(60 days)
The TyTron C-500IR Clinical Infrared Imaging System is intended for adjunctive diagnostic screening for the detection of breast cancer and other uses such as: peripheral vascular disease, neuromusculoskeletal disorders, extracranial cerebral and facial vascular disease, thyroid gland abnormalities, and various other neoplastic, metabolic, and inflammatory conditions. Use of the TyTron C-500IR System is not intended to be the sole diagnostic procedure for these diseases and conditions.
The TyTron C-500IR is a non-contact, non-invasive, non-radiating, thermal (infrared) imaging system composed of an infrared camera which is interfaced to a computer with the intent of viewing and digitally storing thermal patterns generated by the surface of the human body.
The provided text is a 510(k) premarket notification for the TyTron C-500IR Clinical Infrared Imaging System. It describes the device, its intended use, and states that it has been found "substantially equivalent" to a predicate device. However, this document does not contain information about the acceptance criteria and a detailed study proving the device meets those criteria.
Here's why and what's missing:
- Substantial Equivalence: The 510(k) process in the US largely focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This often means demonstrating similar technological characteristics and indications for use, rather than conducting new clinical trials to prove efficacy against specific, pre-defined acceptance criteria.
- Lack of Clinical Study Details: The provided text does not include any information about a clinical study, performance metrics, sample sizes, ground truth establishment, or expert involvement. The 510(k) summary typically includes general information about the device and its equivalence, but not the granular details of a performance study.
Therefore, I cannot populate the table or provide answers to most of your questions based solely on the provided text.
Based on the provided text, here's what can be stated:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided document. | Not specified in the provided document. |
Explanation: The 510(k) summary provided declares the device as "substantially equivalent" to a predicate device (Spectrum 9000MB, K020783). It does not outline specific acceptance criteria for performance within a dedicated study, nor does it report specific performance metrics for the TyTron C-500IR. The equivalence claim implies that its performance is considered acceptable due to its similarity to a device already deemed safe and effective.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided document.
- Data Provenance: Not specified in the provided document. The document refers to a predicate device and a declaration of substantial equivalence, but it does not detail any specific test set data for the TyTron C-500IR.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified in the provided document.
4. Adjudication method for the test set
- Not specified in the provided 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
- Not specified in the provided document. The device description does not imply AI assistance, and no MRMC study details are present.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not specified in the provided document. The document describes a "Clinical Infrared Imaging System," which typically involves trained human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not specified in the provided document, as no specific performance study details are included.
8. The sample size for the training set
- Not specified in the provided document, as no machine learning or AI component with explicit training data is mentioned or detailed.
9. How the ground truth for the training set was established
- Not specified in the provided document, as no machine learning or AI component with explicit training data is mentioned.
§ 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.