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The Medi-Therm is intended for use in supplying warm or cold water at controlled temperatures via water circulating blankets or body wraps for the application of regulating patient temperature in situations where a physician determines that temperature therapy is necessary and desirable.

Indications for use for the Medi-Therm thermal regulating system include:
a. To maintain pre-set body temperature as determined by the physician
b. To maintain normal body temperature during surgical procedures
c. For use in all hospital areas including invasive and coronary care units, in operating, recovery and emergency rooms, in burn units and on medical/surgical floors
d. This system can be used with adult and pediatric patients
e. Monitoring and controlling patient temperature
f. Temperature reduction in patients where clinically indicated, e.g. in hyperthermic patients

The Gaymar Medi-Therm device provides a means of regulating patient temperature by supplying temperature-controlled water through a connector hose to accessory Gaymar Hyper/Hypothermia blanket/s)/body wrap(s). The blanket/body wrap provides an interface for heating or cooling the patient. Accessory YSI 400 series patient probe interfaces between the Medi-Therm and patient to sense patient temperature, which is displayed on the device's control panel. The Medi-Therm device controls output water temperature by mixing hot and cold water using hot and cold solenoid valves under microprocessor control. The device includes a circulating pump, heater and refrigeration system.

The Medi-Therm controller, connector hose, blanket/body wrap and patient probe comprise the Medi-Therm Hyper/Hypothermia System.

The provided document is a 510(k) summary for the Gaymar Medi-Therm Hyper/Hypothermia System. It primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the technological characteristics, intended use, and general safety and effectiveness.

Based on the provided text, there is no information available regarding a study that assesses device performance against specific acceptance criteria in the format you requested (e.g., diagnostic accuracy metrics like sensitivity, specificity, or reader improvement with AI).

The document mentions "Bench testing was conducted to confirm the MTA6900 and MTA7900 and their disposable accessories operate as described in this submission and therefore are as safe and effective as the predicate devices to which it claims substantial equivalence." The types of bench testing listed are:

• Temperature Control Performance
• Temperature Stability and Flow
• Biocompatibility (ISO 10993-5; ISO10993-10; 16 CFR 1500)
• Ship Testing (ISTA 1A)

However, the document does not provide:

• Specific acceptance criteria for these tests (e.g., "temperature control performance must maintain patient temperature within +/- 0.5°C").
• Reported device performance against such criteria in a quantitative table.
• Details about sample sizes, data provenance, ground truth establishment, expert involvement, or MRMC studies. The context of this device (a thermal regulating system) does not typically involve the kinds of diagnostic accuracy studies (MRMC, standalone, human-in-the-loop) that would require such detailed information on ground truth, expert consensus, and reader performance.

Therefore, I cannot populate the table or answer most of your specific questions as the necessary information is not present in the provided 510(k) summary. The document focuses on demonstrating that the device meets safety and performance standards generally expected for its product classification and is substantially equivalent to existing devices through engineering and functional comparisons, not clinical performance metrics in the way a diagnostic AI device would be evaluated.

Table of Acceptance Criteria and Reported Device Performance:

Detailed Study Information (Based on the document):

1. Sample size used for the test set and the data provenance: Not applicable/not provided. The document refers to "Bench testing," which implies laboratory-based tests rather than patient data test sets.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided. Ground truth establishment with experts is typically for diagnostic devices assessing images or other complex data.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/not provided.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is not mentioned and is not typically relevant for a thermal regulating system.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/not provided. This refers to diagnostic algorithm performance.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/not provided. For bench testing, the "ground truth" would be the expected physical or electrical output/behavior based on design specifications or industry standards.
7. The sample size for the training set: Not applicable/not provided. This device is not described as involving machine learning or algorithms that require a "training set" in the context of data analysis. Its "microprocessor control" refers to conventional programming.
8. How the ground truth for the training set was established: Not applicable/not provided.

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The ThermoSuit System™ is a thermal requlating system.
Indications for Use are
a. Temperature reduction in patients where clinically
indicated, e.g. in hyperthermic patients;
b. Monitoring of patient temperature.

The ThermoSuit System (TSS) is a device that allows rapid patient cooling by the circulation of cold water in direct contact with the skin of the patient. Patient temperature measurements control the extent and duration of cooling, by controlling pump output and drainage of cooling fluid. Temperature measurements and associated alarm signals are designed to prevent overcooling.

