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The Fotona 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;

· ENT Surgery Indications: ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia;

· Oral/Maxillofacial Indications: Oral and glossal lesions;

· 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 Handpiece is intended for:

• Dermatological procedures requiring resurfacing of soft tissue with fractionated handpiece;

Dynamis Nd:YAG laser (1064 nm wavelength):

The Fotona Dynamis Nd: YAG laser is intended for incision, ablation, 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, meniscus, 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 uvulopaletoplasty (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 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: o Matrixectomy o Radical nail excision o Periungual and subungual warts o Plantar warts o Neuromas o 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.

The Fotona Dynamis Pro Laser System 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 flashlamp-pumped laser sources in one housing, with optical cavities containing the Er: YAG and Nd: YAG 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 hand piece (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: Y AG 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. Fotona's power supply Variable Square Pulse (VSP) Technology, integrated into the laser system, allows control of the laser energy and the laser pulse duration. The user activates laser emission by means of a footswitch.

The Fotona Dynamis Pro Family is designed to operate in single wavelength (Nd:Y AG or Er: Y AG) configurations (models) and dual wavelength (Nd: Y AG and Er: Y AG) configurations (models).

The provided document describes the Fotona Dynamis Pro Family laser system, a medical device for surgical procedures. It seeks to establish substantial equivalence to previously cleared predicate devices rather than present a study with specific acceptance criteria and performance data for a new, AI-driven diagnostic or prognostic device.

Therefore, the requested information for acceptance criteria and a study proving device performance (including sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) is not directly available in this document. This document is a 510(k) premarket notification for a laser surgical instrument, which typically relies on demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, rather than requiring extensive clinical performance studies with acceptance criteria in the way an AI diagnostic tool would.

Here's a breakdown of what can be extracted or inferred based on the document's nature:

1. A table of acceptance criteria and the reported device performance:

This document does not present specific acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, AUC) or a detailed clinical study comparing the device to a gold standard with predefined thresholds. Instead, the "acceptance criteria" are implied by substantial equivalence to predicate devices. The "reported device performance" is largely framed by its technical specifications matching or being similar to those of its predicates for similar intended uses.

No specific study with acceptance criteria for diagnostic/AI performance is described. The "study" mentioned is laboratory testing to validate and verify that the proposed device meets design specifications and is substantially equivalent to predicate devices. This type of testing focuses on engineering performance and safety, not clinical efficacy in a comparative AI context.

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

• Not applicable. This isn't a diagnostic device using a test set of patient data. The "testing" involved laboratory verification and validation against design specifications and relevant standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

• Not applicable. No ground truth for a test set of patient data was established or used as this is a surgical laser device not an AI diagnostic tool.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. No test set requiring expert adjudication was used.

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. This device is a laser surgical instrument, not an AI-assisted diagnostic tool. No human reader performance, with or without AI, is relevant to its substantial equivalence determination.

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

• Not applicable. This device is hardware (a laser system), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable. For this type of device, the "ground truth" relates to its adherence to technical specifications, safety standards, and functional equivalence to its predicate devices, rather than a clinical ground truth like pathology or outcomes data in the context of an AI diagnostic study.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable. No training set was used.

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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, 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 Handpiece is intended for:
Dermatological procedures requiring resurfacing of soft tissue with fractionated handpiece.

The F-22 Handpiece and FS-01 Handpiece each attach to the Dynamis Er: Y AG/Nd: YAG Laser Systems. The Fotona Dynamis Family is based on Er:YAG (2940 nm) and Nd:YAG (1064 nm) laser technology. The F-22 handpiece and FS-01 handpiece are designed to be used with the Er:YAG (2940 nm) laser wavelength only. The laser system console consists of a flashlamp pumped Er: YAG laser source, power supply, water colling unit, electronics, and a footswitch. Electrical power is supplied to the console by the facility's power source. A red diode aiming beam (650 nm) is combined with the therapeutic Er:YAG laser beam. The combined therapeutic and aiming beams are guided through an articulated arm to an optical manual or scanner hand piece (in the case of the Er:YAG laser). Fotona's power supply and electronics, integrated into the laser system, allows control of the laser energy and the laser pulse duration. The user activates laser emission by means of a footswitch.

This document describes the regulatory submission for the Fotona F-22 Laser Handpiece and Fotona FS-01 Laser Handpiece. It does not contain information about the acceptance criteria or a specific study proving the device meets those criteria in the typical sense of a clinical trial with predefined performance metrics.

Instead, the submission focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices. This means that the new devices are considered safe and effective because they are similar in design, technological characteristics, and intended use to devices already cleared by the FDA.

Therefore, many of the requested categories of information cannot be directly extracted from the provided text in the traditional way an AI model's performance study might be described. However, I will address what information is available and highlight what is not.

Acceptance Criteria and Device Performance

There are no explicit "acceptance criteria" presented in the document in the format of performance thresholds (e.g., sensitivity, specificity, accuracy). Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices, which implies that the new handpieces perform comparably to established devices already deemed safe and effective.

The "reported device performance" is primarily characterized by its technological specifications matching or being similar to the predicate devices, and a general statement about a clinical and histological study.

