(407 days)
The EMD Thermography System, Model RTM-02-RES is an infrared spectrum thermography system used to measure, record and view thermal patterns generated by the human body. It is intended for use as an adjunct to other clinical diagnostic procedures in the screening and diagnosis of abnormalities where a physician chooses to use thermography.
The EMD Thermography System is an infrared frequency thermography system, designed to provide non-invasive temperature measurements of sites on the human body. The device includes an infrared sensor for measuring temperatures at specific areas on the skin surface. This sensor are placed in contact with the skin to perform measurements. A personal computer and software is for analysis of the temperature measurements and display of the temperature distributions.
The provided document is a 510(k) summary for the EMD Thermography System, Model RTM-02-RES. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, the document does not contain detailed information about acceptance criteria or a specific study that proves the device meets those criteria in a quantitative sense.
The "Performance Testing" section broadly states: "Information submitted in this premarket notification for the EMD Thermography System includes results of testing for electrical safety, EMI/EMC, temperature measurement accuracy and results of clinical testing." This indicates that some form of testing was done, but the specifics requested in your prompt (acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, etc.) are not present in the provided text.
Therefore, I cannot populate the table or answer most of your questions based solely on the provided input. I will indicate where information is missing.
Here's an attempt to answer based on the available information, noting the significant gaps:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Clinical Performance: Not specified in the document. | The document broadly states "results of clinical testing" were submitted, but no specific performance metrics (e.g., sensitivity, specificity, accuracy) or reference to a clinical study's outcome are provided. |
| Temperature Measurement Accuracy: Not specified in the document. | The document broadly states "results of testing for... temperature measurement accuracy" were submitted, but no specific accuracy thresholds (e.g., ±X degrees Celsius) or the measured accuracy are provided. |
| Electrical Safety: Not specified in the document. | The document broadly states "results of testing for electrical safety" were submitted, but no specific standards (e.g., IEC 60601-1) or compliance results are detailed. |
| EMI/EMC (Electromagnetic Interference/Compatibility): Not specified in the document. | The document broadly states "results of testing for EMI/EMC" were submitted, but no specific standards or compliance results are detailed. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the document.
- Data Provenance: Not specified in the document. (e.g., country of origin, retrospective or prospective).
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)
- This information is not provided in the document. The document mentions "clinical diagnostic procedures" and physician choice, but no details on expert panels or ground truth establishment for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not provided in the document.
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
- An MRMC comparative effectiveness study is not mentioned in the document. The device is described as an "infrared frequency thermography system" and an "adjunct," suggesting it's a diagnostic tool, but not necessarily an AI-assisted interpretation system in the modern sense. The document does not describe human reader improvement with or without AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document describes the device as being "used to measure, record and view thermal patterns" and "intended for use as an adjunct to other clinical diagnostic procedures in the screening and diagnosis of abnormalities where a physician chooses to use thermography." This implies a human-in-the-loop scenario.
- No specific standalone algorithm performance is discussed, as the system includes a "personal computer and software for analysis of the temperature measurements and display of the temperature distributions," but it doesn't clearly delineate an "AI algorithm" separate from the overall system for standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- This information is not provided in the document. "Clinical testing" is mentioned, but the method for establishing ultimate ground truth for abnormalities is not detailed.
8. The sample size for the training set
- This information is not provided in the document. The concept of a "training set" in the context of machine learning is not explicitly discussed, though software is mentioned for analysis and display.
9. How the ground truth for the training set was established
- This information is not provided in the document, as a training set and its ground truth establishment are not discussed.
Conclusion:
The provided 510(k) summary is a high-level overview for regulatory clearance based on substantial equivalence. It confirms that performance testing (electrical safety, EMI/EMC, temperature measurement accuracy, and clinical testing) was submitted to the FDA, but it does not include the detailed results, acceptance criteria, methodologies, or study specifics that would be necessary to answer most of your questions. Regulatory summaries often omit such granular details, which would typically be found in the full submission documents.
§ 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.