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.

Device Description

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.

AI/ML Overview

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

Criteria Category	Acceptance Criteria (As reported in 510(k))	Reported Device Performance (As reported in 510(k))
Functional Equivalence	Not explicitly stated as quantifiable metrics. Implied: Device performs nerve monitoring function similar to predicate devices.	"Testing was performed to demonstrate the equivalence of the construct design to currently marketed spinal systems." (No specific results provided)
Safety	Not explicitly stated as quantifiable metrics. Implied: Device safe for intended use.	"Its components are manufactured from stainless steel and plastics according to ASTM and USP requirements." (Material safety, not functional safety)
Impedance Feedback	Not explicitly stated. Implied: Provides visual and audible alerts for impedance changes.	"provide feedback to the surgeon via visual and audible alerts that indicate a change in impedance at the tip of the probe..." (Function description, not performance metric)
EMG Surveillance	Not explicitly stated. Implied: Assists in location and evaluation of spinal nerves via EMG monitoring.	"...assist in the location and evaluation of spinal nerves... and EMG monitoring of muscle groups associated with those nerves." (Function description, not performance metric)

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.

Summary

{0}------------------------------------------------

K030526

DEC 2 9 2004

510(k) SUMMARY

NAME OF FIRM:	SpineVision, Inc.3003 Summit Blvd., Suite 1400Atlanta, GA 30319Phone: 404-460-5077
510(K) CONTACT:	Lynnette WhitakerVice President, Regulatory Affairs574-269-9776
TRADE NAME:	PediGuard™ Nerve Detector System
COMMON NAME:	Nerve Stimulator
CLASSIFICATION:	874.1820
DEVICE PRODUCT CODE:	Product code: 77 ETN
SUBSTANTIALLYEQUIVALENT DEVICES:	Neurosign 800, Magstim Company, Ltd.(K980148)NuVasive, Inc.'s INS-1 IntraoperativeNerve Surveillance System (K002677)TOEI Electric Co., Ltd.'s JUSTWO ModelTME 601 Root Apex Locator (K022020)

DEVICE DESCRIPTION AND INTENDED USE:

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administration of low voltage electrical energy to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves.

BASIS OF SUBSTANTIAL EQUIVALENCE:

The components of the PediGuard Nerve Monitoring System are similar in design, material, and intended use to other nerve monitoring systems that have been cleared by FDA for spinal use. Testing was performed to demonstrate the equivalence of the construct design to currently marketed spinal systems.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 9 2004

Ms. Lynnette Whitaker Vice President, Regulatory Affairs SpineVision, Inc. 3003 Summit Boulevard, Suite 1400 Atlanta, Georgia 30319

Re: K030526 Trade/Device Name: PediGuard Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked response electrical stimulator Regulatory Class: II Product Code: GWF Dated: November 24, 2004 Received: November 24, 2004

Dear Ms. Whitaker:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Lynnette Whitaker

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Sincerely yours,

Mark N. Millman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K030526

Device Name: PediGuard

Indications for Use:

Prescription Use X (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use (21 C.F.R. 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K030526

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Regulation Number and Section

§ 882.1870 Evoked response electrical stimulator.

(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).