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With handheld applicators:

PMS mode:

Fotona StarFormer is intended for muscle conditioning, used for stimulating muscles including abdomen muscles in order to improve or facilitate muscle performance.

Fotona StarFormer is intended to be used under medical supervision for adjunctive therapy. Fotona StarFormer is intended for stimulating neuromuscular tissue for bulk muscle excitation in arms, legs, buttocks and thighs for rehabilitative purposes - Prevention of disuse atrophy and increasing local blood circulation.

TENS mode:

Fotona StarFormer is intended to stimulate peripheral nerves for relief of chronic intractable, post traumatic and post-surgical pain for patients 18 years or older.

Fotona StarFormer is to be used for the temporary relief of pain associated with sore or aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

With Chair Back applicator:

TENS mode:

Fotona StarFormer is intended to stimulate peripheral nerves in the back for relief of chronic intractable, post traumatic and post-surgical pain for patients 18 years or older. Fotona StarFormer is to be used for the temporary relief of pain associated with sore or aching muscles in the back due to strain from exercise or normal household work activities.

StarFormer is a non-invasive therapeutic device. The device comprises of a magnetic stimulation coil located in the handheld applicators and in the back of a chair. During the treatment, an alternating electric current is sent into the stimulation coil. The coil builds up a rapidly changing magnetic waves which propagate into the underlying tissue where they induce a secondary electric current. This current stimulates neurons and activates muscle contractions. The device consists of a system controller board which also drives the touchscreen and the GUI, a high voltage current power supply, handheld applicators and a chair.

The provided document is a 510(k) summary for the Fotona StarFormer (M008-3T) device, a transcutaneous electrical nerve stimulator. However, it does not contain the specific details about acceptance criteria or a comparative effectiveness study that demonstrates how the device meets acceptance criteria.

The document indicates that:

• Nonclinical testing was performed, including electrical safety, mechanical strength, thermal safety, electromagnetic compatibility, software verification and validation, and cybersecurity testing. It explicitly states, "All pre-determined acceptance criteria were met" for these tests.
• No premarket clinical investigations were conducted. The rationale provided is that "performance of StarFormer is based on the well-established magnetic stimulation technology and does not carry significant residual risk for patients."

Therefore, I cannot provide details on:

1. A table of acceptance criteria and reported device performance (since these are not specified beyond a general statement of compliance).
2. Sample size used for a test set or data provenance (as no clinical test set is described).
3. Number of experts or their qualifications for ground truth establishment.
4. Adjudication method for the test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study, nor the effect size on human readers.
6. Stand-alone performance (algorithm only) as this is a device and not an AI algorithm being evaluated in a clinical "standalone" sense.
7. Type of ground truth used (as no clinical study is detailed).
8. Sample size for the training set (as no AI/ML model training is described in the context of clinical performance evaluation).
9. How ground truth for the training set was established.

The document focuses on demonstrating substantial equivalence to predicate devices primarily through comparison of technological characteristics and compliance with nonclinical performance standards, rather than clinical efficacy studies with specific acceptance criteria that might be seen for novel AI/ML 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;
• · 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 curettage;
• · Laser removal of porcelain and ceramic crowns and veneers;
• · Flap preparation incision of soft-tissue to prepare a flap and expose the bone;
• · Cutting bone to prepare a window access to the apex (apices) of the root(s);
• · Root-end preparation for retrofill amalgam or composite;
• · Full thickness flap;
• · Partial thickness flap;
• · Split thickness flap;
• · Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket;
• · Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket Iming junctional epithelium:
• · Excisional and incisional biopsies;
• · Flap preparation incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions);
• · Frenectomy and frenotomy;
• · Gingival troughing for crown impressions;
• · Gingivectomy;
• · Gingivoplasty:
• · Implant recovery;
• · Root canal debridement and cleaning;
• · Soft tissue crown lengthening;
• · Laser root canal disinfection after endodontic treatment;

