The NESS Children System is intended for pediatric use for the following indications: maintenance or increase of range of motion, reduction of muscle spasm, prevention or retardation of disuse atrophy, muscle reeducation, and increasing local blood circulation.

Device Description

The NESS Children System is a portable, one-channel electrical neuromuscular stimulator for personal use. The stimulator, which is powered by rechargeable nickel-cadmium batteries, serves surface electrodes held on to the limb by a splint. A selection of four splints for the hand and forearm, the arm, the thigh, or the leg is provided in three sizes each to fit children dimensions. A single channel of constant-voltage symmetrical biphasic Russian waveform stimulation is delivered to the muscles through surface electrodes. Microprocessor-controlled switching of the stimulation between these electrodes allows the muscles to be activated in combinations either cyclically or continuously. The stimulation is ramped up at the beginning and down at the end of each cycle. The electrode locations allow the NESS Children System to provide extension and flexion of the limb segment distal to that of the splint. The user can select from five stimulation programs by pressing the mode button on the control unit and can increase or decrease the stimulation intensity in ten discrete levels.

AI/ML Overview

The provided document is a 510(k) summary for the NESS Children System, which is a powered muscle stimulator. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through a clinical trial or algorithm evaluation.

Instead, the document focuses on regulatory aspects for device clearance, specifically demonstrating substantial equivalence to a predicate device (NESS System, K022776). The core of a 510(k) submission is to show that a new device is as safe and effective as a legally marketed predicate device, not necessarily to prove it meets specific performance metrics against a defined set of acceptance criteria through a dedicated study with the elements you requested.

Therefore, I cannot populate the table or answer most of your questions based on the provided text. The document refers to "Performance Standards" but states "No performance standards have been established for powered muscle stimulators under section 514 of the FDC Act. No special controls apply." This further indicates that the 510(k) process for this device did not involve predefined performance acceptance criteria and a study to meet them in the way you've described for, for example, an AI/ML device.

Here's how I would respond to your request based only on the provided text, highlighting what is missing:

Acceptance Criteria and Device Performance Study for NESS Children System

The provided 510(k) summary for the NESS Children System does not include specific acceptance criteria or an efficacy study demonstrating quantitative performance against such criteria. The submission focuses on demonstrating substantial equivalence to a predicate device (NESS System, K022776) for regulatory clearance. This regulatory pathway typically relies on comparison to a legally marketed device rather than on meeting pre-defined quantitative performance metrics through a dedicated clinical study with the elements you've outlined.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Quantitative/Qualitative)	Reported Device Performance
Not specified in the provided document. The 510(k) summary focuses on substantial equivalence to a predicate device rather than specific performance metrics.	Not specified in the provided document. No quantitative performance data is presented to meet defined acceptance criteria.

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

Sample Size for Test Set: Not mentioned.
Data Provenance: Not mentioned.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not mentioned.
Qualifications of Experts: Not mentioned.

4. Adjudication Method for the Test Set

Adjudication Method: Not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done?: No, an MRMC comparative effectiveness study is not mentioned or described. This type of study is more common for diagnostic imaging AI systems where human reader performance is a key metric.

6. Standalone (Algorithm Only) Performance Study

Standalone Study Done?: Not applicable, as this is a physical medical device (electrical stimulator), not an algorithm-only software device.

7. Type of Ground Truth Used

Type of Ground Truth: Not applicable for this type of device and regulatory submission. The submission focuses on safety and effectiveness comparable to a predicate device through device description and indications for use.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable, as this is a physical medical device. There is no mention of a "training set" in the context of an algorithm.

9. How Ground Truth for the Training Set Was Established

Ground Truth Establishment for Training Set: Not applicable.

Summary

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510(K) Summary NESS Children System 510(k) Number K 024279

Applicant's Name:

N.E.S.S. Neuromuscular Electrical Stimulation Systems Ltd. 19 Ha-Haroshet Street Kiedar Center, Suite 207 P.O. Box 2500, Industrial Zone Ra'anana 43465 ISRAEL Tel: 011-972-9-7485738 Fax: 011-972-9-7485740

Contact Person:

Orly Maor Push-med Ltd. 117 Ahuzah St. Ra'anana 43373, Israel Tel: 972-9- 7718130 Fax: 972-9-7718131 orly@push-med.com

And/or

Jonathan S. Kahan, Esq. Hogan & Hartson, L.L.P. Columbia Square 555 Thirteenth Street, NW Washington, DC 20004-1109 Tel: (202) 637-5794 Fax: (202) 637-5910

Date Prepared:

December, 2002

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Trade Name:

NESS Children System

Classification Name:

Powered Muscle Stimulators

Classification:

The FDA has classified Powered muscle stimulators devices as class II devices (product code 89 IPF, Regulation No. 890.5850) and they are reviewed by the Restorative Devices Branch .

Predicate Device:

Ness System cleared under K022776

Performance Standards:

No performance standards have been established for powered muscle stimulators under section 514 of the FDC Act. No special controls apply.

Indications:

Device Description:

The NESS Children System is a portable, one-channel electrical neuromuscular stimulator for personal use. The stimulator, which is powered by rechargeable nickel-cadmium batteries,

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serves surface electrodes held on to the limb by a splint. A selection of four splints for the hand and forearm, the arm, the thigh, or the leg is provided in three sizes each to fit children dimensions.

A single channel of constant-voltage symmetrical biphasic Russian waveform stimulation is delivered to the muscles through surface electrodes. Microprocessor-controlled switching of the stimulation between these electrodes allows the muscles to be activated in combinations either cyclically or continuously. The stimulation is ramped up at the beginning and down at the end of each cycle.

The electrode locations allow the NESS Children System to provide extension and flexion of the limb segment distal to that of the splint. The user can select from five stimulation programs by pressing the mode button on the control unit and can increase or decrease the stimulation intensity in ten discrete levels.

Substantial Equivalence:

NESS Ltd. believes that the NESS Children System is substantially equivalent to its predicate device cited above without raising new safety and/or effectiveness issues.

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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of what appears to be an abstract representation of a human form or bird-like figure, composed of three curved lines.

FEB 0 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Neuromuscular Electrical Stimulation Systems, Ltd. C/O•Jonathan S. Kahan Hogan & Hartson, L.L.P. Columbia Square 555 Thirteenth Street, NW Washington, D.C.

Re: K024279

Trade/Device Name: NESS Children System Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPG Dated: December 23, 2002 Received: December 23, 2002

Dear Mr. Kahan:

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

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Page 2 - Mr. Jonathan S. Kahan

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.

Mark M 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

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Ness Children System

Indications for Use: The NESS Children System is intended for pediatric use for the following indications: maintenance or increase of range of motion, reduction of muscle spasm, prevention or retardation of disuse atrophy, muscle reeducation, and increasing local blood circulation.

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

fo Mark N Milheras

510(k) Number ___ (Division Sign-Off)

Division of General, Restorative
and Neurological Devices

$10(k) Number. K024279

Prescription Use _ OR Over the Counter
(Per 21 CFR 801.109) Use _

Regulation Number and Section

§ 890.3025 Prosthetic and orthotic accessory.

(a)
Identification. A prosthetic and orthotic accessory is a device intended for medical purposes to support, protect, or aid in the use of a cast, orthosis (brace), or prosthesis. Examples of prosthetic and orthotic accessories include the following: A pelvic support band and belt, a cast shoe, a cast bandage, a limb cover, a prosthesis alignment device, a postsurgical pylon, a transverse rotator, and a temporary training splint.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records and § 820.198, regarding complaint files.