(254 days)
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:
| Test Name | Description (Implied Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Autonomy test | Verify the autonomy of the modified electronics | Not explicitly stated, but implied to have passed. |
| Impaction, weight and cap resistance test | Verify the mechanical resistance of the plastic casing with the modified inner geometry | Not explicitly stated, but implied to have passed. |
| Low-battery mode verification and re-usage prevention | Verify the correct implementation of the low battery detection and the reusage prevention feature in the modified electronics / embedded software | Not explicitly stated, but implied to have passed. |
| Pulse output | Verify that the electrical pulse is sent within the specifications in terms of duration / frequency / intensity | Not explicitly stated, but implied to have passed. |
| Output signal evaluation | Verify that the output signal of the modified device (modified electronics / embedded software) is equivalent to the predicate device for similar conductivity levels | Not explicitly stated, but implied to have passed. |
| Sound evaluation | Verify that the sound volume of the modified device (using a buzzer) is at least equivalent to the predicate device (using a speaker) | Not explicitly stated, but implied to have passed. |
| System Evaluation | System design validation by surgeon in a pig lab | Not explicitly stated, but implied to have passed. |
| Bluetooth communication | Verify the proper connection between the devices and that the data transferred and displayed on the tablet are correct | Not explicitly stated, but implied to have passed. |
| Safety features | Verify the correct implementation of the various safety features in the modified electronics / embedded software (LED and buzzer status when device is on in air, on in conductive medium, on with shortcut, on with low battery and off) | Not explicitly stated, but implied to have passed. |
| DSG Connect App GUI verification | Design verification of the DSG Connect App Graphic User Interface (GUI) | Not explicitly stated, but implied to have passed. |
| Maximum regulated pulse output | Verify that the maximum current that is sent into the patient is within the specifications and as per the predicate device (below 5.5mA) | Not explicitly stated, but implied to have passed (specifically "below 5.5mA"). |
| Curve smoothing / Amplification | Memo on the data treatment to ensure the signal is displayed adequately | Not explicitly stated, but implied to have passed. |
| Electrical safety in accordance with IEC 60601-1 | Compliance with standard | Implied to have passed. |
| Electromagnetic compatibility in accordance with IEC 60601-1-2 | Compliance with standard | Implied to have passed. |
| Wireless coexistence | Not explicitly detailed, but suggests evaluation of wireless interference. | Implied to have passed. |
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.
§ 874.1820 Surgical nerve stimulator/locator.
(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.