(88 days)
ALT Laser, Model AVI HPLL-12 is intended to emit energy in the infrared spectrum to provide topical heating for use when heat is indicated in the temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis, and promoting relaxation of the muscle tissue.
The system will produce a 980nm infrared and a 650 nm red visible laser light in overlapping patterns. The two types of light will be mixed such that the visible 650 nm light becomes a reasonable indicator of the invisible infrared 980nm light. The 650 nm visible aiming laser light will be sensed and if the light is absent, it will lock out the infrared 980nm light and alert the operator.
The provided text is a 510(k) summary for the ALT Laser, Model AVI HPLL-12. This document is a premarket notification for a medical device and primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study with detailed acceptance criteria and testing outcomes for the device itself.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not present in the provided text. The document is about regulatory clearance based on substantial equivalence, not a clinical or performance validation study as might be conducted for a novel device or AI algorithm.
Here's a breakdown of the requested information based on the provided text:
Description of Acceptance Criteria and Proving Device Meets Criteria
The provided document does not describe acceptance criteria in the traditional sense of performance metrics for a study proving a device's effectiveness. Instead, it aims to demonstrate "Substantial Equivalence" to a legally marketed predicate device (ALT Laser, Model VTR75, K031612). The "acceptance criteria" here implicitly revolve around demonstrating that the new device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a substantial equivalence submission for a laser device (infrared lamp), the "performance" is described in terms of its intended function and technological characteristics, not in terms of diagnostic accuracy or treatment efficacy metrics typically found in AI device studies.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (from K091285) |
|---|---|
| Intended Use: Device performs as intended for its specified medical indication. | Intended Use: "ALT Laser, Model AVI HPLL-12 is intended to emit energy in the infrared spectrum to provide topical heating for use when heat is indicated in the temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis, and promoting relaxation of the muscle tissue." This is identical to the predicate device's intended use. |
| Technological Characteristics: Device has similar operational principles and safety features as the predicate. | Technological Characteristics: Produces 980nm infrared and 650nm red visible laser light in overlapping patterns. The 650nm visible light acts as an indicator, locking out the 980nm infrared light if absent (safety feature). "The intended use and technological characteristic of the two devices do not vary significantly." "The light at infrared wavelengths is therapeutic in nature and although the output of infrared energy varies between devices this difference only impacts the amount of time to attain the therapeutic thermal effect of the infrared energy." |
| Safety: Device is as safe as the predicate, with no new safety concerns. | Safety: Comprehensive warnings and cautions are listed, similar to what would be expected for a Class II infrared laser. The aiming laser lockout mechanism is described as a safety feature. The document states, "The safety and effectiveness of the Avicenna Laser Technology, Inc.'s ALT Laser, Model AVI HPLL-12 infrared device is comparable to that of the Avicenna's ALT Laser Model VTR 75 device." |
| Effectiveness: Device is as effective as the predicate. | Effectiveness: "The light at infrared wavelengths is therapeutic in nature and although the output of infrared energy varies between devices this difference only impacts the amount of time to attain the therapeutic thermal effect of the infrared energy. Therefore, the operational differences and output between the predicate device ALT Laser VTR 75 and ALT Laser, Model AVI HPLL-12 does not present a significant effect in the therapeutic outcome." |
Regarding specific AI study questions (samples, experts, adjudication, MRMC, standalone):
The provided text describes a laser device (infrared lamp), not an AI/ML powered medical device. Therefore, the following information is not applicable or not available in this submission.
2. Sample size used for the test set and the data provenance: Not applicable. This is a claim of substantial equivalence for a physical device, not an AI algorithm evaluated on a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth or expert evaluation for a test set is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring expert adjudication is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a standalone physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this submission is demonstrating that the device's technical specifications and intended use align with its predicate.
8. The sample size for the training set: Not applicable. This is not an AI/ML device trained on data.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device trained on data.
§ 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.