• Dermatological procedures requiring resurfacing of soft tissue with fractionated handpiece.
• (F-22 only, non-fractionated) General Surgery Indications: Surgical incision, vaporization and coagulation of soft tissue. |
  | Safety and Standards Compliance: Adherence to relevant IEC and CFR standards. | Fotona F-22 and FS-01 handpieces are designed, tested, and will be manufactured in accordance with standards including 21 CFR 1040.10, 1040.11, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-1-6, IEC 60601-2-22, IEC 60825-1, EN 62304, ISO 17664. |

Study Details (Based on the provided text)

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

   • The document mentions a "clinical and histological study" but does not specify the sample size for human subjects or histology samples.
   • There is no information about data provenance (e.g., country of origin, retrospective/prospective).
   • A "test set" in the context of an AI model's performance is not directly applicable here. This is a medical device submission, not specifically an AI model submission. The "testing" refers to device validation and verification.

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

   • This information is not provided. The "ground truth" for a laser device would typically relate to the biological effect (e.g., tissue ablation, resurfacing), which is assessed by medical professionals. The document mentions a "clinical and histological study" to demonstrate benefits, implying expert assessment, but gives no specifics on the number or qualifications of clinicians/pathologists.

3. Adjudication method for the test set:

   • This information is not provided.

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 MRMC comparative effectiveness study is mentioned. This is a laser handpiece, not an AI diagnostic or assistive tool, so such a study design is unlikely to be performed for this device type.

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

   • This question is not applicable. This is a physical laser handpiece, not a software algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The document states "A clinical and histological study... has been performed to demonstrate the benefits of dermatological procedures requiring resurfacing and ablation of soft tissue with the fractionated handpieces."
   • This suggests that histology (pathology) and clinical observation/outcomes were used to assess the "benefits."

7. The sample size for the training set:

   • This question is not applicable as this is a medical device, not an AI model requiring a "training set."

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

   • This question is not applicable as this is a medical device, not an AI model requiring a "training set."

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Er:YAG laser (2940 nm wavelength) in dentistry:
Intra-oral soft tissue surgery (incision, excision, ablation coagulation)

• Leukoplakia
• Pulpotomy as adjunct to root canal retreatment
• Pulp extirpation
• Removal of fibromae
• Removal of granulated tissue
• Caries removal, cavity preparation, enamel roughening -Sulcular debridement
• Tooth preparation to obtain access to root canal, root canal debridement and cleaning, root canal preparation including enlargement
• Cutting, shaving, contouring and resection of oral osseous tissue (bone)
• Osteotomy, osseous crown lengthening, osteoplasty
• Apicectomy surgery
• Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curetage

Er:YAG laser (2940 nm wavelength) in dermatology and other surgical areas:

• Dermatology and Plastic Surgery Indications: Epidermal nevi, actinic cheilitis, verrucae, skin tags, keratoses and skin resurfacing;
• ENT Surgery Indications: ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia;
• Oral/Maxillofacial Indications: Oral and glossal lesions, gingivectorny;
• 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;
• Podiatry Indications: Warts, plantar verrucae, large mosaic verrucae, matrixectorny;
• Ophthalmology Indications: Soft tissue surrounding the eye;
• Gynecology Indications: Herpes simplex, endometrial adhesion, CIN (Cervical intraepithelial neoplasia), cysts, condiloma;

Nd:YAG laser (1064 nm wavelength) in dentistry:

• 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)
• 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 such as gutta percha or resin as adjunct treatment during root canal therapy
• Removal of post-surgical granulations
  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 aphtous ulcers
  Vestibuloplasty

Nd: YAG laser (1064 nm wavelength) in dermatology and other surgical areas:

• 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 of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
  Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemaongiomae, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins
  Treatment of wrinkles
  Treatment of mild to moderate inflammatory acne vulgaris
  General surgery indications: surgical incision, excision, vaporization and coagulation of soft tissue. All soft tissue is included, striated and smooth tissue, muscle, cartillage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands, fibroma removal.
  Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: Matrixectomy
  Periungual and subungual warts
  Plantar warts
  Radical nail excision
  Neuromas
  The Fotona Light Walker Laser System Family is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T mentagrophytes, and/or yeasts Candida albicans, etc.).

The Fotona Light Walker Laser System 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 flashlamp-pumped laser sources in one housing, with optical cavities containing the Er: YAG and Nd: YAG 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 hand piece (in the case of the Er: YAG laser), or through an optical fiber delivery system to an optical manual or scanner hand piece (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. Fotona's power supply Variable Square Pulse (VSP) Technology, integrated into the laser system, allows control of the laser pulse duration. The user activates laser emission by means of a footswitch.

This submission is a 510(k) Pre-Market Notification, which focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a performance study against specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment for a performance study is not available in this document.

The document states: "The Fotona LightWalker Er:YAG/Nd:YAG Laser System Family is substantially equivalent to Fotona LightWalker Laser System Family (K101817), Fotona Fidelis III Er:YAG/Nd: YAG Laser System Family (K093162), Fotona Dynamis Er:YAG/Nd:YAG Laser System Family (K101306), Fotona XP Nd:YAG Laser System Family (K090126) and (K113702), Cutera GenesisPlus Laser System (K103626) and PinPointe FootLaser (K093547). The Fotona LightWalker Er: YAG/Nd:YAG Laser System Family is substantially equivalent in terms of indications for use and technology based on technical characteristics."

This means the "study" demonstrating the device meets "acceptance criteria" (in the context of a 510(k)) is the comparison of technical specifications and intended uses to already cleared predicate devices. The "acceptance criteria" are effectively the specifications and intended uses of those predicate devices.