Er: Y AG laser (2940 nm wavelength) in dermatology and other surgical areas:
The LightWalker Er: YAG laser is intended for surgical incision, 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, gingivectomy;

• Uvulopalatoplasty by laser resurfacing
  · 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;
• · Podiatry Indications: Warts, plantar verrucae, large mosaic verrucae, matrixectomy;
• · Ophtalmology Indications: Soft tissue surrounding the eye;
  · 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;
• · Dermatological procedures requiring resurfacing of soft tissue with Fotona FS-01 fractionated handpiece.
  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 toothmobility);
• · Tissue retraction for impression;
• Treatment of aphtous ulcers;
• · Vestibuloplasty;
  · Laser assisted new attachment procedure (cementum-mediated periodontal ligament no the root surface in the absence of long junctional epithelium);
  · Periodontal regeneration - true regeneration of the attachment apparatus (new cementum, new periodontal ligament, and new alveolar bone) on a previously diseased root surface.

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, hemangiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins;
· Treatment of wrinkles;
· Treatment of mild to moderate inflammatory acne vulgaris;
· General surgery indications: surgical incision, 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, excision, and coagulation of soft tissue) including: Matrixectomy, Periungual and subungual warts, Plantar warts, Radical nail excision, 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 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 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 diode aiming beam is combined with both therapeutic laser beams. The combined therapeutic and aiming beams are guided through an articulated arm to an optical handpiece (in the case of the Er:YAG laser), or, in the case of the Nd:YAG laser, through an optical fiber delivery system to an optical handpiece or to the bare fiber distal end.

The provided text is a 510(k) Premarket Notification from the FDA for the Fotona LightWalker Laser System Family. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that a device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, and comparative effectiveness studies is not explicitly available in this type of regulatory submission.

Here's why and what information is provided:

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

• Not provided. The document does not specify quantitative acceptance criteria or detailed device performance metrics in a table. It primarily states that "performance testing was conducted on the subject device, and it was established that the newly introduced features do not raise different questions of safety or effectiveness."

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

• Not provided. The document states "Clinical testing was not considered to be needed for this pre-market notification." Therefore, there is no information on sample sizes or data provenance for a clinical test set. The submission relies on non-clinical performance testing.

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. Since no clinical testing was deemed necessary, there was no test set requiring expert-established ground truth.

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

• Not applicable/Not provided. As no clinical test set was used, no adjudication method is mentioned.

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 laser system, not an AI-powered diagnostic tool, so MRMC studies comparing human reader performance with and without AI assistance are not relevant to this submission.

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

• Not applicable/Not provided. This is a physical laser device, not a standalone algorithm. Performance testing was likely focused on the physical characteristics of the laser system (e.g., wavelength, power, pulse energy, safety standards adherence).

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

• Not applicable/Not provided. For the non-clinical performance testing the device underwent, the "ground truth" would be established by engineering specifications and standard test methods (e.g., measurement of laser output parameters) rather than clinical ground truth methods like pathology or expert consensus.

8. The sample size for the training set:

• Not applicable/Not provided. Since "Clinical testing was not considered to be needed" and the device is not an AI/machine learning product requiring a training set, this information is not relevant or available.

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

• Not applicable/Not provided. As there is no training set for this type of device, ground truth establishment for a training set is not applicable.

Summary of what is provided regarding testing and equivalence:

The submission focuses on demonstrating substantial equivalence to a predicate device (K202985 LightWalker Laser System Family) based on:

