(164 days)
The Med-Hot Thermal Imaging Systems are intended to review, measure and record skin temperature patterns and variations emitted from the human body. They are intended for use as adjunctive diagnostic imaging for thermally significant indications in the regions of the head and neck, breast, chest, abdomen, back and extremities. The value of the value of these thermal patterns is determined by professional investigation. This device is intended for use by qualified technical personnel trained in its use.
The Med-Hot Thermal Imaging Systems are non-contact infrared imaging devices, with all functions controlled at the computer screen. TotalVision is a patented, clinical personnel friendly software application, validated in the field. The system is delivered with a computer including installed and tested software. The Med-Hot Thermal Imaging camera is suitable for high quality imaging of the human body. The TotalVision Capture Software allows for incoming image data from the camera head and configures that data in a form that can be displayed on the computer screen. This display will include an image of the scene within the camera's field of view allowing the user to visualize thermal patterns or analyze the image in terms relative temperature values. The software makes no determination regarding what the thermal patterns or relative temperature values mean. It will be left to the user to infer areas of interest based on his/her visual interpretation of those patterns or values. The new device consists of: 1. Infrared Camera (MAX 076 320 x 240 array detector or MAX 307 640 x 480 array detector), 2. TotalVision Software, 3. Laptop or desktop computer.
Here's an analysis of the provided information regarding the Med-Hot Thermal Imaging Systems:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not contain a table of acceptance criteria or reported device performance in the traditional sense of a clinical or performance study. The submission is a 510(k) premarket notification for a Class I device (Telethermographic System, Product Code LHO).
For Class I devices with a predicate, the primary focus is often on demonstrating substantial equivalence to a legally marketed predicate device, rather than meeting specific performance metrics from a de novo clinical study. The "performance" described here relates to the technical specifications of the imaging system and software capabilities, and how they compare to the predicate.
Here's an attempt to structure the information, recognizing it's not a typical performance table found in a clinical study report:
| Feature/Criterion (Implied) | Reported Device Performance (Med-Hot Thermal Imaging Systems) |
|---|---|
| Intended Use | Review, measure, and record skin temperature patterns/variations for adjunctive diagnostic imaging in various body regions. |
| Principle of Operation | Non-contact infrared imaging, capturing and recording objects for evaluation of thermal variations. |
| Resolution | 320 x 240 / 640 x 480 array detector (adequate detail for minute thermal features). |
| Microbolometer Technology | Provides low power consumption and high temperature reliability. |
| Image Frequency | 50-60 Hz (real-time viewing/capture with no loss of detail due to movement). |
| Focus | Automatic focus option (for privacy and comfort). |
| Data Transfer Interface | Gigabit Ethernet (fastest industry standard for data-dense files). |
| Calibration | Factory calibration; temperature conversion files in camera firmware (reliable, enhanced accuracy). |
| Lens | 25-degree standard lens (practical field of view in clinical settings). |
| Software Functionality | TotalVision Capture Software displays incoming image data, visualizes thermal patterns, analyzes relative temperature values, determines no meaning (left to user). |
| Comparison to Predicate (MTI 2000) | Intended use, principle of operation, and similar software features are substantially equivalent. Both view live imagery, record snapshots, include post-processing of fast thermal events, provide region of interest analysis, and save information. Software is an evolution of predicate's. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. No clinical or performance test set (in terms of patient data) was used or described in this submission for defining "acceptance criteria" or "device performance" in a quantitative sense related to clinical outcomes.
- Data Provenance: Not applicable, as no human data (retrospective or prospective) was used for performance evaluation in this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not applicable. No ground truth was established by experts for a test set in this context. The device's function is to display thermal patterns, with the interpretation left to the user.
4. Adjudication Method for the Test Set
- Not applicable. No adjudication method was used, as there was no test set requiring expert review.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. A MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical studies were conducted."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This device is not an AI/algorithm-only device with a standalone performance claim. It is an imaging system (camera + software) that captures and displays thermal data for human interpretation. The software's role is to capture and display the image data, not to make diagnostic determinations. The document states: "The software makes no determination regarding what the thermal patterns or relative temperature values mean. It will be left to the user to infer areas of interest based on his/her visual interpretation of those patterns or values."
7. The Type of Ground Truth Used
- Not applicable. No ground truth based on expert consensus, pathology, or outcomes data was used for performance evaluation in this 510(k) submission, as it explicitly states that no clinical studies were conducted. The "ground truth" for the device's technical specifications would be its manufacturing and calibration standards.
8. The Sample Size for the Training Set
- Not applicable. This device is a telethermographic imaging system, not an AI/machine learning algorithm that requires a training set of patient data. The "TotalVision Capture software" is described as an "evolution of the original Med-Hot software program" with "Improvements and new features added were based on user-driven needs and requests over the years." This suggests an iterative development process driven by user feedback rather than a formal machine learning training paradigm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there was no formal training set requiring ground truth establishment in the context of machine learning. The software's functionality improvement was "based on user-driven needs and requests."
Summary of Device Nature and Regulatory Context:
It's crucial to understand that this 510(k) submission is for a Class I medical device which primarily relies on demonstrating substantial equivalence to an existing predicate device. The device is a diagnostic imaging tool that measures and records skin temperature patterns; it is explicitly stated to be for "adjunctive diagnostic imaging" and the "value of these thermal patterns is determined by professional investigation." The software's role is to present data, not interpret it.
Therefore, the submission focuses on:
- Technical specifications of the hardware (camera resolution, frequency, interface, calibration).
- Functional description of the software (capture, display, basic analysis of regions of interest).
- Comparison of these features to the predicate device.
- Compliance with relevant electrical and environmental safety standards (ISO, IEC, EN, CFR).
The absence of clinical studies, ground truth establishment, or AI-specific performance metrics is typical for this type of device and regulatory pathway.
§ 884.2980 Telethermographic system.
(a)
Telethermographic system intended for adjunctive diagnostic screening for detection of breast cancer or other uses —(1)Identification. A telethermographic system for adjunctive diagnostic screening for detection of breast cancer or other uses is an electrically powered device with a detector that is intended to measure, without touching the patient's skin, the self-emanating infrared radiation that reveals the temperature variations of the surface of the body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(2)
Classification. Class I (general controls).(b)
Telethermographic system intended for use alone in diagnostic screening for detection of breast cancer or other uses —(1)Identification. A telethermographic system for use as the sole diagnostic screening tool for detection of breast cancer or other uses is an electrically powered device with a detector that is intended to measure, without touching the patient's skin, the self-emanating infrared radiation that reveals the temperature variations of the surface of the body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 884.3.