Here's the information that can be extracted, with explanations for what is not applicable or not provided:

1. Table of acceptance criteria and the reported device performance

Since this is a substantial equivalence submission, the "acceptance criteria" are the technical specifications and intended uses of the predicate devices. The "reported device performance" is the new device's technical specifications.

Table of Comparison for Nd:YAG Laser Wavelength

Table of Comparison for Er:YAG Laser Wavelength

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable / Not Provided. This is a 510(k) submission based on substantial equivalence, not a clinical trial with a "test set" in the traditional sense for evaluating diagnostic performance or clinical outcomes. The "test" is the comparison of technical specifications and intended uses.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable / Not Provided. No "ground truth" for a performance study was established as part of this submission. The "ground truth" for substantial equivalence is the FDA's prior clearance of the predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable / Not Provided. There was no "test set" requiring adjudication.

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 device is a surgical laser, not an AI-based diagnostic tool. No MRMC studies were conducted or are relevant to this type of device and submission.

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

• Not Applicable / Not Provided. This is not an algorithm-only device. It is a physical laser system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for this 510(k) submission is the FDA's prior clearance of the predicate devices, meaning their safety and effectiveness for their stated indications have already been accepted by the regulatory body.

8. The sample size for the training set

• Not Applicable / Not Provided. There is no "training set" as this is not an AI/machine learning device. The "training" in a broad sense involved the design and testing of the laser system to ensure it met its own engineering specifications, but this is not reported in terms of a "training set."

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

• Not Applicable / Not Provided. As there is no training set mentioned, no ground truth for it was established.

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Fotona XP Nd:YAG Laser System Family and its accessories are intended for use in the following procedures:

Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:

• Matrixectomy ー
• Radical nail excision -
• Periungual and subungual warts ー
• Plantar warts l
• Neuromas -
• Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes ー Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)

The Fotona XP Nd:YAG Laser System Family is based on thè Nd:YAG (1064 nm) laser technology. There is one optical cavity containing the Nd: YAG crystal. The Nd: YAG laser is activated by means of the use of a flashlamp. After the cavity, a red diode aiming beam is reflected onto a coaxial bcam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided by an optical fiber delivery system to an optical handpiece. Optionally, the laser beams can be guided through fiber having SMA905 connector on the proximal end and bare fiber on distal end. The user activates laser emission by means of a footswitch.

The Nd: YAG (1064 nm) laser can be operated with variable pulse durations in the range of 0.1-50 msec, with repetition rates up to 100 Hz and laser pulse energies up to 20 J. Depending on the type of treatment, the user can choose between a PULSE mode user interface, and a QCW (Quasi-Continuous Wave) mode user interface. The laser operation is the same for both modes, the difference is only in the laser parameters that can be directly selected from the keyboard.

The provided text describes a 510(k) premarket notification for the Fotona XP Nd:YAG Laser System Family. This is a submission to demonstrate substantial equivalence to a legally marketed predicate device, rather than a de novo submission that would typically involve a detailed clinical study with specific acceptance criteria and performance data.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices (Cutera GenesisPlus and PinPointe FootLaser) based on:

• Identical technological and similar design characteristics.
• Similar indications for use.
• Comparable technical characteristics (e.g., laser source, wavelength, output mode, energy per pulse, pulse width, repetition rate, output power, beam delivery, spot sizes).

The table provided in the document is a comparison table of technical characteristics between the Fotona XP Nd:YAG Laser System Family and its predicate devices, not a table of acceptance criteria and reported device performance against those criteria.

To directly answer your request based on the provided text, the following information is NOT available:

• 1. A table of acceptance criteria and the reported device performance: This is not present. The document compares technical specifications to predicate devices.
• 2. Sample size used for the test set and the data provenance: Not applicable to this type of submission.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable.
• 4. Adjudication method for the test set: Not applicable.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a surgical laser, not an AI algorithm.
• 7. The type of ground truth used: Not applicable.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

The submission aims to show that the new device operates similarly and for the same intended uses as previously cleared devices, hence "substantially equivalent," without needing a new clinical trial to establish safety and effectiveness from scratch.

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The Fotona Dynamis Laser System Family, and its accessories, are intended for use in the following procedures:

Dynamis Er: YAG laser (2940 nm wavelength)

• Dermatology and Plastic Surgery Indications: Epidermal nevi, actinic cheilitis, verrucae, skin tags, keratoses and skin resurfacing;
• ENT Surgery Indications: ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia;
• Oral/Maxillofacial Indications: Oral and glossal lesions;
• Ophtalmology Indications: Soft tissue surrounding the eye;
• Gynecology Indications: Herpes simplex, endometrial adhesion, CIN (Cervical intraepithelial neoplasia), cysts, 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 is necessary;
• Podiatry Indications: Warts, plantar verrucae, large mosaic verrucae, matrixectomy;

Dynamis Nd: YAG laser (1064 nm wavelength):

• Surgical incison, excision, vaporization, ablation and coagulation of soft tissue. All soft tissue is included, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands, fibroma removal, frenectomy and frenotomy;
• 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;
• Treatment of wrinkles;
• 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:
• Endo Venous Laser Therapy of superficial incompetent tributary veins associated with varicose veins and varicosities.

