(145 days)
The Abreu BTT 700 System is intended for the continuous monitoring of skin temperature during surgical procedures, recovery room, intensive care, and general patient monitoring. The unit will alert the patient and/or hospital personnel when the monitored temperature exceeds or falls below pre-selected levels.
The Abreu BTT 700 is a device used to measure the temperature of the skin by means of a thermistor coupled with an electronic signal amplification, conditioning, and display unit. As part of its basic design, the thermistor probe is an integral part of a non-disposable "Pen" (covered by a condom), and a disposable "finger." The components of the Abreu BTT 700 consist of a "pen", a disposable "finger", an Interface Module, and a USB A to USB mini cable. The Abreu BTT 700's Interface Module incorporates an onboard computer processing unit which is controlled by a permanently installed software program. Electronic signals received from the thermistor are processed in the Interface Module. With the aid of a computer assisted program, the output is a digital and analog temperature readout. The digital readout is in Celsius and Fahrenheit. The digital analog display is a 270° circular dial illustrating 16-40°C in tenths of a degree
The provided text describes a 510(k) submission for the Abreu BTT 700 Skin Temperature System, claiming substantial equivalence to the YSI Precision 4000 Thermometer. The focus is on technical characteristics and performance, not a multi-reader multi-case comparative effectiveness study or a standalone AI algorithm performance study.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the predicate device's specifications, as the Abreu BTT 700 aims for "substantial equivalence." The "Comparison Table" directly addresses this.
| Characteristic | Acceptance Criteria (from YS14000 K910718) | Reported Device Performance (Abreu BTT 700) | Meets Criteria? |
|---|---|---|---|
| Indication for Use | Skin Temperature Measurement | SAME (continuous monitoring of skin temperature during surgical procedures, recovery room, intensive care, and general patient monitoring; alerts when temperature exceeds or falls below pre-selected levels) | Yes |
| Ambient Operating Temperature Range | 0 to 50° C | SAME | Yes |
| Temperature Display Range | 25 to 45° C | SAME | Yes |
| Accuracy | +/- 0.3° C Between 25 to 35° C | ||
| +/- 0.2° C Between 35 to 37° C | |||
| +/- 0.1° C Between 37 to 39° C | |||
| +/- 0.2° C Between 39 to 41° C | |||
| +/- 0.3° C Between 41 to 45° C | SAME | Yes | |
| Resolution | 0.1° C | SAME | Yes |
| Probe Power | 30 microwatts or less | SAME | Yes |
| Target Population | Adults and children | SAME | Yes |
| Conditions of Use | Doctors and Health Care Professionals | SAME | Yes |
| Alarm Settings | Independent HI and LO alarm settings, user adjustable, flash and audio alerts | SAME | Yes |
| Error indications | No probe, Under Range, Over Range | SAME with the addition of a Shorted Probe detector | Improved |
| Self Check Function | Every temperature scan includes reading the value of an internal precision resistance (37.1° C) checking conversion process | SAME | Yes |
Note on Differences:
- Display: Predicate uses LCD, new device uses Computer Monitor. This is a change in presentation but not a performance metric for accuracy.
- Probes: Predicate uses various, new device uses "Abreu BTT 700 Temperature pen with disposable coverlet or BTT Forehead Finger Sensor." This is a design difference, but the performance (accuracy) is claimed to be equivalent.
- Technology: Predicate uses Precision PTC Thermistor 2250 ohms. New device uses Precision PTC Thermistor 10 K to reduce probe size, isolated with medical grade acrylic. This is a design difference to achieve the same performance.
- Computer Connection: Predicate not available, new device has USB. A new feature, but not a performance metric for temperature accuracy.
- Power Source: Predicate uses internal battery, new device uses USB port, 5 volts @ 175 ma. A design difference.
The claim of substantial equivalence hinges on the "Performance: Laboratory and clinical testing has verified ... accuracy in the clinical environment. Clinical testing was performed on subjects of different age groups: adults, geriatric, and pediatric with results showing performance equivalent to or better than the predicate."
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Clinical testing was performed on subjects of different age groups: adults, geriatric, and pediatric." However, the exact sample size for the clinical test set is not provided in the given text.
The data provenance is implied to be clinical testing of the Abreu BTT 700, making it prospective for this device. The country of origin is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The testing appears to be objective measurements against a standard, not requiring expert ground truth in the subjective medical interpretation sense. For a thermometer, the "ground truth" would likely be a highly accurate reference thermometer or a controlled temperature environment, not expert interpretation.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable in the context of device accuracy testing for a thermometer. Adjudication methods (like 2+1, 3+1) are typically used for subjective diagnostic interpretations where expert consensus is needed to establish ground truth.
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
No MPMC comparative effectiveness study was done or mentioned. This device is a clinical electronic thermometer measuring skin temperature, not an AI-powered diagnostic tool requiring human-in-the-loop performance evaluation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable to a clinical thermometer in the sense of an AI algorithm. The device itself (Abreu BTT 700) performs the measurement and displays it. Its "standalone" performance is its accuracy and reliability in measuring temperature, which was verified through "Laboratory and clinical testing."
7. The Type of Ground Truth Used
For the accuracy testing, the ground truth would have been established by a highly accurate reference temperature source/method during laboratory testing, and potentially comparison against the predicate device or another established accurate method during clinical testing. It is not "expert consensus," "pathology," or "outcomes data" in this context.
8. The Sample Size for the Training Set
This information is not applicable and not provided. This device is a hardware-based thermometer with embedded software, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The permanently installed software program likely performs signal processing and display functions based on fixed algorithms, not learned parameters.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided for the reasons stated in point 8.
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.