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The Intensity Pulsed Light Therapy System is intended for medical use in the treatment of the following conditions: -Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles); -Cutaneous lesions including scars; - Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial truncal and leg telangiectasias, erythema of rosacea, leg veins, spider angiomas and venous malformations. -Permanent hair reduction-long-term stable reduction in number of hairs re-growing after a treatment regimen.

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I apologize, but the provided text from the FDA 510(k) clearance letter for the "Intensity Pulsed Light Therapy System" (K233307) does not contain any information regarding acceptance criteria, device performance studies, or details about the validation of an AI/algorithm-based medical device.

The document is a standard FDA clearance letter confirming substantial equivalence to a predicate device. It outlines:

• The device name and regulation details.
• The FDA's determination of substantial equivalence.
• General controls and regulatory requirements the manufacturer must adhere to (e.g., Quality System regulation, adverse event reporting, labeling).
• Indications for Use for the device.

There is no mention of:

• Specific performance metrics or acceptance criteria for the device (e.g., sensitivity, specificity, accuracy).
• Any study data, sample sizes, data provenance.
• Expert involvement for ground truth, adjudication methods.
• Multi-reader multi-case (MRMC) studies or standalone algorithm performance.
• Details about training sets or how ground truth was established for "AI" or "algorithm" components.

Therefore, I cannot fulfill your request for a table of acceptance criteria, study details, or information about AI/algorithm validation, as this information is not present in the provided text.

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