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The Natus Warmette® Blanket Cabinet is designed to store and warm blankets and hospital linens; while, the Natus Warmette® Dual Cabinet is designed to store and warm blankets and hospital linens in one compartment and fluids (Irrigation and/or Injection) in the other compartment within the storage times and warming temperatures recommended by the manufacturers of those items.

The Natus Warmette® Cabinets are made of stainless steel and are well insulated to reduce heat loss and noise. Cabinet doors are double glazed with safety glass.

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 top of the cabinet and the power cable is connected at the back of the electronic cabinet.

Wheeled shelves and baskets run on mounted rails and automatically stop when they reach the full out position. The shelves and baskets can be removed for cleaning or repositioning.

The Natus Warmette® Blanket Cabinet is factory-set to 130ºF (54ºC) with a temperature range of 95º - 176ºF (35º -80°C). For the Natus Warmette® Dual Cabinet, the blanket and linen compartment is factory-set to 130°F (54°C) with a temperature range of 95° - 1769F (35° - 80°C); while the fluid compartment is factory-set to 110°F (43°C) with a temperature range of 970 - 122°F (36° - 50°C).

The Natus Warmette® Blanket Cabinet is designed to store and warm blankets and hospital linens; while the Natus Warmette® Dual Cabinet is designed to store and warm blankets and hospital linens in one compartment, and fluids (irrigation and/or injection) in the other compartment within the storage times and warming temperatures recommended by the manufacturers of those items.

The cabinet and its contents are warmed by circulating warm air which is heated by a warming element. The hot air is circulated by a fan and distributed evenly through the outlets. The temperature is regulated by the temperature regulator T1 to the set temperature.

Thermostat T2 functions as over temperature protection and will take over the temperature control in case the air temperature exceeds set maximum temperature by 90F (5°C). At the same time the red lamp on the front panel will be lit to indicate that there is a malfunction. Inside the heating element itself, there is an additional over temperature protection that is self-resetting. It will be activated in case the fan stops or goes too slow.

This document describes the Natus Warmette® Blanket and Dual Cabinets, which are medical warming cabinets. The provided text is a 510(k) Premarket Notification summary. It focuses on demonstrating substantial equivalence to a predicate device (Imperial Surgical Blanket and Solution Warming Cabinets) rather than presenting a study to prove the device meets acceptance criteria for an AI/ML context.

Therefore, most of the requested information regarding AI/ML device study parameters (e.g., sample sizes for test and training sets, expert adjudication, MRMC studies, ground truth establishment for AI, effect sizes, etc.) is not applicable to this document. This submission is for a physical medical device (warming cabinet), not a software or AI/ML device.

However, I can extract the closest information regarding "acceptance criteria" and "device performance" in the context of this product.

Acceptance Criteria and Device Performance (for a physical warming cabinet, not an AI/ML device)

The "acceptance criteria" for this device are implicitly derived from its functional specifications and comparison to the predicate device. The "study" proving it meets these is a series of non-clinical tests.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance:

• This is not an AI/ML device. The "test set" in this context refers to the manufacturing quality control and verification tests performed on the physical units.
• The document states: "Each cabinet must meet the specified test requirements per a formal, written test procedure." This implies that every manufactured unit undergoes these tests as part of the quality assurance process.
• Data Provenance: The tests are conducted internally by Natus Nicolet Ireland Limited, presumably at their manufacturing facility in Gort, County Galway, Ireland. The data would be specific to product verification and validation during manufacturing. It is retrospective in the sense that the results are documented after each unit is tested.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• This concept is not relevant to this type of device. The "ground truth" for a warming cabinet is its measurable physical performance (temperature, electrical safety, functional operation) against engineering specifications.
• The individuals involved would be qualified engineers, technicians, and quality assurance personnel responsible for manufacturing and testing medical devices, adhering to established procedures and standards (e.g., ISO 13485 for medical devices).