• Non-clinical Performance Testing: The device underwent performance testing to ensure that its newly introduced features (primarily a change in operating system from Windows to Linux and a larger user interface screen) do not raise new questions of safety or effectiveness.
• Adherence to Standards: The device successfully completed tests based on various IEC and ISO standards related to medical electrical equipment, laser safety, usability, risk management, and software lifecycle processes.
  • Performance Standards Listed:
    • IEC 60601-1:2005 + A1:2012 + A2:2020 (General requirements for basic safety and essential performance)
    • IEC 60601-1-2:2014 + A1:2020 (Electromagnetic disturbances)
    • IEC TR 60601-4-2:2016 (Electromagnetic immunity)
    • IEC 60601-2-22:2019 (Particular requirements for surgical, cosmetic, therapeutic and diagnostic laser equipment)
    • IEC 60601-1-6:2010 + A1:2013 + A2:2020 (Usability)
    • IEC 60601-1-9:2007 + A1:2013 (Environmentally conscious design)
    • IEC 60825-1:2014 (Safety of laser products)
    • IEC 62366:2007 + A1:2014 / IEC 62366-1:2015 (Usability engineering)
    • IEC 62304:2006 + A1:2015 (Medical device software life-cycle processes)
    • ISO 14971:2019 (Risk management)
    • ISO 17664-1:2021 & ISO 17664-2:2021 (Processing of health care products)
    • ISO 10993-1:2018 (Biological evaluation of medical devices)
  • Guidance Documents Applied:
    • FDA Guidance (2023), "Content of Premarket Submissions for Device Software Functions" (Software Verification and Validation Testing)
    • FDA Guidance (2023), "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" (Cybersecurity testing)
• Technological Characteristics Comparison: The document provides a table comparing the technological characteristics of the subject device (K242202) and the predicate device (K202985), showing identical laser output parameters (wavelength, laser media, output mode, pulse energy, pulsewidth, repetition rate, power, beam delivery). The only differences noted are the Operating System (Linux vs. Windows) and the User Interface Screen Size (10.1" vs. 8.4").

The core of this submission is that performance testing against these engineering standards, combined with the identical intended use and very similar technological characteristics relative to the predicate, establishes that the device is substantially equivalent and thus does not require clinical studies.

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Fotona StarFormer is intended to provide entirely non-invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of urinary incontinence in women.

StarFormer is a non-invasive therapeutic device. The device comprises of a magnetic stimulation coil located in the seat of a chair. During the treatment, an alternating electric current is sent into the stimulation coil. The coil builds up a rapidly changing magnetic waves which propagate into the underlying tissue where they induce a secondary electric current which causes muscle contraction in the entire pelvic floor area, increasing the strength and endurance of the pelvic floor. The device consists of a system controller board which also drives the touchscreen and the GUI, a high voltage current power supply and a chair.

This document describes the StarFormer device, a non-invasive electromagnetic stimulator for pelvic floor muscles, and its substantial equivalence to a predicate device (Neotonus Model 100 Muscle Stimulator System).

Here's an analysis of the provided information, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria for clinical efficacy and corresponding device performance. Instead, it relies on demonstrating substantial equivalence to a predicate device (Neotonus Model 100 Muscle Stimulator System). The acceptance criteria were met for nonclinical testing.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a clinical study for the StarFormer device's efficacy, nor does it specify a test set for clinical performance. The clearance is based on substantial equivalence to a predicate device and non-clinical bench testing. Therefore, there is no sample size for a clinical test set or data provenance related to a clinical study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Since no clinical study is described for the StarFormer device itself, there is no mention of experts used to establish ground truth for a clinical test set.

4. Adjudication Method for the Test Set

As there is no described clinical test set for the StarFormer device's efficacy, there is no adjudication method mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC comparative effectiveness study was mentioned or performed. The clearance is based on non-clinical testing and substantial equivalence to a predicate device, not on a clinical trial comparing human readers with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The StarFormer device provides electromagnetic stimulation; it is a therapeutic device, not an AI-based diagnostic tool or analysis algorithm meant to operate standalone in a diagnostic context. Therefore, a standalone algorithm-only performance study, as typically understood for AI/ML devices, was not performed or relevant. The device's performance relies on its physical output (magnetic fields) and its mechanism of action on the human body.

7. The Type of Ground Truth Used

For the non-clinical tests (electrical safety, EMC, software, cybersecurity), the ground truth is established by adherence to recognized international and FDA standards/guidances. For the magnetic field strength, the "ground truth" would be the measured output of the device itself compared to its design specifications.

