl type design to penetrate the bone. After that, a threaded portion of 25mm in length, featuring cutting flutes, allows for an easy insertion in bone. The threads allow for a smooth and progressive penetration in bone that results in steady and consistent readings of the impedance of the tissue, making the determination of potential breaches of the cortical wall easy for the surgeon.

The provided text describes the SpineGuard DSG™ Threaded Drill System (K152747) which is a modification to a previously cleared device, the PediGuard System (K143159). The document focuses on demonstrating substantial equivalence to the predicate device rather than presenting a standalone study with specific acceptance criteria for performance metrics like sensitivity and specificity. Instead, the "acceptance criteria" are implied by the demonstration of equivalence to the predicate device in terms of technological characteristics and performance tests.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission demonstrating substantial equivalence to a predicate device, the "acceptance criteria" aren't explicitly stated as quantitative targets (e.g., sensitivity > X%). Instead, the acceptance criteria are met by demonstrating that the new device's performance is equivalent to the predicate device, particularly in areas that could be impacted by the device modifications.

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

The document does not provide details on the sample size used for performance testing (e.g., number of shafts tested for bending, number of trials for detection performance) or the specific data provenance (e.g., country of origin, retrospective/prospective). The studies mentioned ("tested mechanically," "demonstrated to be equivalent," "device durability was tested") appear to be bench or lab-based tests confirming feature equivalency and safety, not clinical studies with patient data.

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

Not applicable. The document describes performance tests related to mechanical properties, detection equivalency, durability, cleaning, and sterilization, which do not typically involve human expert interpretation for "ground truth" in the way clinical diagnostic or AI performance studies would. The device provides "feedback to the surgeon via visual and audible alerts," and a "skilled surgeon can interpret the varying pitch and cadence of the feedback," but the 510(k) submission focuses on the device's functional equivalence, not a study of surgeon performance metrics.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the performance tests described are not clinical studies requiring adjudication of outcomes or diagnoses.

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

No MRMC comparative effectiveness study is described in the provided text. The device is a surgical tool that provides real-time feedback, not an AI diagnostic tool for human readers.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

The device is inherently "human-in-the-loop," as its function is to provide real-time feedback to a surgeon during a procedure for their interpretation. Therefore, a standalone (algorithm only) performance assessment without human input would not be relevant or possible in its intended use context. The "detection performance" discussed relates to the sensor's ability to identify impedance changes, which is a standalone technical characteristic, but its clinical utility is always in conjunction with a surgeon.

7. The Type of Ground Truth Used

For the specific performance tests mentioned:

• Mechanical performance (bending tests): Ground truth would be defined by engineering specifications and physical measurements.
• Detection performance: Ground truth would be the known electrical impedance properties of different tissues or the physical presence of soft tissue/vertebral cortex perforation as confirmed by other means (e.g., direct observation in a test setup or anatomical models).
• Durability, cleaning, sterilization: Ground truth is established by relevant industry standards and test methodologies (e.g., sterility testing, material degradation analysis).

8. The Sample Size for the Training Set

Not applicable. The device described is a physical surgical instrument with sensors, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its "performance" is based on its physical and electrical characteristics as designed and manufactured, not on learning from a dataset.

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

Not applicable, as there is no "training set" for this type of device.

Ask a specific question about this device

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.

Ask a specific question about this device

The PediGuard® 2.5mm XS (model P1-AU414), PediGuard® Curv XS (model P1-AU451) and Cannulated PediGuard® Needle#2 (model P2ND1002) are 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® 2.5mm XS and PediGuard® Curv XS are single use, single piece devices composed of stainless steel and plastic that are provided sterile, and 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 product visual and audible signal to indicate changes in impedance associated with possible vertebral perforation.

The Cannulated PediGuard® Needle #2 is the needle part of a single-use modular device provided sterile, consisting of a handle containing the electronics, a stainless steel cannulated outer shaft and a stainless steel inner sensor needle for measuring electrical impedance of the tissues immediately in contact with the sensor during use.

PediGuard® 2.5mm XS (model P1-AU414), PediGuard® Curv XS (model P1-AU451) and Cannulated PediGuard® Needle#2 (model P2ND1002) provide realtime 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.

