(316 days)
The OmniCorder BioScan System is thermal camera based imaging device intended for viewing and recording heat patterns generated by the human body in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities or in an environment where patient care is provided by qualified healthcare personnel who will determine when use of this device is indicated, based upon their professional assessment of the patient's medical condition. The patient populations include adult, pediatric and neonatal. The device is for adjunctive diagnostic screening for detection of breast cancer or other uses. This device is intended for use by qualified healthcare personnel trained in its use.
The OmniCorder BioScan System is an infrared camera device which provides the capability for imaging and recording of thermal data radiating from adult, pediatric and neonatal patients in numerous hospital, nursing home and clinical settings; and in the home. It is a prescription device intended for use only by health care professionals.
The provided text (K990416) is a 510(k) summary for the OmniCorder BioScan System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study to prove that the device meets specific performance acceptance criteria.
The 510(k) process is typically for devices that are "substantially equivalent" to already marketed devices, and often does not require new clinical studies for performance metrics if equivalence can be established through design, materials, and intended use.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets them is not explicitly present in the provided 510(k) summary. The document focuses on comparing its features to predicate devices.
Here's a breakdown of why each point cannot be fully addressed with the provided text:
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A table of acceptance criteria and the reported device performance: This information is not present. The document highlights "Operational Principles" and "Indications and Contraindications" as being the "same" as predicate devices, and that the device "complies with" CSA and UL standards. This is not a table of specific measurable acceptance criteria and reported performance values.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set or study data is described. The 510(k) is a comparison document, not a study report.
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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): No ground truth establishment is described for a test set.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: No test set or adjudication method is described.
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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: No MRMC study is mentioned. The device is an infrared camera system, not an AI-assisted diagnostic tool as described in the prompt's context (e.g., "human readers improve with AI").
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The BioScan System uses "CPU/Custom Algorithms" for data processing, but the 510(k) does not describe a standalone performance study. Its use is described as being "by qualified healthcare personnel trained in its use," suggesting human-in-the-loop interpretation.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is mentioned.
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The sample size for the training set: No training set is mentioned as this device predates the common usage of "training set" in the context of deep learning algorithms for medical devices as it is understood today. The "Custom Algorithms" would likely refer to image processing algorithms rather than machine learning models requiring extensive training data.
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How the ground truth for the training set was established: Not applicable, as no training set is described.
In summary, the provided 510(k) K990416 document for the OmniCorder BioScan System is a substantial equivalence submission. It does not contain information about specific performance acceptance criteria or a study designed to prove the device meets those criteria. Instead, it argues for equivalence based on similar intended use, operational principles, design, and adherence to general safety standards (CSA, UL).
§ 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.