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The Enthermics Medical Systems DC Series Fluid Warming Cabinets are designed to safely store and warm irrigation fluids and injection fluids in accordance with the recommended warming temperatures and storage times stated in the fluid manufacturers' labeling.

The DC Series Fluid Warming Cabinets are single cavity warming cabinets intended to heat either irrigation fluids (set point range of 90°F to 150°F) or injection fluids (set point range of 90°F to 110°F). The cabinets consist of powder coated steel exterior panels, and stainless steel cavity panels. The exterior also consists of ABS plastic panels. The heating system of the device includes three or more independent, fully insulated, electrothermal arrays mounted on the outside of the cavity. The device includes an over temperature alarm which provides an audible and visual indication that the cavity temperature has exceeded the set temperature by 10°F. Additional thermal reset switches are present the shut off power to the heating array or unit in the event of an over temperature array or cavity respectively.

The provided text describes a Premarket Notification (510(k)) for the Enthermics Medical Systems DC Series Fluid Warming Cabinets. This document focuses on the device's design and intended use, rather than its performance in diagnostic or clinical efficacy studies as typically seen with AI/ML-based medical devices.

Therefore, the information requested in the prompt, such as acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details, are not applicable to this type of medical device submission. These questions are usually relevant for devices heavily relying on diagnostic accuracy, such as imaging analysis software or AI-driven detection systems.

The DC Series Fluid Warming Cabinets are a physical product designed to warm fluids to specific temperatures. The 510(k) submission primarily demonstrates substantial equivalence to a predicate device (Enthermics Medical Systems EC-770l Fluid Warming Cabinet K993797) based on its technological characteristics, intended use, and safety features (e.g., over-temperature alarms). The "study" mentioned in the prompt's title is implicitly the comparison of the new device to the predicate device to demonstrate substantial equivalence, rather than a clinical trial or performance evaluation against ground truth data.

Key points from the document regarding the device and its compliance:

• Acceptance Criteria & Performance: Not explicitly stated in terms of diagnostic metrics. Acceptance is based on meeting safety standards and functional specifications (e.g., temperature ranges, over-temperature alarms) that are substantially equivalent to a predicate device.
• Sample Size: Not applicable. The "test" is a design and feature comparison, not a data-driven validation study in the context of AI/ML.
• Ground Truth: Not applicable. There's no diagnostic output for which ground truth would be established by experts or pathology.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: Not applicable.
• Standalone Performance: Not applicable as it's a physical warming device, not an algorithm.
• Type of Ground Truth: Not applicable.
• Training Set Sample Size & Ground Truth: Not applicable.

The submission is a declaration of substantial equivalence, asserting that the new device shares the same intended use and similar technological characteristics (electrothermal heating, operational modes, safety features) as the existing predicate device. The differences highlighted (smaller volume, materials, more heating arrays, more accurate temperature detection/control) are presented as design changes that do not alter the fundamental safety or effectiveness compared to the predicate.

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The ivNow Modular Fluid Warmer is intended to warm injection / IV and irrigation fluid bags to a predetermined temperature, and once warm, to monitor and control the temperature of the fluid in the bags.

Enthermics Medical Systems' ivNow Modular Fluid Warmer is designed to rapidly warm and maintain the temperature of injection / IV and irrigation fluid bags. Open on two sides with no cover or door, the device consists of a warming area module (alcove) in a "C" shape with a heating element that warms and maintains the temperature of the fluid. The basic device may be used as a single module or [pre]assembled in multiple configurations comprised of 1-6 modules with a common power switch and cord, fastened together by a unique rear mounting panel. The device is available in either 120v or 230v.

When an injection / IV or irrigation fluid bag is placed in the warming alcove, an optical sensor signals to the control that the alcove is occupied. The control then engages the heating element which warms the fluid in the bag. The temperature of the heating element and fluid is monitored by two sets of sensors contained within the device. When the desired temperature of the fluid is reached and confirmed, the real time temperature of the fluid is displayed on a panel at the front of the device (the control display). Internally, the heating element and fluid temperatures are monitored, and the heating element is regulated to raise the fluid to the desired temperature but never beyond that temperature. When the fluid reaches the desired temperature, the control displays the set temperature and a green indicator light next to the control display turns on. The control will continue to monitor the temperature of the heating element and fluid, and regulate the heating element to maintain the fluid at its set temperature indefinitely. The length of time that a particular bag has been warming in the alcove is also monitored and displayed (total residence time monitor display).

