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The Fotona Fidelis Er.YAG Laser System and Accessories are intended for surgical incision/excision, cutting, ablation, vaporization, and coagulation of soft tissue. All soft tissue is included, such as, skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, lymph vessels and nodes, organs, and glands

DermatologyPlastic Surgery : epidermal nevi, telangiectasia, spider veins, actinic chellitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision (including acne scars), debulking benign tumors and cysts, skin resurfacing, superficial skin lesions, and performing diagnostic biopsies.

General Surgery : surgical incision/excision, cutting, ablation, vaporization, and coagulation of soft tissue where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coagulation may be indicated

Genitourinary : lesions of the external genitalia, urethra and anus, penis, scrotum and urethra, vulvar lesions, polyps and familial polyps of the colon

Gynecology : cerivecal intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma

Oral Surgery : benign oral tumors, oral and glossal lesions and gingivottomy, gingivoplasty, frenectomy, sulcular debridement - removal of diseased or inflamed soft tissue in the periodontal pocket

Otorhinolaryngology(Head and Neck (ENT) : ear, nose and throat lesions, polyps, cysts, lyperkeratosis, excision of carcinogenic tissue and oral leukoplakia

Ophthalmology : soft tissue surrounding the eye and orbit anterior capsulotomy

Podiatry : warts, plantar verrucae, large mosaic verrucae and matrixectomy

The Fotona Fidelis system is based on Er: YAG laser technology. Within the system, an optical cavity contains the Er: YAG crystal, which is activated by means of the use of flashlamps. After the cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapuetic and aiming beams are guided down an articulated arm delivery system to a focusing handpiece. The laser is used in non-contact mode.

The System is capable of emitting up to 1.0 J of pulsed light at 2.94 um. This light has a pulsewidth which varies in the range 75 - 950 us. The laser is intended to be used for surgical incision/excision, cutting, ablation, vaporization, and coagulation of soft 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.

The Fidelis system is designed with 5 major sub-systems:

a) A high voltage power supply which converts and rectifies the a.c. mains current to provide regulated power for the flashlamp simmer current and main triggering pulse.

b) A cooling system consisting of an internal water flow circuit together with water-to-air heat exchanger.

c) An Er: Y AG laser rod, capable of generating 1.0 J optical pulses at a frequency up to 50 Hz.

d) An optical delivery system, interfacing the energy from the laser to the patient via an articulated arm and focusing handpiece.

e) The microprocessor based controller which regulates the functions of the laser and allows parameter selection by the user.

Accessories available for use with Fotona SkinPlus:

· Fotona SkinScan Scanning Device (K970757)

The provided text describes the Fotona Fidelis Er:YAG Laser System and its substantial equivalence to predicate devices, but it does not contain information regarding specific acceptance criteria for performance, a study proving device performance against those criteria, or details regarding ground truth establishment, sample sizes for test/training sets, expert qualifications, or adjudication methods.

Instead, the document is a 510(k) premarket notification approval by the FDA, which focuses on demonstrating substantial equivalence to already legally marketed devices. The core of this submission is a comparison of the new device (Fotona Fidelis) to existing predicate devices (Laserscope Venus and Vela Erbium Laser Systems) based on their technological characteristics and intended use.

Here's a breakdown of what is and isn't present:

Information NOT Found in the Document:

1. A table of acceptance criteria and the reported device performance: This document does not specify quantitative performance metrics or acceptance thresholds for the Fotona Fidelis system (e.g., specific cutting speed, ablation depth, or coagulation efficacy values).
2. Sample sizes used for the test set and the data provenance: There is no mention of a test set, clinical trial, or any patient data used to evaluate the device's performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: As no test set performance is discussed, ground truth establishment is not relevant in this document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as no test set data is presented.
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: This is a laser system, not an AI-assisted diagnostic device, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable as it's a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no clinical performance data is presented.
8. The sample size for the training set: Not applicable as no machine learning algorithm "training" is described.
9. How the ground truth for the training set was established: Not applicable.

Summary of the Document's Content Regarding Device Evaluation:

The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a new performance study with specific acceptance criteria.

The key arguments for substantial equivalence are:

• Intended Use: The Fotona Fidelis system has the same intended use as the predicate devices (Laserscope Venus and Vela Erbium Laser Systems): "surgical incision/excision, cutting, ablation, vaporization, and coagulation of soft 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."
• Technological Characteristics: The Fotona Fidelis has "identical characteristics" to the predicate devices, all of which are flashlamp-pumped Er:YAG lasers generating light at 2.94 um, delivered via an articulated arm and focusing handpiece.
• Performance Comparison (Implicit): While no specific acceptance criteria are listed, the document states: "The Laserscope Venus Erbium Laser System has the ability to deliver laser energy at 2.94 microns, maximum power of 20 watts at repetition rate of up to 20 Hz. These characteristics are very similar to the Fotona Fidelis Erbium Laser System." This implicitly suggests that matching the power and repetition rate of the predicate device is a key performance characteristic considered for equivalence.
• Safety and Effectiveness: "The risk and benefits for the Fotona Fidelis are comparable to the Laserscope Venus and Vela when used for similar clinical applications." The conclusion is that "there are no new questions of Safety or Effectiveness raised by the introduction of this device."

In essence, the "study" demonstrating the device meets "acceptance criteria" is the comparison to predicate devices, showing that it performs similarly to devices already approved for market, rather than a novel clinical trial against predefined performance thresholds. The FDA's approval letter (K990243) explicitly states the device is "substantially equivalent."

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