(250 days)
Long pulse Nd:YAG Laser System is intended for use for :
• Benign pigmented lesions such as but not limited to , lemtigos( age spots), solar lentigos( sun spots), café au lait macules, sebortheic karatoses, nevi, chloasma, verucae, skin tags, karatoses, tattoss( significant reduction in the intensity of black and/or blue black tattoos) and plaques.
• Pigmented lesions to reduce lesion size, for patients with lesions that would potiently benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
• Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
The Long Pulse Nd:YAG Laser System is a flashlamp-excited, Nd:YAG (Neodymium-doped Yttrium Aluminum Garnet) laser system. Pulsed laser energy at a nominal wavelength of 10641m. This wavelength causes maximum energy absorption by targeting the treatment area and minimum absorption by surrounding skin structures. In addition, the laser pulse duration is controlled to be equal to or shorter than the thermal relaxation time of the target, to minimize heat transfer to surrounding tissues.
Deeper penetration and a more moderate hemoglobin absorption makes 1064 nm wavelength more useful for the deeper hair follicles and vessels. Further, with the right combination of parameters, the 1064 nm wavelength is also suitable for more superficial hair, telangiectasia and spider veins.
Base on this, Long Pulse Nd: Y AG Laser System is intended for 1) Benign pigmented lesions such as ,but not limited to , lemtigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic karatoses, nevi, chloasma, verrucae, skin tags, karatoses, tattoss (significant reduction in the intensity of black and/or blue black tattoos) and plaques. 2) Pigmented lesion size, for patients with lesions that would potiently benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. 3) Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
The Nd: Y AG Laser System consists of control system, user interface, power source , laser emission and delivery system, cooling system and safety features
The provided document is a 510(k) summary for a medical device called "Long Pulse Nd:YAG Laser System." It's a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of document focuses on comparing the new device to existing ones rather than detailing a clinical study with acceptance criteria and device performance in the way a clinical trial report would.
Therefore, much of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not present in this 510(k) summary.
Here's what can be extracted and inferred from the document:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical performance metrics. The document focuses on showing substantial equivalence in intended use, technological characteristics, and principles of operation to a predicate device.
- Reported Device Performance: No clinical performance metrics (e.g., success rates, lesion reduction percentages, complication rates) are reported. The document states that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." This implies performance was deemed acceptable if it matched the predicate's capabilities or standards, but specific numbers are absent.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. This document refers to non-clinical tests (electrical safety, EMC, laser safety standards) and a comparison to a predicate device, not a human clinical test set.
- Data Provenance: Not applicable for a clinical test set. The non-clinical tests were presumably conducted by the manufacturer, Advanced Technology Laser Company, Ltd., based in Shanghai, China.
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)
- Number and Qualifications of Experts: Not applicable. No human expert-adjudicated ground truth data is presented.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. No human 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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a laser system, not an AI or diagnostic imaging device that would typically involve human readers interpreting results.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical laser device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable for clinical performance. The "ground truth" for the non-clinical tests refers to compliance with established international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1).
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This a physical laser system, not an AI/machine learning device that would require or report a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable.
Summary of Information from the Document:
While the document does not contain the specific information requested, it does provide key details about the device and its regulatory submission:
- Device Name: Long Pulse Nd:YAG Laser System (Trade Name: SmoothTouch)
- Manufacturer: Advanced Technology Laser Company, Ltd. (Shanghai, China)
- Regulatory Number: K140249
- Intended Use:
- Treatment of benign pigmented lesions (lentigos, solar lentigos, café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos - significant reduction in black/blue-black intensity, and plaques).
- Reduction of pigmented lesion size for aggressive treatment or non-responsive lesions.
- Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is integral.
- Predicate Device: Gentle YAG Laser System (Candela Corporation), K022923
- Technological Characteristics Comparison (Proposed vs. Predicate):
- Product Code: GEX (SAME)
- Regulation Number: 21CFR 878.4810 (SAME)
- Intended Use: SAME
- Energy Source: ND:YAG Laser (SAME)
- Waveform: 1064 nm (SAME)
- Fluence energy range: up to 600J/cm2 (SAME)
- Spot size: 1.5mm, 3mm, 8mm, 10mm, 12mm and 3mm*8mm (SIMILAR)
- Aiming laser: 510nm diode laser (
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.