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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.

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.

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The Acculaser Pro Low Level Laser Therapy Device is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.

The Acculaser Pro LLLT has a hand-held treatment probe, is non-thermal, and emits infrared energy at 830nm.

This 510(k) premarket notification for the Acculaser Pro Low Level Laser Therapy Device does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

This document is a submission for regulatory clearance based on substantial equivalence to a predicate device, not a performance study report. It states that the Acculaser Pro LLLT device has substantially equivalent technological characteristics and indications for use as the MicroLight 830™ Laser System (K010175).

Therefore, I cannot provide the specific details you requested, such as:

• A table of acceptance criteria and the reported device performance: This document does not define specific performance metrics or acceptance criteria for the Acculaser Pro, nor does it report its performance against any such criteria. It relies on the predicate device's established performance.
• Sample size used for the test set and data provenance: No new clinical or performance studies are described for the Acculaser Pro.
• Number of experts used to establish ground truth and qualifications: Not applicable as no new study is presented.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
• Standalone algorithm performance: Not applicable as this is a physical medical device, not an AI algorithm.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable (no algorithmic training is mentioned).
• How the ground truth for the training set was established: Not applicable.

Summary of available information relevant to "performance" (by inference):

The "performance" of the Acculaser Pro is implicitly considered equivalent to its predicate device, the MicroLight 830™ Laser System, which was cleared based on its indication for "adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome." The clearance of the Acculaser Pro is based on its technological characteristics (non-thermal, emits infrared energy at 830nm) and intended use being substantially equivalent to the predicate. Any performance data would have been submitted and reviewed for the predicate device, K010175.

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