The provided document describes the ivNow Modular Fluid Warmer, a medical device designed to warm and maintain the temperature of injection/IV and irrigation fluid bags.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "Device testing included a Thermal Performance Test, Life Cycle Test and Control Failure Test." However, it does not specify the sample size used for these tests (e.g., number of devices tested, number of fluid bags used).

The data provenance is internal testing conducted by Enthermics Medical Systems, Inc. The document does not indicate data from external sources, country of origin of data beyond the manufacturer's location, or if the testing was retrospective or prospective. It's implied to be prospective testing conducted during device development/validation.

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

The document does not mention the use of experts to establish ground truth for the test set. The validation appears to be based on engineering tests (Thermal Performance, Life Cycle, Control Failure) rather than human interpretation or expert assessment.

4. Adjudication Method for the Test Set

As no experts were mentioned for establishing ground truth, and the tests were technical/engineering-based, there was no adjudication method described for a 'test set' in the context of expert review.

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

The document does not describe an MRMC comparative effectiveness study. This type of study is typically used for diagnostic or screening devices where human readers interpret results, often with and without AI assistance, to assess the impact of AI on performance. The ivNow Modular Fluid Warmer is a therapeutic/supportive device, not a diagnostic one.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The studies mentioned ("Thermal Performance Test, Life Cycle Test and Control Failure Test") describe the standalone performance of the device itself. The device's primary function is automated temperature control, and these tests would evaluate the device's ability to perform this function independently, without human interaction during the warming process beyond initial setup. So, yes, the described tests are essentially standalone performance evaluations of the device's core functionalities.

7. Type of Ground Truth Used

The ground truth for the ivNow Modular Fluid Warmer's performance is based on objective, quantifiable physical parameters directly measured by the device and external instruments during testing. This includes:

• Fluid temperature (measured against a known set point).
• Heating element temperature.
• Time (for residence time monitoring).
• Operational integrity over time (for life cycle testing).
• Response to failure conditions (for control failure testing).

This is a form of empirical ground truth established through direct physical measurement and engineering validation.

8. Sample Size for the Training Set

The concept of a "training set" is typically applicable to machine learning algorithms. The ivNow Modular Fluid Warmer is an electro-mechanical device with intelligent controls, but it is not described as utilizing machine learning or AI algorithms in a way that would require a distinct "training set" of data to learn from. Therefore, no sample size for a training set is mentioned or relevant in the context of this device description.

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

Since there is no mention of a "training set" for a machine learning algorithm, this question is not applicable to the information provided in the document. The device's "programming" or operational parameters would have been set during its design and development, validated through the described testing.

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The Enthermics Medical Systems EC-7701 Fluid Warming Cabinet is designed to safely store and warm irrigation fluids or injection fluids in accordance with the recommended warming temperatures and storage times stated in the fluid manufacturers' labeling.

The EC-7701 is a stainless steel fluid warming cabinet that utilizes a fully insulated electrothermal cable array that is wrapped inside the bottom and two sides of the cabinet to provide uniform radiant, conductive and convective heating. The device can be used to heat irrigation fluids to a temperature ranging from 90°F to 150°F, or injection fluids to a range of 90°F to 110°F. The device also contains an over-temperature alarm which provides an audible and visual alarm when the internal temperature reaches 10°F above the selected temperature.

This document, K993797 pertains to the Enthermics Medical Systems EC-7701 Fluid Warming Cabinet. As a submission for a 510(k) premarket notification, it focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against defined acceptance criteria through a clinical study.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment is not available in this document. This type of information is typically found in submissions for novel devices requiring clinical trials, not for devices demonstrating substantial equivalence to already marketed products.

The document states:

• "The EC-770l is nearly identical to the three predicate devices in all material respects."
• "All four devices use the same basic technology (non-electromagnetic heating) and utilize similar over-temperature alarm systems (audible and visual indicators)."
• "The only material difference between the EC-7701 and the predicate devices is the selectable modes of operation (irrigation or injection) on the EC-7701. The selectable modes, however, do not raise additional questions of safety or effectiveness."

