(49 days)
The AlfaSight 9000 is intended for the adjunct diagnosis of the female breast; 2) peripheral vascular disease; 3) musculoskeletal disorders; 4) extracranial cerebral and facial vascular disease; 5) abnormalities of the thyroid gland; and 6) various neoplastic and inflammatory conditions.
The AlfaSight 9000 is not intended to serve as a sole diagnostic screening procedure.
The AlfaSight 9000 system is a non-invasive, handheld and battery-operated adjunctive diagnostic device that measures and records skin surface temperatures. The system is intended for use as an adjunct to other clinical diagnostic procedures to quantify relative skin surface temperatures. It is not intended as a sole diagnostic device and does not replace or substitute any clinical test or device such as X-Ray, CT scans, mammography or other similar equipment. The system is for prescription-only use by licensed medical practitioners for use in hospitals, sub-acute healthcare settings, and private clinics.
The AlfaSight 9000 system consists of: 1) a handheld probe, 2) an off-the-shelf computer 3) a standard USB charging cable and 4) biocompatible sheaths. The single use theath is placed over the handheld probe covering the entire probe, three capacitive pins sense contact of the skin through the sheath to start the temperature measurement. Temperature samples are then sent from the handheld probe to the computer wirelessly using Bluetooth technology and are represented in a graphical display on the computer. Samples are organized into specified regions of the body as they are sampled in a fixed order as directed by the software.
The provided text does not contain detailed acceptance criteria or a study proving the device meets specific performance metrics in terms of accuracy, sensitivity, or specificity for its intended diagnostic uses. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Eidam's CRT 2000, K971956) based on technological characteristics and safety.
Here's a breakdown of what information is available and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific, quantifiable acceptance criteria for diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) and then reporting the device's performance against those criteria.
The only direct performance metric mentioned for the probe is:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Probe Error Margin: +/-0.2 degrees C | +/-0.2 degrees C |
| Probe Optimum Range: 25-40°C | 25-40°C |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable as no clinical performance study demonstrating diagnostic accuracy was conducted. The "test set" in this context refers to non-clinical bench testing.
- Data Provenance: Not applicable for diagnostic performance. Bench testing data is implicitly from internal lab settings.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable as no clinical study with ground truth established by experts was performed for diagnostic performance validation.
4. Adjudication Method for the Test Set:
- Not applicable as no clinical study with adjudication of ground truth was performed.
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. The document states that the new device measures skin temperature using infrared technology rather than the thermocouple measurements employed by the predicate device, but it asserts that this difference "does not affect the safety or effectiveness" without providing a comparative clinical trial.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- The device, a "Thermographic System," measures and presents temperature data to a healthcare practitioner. It's not an AI algorithm in the contemporary sense that provides diagnostic outputs. Therefore, the concept of "standalone (algorithm only)" as typically applied to AI/ML devices is not directly applicable. The performance testing conducted was non-clinical bench testing of the hardware and software's ability to measure and process temperature data.
7. The Type of Ground Truth Used:
- For the non-clinical testing, the "ground truth" implicitly refers to physical standards and measurements (e.g., precise temperature references) used to verify the probe's accuracy and internal consistency during bench testing. There is no mention of clinical ground truth (like pathology, expert consensus, or outcomes data) being used to validate the device's diagnostic claims.
8. The Sample Size for the Training Set:
- Not applicable. This device is not an AI/ML system that requires a "training set" in the context of machine learning model development. The software development focuses on requirements, validation, and verification, typical for traditional medical device software.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable for the same reason as above.
Summary of what the document does provide regarding "performance testing":
The "PERFORMANCE TESTING" section primarily describes non-clinical bench testing to demonstrate the device's technical specifications and safety profile, asserting that these differences from the predicate do not affect its safety or effectiveness for its intended use.
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Testing Categories:
- Biocompatibility (conforms to ISO 10993-1)
- Software Risk Analysis
- Software Requirements Specification
- Software Validation Protocol
- Software Verification Summary and Test Case Report
- Software Test Results Report and Revision History
- Software Design Specification
- Software Development Environment Description Document
- Electromagnetic Compatibility and Electrical Safety (conforms to IEC 60601-1; IEC 60601-1-2)
- Corvalent Design Verification Testing
- Temperature Probe with Sheath Performance Testing (this likely verified the +/- 0.2 degrees C error margin)
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Conclusion: "In sum, the results of non-clinical testing demonstrate that the AlfaSight 9000 System is as safe, as effective and performs as well as the predicate device." This conclusion is based on the technical and safety performance, not on direct clinical diagnostic accuracy comparison.
Key Missing Information:
The document does not include any clinical studies (e.g., prospective, retrospective, expert-read) that quantify the diagnostic accuracy (sensitivity, specificity, AUC) of the AlfaSight 9000 Thermographic System for any of its stated indications for use (e.g., "adjunct diagnosis of the female breast," "peripheral vascular disease"). The FDA clearance is based on substantial equivalence to an existing predicate device (CRT 2000), assuming the new technology (infrared vs. thermocouple) does not alter the fundamental safety or effectiveness for the adjunct diagnostic purpose, as demonstrated by bench testing.
§ 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.