The AMES Therapy Device is a rehabilitative exercise therapy device that uses assisted movement to measure, evaluate, exercise, re-educate and strengthen muscles, and to increase joint range of motion. It also uses muscle vibration for muscle relaxation.

Device Description

The AMES Therapy Device is an electromechanical physical therapy device that combines 3 motion assemblies (one for the ankle, one for the wrist, and one for the thumb-and-fingers), 5 therapeutic vibrators, and a visual feedback unit, all contained in one device. The patient is seated in a separate conventional chair or wheelchair so that the appropriate limb can be attached to the AMES Therapy Device for therapy. The AMES Therapy Device includes assisted movement to the limb being treated and applies simultaneous vibration to the antagonist muscle. The device provides visual feedback to the patient to indicate whether he/she is producing the requisite force (torque) in assisting the device's motion and encourages the patient to keep working the agonist muscle. The feedback also includes a force (torque) "target," set to a level by the the patient can achieve repeatedly during therapy without becoming too fatigued, but that is also moderately challenging. The torque produced by the patient is indicated on the video touch screen. Testing and reporting on the patient's therapy and functional status can be performed at each therapy session prior to or following administration of therapy. Data for each session include therapy delivery (date, duration, performance) and test results. Two tests are carried out during the treatment session to measure: 1) active range-of-motion, and 2) strength. These test scores permit the therapist: (i) to determine each patient's baseline status at the time that the patient first receives the AMES therapy, and (ii) to monitor changes in rehabilitation status during the course of the patient's therapy. This testing enables therapists to modify the treatment regimen in response to observed improvements and to determine when is no longer benefitting from the therapy. The AMES Therapy Device is non-invasive and there is no electrical stimulation involved in the device, nor any recording of bioelectric potentials. No heat is applied by the AMES Therapy Device.

AI/ML Overview

Here's an analysis of the AMES Therapy Device's acceptance criteria and studies, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or detailed performance metrics from a clinical study. Instead, it focuses on demonstrating that the device performs as designed and is substantially equivalent to predicate devices. The "performance" described is largely qualitative or pertains to general safety and functionality.

Acceptance Criterion (Implicit)	Reported Device Performance (from Non-Clinical & Clinical Testing)
Electrical Safety	Meets UL 60601-1 and IEC 60601-1-2 (EMC) standards.
Biocompatibility	Patient-contacting materials are not irritating, sensitizing, or cytotoxic.
Design Functionality	Performs as designed and met its specifications (Design Verification Testing).
Clinical Safety (Skin Integrity)	Safety data from clinical evaluations evaluated safety with respect to skin integrity.
Substantial Equivalence	Demonstrated substantial equivalence in intended use, indications for use, and device function/features to predicate devices (System 4 and Vibracussor).

Regarding the Absence of Detailed Performance Criteria:

It's crucial to understand that for a 510(k) submission, particularly for devices with well-established predicate technology, the primary goal is often to demonstrate substantial equivalence rather than to prove novel efficacy against specific, high-bar performance criteria. The "acceptance criteria" here are more about meeting recognized safety standards, demonstrating intended functionality, and showing comparability to legally marketed devices.

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

Sample Size for Test Set: Not explicitly stated. The document mentions "clinical evaluations" and "safety data from clinical evaluations" but does not specify the number of participants or the size of these evaluations.
Data Provenance: Not explicitly stated. The document does not mention the country of origin of the data. It implies the data is prospective as it refers to "clinical evaluations" of the AMES Therapy Device itself, rather than retrospective analysis of existing data.

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

This information is not provided in the document.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No MRMC comparative effectiveness study is mentioned. The submission focuses on demonstrating the device's own safety and functionality, and its substantial equivalence to predicate devices, not on comparing the efficacy or improvement of human readers (or therapists in this context) with or without AI assistance. The AMES Therapy Device is described as a standalone physical therapy device, not an AI-assisted diagnostic or interpretation tool.

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

The AMES Therapy Device is a physical therapy device with a human (patient) interacting directly with it, guided by a therapist. It's not an algorithm-only device in the diagnostic or imaging sense. The device itself is "standalone" in the sense that its performance evaluation (safety, functionality) does not involve a human interpreting its output for diagnostic purposes. However, a human is inherently "in-the-loop" as a patient receiving therapy and a therapist managing the treatment.

7. The Type of Ground Truth Used

Given the nature of the device (physical therapy), "ground truth" in the typical AI/diagnostic sense (e.g., pathology, expert consensus on imaging) is not directly applicable. For the AMES Therapy Device, the "ground truth" during its "clinical evaluations" would likely relate to:

Observed clinical safety outcomes: Was there skin irritation? Were there adverse events?
Device functionality: Did the device perform its movements, provide vibration, and measure torque/ROM as designed?
Patient feedback/clinical assessment: Did the patient tolerate the therapy? Did therapists observe expected changes in patient status during the course of therapy (as the device aids in monitoring ROM and strength, but doesn't "diagnose").

The document primarily highlights "Safety data from clinical evaluations... to evaluate the safety of the device with respect to skin integrity." This suggests observed clinical safety outcomes were a primary "ground truth" during its human-use testing.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The AMES Therapy Device, as described, is an electromechanical physical therapy device. It does not appear to employ machine learning or AI algorithms that would require a "training set" in the context of typical AI device development.

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

This information is not applicable for the same reasons as point 8.