There is no ground truth described for clinical efficacy for the StarFormer device, as no clinical study for its efficacy is presented. The substantial equivalence argument relies on the predicate device's proven efficacy for similar indications.

8. The Sample Size for the Training Set

The StarFormer device is described as a non-invasive therapeutic device that uses electromagnetic stimulation; it is not presented as an AI/ML-based diagnostic or predictive system that typically requires "training sets." Therefore, there is no mention of a training set or its sample size.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for an AI/ML component, this question is not applicable.

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Fotona StarFormer is intended to be used under medical supervision for therapy for the treatment of medical diseases and conditions.

Fotona StarFormer is indicated for use in stimulating neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes.

-Relaxation of muscle spasm,

-Prevention or retardation of disuse atrophy,

-Increasing local blood circulation,

-Muscle re-education,

-Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis,

-Maintaining or increasing range of motion.

Fotona StarFormer is indicated for improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen

-Strengthening, Toning and Firming of buttocks and thighs

StarFormer is a non-invasive therapeutic device. The device comprises a magnetic stimulation coil located in the applicator which is placed over the treatment area. During the treatment, an alternating electric current is sent into the stimulation coil. The alternations in the electric current produce electromagnetic field that interacts with the tissues of the human body. The device consists of a system controller board which also drives the touchscreen and the GUI, a high voltage current power supply and an applicator with electromagnetic coil.

The provided text is a 510(k) summary for the Fotona StarFormer device. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with defined performance metrics. In the context of a 510(k), "acceptance criteria" are typically related to the device's ability to perform as intended and raise no new questions of safety or effectiveness compared to a predicate device.

Therefore, the requested information regarding acceptance criteria and a study proving those criteria are met is not directly present in this document in the format you've requested for AI/software performance. The information provided is about the device's technical specifications and the comparison to predicate devices to establish substantial equivalence.

Here's an attempt to extract and interpret the information based on the premise of the FDA 510(k) process for this type of medical device:

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

Since this is a 510(k) for a physical medical device (muscle stimulator) rather than an AI/software device with measurable performance metrics like sensitivity/specificity, the acceptance criteria are not in the form of numerical performance targets. Instead, the acceptance criteria for a 510(k) revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device and does not raise new questions of safety or effectiveness.

Indications for Use Comparison Table (Extracted from the document, relevant to equivalence):

• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• Maintaining or increasing range of motion | - Improvement of abdominal tone, strengthening of abdominal muscles, development of firmer abdomen.
• Strengthening, Toning and Firming of buttocks and thighs. | - Relaxation of muscle spasm
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• Maintaining or increasing range of motion.
• Improvement of abdominal tone, strengthening of abdominal muscles, development of firmer abdomen.
• Strengthening, Toning and Firming of buttocks and thighs. | Same (StarFormer combines the indications of both predicates)

Technological Comparison (Selected key parameters from the document):

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

The document explicitly states: "No premarket clinical investigations were conducted since the performance of StarFormer is based on the well-established magnetic stimulation technology and does not carry significant residual risk for patients." Therefore, there is no clinical test set, sample size, or data provenance to report. The evaluation relies on non-clinical testing and comparison to predicates.

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, as no clinical investigations were conducted.

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

Not applicable, as no clinical investigations were conducted.

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 physical muscle stimulator, not an AI-assisted diagnostic or interpretive device that would involve human readers or an MRMC study.

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

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

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

Not applicable, as no clinical investigations were conducted. The "ground truth" for a 510(k) submission for a physical device is primarily the established safety and effectiveness of the legally marketed predicate devices and their underlying technology.

8. The sample size for the training set

Not applicable, as no clinical investigations were conducted and this is not an AI/ML device that requires a training set.

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

Not applicable.

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The AvalancheLase Family and its accessories will be marketed for the following indications for use:

Alexandrite laser (755 nm wavelength): Indications in Dermatology and Aesthetics

• Temporary hair reduction.
• Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment 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. On all skin types (Fitzpatrick I- VI) including tanned skin.
• Treatment of benign pigmented lesions.
• Treatment of wrinkles
• The photocoagulation of benign dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).

