The ProStim Reusable Neurostimulation Electrodes are intended for use as a disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. ProStim Reusable Neurostimulation Electrodes are designed and intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation), MENS (Microcurrent Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation).

Device Description

ProStim Reusable Neurostimulation electrodes arc non-sterile, disposable laminated. flexible structures composed of materials commonly used in this application: First Layer-White spun laced nonwoven tape or White 1/32" thick Polyethylene foam or a polypropylene substrate, coated with biocompatible adhesive. Second Layer- Conductive plastic film. Third Layer-Biocompatible conductive hydrogel coupling media. The electrodes are designed for single-patient/multiple application use. Because of the adhesive nature of the biocompatible hydrogel, no securing materials are required to secure the device to the patient's skin. The electrode has one type of connection point that can be used to connect the stimulation device to the electrodes. This connection point is compatible with all standard, marketed Neurostimulation devices. Lead wire assembly - 6" wire with .080 in. diameter female socket connected to one side of the wire.

AI/ML Overview

The provided document describes the ProStim Reusable Neurostimulation Electrodes and its 510(k) summary for market clearance. The study presented focuses on demonstrating substantial equivalence to predicate devices, primarily through impedance testing and biocompatibility assessments, rather than a clinical efficacy study with human readers or outcomes data.

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

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (if stated)	Reported Device Performance
Safety - Biocompatibility	"Required skin sensitivity testing criteria as specified in the Tripartite Biocompatibility Guidance for Medical Devices and ISO 10993-1 requirements for skin contact." This includes Cytotoxicity, Sensitization, and Primary Skin Irritation Tests.	The Katecho KM 10 Series of gels (file number K00870) and the Amgel 700 Series gels (file number K983741), which may be used in these electrodes, have passed these tests.
Effectiveness - Impedance	"Impedance levels as the criteria for effectiveness testing." Specific numerical thresholds are not provided, but the criterion is comparability to predicate devices.	"Results of the impedance testing revealed that the subject device's impedance values were comparable to the other predicate device(s) impedance values."

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

The document does not explicitly state the sample size for the impedance testing or biocompatibility tests. It only states that the gels "have passed" the required tests and that impedance values "were comparable."

Test Set Sample Size: Not explicitly stated for either biocompatibility or impedance testing in this summary.
Data Provenance: Not explicitly stated. The biocompatibility tests refer to file numbers for the specific gels, implying these are existing test results for components rather than a new study specific to the ProStim device's final configuration. The impedance testing is described as being performed for the subject device in comparison to predicate devices, but details on where or when this was conducted are not provided.

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

Not applicable. The study did not involve human expert interpretation or ground truth establishment in the context of clinical images or diagnoses. The "ground truth" for biocompatibility is established by standardized testing protocols, and for effectiveness, it's defined by impedance measurements against predicate devices.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical study with human readers requiring adjudication.

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, an MRMC comparative effectiveness study was not done. This device is an electrode for neurostimulation, not an AI-powered diagnostic tool. The submission is a 510(k) for substantial equivalence based on technological characteristics and safety/effectiveness data, not a clinical efficacy study involving human readers.

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

Yes, in a conceptual sense. The "performance" of the device was assessed on its intrinsic characteristics (biocompatibility and electrical impedance) without human intervention in the measurement of these characteristics, or human interpretation as part of a diagnostic workflow. The device itself is a component in a system where a human typically applies it and uses it with an electrical stimulator.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For Biocompatibility: The "ground truth" was established by the results of standardized in vitro and in vivo tests for cytotoxicity, sensitization, and primary skin irritation as specified by the "Tripartite Biocompatibility Guidance for Medical Devices and ISO 10993-1 requirements for skin contact."
For Effectiveness (Impedance): The "ground truth" was indirectly established by the electrical impedance values of legally marketed predicate devices. The acceptance criterion was that the subject device's impedance values were "comparable" to these predicate devices.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm and therefore does not have a "training set" in the machine learning sense. The safety and effectiveness data were generated through specific tests and comparisons to predicate devices, not through a learning phase.

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

Not applicable, as no training set was used.

Summary

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K052875

DEC 2 7 2005

Exhibit #1

510(k) Summary

Submitter's name:	Dan WoodySummit Manufacturing, L.L.C.1307 N. Glenville Dr.Richardson, TX 75081Phone: 972-235-9212FAX: 972-235-0421E-mail Address: Dan.Woody@namedical.com
Contact person:	Dan Woody
Date prepared:	October 4, 2005
Device Name:	ProStim Reusable Neurostimulation Electrodes
Classification Name:	Neurostimulation Electrodes
Predicate devices:	K050469 (Naimco, Inc.)K010431 (Lead-Lok, Inc.)

