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HeatLux Pro II is an over the counter hand held device intended to emit energy in the visible, near IR, and RF spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscular and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and temporary relaxation of muscles.

The HeatLux Pro II Device is an over the counter, hand held device, utilizing low power light spectrum, array of 24 LEDs, at wavelength of 630±10nm and 850±50nm, RF output power (1MHz. maximal output power 24W) and electrical heating. The HeatLux Pro II Device consists of an applicator and an adaptor. The applicator is a hand held unit used for treatment, as the treatment surface at the applicator tip comes in direct contact with the skin. The device applicator comprises temperature stabilizer, which constantly maintains the applicator temperature to 41ºc.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Preamble: This document describes the acceptance criteria and studies for the HeatLux Pro II Device, an over-the-counter handheld device intended for temporary relief of minor muscular and joint pain and stiffness, minor arthritis pain or muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the device's compliance with several performance standards and safety tests rather than explicit quantitative acceptance criteria with numerical targets. However, the overall acceptance criterion is Substantial Equivalence to legally marketed predicate devices, which is demonstrated by meeting various technical specifications, safety standards, and performance characteristics.

Key Device Specifications (Relevant for comparison to predicates):

• RF frequency: 1MHz
• Maximal RF output power: 24W
• Maximal heating plates output power: 12W
• Maximal optical power density: 60mWatts/cm²
• LED Wavelengths: 630±10nm and 850±50nm

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

• Sample Size for Usability Study: Twenty eligible device users.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the study was conducted to evaluate user performance for this specific device, implying it was a prospective study. The applicant is Home Skinovations Ltd., located in Israel, so it's possible the study was conducted there.

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

• Usability Study: The document describes a "user performance (usability) study" with "device users." It does not mention the use of experts to establish a "ground truth" in the traditional sense of medical diagnosis. Instead, the study assessed the users' ability to operate the device and understand its labeling. The "ground truth" here would be the observed user interactions and safety outcomes. It tested if users could act safely and effectively, not if they could accurately diagnose a condition.

4. Adjudication Method for the Test Set

• Usability Study: No explicit adjudication method (e.g., 2+1, 3+1) is mentioned. The study's focus was on direct observation of user performance and comprehension of instructions, rather than expert judgment on ambiguous cases. The "study results showed that potential device users had successfully operated the device as intended with no safety issues reported," suggesting a clear outcome was observed for each participant.

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 done.

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

• This device is not an AI/algorithm-based diagnostic or assistive device. It is a physical medical device that emits energy. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable. The performance studies focus on the physical device's specifications, safety, and human interaction/usability.

7. The Type of Ground Truth Used

• Bench Tests (Thermal Profile, RF Depth, Temperature Stability): The ground truth was based on objective measurements against pre-defined system requirements and engineering specifications.
• Safety Standards (IEC series): The ground truth was compliance with the requirements set forth in the international voluntary standards.
• Biocompatibility (ISO 10993-1): The ground truth was compliance with the international standard for biological evaluation of medical devices, leveraging prior testing of the predicate device.
• Usability Study: The "ground truth" was the observed actual performance of users in operating the device and understanding its labeling, confirming safe and effective use.

8. The Sample Size for the Training Set

• This is not an AI/machine learning device; therefore, the concept of a "training set" in that context is not applicable.
• However, regarding device development and testing: The device's design and software modifications were likely guided by previous versions (like HeatLux Pro I) and engineering principles. The "training" or development data would be internal engineering data, prototypes, and iterative testing, which is not detailed in the summary.

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

• As this is not an AI/machine learning device, the concept of "ground truth for a training set" as typically understood in AI development is not applicable.
• For the development and optimization of the physical device, ground truth would have been established through engineering principles, physical laws, established safety standards, and iterative bench testing during the design and manufacturing process, to ensure the device met its intended specifications and safety profile.

Ask a specific question about this device

HeatLux Pro I is over the counter hand held device intended to emit energy in the visible and near IR spectrum to provide topical heating for the purpose of elevating tissue temperary relief of minor muscular and joint pan and stiffness, minor arthritis pam or muscle spasm, the temporary increase in local and blood carculation, and temporary relaxation of muscles.

