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.

Device Description

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.

AI/ML Overview

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.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

SpineGuard, S.A. % John Smith, M.D., J.D. Partner Hogan Lovells US LLP 555 Thirteenth Street NW Washington, District of Columbia 20004

Re: K201454

Trade/Device Name: DSG Connect Technology Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: PDQ, ETN Dated: January 21, 2021 Received: January 21, 2021

Dear John Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201454

Device Name DSG Connect Technology

Indications for Use (Describe)
PediGuard and PediGuard Cannulated systems:

PediGuard Threaded System:

DSG Zavation screw system:

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) SUMMARY

DSG Connect Technology

l. Submitter

SpineGuard S.A. 10 Cours Louis Lumière Vincennes, France 94300

Phone: +33 1 45 18 45 19 Facsimile: +33 1 45 18 45 20

Contact Person: Stephane Bette

Date Prepared: June 1, 2020

II. Device

Name of Device: DSG Connect Technology

Common or Usual Name: Nerve Stimulator

Classification Name: 21 C.F.R. §874.1820 (Surgical Nerve stimulator/ locator) Regulatory Class: Class II

Product Code: PDQ, ETN

lll. Predicate Devices

K143159, PediGuard devices, SpineGuard SA K143159, Cannulated PediGuard devices, SpineGuard SA K152747, PediGuard Threaded systems, SpineGuard SA K162884, DSG Zavation screw system, SpineGuard SA

IV. Device Description

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

V. Indications for Use

PediGuard and PediGuard Cannulated systems:

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 vertebral cortex perforation. 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:

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K201454

VI. Comparison of Technological Characteristics With the Predicate Devices

The following technological differences exist between the subject and predicate devices:

Integration of DSG Connect Technology ●
- Modification of electronics board to include wireless transmitter O
- Added Connect App using commercial tablet as Hardware platform (Microsoft Go) o
Hardware changes ●
- o Change of audio technology (speaker→ buzzer)
- Change of integration of low battery threshold detection into design O
- Changes to some electronic components, manufacturing process & configuration of board O
- Change in electronic component for device activation (replacement of legacy electronic contact O blade, PediGuard device only)
- O Added BLE communication module (Bluetooth)
Software changes ●
- Addition of low battery threshold detection o
- Monitoring of new parameters (battery voltage, reference voltage, microcontroller (MCU) O temperature)
- Added firmware to manage BLE transmission of data pushed by MCU o

VII. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Electrical safety in accordance with IEC 60601-1 ●
Electromagnetic compatibility in accordance with IEC 60601-1-2 ●
Wireless coexistence

Name	Description
Autonomy test	Verify the autonomy of the modifiedelectronics
Impaction,weight and capresistance test	Verify the mechanical resistance of theplastic casing with the modified innergeometry
Low-batterymodeverification andre-usageprevention	Verify the correct implementation of the lowbattery detection and the reusage preventionfeature in the modified electronics /embedded software
Pulse output	Verify that the electrical pulse is sent withinthe specifications in terms of duration /frequency / intensity
Output signalevaluation	Verify that the output signal of the modifieddevice (modified electronics / embeddedsoftware) is equivalent to the predicatedevice for similar conductivity levels
Soundevaluation	Verify that the sound volume of the modifieddevice (using a buzzer) is at least equivalentto the predicate device (using a speaker)

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K201454

SystemEvaluation	System design validation by surgeon in a piglab
Bluetoothcommunication	Verify the proper connection between thedevices and that the data transferred anddisplayed on the tablet are correct
Safety features	Verify the correct implementation of thevarious safety features in the modifiedelectronics / embedded software (LED andbuzzer status when device is on in air, on inconductive medium, on with shortcut, on withlow battery and off)
DSG ConnectApp GUIverification	Design verification of the DSG Connect AppGraphic User Interface (GUI)
Maximumregulated pulseoutput	Verify that the maximum current that is sentinto the patient is within the specificationsand as per the predicate device (below5.5mA)
Curvesmoothing /Amplification	Memo on the data treatment to ensure thesignal is displayed adequately

VIII. Conclusions

The DSG Connect family of products are comparable to the predicate PediGuard devices, Cannulated PediGuard, PediGuard Threaded, and DSG Zavation Screw systems, with the technological differences in comparison to the predicate devices not raising new or different questions of safety and effectiveness. Additionally, the non-clinical data support the safety and effectiveness of the DSG Connect family of systems when used as intended in the specified use conditions.

Regulation Number and Section

§ 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.