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The APOLLO IR Heat Lamp System is intended 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 and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.

The APOLLO IR Heat Lamp System is a non-invasive, easy to use, hand-held therapeutic device providing continuous heat therapy. The System is comprised of a Control Unit that houses the electronics and controls the handheld treatment probe, which delivers infrared energy.

The APOLLO IR Heat Lamp System's 510(k) premarket notification (K060134) does not contain a study that proves the device meets specific acceptance criteria in the way described by your request. Instead, it relies on a demonstration of substantial equivalence to predicate devices already cleared by the FDA.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The document does not specify quantitative acceptance criteria or provide performance metrics in the format of a clinical study with results alongside those criteria. The clearance is based on equivalence to predicate devices and functional/safety testing, not on achieving specific clinical performance thresholds.

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

Not applicable. This document is a 510(k) premarket notification. It does not describe a clinical study with a "test set" of patient data for performance evaluation in the usual sense. The "testing" mentioned refers to functional performance and electrical safety of the device itself, not evaluation on a dataset representing patient cases or outcomes.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. There is no clinical study described that would require experts to establish ground truth for a test set of patient data.

4. Adjudication Method

Not applicable. As no clinical study on patient data is described, adjudication methods are irrelevant here.

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

No. The document makes no mention of an MRMC comparative effectiveness study involving human readers or AI assistance. The APOLLO IR Heat Lamp System is a physical therapy device that emits infrared energy, not an AI-powered diagnostic or assistive tool.

6. Standalone (Algorithm Only) Performance Study

No. This is not an AI algorithm; it's a physical therapy device. Thus, a standalone algorithm performance study is not applicable.

7. Type of Ground Truth Used

Not applicable. Since no clinical study on patient data is described for performance evaluation, there is no "ground truth" established in that context. The "truth" demonstrated for the device's functionality is its ability to emit infrared energy and comply with safety standards.

8. Sample Size for the Training Set

Not applicable. As this device is not an AI/ML algorithm, there is no "training set."

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

Not applicable.

Summary of Device Acceptance and "Study" Information from the Document:

Instead of a clinical study proving acceptance criteria, the 510(k) process for the APOLLO IR Heat Lamp System relies on the following:

• Intended Use Equivalence: The device is intended to emit infrared energy for topical heating, temporary relief of pain and stiffness, arthritis pain, muscle spasm, increased local blood circulation, and muscle relaxation. This intended use is stated to be similar to that of predicate devices.
• Technical Characteristic Equivalence: The APOLLO IR Heat Lamp System and the listed predicate devices (e.g., Meditech International Inc BioFlex Professional Therapy System, Thor International, Ltd. DDII Laser System) are all classified as "Infrared Lamps" (21 CFR 890.5500) and utilize infrared/visible laser diodes for topical heating. The submission states the device has "similar functional and performance characteristics" to these predicates.
• Functional and Safety Testing: The document states:
  • "Testing of the APOLLO IR Heat Lamp System will include functional performance testing and electrical safety testing in accordance with all applicable standards for this type medical device."
  • "The System is designed to comply with the generally accepted therapeutic heat performance specifications by producing a level of tissue temperature reported in literature and accepted by the Federal Food and Drug Administration."

Conclusion:

The "acceptance criteria" for the APOLLO IR Heat Lamp System, as presented in the 510(k) notification, are met by demonstrating substantial equivalence to legally marketed predicate devices in terms of intended use, technological characteristics, and by confirming functional and electrical safety through standard testing. There is no clinical study, patient dataset, or AI performance evaluation described in this documentation. The FDA clearance (K060134) letter confirms that the device was found substantially equivalent to predicate devices for its stated indications for use.

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