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Non-fractional mode is indicated for incision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery. Fractional mode is indicated for only ablative skin resurfacing.

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This FDA clearance letter for the Copro 3 provides limited information regarding the performance study that proves the device meets acceptance criteria. The letter primarily focuses on the substantial equivalence determination and regulatory compliance.

Therefore, I cannot provide a detailed response to all aspects of your request based solely on the provided text. Specifically, the document does not contain:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or its provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
• Details about a standalone (algorithm only) performance study.
• The type of ground truth used for performance evaluation.
• The sample size for the training set.
• How the ground truth for the training set was established.

The letter states, "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 (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This heavily implies that the device's performance was compared to a predicate device, and its safety and effectiveness were demonstrated through bench testing, perhaps some animal studies, or a literature review rather than a large-scale clinical trial with human subjects and a detailed AI/software performance study as typically seen for AI/ML devices.

Based on the provided information, I can only state the following:

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

• Not provided in the document. The letter confirms substantial equivalence without detailing specific performance metrics or acceptance criteria for studies typically associated with AI/ML devices. The "Indications for Use" section describes the intended applications of the device (e.g., incision, ablation, vaporization, coagulation of soft tissues, and ablative skin resurfacing). The acceptance criteria would likely relate to the device's ability to perform these functions safely and effectively, possibly measured by parameters like power output accuracy, tissue damage characteristics, or procedural outcomes, which are not detailed here.

2. Sample size used for the test set and the data provenance:

• Not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not provided in the document.

4. Adjudication method for the test set:

• 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:

• Not applicable/Not mentioned. This device
  ("Laser Surgical Instrument") is a hardware device, not an AI/ML algorithm that assists human readers.

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

• Not applicable/Not mentioned. This is a hardware device, not a standalone AI algorithm.

7. The type of ground truth used:

• Not provided in the document. For a laser surgical instrument, ground truth would typically refer to objective measurements of the device's physical output (e.g., laser power, beam profile) and its effects on biological tissues (e.g., depth of ablation, coagulation zone), potentially verified through histology or other objective means.

8. The sample size for the training set:

• Not applicable/Not mentioned. As this is a hardware device, the concept of a "training set" as understood for AI/ML algorithms does not directly apply. Performance is typically established through engineering tests, bench tests, and possibly animal or cadaver studies.

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

• Not applicable/Not mentioned.

In summary, the provided FDA letter confirms substantial equivalence for the Copro 3 laser surgical instrument, indicating that it meets the regulatory requirements for market approval. However, it does not include the detailed performance study information, particularly for AI/ML-specific criteria, that you requested. Such details would typically be found in the manufacturer's 510(k) submission, not in the FDA's clearance letter itself.

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Lucas Plus Nd : YAG Laser System is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for Coagulation and hemostasis.

532nm Wavelength

Tattoo removal light ink (red, tan, purple, orange, sky blue,) Removal of Epidermal Pigmented Lesions, Minor Vascular Lesions, Talangiectasias Treatment of Lentigines, Cafe-Au-Lait, Sebrorrheic Keratoses, Becker's Nevi, Freckles, Treatment of Post Inflammatory Hyperpigmentation (PIH)

1064nm Wavelength:

Tattoo removal: dark ink (black, blue, green ) Removal of Nevus of Ota Removal or lightening of unwanted hair with or without adjuvant preparation Treatment of Common Nevi, Melasma, Skin resurfacing procedures for the treatment of acne scars, wrinkle

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I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a device called "Lucas Plus Nd : YAG Laser System." The letter confirms that the device is substantially equivalent to legally marketed predicate devices.

While it lists the indications for use of the laser system, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any other details related to clinical trials or performance evaluations.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

Ask a specific question about this device