The ThermoSuit System™ consists of the following main components:

• . ThermoSuit Body Enclosure
• Multi-lumen Umbilicus Hose .
• . Reservoir/Pump Assembly
• . Pump Controller Console
• . Other Components

Here's an analysis of the acceptance criteria and study information for the ThermoSuit System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly define numerical acceptance criteria (e.g., cooling rate target, temperature accuracy range) or quantifiable performance metrics for the ThermoSuit System. Instead, the performance testing focuses on functional verification and comparison with a predicate device.

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

• Human Volunteers (for suit optimization): Sample size not specified.
• ThermoSuit Body Enclosures (mechanical integrity): "All suits" implies the entire production batch or a representative sample from it. Sample size not specified quantitatively.
• Functional Testing (new and aged components): Sample size not specified quantitatively for components, but refers to "ThermoSuit System" and "ThermoSuit Body Enclosures."
• Comparative Cooling Bench Study:
  • Test Set: One "Heated Mannequin."
  • Data Provenance: Benchtop study (laboratory setting).
• Animal Study:
  • Test Set: "Large pigs." Sample size not specified quantitatively.
  • Data Provenance: Animal study (presumably in a controlled laboratory or research facility).
• Design Validation (User Testing):
  • Test Set: Four (4) Users, completing a total of nine (9) test runs.
  • Data Provenance: User testing, likely in a simulated clinical or laboratory environment.
• Data Provenance (overall): Primarily internal testing (bench, animal, user validation). Country of origin is not specified, but the company is US-based (Kinnelon, NJ), suggesting US provenance. All studies appear to be prospective.

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

• For the technical and functional performance tests (mechanical integrity, pump/controller, software), the "ground truth" would be established by the engineering and testing protocols themselves, not typically by experts in a clinical sense.
• For the cooling studies (mannequin and animal), the ground truth is the actual measured temperature change and cooling rates. This is a direct measurement, not an expert consensus.
• For the user validation test, the ground truth for understanding the manual and device operation was established through a "detailed questionnaire" answered by the four users. Their qualifications as "Users" are not further specified (e.g., nurses, technicians, physicians), but they are implied to be representative of target operators.

4. Adjudication Method for the Test Set:

Not applicable in the conventional sense. The studies described are primarily objective measurements (temperature, pressure, functional checks) or direct user feedback (questionnaire). There's no mention of subjective interpretation of results requiring adjudication by multiple readers or evaluators.

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

No, an MRMC study was not done. The comparative studies involved the device and a predicate device in bench and animal models, not human readers interpreting cases.

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

The ThermoSuit System is a medical device that involves direct interaction with a patient and a human operator. Its "performance" isn't a standalone algorithm in the way an AI diagnostic tool would be. The closest equivalent would be the automated functions of the pump controller and software. The document states:

• "Performance testing of the ThermoSuit System included a full evaluation of the Pump/Controller functions and software validation; the results conformed to the device specifications."
  This indicates that the automated control aspects were tested for their inherent functionality according to specifications, representing a form of standalone performance for the automated components.

7. The Type of Ground Truth Used:

• Objective Measurements: For mechanical tests (pressure), functional tests (pump/controller, software), and cooling studies (temperature reduction, cooling rate).
• Test Specifications: The device was tested against its own "performance specifications" and "design parameters."
• User Feedback: For understanding of the Operator's Manual and device operation in the design validation.
• Compliance with Standards: For biocompatibility, electrical safety, and electromagnetic compatibility.
• Comparison to Predicate Device: For cooling effectiveness, where the predicate device's performance served as a benchmark for "comparable" results.

8. The Sample Size for the Training Set:

This device is not an AI/ML algorithm that requires a "training set" in the computational sense. The development and optimization processes of the ThermoSuit System likely involved iterative design, prototyping, and testing (including the human volunteer testing for suit dimensions/operating parameters), which could be considered analogous to "training" in an engineering context, but not a data-driven training set for an algorithm. No specific sample sizes for such iterative development are provided here.

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

As above, there is no "training set" in the AI/ML context for this device. The development process would have involved engineering design principles, physical testing, and potentially user feedback during various stages to refine the product, with "ground truth" being established by physical measurements, functional requirements, and design specifications.

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