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The Profile 1064 Laser Systems and Accessories are intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic/laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications.

Dermatology:

Coagulation and hemostasis of benign vascular lesions such as, but not limited to port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. The lasers are also intended for the treatment of benign 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 lasers are 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.

Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

Removal of unwanted hair, for the stable long term, or permanent hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). The Profile 1064 Laser Systems and Accessories are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.

The Profile 1064 Laser Systems and Accessories are indicated for the treatment of facial wrinkles.

The intended use of the contact cooling system in the Profile handpiece is to provide cooling of the skin prior to, during and after laser treatment, for the epidermal protection and reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments.

Surgical Applications:

Incision/excision and cutting, ablation, coagulation/hemostasis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy, gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g. menorrhagia) and urology.

Profile Laser System is an Nd:YAG laser producing emission at a wavelength of 1064nm. It consists of a laser console, internal computer, control panel and display, an optical delivery system comprised of an articulated arm and a handpiece or scanner with cooling capability, and a footswitch.

The provided text describes a 510(k) submission for the Sciton Profile 1064 Laser System, demonstrating its substantial equivalence to previously marketed predicate devices. This type of submission generally relies on demonstrating equivalence rather than conducting new clinical studies with defined acceptance criteria and performance metrics.

Therefore, this document does not contain the information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9 as it is a regulatory submission focused on substantial equivalence rather than a study report detailing specific performance criteria, test sets, or training sets for an AI/ML device.

Here's why the information is not present based on the provided text:

• Acceptance Criteria and Reported Device Performance (1): The submission focuses on substantial equivalence to predicate devices, meaning its performance is considered acceptable if it is similar to those already on the market. There are no explicit acceptance criteria or a quantitative performance table mentioned.
• Sample Size, Data Provenance (2): No new clinical study data with test sets, sample sizes, or data provenance is presented. The argument is based on the similarity of the device's technological characteristics and intended use to existing devices.
• Experts, Qualifications, Adjudication (3, 4): These details are relevant for studies establishing ground truth, which is not the primary mechanism of this 510(k) submission.
• MRMC Study (5): The submission does not mention an MRMC study or any assessment of human reader improvement with AI assistance, as the device is a laser system, not an AI-assisted diagnostic tool.
• Standalone Performance (6): Similar to the above, this concept applies to AI/ML devices, not a laser system.
• Type of Ground Truth (7): Ground truth is not established in this context as new clinical validation is not the basis of the submission.
• Training Set Sample Size/Ground Truth (8, 9): These concepts are applicable to AI/ML model development. This submission is for a physical medical device (laser system), not an AI algorithm.

In summary, the provided 510(k) summary focuses on demonstrating that the "Profile 1064 Laser System" is substantially equivalent to other legally marketed Nd:YAG laser systems based on shared indications for use and technological characteristics. It is not a report of a study designed to establish new performance criteria or to validate an AI/ML algorithm against a ground truth dataset.

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The Acme Medical Aesthetic Nd: YAG Laser is intended for dermatologic use. The 1064nm wavelength, long pulse duration, and large spot size of the Acme Medical Aesthetic Nd: YAG Laser allows for effective coagulation and hemostasis of vascular lesions. The laser system consists of a laser console and a delivery handpiece. The delivery handpiece is placed in contact with the target via a contact tip that is capable of cooling the epidermis. Clinical use of the device is indicated for clinical practitioners in plastic surgery and dermatology who have been technically trained on the use of the Acme Medical Aesthetic Nd: YAG Laser.
For coagulation and hemostasis of vascular lesions.

The Acme Medical Nd:YAG Aesthetic Laser is a long pulsed, solid-state infrared laser. It is intended to deliver laser energy for use in surgical applications requiring coagulation and hemostasis of vascular lesions. The Aesthetic Nd: YAG Laser produces a beam of infrared light at a wavelength of 1064nm. The system consists of:

• a laser console; .
• internal computer; .
• control and display panel; .
• permanently attached fiber optic delivery system; .
• handswitch with the option of a footswitch; and .
• fiber optic coupled handpiece and tip with cooling capability. .

The provided document is a 510(k) Summary Statement for the Acme Medical Nd:YAG Aesthetic Laser. It indicates that no performance data was submitted in conjunction with this Pre-market Notification submission. The determination of substantial equivalence was based solely on the comparison of technical and functional characteristics between the Acme Medical Aesthetic Nd:YAG Laser and predicate lasers. Therefore, the document explicitly states that performance data was not required.

This means that the document does not contain information about acceptance criteria or a study proving the device meets those criteria.

To specifically address the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not available. The document states, "No performance data was submitted in conjunction with this Premarket Notification submission."
2. Sample size used for the test set and the data provenance: No test set was used as no performance data was submitted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set was used and no performance data was submitted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no test set was used and no performance data was submitted.
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: Not applicable. This device is a laser, not an AI-assisted diagnostic tool, and no performance studies were conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a laser, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no performance data was submitted.
8. The sample size for the training set: Not applicable, as no performance data or algorithm training was relevant for this type of device submission.
9. How the ground truth for the training set was established: Not applicable.

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