The Back-tek system is indicated for the temporary relief of minor muscle and joint pain and stiffness; and the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains and sprains and minor muscular back pain; muscular relaxation; and the temporary increase of local circulation where applied.

Device Description

The Back-tek device is a far infrared heating device that is provided in a back support belt.

AI/ML Overview

The provided text describes the 510(k) summary for the Back-Tek device, an infrared lamp, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria related to its performance beyond general therapeutic heat.

Here's a breakdown of what is and is not in the provided text, aligning with your requested information:

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

Acceptance Criteria: Not explicitly stated as quantifiable metrics. The only performance data mentioned is "Skin temperature testing is provided to show that the Back-Tek provides therapeutic heat during the treatment cycle."
Reported Device Performance: The text states the device "provides therapeutic heat during the treatment cycle." It does not provide specific temperature ranges, rise times, or other quantifiable performance metrics that would typically be part of an acceptance criterion.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not found. The document mentions "Skin temperature testing" but provides no details on the sample size used, whether the study was retrospective or prospective, or the country of origin of the data.

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 applicable / Not found. This type of information is typically relevant for diagnostic devices where expert review establishes a "ground truth" for classification tasks. The Back-Tek is a therapeutic device (infrared lamp) for pain relief and circulation. The "performance data" mentioned is purely related to physical parameters (temperature), not diagnostic interpretation.

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

Not applicable / Not found. Similar to point 3, adjudication methods are used in studies involving expert review for diagnostic agreement. This is not relevant for a device like the Back-Tek.

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 / Not found. This device is an infrared lamp, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and effects on human readers are not relevant.

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

Not applicable / Not found. The Back-Tek is a physical device, not an algorithm.

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

Not applicable / Not found. For the "Skin temperature testing," the "ground truth" would be the actual temperature measurements, which are objective physical parameters, not a subjective interpretation requiring expert consensus, pathology, or outcomes data in the usual sense.

8. The sample size for the training set

Not applicable / Not found. This device is not an AI/ML algorithm that requires a "training set."

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

Not applicable / Not found. As it's not an AI/ML algorithm, there is no training set or associated ground truth establishment process.

Summary of available information:

The provided documents focus on the regulatory classification (510(k) submission) of the Back-Tek device as an infrared lamp. Its "Performance Data" section merely states that "Skin temperature testing is provided to show that the Back-Tek provides therapeutic heat during the treatment cycle." This is a general statement of functionality rather than a detailed report of a study with specific acceptance criteria, methodology, or results. The primary argument for clearance is substantial equivalence to a predicate device (Thermotex Platinum Heat Therapy System cleared in K092589) based on "indication for use and technological characteristics," implying that if the predicate device met safety and effectiveness standards, the similar Back-Tek device should as well.

Summary

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

York Biomedical

, ,

5.0 510(k) Summary or 510(k) Statement

In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Back-Tek device is provided below.

Device Common Name:	Infrared Lamp
Device Proprietary Name:	Back-Tek	JUN 23 2010
Submitter:	York Biomedical Inc.8132 Artie Kemp Rd.Frederick, MD 21701Phone: 301-788-0702
Contact:	Calley HerzogConsultantBiologics Consulting Group, Inc.Phone: 720-883-3633Email: cherzog@bcg-usa.com
ClassificationRegulation:	21 CFR 890.5500
Panel:	Physical Medicine
Product Code:	ILY

Indication for Use:

Device Description:

The Back-tek device is a far infrared heating device that is provided in a back support belt.

Performance Data:

Skin temperature testing is provided to show that the Back-Tek provides therapeutic heat during the treatment cycle.

Substantial Equivalence:

The Back-Tek device is a far infrared heating device that is substantially equivalent to the Thermotex Platimun Heat Therapy System cleared in K092589 based on indication for use and technological characteristics.

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

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

York Biomedical, Inc. % Biologics Consulting Group, Inc. Ms. Calley Herzog 13417 Quivas Street Westminster, Colorado 80234

Re: K101227

Trade/Device Name: Back-Tek Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: May 3, 2010 Received: May 3, 2010

Dear Ms. Herzog:

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. Ilsting 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

JUN 2 3 2010

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

Page 2 - Ms. Calley Herzog

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/ucm1.1.5809.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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Sincererly, years,

Mark A. Milkus

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

York Biomedical

くな

4.0 Indications for Use Statement

510(k) Number (if known): __

Device Name: Back-Tek

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use__X (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)

(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices

Page 1 of

Number K1012

Page 10

Regulation Number and Section

N/A