The Tremorometer is designed to be used to measure and record tri-axial readings of a patient's tremor motions, to optionally combine the three axis tremor information into a single measurement of total tremor movement by a proprietary algorithm that eliminates some of the rotational, orientation and other artifacts, to display the information graphically, and to transfer the data to a PC for further analysis, display, printing or storage.

Device Description

The Tremorometer is a system designed to improve the measurement and quantification of tremor in human patients regardless of the underlying etiology of the tremor. It consists of a Tremor Sensor, a microcomputer and programs to operate the microcomputer. The federally registered trademark "Tremorometer" is intended to cover the system comprised of these three parts.

The Tremor Sensor is a three axis accelerometer that attaches to a patient's finger and transmits the tri-axial tremor measurements to the Tremorometer. Other acceleration measuring devices could be used in place of the current Tremor Sensor provided they met the sensitivity, accuracy, resolution and range of the current device.

The microcomputer is the FlexLab™ manufactured by FlexAble Systems, Inc. that is used in a number of industrial applications. It is a battery powered, hand-held, self-contained, programmable device. Other microcomputers with the capability of reading the pulse width modulated signals generated by the Tremor Sensor could be used in place of the FlexLab.

The programs range from general system software to control the keypad and LCD displays to proprietary algorithms that process the tremor data. The code is written in 'C' and could be easily ported to another microcomputer.

The FlexLab has a keypad and LCD display for interaction with the user. General purpose software provides for setting and reading date and time from a clock/calendar IC; bi-directional serial communication using Xmodem CRC and CSum protocols at selectable Baud rates; display and control of system settings; and more. Custom software designed specifically for the tremor measuring and processing application include routines to take precisely timed measurements from the Tremor Sensor; perform calibration of the Tremor Sensor using Earth's gravity as a reference; run automated, timed series of tests; process and store data with check digits to insure data integrity; display the data graphically on the LCD; generate and maintain record headers; control the transmission of complete records to a PC; clear records; download user generated test lists; and more.

The three-axis reading may be combined into a single composite measure of total movement by proprietary algorithms that eliminate some of the non-tremor signals such as rotational components, orientation relative to Earth's gravity and other artifacts.

AI/ML Overview

Here's an analysis of the provided text regarding the Tremorometer, structured to address your specific points.

Acceptance Criteria and Device Performance Study for the Tremorometer®

The provided document is a 510(k) summary for the Tremorometer, focusing on demonstrating substantial equivalence to predicate devices rather than specific, quantitative acceptance criteria for device performance. Therefore, direct "acceptance criteria" and "reported device performance" in numerical terms are not explicitly stated. The study proves substantial equivalence, not a pre-defined performance threshold.

However, based on the intent of the 510(k) submission, the "acceptance criteria" can be inferred as performing as well as the legally marketed predicate devices (FlexiPlus™ and/or Actiwatch®) for the stated indications for use.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance (Summary)
Functional Equivalence: Measure tremor movements.	The Tremorometer is "designed to measure a patient's tri-axial tremor movements."
Technological Equivalence: Possess similar technological characteristics to predicate devices.	"The technological characteristics of the Tremorometer are very similar to those of the legally marketed FlexiPlus™ and/or the Actiwatch® devices." Specific features like battery operation, internal data storage, data amplification, proprietary software analysis, and PC download are shared.
Performance Equivalence: Perform "as well as" legally marketed predicate devices (FlexiPlus™ and/or Actiwatch®).	"The results of this testing documents that the Tremorometer performs as well as the legally marketed FlexiPlusTM and/or the Actiwatch® devices."
Software Verification & Validation: Tremorometer software functions correctly and reliably.	"The Tremorometer software was subjected to internal verification and validation testing, the results of which are documented in this submission."
Accessory/Third-Party Software Compatibility: Proper function and data management with other systems.	"The accessory software and third-party software used in combination with this device and the data created by this device has been subject to validation and comparison to other data management system."

2. Sample Size and Data Provenance for the Test Set

Sample Size: The document does not specify a numerical sample size for the test set used in beta testing. It mentions "a variety of study centers."
Data Provenance: The beta testing was conducted at "a variety of study centers" under "current and valid IRBs, informed consent and protocols." This indicates prospective data collection. The country of origin is not explicitly stated, but the context of an FDA 510(k) submission suggests United States studies.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: The document does not specify the number of experts used to establish ground truth.
Qualifications of Experts: The testing was "conducted by qualified researchers operating under current and valid IRBs, informed consent and protocols coordinated by Robert M. Tripp, Ph.D., and Michael P. Caligiuri, Ph.D. a qualified Scientific Investigator." This indicates the involvement of qualified scientific investigators (Ph.D. level), but their specific medical or technical specializations relevant to tremor assessment are not detailed (e.g., neurologists).

4. Adjudication Method for the Test Set

The document does not describe any explicit adjudication method (e.g., 2+1, 3+1). It states that testing was "coordinated" by two Ph.D.s, implying oversight, but not a specific consensus or arbitration process for ground truth.

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

There is no indication of a multi-reader multi-case (MRMC) comparative effectiveness study being performed to assess how human readers improve with AI vs. without AI assistance. The Tremorometer is described as a measurement device, not an AI-assisted diagnostic tool for human readers.

6. Standalone (Algorithm Only) Performance

The document describes the Tremorometer as a standalone device with proprietary algorithms that "process the tremor data" and "eliminate some of the non-tremor signals such as rotational components, orientation relative to Earth's gravity and other artifacts." This implies that the algorithm's performance in processing and quantifying tremor is inherent to the device's function.

