Percutaneous Neuromodulation Therapy (PNT) is indicated for the symptomatic relief and management of chronic or intractable pain and/or as an adjunctive treatment in the management of post-surgical pain and post-trauma pain.

The PNT Control Unit is to be used with PNT Lumbar Safeguides for low back pain or PNT Cervical Safeguides for neck and/or upper back pain.

Device Description

The Vertis PNT System is designed for delivering percutaneous electrical stimulation (termed: Percutaneous Neuromodulation Therapy -PNT ). The Vertis PNT System is intended to be used in pain management by a physician (e.g., anesthesiologists or physical medicine and rehabilitation physicians) or on the order of a physician (e.g., by a physical therapist) in a clinic environment. The device system includes 3 major components:

the Vertis PNT Control Unit a software-driven, ● five channel, AC powered nerve stimulator which generates the electrical stimulus;
the sterile Safeguides which are sterile, needle electrodes; ●
the Patient Cable - which interconnects the PNT Control Unit to the electrodes

AI/ML Overview

The provided text describes a 510(k) submission for a modification to an existing device, the Vertis Percutaneous Neuromodulation Therapy (PNT) System. The submission is specifically to request clearance for a new cervical electrode kit and cable and to update the labeling.

The document states that "Extensive data were provided that evaluated the use of PNT cervical electrodes and cervical percutaneous electrical stimulation. These data included the following. Data demonstrated acceptable results for the device and therapy." However, it does not provide explicit acceptance criteria, thresholds for device performance, or detailed results beyond stating that they were "acceptable."

Therefore, I cannot populate the table of acceptance criteria and reported device performance as requested. Similarly, the study itself is not described in enough detail to answer many of the subsequent questions.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is missing:

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

Acceptance Criteria	Reported Device Performance
Not specified	"Data demonstrated acceptable results for the device and therapy."

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 for Test Set: Not specified.
Data Provenance: The document mentions "published human clinical trial data for cervical pain management" and "post-market data for the Vertis PNT System." This suggests a combination of prospective clinical study data and retrospective post-market surveillance. The country of origin is not specified, but the applicant company is based in Seattle, Washington, USA.

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)

Not specified. The data includes "human magnetic resonance images (MRI)/ computerized tomography (CT) imaging data," which would typically involve expert interpretation, but the number or qualifications of these experts are not provided.

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

Not specified.

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

Not applicable. The device is a nerve stimulation system, not an AI-powered diagnostic imaging tool that would typically involve human readers.

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

Not applicable. This is a medical device (nerve stimulator) that requires human operation and interaction with a patient, not a standalone algorithm.

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

Given the nature of the device (pain management), the "published human clinical trial data for cervical pain management" likely relied on patient-reported outcomes data (e.g., pain scales, functional assessments) as the primary ground truth for efficacy. The "post-market data" would also likely include outcomes data and adverse event reporting. "Electrode performance and dimensional (bench) data" and "MRI/CT imaging data" would have engineered or expert-evaluated ground truths, respectively, but these relate to device safety and characteristics rather than clinical efficacy.

8. The sample size for the training set

Not specified. This device is a hardware system, not a machine learning algorithm, so the concept of a "training set" in the context of AI does not directly apply. If "training set" refers to data used in the design or optimization of the device, it is not detailed.

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

Not applicable. See explanation for question 8.

Summary

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K022241

SEP 1 1 2002

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Appendix 13 510(k) Summary of Safety and Effectiveness

Vertis Neuroscience, Inc. Percutaneous Neuromodulation Therapy (PNT) ™ Control Unit and Accessories

General Information

Classification	Class II
Trade Name	Percutaneous Neuromodulation Therapy(PNT) Nerve Stimulation System
Submitter	Vertis Neuroscience, Inc.2101 Fourth Avenue, Suite 200Seattle, Washington, USA 98121
Contact	Lori GlastetterVice President, Regulatory Affairs/Quality Assurance

Nature of this 510(k)

The Vertis Percutaneous Neuromodulation Therapy (PNT) System (nerve stimulator and accessories) was cleared for marketing under 510(k) Notification K011702. This submission was filed to request clearance to market a new cervical electrode kit and cable and modify the existing PNT labeling to accommodate these new accessories.

Device Description

the Vertis PNT Control Unit a software-driven, ● five channel, AC powered nerve stimulator which generates the electrical stimulus;
the sterile Safeguides which are sterile, needle electrodes; ●
the Patient Cable - which interconnects the PNT Control Unit to the electrodes

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K022241
205-2

Indications for use

The PNT Control Unit is to be used with PNT Lumbar Safeguides for low back pain or PNT Cervical Safeguides for neck and/or upper back pain.

Substantially Equivalent Devices

Manufacturer	Substantially Equivalent devices	510(k)
Vertis Neuroscience,Inc.	Vertis Percutaneous NeuromodulationTherapy (PNT) Stimulation System (VertisPNT Control Unit and Accessories)Model CU 100 and SG 101-xxx	K011702
Empi, Inc.St. Paul, MN	EPIX Tens Device SystemModel EPIX VTModel EPIX XL	K970203 K951903
Rehabilicare, Inc.New Brighton, MN	SMP-PlusTMModel 4930	K982410

Safety and Effectiveness - Testing

Extensive data were provided that evaluated the use of PNT cervical electrodes and cervical percutaneous electrical stimulation. These data included the following. Data demonstrated acceptable results for the device and therapy.

electrode performance and dimensional (bench) data ●
human magnetic resonance images (MRI)/ computerized tomography . (CT) imaging data
published human clinical trial data for cervical pain management ●
. post-market data for the Vertis PNT System

Summary of Substantial Equivalence

Based on the information provided in this Notification, we believe the described modification to the legally marketed predicate Vertis PNTTM Control Unit and Accessories has been shown to be substantially equivalent to devices in commercial distribution prior to May 28, 1976.

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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 caduceus, which is a symbol of medicine, with three lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.

SEP 1 1 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Lori J. Glastetter Vice President, Regulatory Affairs/Quality Assurance Vertis Neuroscience, Inc. 2101 Fourth Avenue, Suite 200 Seattle, Washington 98121

Re: K022241

Trade/Device Name: Vertis Percutaneous Neuromodulation Therapy (PNT) Nerve Stimulation System (Vertis PNT Control Unit, Vertis PNT Lumbar Safeguides and Vertis PNT Cervical Safeguides) Regulation Number: 21 CFR 882.5890 and 21 CFR 882.1350 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief and Needle Electrode Regulatory Class: Class II Product Code: NHI and GXZ Dated: July 10, 2002 Received: July 11, 2002

Dear Ms. Glastetter:

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

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Page 2 - Ms. Lori Glastetter

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.

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

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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Page__________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): K 0222 4 |

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The PNT Control Unit is to be used with PNT Lumbar Safeguides for low back pain or PNT Cervical Safeguides for neck and/or upper back pair.

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Mark N. Milliken

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

510(k) Number -

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).