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The Palomar Lux1440 Handpiece is intended for skin resurfacing procedures in addition to dermatological procedures requiring the coagulation of soft tissue.

Dermatological procedures requiring the coagulation of soft tissue;
Skin resurfacing procedures.

The Palomar Lux1440 Handpiece attaches to the StarLux Pulsed Light and Laser System. The complete system consists of a cart, base unit, chiller, a footswitch, and a handpiece.

The provided 510(k) summary for the Palomar Lux1440 Handpiece (K073583) does not contain any information about acceptance criteria or a study proving the device meets said criteria.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices (K071768 and K061652) based on:

• Intended Use: Similar applications (skin resurfacing and dermatological procedures requiring soft tissue coagulation).
• Device Description: The Lux1440 Handpiece attaches to the existing StarLux Pulsed Light and Laser System, implying similar underlying technology and components.
• Performance Data (as stated by the submitter): A claim that "The review of the technical characteristics, indications for use, mechanism of action, and verification and validation information provided demonstrate that the modified Palomar Lux1440 Handpiece is substantially equivalent to its predicate device."

Therefore, I cannot provide the requested information in the table or the subsequent points because it is not present in the provided text.

The document's purpose is to establish substantial equivalence for regulatory clearance, not to detail specific performance metrics against pre-defined acceptance criteria through a clinical study. The FDA's letter confirms this, stating, "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...".

Summary of missing information:

• Table of Acceptance Criteria and Reported Device Performance: Not present.
• Sample size used for the test set and data provenance: No test set or clinical study is described.
• Number of experts used to establish the ground truth and their qualifications: Not applicable as no ground truth establishment is described.
• Adjudication method: Not applicable.
• Multi reader multi case (MRMC) comparative effectiveness study: Not mentioned.
• Standalone (algorithm only without human-in-the-loop performance): Not applicable, as this is a laser handpiece, not an AI algorithm.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable, as this is not a machine learning device.
• How the ground truth for the training set was established: Not applicable.

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