4. Adjudication Method for the Test Set:

• Not applicable in the AI/ML sense. "Adjudication" here would simply be a pass/fail determination based on whether the measured performance during testing meets the defined specifications. Any discrepancies would lead to re-work, re-test, or rejection, not an expert consensus process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. This is entirely irrelevant for a warming cabinet. MRMC studies are used for evaluating the performance of diagnostic imaging aids where human interpretation is involved.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

• Not Applicable. There is no algorithm in the AI/ML sense. The device's operation is purely electro-mechanical with basic electronic controls for temperature regulation.

7. The Type of Ground Truth Used:

• The "ground truth" (or objective performance benchmark) for this device is based on engineering specifications and established test procedures that verify the physical and functional characteristics, such as:
  • Direct temperature measurements (e.g., using calibrated thermometers).
  • Electrical safety measurements (e.g., leakage current, grounding integrity).
  • Functional checks (e.g., fan operation, lamp indicators, control panel response).
  • Comparison to the performance and characteristics of the predicate device (as shown in the comparison table).

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/ML device. There is no "training set."

9. How the Ground Truth for the Training Set Was Established:

• Not Applicable. There is no "training set" or "ground truth" in the AI/ML context. The device's design and manufacturing rely on established engineering principles, material science, and quality control processes for physical products.

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For WAZMING BLANKETS/LINEN o R or Solutions SOLUTIONS MUST 136 . 197 EXTERNAL ાર્ટ હ ONLy ,

All Olympic Warmettes are essentially double walled, insulated cabinets with transparent doors. The Warmettes normally remain on continuously. The temperature is user selectable. The Model 10 uses a resistance element heater encapsuled in a high temperature r lie Model 10 uses a roclocanos element of the interior. Due to the small size, forced air circulation is not needed. The Models 30, 31 and 40 make use of a fan to force recirculating air past The Models 50, of and 10 make see above the main chamber) and then into the resistence heating bientified (roothe heaters via an air duct built into the left wall. The Models 31 and 40 differ from the Model 30 in two respects: · The selectable maximum temperature is higher. - · The delivery duct/plenum inside the right wall is more efficient, allowing the Models 31 and 40 to operate at the higher temperatures.

The provided document is a 510(k) premarket notification letter from the FDA regarding a medical device called "Warmette" by Olympic Medical. It is a Class I device, a powered heating unit intended for warming blankets/linen or external solutions.

Based on the provided text, the device Warmette (Models 30, 31, and 40) meets acceptance criteria primarily through nonclinical testing, demonstrating substantial equivalence to a predicate device (Olympic Warmette Model 10). There is no mention of a study involving human readers or clinical trials for performance evaluation in the context of typical AI/diagnostic device acceptance criteria. The device is a heating cabinet, not an AI or diagnostic tool.

Here's a breakdown of the requested information based on the document:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly state "acceptance criteria" in a formal table with pass/fail thresholds for specific performance metrics in the way one would see for a diagnostic device. Instead, it demonstrates performance by comparing its specifications to a predicate device and verifying certain safety functions. The key performance parameter is temperature range and accuracy.

¹ Preliminary specifications, will not exceed the range of the predicate device (75° - 150°F)

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 applicable as the device is a heating unit, not a diagnostic or AI-driven device with a "test set" in the context of patient data. The "tests" refer to engineering and safety verification.

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 applicable. The "ground truth" for a heating unit involves physical measurements and engineering standards, not expert medical interpretation of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods are relevant for ambiguous diagnostic findings, which is not relevant to this device.

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 applicable. An MRMC study is relevant for AI-assisted diagnostic tools. This device is a powered heating unit, not an AI or diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable. This device does not involve an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context is based on engineering specifications, physical measurements, and compliance with recognized safety standards. For example, a thermometer would be used to verify the actual temperature of the unit and its contents, and electrical testing equipment would verify electrical safety parameters.

8. The sample size for the training set

This information is not applicable. The device is not an AI/machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

This information is not applicable. There is no training set for this device.

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