(170 days)
Measures and displays long-term "body temperature" as calibrated to the equivalent oral temperature standard.
Will not provide valid data in ambient temperatures greater than patient body temperature.
Requires 30 minute warm-up before achieving accurate readings.
Will not operate while exposed directly to sun or other forms of radiant heat.
Measures and displays patient temperature as calibrated to the equivalent oral temperature standard. The APM-2000 Ambulatory Patient Transcutaneous Temperature Monitor is an element of the Sabratek Corporation APM-2000 System.
The document describes the Sabratek APM-2000 Ambulatory Patient Transcutaneous Temperature Monitor, which is an electronic thermometer that measures and displays patient transcutaneous temperature. It has a digital display with a resolution of ± 0.1 F, a warm-up time of 30 minutes, and an accuracy of 0.3° F over a range of 95° F-105° F. It uses a skin surface probe and is powered by a battery.
The document provided is a 510(k) summary for the Sabratek APM-2000 Ambulatory Patient Transcutaneous Temperature Monitor. It outlines substantial equivalence to predicate devices but does not contain detailed information about a study proving the device meets specific acceptance criteria in the format requested.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a separate section with pass/fail metrics. Instead, it compares the Sabratek APM-2000's parameters to those of predicate devices. The implication is that meeting or being comparable to the predicate's performance makes the device acceptable for market.
| Parameter | Acceptance Criteria (Implied from Predicate/Sabratek) | Reported Device Performance (Sabratek APM-2000) |
|---|---|---|
| Intended Use | Patient body temperature | Patient body temperature |
| Temperature Range | Comparable to predicate (e.g., 78.8°F-107.6°F) | 90°F (31.9°C) – 106°F (40.7°C) |
| Display Type | Digital | Digital |
| Display Resolution | ± 0.1°C or ± 0.1°F | ± 0.1°F |
| Warm-up Time | 30 Minutes | 30 Minutes |
| Accuracy | 0.3°C or 0.3°F | 0.3°F over range of 95°F-105°F |
| Counts Up and Down | Yes (preferred, or Up only) | Yes |
| Ambient Temperature environment | Less than temperature being taken | Less than temperature being taken |
| Skin surface probe | Yes | Yes |
| Power Supply | Battery or Mains | Battery |
| Battery Charger | Yes or No | No |
| Single Patient Probe | Yes | Yes |
| Shipped Sterile | No | No |
| Microprocessor | No or Unknown | No |
| Alarms | No | No |
2. Sample Size Used for the Test Set and Data Provenance:
The document briefly mentions "Non-clinical tests included comparison with temperature standard." However, it does not provide any specific information regarding:
- The exact sample size used for any test set.
- The data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of Experts Used to Establish Ground Truth and Qualifications:
The document states that non-clinical tests compared the device with a "temperature standard." It does not mention the involvement of human experts in establishing ground truth for any test set. The ground truth appears to be based on an objective measurement standard.
4. Adjudication Method:
Since no human experts are mentioned in establishing ground truth for a test set, there is no adjudication method described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not describe an MRMC comparative effectiveness study. This device is a transcutaneous temperature monitor, not an AI diagnostic tool that would typically involve human readers to interpret outputs. Therefore, there's no discussion of human readers improving with or without AI assistance.
6. Standalone Performance Study:
The "Non-clinical tests included comparison with temperature standard" can be interpreted as a standalone performance evaluation of the device. However, the details are extremely limited. It does not provide metrics like sensitivity, specificity, or any specific numerical outcomes beyond the accuracy claim.
7. Type of Ground Truth Used:
The ground truth used for the device's evaluation was a "temperature standard." This implies a reference thermometer or a calibrated temperature source.
8. Sample Size for the Training Set:
The document does not mention a training set or any machine learning/AI components that would require one. The APM-2000 appears to be a traditional electronic measurement device.
9. How Ground Truth for the Training Set Was Established:
Since there is no mention of a training set, there is no information on how ground truth for a training set was established.
Conclusion:
The K983355 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on device specifications and a general statement about non-clinical testing against a "temperature standard." It does not provide the detailed study information typically associated with proving a device meets specific acceptance criteria through a rigorous clinical or performance study, especially not for AI/ML-enabled devices that require such extensive validation. The lack of information on sample sizes, expert involvement, and specific study designs is characteristic of 510(k) summaries for less complex devices where performance is primarily demonstrated through comparison with well-established predicate technology.
§ 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.