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The Greenton Ecolite IPL System is indicated for permanent hair reduction, photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions and inflammatory acne (ache vulgaris).

The Greenton Ecolite IPL System is a pulsed light, wavelength range adjustable system. It provides selectable handpiece aperture sizes for a variety of applications. Light emission activation is by foot switch. Overall weight of the system is 110 lbs., and the size is 13.8" X 19" X 40". Electrical requirement is 110 VAC, 15A, 50/60 Hz, single phase.

This submission describes the Greenton Ecolite IPL System, an Intense Pulsed Light (IPL) system.

Here's an analysis of the provided text in relation to your request:

Acceptance Criteria and Device Performance:

The document states: "The Greenton Ecolite IPL System is identical to the Quanta System Eterna Giovinezza, has the same indications for use, the same principle of operation, and the same wavelength range and pulse energy range as the predicate device."

This implies that the acceptance criteria for the Greenton Ecolite IPL System are met by demonstrating its equivalence to the predicate device, the Quanta System Eterna Giovinezza (K051113). The performance of the Greenton Ecolite IPL System is considered acceptable if it operates identically and within the same specifications as the predicate device for the stated indications.

However, the document explicitly states:

• Nonclinical Performance Data: None
• Clinical Performance Data: None

Therefore, there is no direct demonstration of the Greenton Ecolite IPL System's performance against specific, quantifiable acceptance criteria. Its acceptance is based purely on substantial equivalence to a predicate device.

Table of Acceptance Criteria and Reported Device Performance:

Based on the provided text, a conventional table of acceptance criteria and reported device performance cannot be generated because:

• No explicit, measurable acceptance criteria for the Greenton Ecolite IPL System are given (e.g., "achieves X% reduction in hair growth," or "clears Y% of lesions").
• No performance data for the Greerton Ecolite IPL System is reported.

Instead, the acceptance hinges on the following comparison:

Study Details:

1. Sample size used for the test set and the data provenance: Not applicable. No test set or clinical study was performed.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set or ground truth establishment was performed.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set was used.
4. 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 is a medical device, not an AI or diagnostics software, and no MRMC study was performed.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device (pulsed light system), not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth was established for this device, as no clinical performance data was provided.
7. The sample size for the training set: Not applicable. No training set was used as no AI/machine learning component is mentioned, and no clinical data was presented.
8. How the ground truth for the training set was established: Not applicable.

Summary Conclusion based on the provided text:

The Greenton Ecolite IPL System received 510(k) clearance based solely on its substantial equivalence to a previously cleared predicate device (Quanta System Eterna Giovinezza, K051113). The submission explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None." Therefore, no studies were conducted to demonstrate the device's performance against specific acceptance criteria or to establish any ground truth. Its acceptance is predicated on the assumption that if it is identical in design and operation to a legally marketed equivalent device, it raises "no new safety or effectiveness questions."

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