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510(k) Data Aggregation
(98 days)
CHANGSHAN ESTAR ELECTRONICS CO., LTD.
ECT digital thermometer is an electronic clinical thermometer which is intended to measure the human body temperature in regular mode orally, rectally or underarm. The device is reusable for clinical or home use on people of all ages.
The ECT digital thermometer comprises of a thermistor for measuring sensor, a reference resistor for comparison of the temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermistor contacts. This thermometer uses a DC 1.5V battery for operation of complete system whenever the battery is low, the ASIC circuit will detect the low battery condition automatically, and displays ' ▼' in LCD display.
Here's a breakdown of the acceptance criteria and study information for the ECT digital thermometer, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the ECT digital thermometer are based on compliance with the ASTM E1112-00 (2006) standard specifications and other relevant IEC and ISO standards. The reported device performance is presented in comparison to predicate devices, demonstrating its substantial equivalence.
| Feature / Criterion | Acceptance Criteria (Implied by standard compliance and predicate comparison) | Reported Device Performance (ECT Digital Thermometer) |
|---|---|---|
| Accuracy | Should be within acceptable limits as per ASTM E1112-00 (e.g., ±0.1°C or ±0.2°F). | ±0.2 °F / ±0.1 °C |
| Measurement Range | Consistent with typical clinical thermometers. | 90.0 ~ 109.9 °F (32.0 ~ 42.9 °C) |
| Display Resolution | Clear and precise display for clinical use. | 0.1 °F/°C (3 1/2 digits, 0.1 increments) |
| Response Time | Timely temperature measurement for different sites. | Approx. 1 min (oral) |
| Approx. 3 to 5 min (underarm) | ||
| Approx. 1 min (rectal) | ||
| Operating Environment (Temperature) | Functional within typical clinical and home environments. | 41 ~ 104 °F (5 ~ 40 °C) |
| Operating Environment (Relative Humidity) | Functional within typical clinical and home environments. | 15 ~ 95% |
| Storage Environment (Temperature) | Withstand typical storage conditions. | -14 ~ 128 °F (-10 ~ 60 °C) |
| Storage Environment (Relative Humidity) | Withstand typical storage conditions. | ≤ 85 % |
| Automatic Shut-off | Energy saving feature. | YES / after about 10 min |
| Memory | Recall last temperature reading. | Recalls last temperature |
| Waterproof | For hygiene and durability. | YES |
| Materials | Biocompatible and durable. | Probe: 316 S.S., Case: ABS |
| Cleanability | Easily cleaned for reuse. | By 70% isopropyl alcohol or soap and water |
| Compliance | Adherence to relevant safety and performance standards. | ASTM E1112, IEC 60601-1, ISO 10993-5, ISO 10993-10 |
2. Sample Size for the Test Set and Data Provenance
The document states "Bench testing confirmed the temperature range, accuracy, operating environment, storage environment, resolution, readability and repeatability." However, it does not specify the sample size used for this bench testing.
The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data mentioned. Given it's basic bench testing for a physical device, it's highly likely to be prospective data generated in a lab setting, presumably by the manufacturer in China (Changshan Estar Electronics Co., LTD is located in China).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for the test set. For a digital thermometer, ground truth is typically established by comparing the device's readings against a highly accurate reference thermometer in a controlled environment, not via expert consensus.
4. Adjudication Method for the Test Set
No adjudication method is mentioned as experts were not used. The testing described is objective, comparing measurements against established, calibrated standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for interpretative diagnostic devices where human reader performance is a key metric. For a digital thermometer, the measurement output is objective.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a standalone performance evaluation was done. The "Bench testing confirmed the temperature range, accuracy, operating environment, storage environment, resolution, readability and repeatability" directly pertains to the standalone performance of the device itself (its hardware and embedded software/ASIC for calculation). There is no "human-in-the-loop" aspect to the fundamental temperature measurement process of a digital thermometer that would require such a study distinction.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for testing an electronic thermometer is established by calibrated reference standards. This involves comparing the device's temperature readings to those of a highly accurate and traceable thermometer in controlled temperature environments.
8. The Sample Size for the Training Set
The document does not refer to a "training set" as this device does not use machine learning or AI algorithms that require training data in the conventional sense. Its functionality is based on direct physical measurement and pre-programmed algorithms.
9. How the Ground Truth for the Training Set was Established
As there is no "training set" in the context of a digital thermometer, this question is not applicable. The device's internal algorithms for converting thermistor readings to temperature values are based on established thermodynamic principles and calibration, not machine learning model training.
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