(97 days)
Skin Temperature Sensor (400-STS)
The Starboard Medical Skin temperature sensor is indicated for continuous patient temperature monitoring when the skin placement site is clinically recommended. The sensor is designed for placement on the surface of the skin.
Tympanic Temperature Sensor (400-TY, 400-TYP)
The Starboard Medical Tympanic Temperature sensor is indicated for continuous monitoring of patient temperature when the ear canal placement site is clinically recommended. The probe is designed for insertion into the ear canal in the proximity of the Tympanic membrane.
Interconnect Instrument Cables (C400MP-M, C400MP-MJ, C400P-M, and C400M-MJ)
The instrument cables are indicated for interconnecting the disposable temperature sensor or probe with the monitoring instrument.
The Starboard Medical temperature sensors are intended for use in clinical situations where continuous monitoring of patient's body temperatures is required. The sensors are compatible with all monitoring instrumentation designed to accept YSI 400 series temperature sensors or equivalent. The Interconnect Instrument cables are used to interconnect the disposable temperature probe / sensor with the patient monitor.
This 510(k) includes the following probes:
400-SK (Skin Temperature Sensor)
400-TY (Tympanic Temperature Sensor - Adult)
400-TYP (Tympanic Temperature Sensor - Pediatric)
C400MP-M (Interconnect Instrument Cable)
C400MP-MJ (Interconnect Instrument Cable)
C400P-M (Interconnect Instrument Cable)
C400P-MJ (Interconnect Instrument Cable)
The probes / sensors are single use, and they are sterile.
The provided text describes Starboard Medical's Disposable Temperature probes/sensors and Interconnect Instrument Cables. However, it does not include detailed acceptance criteria or the specific study results proving the device meets those criteria.
Therefore, for aspects of your request that require such detail (e.g., specific acceptance criteria values, sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details), the information is not available in the provided document.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
This information is not explicitly provided in the given text. The document states: "Both devices have been subjected to materials bio-compatibility testing, accuracy testing, and electrical testing and comparison." It then concludes: "We believe the differences between the Starboard Medical devices and the predicate devices are minor, and conclude that the subject devices are as safe and effective as the predicate devices, therefore substantially equivalent to the predicate devices." This implies that existing performance standards for similar devices were met, but the specific numerical acceptance criteria and reported device performance values are not detailed.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not available in the provided text. The document mentions "accuracy testing" but does not specify the sample size or the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not available in the provided text. The study discussed involves physical device performance (temperature measurement), not expert interpretation of medical images or data. Therefore, the concept of "experts establishing ground truth" in that context is not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable/available from the provided text. As mentioned above, the study focuses on physical device performance, not expert review or adjudication.
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
This information is not applicable/available from the provided text. This study pertains to a temperature sensor, not an AI-powered diagnostic tool for human readers. Therefore, an MRMC study comparing human readers with AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not directly applicable/available as presented. The device is a physical temperature sensor, not a standalone algorithm. The "performance data" refers to the device's accuracy in measuring temperature.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Based on the nature of the device (temperature sensor), the ground truth for "accuracy testing" would typically be established by a highly accurate reference thermometer or calibrated temperature source. The document does not explicitly state this, but it is the standard method for validating temperature measurement devices.
8. The sample size for the training set
This information is not applicable/available in the provided text. The devices are hardware temperature sensors, not machine learning algorithms that require a "training set."
9. How the ground truth for the training set was established
This information is not applicable/available in the provided text. As explained above, the concept of a "training set" for this type of device is not relevant.
§ 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.