The Fotona Dynamis Laser System 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 flashlamp-pumped laser sources in one housing, with optical cavities containing the Er: YAG and Nd: YAG crystals. A red diode aiming beam (650 nm) is combined with both therapeutic laser beams. The combined therapeutic and aiming beans are guided through an articulated arm to an optical manual or scanner hand piece (in the case of the Er: YAG laser), or through an optical fiber delivery system to an optical manual or scanner hand piece (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. Fotona's power supply Variable Square Pulse (VSP) Technology, integrated into the laser system, allows control of the laser energy and the laser pulse duration. The user activates laser emission by means of a footswitch.

The Fotona Dynamis Laser System Family is designed to operate in five configurations (models):

• XS Dynamis: Single Er:YAG laser system
• XP Dynamis: Single Nd:YAG laser system
• SP Dynamis: Combined Er: YAG/Nd: YAG laser system
• XP Spectro: Single Nd:YAG laser system, with lower average output power of Nd:YAG laser and smaller housing
• SP Spectro: Combined Er:YAG/Nd:YAG laser system, with lower average output power of -Nd:YAG laser and unchanged specifications of Er:YAG laser, and smaller housing.

This document is a 510(k) summary for the Fotona Dynamis Er:YAG/Nd:YAG Laser System Family, aimed at demonstrating substantial equivalence to previously cleared devices. It does not contain information about a study proving the device meets a set of acceptance criteria in the way a clinical trial or performance study for a diagnostic AI device would.

Instead, the submission relies on demonstrating technological equivalence to existing devices. This means that the device's characteristics and intended uses are so similar to already approved predicate devices that it is considered equally safe and effective.

Therefore, many of the requested categories for a study proving acceptance criteria are not applicable to this type of submission. However, I can extract the relevant information regarding the comparative aspects presented.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are not explicit performance metrics for a novel technology but rather the demonstration that the new device's technical specifications and intended uses fall within the established parameters of predicate devices. The "reported device performance" is essentially a comparison of these specifications.

Summary of Equivalence: The document states, "The Fotona Dynamis Er:YAG/Nd:YAG Laser System Family is substantially equivalent to Fotona Dualis SP Nd:YAG/Er:YAG Laser System (K021548), Fotona Fidelis III Er:YAG/Nd: YAG Laser System (K093162), Fotona XP Nd:YAG Laser System (K090126) and Fotona XP Plus Nd:YAG Family of Laser Systems (K050293). The Fotona Dynamis Er: YAG/Nd:YAG Laser System Family is substantially equivalent in terms of indications for use and technology based on technical characteristics."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• This information is not applicable as there was no "test set" in the context of a performance study for a novel diagnostic or AI device. The submission relies on a comparison of technical specifications to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This information is not applicable as there was no "test set" and no ground truth establishment by experts for performance evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This information is not applicable as there was no "test set" requiring adjudication.

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 information is not applicable. This is a laser surgical instrument, not an AI diagnostic device. No MRMC study was conducted.

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

• This information is not applicable. This is a physical laser device, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• This information is not applicable. The "ground truth" in this context is the established safety and effectiveness of the predicate devices based on their prior clearances and clinical use. No new ground truth data of this type was generated for this submission.

8. The sample size for the training set

• This information is not applicable. This is a medical device clearance based on substantial equivalence, not an AI model requiring a training set.

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

• This information is not applicable. As above, there was no training set for an AI model.

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The LightWalker Er:YAG laser, and its accessories, are intended for use in dentistry, dermatology and other surgical areas in the following procedures:

In dentistry, for:

• Intra-oral soft tissue surgery (incision, excision, ablation, coagulation)
• Leukoplakia
• Pulpotomy as adjunct to root canal retreatment
• Pulp extirpation
• Removal of fibromae
• Removal granulated tissue
• Caries removal, cavity preparation, enamel roughening
• Sulcular debridement
• Tooth preparation to obtain access to root canal debridement and cleaning, root canal preparation including enlargement
• Cutting, shaving, contouring and resection of oral osseous tissue (bone)
• Osteotomy,osseous crown lengthening, osteoplasty
• Apicectomy surgery
• Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curetage

In dermatology and other surgical areas, for:

• Dermatology and Plastic Surgery Indications: Epidermal nevi, actinic cheilitis, skin tags, keratoses, verrucae, and skin resurfacing
• ENT Surgery Indications:ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia
• Oral/Maxillofacial Indications: Oral and glossal lesions, gingivectomy
• 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
• Podiatry Indications: warts, plantar verrucae, large mosiac verrucae, matrixectomy

The LightWalker Nd:YAG laser, and its accessories, are intended for use in dentistry, dermatology and other surgical areas in the following procedures:

In dentistry, for:

• 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)
• 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 such as gutta percha or resin as adjunct treatment during root canal therapy
• Removal of post-surgical granulations
• Soft tissue crown lengthening
• Sulcular debridement or soft tissue curettage (removal of diseased or imflamed soft tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss, and tooth mobility)
• Tissue retraction for impression
• Treatment of aphtous ulcers
• Vestibuloplasty

In dermatology and other surgical areas, for:

• 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
• Photocoagulation and hemostasis of pigmented and vascular lessons, such as, but not limited to, port wine stains, hemaongiomae, warts, telengiectasiae, venus lake, leg veins and spider veins
• Treatment of wrinkles
• Treatment of mild to moderate inflammatory acne vulgaris

The Fotona LightWalker laser system family is based on Er:YAG (2940 nm) and Nd:YAG (1064 nm) laser technology. It combines two flashlamp-pumped laser sources in one housing, with optical cavities containing the Er.YAG and Nd:YAG crystals. A red diode aiming beam (650 mm) is combined with both therapeutic laser beams. The combined therapeutic and aiming beams are guided through an articulated arm to an optical hand piece (in the case of the Er: YAG laser), or through an optical fiber delivery system to an optical hand piece (in the case of the Nd: YAG laser).