Therefore, a standalone (algorithm only) performance would have been evaluated as part of the overall device performance, specifically its ability to accurately measure and quantify tremor. The statement that "The Tremorometer performs as well as the legally marketed FlexiPlusTM and/or the Actiwatch® devices" serves as the overall validation for this standalone performance, although specific metrics for the algorithm's accuracy in artifact removal are not provided.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used. However, given that it's comparing a device designed to "measure a patient's tri-axial tremor movements" against other activity/motion measurement devices, the ground truth would most likely involve:

Direct comparison to existing, validated methods/devices: This is heavily implied by the substantial equivalence argument where the Tremorometer is shown to perform "as well as" predicate devices. The "ground truth" implicitly comes from the established performance of the legally marketed predicate devices.
Clinical observation/assessment by the "qualified researchers": The Ph.D.s and researchers conducting the beta testing would likely be assessing the tremor characteristics, which would form the basis of comparison for the device's measurements.

It is unlikely to be pathology or outcomes data in this context, as the device is for measurement, not diagnosis or prognosis.

8. Sample Size for the Training Set

The document does not mention a separate "training set" or its sample size. The description of "alpha and beta testing" primarily pertains to testing and validation. The proprietary algorithms were likely developed and refined internally, but information on a dedicated training set for machine learning models (if applicable to the "proprietary algorithms") is absent.

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

Since a specific "training set" is not mentioned in the context of machine learning model development (which is what "ground truth for training set" typically refers to), this information is not provided. The proprietary algorithms were developed by FlexAble Systems, Inc., suggesting internal development and validation against potentially curated datasets or expert knowledge, but the specifics are not detailed.

Summary

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FlexAble Systems, Inc. 510(k) SUMMARY

EXHIBIT 1 Page 1

510(k) SUMMARY

K010270

JUL 2 5 2001

TREMOROMETER®

Common/Classification Name:

System, Telemetry, Physiological Signal Conditioner

FlexAble Systems, Inc. 16410 East Tombstone Avenue Fountain Hills, AZ 85268-6545.

Contact:

Robert M. Tripp, Ph. D., President

Preparation Date:

January 12, 2001

LEGALLY MARKETED PREDICATE DEVICES A.

The Tremorometer® is substantially equivalent to the legally marketed Axiom or FlexiPlus™ and/or the Actiwatch® devices.

B. DEVICE DESCRIPTION

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C. INDICATIONS FOR USE

The Tremorometer is designed to measure a patient's tri-axial tremor movements.

SUBSTANTIAL EQUIVALENCE SUMMARY D.

The Tremorometer has the same indications for use as the legally marketed Axiom or FlexiPlus™ (referred to as the FlexiPlus) and/or the Actiwatch® devices. The Tremorometer has the same technological characteristics as the legally marketed FlexiPlus™ and/or the Actiwatch® devices. However, the characteristics may not be sufficiently precise to assure equivalence. Therefore, FlexAble Systems, Inc. has carried out validation and performance testing. The results of this testing documents that the Tremorometer performs as well as the legally marketed FlexiPlusTM and/or the Actiwatch® devices.

TECHNOLOGICAL CHARACTERISTICS E.

Characteristic	FlexiPlus™	Actiwatch	Tremorometer
Measures muscle testing	Yes	No	No
Measures occurrence and degree of motion	No	Yes	No
Measures tremor	No	No	Yes
Attaches to arm	Yes	No	Yes
Attaches to wrist	No	Yes	Yes
Attaches to finger	No	No	Yes
Battery operated	Yes	Yes	Yes
Stores measured data internally	Yes	Yes	Yes
Amplifies data	Yes	Yes	Yes
Proprietary software analyses data	Yes	Yes	Yes
Downloads collected data to PC	Yes	Yes	Yes

The technological characteristics of the Tremorometer are very similar to those of the legally marketed FlexiPlus™ and/or the Actiwatch® devices. The similarities and differences include:

F. TESTING

The Tremorometer device has undergone extensive alpha and beta testing. Beta testing included testing at a variety of study centers conducted by qualified researchers operating under current and valid IRBs, informed consent and protocols coordinated by Robert M. Tripp, Ph.D., and Michael P. Caligiuri, Ph.D. a qualified Scientific Investigator.

The Tremorometer software was subjected to internal verification and validation testing, the results of which are documented in this submission.

The accessory software and third-party software used in combination with this device and the data created by this device has been subject to validation and comparison to other data management system.

G. CONCLUSIONS

The validation studies document that the Tremorometer is substantially equivalent to the legally marketed FlexiPlus™ and/or the Actiwatch® devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 5 2001

Robert M. Tripp, Ph.D. President Flexable Systems, Inc. 16410 E. Tombstone Avenue Fountain Hills, Arizona 85268

Re: K010270

Trade/Device Name: Tremorometer® Regulation Number: 882.1400 Regulatory Class: II Product Code: GWQ Dated: April 24, 2001 Received: April 27, 2001

Dear Dr. Tripp:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Robert M. Tripp, Ph.D.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nothloate 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 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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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STATEMENT OF INDICATIONS FOR USE

Kolo270 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: TREMOROMETER®

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative and Neurological Devices
510(k) Number	K010270

Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter Use
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Regulation Number and Section

§ 882.1950 Tremor transducer.

(a)
Identification. A tremor transducer is a device used to measure the degree of tremor caused by certain diseases.(b)
Classification. Class II (performance standards).