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For use in dermatology for all currently approved indications for the Medlite C-Series Nd: YAG Laser Systems and MultiSpot Handpiece.
Tattoo Removal
Nevus of Ota
Hair Removal
Vascular Lesions
Dermal Pigmented Lesions
Epidermal Pigmented Lesions
Laser Resurfacing for Acne scars and wrinkles
Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology

The Compression Tool and Handpiece Attachment Accessories are intended to be used to assist and enhance the procedure of treating dermatological conditions The Compression Tool and Handpiece Attachment Accessories are additional accessories designed to accompany the currently offered MedLite MultiSpot Handpiece. The purpose for these accessories are purely for a cosmetic end to help reduce undesirable purpura while treating with the Medlite C Series lasers.

The provided text describes a 510(k) submission for the "HOYA ConBio Compression Tool and Handpiece Accessories for use with MedLite™ C Series Q-Switched Nd: YAG Laser Systems". This submission is for accessory devices to an already approved laser system, aimed at reducing purpura during dermatological treatments.

Based on the content of the provided 510(k) summary and FDA letter, the primary focus is on substantial equivalence to predicate devices, rather than establishing new performance criteria through clinical studies with acceptance criteria, ground truth, or statistical analysis typically associated with AI/software devices. The devices in question are physical accessories (a compression tool and handpiece attachment), not a software or AI device that would have performance metrics like sensitivity, specificity, or AUC.

Therefore, many of the requested categories for AI/software device evaluation are not applicable here.

Here's a breakdown of the information that is available or can be inferred:

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

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics (e.g., sensitivity, specificity). The acceptance criteria for this type of submission would primarily revolve around demonstrating that the device is substantially equivalent to legally marketed predicate devices in terms of intended use, technological characteristics, and safety and effectiveness. This often involves engineering bench testing and potentially limited human factors evaluations for new accessories, rather than clinical efficacy studies with specific performance targets.
• Reported Device Performance: The submission states that the purpose of the accessories is "purely for a cosmetic end to help reduce undesirable purpura while treating with the Medlite C Series lasers." The "performance" is implicitly deemed acceptable by virtue of its substantial equivalence to the predicate device, which also aims to manage purpura. No specific numerical performance results (like "purpura reduction by X%") are provided.

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

• Not Applicable. This is a hardware accessory (compression tool and handpiece attachment) for a laser system, not a software or AI device that would typically rely on a "test set" of data or patient images for performance evaluation in the context of sensitivity/specificity. The evaluation would have been engineering/bench testing for safety and functionality.

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)

• Not Applicable. See point 2. Ground truth is not established in the same way for a physical accessory as it would be for an AI diagnostic device.

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

• Not Applicable. See point 2.

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

• No. This is not an AI device, and therefore, an MRMC study is not relevant.

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

• Not Applicable. This is a physical accessory to a laser system, not an algorithm.

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

• Not Applicable. The evaluation of these accessories likely focused on their mechanical fit, durability, and ability to apply compression without adverse effects, rather than a diagnostic ground truth. Safety and performance conformity to standards and predicate device characteristics would be the "ground truth" for this type of submission.

8. The sample size for the training set

• Not Applicable. This is a hardware accessory and does not involve AI training.

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

• Not Applicable. See point 8.

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