The NESS L300 is intended to provide ankle dorsiflexion in individuals with drop foot following an upper motor neuron injury or disease. During the swing phase of gait, the NESS L300 electrically stimulates muscles in the affected leg to provide dorsiflexion of the foot; thus, it may improve the individual's gait. The NESS L300 may also facilitate muscle re-education, prevent/retard disused atrophy, maintain or increase joint range of motion and increase local blood flow.

Device Description

This neuroprosthesis device consists of a RF foot sensor (Intelli-sense gait sensor), RF control unit (waist mounted / neck strap / in pocket), and a below the knee orthosis containing electrodes and a RF controlled stimulation unit (RF stim unit).

The Intelli-gait sensor detects "heel off" and "heel contact" events during gait and transmits signals to the RF stim unit. Accordingly, the RF stim unit initiates and pauses the stimulation, activating the foot dorsiflexors to ensure proper foot clearance during the swing phase and proper foot placement during the stance phase.

The NESS L300 comprises of 4 main parts:

A lower leg orthosis with integrated RF stim unit and electrodes, RF communication, and rechargeable battery,
A waist mounted (or in-pocket) Control Unit (CU), including a PDA (clinician programmer) interface, RF communication, and AAA rechargeable battery.
Intelli-sense gait sensor with RF communication and non-rechargeable coin battery.
Clinician Programmer Handheld computer (PDA)

AI/ML Overview

The provided text describes a Special 510(k) submission for a modification to the NESS L300 device, not a study setting acceptance criteria based on performance data. Therefore, many of the requested details about a study and its methodology are not present in this document.

The document states: "Performance data demonstrates that the modified NESS L300 is as safe and effective as the predicate device." However, it does not provide specific details about this performance data or the study design. A Special 510(k) relies heavily on demonstrating that modifications do not raise new questions of safety or effectiveness compared to a previously cleared device.

Here's a breakdown of what can be extracted from the provided text, and what information is missing:

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

Acceptance Criteria	Reported Device Performance
Implicit: The modified NESS L300 must be "as safe and effective" as the predicate device (NESS L300, K053468). This is the fundamental criterion for a Special 510(k).	The submission claims: "Performance data demonstrates that the modified NESS L300 is as safe and effective as the predicate device." However, no specific performance metrics (e.g., success rates, error rates, improvement in gait parameters) or quantitative data are provided in this summary.
Specific to modifications: The minor differences in embedded software, Intelli-Gait (PDA) software, hardware, and accessories must not raise "any new questions of safety or effectiveness."	The submission implies this was met by showing substantial equivalence and receiving FDA clearance. No detailed report of how these specific modifications were tested to ensure they did not introduce new risks or reduce effectiveness is included.

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: Not specified in the provided text.
Data Provenance: Not specified in the provided text.
Retrospective or Prospective: Not specified in the provided text.

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)

This information is not applicable as the document does not describe a study involving expert-established ground truth for a test set. This is a regulatory submission for a device modification, relying on equivalence to a predicate, not a de novo study with subjective ground truth.

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

Not applicable. No study with a test set requiring adjudication is described.

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. This device is an electrical stimulator, not an AI or imaging device requiring human reader interpretation, so an MRMC study is not relevant here.

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

Not applicable. This device is a therapeutic neuromuscular stimulator, not an algorithm, so the concept of "standalone performance" in this context is not relevant as it would be for a diagnostic AI. Its performance is always "human-in-the-loop" in the sense that it's applied to a patient.

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

Not explicitly defined or discussed. The "ground truth" for this type of device (functional electrical stimulation) would typically be clinical outcomes data related to gait improvement, muscle re-education, range of motion, and blood flow, as described in its indications for use. However, the document does not detail how "performance data" was collected or what specific metrics were measured for the modified device versus the predicate, or what the "ground truth" reference for these outcomes would be.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that uses a "training set."

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

Not applicable. This is not an AI/machine learning device that uses a "training set."

In summary:

This document is a 510(k) summary for a device modification, emphasizing its substantial equivalence to a previously cleared predicate device. It states that "performance data demonstrates that the modified NESS L300 is as safe and effective as the predicate device," which is the core acceptance criterion for this type of submission. However, it does not provide any specific details about the nature, methodology, sample size, or results of that performance data. The document essentially asserts that such data exists and supported the claim of equivalence, rather than presenting the study itself.

Summary

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K080219

ﻥ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮐﮯ ﺍﻧﺘﻈﺎﻣﯿﺎﺕ ﮐﮯ ﺷﮩﺮ

510(k) SUMMARY

NESS, Ltd.'s NESS L300

510(k) Summary:

NESS L300

Company Name:

NESS-Neuromuscular Electrical Stimulation Systems, Ltd.

Contact Person:

Amit Dar R&D and Clinical Manager

Telephone:	+972-9-748-5738
Fax:	+972-9-748-5740
E-mail:	amit@ness.co.il

Authorized US Agent:

Bioness, Inc. 25103 Rye Canyon Loop Valencia, CA 91355

Date prepared:

January 29, 2008

Trade Name:

NESS L300

Classification name:

External functional neuromuscular stimulator

Class: II

Panel identification: Neurological devices

Product code:

GZI and IPF

Regulation number:

882.5810 External functional neuromuscular stimulator 890.5850 Powered Muscle Stimulator

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Predicate Devices:

Neuromuscular Electrical Stimulation Systems, Ltd.'s NESS L300 (K053468)

Purpose of the Special 510(k) notice.

The NESS L300 is a modification to the NESS L300 (K053468).

Device description:

The NESS L300 comprises of 4 main parts:

1. A lower leg orthosis with integrated RF stim unit and electrodes, RF communication, and rechargeable battery,
1. A waist mounted (or in-pocket) Control Unit (CU), including a PDA (clinician programmer) interface, RF communication, and AAA rechargeable battery.
1. Intelli-sense gait sensor with RF communication and non-rechargeable coin battery.
1. Clinician Programmer Handheld computer (PDA)

Indications for Use:

Substantial Equivalence:

The modified NESS L300 has the same intended use and similar indications, principles of operation, and technological characteristics as the original, cleared NESS L300. The minor differences in the embedded software, the Intelli-Gait (PDA) software, the hardware, and the accessories do not raise any new questions of safety or effectiveness. Performance data demonstrates that the modified NESS L300 is as safe and effective as the predicate device. Thus, the NESS L300 is substantially equivalent to its predicate device.

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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 symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

FEB 28 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Neuromuscular Electrical Stimulation Systems % Dr. Evan Rosenfeld Bioness Incorporated 25103 Rye Canyon Loop Valencia, CA 91355

Re: K080219 Trade/Device Name: Modification to NESS L300 Regulation Number: 21 CFR 882.5810 Regulation Name: External functional neuromuscular stimulator Regulatory Class: Class II Product Code: GZI Dated: January 29, 2008 Received: January 29, 2008

Dear Dr. Rosenfeld:

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 - Dr. Evan Rosenfeld

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Millman

Mark N. Melkerson 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):_____________________________________________________________________________________________________________________________________________________ K080219

Device Name: NESS L300

Indications for Use:

Prescription Use X (Per 21 C.F.R. 801.109)

AND/OR

Over-The-Counter Use (Per 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)

Mark M. Millerson

Division of General, Restorative,

and i

K08021

510(k) Number

Regulation Number and Section

§ 882.5810 External functional neuromuscular stimulator.

(a)
Identification. An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait.(b)
Classification. Class II (performance standards).