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

Indications in Dermatology and Aesthetics:

• 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 thair 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 (LX Runner) 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, 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 Trichophylla rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)

NNd: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 AvalancheLase Family is based on Nd:YAG (1064 nm) and Alexandrite (755 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 Nd:YAG and Alexandrite crystals. A green diode aiming beam (520 mm) is combined with both therapeutic laser beams. The combined therapeutic and aiming beams are guided through an optical fiber delivery system to an optical manual handpiece or scanner. The AvalancheLase Family is designed to operate in single wavelength (Nd:YAG or Alexandrite) configurations (models) and dual wavelength (Nd: YAG and Alexandrite) configurations (models).

The provided text is a 510(k) summary for the Fotona AvalancheLase Family device. This document focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing and comparison of technical characteristics and indications for use. It does not include a description of acceptance criteria for a device performance study or the study that proves the device meets those criteria in the way typically associated with AI/ML device evaluations.

Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, AI assistance effect size, standalone performance, training set details) are not applicable as this document describes a traditional laser surgical instrument undergoing a 510(k) clearance, not an AI/ML powered device.

However, I can extract the information that is present concerning performance claims and the basis for substantial equivalence.

Here's the breakdown based on the provided text:

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

The document doesn't explicitly state "acceptance criteria" in the formal sense for performance metrics like sensitivity, specificity, accuracy, etc., as it's not an AI/ML device. Instead, it relies on demonstrating substantial equivalence to predicate devices through technical specifications and adherence to recognized standards. The "performance" is implicitly considered to be comparable to the predicate devices if the technical characteristics are similar and the device meets safety standards.

2. Sample size used for the test set and the data provenance
Not applicable. This device is a laser surgical instrument, and the provided document does not describe a performance study with a test set of data samples (e.g., medical images, patient records). The evaluation is based on non-clinical testing of the device itself (electrical, mechanical safety, software V&V, biocompatibility) and a comparison of its technical specifications and intended use against legally marketed predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as there is no "test set" or "ground truth" establishment in the context of an AI/ML performance study described. The document relies on recognized standards and the established safety and efficacy of predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is 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
No. This device is a laser surgical instrument and does not involve AI assistance for human readers or interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm. Its performance is inherent to its physical and functional design, which is assessed through non-clinical bench testing and comparison.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of an AI/ML performance study. The "ground truth" for this submission is adherence to established industry safety and performance standards (e.g., IEC, ISO) and demonstrating that the device's technical characteristics and indications for use are substantially equivalent to those of legally marketed predicate devices.

8. The sample size for the training set
Not applicable, as this is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device requiring a training set or its associated ground truth.

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1064 nm Diode Laser in dentistry:

• · Excisional and incisional biopsies
• · Excision and vaporization of herpes simplex I and II
• · Frenectomy and frenotomy
• · Gingivectomy
• Gingivoplasty
• · Gingival incision and excision
• · Hemostasis
• · Implant recovery
• · Operculectomy
• Pulpotomy and pulpotomy as an adjunct to root canal therapy
• · Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy
• · Sulcular debridement or soft tissue curettage (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss, and tooth mobility)
• · Treatment of aphthous ulcers and herpetic lesions

1064 nm Diode Laser in dermatology and other surgical areas:
· General surgery indications: surgical incision, vaporization and coagulation of soft tissue. All soft tissue is included, striated and smooth tissue, muscle, cartillage, menibrane, lymph vessels and nodes, organs and glands, fibroma removal.
• Podiatry (ablation, vaporization, excision, and coagulation of soft tissue) including: Matrixectomy, Periungual and subungual warts, Plantar warts, Radical nail excision, Neuromas.
· Temporary increase of clear nail in patients with onychomycosis (e.g. dermatophytes Trichophyton rubrum and T mentagrophytes and/or yeasts Candida albicans, etc.)