The Er:YAG laser is capable of delivering up to 1.5 J of laser energy in pulses with durations of up to 1000 us and frequencies (repetition rates) of up to 50 Hz. The maximum average output power is 20 W.

For aesthetic indications, the Nd:YAG laser is capable of delivering laser fluences up to 300 J/cm² in pulses with durations of up to 25 ms. For dental indications, it is capable of delivering laser pulses with durations of up to 320 us, frequencies (repetition rates) up to 100 Hz and a maximum output power of 15 W.

Fotona's power supply Variable Square Pulse (VSP) Technology, integrated into the laser system, allows ultimate control of the laser energy and the laser pulse duration. This ensures treatment precision, patient comfort, safety and ease-of-use in all treatments.

The provided text is a 510(k) summary for the Fotona LightWalker Laser System Family. This document focuses on establishing substantial equivalence to a predicate device and outlines the intended uses and technical specifications of the laser system. It does not contain information about acceptance criteria, detailed study designs, sample sizes, ground truth establishment, or multi-reader multi-case (MRMC) studies typically associated with validating algorithms or AI-powered devices.

Therefore, I cannot provide the requested information in the format of a table or answer many of the specific questions because the document does not contain this type of data.

Here's what can be inferred or explicitly stated based on the provided text, along with what cannot be answered:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a study. The primary "acceptance" criteria for a 510(k) submission are based on demonstrating substantial equivalence to a predicate device, meaning it has similar indications for use, design, and functional features, and does not raise new questions of safety or effectiveness.
• Reported Device Performance: The document describes the technical specifications (e.g., laser wavelengths, energy, pulse durations, repetition rates, maximum average output power, fluence) but does not present performance metrics (e.g., accuracy, sensitivity, specificity) against specific clinical outcomes or ground truth for the stated indications.

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

• Not applicable as no performance study data against a test set is provided. The submission is a comparison to a predicate device, not a de novo clearance requiring clinical validation of performance.

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

• Not applicable as no performance study data against a test set is provided.

4. Adjudication method for the test set:

• Not applicable as no performance study data against a test set is provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• No. This document does not mention an MRMC study or any AI component. The device described is a laser system, not an AI-assisted diagnostic tool.

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

• No, as the device is a laser system, not an algorithm.

7. The type of ground truth used:

• Not applicable as no performance study data against a test set is provided. The "ground truth" for a 510(k) for a non-AI device like this is the established safety and effectiveness of the predicate device and relevant scientific literature for the stated indications.

8. The sample size for the training set:

• Not applicable as no AI or algorithm training is mentioned.

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

• Not applicable as no AI or algorithm training is mentioned.

Summary of the K101817 Submission Content:

The Fotona LightWalker Laser System Family (K101817) is an Er:YAG/Nd:YAG laser system. The submission aims to demonstrate substantial equivalence to a previously cleared predicate device: Fotona Fidelis III Er:YAG/Nd:YAG Laser System Family (K093162).

The document lists extensive intended uses and indications for both the Er:YAG and Nd:YAG lasers in dentistry, dermatology, ENT surgery, oral/maxillofacial surgery, general surgery, and podiatry. These indications range from soft tissue surgery, caries removal, skin resurfacing, hair reduction, and treatment of vascular lesions.

The justification for substantial equivalence is based on the same indications for use, similar design, and functional features compared to the predicate device. This is a common pathway for device clearance and usually does not involve new clinical studies to prove efficacy against specific acceptance criteria for a novel algorithm or diagnostic tool. Instead, it relies on the known performance and safety profile of similar, legally marketed devices.

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Er:YAG laser (2940 nm wavelength) in dentistry:

• Intra-oral soft tissue surgery (incision, excision, ablation coagulation) -
• -Leukoplakia
• Pulpotomy as adjunct to root canal retreatment ー
• Pulp extirpation -
• Removal of fibromae -
• Removal of granulated tissue -
• -Caries removal, cavity preparation, enamel roughening
• Sulcular debridement -
• Tooth preparation to obtain access to root canal debridement and cleaning, root canal preparation including enlargement
• Cutting, shaving, contouring and resection of oral osseous tissue (bone) -
• Osteotomy, osseous crown lengthening, osteoplasty -
• Apicectomy surgery -
• Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open = curretage

Er:YAG laser (2940 nm wavelength) in dermatology and other surgical areas:

• Dermatology and Plastic Surgery Indications: Epidermal nevi, actinic cheilitis, verrucae, skin tags, keratoses and skin resurfacing;
• ENT Surgery Indications: ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia; ।
• Oral/Maxillofacial Indications: Oral and glossal lesions, gingivectomy: -
• 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, tissue ablation and vessel coagulation is necessary;
• Podiatry Indications: Warts, plantar verrucae, large mosaic verrucae, matrixectomy;

Nd:YAG laser (1064 nm wavelength) in dentistry:

• 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
• w Gingival incision and excision
• Gingivectomy -
• Gingivoplasty -
• Hemostasis -
• Implant recovery -
• Incision and drainage of abscess -
• Laser assisted uvulopaletoplasty (LAUP) -
• -Operculectomy
• Oral papillectomies l
• Pulpotomy and pulpotomy as an adjunct to root canal therapy ー
• Reduction of denture hyperplasia -
• Reduction of gingival hypertrophy -
• Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy
• Removal of post-surgical granulations -
• Soft tissue crown lengthening ー
• Sulcular debridement or soft tissue curettage (removal of diseased or imflamed 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 ー
• Treatment of aphtous ulcers ー
• -Vestibuloplasty

