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510(k) Data Aggregation
(406 days)
TD-1035 Thermometer is a temperature detector which is intended to measure the body temperature on axillary region. The device is intended for population age of six months and above, which is designed for home use.
TD-1035 Thermometer is a temperature detector which is intended to measure the body temperature on axillary region, and transmit data to personnel device via Bluetooth pairing. The design concept is equivalent to the predicate device, K152680. There are two modifications made to the subject device: (1) indication for use (2) an elastic band was added. The elastic band is designed for more suitable and comfortable wearing. Moreover, the detected sensor contacts user skin directly, which is located on the silicone belt. The parts that contact the user are: (1) elastic band (2) sensor head (3) silicone belt.
The device in question is the TaiDoc TD-1035 Thermometer, intended for measuring body temperature in the axillary region for individuals aged six months and above, designed for home use.
Here's an analysis of the acceptance criteria and the studies performed:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Attachment | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|---|
| Software | A1.1 | IEC 62304 | Safety and effectiveness of software meet the device's indications for use. | PASS |
| Electrical Safety & Performance | A1.2 | IEC 60601-1 | Basic safety and essential performance of medical electrical equipment and systems. | PASS |
| A1.3 | IEC 60601-1-11 | Basic safety and essential performance of medical electrical equipment and systems for use in the home healthcare environment. | PASS | |
| A1.4 | IEC 60601-1-2 | Maintain Essential Performance and Basic Safety of EMC requirements when exposed to electromagnetic disturbances. | PASS | |
| Risk Management | A2.1 | ISO 14971 | Acceptable level of risk established against risk criteria. | Overall the risks are acceptable. |
| General Performance - Accuracy | A1.5 | ISO 80601-2-56 | Storage Test: Greatest calculated error (δ) should not be > 0.09°F (0.05°C) between 95.00°F to 100.40°F (35.00°C to 38.00°C), and not > 0.18°F (0.10°C) between 68.00°F to 94.98°F (20.00°C to 34.99°C) and 100.42°F to 113.00°F (38.01°C to 45.00°C). | When error δ < 0.09°F (0.05°C) or < 0.18°F (0.10°C) PASS |
| A1.6 | ISO 80601-2-56 | Mechanical Shock Test: Same accuracy criteria as the storage test. | When error δ < 0.09°F (0.05°C) or < 0.18°F (0.10°C) PASS | |
| A1.7 | Display Temperature Range | All measurements meet the manufacturer-claimed display temperature range (68°F (20°C) to 113°F (45°C)) and comply with ISO 80601-2-56:2009 minimum display range (95°F (35.0°C) to 107.6°F (42.0°C)). | PASS (implicitly, as it states "All measurements meet...") | |
| A1.8 | Accuracy Test Report (Laboratory) | A sample size of 80 measurements, with no single measurement error exceeding the allowable limit, provides a confidence of 99% that at least 95% of all measurements will meet the acceptable criteria (same δ criteria as A1.5). | When error δ < 0.09°F (0.05°C) or < 0.18°F (0.10°C) PASS | |
| A1.9 | Operating Environment Test Report | Maximum errors in the operation environment range (41°F to 104°F (5°C to 40°C), 15% to 93% RH) must meet the accuracy requirements (δ < 0.09°F (0.05°C)). | When error δ < 0.09°F (0.05°C) PASS | |
| A1.11 | Accuracy Test Report After Cleaning Procedure | Same accuracy criteria as the storage test, after performing the manufacturer's cleaning procedure. | When error δ < 0.09°F (0.05°C) or < 0.18°F (0.10°C) PASS | |
| Biocompatibility | A1.12 | ISO 10993-1, -5, -10, -12 | Cytotoxicity Test: Cell viability not reduced to < 70% of reagent control extract. Skin Sensitization Test: Grades of 1 or greater in test group generally indicate sensitization (provided control animals have <1). Irritation Test: Calculated irritation score. | Cytotoxicity Test: ≥95% cell viability PASS Skin Sensitization Test: No evidence of causing delayed dermal contact sensitization PASS Irritation Test: PII of the test article was zero PASS |
| A1.13 | ISO 10993-1, -5, -10, -12 | (For Stainless Steel Cap) Same biocompatibility criteria as A1.12. | PASS (Implied by overall biocompatibility results) | |
| A1.14 | ISO 10993-1, -5, -10, -12 | (For Elastic Band) Same biocompatibility criteria as A1.12. | PASS (Implied by overall biocompatibility results) | |
| A1.15 | ISO 10993-1, -5, -10, -12 | (For Silicone Belt) Same biocompatibility criteria as A1.12. | PASS (Implied by overall biocompatibility results) | |
| Clinical Accuracy | A1.16 | ISO 80601-2-56 | Clinical accuracy verified by comparing device output with a reference device. Statistical analysis results for system accuracy of body temperature measurement in non-febrile and febrile groups (infants (6 months and above), children, adults, and elderly) must meet 95% limit of agreement criteria. | The statistics analysis results have demonstrated that the system accuracy of body temperature measurement... were met the criteria of 95% limit of agreement and [remaining text cut off] |
2. Sample Size Used for the Test Set and Data Provenance
- Laboratory Accuracy Test (A1.8): A sample size of 80 measurements was used.
- Clinical Test (A1.16): The document mentions "non-febrile and febrile group of subjects, infants (6 months and above), children, adults and elderly," but does not specify the exact sample size for the clinical test set.
- Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given that TaiDoc Technology Corporation is based in Taiwan, it is likely the studies were conducted there. The nature of the performance tests (laboratory, mechanical, storage, operating environment) suggests prospective testing. The clinical trial would also typically be prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
The document does not provide information on the number of experts or their qualifications for establishing ground truth, particularly for the clinical study. For temperature measurement, ground truth for clinical accuracy studies typically involves highly accurate reference thermometers or direct measurement of core body temperature by qualified medical professionals.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method.
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 applicable. This is a medical device (thermometer), not an AI-assisted diagnostic tool that involves human "readers" interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is a physical thermometer. The performance tests (A1.1 - A1.16) evaluate the device's inherent capabilities, which can be considered "standalone" as they assess the device's readings against established standards or reference measurements. There isn't an "algorithm only" in the sense of software interpreting medical images, but rather the device's internal processing of temperature signals.
7. The Type of Ground Truth Used
- Laboratory Accuracy Tests (A1.5, A1.6, A1.8, A1.9, A1.11): The acceptance criteria refer to "calculated error δ" against a known or reference temperature. This implies comparison against calibrated reference standards/devices in controlled laboratory environments.
- Clinical Test (A1.16): The clinical accuracy is verified "by comparing its output with that of a reference device, which has a specified uncertainty for measuring true temperature." This strongly suggests the use of a highly accurate reference thermometer or method to establish the "true" body temperature for comparison.
8. The Sample Size for the Training Set
The document does not provide information on a "training set" as this is not an AI/machine learning device that typically involves distinct training data. The device's performance is based on its engineering design and calibration, not a learned model from a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for an AI/machine learning model.
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