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The Palmo Thermoregulation Interface Accessory for the Cincinnati Subzero Blanketrol II is designed to noninvasively lower or raise a patient's temperature and/or maintain a desired patient temperature. This is accomplished with local application of negative pressure and heating/cooling to distal appendage.

The Palmo consists of three main parts: 1) a vacuum chamber that contains the 2) thermal exchange surface and an 3) arm seal.

The patient inserts his/her hand through the arm seal and into the vacuum chamber. The palm is placed on the thermal exchange surface. A light vacuum is created by connecting the Palmo to the hospital's regulated vacuum source. The physician can monitor the adequacy of the vacuum and seal from the dial on the mechanical vacuum gauge attached to the top of the Palmo unit. A light vacuum is applied to increase the amount of blood available in the appendage.

The Cincinnati Subzero Blanketrol II (or equivalent) creates the temperature-controlled water that flows through the water channels of the Palmo and heats/cools the thermal exchange plate. The thermal exchange surface is warmed if the patient needs to have the body core temperature increased, and cooled if the body core temperature needs to be decreased.

This combination of light vacuum and a thermal exchange surface provides a rapid and noninvasive mechanism for changing the temperature of the blood flowing through the appendage. This, in turn, changes the temperature of the body core.

The arm seal of the Palmo is available in three different sizes (small, medium & large) to accommodate the range of possible hand and wrist sizes of patients. A variation of the device can also be applied to the foot.

The provided text describes the Palmo Thermoregulation Interface Accessory, a medical device. However, it does not include information about specific acceptance criteria for performance metrics (like accuracy, sensitivity, or specificity), nor does it detail a study designed to prove the device meets such criteria in terms of quantitative performance outcomes.

The submission is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to predicate devices. This means the primary "study" is a comparison to existing, legally marketed devices, rather than a de novo clinical trial proving specific performance targets.

Here's an analysis based on the provided text, highlighting what is and is not present:

Missing Information:
The document does not provide:

• A table of specific acceptance criteria for quantitative performance metrics.
• Reported device performance data against quantitative criteria (e.g., how quickly it changes temperature, by how much, or with what accuracy).
• Details about a "test set" in the context of an algorithm or diagnostic device.
• Information about experts establishing ground truth, adjudication methods, MRMC studies, standalone performance, types of ground truth (pathology, outcomes), or training set details. These concepts are typically relevant for diagnostic or AI-driven devices, which this is not.

Analysis of the Provided Information:

The document outlines the basis for substantial equivalence, which is the primary "acceptance criteria" for a 510(k) submission when no new questions of safety or efficacy are raised.

1. Table of Acceptance Criteria and Reported Device Performance

• "The Palmo is also substantially equivalent in intended use... as the Aquarius Thermo-STAT System."
• "Designed to noninvasively lower or raise a patient's temperature and/or maintain a desired patient temperature. This is accomplished with local application of negative pressure and heating/cooling to a distal appendage." |
  | Technological Equivalence: Local application of negative pressure and a thermal exchange surface to a distal appendage. | * "Uses the same CSZ Blanketrol II as a source of temperature controlled water." (in common with predicate)
• "Technology uses a local application of negative pressure and a thermal exchange surface to a distal appendage." (consistent with predicate)
• "As demonstrated in the bench testing, there are no significant differences in technology between the two systems." |
  | Safety and Efficacy: No new questions of safety or efficacy raised. | * "There are no new questions of safety or efficacy raised between the two systems."
• "The results of bench testing support the substantial equivalence claims..."
• "Earlier human studies have demonstrated that the simultaneous application of light vacuum and thermal exchange can effectively and noninvasively change the body core temperature of a patient." |

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

• Test Set: Not applicable in the traditional sense of a diagnostic or AI performance study. The "test" for a 510(k) is the comparison to predicate devices and potentially bench testing.
• Data Provenance:
  • Bench testing: Performed to confirm technological equivalence ("As demonstrated in the bench testing, there are no significant differences in technology between the two systems."). The location or specific details of this bench testing are not provided.
  • Earlier human studies: Referenced as evidence for the underlying mechanism ("Earlier human studies have demonstrated that the simultaneous application of light vacuum and thermal exchange can effectively and noninvasively change the body core temperature of a patient."). No details about these studies (sample size, country of origin, retrospective/prospective) are provided beyond their existence and conclusion.

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

• Not applicable. This device is not a diagnostic device or an AI algorithm requiring expert-established ground truth for its performance assessment in a 510(k) context.

4. Adjudication Method for the Test Set

• Not applicable, as there is no "test set" in the context of expert review for 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 therapeutic interface, not a diagnostic imaging or AI-assisted diagnostic tool involving human readers.

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

• Not applicable. This device is a hardware interface for thermoregulation, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this 510(k) is the established performance and safety profile of the predicate devices (Cincinnati Subzero Blanketrol II and Aquarius Thermo-STAT System) and the general scientific understanding that negative pressure and thermal exchange can affect core body temperature. The bench testing serves to show that the Palmo system operates within this established technological equivalence.

8. The Sample Size for the Training Set

• Not applicable. This device does not use a "training set" like an AI algorithm would.

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

• Not applicable.

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