Summary

{0}------------------------------------------------

AMES Therapy Device, K123746/S001 Response to Request for Additional Information

510(k) SUMMARY

1. Contact Information

Submitter's name:	AMES Technology, Inc.657 SW Regency PlacePortland, OR 97225
Contact name and address:	Sheila Ramerman, RACSJR Associates927 Throne Dr.Eugene, OR 97402PH/FAX: 541.683.3017Email: sramerman@aol.com
Date summary prepared:	May 17, 2013

2. Device names:

Proprietary name	Common name	Classification names
AMES Therapy Device	Electromechanical physical therapydevice	Isokinetic Testing &Evaluation DeviceTherapeutic Vibrator

Device Classification:

Classification Name	Product Code	21 CFR citation	Class	Panel
Isokinetic Testing &EvaluationDevice	IKK	890.1925	II	Physical Medicine
Therapeutic Vibrator	IRO	890.5975	I	Physical Medicine

3. Predicate Devices:

The AMES Therapy Device is a combination of the intended use, functions, and features of the following currently marketed physical therapy devices:

510(k) Number	Product Code,Class	Trade Name	Manufacturer
K951770(now 510(k)-exempt)	IKKClass II	System 4	Biodex Medical Systems, Inc.
N/A(510(k)-exempt)	IROClass I	Vibracussor	Innovative MachineryPackaging and Converting,Inc.

Page 4- 1

{1}------------------------------------------------

4. Device Description:

The AMES Therapy Device includes assisted movement to the limb being treated and applies simultaneous vibration to the antagonist muscle. The device provides visual feedback to the patient to indicate whether he/she is producing the requisite force (torque) in assisting the device's motion and encourages the patient to keep working the agonist muscle. The feedback also includes a force (torque) "target," set to a level by the the patient can achieve repeatedly during therapy without becoming too fatigued, but that is also moderately challenging. The torque produced by the patient is indicated on the video touch screen.

Testing and reporting on the patient's therapy and functional status can be performed at each therapy session prior to or following administration of therapy. Data for each session include therapy delivery (date, duration, performance) and test results. Two tests are carried out during the treatment session to measure: 1) active range-of-motion, and 2) strength. These test scores permit the therapist: (i) to determine each patient's baseline status at the time that the patient first receives the AMES therapy, and (ii) to monitor changes in rehabilitation status during the course of the patient's therapy. This testing enables therapists to modify the treatment regimen in response to observed improvements and to determine when is no longer benefitting from the therapy.

The AMES Therapy Device is non-invasive and there is no electrical stimulation involved in the device, nor any recording of bioelectric potentials. No heat is applied by the AMES Therapy Device.

5. Intended Use/Indications for Use:

6. Comparison with the Predicate Devices:

Because the AMES Therapy Device combines the functions and characteristics of different physical therapy devices, multiple predicate devices are presented. Like the System 4 device, the AMES Device is intended to exercise, measure, evaluate and increase the strength of muscles and increase the Range of Motion (ROM) of joints. Like the Vibracussor device, the AMES Device is intended to relax muscles using vibration. The AMES Therapy Device uses isokinetic principles like the System 4 device to deliver therapy, and uses vibration like the Vibracussor device to deliver therapy to relax muscles. Based on these comparisons, the AMES Therapy Device is substantially equivalent to the predicate devices in intended use, indications for use, and device function and features.

Page 4- 2

{2}------------------------------------------------

7. Non-Clinical Testing:

Testing has been conducted to UL 60601-1 Standard for Safety for Medical Electrical Equipment, Part 1: General Requirements for Safety and IEC 60601-1-2 Medical Electrical Equipment - Part 1-2: General Requirements for Safety: Electromagnetic Compatibility - Requirements and Tests.

Biocompatibility testing for patient-contacting materials is included that demonstrates that the patient-contacting materials are not irritating, sensitizing, or cytotoxic.

Design verification testing was performed on fully functional AMES Therapy Devices to demonstrate that the AMES device performed as designed and met its specifications.

8. Clinical Testing:

Safety data from clinical evaluations of the AMES Therapy Device were used to evaluate the safety of the device with respect to skin integrity.

9. Conclusions:

Non-clinical testing showed that the AMES device performs as designed. Based on the information presented in this submission, we believe that the AMES Therapy Device is substantially equivalent to the predicate devices in intended use, indications for use, and device function and features.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Public Health Service

May 24,2013

AMES Technology, Inc. C/O Ms. Sheila Ramerman. RAC SJR Associates 927 Thorne Drive Eugene, Oregon 97402

Re: K123746

Trade Name: AMES Therapy Device Regulation Number: 21 CFR 890.1925 Regulation Name: Isokinetic Testing and Evaluation Device Regulatory Class: Class II Product Code: IKK, IRO Dated: April 25, 2013 Received: April 26, 2013

Dear Ms. Ramerman:

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

{4}------------------------------------------------

Page 2 - Ms. Sheila Ramerman

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 go to: http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

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

Sincerely yours,

Joyce M. Whang -S

for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use

510(k) Number (if known): _ K123746

Device Name:

Indications For Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joyce M. Whang

(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)

510(k) Number __ K123746

Page 1 of 1

Regulation Number and Section

§ 890.1925 Isokinetic testing and evaluation system.

(a)
Identification. An isokinetic testing and evaluation system is a rehabilitative exercise device intended for medical purposes, such as to measure, evaluate, and increase the strength of muscles and the range of motion of joints.(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 § 890.9.