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The Heat Exchange Equipment for Cryotherapy and Thermotherapy provides a combination of cold, heat, contrast, and compression therapies.

It is intended to treat post-surgical and trauma injuries to reduce edema, swelling and pain, for which cold and compression are indicated.

It is intended to treat post traumatic and post-surgical medical and/or surgical conditions, for which localized thermal therapy (hot or cold or contrast) are indicated.

The equipment is intended to be used by, or on the order of, licensed health care professionals in rehabilitation facilities, outpatient clinics, and athletic training settings.

The Heat Exchange Equipment for Cryotherapy and Thermotherapy (Z-ONE, ZT Cube and ZT Clinic) are AC-powered, software-controlled multi-modality devices, designed to impart localized heat exchange and compression therapies. The devices have been developed with the possibility of choosing between different programs: cold therapy, heat therapy and contrast therapy (alternating hot and cold). Moreover, they also possess an intermittent pneumatic compression activity, which is the effect of an alternance of compression and decompression. The compression activity is available in four different levels: minimum (15 mmHg), low-medium (40 mmHg), medium (60 mmHg) and maximum (80 mmHg). It is also possible for the professional user to select the duration of the pulsed compression. With heat treatment, only a low compression level, i.e. 15 mmHg can be selected.

The device allows for a maximum treatment time of 30 minutes for heat therapy, 90 minutes for cold therapy, and 90 minutes for contrast therapy.

The devices are designed to be compatible with a series of Thermal Wraps, that are available for different parts of the body: full leg, shoulder, thigh, knee, calf, elbow, wrist, ankle and hip.

The devices are designed to be used in rehabilitation facilities, outpatient clinics, and athletic training settings, by, or on the order of, licensed health care professionals.

The Heat Exchange Equipment for Cryotherapy and Thermotherapy is available in 3 different models:

• Z-ONE: portable unit with a comfortable handle for moving. This model is developed to deliver only cold therapy, with a temperature range between 41°F and 59°F (5°C - 15°C) and it allows the connection of up to two wraps at the same time and therefore the possibility to treat more patients using the same program simultaneously.

• ZT Cube: portable unit with a comfortable handle for moving. This model allows the delivery of cold therapy, heat therapy and contrast therapy (alternating hot and cold), with a temperature range of 34°F as minimum and 104°F as maximum (1°C - 40°C). Up to two wraps can be connected at the same time.

• ZT Clinic: unit designed and built for the complex needs of clinics and hospitals, as it can suit up to 4 thermal wraps simultaneously. This model can be used to deliver cold therapy, heat therapy and contrast therapy, alternating hot and cold. Temperature range is 34°F as minimum and 113°F as maximum (1°C - 45°C).

The devices are controlled by an intuitive touch screen computer interface, allowing the user to manage the therapy modalities as well as easily adjust and monitor treatment times, temperature and compression settings.

The provided text is an FDA 510(k) clearance letter for a medical device. It details the device's characteristics, intended use, and a comparison to a predicate device to demonstrate substantial equivalence. However, it does not contain information about a study proving the device meets acceptance criteria related to a diagnostic algorithm's performance.

The document describes "performance bench tests" for the heat exchange equipment (temperature and pressure accuracy, wrap seam strength, leakage) and "skin temperature tests on healthy volunteers" and "durability tests of thermal wraps." These are engineering and safety performance tests for the physical device, not a study evaluating a diagnostic algorithm's accuracy against clinical ground truth.

Therefore, many of the requested fields related to a diagnostic study (like sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, ground truth type, training set details) cannot be extracted from this document.

Below is a table summarizing the relevant information that can be extracted, along with an explanation for the missing information.

Acceptance Criteria and Device Performance Study for ZAMAR Medical Heat Exchange Equipment

As per the provided FDA 510(k) Clearance Letter (K242754), the device in question is a ZAMAR Medical heat exchange equipment for cryotherapy and thermotherapy, not an AI/diagnostic algorithm. Therefore, the acceptance criteria and study detailed in the document are related to the physical and functional performance of this therapeutic device, not the diagnostic performance of a software or AI.

The document does not describe a study that involves clinical outcomes or a diagnostic algorithm's performance. Instead, it describes engineering and safety verification tests.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

• Sample Size:
  • For "skin temperature tests": "healthy volunteers who provided informed consents" (specific number not provided).
  • For "durability of the thermal wraps": Tested over "200 repeated application cycles."
  • For other performance tests (temperature accuracy, pressure accuracy, wrap seam strength): Not specified, typically done on a representative sample of devices/components during manufacturing/design verification.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The tests described are engineering/bench tests and volunteer-based safety tests, not large-scale clinical data collection.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable: This document describes tests for a therapeutic device's physical performance and safety, not a diagnostic algorithm requiring expert-established ground truth for image interpretation or diagnosis.

4. Adjudication Method for the Test Set

• Not Applicable: As no diagnostic algorithm's performance is being evaluated against a ground truth, there is no need for an adjudication method for a test set in this context.

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

• No: This type of study is relevant for evaluating the impact of AI assistance on human reader performance in diagnostic tasks. Since the device is a therapeutic heat exchange unit, an MRMC study was not performed or described.

6. Standalone Performance Study (Algorithm Only)

• No: The device is not a standalone diagnostic algorithm. The performance evaluation presented is for the physical medical device itself.

7. Type of Ground Truth Used

• Engineering/Performance Specifications and Safety Limits: For temperature, pressure, durability, and leakage, the "ground truth" is adherence to pre-defined engineering specifications and safety thresholds.
• Physiological Response (Safety): For skin temperature tests, "ground truth" would be the observed skin temperatures remaining within safe physiological limits.
• Not Clinical Ground Truth for Diagnosis: No clinical diagnosis or pathology reports were used as ground truth, as this is not a diagnostic device.

8. Sample Size for the Training Set

• Not Applicable: This device is a physical therapeutic unit, not an AI/machine learning algorithm that requires a training set.

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

• Not Applicable: As there is no training set for an AI algorithm, no ground truth needed to be established for it.

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