1064 nm Diode Laser in 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.

810 nm Diode Laser in dentistry:
· Surgical applications requiring the ablation, vaporization, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, neurosurgery, otolaryngology, ophthalmology, and pulmonology

• · Oral/Maxillofacial Indications: Incision, excision, vaporization, ablation and/or coagulation of soft tissue
• · Gingival troughing for crown impression
• · Gingivectomy
• Gingivoplasty
• 。 Gingival incision and excision
• 。 Hemostasis and coagulation
• · Excisional and incisional biopsies
• Fibroma removal
• 。 Frenectomy and frenotomy
• 。 Oral papillectomies
• · Soft tissue crown lengthening
• 。 Treatment of aphthous ulcers
• 。 Treatment of herpetic lesions
• · Periodontology:
• · Laser soft tissue curettage
• · Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
• Cosmetic Dentistry:
• 。 Laser-assisted bleaching/whitening of the teeth
• · Light activation for bleaching materials for teeth whitening
• Implant recovery

810 nm Diode Laser in therapy:
· Temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.

980 nm Diode Laser in dentistry:
· Surgical applications requiring the ablation, vaporization, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, ophthalmology, pulmonology and thoracic surgery

• Gingival troughing
• Crown lengthening
• Gingivoplasty •
• · Coagulation
• Implant uncovery
• Implant recovery
• Soft tissue curettage
• Sulcular debridement
• · Biopsy
• · Frenectomy
• Hemostasis of donor site
• Operculectomy
• Exposure of unerupted teeth .
• Pulpotomy .
• Treatment of aphthous ulcers .
• Excision of lesions ·
• Light activation of bleaching materials for teeth whitening •

The Fotona XPulse Laser System Family is a multi-application, multi-technology laser system family that supports the diode laser technology. A diode aiming beam is combined with all therapeutic laser beams. The combined therapeutic and aiming beams are guided through an optical fiber delivery system to an optical handpiece or to the bare fiber distal end. The Fotona XPulse Laser System Family consists of a console and a footswitch. Output parameters and other system features are controlled from the touch-screen control panel on the console, which provides an interface to the system micro-controller through an LCD touch-screen. A diode aiming beam is combined with all therapeutic laser beams. The combined therapeutic and aiming beams are guided through an optical fiber delivery system to an optical handpiece or to the bare fiber distal end. The following wavelengths are currently available with the XPulse System Family: 810 nm, 980 nm and 1064 nm. The following handpieces are to be used with Fotona XPulse Laser System Family: R21 (variants C2, C3, SHP and EHP), R26 (variants: black, green, blue, silver and red), Genova- and MarcCo (variants S, M and L).

The provided text is an FDA 510(k) clearance letter and associated summary for the Fotona XPulse Laser System Family. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than proving a medical device meets specific performance acceptance criteria through the kind of study described in the prompt.

Therefore, the information required to populate the fields related to acceptance criteria, test set, expert ground truth, adjudication, MRMC, standalone performance, training set, and ground truth establishment is not present in the provided text.

This document specifically states:

• "Clinical testing: No clinical testing was needed." (Page 11)
• The device's substantial equivalence is based on "technical characteristics, performance test data, and its intended use" compared to predicate devices, referencing adherence to various IEC and ISO standards for safety, electromagnetic compatibility, usability, and software (Pages 9-11). The "performance test data" mentioned here refers to engineering and quality assurance tests demonstrating the device's technical specifications match the predicate devices, not clinical studies for diagnostic accuracy or treatment efficacy.

In summary, the provided text does not contain the information requested in the prompt because the 510(k) pathway for this device did not require such a clinical study to demonstrate "acceptance criteria" and "device performance" in the way typically associated with diagnostic AI/ML products.