This indicates that the FDA's clearance of this device is based on its similarity to existing, legally marketed devices, not on a new study demonstrating its efficacy against specific pre-defined acceptance criteria.

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The function of the ENTHERMICS TRU-5000™ Thermal Recovery Radiant Heating Unit is to provide a safe yet effective means of patient rewarming in the recovery of adult hypothermic human subjects. The use of the TRU-5000 is a physician prescribed therapy for surgically- or trauma-induced hypothermia, with the ultimate responsibility of the patients overall recovery falling on the physician.

The TRU-5000 consists of (1) an aesthetically pleasing fiberglass exterior encasing the semicylindrical heating chamber, (2) a modified heat resistant stretcher with a unique lock and key design, (3) a stand-alone, dual-probe, skin temperature audible-alarm system and (4) standard hospital sheets used as insulating drapes. An easy to operate control panel provides quick and easy control of all rewarming operations. The control system includes an LED readout of chamber control temperature, two independent skin temperatures and control setpoint with an audible alarm which sounds whenever the skin temperature setpoint is exceeded. The heating surface temperature controller of the TRU-5000 is factory preset at 70 °C to minimize operator error and provide optimum patient warming. The system requires no additional power demands and includes self diagnostic features to ensure operational accuracy. Quick and easy access to the heating chamber is devised in case of medical intervention.

The provided text is a 510(k) Summary of Safety and Effectiveness for the ENTHERMICS TRU-5000™ Thermal Recovery Radiant Heating Unit. This document states that the device is "identical in function" to two predicate devices (Augustine Medical Bair Hugger™ Convective Warming System (K873745) and Marquest Temp Marq™ Convective Warming System (K904690)).

The summary focuses on demonstrating substantial equivalence to these predicate devices, rather than presenting a detailed study with specific acceptance criteria and performance data for the TRU-5000 itself. It leverages the historical safety and effectiveness of the existing devices. Therefore, the information required for the requested table and study details cannot be fully extracted from the provided text.

Here's a breakdown of what can be inferred and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Limitations: The text does not provide quantitative acceptance criteria (e.g., target temperature ranges, maximum allowable temperature deviations, or specific thresholds for thermal injury prevention). Performance is described qualitatively and by referencing the predicate devices.

Regarding a specific study for the ENTHERMICS TRU-5000:

The document clearly states: "The ENTHERMICS TRU-5000 Thermal Recovery Radiant Heating Unit is identical in function to the Augustine Medical Bair Hugger™ Convective Warming System (K873745) and the Marquest Temp Marq™ Convective Warming System (K904690)..." This is a claim of substantial equivalence, not a description of a separate clinical study conducted explicitly for the TRU-5000 to define its acceptance criteria and prove performance independently.

Therefore, the following information is not present in the provided text:

• 2. Sample size used for the test set and data provenance: No test set is described. The device's safety and effectiveness are inferred from predicate devices.
• 3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable as no explicit 'test set' or 'ground truth' establishment is described for the TRU-5000.
• 4. Adjudication method for the test set: Not applicable.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this type of study is not mentioned. The document is comparing a new device to existing predicate devices, but not in an MRMC format for human reader performance.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a physical medical device, not an algorithm.
• 7. The type of ground truth used: Not explicitly stated, as no independent detailed study for the TRU-5000 is presented. The "ground truth" seems to be the established safety and efficacy profiles of the predicate devices.
• 8. The sample size for the training set: Not applicable; there is no AI/algorithm training set.
• 9. How the ground truth for the training set was established: Not applicable.

Conclusion:

The provided 510(k) summary relies on the "Substantial Equivalence" pathway to demonstrate safety and effectiveness. It asserts that the ENTHERMICS TRU-5000 is functionally identical to predicate devices and will meet or exceed their established safety and effectiveness standards due to its design features. It does not detail a separate, comprehensive study with explicit acceptance criteria and performance data for the TRU-5000 in the way one might for an AI/ML-based device or a novel therapeutic with clinical trials. The "study" here is the comparison to existing, cleared devices.

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