ProStim Reusable Neurostimulation electrodes arc non-Device Description: sterile, disposable laminated. flexible structures composed of materials commonly used in this application:

First Layer-White spun laced nonwoven tape or White 1/32" thick Polyethylene foam or a polypropylene substrate, coated with biocompatible adhesive.

Second Layer- Conductive plastic film.

Third Layer-Biocompatible conductive hydrogel coupling media (

The electrodes are designed for single-patient/multiple application use. Because of the adhesive nature of the biocompatible hydrogel, no securing materials are required to secure the device to the patient's skin. The electrode has one type of connection point that can be used to connect the stimulation device to the electrodes. This connection point is compatible with all standard, marketed Neurostimulation devices.

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Lead wire assembly - 6" wire with .080 in. diameter female socket connected to one side of the wire.

Predicate Technological Characteristics Comparison: ProStim Reusable Neurostimulation electrodes are technologically equivalent to the predicate devices. They are physically and technically similar to those currently being marketed for "Neurostimulation" i.e., TENS (Transcutaneous Electrical Nerve Stimulation), MENS (Microcurrent Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) and PGS (Pulsed Galvanic Stimulation).

Safety and Effectiveness: ProStim Reusable Neurostimulation electrodes are as safe and effective as the Naimco E-Z stik electrodes (K050469) and Lead-Lok (K010431) which were previously found to be substantially equivalent via 510(k) Premarket Notifications.

The first safety issue considered was whether the gel, which is used to adhere the electrode to the skin and which is the only portion of the electrode to maintain skin contact, would cause any skin irritation. The Katecho KM 10 Series of gels (file number K00870) and the Amgel 700 Series gels (file number K983741), which may be used in this family of electrodes, have passed the required skin sensitivity testing criteria as specified in the Tripartite Biocompatibility Guidance for Medical Devices and ISO 10993-1 requirements for skin contact. These tests include Cytotoxicity, Sensitization, and Primary Skin Irritation Tests.

Because there are no published performance standards for Neurostimulation electrodes, Summit Manufacturing, L.L.C. uses impedance levels as the criteria for effectiveness testing. Results of the impedance testing revealed that the subject device's impedance values were comparable to the other predicate device(s) impedance values.

Based on the aforementioned information, ProStim considers its Reusable TENS/NMES electrodes to be as safe and effective as the predicate devices, as well as multiple other TENS/NMES electrodes currently being marketed including those manufactured by: Uni-Patch(K962910), MSB Limited (K980229), Axelgaard (K983741), Selective Med components, Inc. (K946230).Medtronic, Inc. (K875284), Medical Design & Manufacturing Corp. (K895604), and Labeltape Meditect. Inc. (K900656,K902719 and K894043).

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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 features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Public Health Service

DEC 2 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Summit Manufacturing, L.L.C. c/o Ms. Susan D. Goldstein-Falk mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021

Re: K052875

Trade/Device Name: ProStim Reusable Neurostimulation Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: II Product Codes: GXY Dated: October 11, 2005 Received: October 12, 2005

Dear Ms. Goldstein-Falk:

We have reviewed your Section 510(k) premarket notification of intent to market the device in the device in We nave reviewed your Section 310(tr) prehistantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, enclosure) to regarly mankelou prodreate a Amendments, or to devices that have been reclassified in the ellacinent date of the Mediour Do researl Food, Drug, and Cosmetic Act (Act) that do not require accordance with the provisions of the Fouolar Food, I reg, therefore, market the device, subject to approval of a provisions of the Act. The general controls provisions of the Act include the general connels providents of any 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 If your device is classified (see above) into ense lations affecting your device can be found in the Subject to such additional controlly - Entralignation, 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 Please be advised mat 1 DA 3 issuance of a saceannal securements of the Act or any Foderal statutes and regulations administered by other Federal agencies. You must comply with all the Federal Statues and Tegulations administered of vegistration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

CFK Fall 801), good manufacturing praction (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 5 10(k) premarkete notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate hourication. The 112A inding of substantal equive and thus, permits your device to proceed to the market.

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Page 2 – Mrs. Susan Goldstein-Falk

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact and If you desire specific advice tor your develop on on also regulation entitled, "Mishranding by the Office of Compliance at (240) 270-0720. Also, presentation of the general information on
reference to premarket notification" (21CFR Part 807.97). Your may of any mate reference to premarket notification (21) I I Pair of Small Manufacturers, International and your responsibilities under the Act non the DIVIsion of Sharless of Collection of Coll ) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Melkerson

ﻖ Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Exhibit B

Page __ 1 __ of __ 1

510(k) Number (if known):

K052875

Device Name: ProStim Reusable Neurostimulation Electrodes

Indications For Use:

Prescription Use X (Per 21 CFR 801 Subpart D)

Over-The Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

202

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

Regulation Number and Section

§ 882.1320 Cutaneous electrode.

(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).