(553 days)
The Acculaser™ Pro4 is indicated for adjunctive use in providing temporary relief of pain associated with iliotibial band syndrome.
The Acculaser™ Pro4 is a low level laser therapy device. It is non-thermal and emits infrared energy at 830 nm.
The provided document is a 510(k) summary for the Acculaser™ Pro4, a low-level laser therapy device. It primarily focuses on demonstrating substantial equivalence to predicate devices for market clearance rather than detailing specific acceptance criteria and a study proving device performance against those criteria in the way a clinical trial typically does for a PMA.
However, based on the available information, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state quantitative acceptance criteria. Instead, it makes a general claim about safety and effectiveness.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| The device is safe for its intended use. | Bench test and clinical performance data demonstrate that the Acculaser™ Pro4 low level laser therapy device is safe. |
| The device is effective in providing adjunctive therapy for the temporary relief of pain and disability associated with iliotibial band syndrome (ITBS). | Bench test and clinical performance data demonstrate that the Acculaser™ Pro4 low level laser therapy device is effective in providing adjunctive therapy for the temporary relief of pain and disability associated with ITBS. |
| The device is substantially equivalent to legally marketed predicate devices. | Based on the same intended use and similarity in design and technological characteristics, the Acculaser™ Pro4 is substantially equivalent to the predicate devices (K020657, K010175, K012580). |
2. Sample size used for the test set and the data provenance:
The document mentions "clinical performance data" but does not specify the sample size for any clinical tests or the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. Given the nature of a low-level laser for pain relief, "ground truth" might refer to patient-reported outcomes or clinical assessments, but the document does not elaborate.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided in the document.
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:
The Acculaser™ Pro4 is a low-level laser therapy device for pain relief, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not applicable and was not performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The Acculaser™ Pro4 is a physical medical device, not a standalone algorithm. Therefore, "standalone (algorithm only)" performance is not applicable and was not performed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The document broadly refers to "clinical performance data." For a pain relief device, the "ground truth" would most likely involve patient-reported outcomes related to pain and disability as assessed by clinicians or through patient surveys. However, the exact type of data and its collection methodology are not detailed.
8. The sample size for the training set:
The document refers to "bench test and clinical performance data" but does not mention a training set in the context of machine learning, as this device would not typically involve such a concept. If a clinical study was done, it would be a "study population" or "test set," not a "training set."
9. How the ground truth for the training set was established:
As there is no mention of a training set in this context, this question is not applicable.
§ 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.