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The Dye VL Handpiece (500-600 nm) is indicated for:

• The treatment of benign pigmented lesions including café -au-lait (macules), lentigines (senile and solar), freckles (ephelides), chloasma, nevi, nevus spillus, nevus of Ota, and Becker's Nevi.
• The treatment of other pigmented cutaneous lesions including verrucae, skin tags, keratosis, and plaques.
• The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
• Use on skin types (Fitzpatrick I-V).

The Harmony XL™ continues to be comprised of the identical console unit, footswitch, and a variety of handpieces. The main console of the Harmony XL™ continues to consist of the same control panel, system controller, power supply modules, cooling system, switching module, and isolation transformer.

The subject change is to add a version of the 515-950 nm SVL515 Module AFT handpiece ("SVL515") provided in the company's cleared Harmony XL™ (K072564) to the Harmony XL™ system. The modified handpiece has a narrowed wavelength range of 500-600 nm as compared to the SVL515 handpiece that has a wavelength of 515-950 nm. In addition, the modified handpiece is named the "Dye VL handpiece." Further, the identification color of the distal end of the handpiece is being changed from turquoise to light green.

The provided text is a 510(k) summary for the Alma Lasers Harmony XL™ Multi-Application Platform with the Dye VL Handpiece. This document is a regulatory submission to the FDA for demonstrating substantial equivalence to a predicate device, not a detailed scientific study on device performance against specific acceptance criteria. Therefore, the information required to fully answer your request regarding acceptance criteria and a study proving the device meets them is limited and largely not present in the provided text.

Here's an analysis based on the available information:

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

The document does not provide a table with specific acceptance criteria (e.g., in terms of clinical efficacy metrics like lesion reduction percentage, or safety metrics like adverse event rates) and reported device performance against those criteria.

The "Performance Data" section states:

• "Software verification and validation was performed, and demonstrates that the software performs as intended."
• "Electrical safety (IEC 60601-1) and electromagnetic compatibility (IEC 60601-1-2) was established."
• "Biocompatibility of patient-contacting components was established per ISO 10993."
• "In all instances, the subject device functions as intended and meets all the same acceptance criteria as the predicate devices."

This indicates that the acceptance criteria are based on fulfilling engineering and safety standards, and that device functions as intended. However, the specific quantitative or qualitative criteria are not detailed.

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

The document does not mention any clinical test set, sample size, or data provenance (country of origin, retrospective/prospective). The performance data cited refers to engineering verifications and validations (software, electrical safety, EMC, biocompatibility), which typically do not involve human subjects or clinical data in the same way as a clinical trial.

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 applicable and not available in the document, as no clinical test set requiring expert ground truth establishment is described.

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

This information is not applicable and not available, as no clinical 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

There is no mention of an MRMC comparative effectiveness study, nor is there any AI component described in the device. The device is a laser/light platform, not an imaging analysis or diagnostic AI device. Therefore, this question is not applicable to the provided document.

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

This question is not applicable. The device is a physical laser/light therapy platform, not an algorithm.

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

For the engineering performance data mentioned, the "ground truth" would be established by the relevant engineering standards (e.g., IEC 60601-1 for electrical safety, ISO 10993 for biocompatibility) and the functional specifications of the device. There is no mention of clinical ground truth (like pathology or outcomes data) because the document focuses on demonstrating substantial equivalence based on technological characteristics and safety, rather than presenting new clinical efficacy data.

8. The sample size for the training set

The document does not mention any training set. This device is not described as an AI/ML device that would require a "training set" in the context of machine learning.

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

Not applicable, as no training set for an AI/ML component is mentioned.

Summary of what is present:

The document is a 510(k) summary for a medical device (Harmony XL™ Multi-Application Platform with Dye VL Handpiece). It aims to demonstrate substantial equivalence to existing predicate devices, not necessarily to prove new clinical efficacy.

• Acceptance Criteria (Implied): The device is stated to meet the "same acceptance criteria as the predicate devices" for software, electrical safety, electromagnetic compatibility, and biocompatibility. These criteria are based on established engineering and safety standards (IEC 60601-1, ISO 10993) and the device's functional specifications. Specific quantitative or qualitative performance targets are not listed.
• Study: The "studies" conducted are non-clinical:
  • Software verification and validation.
  • Electrical safety testing (IEC 60601-1).
  • Electromagnetic compatibility testing (IEC 60601-1-2).
  • Biocompatibility testing (ISO 10993).
• Sample Size/Data Provenance/Experts/Adjudication/MRMC/Standalone Performance/Ground Truth (for clinical data or AI): These details are not provided because the 510(k) submission primarily relies on demonstrating that the modified device's technological characteristics and intended use are substantially equivalent to a cleared predicate, and that it conforms to relevant engineering and safety standards. It does not describe a clinical performance study using patient data and expert review.

Ask a specific question about this device

The Alma Lasers Harmony XL™ Multi-Application Platform is intended for use in dermatologic and general surgical procedures. The Harmony XL™ Multi-Application Platform is intended for use in aesthetic, cosmetic, and surgical applications requiring the ablation, vaporization, excision, and photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialties of dermatology, general and plastic surgery, endoscopic/laparoscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, oral surgery, ophthalmology (skin around the eyes), orthopedics, pulmonary/thoracic surgery, and urology for surgical and aesthetic applications.

The Alma Lasers Harmony XL™ Multi-Application Platform is comprised of the following main components: The main console unit that incorporates the touch-screen control panel, power supply modules, cooling system, switching module, service panel and isolating transformer. Variety of handpieces and attachment accessories. Footswitch.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) summary for the Harmony XL™ Multi-Application Platform, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting performance criteria and a study to meet them.

The text outlines:

• General information about the device and submitter.
• A list of predicate devices.
• A product description.
• Extensive indications for use for various modules and handpieces in dermatologic and general surgical procedures.
• A rationale for substantial equivalence.
• A conclusion of substantial equivalence.

It does not contain details regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any test set.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Standalone algorithm performance.
7. Type of ground truth used in a study.
8. Sample size for a training set.
9. How ground truth for a training set was established.

This document is a regulatory submission for substantial equivalence, not a scientific publication detailing performance studies against specific acceptance criteria.

Ask a specific question about this device