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The CLARIMEDIX device is indicated for use to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting relaxation of muscle tissue; and to temporarily increase blood circulation where applied.

The system is a self-contained unit with four treatment areas.

• . Popliteal treatment zone
• Calf treatment zone .
• Foot treatment zone .
• . Heel treatment zone

The provided 510(k) summary for the CLARIMEDIX Model 2200 System does not contain the information requested to describe acceptance criteria and a study proving the device meets those criteria.

This document is a 510(k) premarket notification, which establishes substantial equivalence to predicate devices, rather than demonstrating clinical efficacy through performance studies against pre-defined acceptance criteria. The summary focuses on comparing the new device's intended use and technological characteristics to existing devices to show it is "substantially equivalent."

Therefore, I cannot populate the table or provide answers to the specific questions regarding acceptance criteria, study details, sample sizes, ground truth, or MRMC studies, as this information is not present within the provided text.

The closest relevant information is contained in the "Comparison with Predicate Devices" section:

• Intended Use: The device is indicated for use for the treatment of chronic pain by emitting energy in the IR spectrum for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
• Technological Characteristics: Key characteristics like temperature at the skin surface (Less than 95° F), energy source (Multidiodes), and safety features (Remains cool to touch) are listed for the subject device.

However, these are descriptive characteristics and intended uses, not quantified acceptance criteria with reported performance from a study designed to validate those criteria.

In summary, the provided document does not include the requested information about acceptance criteria and a study that proves the device meets those criteria.

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The CTC Workstation system is intended for use by a qualified physician to direct the storage, display, enhancement, and viewing of ultrasound images.

Under the direction of the physician the device stores, displays, and enhances ultrasound images. The image enhancement is performed by assigning pixels numeric values. The system is comprised of a software package running on off-the-shelf hardware.

The provided text does not contain detailed acceptance criteria for the CTC Workstation or a study proving that the device meets specific performance criteria. Instead, it describes a 510(k) submission for the CTC Workstation, focusing on its substantial equivalence to predicate devices, its intended use, and general product description.

The relevant sections state:

• "The CTC Workstation has completed design verification and validation tests for conformance with specifications." However, no specific performance metrics, acceptance criteria, or results of these tests are provided.
• "CTC Workstation provides functionality that is substantially equivalent to the cited predicate devices." This is a regulatory statement relying on a comparison to existing devices, not a direct demonstration of meeting quantitative performance criteria.
• "The main technological difference is that the MDT device uses a different set of known algorithms to perform enhancement and assign numeric values to pixels." This highlights a difference but does not quantify performance.

Therefore, the requested information regarding acceptance criteria and performance study details cannot be extracted from the provided text. The document primarily serves as a regulatory clearance (510(k)) decision, affirming substantial equivalence rather than detailing a direct performance study to acceptance criteria.

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Ask a specific question about this device

Ask a specific question about this device