The intended use of the AcQPoint Thermajade Massage Table is to provide the user with muscle relaxation therapy by delivering heat and gentle massage. Additionally the heat elements provide topical heating for

temporary relief of minor muscle and joint pain and stiffness;
temporary relief of joint pain associated with arthritis
temporary increase in local circulation in the areas affected by the device
relaxation of muscles.

Device Description

The AcQPoint Thermajade Massage Table is an electrically powered, motorized multi-function physical therapy table. It is intended to provide muscle relaxation therapy by delivering heat and gentle massage. The massage function is delivered by two sets of natural jade rollers mounted on carriages in both the torso and leg sections of the device, These roller carriages travel along a guide rail track which is curved to conform to the natural curve of the spine. They are moved by a cable and pulley arrangement powered by two DC motors, one each for the torso and the leg sections.. Heat is delivered by both halogen heat lamps located inside the jade rollers and carbon epoxy heating panels on the platform beneath them. The panels emit radiant heat and the rollers conductive heat. During use, as the rollers traverse the torso and liefers the device applies light pressure as well as heat to the user.

The motion of the rollers is selectable by the user. different programs as well as a manual, user controlled, mode. There are unfo the programs last forty minutes and concentrate the massage action on different parts of the back, as well as stopping for 20 to 30 seconds at various acupressure points, and the third lasts fifteen minutes and travels continuously up and down the entire back.

The functions of the device, the temperature settings for both the carbon/epoxy emitters and the rollers and the program selection are controlled by a wired remote control with a LED display that indicates the selected program, the temperature settings and current temperatures along with a timer.

The motion of the rollers, the temperature settings and the displays on the remote are controlled by a microprocessor unit employing a microcontroller with 28k of built-in flash ROM as well as timers, EEPROM, a UART to interface with external devices and other elements required for the proper execution of the installed software and the function of the device. The software has been verified by both single step and breakpoint checks in the debugging process and validated by final bench testing on the completed device.

The device measures 27" (68.5 cm) wide by 78" (198 cm) long and has a table height of 20" (51 cm). It weighs 160 lbs. (72 kg) and has a working weight load limit of 300 lbs. (136 kg.). It is wired for 120 volt flass a cycle current and draws a maximum of 480W.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the AcQPoint Thermajade Massage Table, structured according to your request:

Based on the provided 510(k) premarket notification summary for the AcQPoint Thermajade Massage Table Model BL-7600 (K102938), the device's performance data primarily focuses on heat delivery and safety, with references to conformance with electrical safety and electromagnetic compatibility standards.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Therapeutic Heat	Consistently deliver skin temperatures within a therapeutic range and below a burn risk threshold for the entire period of use.	"Testing was performed to ensure that the device operates in a therapeutic heat range while maintaining safety. These tests show that the tables, after the warm-up period, consistently deliver skin temperatures of between 40° C and 42.5° C for the entire period of use. This is within the range considered therapeutic and below that considered to pose a risk of burn."
Safety (Electrical)	Conformance to ISO/IEC 60601-1: Medical Electrical Equipment—Part 1: General Requirements for Safety.	"An independent testing laboratory has confirmed conformance to the following standards: ISO/IEC 60601-1: Medical Electrical Equipment— Part 1: General Requirements for Safety."
Safety (EMC)	Conformance to ISO/IEC 60601-1-2: collateral standard: Electromagnetic compatibility for medical devices.	"An independent testing laboratory has confirmed conformance to the following standards: ISO/IEC 60601-1-2: collateral standard: Electromagnetic compatibility for medical devices."
Risk Management	Application of risk management to medical devices (ISO 14971:2007) to ensure no unmitigated risks that pose an unacceptable hazard, classifying the device as a minor level of concern.	"We have conducted a risk analysis with consideration of ISO 14971:2007, application of risk management to medical devices, and relevant FDA guidance documents. We have found no unmitigated risks that pose any unacceptable hazard and that it is a device with a minor level of concern."
Software Validation	Software verified by single-step and breakpoint checks and validated by final bench testing. (Implicit acceptance of proper execution and function)	"The software has been verified by both single step and breakpoint checks in the debugging process and validated by final bench testing on the completed device."

