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The MAC Medical D-Series 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 guidelines provided by the manufacturers of such products.

The MAC Medical D-Series Blanket and Solution Warming Cabinets are designed to store and warm sterile IV solutions, surgical irrigation solutions, linens and/ or blankets to an acceptable level for hospital and surgical outpatient center applications.

The MAC Medical D-Series Warming Cabinets are constructed with stainless steel panels, headers and doors. The Warming Cabinets are doubled walled constructed and are fully insulated to provide uniform heating. Optional glass doors are double paned tempered glass with aluminum.

A pull-out shelf inside the top of the cabinet contains the heating element, fan, thermostat, and temperature sensor. The electronics are located on the outside of the cabinet and the power cable is connected in the back of the cabinet. The wheeled baskets run on mounted rails and automatically stop when they reach the full out position. The shelves and baskets can be removed for cleaning and repositioning.

This document describes the premarket notification (510(k)) for the MAC Medical D-Series Blanket and Solution Warming Cabinets. It focuses on demonstrating substantial equivalence to predicate devices rather than proving novel clinical effectiveness with detailed AI or human reader studies. Therefore, many of the requested elements for an AI/MRMC study are not applicable or not present in this type of submission.

Here's a breakdown based on the provided document:

Acceptance Criteria and Device Performance

The acceptance criteria for this device are based on demonstrating substantial equivalence to legally marketed predicate devices, primarily regarding safety and performance specifications related to warming and temperature control. The performance is assessed through non-clinical bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a warming cabinet and not an AI-driven diagnostic device, the "acceptance criteria" are primarily based on meeting safety standards and functional specifications similar to predicate devices. The document compares technical characteristics.

• 0/ - 3° F - For settings 110° F to 150° F | +0/ - 2.7° F |
  | Installation | Free Standing or Recessed | Free Standing (Mobile) or Recessed | Free Standing or Recessed |
  | Controls | Electronic temperature controller with LED display. Element on the red neon indicator display. | Electronic control consists of 4 digit LED display, on/off keys, integrated lock feature and a series of prompt sequence indicators. | Electronic temperature controller with LED display. Illuminated power switch/ breaker (red). Amber neon indicator for element on red neon indicator for trouble. |
  | Unit Configuration | Single/ Dual/ Triple | Single | Single/ Dual |
  | Unit Depth | Inside Cavity 18" or 24"
  Overall 20.5" or 26.5" | 34.9" | 22" or 28" for table top and full-size cabinets. |
  | Cabinet Volume | Triple compartment capacity - 14.01 cu ft overall
  Upper - 3.89 cu ft
  Middle - 3.73 cu ft
  Lower - 6.4 cu ft | Single compartment - 7.8 cu ft | Dual compartment capacity - 18.1 cu ft overall
  4.3 cu ft upper
  13.8 cu ft lower |
  | Voltage Requirements | 120 VAC 50/60 HZ or 240 VAC 50/60 HZ | 120 VAC 50/60 HZ or 230 VAC 50/60 HZ | 120 VAC 60 HZ |
  | Expected Life | 10 years | Not available | Not available |

2. Sample Size for Test Set and Data Provenance

This is a warming cabinet, not a device processing patient data. The "test set" refers to the specific warming cabinet units manufactured by MAC Medical that underwent non-clinical bench testing.

• Sample Size: Not explicitly stated as a number of units, but implies that the tests were performed on representative units of the D-Series.
• Data Provenance: Not applicable in the context of patient data. The provenance is from internal testing performed by MAC Medical. The document does not specify the country of origin of the testing, but the company is based in Illinois, USA. The testing is prospective for the purpose of this submission.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This device does not generate diagnostic interpretations requiring expert ground truth in the way AI algorithms do. Ground truth here refers to metrological standards for temperature measurement and adherence to electrical safety standards.

4. Adjudication Method for Test Set

Not applicable. This is not a study involving human interpretation. The "adjudication" is through engineering and quality control procedures confirming the device meets specified performance criteria and safety standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is a warming cabinet, not an AI-assisted diagnostic tool for medical imagery or patient interpretation. There is no human reader component that would be "assisted" by this device.

6. Standalone Performance (Algorithm Only)

Not applicable. There is no AI algorithm in this device. Its performance is measured directly through its physical function (heating, temperature control, safety).

7. Type of Ground Truth Used

The "ground truth" for the non-clinical bench testing is based on:

• Engineering specifications and design requirements.
• International safety standards (e.g., IEC 61010-1 for electrical safety, IEC 61326 for EMC).
• Metrological accuracy for temperature measurements (e.g., using calibrated temperature probes).
• Functional verification against specified temperature ranges and alarm conditions.

8. Sample Size for Training Set

Not applicable. This is not an AI/machine learning device. There is no "training set" in the context of data for an algorithm. The design and manufacturing processes are refined through engineering, quality control, and adherence to established medical device manufacturing practices.

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no training set for an AI algorithm. The device's design is based on established engineering principles for warming cabinets and safety standards.

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