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Temperature reduction for adult patients where clinically indicated, e.g., in hyperthermic patients.

Global Healthcare SG has developed the CarbonCool® products as a portable, non-invasive body cooling solution designed to enhance temperature reduction for adult patients. The CarbonCool® also enables more widespread applications by reducing treatment cost and increasing treatment flexibility and accessibility. The CarbonCool® System is a single use passive body cooling solution designed for medical and comfort cooling purposes. The CarbonCool® System utilizes the MPad™ which consist of multiple cooling-cells made of thermoplastic polyurethane, filled with high thermal conductivity material.

The provided text describes the CarbonCool System, a thermal regulating system, and compares it to a predicate device (EMCoolspad, K100071) to demonstrate substantial equivalence. However, it does not contain detailed acceptance criteria for specific device performance metrics or a study that rigorously proves the device meets those criteria with statistical data.

Instead, the document focuses on:

• Indications for Use: Temperature reduction for adult patients where clinically indicated, e.g., in hyperthermic patients.
• Device Description: Portable, non-invasive body cooling solution using MPad™ (thermoplastic polyurethane filled with high thermal conductivity material) and pad holders.
• Mechanism: Optimizes heat exchange by minimizing ambient temperature interference and ensuring snug fit.
• Comparison to Predicate: Highlights similarities in regulation, product code, class, indications, materials (HypoCarbon®), technological characteristics (thermal regulating, non-invasive, patient surface cooling, permanent skin contact, thermal energy removal, temperature monitoring, rewarming function, compatible freezer details, imaging compatibility, shelf life), and general safety/effectiveness claims.
• Non-Clinical Testing: Biocompatibility and packaging integrity according to ISO and ASTM standards.
• General Performance Claims (Bench): "In-house testing confirms the high performance of the MPad™, surpassing traditional cooling methods like ice and water. The MPad™ withstands pressure and maintains durability over extended periods, ensuring reliability in critical situations."

Limitations in the provided text for answering the request:

• No specific numerical acceptance criteria are listed for performance (e.g., target temperature reduction, rate of cooling, duration of cooling effectiveness).
• No detailed study results or data are presented to quantify "high performance," "surpassing traditional methods," or "withstanding pressure and maintaining durability."
• No information on sample size for test or training sets, data provenance, expert involvement for ground truth, or adjudication methods.
• No mention of MRMC comparative effectiveness studies or standalone algorithm performance.

Therefore, based only on the provided text, I cannot complete the table or provide the requested study details. The document claims equivalence based on technical characteristics and general performance statements rather than specific, quantified performance acceptance criteria and a detailed study demonstrating their fulfillment.

If this were a real submission, a full demonstration of substantial equivalence would typically include:

• Specific performance goals/acceptance criteria (e.g., "device must reduce core body temperature by X degrees Celsius within Y minutes").
• Detailed protocols and results of performance testing against these criteria.
• Validation data where the new device's performance is quantitatively compared to the predicate device or established clinical benchmarks.

Given the information available, I can only create a table that summarizes the claims and types of testing mentioned, rather than specific acceptance criteria and detailed performance data.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Not provided. The document refers to "in-house testing" but gives no details about sample sizes, whether it was prospective or retrospective, or the country of origin of any data used for performance validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not provided. The document describes a physical medical device for temperature regulation, not an AI or diagnostic device that would typically involve experts establishing ground truth for a test set.

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

• Not applicable/Not provided. As above, this type of detail is typically relevant for diagnostic or AI-driven systems where expert consensus is needed to establish ground truth.

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:

• Not applicable. This device is a physical thermal regulating system, not an AI-assisted diagnostic tool.

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

• Not applicable. This is a physical device, not an algorithm. However, its "standalone" performance implies the performance of the device itself without human intervention defining its core function (beyond application and monitoring). The document claims "in-house testing confirms the high performance of the MPad™" in this context.

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

• Not applicable / Performance-based. For a thermal regulating system, "ground truth" generally refers to quantitative measurements against engineering specifications and relevant physiological outcomes (e.g., actual temperature reduction in a controlled environment or in a simulated body). The document mentions "in-house testing" and "compliance with recognized standards" for biocompatibility and packaging, but does not detail the "ground truth" for its core cooling performance.

8. The sample size for the training set:

• Not applicable/Not provided. This is a physical device, not an AI model that requires a training set.

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

• Not applicable. As above.

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