(166 days)
Getinge Series Warming Cabinet (models 5524, 5618, 5624) are designed for the heating and storage of irrieation solutions and/or blankets used in the care of patients in areas such as surgery, recovery, OB/GYN, ICU or ER.
The Getinge Series Warming Cabinets are designed for warm storage of solutions and blankets used for patient care in healthcare facilities. The model designations include 5618, 5624, and 5524. The Getinge Series Warming cabinet is not intended for the storage of injectable fluids, blood or blood products.
The provided text describes a 510(k) premarket notification for the Getinge Series Warming Cabinet. This document primarily focuses on establishing substantial equivalence to a predicate device, rather than providing a detailed study of acceptance criteria and performance as might be seen for more complex medical devices like those involving AI.
Therefore, many of the requested categories for the description of "acceptance criteria and the study that proves the device meets the acceptance criteria" are not fully applicable or are not explicitly detailed in this type of submission.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of acceptance criteria and reported device performance in the way a clinical trial or performance study for a high-risk device might. Instead, it summarizes "performance testing" and compares features to a predicate device.
However, based on the "Summary of Performance Testing" and the comparison table, we can infer some criteria and reported performance:
| Acceptance Criteria (Inferred from testing and comparison) | Reported Device Performance (Summary) |
|---|---|
| Temperature Control & Performance | |
| Empty chamber temperature profiles | Performed as intended (exact profiles not detailed) |
| Heat-up time with loads | Performed as intended (exact times not detailed) |
| Temperature Selection Range | 32°C (90°F) to 71°C (160°F) - Matches predicate |
| Overheat Alarm Condition (Functional) | "OH" displayed, audible alarm, power to heaters shut off when chamber temp exceeds selected temp by 4°C (7°F) |
| Overheat Alarm Point (Threshold) | Alarms at 4°C (7°F) above set temperature (lower than predicate's 5.5°C/10°F threshold) |
| Temperature Lock-out Function | Present and functional (prevents unauthorized changes) |
| Electrical Safety and EMC | |
| Compliance to IEC 61010-1 | Verified |
| Compliance to IEC 61010-2-010 | Verified |
| Compliance to IEC 61326-1 | Verified |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document states, "All tests were conducted on current production units." It doesn't specify the number of units tested.
- Data Provenance: The tests appear to be internal performance verification conducted by Getinge Sourcing LLC, based in Rochester, New York, USA. The testing is prospective for the purpose of this submission. It is not patient or clinical data.
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 is not applicable. The device is a warming cabinet, and its performance criteria are primarily engineering and safety standards, not clinical diagnostic accuracy. "Ground truth" in the clinical sense (e.g., confirmed disease diagnosis) is not relevant here. The "ground truth" for this device's performance would be derived from physical measurements and adherence to specified design parameters and referenced safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human readers interpret data, often with disagreements that need resolution (e.g., in medical image analysis). For a warming cabinet's functional and safety testing, the "ground truth" is established by physical measurement equipment and compliance with engineering specifications, not by expert consensus on subjective interpretation.
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 is not applicable. The Getinge Series Warming Cabinet is a physical device for heating and storing solutions/blankets, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and analysis of AI-assisted human reader improvement are entirely irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. As stated above, this is a warming cabinet, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance testing of this device is based on:
- Engineering specifications and measurements: For temperature control, heat-up times, and adherence to design parameters.
- Compliance with recognized standards: Such as IEC 61010-1, 61010-2-010, and 61326-1 for electrical safety and electromagnetic compatibility (EMC).
The measurements and verification against these standards serve as the "ground truth."
8. The sample size for the training set
This is not applicable as this is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
This is not applicable as this is not an AI/machine learning device.
§ 890.5950 Powered heating unit.
(a)
Identification. A powered heating unit is a device intended for medical purposes that consists of an encased cabinet containing hot water and that is intended to heat and maintain hot packs at an elevated temperature.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.