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The LuxGTM handpiece is intended for photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels (treatment of facial and leg veins), and the treatment of benign pigmented lesions.

The LuxGTM handpiece is an accessory to the EsteLux Pulsed Light System, a light-based medical device designed for effective treatment of facial and leg veins, and treatment of pigmented lesions in all skin types (I-VI).

The provided text describes the Palomar LuxG™ handpiece and its 510(k) submission. However, it explicitly states that no performance data is presented because "The differences in the specifications... do not result in different performance or raise new questions of safety or efficacy."

Therefore, based on the provided text, I cannot complete the requested information regarding acceptance criteria and the study that proves the device meets them, as no such study or data is detailed. The submission relies on substantial equivalence to predicate devices rather than direct performance testing for this particular 510(k).

Here's a breakdown of why each section cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

   • Reason: The text states, "The differences in the specifications... do not result in different performance or raise new questions of safety or efficacy." No performance data or acceptance criteria are presented for the LuxG™ handpiece itself.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Reason: No test set or performance study is detailed in the provided information.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Reason: No test set or ground truth establishment relevant to the LuxG™ handpiece's performance is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Reason: No test set or adjudication process is mentioned.

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

   • Reason: This device is a laser handpiece, not an AI-assisted diagnostic tool. No MRMC study is relevant or described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • Reason: This is a physical medical device (handpiece), not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • Reason: No ground truth for performance evaluation is described for the LuxG™ handpiece.

8. The sample size for the training set

   • Reason: No training set is mentioned as no performance study or machine learning component is detailed for this device's 510(k).

9. How the ground truth for the training set was established

   • Reason: No training set or ground truth for it is mentioned.

Conclusion from the provided text:

The 510(k) submission for the LuxG™ handpiece did not include new performance data or studies. Instead, it argued for substantial equivalence based on the premise that its specifications, while different from predicate devices (EsteLux Standard handpiece, Lumenis (ESC) Quantum SR), "do not result in different performance or raise new questions of safety or efficacy." Therefore, the submission relied on the established safety and effectiveness of its predicate devices rather than new performance testing for its clearance.

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