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The McCue Energist ULTRA™ VPL Intense Pulsed Light System is intended for permanent hair reduction and the treatment of mild to moderate inflammatory Acne Vulgaris. It is also indicated for photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels and the treatment of benign pigmented lesions.

• . Intense Pulsed Light Energy / wavelengths (530 - 950nm)
  The 530 - 950nm intense pulsed wavelengths are indicated for:

The treatment of mild to moderate inflammatory Acne Vulgaris.

The treatment of benign pigmented epidermal and cutaneous lesions including warts, scars and striae.

The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins, facial veins and venous malformations.

• . Intense Pulsed Light Energy / wavelengths (610 - 950nm)
  The 610 - 950nm intense pulsed wavelengths are indicated for:

The removal of unwanted hair from all skin types and to effect stable longterm or permanent 1 hair reduction in skin types I - V through selective targeting of melanin in hair follicles.

11 Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.

The McCUE Energist ULTRA VPL™ System is a light based medical device that delivers a beam of pulsed non-ionising radiation in the region of 530nm to 950nm. The system is designed to be compact and self contained and includes the following features:

• . Control console unit
• Display panel .
• Power supply .
• Cooling system .
• Removable handpiece with integrated switch, lamp, filter and glass coupling . block

The provided text is a 510(k) summary for the McCUE Energist ULTRA Variable Pulsed Light (VPL™) System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain the detailed information necessary to answer all sections of your request regarding acceptance criteria and a specific study proving the device meets those criteria.

Here's what can be extracted and what is missing:

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

The document states: "Performance data was provided to demonstrate that the system is capable of providing the outputs necessary to achieve its required treatment parameters."

This is a general statement and does not provide specific acceptance criteria or reported performance data in a table format.

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

This information is not provided in the given text. A 510(k) summary often summarizes extensive testing, but the details of the studies themselves (like sample sizes, data provenance) are typically found in the full 510(k) submission, not the summary.

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)

This information is not provided in the given text.

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

This information is not provided in the given text.

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

This device is an Intense Pulsed Light System for dermatological treatments, not an AI-assisted diagnostic or imaging device used by human "readers." Therefore, an MRMC comparative effectiveness study with human readers assisting AI is not applicable and not mentioned.

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

This device is a physical light-based medical device, not an algorithm. Therefore, a standalone algorithm performance study is not applicable and not mentioned.

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

Since the specific "performance data" is not detailed, the type of ground truth used to evaluate its efficacy for indications like hair reduction or acne treatment is not explicitly stated. It would likely involve clinical outcomes (e.g., reduction in hair count, reduction in lesion severity), but this is not specified in the document.

8. The sample size for the training set

This information is not provided in the given text. This device is not an AI/ML model that requires a training set in the conventional sense. The "training" for such a device would refer to its manufacturing and calibration against established specifications.

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

This information is not provided in the given text, and the concept of "ground truth for a training set" as it applies to AI/ML models is not directly relevant to this type of device.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on identical intended use and technological characteristics, with minor modifications to software and high-voltage components. It mentions that "performance data was provided," but it does not elaborate on the specific details of that data, study designs, sample sizes, or how acceptance criteria were met with quantified results.

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