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

The document does not explicitly state the sample size used for the heat delivery performance tests (e.g., number of units tested, number of subjects, or duration of tests beyond "entire period of use"). It also does not specify the country of origin for this particular testing data. All testing appears to be prospective as it was performed to ensure the device operates as intended.

For the conformance to ISO/IEC standards, it is implied that a sample of devices (likely at least one production unit) was subjected to the tests by an independent laboratory.

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

Heat Delivery: The document does not specify the number or qualifications of experts involved in establishing the "therapeutic range" of 40-42.5°C or the "risk of burn" threshold. This is likely based on established medical/safety literature rather than immediate expert adjudication for this specific study.
Safety Standards (ISO/IEC): The "independent testing laboratory" would employ qualified engineers and technicians to perform these tests. Their specific titles or years of experience are not detailed.
Risk Analysis: The internal team conducting the risk analysis would consist of individuals knowledgeable in device design, manufacturing, and regulatory affairs, but their specific expert qualifications are not listed.

4. Adjudication Method for the Test Set

There's no mention of an adjudication method in the traditional sense (e.g., for image interpretation or clinical outcomes). The testing performed (heat output, electrical safety, software validation) are objective measurements and assessments against predefined physical and technical standards.

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

No. This type of study is not relevant to the device described (a thermal massage table). MRMC studies are typically used for diagnostic devices where human readers interpret medical images or data, and the focus is on how AI impacts their diagnostic accuracy or efficiency.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, implicitly. The performance data presented (heat output, safety standard conformance, software validation) are all "standalone" in the sense that they are measurements of the device's intrinsic physical and technical properties without a human operator's diagnostic or interpretative input affecting the performance measurement itself. For instance, the device's ability to maintain a specific temperature range is tested directly, not in conjunction with human decision-making.

7. The Type of Ground Truth Used

Heat Delivery: The ground truth for therapeutic heat and burn risk is based on established medical and safety thresholds/ranges (e.g., physiological responses to heat, tissue damage thresholds).
Safety Standards (ISO/IEC): The ground truth is the defined requirements and methodologies of the international standards themselves.
Software Validation: The ground truth for software functionality is the intended design specifications and expected behavior of the software.
Risk Analysis: The ground truth is the principles and guidelines of ISO 14971:2007 for risk management.

8. The Sample Size for the Training Set

The document does not mention any "training set" in the context of machine learning or AI. This device does not appear to involve a learning algorithm that would require a distinct training set. The software mentioned is pre-programmed with fixed cycles without adaptive learning.

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

As no training set is indicated, this question is not applicable.

Summary

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DIANE GREIF-SHEPPARD, PH.D.

K102938

SEP 2 3 2011

SECTION 3

510 (K) PREMARKET NOTIFICATION SUMMARY

Date: September 20, 2010

Owner And Submitter:

AcQPoint, Inc. Diane Greif-Sheppard, Ph.D. 79-825 Highway 111, Suite 101 Loa Quinta, CA 92253 Tel: (760) 775-7900; Fax: (760) 775-7911 Contact : Diane Greif-Sheppard or Morris Sheppard

Proprietary Name:

AcQPoint Thermajade Massage Table Model BL-7600.

Common or Usual Name:

Thermal Massage Table

Classification Name:

Multi-Function Physical Therapy Table (21 CFR 890.5880, Product Code JFB).

Predicate Device:

Ceragem RH-1, 510 (K) number K06276

Device Description:

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the torso and the leg sections.. Heat is delivered by both halogen heat lamps located inside the jade rollers and carbon epoxy heating panels on the platform beneath them. The panels emit radiant heat and the rollers conductive heat. During use, as the rollers traverse the torso and liefers the device applies light pressure as well as heat to the user.

Intended Use:

The intended use of the AcQPoint Thermajade Massage Table is to provide the user with muscle relaxation therapy by delivering have as a gentle massage. Additionally the heat elements provide topical heating for temporary relief of minor muscle and joint pain and stiffness; temporary relief of joint pain associated with arthritis; temporary increase in local circulation in the areas affected by the device and relaxation of muscles.

