Search Results

The SunLase 800P laser device is to provide the ability to perform intraoral soft tissue dental, general, oral maxillo-facial and cosmetic surgery. The device is indicated for ablating, incising, excising, vaporization and coagulation of soft tissues using a contact, fiber-optic delivery system. The device will be used in the following areas: general and cosmetic dentistry, otolaryngology, oral surgery. The following are the oropharangeal indications for use for which the device will be marketed:

• Excisional and incisional biopsies
• Excision and vaporization of herpes simplex I and II
• Exposure of unerupted teeth
• Fibroma removal
• Frenectomy and Frenotomy
• Gingival troughing for crown impressions
• Gingivectomy
• Gingivoplasty
• Gingival incision and excision
• Hemostasis
• Implant recovery
• Incision and drainage of abscess
• Laser Assisted Uvulopaletoplasty (LAUP)
• This laser is effective for cutting, ablating, coagulating and removing oropharangeal soft tissue that has been diagnosed as anatomically abnormal or naturally occurring hypertrophic which has been identified and confirmed as being associated with chronic palatal snoring.
• Leukoplakia
• Operculectomy
• Oral Papillectomies
• Pulpotomy and Pulpotomy as an adjunct to root canal therapy
• Reduction of denture hyperplasia
• Reduction of gingival hypertrophy
• Reduction of filling material such as gutta percha or resin as adjunct treatment during root canal therapy
• Removal of post-surgical granulations
• Selective ablation of enamel (First Degree Caries Removal)
• Soft tissue crown lengthening
• Sulcular debridement or soft tissue curettage (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss, and tooth mobility)
• Tissue retraction for impression
• Treatment of Apthous ulcers
• Vestibuloplasty

The laser device produces an invisible treatment beam for surgery and a visible aiming beam. The pulsed Nd:YAG treatment beam is an invisible beam of light (1064 nanometer wavelength); a Helium-Neon (HeNe) laser within the laser head console supplies the red aiming beam. The laser energy is developed inside an optical resonant cavity. A crystal rod of neodymium-doped Yttrium Aluminum Garnet (pulsed Nd:YAG) is placed between two mirrors. The rod is "pumped" by a flashlamp that excites the Neodymium ions in the YAG crystal. Once excited, stimulated emission of photons occurs. Laser energy exits the cavity through a partially transmitting mirror and enters the distal end of the contact fiber-optic cable at the aperture. The laser energy is transmitted though the fiber-optic cable and exits the proximal tip of the fiber. The device is controlled by microprocessor via keyboard access by the operator, which allows various settings for energy levels, pulse widths and repetition rates. Software controls preclude emission of laser energy in any of a number of fault conditions.

The provided text describes a medical device, the SunLase 800P Dental Laser (also marketed as PocketPro or PocketPro S4), and its intended uses. It is a 510(k) premarket notification and primarily focuses on establishing substantial equivalence to predicate devices, rather than detailing a specific study to prove the device meets acceptance criteria.

Therefore, many of the requested elements for describing an acceptance criteria study, such as sample sizes, expert qualifications, adjudication methods, and details about training/test sets, are not explicitly present in the provided document.

However, I can extract information related to the device description, its indications for use (which act as a form of acceptance criteria in regulatory submissions), and the rationale for its approval.

Here's a breakdown of the available information in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this 510(k) submission are implicitly defined by the "Indications for Use" and the device's ability to perform these functions substantially equivalently to predicate devices. The "reported device performance" is essentially that it can perform these specified functions.

• Excisional and incisional biopsies
• Excision and vaporization of herpes simplex I and II
• Exposure of unerupted teeth
• Fibroma removal
• Frenectomy and Frenotomy
• Gingival troughing for crown impressions
• Gingivectomy
• Gingivoplasty
• Gingival incision and excision
• Hemostasis
• Implant recovery
• Incision and drainage of abscess
• Laser Assisted Uvulopaletoplasty (LAUP) for cutting, ablating, coagulating and removing anatomically abnormal or naturally occurring hypertrophic oropharyngeal soft tissue associated with chronic palatal snoring.
• Leukoplakia
• Operculectomy
• Oral Papillectomies
• Pulpotomy and Pulpotomy as an adjunct to root canal therapy
• Reduction of denture hyperplasia
• Reduction of gingival hypertrophy
• Removal of filling material (gutta percha or resin) as adjunct treatment during root canal therapy
• Removal of post-surgical granulations
• Selective ablation of enamel (First Degree Caries Removal)
• Soft tissue crown lengthening
• Sulcular debridement or soft tissue curettage (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss, and tooth mobility)
• Tissue retraction for impression
• Treatment of Apthous ulcers
• Vestibuloplasty | The device is indicated for and effectively used in these procedures, with the rationale that its technology and tissue effects are substantially equivalent to legally marketed predicate devices for these applications. |
  | Safety: Software controls preclude emission of laser energy in a number of fault conditions. | Not explicitly quantified in terms of specific performance metrics, but presented as a design feature for safety. |

2. Sample size used for the test set and the data provenance

Not applicable/Not provided. The document is a 510(k) notification, which primarily relies on substantial equivalence to predicate devices rather than a de novo clinical study with a detailed test set. The approval is based on the argument that the SunLase 800P is "based on the same technology" and that its operational technology differs "only by source of emission, pulse rate, and wavelength" from predicate devices. It states, "Tissue effects by predicate Nd. YAG and diode devices exhibit identical physical characteristics." This suggests a reliance on existing knowledge and effects of similar devices, rather than a specific test set of cases.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided. As there is no described test set or clinical study to establish ground truth in the traditional sense, information on experts is not part of this document. The "ground truth" for this application is essentially the established clinical utility and safety of the predicate devices.

4. Adjudication method for the test set

Not applicable/Not provided. No test set or clinical study 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

Not applicable/Not provided. This is a hardware device (laser) and the submission does not involve AI or human "readers."

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

Not applicable/Not provided. This is a physical laser device, not an algorithm. Its operation inherently involves a human operator.

7. The type of ground truth used

The "ground truth" for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices for the specified indications. The applicant argues that the SunLase 800P is substantially equivalent to these predicates due to similar technology, operational characteristics, and identical physical characteristics of tissue effects.

8. The sample size for the training set

Not applicable/Not provided. There is no mention of a "training set" as this is not a machine learning or AI device. The device's design and functionality are based on established laser technology.

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

Not applicable/Not provided. As there is no training set in the context of this device, this question is not relevant to the provided text.

Ask a specific question about this device