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510(k) Data Aggregation
(195 days)
IMPERIAL SURGICAL LTD.
The Imperial Surgical Ltd. Blanket and Solution Warming Cabinets are designed to store and warm blankets, hospital linens, irrigation fluids and/or injection fluids in accordance with the recommended warming temperatures and storage time guidelines provided by the manufacturers of such products.
The Imperial Surgical Ltd. Blanket and Solution Warming Cabinets are designed to store and warm blankets, hospital linens, irrigation fluids and/or injection fluids in accordance with the recommended warming temperatures and storage time guidelines provided by the manufacturers of such products. The subject device is available with either single compartment or double compartment cabinets, all designed to ensure maximum storage capability. The 7000 series are made of 18 gauge stainless steel with the doors and shelves made of 20 gauge stainless steel. The 8000 series are of a similar design to the 7000 series, however the stainless steel doors have an inset double pane tempered glass to allow interior cabinet viewing. The small 9000 series are made of powder coated steel, and the doors have an inset Plexiglas also to allow interior cabinet viewing.
Imperial Surgical Ltd. Blanket and Solution Warming Cabinets are designed to store and warm blankets, hospital linens, irrigation fluids, and/or injection fluids. The following details the acceptance criteria and the study proving the device meets these criteria as described in the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Expected Specifications) | Reported Device Performance |
|---|---|
| Electrical Safety | Met by CSA International certification using CSA Standard(s) C22.2 No(s). 0, 0.4 as a guide and SPE-1000, UL1262, US Field Evaluation. |
| Temperature Control & Distribution | |
| Accuracy of the temperature controller | Tested and met. |
| Even distribution of heat throughout the cabinet with limited temperature variance | Tested and met. |
| Multiple temperature readings within +/- 1.5ºC accepted variance | Tested and met. |
| Heating Performance | |
| Quickness to reach desired temperature from a cold start | Tested and met. |
| Recovery time after repeated door openings to return to desired setting | Tested and met. |
| Time to achieve desired temperature when loaded to 3/4 capacity | Tested and met. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in terms of cases or patient data, as this is a device for warming medical items rather than diagnosing or treating patients. The testing involved the manufactured Blanket and Solution Warming Cabinets themselves.
- Sample Size: The number of units tested is not explicitly stated but implies testing on at least one (or more, representative) unit of each model type to evaluate performance characteristics.
- Data Provenance: The testing was conducted by Imperial Surgical Ltd., presumably at their manufacturing facility or a contracted testing lab, as part of their premarket notification process for the Canadian and US markets. The CSA International certification indicates testing conducted by a recognized third-party organization. This is prospective testing of the manufactured device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable to a non-clinical device performance study. "Ground truth" in this context refers to established engineering and safety standards (e.g., electrical safety standards, temperature accuracy specifications) rather than expert consensus on medical images or diagnoses.
4. Adjudication Method for the Test Set
This is not applicable, as there was no expert adjudication of subjective results. The evaluation relied on objective measurements and adherence to predetermined technical specifications and safety standards.
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 device is a warming cabinet, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related comparative effectiveness analysis was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical warming cabinet, not an algorithm or software. Its performance is inherent to its mechanical and electrical operation.
7. The Type of Ground Truth Used
The "ground truth" for the performance testing comprised established engineering specifications, electrical safety standards (e.g., CSA Standard(s) C22.2 No(s). 0, 0.4, SPE-1000, UL1262), and the manufacturer's own design specifications for temperature accuracy and distribution (e.g., +/- 1.5ºC variance).
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of this device. The warming cabinet is a hardware device, not a machine learning model that requires training data.
9. How the Ground Truth for the Training Set was Established
This is not applicable, as there is no training set for this type of device.
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