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510(k) Data Aggregation
(343 days)
The Reusable Temperature Probes are intended to be used for monitoring temperature. The temperature probes are reusable and designed for use with monitors of Nihon Kohden model BSM-5135A. These devices are indicated for used by qualified medical personnel only.
Reusable temperature probes are used during patient temperature measurement for multi-patient use. These probes consist of a phone plug connector on the monitor 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 either directly by using a phono plug or by an interconnect cable. These probes have a skin or core contact with a patient.
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 ".
The provided text describes the performance data for the Reusable Temperature Probe (Models: TRAG-2252, TRAS-2252, TRCG-2252 and TRCS-2252) in support of its substantial equivalence determination.
Here's a breakdown of the requested information based on the text:
1. A table of acceptance criteria and the reported device performance
| Criteria | Acceptance Criteria (Standard / Description) | Reported Device Performance |
|---|---|---|
| Material Accuracy | 25-45°C | 25-45°C |
| Accuracy | ±0.2°C | ±0.2°C |
| Laboratory Accuracy | Not greater than 0.3 °C for a continuous clinical thermometer that is not an adjusted mode clinical thermometer (per ISO 80601-2-56) | Pass (within ±0.2°C) |
| Time Response | Heating transient time < 150s | < 150s |
| Electrical Safety | Meets requirements of IEC 60601-1 | Pass |
| Electromagnetic Compatibility (EMC) | Meets requirements of IEC 60601-1-2 and ISO 80601-2-56 | Pass |
| Disinfection Validation | Low-level disinfection validation; High-level disinfection validation | Pass |
| Chemical Disinfection Agent Residue | Non-Cytotoxicity according to ISO 10993-5 (after disinfection) | Pass |
| Biocompatibility | Complies with ISO 10993-1 (Cytotoxicity, Skin Sensitization, Skin Irritation, Rectal Irritation) | Pass (no cytotoxicity, negligible irritation, no sensitization) |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size used for performance testing (e.g., how many probes were tested) nor does it specify the provenance (e.g., country of origin) of the data. It indicates that "All subject devices were conducted performance testing according to ISO 80601-2-56" and references "Laboratory accuracy" and "Time response" results as well as biocompatibility testing. The nature of these tests (e.g. for electrical safety and accuracy) suggests they are conducted in a laboratory setting, not on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the device is a temperature probe, and the performance testing described is objective measurement against standards and physical characteristics, not expert interpretation of diagnostic images or clinical scenarios requiring ground truth establishment by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable for the reasons stated above. Adjudication methods are typically relevant for studies involving human interpretation (e.g., radiologists reading images) where disagreement among experts needs resolution.
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 section is not applicable. The device is a Reusable Temperature Probe, which is a physical measurement device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable, as the device is a temperature probe and does not involve an algorithm for diagnostic interpretation. Its performance is inherent in its design and manufacturing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the performance metrics (accuracy, time response, safety, EMC) of the temperature probe, the "ground truth" is established by objective measurement against the specified international standards (e.g., ISO 80601-2-56 for accuracy and time response, IEC 60601-1 for electrical safety, ISO 10993 series for biocompatibility). There is no "expert consensus" or "pathology" involved in determining if a physical temperature measurement falls within a specified range.
8. The sample size for the training set
This section is not applicable. The device is a Reusable Temperature Probe, which is a hardware medical device, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This section is not applicable, as there is no training set for this type of device.
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