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The Epilaser I is intended to effect hair removal of patients with skin types 1 - 4 through selective targeting of melanin in hair follicles in dermatology and plastic surgery.

The upgrade kit for the Epilaser® I consists of a laser head with a slightly higher energy output, a fiber optic beam connector with a standard SMA 905 connector, a fiber optic, and modified hand pieces adapted with a quick connect to the fiber optic.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

This document describes an upgrade kit for an existing device, the Epilaser I Normal Mode Ruby Laser. The core of the submission is to demonstrate that the upgrade kit does not negatively impact the safety and effectiveness of the original device, and therefore, no new performance data is required.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not applicable. No test set involving human subjects or performance data was required for this submission. The submission is based on the premise that the upgrade does not alter the device's performance.
• Data Provenance: Not applicable, as no new performance data was generated or analyzed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable. No ground truth establishment related to a test set was required as no new performance data was generated for the upgrade kit.

4. Adjudication Method for the Test Set

• Not applicable. No test set requiring adjudication was performed.

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. This device is a laser for hair removal, not an AI-assisted diagnostic or interpretive device that would involve human readers or MRMC studies.

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

• Not applicable. This is a medical device (laser), not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Not applicable. No new ground truth was established for the upgrade kit. The regulatory decision hinges on the substantial equivalence to the predicate device, which inherently relied on the predicate possessing established safety and effectiveness.

8. The Sample Size for the Training Set

• Not applicable. This is a medical device (laser), not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set was Established

• Not applicable. No training set was used.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The "study" in this case is not a traditional clinical or performance study with new data generation. Instead, the "proof" is a regulatory argument of substantial equivalence to a legally marketed predicate device (the Epilaser I before the upgrade).

The acceptance criteria are effectively that the upgraded device maintains the safety and effectiveness of the predicate device. The study to prove this involved:

• Comparison of Technical Specifications: The submission details that the upgrade kit consists of a laser head with slightly higher energy output, a fiber optic beam connector, a fiber optic, and modified hand pieces.
• Assessment of Impact on Operational Specifications, Performance, and Intended Use: The core argument is stated as: "The operational specifications, performance and intended use of the Epilaser® I are not affected by the installation of the upgrade kit. The changes in specifications after installation of the upgrade kit, e.g., a fiber optic in place of an articulated arm, do not affect the performance characteristics of the Epilaser® I."
• Conclusion of Substantial Equivalence: Based on the above, the manufacturer concludes that the Epilaser I with the upgrade kit is substantially equivalent to the Epilaser I without the upgrade kit.

Therefore, the "study" is a technical and regulatory justification rather than a data-driven performance study. The FDA's letter (K980160) confirms their agreement with this assessment, stating, "We have determined the device is substantially equivalent... You may, therefore, market the device..." and that "The FDA finding of substantial equivalence... results in a classification for your device and thus, permits your device to proceed to the market." The underlying performance data for the original Epilaser I (K963947) served as the basis for its initial market clearance, and this submission leverages that existing clearance by demonstrating that the upgrade causes no adverse change.

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