Search Results
Found 1 results
510(k) Data Aggregation
(49 days)
Tyto Thermometer
The Tyto Thermometer is a non - contact clinical infrared thermometer intent determination of human body temperature from the center of the forehead on people of all ages. The Tyto Thermometer is intended for use by both adult lay users and clinicians. It can be used both at home and in clinic environments.
The Tyto Thermometer is a non-contact infrared thermometer that enables measuring of the human body temperature for persons of all ages. The device is a hand-held infrared thermometer that, when positioned within 2 inches of a patient's forehead, measures the infrared energy emitted from the surface of the skin and converts it to a Core body temperature scale (Celsius, Fahrenheit) as represented on the oral body site. The device is designed for use by professional as well as lay users in clinical or nonclinical environments. The device can optionally be connected wirelessly to a user's mobile phone for use with a dedicated app (TytoCare App). Measurement results are displayed on the device LCD screen and in parallel on the mobile phone. Results of temperature recordings can be stored on the Tyto Server.
The Tyto Thermometer is a non-contact infrared thermometer intended for intermittent determination of human body temperature from the center of the forehead on people of all ages.
Here's an analysis of its acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion | Acceptance Criteria (from predicate) | Reported Device Performance (Tyto Thermometer) |
|---|---|---|
| Laboratory Accuracy | ±0.2°C on 35.5°C – 42.0°C range (±0.4°F on 95.9°F – 107.6°F range), ±0.3°C (±0.5°F) outside this range | ±0.2°C (0.4°F) on 36°C - 39°C (96.8°F - 102.2°F) range, ±0.3°C (0.5°F) accuracy outside the above range. Matched/Comparable to predicate |
| Resolution | 0.1°C / 0.1°F | 0.1°C / 0.1°F Met |
| Response Time | 2 seconds (Predicate NTF3000) | Within 3 seconds Comparable; deemed not to raise safety/effectiveness questions |
| Biocompatibility | All parts in contact with patient/operator comply with ISO 10993-1 | All parts in contact with the operator comply with ISO 10993-1 Met |
| Electrical Safety & EMC | Compliance with IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2 | Compliance demonstrated Met |
| Software Assessment | Verification and validation according to FDA guidance | Verification and validation performed, found moderate level of concern, performs as intended Met |
| Cybersecurity | Assessment according to FDA guidance | Threat analysis performed according to FDA guidance Met |
| Clinical Performance (Bias & Standard Deviation) | Clinically and statistically acceptable bias and standard deviation compared to reference standard | Meets specifications, substantially equivalent to predicate in all age groups regarding bias and standard deviation compared to reference gold standard Met |
| Clinical Performance (Repeatability) | Clinically and statistically acceptable repeatability | Clinically and statistically acceptable for all age groups and sub-groups Met |
2. Sample Size and Data Provenance for Test Set (Clinical Validation Study)
- Sample Size: 124 subjects.
- Group 1: Up to 1 year (Sub-group 1a: up to 3 months, Sub-group 1b: 3 months up to 1 year)
- Group 2: 1 to 5 years
- Group 3: Older than 5 years
- Data Provenance: Not explicitly stated regarding country of origin. The study was conducted in accordance with ASTM E1965-98 (R 2009) and ISO 80601-2-56 (2009), which are international standards for clinical thermometers. The study is described as a "clinical validation study," implying it was prospective data collection.
3. Number of Experts and Qualifications for Ground Truth for Test Set
This information is not provided in the given text. The ground truth was established by a "reference gold standard Welch Allyn contact thermometers," but details about the operators or experts using these reference thermometers are not included.
4. Adjudication Method for the Test Set
This information is not provided in the given text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or performed as part of this submission for the clinical validation. The study focused on the device's accuracy and repeatability against a reference standard, not on comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
The clinical validation study described is a standalone performance study of the Tyto Thermometer itself, measuring its accuracy and repeatability against a reference standard. The device has an "infrared sensor" and uses "predictive algorithms to estimate the body temperature," which constitutes the algorithm-only performance being evaluated.
7. Type of Ground Truth Used
The ground truth for the clinical validation study was established using reference gold standard Welch Allyn contact thermometers.
8. Sample Size for the Training Set
The document does not specify a separate training set or its sample size. The "predictive algorithms" are mentioned as part of the device's functioning, implying they were developed and potentially trained, but details of this process are not provided in the 510(k) summary.
9. How Ground Truth for Training Set Was Established
This information is not provided in the document.
Ask a specific question about this device
Page 1 of 1