Nd:YAG laser (1064 nm wavelength) in dermatology and other surgical areas:

• 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
• । 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
• Treatment of wrinkles -.
• Treatment of mild to moderate inflammatory acne vulgaris

The Fotona Fidelis III laser system family is based on Er: Y AG (2940 nm) and Nd: Y AG (1064 nm) laser technology. It combines two flashlamp-pumped laser sources in one housing, with optical cavities containing the Er:YAG and Nd:YAG 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 hand piece (in the case of the Er: YAG laser), or through an optical fiber delivery system to an optical hand piece (in the case of the Nd. YAG laser).

The Er:Y AG laser is capable of delivering up to 1.5 J of laser energy in pulses with durations of up to 1000 us and frequencies (repetition rates) of up to 50 Hz. The maximum average output power is 20 W.

The Nd: YAG laser is capable of delivering laser fluences up to 300 J/cm² in pulses with durations of up to 25 ms. and laser pulses with durations of up to 320 us. frequencies (repetition rates) up to 100 Hz and a maximum output power of 15 W.

Fotona's power supply Variable Square Pulse (VSP) Technology, integrated into the laser system, allows ultimate control of the laser energy and the laser pulse duration. This ensures treatment precision, patient comfort, safety and case-of-use in all treatments.

The provided text is a 510(k) summary for the Fotona Fidelis III Er:YAG/Nd:YAG Laser System Family. It describes the device, its intended use, and a statement of substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or adjudication methods.

The core of the document is a regulatory submission demonstrating that the new device is "substantially equivalent" to previously cleared devices. This type of submission relies on showing that the new device has "the same intended use and the same technological characteristics as the predicate device" or "has the same intended use as the predicate device and has different technological characteristics than the predicate device, but the different technological characteristics do not raise different questions of safety and effectiveness."

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them from the provided text, as this information is not present. The document focuses on demonstrating substantial equivalence to existing devices rather than a de novo clinical study with specific performance metrics and acceptance criteria.

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Nd: YAG laser (1064 nm wavelength) in dermatology and other surgical areas:

• 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. It is further indicated for 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
• Treatment of wrinkles -
• 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
• Endo Venous Laser Therapy of superficial incompetent tributary veins associated with varicose veins and varicosities

Nd:YAG laser (1064 nm wavelength) in dentistry:

• 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) -
• 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 such as gutta percha or resin as adjunct treatment during root canal therapy
• Removal of post-surgical granulations -
• Soft tissue crown lengthening
• Sulcular debridement or soft tissue curettage (removal of diseased or imflamed 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 aphtous ulcers
• Vestibuloplasty

The Fotona XP Laser System Family is based on the Nd: YAG (1064 nm) laser technology. There is one optical cavity containing the Nd: YAG crystal. The Nd: YAG laser 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 therapeutic and aiming beams are guided by an optical fiber delivery system to an optical handpiece. Optionally, the laser beams can be guided through fiber having SMA905 connector on the proximal end bare fiber on distal end. The user activates laser emission by means of a footswitch.

The Nd:YAG (1064 nm) laser can be operated with variable pulse durations in the range of 0.1-50 msec, with repetition rates up to 100 Hz and laser pulse energies up to 10 J. Depending on the type of treatment, the user can choose between a PULSE mode user interface, and a OCW (Ouasi-Continuous Wave) mode user interface. The laser operation is the same for both modes, the difference is only in the laser parameters that can be directly selected from the keyboard.

In the PULSE user interface mode the user can directly select the handpiece treatment spot size, laser fluence, pulse duration and pulse repetition rate. This mode is intended primarily for treatments at relatively small repetition rates, or in individual pulses, and at relatively high pulse energies. In this mode, a major expected treatment effect is the selective photothermolysis of target chromophores in soft tissue. For this reason it is more effective and safer that the energy is delivered to target chromophores in a relatively short time, in order not to cause damage to the surrounding tissue. Typically, the illuminated areas, or spotsizes are larger than 1 mm. A spotsize is determined by choosing and adjusting the handpiece. In this mode, the relevant and sufficient treatment parameters that have been accepted by the medical community are laser pulse energy, laser pulse fluence (energy over the spot-size area), pulse duration and pulse repetition rate.

In the QCW user interface mode the user can directly select the laser pulse repetition rate, pulse width and the average laser power. This mode is intended primarily for treatments at relatively high repetition rates and small pulse energies. In this mode, a major expected treatment effect is incision, excision and coagulation of tissue via heating of the tissue in close contact with the fiber delivery of a known diameter (typically smaller than 1.0 mm), and over a time typically longer than 0.5 sec. For this reason, in this mode, average power, repetition rate (frequency) and pulse-width are the relevant and sufficient treatment parameters, accepted by the medical community, for performing various dental or surgical procedures.

This document is a 510(k) Pre-market Notification for the Fotona XP Nd:YAG Laser System Family. It focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than presenting a study proving the device meets specific performance acceptance criteria. Therefore, the information requested in your prompt regarding acceptance criteria and a study to prove devices meet these criteria is not contained within this document.

