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This infrared heat lamp is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This unit may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This unit may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue.

The Nu Photonics Pain Therapist consists of a collection of both infrared and red diodes packaged in a compact plastic case. The system emits pulsed light in the infrared spectrum to provide topical heating, arranged in an area covering just over 11 square inches. The red diodes provide a visible indication that the unit is in operation. The system incorporates an "Auto Off" feature, in the event that the user may inadvertently leave the device on.

The provided text is a Premarket Notification [510(k)] Summary for the "Nu Photonics Pain Therapist," an infrared heat lamp. It does not contain information about acceptance criteria, device performance, a study proving the device meets acceptance criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, or standalone algorithm performance.

The document primarily focuses on:

• Device Description: An infrared heat lamp consisting of infrared and red diodes packaged in a compact plastic case, emitting pulsed light for topical heating. It has an "Auto Off" feature.
• Intended Use: To emit energy in the infrared spectrum for topical heating, elevating tissue temperature, and providing temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, or muscle spasm. It may temporarily increase local blood circulation and promote muscle tissue relaxation.
• Predicate Device Comparison: The device is stated to be substantially equivalent to other infrared lamps on the market, sharing similar intended uses, technological characteristics (infrared diodes for topical heating), temperatures, coverage area, and being handheld for use on or just over the skin.
• Testing: Only "functional performance testing and electrical leakage testing" are mentioned. No specific acceptance criteria or performance results from these tests are provided.
• Conclusion: The device has the same intended uses and similar technological characteristics as predicate devices, performs as intended, and raises no new safety or effectiveness issues.

Therefore, I cannot provide the requested table or information regarding acceptance criteria, device performance, or a study proving it meets such criteria, as this information is not present in the provided text.

The document is a 510(k) submission, which aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving efficacy against a set of predefined performance criteria through a detailed clinical study in the way a PMA (Premarket Approval) might require for novel devices. The testing described (functional performance and electrical leakage) appears to be for safety and basic operational assurance, not for demonstrating clinical effectiveness against specific performance metrics for pain relief or tissue temperature elevation.

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