The provided text describes different models of SpineGuard's PediGuard devices and their substantial equivalence to a predicate device, the PediGuard Nerve Detector (K030526). This submission is for a 510(k) premarket notification, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies to establish new safety and effectiveness criteria.

For this type of submission, "acceptance criteria" are usually based on meeting established standards (e.g., ISO, ASTM, IEC) and demonstrating comparable performance to the predicate device in specific technical and functional aspects, rather than clinical efficacy metrics like sensitivity or specificity. The "study" here refers to the various verification and validation tests performed.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance for SpineGuard PediGuard Devices

The acceptance criteria for the PediGuard® 2.5mm XS, PediGuard® Curv XS, and Cannulated PediGuard® Needle#2 are primarily based on demonstrating substantial equivalence to their predicate device, the SpineGuard S.A., PediGuard Nerve Detector (K030526). This involves meeting relevant industry standards and showing comparable performance in key areas.

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are implicitly defined by compliance with recognized standards and demonstration of performance comparable to the predicate device. The device performance listed below demonstrates this equivalence.

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

• Test Set Sample Size: The document does not specify a distinct "test set" sample size in terms of clinical cases or patient data, as this is a 510(k) submission primarily relying on design verification and validation (bench testing, material compliance) rather than a clinical trial with a patient cohort. The testing involved various quantities of the devices themselves for mechanical, electrical, and biocompatibility evaluations. For "Surgeon testing," the number of surgeons or cases is not specified.
• Data Provenance: The studies are primarily in-house design verification and validation activities conducted by SpineGuard or contracted laboratories.
  • Country of Origin: France (SpineGuard, S.A. is located in Saint Mande, France).
  • Retrospective or Prospective: These are laboratory and bench tests, not clinical studies. Therefore, the terms "retrospective" or "prospective" as applied to patient data do not directly apply. They are prospective tests conducted on the devices as part of their development and regulatory submission.

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

• This information is not provided in a way that aligns with establishing ground truth for a clinical test set. The document refers to "Surgeon testing" but does not specify the number or qualifications of surgeons involved or how their input was used to establish a "ground truth." For biocompatibility, testing was conducted under 21 CFR, Part 58, Good Laboratory Practices, implying certified labs and personnel, but not "experts establishing ground truth" in a clinical sense.

4. Adjudication Method for the Test Set

• Not applicable in the context of this 510(k) submission, which focuses on device performance validation against engineering and safety standards, and equivalence to a predicate, rather than human expert adjudication of clinical outcomes or images.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement with AI vs. Without AI Assistance

• No MRMC or comparative effectiveness study involving human readers or AI assistance was mentioned or conducted, as this device (PediGuard) is a surgical tool providing real-time feedback, not an imaging or diagnostic AI system.

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

• The device explicitly provides "real-time visual and auditory feedback to the surgeon." The "impedance detection algorithm is identical" to the predicate. The device is designed to be used with a human surgeon in the loop. Therefore, a standalone algorithm-only performance assessment in the absence of human interaction (as understood in AI/imaging contexts) is not relevant or described. The firmware of the device, which contains the algorithm, underwent verification and validation.

7. The Type of Ground Truth Used

• The "ground truth" for this submission is based on engineering and performance standards, and comparison to the predicate device.
  • Biocompatibility: Based on established biological response criteria (e.g., absence of cytotoxicity, irritation, sensitization, systemic toxicity) as defined by ISO 10993 standards and tested in GLP-compliant laboratories.
  • Mechanical & Electrical Performance: Based on objective measurements against engineering specifications and direct comparability to the predicate device's measured performance (e.g., bending strength, electrical signal emission, impedance detection actability, audible signal volume).
  • Material Composition: Based on compliance with ASTM material standards.

8. The Sample Size for the Training Set

• Not applicable. This is not a machine learning or AI algorithm in the contemporary sense requiring a "training set" of data to learn from. The impedance detection algorithm is stated to be "identical" to the predicate and is based on established principles of electrical impedance measurement. The firmware itself was subject to verification and validation, but this does not involve a "training set" as understood in AI.

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

• Not applicable, as there is no "training set" for the type of device and submission described.

Ask a specific question about this device