(30 days)
The ASTOPAD® Patient Warming System is intended to prevent or treat hypothermia and to provide warmth to patients. The ASTOPAD Patient Warming System is indicated for use in all areas of healthcare facilities for preventing or treating hypothermia or maintaining normothermia. The warming blankets can be used over or under the patient (pediatric and adult) by appropriately trained healthcare professionals.
The ASTOPAD Patient Warming System is a thermal regulating system which includes a connection cable that attaches to reusable conductive warming blankets for patient warming in clinical environments. The system consists of a control unit (DUO310-NA) and one or optionally two applied parts (warming blankets/COVXXX-NA) with different sizes to fit different applications.
The provided text describes the Stihler Electronic GmbH's ASTOPAD Patient Warming System. However, it does not contain information about acceptance criteria for device performance related to diagnostic accuracy, a study proving the device meets said criteria, or any details about sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these are typically associated with artificial intelligence/machine learning diagnostic devices.
The document is a 510(k) summary for a medical device (a patient warming system) and focuses on establishing substantial equivalence to a predicate device through performance data for safety and effectiveness related to its function as a warming device.
Therefore, most of the requested information is not applicable or cannot be extracted from this document.
Here's an attempt to answer based on the available information:
1. A table of acceptance criteria and the reported device performance:
The document primarily references compliance with various international standards for safety and effectiveness, rather than specific performance metrics directly related to diagnostic accuracy. The "acceptance criteria" are implied by meeting the requirements of these standards.
| Acceptance Criteria (Implied by standard compliance) | Reported Device Performance (Compliance) |
|---|---|
| Biocompatibility: Absence of cytotoxicity, sensitization, and irritation as per ISO 10993-1. | The device passed cytotoxicity, sensitization, and irritation tests as recommended by FDA guidance. |
| Electrical Safety: Compliance with IEC 60601-1, IEC 60601-1-6, IEC 60601-1-8, and IEC 80601-2-35. | The system complies with applicable electrical safety requirements of these standards. |
| Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2. | The system complies with applicable EMC requirements of the standard, as documented per FDA guidance. |
| Software Verification & Validation: Adherence to FDA guidance for software in medical devices (minor level of concern). | Software verification and validation were conducted, and documentation provided, as recommended by FDA guidance. |
| Mechanical Safety: Compliance with IEC 60601-1 and IEC 80601-2-35 standards. | The system complies with applicable mechanical requirements of these standards. |
| Thermal Performance: Compliance with IEC 60601-1 and IEC 80601-2-35 standards. | The system complies with applicable thermal requirements of these standards. |
| Human Factors/Usability: Safety and effectiveness for intended users, use, and environments as per FDA guidance. | The system was found to be safe and effective for intended users, use, and use environments. |
| Reprocessing Effectiveness: Validation of cleaning and disinfection as per FDA guidance. | The system meets applicable cleaning & disinfecting performance criteria when cleaned and disinfected as labeled. |
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 provided in the document as it is not an AI/ML diagnostic device study. The performance data listed (biocompatibility, electrical safety, etc.) are standard engineering and laboratory tests, not clinical studies with patient data in the typical sense.
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 provided and is not applicable to the type of device and testing described in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided and is not applicable to the type of device and testing described in the document.
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 provided and is not applicable. The device is a patient warming system, not a diagnostic imaging device with human readers and AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not provided and is not applicable. The ASTOPAD Patient Warming System does not involve an algorithm for standalone diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the various performance tests (biocompatibility, electrical safety, etc.) is the adherence to the specifications and limits defined within the referenced international standards (e.g., IEC 60601 series, ISO 10993-1). This is verified through laboratory testing and validation protocols rather than clinical outcomes or expert consensus on a diagnostic task.
8. The sample size for the training set:
This information is not provided and is not applicable. The device does not use an AI/ML model that requires a training set.
9. How the ground truth for the training set was established:
This information is not provided and is not applicable. The device does not use an AI/ML model that requires a training set with established ground truth.
§ 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).