The document primarily provides:

• Device Description: Details the technical specifications and operational modes (PULSE and QCW) of the Fotona XP Laser System Family.
• Indications for Use: Lists the intended medical applications for the laser system in dermatology, other surgical areas, and dentistry.
• Statement of Substantial Equivalence: Compares the Fotona XP system to several legally marketed predicate devices, asserting comparability in terms of indications, technical specifications, and design. The FDA's letter of clearance confirms this substantial equivalence.

Since this submission is a 510(k) for substantial equivalence, it relies on the safety and effectiveness of the predicate devices. It does not contain an independent clinical study with defined acceptance criteria for the Fotona XP Nd:YAG Laser System Family itself.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement as this information is not provided in the supplied text.

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The Fotona OX Nd: YAG/KTP Laser System Family is indicated for incision, excision, ablation and vaporization of soft tissue for general dermatology.

Specific Indications:

1064 nm wavelength in Q-switched mode:

• Removal of dark ink (black, blue and brown) tattoos
• Treatment of nevus of Ota
• Treatment of common nevi
• Removal or lightening of unwanted hair
• Skin resurfacing procedures for the treatement of acne scars and wrinkles

1064 nm wavelength in non- Q-switched mode:

• 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
• Photocoagilation and hemostasis of pigmented and vascular lesions, such as, but not limited to. port wine stains, hemaongiomae, warts, telangiectasiae, venus lake, leg veins and spider veins
• Coagulation and hemostasis of soft tissue
• Treatment of wrinkles
• Treatment of mild to moderate inflammatory acne vulgaris

532 nm wavelength in Q-switched mode (nominal delivered energy of 585 nm and 650 nm with the optional 585 nm and 650 mm dye converter handpieces):

• Removal of light ink (red, sky blue, green, tan, purple, and orange) tatoos
• Treatment of vascular lesions including, but not limited to:
  • port wine birthmarks
  • telangiectasias
  • spider angioma
  • cherry angioma
  • spider nevi
• Treatment of pigmented lesions including, but not limited to:
  • cafe-au-lait birthmarks
  • solar lentigines
  • senile lentigines
  • -Becker's nevi
  • freckles
  • common nevi
  • nevus spilus
• Treatment of seborrheic keratosis
• Treatment of post inflammatory hyperpigmentation
• Skin resurfacing procedures for the treatment of acne scars and wrinkles.

The Fotona QX laser system family is based on the Nd:YAG (1064 nm) and frequency doubled KTP Nd: YAG (532 nm) laser technology. There is one optical cavity containing the Nd: YAG crystal. The frequency doubled KTP Nd: YAG wavelength is achieved by directing the Nd: YAG laser beam through a frequency doubling non-linear crystal. The Nd: YAG laser 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 therapeutic and aiming beams are guided by articulated arm to a focusing variable spot handpiece. Optionally, the KTP Nd: YAG beam can be guided to a 585nm dye converter handpiece, or to a 650nm dye laser converter handpiece. The dye handpieces convert the KTP 532 nm wavelength beam into a 585 mm or a 650 nm wavelength, correspondingly. Both lasers are used in non-contact mode. The user activates laser emission by means of a footswitch.

The Nd:YAG (1064 nm) laser can be operated in a Q-switched (nominal pulse duration 5-20 nsec) and in a non-Qswitched mode (nominal pulse duration 0.25 msec) of operation. The KTP: YAG (532 nm) laser with optional 585 nm and 650 nm wavelengths can be operated only in a Q-switched mode (nominal pulse duration 5-20 nsec).

In the O-switched mode, the Nd: Y AG (1064 nm) laser is capable of delivering up to 1.6 J of laser energy. Spot sizes available range from 2 to 8 mm.

In the non-Q-switched mode, the Nd: YAG (1064 nm) laser is capable of delivering up to 5 J of laser energy. Spot sizes range from 2 to 8 mm.

The frequency doubled Nd:YAG (532 nm) KTP laser delivers up to 0.6 J of laser energy in 5-20 nanosecond pulses. Spot sizes available range from 2 to 8 mm.

All three modes of operation are intended to be used for incision/excision, ablation, vaporization of soft tissue in general dermatology and for the indications for use as stated below.

The provided document is a 510(k) summary for the Fotona QX Nd:YAG/KTP Laser System Family. This type of submission to the FDA focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than conducting new clinical studies to prove safety and effectiveness from scratch. Therefore, the document does not describe acceptance criteria or a study that proves the device meets those criteria in the way a clinical trial might for a novel device.

Instead, the core of this submission is a comparison to predicate devices, asserting that the new device shares similar indications for use, technical specifications, operating performance features, and general design features with already cleared devices.

Based on the provided text, here's an analysis of the requested information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" and "reported device performance" in the context of a clinical study demonstrating effectiveness. The acceptance criteria for a 510(k) submission are typically related to demonstrating substantial equivalence, meaning the new device is as safe and effective as a legally marketed predicate device.

The document lists the indications for use for the Fotona QX Nd:YAG/KTP Laser System Family (pages 5-6). These are the intended uses for which the device is considered substantially equivalent to predicates. The "performance" is implicitly deemed acceptable because it is similar to the performance of the predicate devices for the same indications.

