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Rectal Temperature Probe:

The Disposable Rectal Temperature Probes are intended to be used for monitoring temperature from the rectum. The temperature probes are non-sterile and designed for single patient use with monitors of Nihon Kohden model BSM-5135A. These devices are indicated for use by qualified medical personnel only.

Skin Temperature Probe:

The Disposable Skin Temperature Probes are intended to be used for monitoring temperature from skin. The temperature probes are non-sterile and designed for single patient use with monitors of Nihon Kohden model BSM-5135A. These devices are indicated for use by qualified medical personnel only.

Disposable temperature probes are used during patient temperature measurement. These probes consist of a plug connector on the adapter cable end and a thermistor on the patient end. Temperature probes measure temperature by a resistor that is sensitive to temperature changes. These probes are connected to the patient monitor by using an interconnect cable. These probes have a skin or rectal contact with adult patients. Both the skin and rectal probe are single use and provided non-sterile.

These temperature probes are typically used with legacy Nihon Kohden monitors BSM-5135A.

Products are packed individually into a plastic bag in non-sterile condition. Package label describes product LOT codes, CE-mark, legal entity information and a caution "Rx Only ".

Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance, formatted to address your specific questions.

Based on the provided document, the device in question is a "Disposable Temperature Probe" (Rectal and Skin types). This is a 510(k) submission, meaning the manufacturer is demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness from scratch. Therefore, the "acceptance criteria" and "study" are primarily focused on showing that the new device performs comparably to the predicate and meets relevant safety and performance standards for its intended use.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission for a temperature probe, the "acceptance criteria" are intrinsically tied to the performance standards for clinical electronic thermometers and the performance of the predicate device. The document explicitly states the criteria and the results obtained for the subject device.

Notes on the Table:

• The document doesn't explicitly state "acceptance criteria" as a separate list, but rather "Performance Data" which includes the tests conducted and their "Pass" results, demonstrating compliance with established standards and equivalence to the predicate.
• The "Accuracy" value listed under "Features" in the comparison table (±0.1°C) is more stringent than the general laboratory accuracy acceptance criterion (Not greater than 0.3 °C). However, the document states Pass for the laboratory accuracy test, implying it met the more stringent ±0.1°C as well, given the direct comparison to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for the performance tests (e.g., how many probes were tested for accuracy, biocompatibility, etc.).

• Data Provenance: Not explicitly stated as "country of origin" for the test data itself (e.g., where the lab tests were conducted). However, the manufacturer is Shenzhen Caremed Medical Technology Co., Ltd. in China, and the correspondent is also in China, suggesting the testing likely occurred there or was overseen by the Chinese entity preparing the submission.
• Retrospective or Prospective: The testing described (biocompatibility, electrical safety, EMC, laboratory accuracy, time response) appears to be prospective testing conducted specifically for the purpose of this 510(k) submission, rather than retrospective analysis of existing data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not provided in the document. For a temperature probe, "ground truth" for performance would typically be established by calibrated laboratory equipment and standard test methods (e.g., temperature baths, reference thermometers) rather than human experts. Biocompatibility testing follows laboratory protocols and analysis by qualified lab personnel.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. "Adjudication" usually refers to a process where multiple human readers or experts review data and resolve discrepancies to establish a consensus ground truth. This is not how performance data for a temperature probe is typically validated; it relies on objective physical measurements and standardized test procedures.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. Such studies are typically performed for diagnostic imaging AI devices where human interpretation is a critical component, to assess how AI assistance impacts human reader performance. This device is a measurement tool, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This question is not applicable in the context of this device. The disposable temperature probe is a physical measuring device, not an AI algorithm. Its performance is inherent in its design and manufacturing, not an algorithm that operates independently. The device's performance characteristics (accuracy, time response) are "standalone" in that they are measured directly from the device's output.

7. The Type of Ground Truth Used

The ground truth for this device's performance was established through:

• Standardized laboratory measurements: Using calibrated equipment and following established international standards (e.g.,
  • ASTM E1112 for "Standard Specification for Electronic Thermometers for Intermittent Determination of Patient Temperature" (implied for accuracy)
  • ISO 80601-2-56 for "Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement" (referenced for EMC and time response)
  • IEC 60601-1 for "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance" (referenced for electrical safety)
• Biocompatibility testing: Following ISO 10993 series standards, which involve in-vitro and/or in-vivo tests to assess biological responses.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. This device is a physical medical instrument, not a machine learning model. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no "training set" for this device.

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