(62 days)
The EntraCare Thermometer, Model 1000, is intended to be used under a physicians orders when an accurate temperature measurement is required. The device is intended to be used orally or rectally in the human body temperature range of 92°F to 108°F. It may be used with infants, children, or adults in all settings under the order of a physcian. The heart rate timer is also provided to aid in establishing a patients approximate heart rate.
The EntraCare Thermometer, Model 1000, is a hand-held, battery powered thermometer. This thermometer is capable of measuring and displaying temperatures over the entire human body temperature range (92.0° to 108.0° F or 33.0° to 42.0° C). This device also is capable of calculating a persons approximate heart rate through the use of a stopwatch type function and will display the rate simultaneously with temperature. This feature acts like a stop watch and does not attempt to directly measure a patients pulse.
Here's an analysis of the provided text regarding the EntraCare 1000 Thermometer's acceptance criteria and studies:
Based on the provided 510(k) summary, the device is a thermometer and the safety and efficacy are primarily demonstrated through substantial equivalence to predicate devices, rather than a clinical study with specific acceptance criteria in the traditional AI/medical imaging sense.
However, we can infer performance characteristics based on the device's function and the comparison to predicate devices. The primary "performance" would relate to its ability to accurately measure temperature and its features.
Here's a breakdown of the requested information, acknowledging that the format of the provided text is for a thermometer and not an AI or imaging device, so some categories might not apply or will be interpreted based on the available information:
Acceptance Criteria and Device Performance for EntraCare 1000 Thermometer
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) summary for a thermometer, the "acceptance criteria" are implied by its technological characteristics being "the same" as the predicate devices, and its ability to measure within the specified human body temperature range. The core performance is accurate temperature measurement within a defined range.
| Acceptance Criteria (Inferred from Intended Use & Predicate Comparison) | Reported Device Performance (Implied) |
|---|---|
| Temperature Measurement Range: 92.0° to 108.0°F (33.0° to 42.0°C) | Capable of measuring and displaying temperatures over the entire human body temperature range (92.0° to 108.0° F or 33.0° to 42.0° C). |
| Measurement Sites: Oral or Rectal | Intended to be used orally or rectally. |
| Patient Population: Infants, children, or adults | May be used with infants, children, or adults. |
| Functional Features: Monitor Mode, Night-View Display, °F/°C display, Pulse Timer, Disposable Probe Cover, Battery Powered, Hand-Held/Portable, Replacement Probes, Diagnostic Self-Test | All these features are present in the EntraCare 1000, aligning with or exceeding predicate devices. |
| Technological Characteristics: (Design, Material, Energy Source) as predicate devices | "The new device has the same technological characteristics (i.e., design, material, energy source) as the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable or not explicitly mentioned in this 510(k) summary. For a thermometer, the "test set" would typically refer to the number of measurements taken to validate accuracy, bias, and precision against a reference standard. This information is not provided.
- Data Provenance: Not applicable or not explicitly mentioned. Clinical studies with data provenance (e.g., country of origin, retrospective/prospective) are not detailed in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not applicable. For a basic medical device like a thermometer, "ground truth" would be established by validated reference temperature standards (e.g., traceable to NIST) and potentially by expert medical supervision during usability/performance testing, but not in the sense of expert image interpretation.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., interpreting medical images), not for objective measurements like temperature.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not applicable. An MRMC study is relevant for interpretive tasks, often with AI assistance for human readers. This device is a standalone measurement tool.
6. Standalone Performance Study
- Was a standalone study done? Yes, implicitly. The document states that "The new device has the same technological characteristics (i.e., design, material, energy source) as the predicate devices." This implies that the device's technical specifications and performance were evaluated to ensure they meet the expected standards for a clinical thermometer, equivalent to the predicate devices. While a detailed study report isn't here, the regulatory pathway based on substantial equivalence requires demonstrating that the device performs as intended and is safe and effective on its own merits, relative to the predicates. The ability to measure and display temperatures within the specified range is its standalone performance.
7. Type of Ground Truth Used
- Ground Truth Type: For a thermometer, the ground truth would be objective reference standards. This would involve traceable temperature standards (e.g., calibrated baths, reference thermometers) used to verify the accuracy and precision of the EntraCare 1000 across its operating range.
8. Sample Size for the Training Set
- Not applicable. This device is not an AI/machine learning model, so there is no training set in that context. The device's design and calibration are based on established engineering principles for temperature measurement.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no "training set." The "ground truth" for the device's design and calibration would be established through engineering specifications, metrology standards, and validation processes used in the manufacturing of clinical thermometers.
§ 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.