• Treatment of nevus of Ota
• Treatment of common nevi
• Removal or lightening of unwanted hair
• Skin resurfacing procedures for the treatment of acne scars and wrinkles | Deemed similar to predicate devices. |
  | 1064 nm non-Q-switched mode | - 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
• Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemangiomae, warts, telangiectasiae, venus lake, leg veins and spider veins
• Coagulation and hemostasis of soft tissue
• Treatment of wrinkles
• Treatment of mild to moderate inflammatory acne vulgaris | Deemed similar to predicate devices. |
  | 532 nm Q-switched mode | - Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos
• Treatment of vascular lesions including, but not limited to: port wine birthmarks, telangiectasias, spider angioma, cherry angioma, spider nevi
• Treatment of pigmented lesions including, but not limited to: cafe-au-lait birthmarks, solar lentigines, senile lentigines, Becker's nevi, freckles, common nevi, nevus spilus
• Treatment of seborrheic keratosis
• Treatment of post inflammatory hyperpigmentation
• Skin resurfacing procedures for the treatment of acne scars and wrinkles. | Deemed similar to predicate devices. |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. As a 510(k) submission based on substantial equivalence, there is no mention of a "test set" in the context of a new clinical study. The submission relies on the established safety and effectiveness of the predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. No specific "test set" requiring ground truth establishment by experts is mentioned, as this is not a de novo clinical trial.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document. No "test set" or 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

An MRMC comparative effectiveness study is not mentioned in the document. This type of study is not relevant for a laser device submission focused on substantial equivalence to existing laser systems, nor does the device involve AI assistance.

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

This information is not applicable as the device is a laser system, not an algorithm, and the concept of "standalone performance" for an algorithm is not relevant here.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided in the document. The submission is based on the previously established ground truth (safety and effectiveness) of the predicate devices for their respective indications.

8. The sample size for the training set

This information is not provided in the document. There is no mention of a "training set" as this is not an algorithm being developed or validated.

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

This information is not provided in the document. Not applicable for the reasons stated above.

In summary:

The provided 510(k) summary is a regulatory document focused on demonstrating substantial equivalence. It does not contain the details typically found in a clinical study report or a submission for a novel device that requires de novo clinical validation. The "acceptance criteria" and "performance" are implicitly linked to the existing cleared status and indications for use of the specified predicate devices.

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The Fotona XD Diode Laser System, and its accessories, are intended for use in

• Periodontology for
  • Laser soft tissue curettage r
  • Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
  • Oral Soft Tissue surgery for
    • Gingivectomy
    • Gingivoplasty
    • Fibroma removal
    • Treatment of Aphthous Ulcers
    • Crown Lenghtening
    • Frenectomy
    • Papillectomy
    • Photocoagulation
• Cosmetic Dentistry for
  • Light activation for bleaching materials for teeth whitening -
  • Lasers-assisted bleaching/whitening of the teeth -

The Fotona XD Diode Laser System is based on a semiconductor laser that operates in the nearinfrared range of the electromagnetic spectrum. The laser source consists of a compact semiconductor laser diode module that emits laser light at a wavelength of 810 nm in continuous wave mode or pulse operation mode from 20 Hz to 10 kHz. The output power can be set from 250 m W to 7.0W. A red diode aiming beam (650 nm) is combined with the therapeutic laser beam and , both beams are guided through an optical fiber delivery unit and an optical handpiece to the treatment site.

The provided text describes a 510(k) submission for the Fotona XD Diode Laser System, seeking substantial equivalence to existing predicate devices. This type of submission relies on demonstrating that a new device is "as safe and effective" as a legally marketed predicate device, rather than requiring a detailed study proving performance against specific acceptance criteria.

Therefore, much of the requested information regarding acceptance criteria and a study to prove device performance (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable to this document. The document focuses on regulatory clearance through substantial equivalence.

Here's an explanation of what can be extracted and why other parts are not available:

1. A table of acceptance criteria and the reported device performance

Not applicable. The 510(k) summary does not present specific acceptance criteria in terms of quantitative performance metrics for the Fotona XD Diode Laser System itself. Instead, it relies on demonstrating substantial equivalence to predicate devices that have already met safety and effectiveness standards. The "device performance" is implicitly considered to be equivalent to the predicate devices for the specified indications for use.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No new clinical trials or performance studies with test sets are described in this 510(k) summary. The submission relies on the established safety and effectiveness of the predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No new test set requiring expert ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No new test set 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. This document pertains to a medical device (laser system), not an AI-powered diagnostic tool. Therefore, MRMC studies and AI-related performance improvements are irrelevant.

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

Not applicable. This is a medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable to this 510(k) submission directly. The "ground truth" for the Fotona XD Diode Laser System's approval is based on the established safety and effectiveness of the legally marketed predicate devices for their approved indications.

8. The sample size for the training set

Not applicable. No machine learning or AI component requiring a training set is part of this device or its submission.

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

Not applicable. No machine learning or AI component requiring a training set is part of this device or its submission.

Summary of Relevant Information from the Provided Text:

The essence of this 510(k) submission is to demonstrate substantial equivalence to existing devices, specifically:

• Predicate Device 1: Odyssey 2.4G Diode Laser (K050453)
• Predicate Device 2: Opus 10 Dental Diode Laser System (With Tooth Whitening Application) (K011769)

The Fotona XD Diode Laser System shares the same indications for use and similar design and functional features with these predicate devices. The approval letter from the FDA (FEB - 4 2009) confirms that the device is "substantially equivalent" to legally marketed predicate devices, thereby allowing it to proceed to market. This indicates that the device met the regulatory requirements for 510(k) clearance by proving its similarity to already approved devices, rather than through a de novo performance study against specific acceptance criteria.

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