Technological Characteristics and Substantial Equivalence:

The AcQPoint Thermajade Massage Table and the predicate device both provide heat by both carbon/epoxy heating elements under the roller carriages and halogen heating lamps mounted within the rollers, which heat them. The temperature is user-controlled and limited for

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safety. In both The AcQPoint Thermajade Massage Table and the predicate device the massage function is delivered by jade rollers that are mounted on a carriage which travels along a curved track corresponding to the curvature of the spine and which is pulled by a cable and pulley mechanism powered by a small electric motor. A microprocessor chip pre-programmed with three different cycles, as well as a manually controlled cvcle, controls the forward and back action of the motion. This is identical to the predicate device. Both devices are controlled by wired handheld remotes with LED displays. Both devices are constructed with all elements mounted on a platform that is surrounded with a dense polyurethane foam mattress that is cut out where the roller mechanism operates. Both have synthetic leather zippered covers.

The AcQPoint Thermajade Massage Table differs from the predicate device only in the particular shape of the jade rollers, that it also provides a second set of rollers powered by an additional motor to massage the leg area, that it has an additional roller attached to the carriage in the torso area to provide massage to the neck area and has a torso section that can be tilted up to an approximate 30 degree angle by means of a small motor should the user so desire.

These distinctions do not negatively impact the safety or effectiveness of the device.

Performance Data:

Testing was performed to ensure that the device operates in a therapeutic heat range while maintaining safety. These tests show that the tables, after the warm-up period, consistently deliver skin temperatures of between 40° C and 42.5° C for the entire period of use. This is within the range considered therapeutic and below that considered to pose a risk of burn.

There are no performance standards for this type device but, as with the predicate device, the AcQPoint Thermajade Massage Table bears the CE mark. An independent testing laboratory has confirmed conformance to the following standards:

ISO/IEC 60601-1: Medical Electrical Equipment--- Part 1: General Requirements for Safety.

ISO/IEC 60601-1-2: collateral standard: Electromagnetic compatibility for medical devices.

Risk analysis:

We have conducted a risk analysis with consideration of ISO 14971:2007, application of risk management to medical devices, and relevant FDA guidance documents. We have found no unmitigated risks

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that pose any unacceptable hazard and that it is a device with a minor level of concern.

Conclusion:

The AcQPoint Thermajade Massage Table Model BL-7600 has the same intended use, with similar functional and performance characteristics and has met similar standards as the predicate device. They are substantially equivalent. Other distinctions do not negatively impact the safety or effectiveness of the device.

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Image /page/4/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 department's name around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure, composed of three angled lines above a wavy base.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MI) 20995-0002

AcQpoint Inc. % Mr. Morris Sheppard 79-825 Highway 111, Suite 101 Loa Quinta, California 92253

Re: K102938

Trade/Device Name: AcQPoint Thermajade Massage Table Regulation Number: 21 CFR 890.5880 Regulation Name: Multi-function physical therapy table Regulatory Class: II Product Code: JFB Dated: September 13. 2011 Received: September 13, 2011

SEP 2 3 2511

Dear Mr. Sheppard:

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 fisting (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

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Page 2 - Mr. Morris Sheppard

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.lda.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 Pari 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/dgfault.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 yours

For

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

Enclosure

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Indications for Use

510(k) Number (if known): K 102938

Device Name: AcQPoint Thermajade Massage Table

Indications For Use:

temporary relief of minor muscle and joint pain and stiffness;
temporary relief of joint pain associated with arthritis
temporary increase in local circulation in the areas affected by the device
relaxation of muscles.

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)

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102938

Page 1 of ___ 1_______________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 890.5880 Multi-function physical therapy table.

(a)
Identification. A multi-function physical therapy table is a device intended for medical purposes that consists of a motorized table equipped to provide patients with heat, traction, and muscle relaxation therapy.(b)
Classification. Class II (performance standards).