(156 days)
Designed for use in the neonatal intensive care unit (NICU), Special Care Baby Unit (SCBU), delivery suite, post-natal wards and during transport, the CosyTherm warming system provides safe and controlled warming to assist newborn infants to maintain normal body temperature. In addition to providing warming, the mattress also includes a pressure relief pad.
The Inditherm CosyTherm system consists of a precision temperature control unit that controls and monitors the temperature of a mattress or blanket composed of a carbon polymer material. A pressure relief pad is integrated into the mattress, underneath the flexible warming surface.
The provided text describes the CosyTherm Neonatal Warming System (K061902) and its 510(k) submission. However, it does not contain specific acceptance criteria, a detailed study proving the device meets those criteria, or the other specific details requested in your prompt (e.g., sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set information).
The document states:
- Non-Clinical Testing: "Inditherm conducted testing against recognized standards for electrical safety and electromagnetic emissions and immunity. Performance testing was also conducted to assure adequate temperature accuracy and stability as well as the proper functioning of thermal safety features. All test results verify the device meets or exceeds predetermined specifications."
- Clinical Testing: "None submitted"
- Summary: "Based on Performance Testing results and specifications, the CosyTherm system is substantially equivalent to the Inditherm Patient Warming System."
This indicates that acceptance was based on non-clinical performance and safety testing against predetermined specifications, and a demonstration of substantial equivalence to a predicate device. The detailed "predetermined specifications" that would serve as acceptance criteria are not explicitly listed, nor are the specific results of those tests.
Therefore, I cannot populate the table or answer most of your questions with the information provided.
Here is what can be inferred or stated from the provided text:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: "predetermined specifications" for electrical safety, electromagnetic emissions and immunity, temperature accuracy, stability, and proper functioning of thermal safety features. (Specific values or ranges are not provided).
- Reported Device Performance: "All test results verify the device meets or exceeds predetermined specifications." (Specific results or metrics are not provided).
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Sample sized used for the test set and the data provenance: Not provided for non-clinical testing. No clinical test set.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical testing or expert ground truth was established for the 510(k) given.
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Adjudication method for the test set: Not applicable.
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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: Not applicable. This device is a thermal regulating system, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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The type of ground truth used: For the non-clinical performance testing, the ground truth would be established by calibrated measurement instruments against engineering specifications.
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The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
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How the ground truth for the training set was established: Not applicable.
§ 870.5900 Thermal regulating system.
(a)
Identification. A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.(b)
Classification. Class II (performance standards).