Symptomatic relief of chronic, intractable pain, post-surgical and posttraumatic acute pain.
Symptomatic relief of acute pain.
Symptomatic relief of post-operative pain.

Device Description

The Scrambler Therapy MC-5A Device is a multi-channel device which allows simultaneous treatment of a number of pain sites. Stimulation impulses are generated and controlled according to a stored program to provide pain relief.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device called the "Scrambler Therapy MC-5A Device." This document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than detailing specific acceptance criteria and the results of a primary clinical study for this device.

Therefore, many of the requested details about acceptance criteria, specific study design elements (sample sizes, ground truth establishment, expert qualifications, adjudication, MRMC studies, standalone performance), and training set information are not present in this regulatory submission.

The document states: "Testing of the Scrambler Therapy MC-5A Device demonstrates that the device meets design and performance specifications." However, it does not provide the specifics of these specifications (acceptance criteria) or the detailed results of such testing. The core of this 510(k) is a comparison to a predicate device (SCRAMBLER MC-5A TENS DEVICE, K081255).

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a clinical outcome (e.g., pain reduction percentage, adverse event rate threshold). The document implies that the device must meet "design and performance specifications," but these are not detailed.
Reported Device Performance: Not explicitly stated as quantifiable outcomes from a primary clinical study on the device itself. The 510(k) aims to show that the new device is "substantially equivalent" to an existing one, implying similar performance.

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

Sample Size: Not mentioned. The document references "testing" but does not specify a clinical study test set size.
Data Provenance: Not mentioned. It's likely that the "testing" referred to might be bench testing or verification/validation, not necessarily a clinical trial with human subjects whose provenance would be relevant in this context.

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

Not Applicable/Not Provided. As there's no detailed clinical study described with a "test set" requiring ground truth established by experts for classification or diagnosis (as would be common for AI/imaging devices), this information is absent.

4. Adjudication Method for the Test Set

Not Applicable/Not Provided. For the same reasons as above, an adjudication method is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This type of study is not mentioned. MRMC studies are typically used for diagnostic devices (like imaging AI) to compare human performance with and without AI assistance. This device is a therapeutic electrical stimulator.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Not Applicable/Not Provided. This device is a physical medical device (electrical stimulator), not an algorithm or AI software that would have a "standalone" performance. Its operation inherently involves a human user applying it.

7. The Type of Ground Truth Used

Not Applicable/Not Provided. The concept of "ground truth" (e.g., pathology, outcomes data for diagnosis) is not applied in the context of this device's regulatory review in the provided document. The 510(k) process for this type of device typically relies on engineering and electrical safety testing, biocompatibility, and functional performance, compared to an already cleared predicate.

8. The Sample Size for the Training Set

Not Applicable/Not Provided. This device is hardware for electrical stimulation. There is no "training set" in the context of machine learning.

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

Not Applicable/Not Provided. As above, there is no training set for this type of device.

Summary based on the provided document:

The 510(k) notification for the Scrambler Therapy MC-5A Device establishes substantial equivalence to a predicate device (SCRAMBLER MC-5A TENS DEVICE, K081255) based on intended use, fundamental technology, and operation characteristics. It generally states that "Testing... demonstrates that the device meets design and performance specifications." However, it does not provide the detailed acceptance criteria or the specific results of a clinical study in the format requested. The document does not describe a clinical study for performance evaluation that would necessitate the concepts of "test set," "training set," "ground truth experts," or "MRMC studies" as commonly understood in the context of AI/diagnostic device approvals.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines above and below them. The profiles are stacked, creating a sense of depth and unity.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 22, 2015

Delta international Service & Logistics S.r.l. Ms. Mariella Giorgieri CEO Piazza Adriana 4 00193 Roma Italy

Re: K142666

Trade/Device Name: Scrambler Therapy MC-5A Device Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ Dated: May 6, 2015 Received: May 11, 2015

Dear Ms. Giorgieri:

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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Felipe Aquel -S

Carlos Peña, PhD, MS for Director Division and Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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	510(k)	Scrambler Therapy MC-5A
--	--------	-------------------------

INDICATION FOR USE STATEMENT

510(k) Number (if you know):	K142666
Device Name:	SCRAMBLER THERAPY MC-5A DEVICE

Indication for Use:

The Scrambler Therapy MC-5A Device is indicated for:

Symptomatic relief of chronic, intractable pain, post-surgical and posttraumatic acute pain.
Symptomatic relief of acute pain.
Symptomatic relief of post-operative pain.

Prescription Use X(Part 21 CFR 801 Subpart D)	AND / OR	Over-The-Counter Use ______(Part 21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k)

510(K) SUMMARY

1. SUBMITTER/510(K) HOLDER:

Company Name:	Delta International Services & Logistics S.r.l.
Company Address:	Piazza Adriana 400193, Roma - Italy
Company Phone:	039- 3921603399
Company Fax:	039-063215142
Company e-mail:	ceo@st-team.eu
Contact person:	Ms. Mariella GiorgieriCEODelta International Services & Logistics S.r.l.
Date Summary Prepared:	May 13, 2015

2. DEVICE IDENTIFICATION

Common Usual Name:	Electrical Nerve Stimulator
Trade/Proprietary Name:	Scrambler Therapy MC-5A Device
Classification:	Class II
Product Code:	GZJ
Classification Panel:	882 Neurological Devices
Regulation Number:	882.5890

3. PREDICATED DEVICES

Predicate device	510 (k) Holder	510 (k) No
SCRAMBLER MC-5A TENSDEVICE	COMPETITIVE TECHNOLOGIES,INC.	K081255

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4. DEVICE DESCRIPTION

5. INTENDED USE

The Scrambler Therapy MC-5A Device is indicated for:

· Symptomatic relief of chronic, intractable pain, post-surgical and posttraumatic acute pain.
· Symptomatic relief of acute pain.
· Symptomatic relief of post-operative pain.

6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

Delta International Services & Logistics s.r.l. claims substantial equivalence of the Scrambler Therapy MC-5A Device to the predicate devices based on the intended use, fundamental technology, and operation characteristics. A side-by-side comparison of the Scrambler Therapy MC-5A Device and the cited predicate device is included in the 510(k).

7. PERFORMANCE TESTING

Testing of the Scrambler Therapy MC-5A Device demonstrates that the device meets design and performance specifications.

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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).