Search Results

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.

Ask a specific question about this device

The McCue Energist ULTRATM VPL Intense Pulsed Light System is intended for permanent hair reduction. 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 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 long-term or permanent " 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™ is a light-based medical device that delivers a beam of pulsed non-ionising radiation in the region of 530nm to 950nm. The system has been designed to be compact and self-contained that includes: Control console unit Display panel Power supply Cooling system Removable handpiece with integrated switch, lamp, filter and glass coupling block

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study information for the McCue Energist ULTRA™ Pulsed Light System.

It's important to note that the provided text is a 510(k) Summary, which is a high-level overview. For detailed study protocols, raw data, and comprehensive acceptance criteria, one would typically need to consult a full 510(k) submission or scientific publications.

Acceptance Criteria and Device Performance

The provided 510(k) Summary, K040659 for the McCue Energist ULTRA™ Pulsed Light System, does not explicitly state specific quantitative acceptance criteria or detailed device performance metrics in a table format as might be found in a clinical study report.

Instead, the submission relies on the concept of substantial equivalence to predicate devices. The primary "performance data" statement is qualitative:

"The differences in specifications of the McCue Energist ULTRA™ and the predicate devices do not result in different performance or raise new questions of safety and efficacy."

This indicates that the device is deemed to meet acceptance criteria by demonstrating that its technical specifications and intended uses are similar enough to already legally marketed devices that it does not introduce new safety or efficacy concerns. Therefore, the "acceptance criteria" are implicitly met by being substantially equivalent to the predicates.

Given this, a table of explicit acceptance criteria and corresponding performance cannot be generated directly from the provided text.

Study Information

Based on the provided 510(k) Summary, there is no detailed human or animal clinical study data presented to "prove the device meets acceptance criteria." The submission relies on substantial equivalence to predicate devices, meaning it leverages the established safety and effectiveness of those previously cleared devices.

Here's a breakdown of the requested information, mostly indicating what is not explicitly provided in the summary:

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

   • Acceptance Criteria: Not explicitly stated as quantitative targets (e.g., "90% hair reduction," "lesion clearance in X% of patients"). The acceptance criteria are implicitly met by demonstrating substantial equivalence to predicate devices.
   • Reported Device Performance: Not detailed in quantitative terms for efficacy. The performance is indirectly supported by the statement that "differences in specifications... do not result in different performance or raise new questions of safety and efficacy" compared to the predicate devices.

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

   • No specific sample size for a test set is mentioned. No clinical study data is detailed in this summary.
   • Data Provenance: Not applicable as specific study data is not presented.

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 as no specific test set or ground truth establishment based on expert review is described. The assessment is based on comparison to predicate devices and their established safety/efficacy.

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

   • Not applicable as no specific test set requiring adjudication is described.

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 MRMC study was done or reported. This device is an Intense Pulsed Light System, not an AI-powered diagnostic tool, so an MRMC study with human readers and AI assistance would not be relevant in this context.

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

   • Not applicable. This is a physical light-based treatment device, not an algorithm.

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

   • Not applicable for a new clinical study. The "ground truth" for the device's safety and efficacy is implicitly derived from the existing clearances and performance history of the predicate devices.

8. The sample size for the training set:

   • Not applicable as this is a physical medical device, not a machine learning algorithm requiring a training set.

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

   • Not applicable as this is a physical medical device, not a machine learning algorithm.

Summary of Findings from K040659:

The 510(k) summary for the McCue Energist ULTRA™ Pulsed Light System primarily focuses on demonstrating substantial equivalence to a list of previously cleared predicate devices (Lumenis IPL Quantum, Radiancy SpaTouch/Skin Station, Palomar EsteLux, Alderm/MBC Prolite/Plasmalite).

The basis for this substantial equivalence is the claim that "The differences in specifications of the McCue Energist ULTRA™ and the predicate devices do not result in different performance or raise new questions of safety and efficacy."

Therefore, this submission does not present detailed clinical study data, sample sizes, expert ground truth establishment, or specific performance metrics from a new study of the McCue Energist ULTRA™ itself. Instead, its acceptance is based on the premise that it is sufficiently similar to devices already proven safe and effective.

Ask a specific question about this device