(23 days)
The Cl1000 IR Laser 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 CL1000 IR Laser 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.
Here's a breakdown of the acceptance criteria and the study information for the CL1000 IR Laser System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| 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. (Implied: device should provide topical heating for therapeutic purposes) | The CL1000 IR Laser System is a non-invasive, easy to use, hand-held therapeutic device providing continuous heat therapy. It delivers infrared energy (implied to cause topical heating). The device was determined substantially equivalent to predicate devices that also utilize infrared and visible laser diodes to generate topical heating for the purpose of elevating tissue temperatures. |
| The CL1000 IR Laser System should have the same intended uses as the predicate devices. | The CL1000 IR Laser System was found to have "the same intended uses" as the predicate devices. |
| The CL1000 IR Laser System should have similar functional and performance characteristics to the predicate devices. | The CL1000 IR Laser System was found to have "similar functional and performance characteristics" to the predicate devices. |
| The device must meet functional performance and electrical safety testing in accordance with all applicable standards for this type of medical device. | "Testing of the CL1000 IR Laser System will include functional performance testing and electrical safety testing in accordance with all applicable standards for this type medical device." (Note: The specific results of these tests are not provided, only the intent to perform them). |
2. Sample Sizes Used for the Test Set and Data Provenance:
The document does not describe a clinical study with a test set of data. The filing is a 510(k) premarket notification for a Class II medical device, which typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than de novo clinical trial data for effectiveness.
The "testing" mentioned refers to functional and electrical safety testing of the device itself, not a study involving human subjects or data comparison against a ground truth for classification/diagnosis.
3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set):
Not applicable, as a clinical study with a test set and associated ground truth established by experts is not described in the provided text.
4. Adjudication Method (Test Set):
Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study is not described in the provided text. This type of study is more common for diagnostic or AI-assisted interpretation devices to quantify the improvement in human reader performance. The CL1000 IR Laser System is a therapeutic device intended for topical heating.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. The CL1000 IR Laser System is a physical therapeutic device, not an algorithm, so the concept of "standalone performance" in the context of AI algorithms is not relevant here. The device's "performance" would be related to its ability to emit infrared energy and generate heat, as described under functional testing.
7. Type of Ground Truth Used:
Not applicable, as there is no mention of a study involving ground truth in the context of diagnostic accuracy or output classification. The "ground truth" implicitly referred to is the generally accepted therapeutic heat performance specifications and the intended physiological effects (elevating tissue temperature, temporary pain relief, etc.) which are established medical understanding rather than specific data labels for a study.
8. Sample Size for the Training Set:
Not applicable. The CL1000 IR Laser System is a hardware device, and the filing process described does not involve an AI algorithm with a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set mentioned.
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.