Search Results

The FotonA Dualis "KTP laser is intended for incision, ablation, vaporization, coacjulation, and hemostasis of vascular lesions and soft tissue in vanous surgical areas. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands. Dermatology : The treatment (hemostasis, color lightening, flattening, reduction of lesion size) of the vascular lesions (Angiomas, Hemangiomas, Telangiectasia). The Fotona Dualis Er:YAG laser is intended for surgical incision/excision, variorization and coaqulation of soft and hard tissue. All soft tissue is included, such as skin, subcutaneous tissue, striated and smooth tissue, cartilage meniscus, mucous membrane, lymplı vessels and nodes, organs and glands. Dermatology an Plastic Surgery Indications: Epidermal nevi, telangiectasias, spider veins, actinic sheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, decubitis ulcers, and skin resurfacing. ENT Surgery Indications: ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia Gynecology Indications: Herpes simplex, endomaterial adhesion, CIN (Cervical intraepithelial neoplasia), cysts, and condiloma. General Surgery Indications: Surgical incision/excision, vaporization and coagulation of soft tissue during any general surgery application where skin incision, tissue dissection, excision of lesions, complete or partial resection of internal organs, lesions, tissue ablation and vessel coagulation. Oral/Maxillofacial Indications: Oral and glossal lesions and gingivectorny Ophtalmology Indications: Soft tissue surrounding the eye and orbit and anterior capsulotomy Podiatry Indications: Warts, plantar verrucae, large mosaic verrucae and matrixectomy Dentistry indications: Caries removal, cavity preparation, enamel etching

The Fotona Dualis " laser system is based on the Er: YAG (2940 nm) and KTP (532 nm) laser technology. It is modification to combine two lasers into one housing. The unmodified devices are the Fotona Fidelis Er:YAG laser and the Fotona Dualis " KTP laser system. There are two optical cavities containing the KTP and Er:Y.AG crystals, Both are activated by means of the use of flashlamps. After each cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided: - In case of the KTP laser through an optical fiber delivery system to a focusing . handpiece. - . In case of the Er: Y AG laser through articulated arm to a focusing handpiece. Both lasers share a common power supply, control system, and cooling system. The internal computer can be directed to select either the Er.YAG laser source or the KTP laser source. When the laser is first turned on the physician is able to select the desired wavelength via control panel.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

Acceptance Criteria and Device Performance

The provided document (a 510(k) premarket notification) does not define specific, quantifiable acceptance criteria in the typical sense (e.g., minimum sensitivity, specificity, or accuracy levels). Instead, the core acceptance criterion for the Fotona Dualis® Er:YAG/KTP Laser System is "Substantial Equivalence" to previously cleared predicate devices.

Table of Acceptance Criteria and Reported Device Performance:

• Fotona DualisVP long pulse KTP laser system
• Fotona Fidelis Er:YAG laser system | Fotona believes its Dualis® laser system is substantially equivalent because:
• Intended Use: The Fotona Dualis®'s intended uses for both KTP and Er:YAG lasers are the same as those of their respective predicate devices.
• Design Features: Shares the same design features (wavelength, active medium, cooling system, power supply, beam deliveries, controls, housing) as the predicate devices.
• Output Characteristics: The output characteristics are the same as those of the predicate devices.
• Risk and Benefits: Risk and benefits for the Dualis® laser system are comparable to the predicate devices when used for similar clinical applications.
  Conclusion: "It is therefore believed that there are no new questions of Safety or Effectiveness raised by the introduction of the Dualis® Er:YAG/KTP laser system." The FDA's letter concurs with this finding of substantial equivalence. |

Study Information:

Based on the provided document, the "study" conducted to demonstrate substantial equivalence is a comparative analysis of the new device's technical specifications and intended use against those of legally marketed predicate devices, rather than a clinical trial with performance metrics.

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Sample Size: Not applicable. This submission relies on a comparison to existing devices, not a new clinical trial with a defined "test set" of patient data.
   • Data Provenance: Not applicable. No new patient data was generated or analyzed for this 510(k) submission. The provenance would refer to the data supporting the predicate devices' clearances, which is not detailed here.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

   • Not applicable. There was no "test set" requiring ground truth established by experts in the context of a performance study. The "ground truth" here is the established safety and effectiveness of the predicate devices as determined by their previous clearances.

3. Adjudication Method for the Test Set:

   • Not applicable. No "test set" or adjudication of results was performed. The regulatory body (FDA) reviewed the manufacturer's comparison to predicate devices.

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 is a laser surgical instrument, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • No. This is a medical device (laser system), not an algorithm. Therefore, "standalone" algorithm performance is not relevant.

6. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for this substantial equivalence determination is the regulatory clearance and established safety and effectiveness of the predicate devices as proven through their own previous regulatory filings and real-world clinical use.

7. The Sample Size for the Training Set:

   • Not applicable. This submission does not involve machine learning or AI, and therefore no "training set" in that context. The "training" for this device's design and manufacturing would come from established engineering principles and data from the predicate devices.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as there is no "training set" in the machine learning sense. The "ground truth" related to the device's development is rooted in the proven design, performance, and safety of its predicate laser systems, which were themselves cleared based on their own data and clinical experience.

Ask a specific question about this device