Search Results

The Picasso Plus / Picasso Lite Plus is generally indicated for incision, excision, vaporization, ablation and coagulation of oral soft tissues including the following: Gingival troughing for crown impression; Gingivectomy; Gingivoplasty; Gingival incision and excision; Hemostasis and coagulation; Excisional and incisional biopsies; Exposure of unerupted teeth; Fibroma removal; Frenectomy and frenotomy; Implant recovery; Incision and drainage of abscess; Leukoplakia; Operculectomy; Oral papillectomies; Pulpotomy; Pulpotomy as an adjunct to root canal therapy; Reduction of gingival hypertrophy; Soft tissue crown lengthening; Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa; and Vestibuloplasty.
Laser Periodontal Procedures, including: Sulcular debridement (curettage, removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including: gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility); Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium; and Picasso assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium).
Teeth Whitening Indications (Picasso Plus Only): Laser assisted whitening of teeth and Light activation for whitening materials for teeth whitening.

The Picasso line of soft tissue dental lasers is designed for a wide variety of oral soft tissue surgical, non-surgical, and teeth whitening procedures. Picasso Plus and Picasso Lite Plus lasers employ semiconductor diodes as a laser energy source. The energy is delivered to the operating area by means of a delivery system consisting of a flexible fiber connecting the laser source and the handpiece. The laser delivery used may be in the form of strippable fiber or a multi-tip handpiece that is used in conjunction with disposable tips. The device is activated by means of a wireless footswitch.

The provided text describes a 510(k) premarket notification for the Picasso Plus and Picasso Lite Plus laser surgical instruments. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical trials or extensive performance studies with specific acceptance criteria that would typically be associated with a PMA (Premarket Approval) submission for novel devices.

Therefore, the document does not contain the following information typically expected when asked to "describe the acceptance criteria and the study that proves the device meets the acceptance criteria":

• A table of acceptance criteria and reported device performance (in terms of clinical outcomes or diagnostic accuracy).
• Sample sizes used for a test set, data provenance, number of experts, adjudication methods, MRMC studies, or standalone performance results in a clinical context.
• Ground truth details (pathology, outcomes data, etc.) for a test set.
• Details about a training set or how its ground truth was established.

Instead, the document focuses on demonstrating substantial equivalence based on:

• Identical Indications for Use: The devices are indicated for the same oral soft tissue procedures and teeth whitening (for Picasso Plus).
• Identical Fundamental Scientific Technology: Both the proposed and predicate devices use semiconductor diodes as a laser energy source, with energy delivered via a flexible fiber to a handpiece, and activated by a wireless footswitch.
• Similar Design Features, Functional, and Performance Characteristics: This includes identical wavelength, operating controls, laser delivery method, control systems, safety features, operation, power output, and energy type.
• Compliance with Relevant Federal and International Safety and Performance Standards: The document states that the devices are designed to comply with these standards, implying that engineering and safety tests were conducted, but specific acceptance criteria or results from these tests are not detailed for external review in this summary.

The study that "proves the device meets the acceptance criteria" in this context is the comparison to the predicate devices (Picasso and Picasso Lite) and the internal testing to ensure compliance with standards. The "acceptance criteria" here are largely met by demonstrating that the new devices are essentially the same as the already cleared predicate devices, with only minor design changes aimed at improving functionality and user experience, and without raising new issues of safety or effectiveness.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the 510(k) summary):

In summary, for a 510(k) submission like this, the "study" is the comprehensive comparison to the predicate device and the "acceptance criteria" are met by demonstrating that the new device does not differ significantly in terms of technology, performance, and safety from an already cleared device for the same intended use.

This document does not provide details on:

• Sample sizes for test sets, data provenance, expert qualifications, or adjudication methods for clinical studies.
• MRMC comparative effectiveness studies.
• Standalone algorithm performance (as this is a medical device, not an AI algorithm in the typical sense implied by the question).
• Details about a training set or ground truth for such a set.

Ask a specific question about this device