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The Dynamis Pro Family and its accessories will have the same intended use as predicate device and will be marketed for the following indications for use:

Er: YAG laser (2940 nm wavelength):
The Dynamis Er:YAG laser is intended for surgical incision/excision, cutting ablation, vaporization and coagulation of soft and hard tissue. 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 and Plastic Surgery Indications: Epidermal nevi, actinic cheilitis, verrucae, skin tags, keratoses and soft tissue resurfacing;
• Soft tissue resurfacing with S22 and S22-T scanner;
• ENT Surgery Indications: ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia;
• Oral/Maxillofacial Indications: Oral and glossal lesions;
• Uvulopalatoplasty by laser resurfacing
• Ophtalmology Indications: Soft tissue surrounding the eye;
• Intra-oral soft tissue incision, excision, ablation, coagulation
• 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 is necessary:
• Gynecology Indications: Herpes simplex, endometrial adhesion, CIN (Cervical intraepithelial neoplasia), cysts, condiloma;
• Genitourinary Indications: lesions of the external genitalia, urethra and anus, penis, scrotum and urethra, vulvar lesions, polyps and familial polyps of the colon;
• Podiatry Indications: Warts, plantar verrucae, large mosaic verrucae, matrixectomy;
• The Fotona F-22 Handpiece is intended for:
• In fractionated mode:
  Dermatological procedures requiring resurfacing of soft tissue with fractionated handpiece;
• In non-fractionated mode:
• 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 is necessary;
• The Fotona FS-01 and X-Restart Handpieces are intended for:
• Dermatological procedures requiring resurfacing of soft tissue with fractionated handpiece;

Nd:YAG laser (1064 nm wavelength):
The Dynamis Nd:YAG laser is intended for incision, vaporization coagulation and hemostasis of vascular lesions and soft tissue in various dermatological and surgical areas, and for permanent reduction of unwanted hair in Fitzpatrick skin types I - VI.

• Surgical incison, excision, vaporization, ablation and coagulation of soft tissue. All soft tissue is included, striated and smooth tissue, muscle, cartilage, mucous membrane, lymph vessels and nodes, organs and glands, fibroma removal, frenectomy and frenotomy;
• Treatment of Aphthous Ulcers;
• Excision and Vaporization of Herpex Simplex I and II;
• Laser assisted uvulopalatoplasty (LAUP);
• Laser assisted lipolysis;
• Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number if hair regrowing when measured at 6, 9 and 12 months after the completion of a treament regime;
• Treatment of wrinkles;
• Treatment of wrinkles with S11 scanner;
• Treatment of mild to moderate inflammatory acne vulgaris;
• Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins;
• Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
• Matrixectomy
• Radical nail excision
• Periungual and subungual warts
• Plantar warts
• Neuromas
• Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)
• Endo Venous Laser Therapy of superficial incompetent tributary veins associated with varicose veins and varicosities.

Nd:YAG laser (1064 nm wavelength) therapy:

• Temporary relief of muscle and joint pain and stiffness, arthritis pain or muscle spasm, temporary increase in local blood circulation and/or promoting relaxation of muscle.

The Dynamis Pro Family is based on Er:YAG (2940 nm) and Nd:YAG (1064 nm) laser technology. The laser unit and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. The unit combines two flashlamppumped laser sources in one housing, with optical cavities containing the Er: Y AG and Nd: Y AG crystals. A red diode aiming beam (650 nm) is combined with both therapeutic laser beams. The combined therapeutic and aiming beams are guided through an articulated arm to an optical manual or scanner handpiece (in the case of the Er:YAG laser), or through an optical fiber delivery system to an optical manual or scanner handpiece (in the case of the Nd:YAG laser). Optionally, the Nd:YAG therapeutic and aiming laser beams can be guided through a fiber having a connector on the proximal end and a bare fiber on the distal end. The Dynamis Pro Family is designed to operate in single wavelength (Nd: YAG or Er.Y AG) configurations (models) and dual wavelength (Nd: Y AG and Er: Y AG) configurations (models).

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:

The document provided (K213267) is a 510(k) summary for the Fotona Dynamis Pro Family laser system. It focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a performance study with explicit acceptance criteria for a new AI/software feature.

Therefore, many of the requested categories (e.g., sample size, expert qualifications, adjudication, MRMC study, training set details) are not applicable because this submission is for a physical medical device (laser) and not an AI or software as a medical device (SaMD) that typically undergoes such performance evaluations.

The "acceptance criteria" discussed in this document are primarily related to compliance with recognized standards for medical electrical equipment, laser safety, usability, and risk management, which are typical for hardware medical devices. The "study" proving acceptance is thus a compilation of verification and validation (V&V) tests performed to demonstrate adherence to these standards and the equivalence of the device's technological characteristics to its predicates.

Acceptance Criteria and Device Performance (Based on provided text)

1. Table of Acceptance Criteria and Reported Device Performance

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

• N/A. This submission does not involve an AI/software performance study with a 'test set' of clinical data in the traditional sense. The "tests" refer to engineering verification and validation testing for hardware and software compliance with standards.

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

• N/A. As above, no clinical "ground truth" establishment by experts is described for a performance study. "Experts" involved would be engineers and quality assurance personnel performing the V&V tests, and potentially clinical representatives verifying usability, but these are not specified in the document in the context of establishing a truth set.

4. Adjudication method for the test set:

• N/A. No adjudication method 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:

• No. This is not an AI-assisted device, so an MRMC study is not relevant and was not performed.

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

• N/A. This is a hardware laser device, not a standalone algorithm.

7. The type of ground truth used:

• N/A. For this type of device, the "ground truth" for the V&V tests often involves:
  • Compliance with specified engineering requirements (e.g., laser power output must be within X% of setting).
  • Adherence to recognized industry standards (e.g., IEC, ISO).
  • Functional performance as per design specifications (e.g., beam delivery, pulse characteristics).
  • Equivalence to predicate device capabilities.

8. The sample size for the training set:

• N/A. No training set for an AI/ML model is involved.

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

• N/A. No training set or associated ground truth establishment is relevant to this submission.

In summary, the provided document K213267 is a regulatory submission for a traditional medical laser system seeking substantial equivalence. It demonstrates compliance with general medical device regulations and specific standards for laser devices through non-clinical testing and comparison to predicates, rather than through clinical performance studies typically seen for diagnostic devices or AI/SaMD.

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