(354 days)
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.
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.
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.
§ 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).