Search Results

The Aerolase Nd:YAG Laser is intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic/laparoscopic general surgery, gastroenterology, gynecology, otolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary/thoracic surgery, podiatry, and urology for surgical and aesthetic applications.

Dermatology:
The Aerolase Nd:YAG Laser is intended for the coagulation and hemostasis of benian vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte: and treatment of benian cutaneous lesions, such as warts, scars, striae, debridement of decubitus ulcer, treatment of keloids, and psoriasis. The laser is also intended for the treatment of benian pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques.
Additionally, the Aerolase Nd:YAG Laser is indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The Aerolase Nd:YAG Laser is also indicated for the treatment of wrinkles, such as. but not limited to, periocular and perioral wrinkles.
The Aerolase Nd:YAG Laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
The Aerolase Nd:YAG Laser is also indicated for treatment of mild to moderate inflammatory acne vulgaris.
The Aerolase Nd: YAG Laser is also indicated for the removal of unwanted hair, for stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
The Aerolase Nd:YAG Laser is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.

Podiatry:
Podiatry (ablation, vaporization, incision, excision, and coaqulation of soft tissue), including:

• . Matrixectomy:
• . Periungual and subungual warts:
• Plantar warts: ●
• Radical nail excision; ◆
• Neuromas. .

General Surgery:
The Aerolase Nd: YAG Laser is indicated for the incision/excision and cutting, ablation, coaqulation/hemostatis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy gastroenterology, general surgery, head and neck/otolaryngology (ENT) neurosurgery, oculaplastics, orthopedics, plastic surgery, pulmonary/ thoracic surgery, gynecology (e.g. menorrhagia), podiatry and urology. All soft tissue is included, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands.

The Aerolase Nd:YAG 1064nm Laser is Neodynmium doped Yttriuim-Aluminum-Garnet ("Nd:YAG") Laser. This device consists of the following components and accessories: a power supply unit with an air-cooling system, and a laser hand piece connected to the power supply/air cooling system using umbilical cords. Laser parameters are controlled from a display panel located on the front of the power supply unit.

Here's a breakdown of the acceptance criteria and study information for the Aerolase Model Nd:YAG 1064nm Laser, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device cleared in 2012. Historically, such summaries, especially for predicate device clearances, often focused on demonstrating safety and effectiveness through substantial equivalence to existing devices, relying heavily on compliance with recognized standards and published clinical data rather than novel clinical trials with specific statistical endpoints. This document reflects that approach.

Acceptance Criteria and Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics from new clinical studies. Instead, it relies on demonstrating compliance with specified standards and leveraging existing published clinical data to support safety and effectiveness.

Acceptance Criteria (Implied by the context of a 510(k) and provided text):

Study Information (Based on the Provided Document)

This 510(k) summary does not describe a new, standalone clinical study conducted specifically for the Aerolase Model Nd:YAG 1064nm Laser to establish its safety and effectiveness against explicit acceptance criteria using a test set as typically understood in AI/ML performance evaluation. Instead, it relies on:

• Substantial Equivalence: Comparing the device to predicate devices.
• Compliance with Standards: Demonstrating the device meets established safety and performance standards relevant to a laser.
• Published Clinical Data: Referring to existing literature that supports the general use of Nd:YAG lasers for the claimed indications.

Therefore, many of the specific questions about sample sizes, ground truth establishment, and expert involvement for a new study cannot be answered from this document.

1. Sample sizes used for the test set and the data provenance:
* Test Set Sample Size: Not applicable. No new "test set" from a clinical study for this specific device is described.
* Data Provenance: Not applicable. The document refers to "published clinical data," which would be from various sources (countries, prospective/retrospective), but doesn't specify data provenance for a study unique to this device.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable. No new test set with expert-established ground truth is described for this device. The "ground truth" for the device's efficacy is implicitly established by the broad body of existing medical literature supporting Nd:YAG laser use in specified procedures, reviewed by the FDA as part of the 510(k) process.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not applicable. No new test set requiring adjudication is described.

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:
* No. This device is a laser system, not an AI/ML diagnostic tool involving human readers or AI assistance in interpretation. Therefore, MRMC studies and AI effect sizes are not relevant to this submission.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* No. This is a physical laser device, not a software algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* For the general efficacy of Nd:YAG lasers in the indicated applications, the "ground truth" would be clinical outcomes (e.g., reduction in lesion size, hair reduction, successful coagulation/hemostasis, pathology reports where applicable for lesion confirmation), established over years of medical practice and reported in peer-reviewed literature. For this specific 510(k), the ground truth is primarily established through substantial equivalence to legally marketed predicate devices further supported by compliance with recognized standards and broad published clinical data relating to Nd:YAG lasers.

7. The sample size for the training set:
* Not applicable. This is not an AI/ML device that requires a training set. If we consider the "training" for the device's design and manufacturing, it would be based on established engineering principles and safety standards, not a data training set.

8. How the ground truth for the training set was established:
* Not applicable for the same reasons as above.

Ask a specific question about this device

Fotona XP Nd:YAG Laser System Family and its accessories are intended for use in the following procedures:

Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:

• Matrixectomy ー
• Radical nail excision -
• Periungual and subungual warts ー
• Plantar warts l
• Neuromas -
• Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes ー Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)

The Fotona XP Nd:YAG Laser System Family is based on thè Nd:YAG (1064 nm) laser technology. There is one optical cavity containing the Nd: YAG crystal. The Nd: YAG laser is activated by means of the use of a flashlamp. After the cavity, a red diode aiming beam is reflected onto a coaxial bcam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided by an optical fiber delivery system to an optical handpiece. Optionally, the laser beams can be guided through fiber having SMA905 connector on the proximal end and bare fiber on distal end. The user activates laser emission by means of a footswitch.

The Nd: YAG (1064 nm) laser can be operated with variable pulse durations in the range of 0.1-50 msec, with repetition rates up to 100 Hz and laser pulse energies up to 20 J. Depending on the type of treatment, the user can choose between a PULSE mode user interface, and a QCW (Quasi-Continuous Wave) mode user interface. The laser operation is the same for both modes, the difference is only in the laser parameters that can be directly selected from the keyboard.

The provided text describes a 510(k) premarket notification for the Fotona XP Nd:YAG Laser System Family. This is a submission to demonstrate substantial equivalence to a legally marketed predicate device, rather than a de novo submission that would typically involve a detailed clinical study with specific acceptance criteria and performance data.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices (Cutera GenesisPlus and PinPointe FootLaser) based on:

• Identical technological and similar design characteristics.
• Similar indications for use.
• Comparable technical characteristics (e.g., laser source, wavelength, output mode, energy per pulse, pulse width, repetition rate, output power, beam delivery, spot sizes).

The table provided in the document is a comparison table of technical characteristics between the Fotona XP Nd:YAG Laser System Family and its predicate devices, not a table of acceptance criteria and reported device performance against those criteria.

To directly answer your request based on the provided text, the following information is NOT available:

• 1. A table of acceptance criteria and the reported device performance: This is not present. The document compares technical specifications to predicate devices.
• 2. Sample size used for the test set and the data provenance: Not applicable to this type of submission.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable.
• 4. Adjudication method for the test set: Not applicable.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a surgical laser, not an AI algorithm.
• 7. The type of ground truth used: Not applicable.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

The submission aims to show that the new device operates similarly and for the same intended uses as previously cleared devices, hence "substantially equivalent," without needing a new clinical trial to establish safety and effectiveness from scratch.

Ask a specific question about this device