The TyTron C-3000 is indicated for use in detecting, measuring, recording, and graphing the skin surface temperature on both sides of the spine of adults and children by professional health care providers. It is to be used before and after therapy is rendered as part of monitoring the patient's response to care.

Device Description

The TyTron C-3000 is a hand held paraspinal thermographic scanning system. It consists of two probes which each contain infrared sensors designed to be placed on either side of the spinal column to detect temperatures. With the aid of a computer assisted program the system is capable of recording and graphing thermal differentials (right to left thermal asymmetries) on a horizontal scale. It also records direct temperatures on the vertical scale.

AI/ML Overview

Here's an analysis of the provided information regarding the TyTron C-3000, addressing your specific questions:

Acceptance Criteria and Study for TyTron C-3000

The provided document describes the TyTron C-3000, a hand-held paraspinal thermographic scanning system, and compares it to a predicate device, Thermatrax, to establish substantial equivalence. The "study" in this context is a technical comparison of device specifications to demonstrate that the TyTron C-3000 performs as well as or better than the predicate device for specified technical parameters. This is not a clinical trial in the sense of patient outcomes or diagnostic effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the performance characteristics of the predicate device, Thermatrax. The TyTron C-3000 demonstrates performance that meets or exceeds these criteria.

Test	Acceptance Criteria (Predicate: Thermatrax)	Reported Device Performance (TyTron C-3000)	Meets Criteria?
Accuracy	± 1°C	± 1°C	Yes
Orientation of sensors	Parallel, 2" centers	Parallel, 1.85" centers	Yes (Similar)
Filtering circuit	Yes	Yes	Yes
Sensitivity	± 0.05°C	± 0.01°C	Yes (Better)
Reproducibility	± 0.10°C	± 0.05°C	Yes (Better)
Accuracy, odometer	Not applicable	± 0.25 cm	N/A (New feature/test)
Sensor Wavelength	Must contact skin	6 - 14 micrometers	Yes (Broader/Different)

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

The document does not describe a clinical "test set" in the traditional sense of patient data. The "testing" referred to is a comparison of technical specifications against a predicate device. Therefore, a sample size for a test set and data provenance (country of origin, retrospective/prospective) are not applicable in this context. The testing is focused on the inherent device characteristics and performance.

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

This information is not provided. Given that the "study" is a technical comparison of device specifications, it's unlikely that external experts were used to establish a "ground truth" for a test set in the way one would for diagnostic imaging. The performance parameters (accuracy, sensitivity, reproducibility) would typically be verified by engineering and quality control processes.

4. Adjudication Method

Not applicable. There is no mention of a human-adjudicated test set or a need for an adjudication method like 2+1 or 3+1.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This document outlines a 510(k) submission for substantial equivalence based on technical specifications and indications for use, not a clinical effectiveness study involving human readers and interpretation. Therefore, an effect size of human readers improving with AI vs without AI assistance is not applicable.

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

Yes, in a way. The performance metrics of the device (accuracy, sensitivity, reproducibility) are standalone measures of the device's technical capabilities without inherent human-in-the-loop performance measurement. The device itself performs the sensing and data recording. The "algorithm" here is the device's inherent measurement and processing capability.

7. The Type of Ground Truth Used

The "ground truth" for the technical specifications is the established engineering standards for measurement accuracy, sensitivity, and reproducibility. These are fundamental physical properties and performance characteristics of the sensors and the system as a whole, typically verified through calibration and controlled laboratory testing. The predicate device's specifications serve as the benchmark for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. The TyTron C-3000 is a measurement device, not an AI/machine learning algorithm requiring a separate training set of data. Its performance is based on its physical design, sensor technology, and electronic processing, all of which are established during the device's design and manufacturing process, not through statistical learning from a training dataset.

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

Not applicable, as there is no training set in the context of an AI/machine learning algorithm. The "truth" for the device's design and engineering would be based on fundamental physics, sensor calibration standards, and established electronic design principles.

Summary

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FEB 3 1998

SUMMARY OF SAFETY AND EFFECTIVENESS XIV.

TyTron C-3000

K974208

દર્દર

Manufacturer:	Titronics Research and Development Company2046 Redwing Hollow S.W.Oxford, IA 52322-9112
Contact Person:	Joseph Roger Titone, B.S.M.E.Same address as above
Telephone:Fax: .	(319) 683-2702(319) 683-2862
Date Summary Prepared:	October 26, 1997
Product Trade Name:	TyTron C-3000
Common Name:	Computer Aided Paraspinal ThermographicScanning System
Classification:	Powered direct-contact temperature measurement deviceNeurological Devices Classification Panel21 Code of Federal Regulations 882.1570
Class:	II
Panel:	84
Procode:	84HCS
Predicate Device:	Thermatrax submitted by Artronics K-950986

Description:

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Indications For Use:

Substantial Equivalence:

The TyTron C-3000 is substantially equivalent to Thermatrax in that it provides the following characteristics:

-Thermocouple material used in the sensors -Physical characteristics are essentially the same -Material composition is essentially the same -Same indications for use -Same presentation of paraspinal temperature data -Both use microprocessors to process data -Both powered by isolated low voltage power supplies
Summary of Testing:

Test	Thermatrax	C-3000
Accuracy	$\pm$ 1°C	$\pm$ 1°C
Orientation of sensors	parallel, 2" centers	parallel, 1.85" centers
Filtering circuit	yes	yes
Sensitivity	$\pm$ 0.05°C	$\pm$ 0.01°C
Reproducibility	$\pm$ 0.10°C	$\pm$ 0.05°C
Accuracy, odometer	not applicable	$\pm$ 0.25 cm
Sensor Wavelength	must contact skin	6 - 14 micrometers

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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 features a stylized eagle with its wings spread, formed by three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 3 1998

Mr. Joseph R. Titone, BSME President Titronics Research & Development Company 2046 Redwing Hollow S.W. Oxford, Iowa 52322

Re: K974208 Trade Name: Tytron C-3000 Regulatory Class: II Product Code: HCS Dated: October 28, 1997 Received: November 10, 1997

Dear Mr. Titone:

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 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 Quality 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

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Page 2 - Mr. Titone

devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 predicate device results in a classification for your device and thus, permits vour 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) 594-4595. 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" (21 CFR 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/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Titronics Research & Development Co. TyTron C-3000 PARASPINAL INFRARED TEMPERATURE RECORDER PREMARKET NOTIFICATION 510(k)

974208

INDICATIONS FOR USE IX.

The TyTron C-3000 is indicated for use in detecting, measuring, recording, and graphing the skin surface temperature on both sides of the spine of adults and children by chiropractors. It is to be used before and after therapy is rendered as part of monitoring the patient's response to care, similar to a common thermometer. ( Exhibit K - COMMENTS ON THE CLINICAL APPLICATION OF THE C-3000)

Prescription Use
(Per 21 CFR 801.109)

Ascotter

Regulation Number and Section

§ 882.1570 Powered direct-contact temperature measurement device.

(a)
Identification. A powered direct-contact temperature measurement device is a device which contains a power source and is used to measure differences in temperature between two points on the body.(b)
Classification. Class II (performance standards).