The HeatLux Pro I device is a hand held device, using low power light spectrum, array of 24 LEDs, at wavelength of 630±10nm, combined with four metal heating plates (temperature stabilized to 41%). The HeatLux Pro I device consists of an applicator and an AC/DC power adaptor. The applicator is a hand held unit used for treatment, as the treatment surface at the applicator tip comes in direct contact with the skin.

I am sorry, but the provided text is a 510(k) summary for a medical device and does not contain the detailed information necessary to answer your request in the specified format. The document focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria for performance, clinical study designs, or expert-based ground truth establishment for a machine learning algorithm.

Specifically, the document states:

• "Clinical Performance Data: Not Applicable"
• "Pre-Clinical (Animal Study) Performance Data: Not Applicable"
• "Non-Clinical (Bench) Performance Data: A set of bench tests were performed to evaluate the thermal profile and temperature stability of the HeatLux Pro I device and to compare them to the thermal profile and temperature stability of the HeatLux 1 device. The results of the bench tests demonstrated that the HeatLux Pro I device has the same thermal profile and temperature stability properties as those reported for the predicate device."

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance related to a diagnostic or AI-driven task.
2. Sample sizes, data provenance, or details on test sets.
3. Information on experts, ground truth establishment, or adjudication methods.
4. Details on MRMC studies or human reader improvement with AI.
5. Standalone algorithm performance.
6. Ground truth types for algorithm training or testing.
7. Training set sample size or how its ground truth was established.

This document describes a device that provides topical heating and relies on demonstrating similar thermal characteristics to a previously cleared device, rather than an AI/ML-driven diagnostic or treatment selection device that would require the information you've requested.

Ask a specific question about this device

HeatLux is over the counter hand held device intended to emit energy in the visible and near IR spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscular and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local and blood circulation, and temporary relaxation of muscles.

HeatLux is a hand held device battery operated that uses low power light spectrum, LED, at wavelength of 645 ±10 nm, combine with tip temperature stabilizer at 41°C. The emitting optical power is in a uniform distribution with no hot spots.

The provided 510(k) summary for the HeatLux device (K120582) describes primarily bench testing for performance verification and does not mention a clinical study with human participants. Therefore, an in-depth analysis of acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, or comparative effectiveness studies (MRMC) for clinical outcomes is not available from this document.

However, based on the information provided, here's a breakdown of the available details:

1. Acceptance Criteria and Reported Device Performance

The document describes bench testing to ensure the device performs as intended with regard to temperature.

2. Sample Size and Data Provenance

• Test Set Sample Size: Not applicable, as detailed clinical testing with a specific "test set" of human subjects is not described. The bench testing involved "multiple body areas and skin types" for thermal camera measurements, but specific participant numbers are not provided.
• Data Provenance: The testing was likely conducted in Israel, the country of origin of the manufacturer (Home Skinovations Ltd.). It was retrospective in the sense that it was performed as part of the device development and verification process.

3. Number of Experts and Qualifications

Not applicable. This information is not provided in the context of the bench testing described. Expert involvement for ground truth establishment is typically relevant for clinical studies involving diagnostics or subjective assessments.

4. Adjudication Method

Not applicable. Adjudication methods are typically used in clinical studies to resolve discrepancies between expert assessments.

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

No MRMC comparative effectiveness study is mentioned. The submission focuses on device technical performance (heating capability) and substantial equivalence to predicate devices based on technical specifications and intended use. The document does not describe studies on how human readers (or users) improve with or without AI assistance, as AI is not a component of this device.

6. Standalone Performance Study

A standalone performance bench test was done to verify the device's ability to reach and maintain a target temperature. This is analogous to standalone performance for hardware, ensuring it functions according to specifications.

• Test 1: Temperature sensor attached to the metal surface of the device monitored temperature as a function of time.
• Test 2: A thermal camera was used to monitor skin temperature and uniformity on multiple body areas and skin types.

7. Type of Ground Truth Used

For the bench testing, the "ground truth" was established by engineering measurements of temperature using sensors and a thermal camera, verifying adherence to the designed temperature output (41°C).

8. Sample Size for the Training Set

Not applicable. This device is a physical therapeutic device, not an algorithm that requires a "training set" of data in the machine learning sense.

9. How Ground Truth for the Training Set Was Established

Not applicable, as no training set for an algorithm is involved.

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