The SmartStep System is intended to sense the amount of weight applied to the plantar surface of the foot during rehabilitation. The device alerts the user and/or therapist with alarm when the weight exceeded the pre-selected value. Furthermore, the SmartStep System is intended to be used in any situation in which therapist and/or patient would benefit from objectively assessing the amount of weight that is being applied to a lower limb.

Device Description

The SmartStep System is a biofeedback system for gait training and reeducation. The device is a tool to assist clinicians accurately assess patients who are undergoing weight bearing restrictions and gait therapy training.

The SmartStep is used to measure the amount of weight being applied to an affected limb, to teach and promote specific weight bearing skills, and to test patient's ability to maintain a weight bearing rang. A patient's weight bearing status is important to know because it is an indicator of overall progress, and with certain conditions, under-weight bearing or over-weight bearing can lead to complication in the rehabilitation process.

The SmartStep system is to be used under the supervision of physician or licensed health care provider such as physiotherapist.

The SmartStep system is comprised of three sub elements:

Flexible Foot force insole that is placed on the inside of a shoe worn by the patient over a sock.

Central Processing Unit (CPU)- the unit is connected to computer software.

Computer software that acts as a patient medical record and patient assessment tool.

AI/ML Overview

This document, a 510(k) summary for the SmartStep System, references performance testing but does not provide specific acceptance criteria or detailed study results. Therefore, I cannot fully answer all parts of your request.

However, based on the provided text, here's what can be extracted and what cannot:

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

Acceptance Criteria	Reported Device Performance
Not Specified	Not Specified

Explanation: The document states, "Based on validations and performance testing results, Andante Medical Devices Ltd. believes that the SmartStep System is substantially equivalent to its predicate device cited above without raising new safety and/or effectiveness issues." However, it does not provide any specific quantitative acceptance criteria (e.g., accuracy thresholds, precision ranges) or the numerical results of this performance testing.

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 (Test Set): Not specified.
Data Provenance: Not specified. (The applicant is based in Israel, but the origin of the data is not mentioned).
Retrospective or Prospective: Not specified.

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 document does not describe the establishment of a ground truth by experts in the context of performance testing.

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

No, an MRMC comparative effectiveness study was not done or reported. The SmartStep System is a biofeedback device that senses and alerts based on weight applied, not an AI-assisted diagnostic tool that would involve "human readers" interpreting data. Therefore, this type of study is not applicable to this device as described.

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

Yes, implied. The device itself senses and alerts, which is an algorithmic standalone function. The "study" mentioned ("validations and performance testing results") would have assessed this standalone performance, although the details are not provided. The system is designed to "objectively assessing the amount of weight."

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

Not explicitly stated. Given the device's function (sensing weight), the "ground truth" for its performance testing would likely be derived from a highly accurate and calibrated weight measurement system, rather than expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not applicable/Not specified. This device is described as a biofeedback system that senses and alerts. There is no mention of a "training set" in the context of machine learning, as this is not an AI/ML-based diagnostic system that would require such a set.

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

Not applicable/Not specified, as there is no mention of a training set.

Summary

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510(K) SUMMARY

SmartStep System

510(k) Number K_ ○ 2 3 L G 1

Applicant's Name:

DEC 1 0 2002

Andante Medical Devices Ltd. 15 Yehoshua Hatsoref Street Beer-Sheva 84106, Israel Tel.: 972-8-6239043 Fax: 972-8-6231246

Contact Person:

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

Date Prepared:

September 2002

Trade Name:

SmartStep System

Classification Name:

DEVICE, WARNING, OVERLOAD, EXTERNAL LIMB, POWERED

Classification:

The FDA has classified Enteroscopes as class II devices (product code IRN, Regulation No. 890.5575) and they are reviewed by the Physical Medicine Panel.

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page 2 of 3

Predicate Device:

Ped Alert Plenet manufactured by Planet Products Corp USA (former ● Orbitec Technologies Corp.) cleared under K950656.
ForceGuard manufactured by Impact Monitors, Inc. USA cleared under ● K955034.
AccuTread™ System manufactured by Chattanooga Group Inc. cleared ● under K991313.

Performance Standards:

No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act. However, the SmartStep System complies with the voluntary standards such as IEC 60601-1, IEC 60601-2, IEC 60601-1-4, EN-1441.

Intended Use:

Device Description:

The SmartStep system is to be used under the supervision of physician or licensed health care provider such as physiotherapist.

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K023161
page 3 of 3

The SmartStep system is comprised of three sub elements:

Flexible Foot force insole that is placed on the inside of a shoe worn by the patient over a sock.

Central Processing Unit (CPU)- the unit is connected to computer software.

Computer software that acts as a patient medical record and patient assessment tool.

Substantial Equivalence:

Based on validations and performance testing results, Andante Medical Devices Ltd. believes that the SmartStep System is substantially equivalent to its predicate device cited above without raising new safety and/or effectiveness issues.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

nd Drug Administration 00 Corporate Boulevard Rockville MD 20850

DEC 1 0 2002

Mr. Orly Maor Push-Med Ltd. for Andante Medical Devices Ltd. 117. Ahuza Street Ra'ananna 43373, ISRAEL

Re: K023161

Trade/Device Name: Andante SmartStep System Regulation Number: 21 CFR 890.5575 Regulation Name: Powered External Limb Overload Warning Device Regulatory Class: II Product Code: IRN Dated: September 18, 2002 Received: September 23, 2002

Dear Mr. Maor:

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.

Image /page/3/Picture/12 description: The image shows a partial view of a logo or emblem. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the edge of the image. A stylized graphic element, consisting of a series of curved lines, is also visible.

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Page 2 - Mr. Orly Maor

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. 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 Office of Compliance at (301) 594- _ . 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 N. 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 STATEMEN

510(k) Number (if known):

Device Name:

SmartStep System

Indications for Use:

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

510(k) Number

Prescription Use (Per 21 CFR 801.109) OR

Over the Counter Use

for Mark n Melleen
(Division Sign-Off)

eral, Restorative

510(k) Number k0231

Regulation Number and Section

§ 890.5575 Powered external limb overload warning device.

(a)
Identification. A powered external limb overload warning device is a device intended for medical purposes to warn a patient of an overload or an underload in the amount of pressure placed on a leg.(b)
Classification. Class II (special 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.