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RPI Skin or Air Temperature Probes are designed to be used as replacement temperature sensing probes for use with the temperature controller portion of Air Shields infant radiant warmers and infant incubators. The probes provide skin or air temperature feedback in order to maintain preselected temperature settings.

The RPI Temperature Probes are intended to be used as replacement parts for Air Shields infant radiant warmers and infant incubators. The RPI Temperature Probes are used to monitor the patient's skin temperature or the unit's air temperature when used in conjunction with the infant radiant warmer or infant incubator. The probes are connected to a unit controller to automatically adjust the heater output of the unit to maintain a pre-selected skin or air temperature. Two of the probes are used in "baby-controlled mode" to monitor the skin temperature of the baby and one of the probes is designed to be used in "air controlled mode", to monitor the air temperature of the incubator or radiant warmer. One probe is a disposable skin temperature probe. The RPI Skin Temperature Probes have a thermistor tip which is attached to the infant's skin. A cable attaches the probe to the unit controller. The electrical flow resistance changes in response to changes in the skin temperature. This resistance change is converted into a temperature reading. The Skin Temperature Probe is available in three models, including a disposable probe and a reusable probe. The Air Temperature Probe has the same thermistor tip, which is attached to a cable connecting the probe to the controller. The Temperature Probes are provided nonsterile.

The provided text is a 510(k) summary for RPI Replacement Temperature Probes. It does not contain information about acceptance criteria or a study proving device performance in the context of detailed performance metrics, test set characteristics, expert involvement, or statistical analysis.

A 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device, which in this case, involves showing similar design, materials, indications for use, and technological characteristics. Performance data, if present, would likely be limited to confirming that the device functions as expected and is comparable to the predicate.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance: This detailed performance data is not included.
• Sample size used for the test set and data provenance: No test set or related detailed evaluation is mentioned.
• Number of experts used to establish ground truth and their qualifications: Not applicable, as detailed performance validation regarding ground truth is not described.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not mentioned.
• Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an algorithm.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable (not an AI/ML device requiring a training set).
• How the ground truth for the training set was established: Not applicable.

The document primarily focuses on:

• Device Name: RPI Skin and Air Temperature Probes
• Intended Use: To be used as replacement temperature sensing probes for use with the temperature controller portion of Air Shields infant radiant warmers and infant incubators. The probes provide temperature feedback to maintain pre-selected temperature settings.
• Predicate Devices:
  • Accutemp-Probe, Kentec Medical, Inc. (K970686)
  • Hill-Rom ISOLETTE Infant Incubator; Hill-Rom Air-Shields (K001242)
  • First Touch Disposables Temperature Probes, First Touch Disposables, Inc. (K950422)
• Technological Characteristics: States that "No new technology, materials, or change in efficacy have been introduced by RPI in the manufacture of the RPI Temperature Probes. The design, form, and materials of the probes are equivalent to their predicate devices." This is the core argument for substantial equivalence, implying that since the predicate devices are already cleared, this device, being equivalent, meets the necessary "acceptance criteria" by extension.

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