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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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810 nm Diode Laser System:

• · Incision, excision, vaporization, ablation and coagulation of oral soft tissues including the following:
  • 。 Gingival troughing for crown impression
  • · Gingivectomy
  • · Gingivoplasty
  • 。 Gingival incision and excision
  • 。 Hemostasis and coagulation
  • · Excisional and incisional biopsies
  • Fibroma removal
  • · Frenectomy and frenotomy
  • · Oral papillectomies
  • · Soft tissue crown lengthening
  • 。 Treatment of aphthous ulcers
  • · Treatment of herpetic lesions
• · Periodontology:
  • · Laser soft tissue curettage.
  • · Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
• Cosmetic Dentistry:
  • · Laser-assisted bleaching/whitening of the teeth,
  • · Light activation for bleaching materials for teeth whitening
• · Implant recovery
• · Surgical applications requiring the ablation, vaporization, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, otolaryngology, ophthalmology, and pulmonology

810 nm Diode Laser Module:
· Incision, excision, vaporization, ablation and coagulation of oral soft tissues including the following:

• 。 Gingival troughing for crown impression
• · Gingivoplasty
• · Soft tissue crown lengthening
• 。 Treatment of aphthous ulcers
• 。 Treatment of herpetic lesions

810 nm Diode Laser System & Module in therapy:
· Temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.

980 nm Diode Laser:

• · Gingival troughing
• · Crown lengthening
• · Gingivoplasty
• · Coagulation
• Hemostasis of donor site
• Implant recovery
• Implant uncovery
• · Soft tissue curettage
• · Sulcular debridement
• Biopsy
• · Frenectomy
• Operculectomy
• Exposure of unerupted teeth
• Pulpotomy
• Treatment of aphthous ulcers
• · Excision of lesions
• · Light activation of bleaching materials for teeth whitening
  · Surgical applications requiring the ablation, vaporization, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, ophthalmology, and thoracic surgery.

445 nm Diode Laser:
· Incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue

The Fotona XPulse Pro Laser Platform is a multi-application, multi-technology platform that supports the diode laser technology. A diode aiming beam is combined with all therapeutic laser beams. The combined therapeutic and aiming beams are guided through an optical fiber delivery system to an optical handpiece or to the bare fiber distal end.

The Fotona XPulse Pro Laser Platform consists of a console, a footswitch and attachable laser modules. Output parameters and other system features are controlled from the touch-screen control panel on the console, which provides an interface to the system micro-controller through an LCD touch-screen.

A diode aiming beam is combined with all therapeutic laser beams. The combined therapeutic and aiming beams are guided through an optical fiber delivery system to an optical handpiece or to the bare fiber distal end. The following wavelengths are currently available with the XPulse platform: 445 nm, 810 mm and 980 nm.

Following handpieces are to be used with Fotona Xpulse Pro Laser Platform: R21-SHP, R26 (variants: black, green, blue, silver and red), R24, R30, Genova and MarcCo (variants S, M & L).

Please note: The provided text describes a medical device submission (510(k) Premarket Notification) for the Fotona XPulse Pro Laser Platform. This document focuses on demonstrating substantial equivalence to predicate devices and does not present a typical study with acceptance criteria and results in the way one might expect for a new diagnostic or AI-powered device.

Therefore, the requested information elements related to AI-specific study design (e.g., sample size for test sets, number of experts for ground truth, MRMC study, training set details) are not available in this document because this is a laser surgical instrument, not an AI diagnostic device. The document states "Clinical testing: No clinical testing was needed."

Here's the information that can be extracted from the provided text, structured to address your request where possible, and indicating where information is not applicable (N/A) or not provided:

Acceptance Criteria and Device Performance Study for Fotona XPulse Pro Laser Platform

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for a laser surgical instrument, and not an AI or diagnostic device with quantifiable performance metrics like sensitivity/specificity, the "acceptance criteria" are based on demonstrating substantial equivalence to existing predicate devices. The performance is assessed through technical specifications and adherence to standards rather than clinical endpoints in this 510(k) summary.

• 810 nm Diode Laser Module: Incision, excision, vaporization, ablation, and coagulation of oral soft tissues (similar sub-indications as system).
• 810 nm Diode Laser System & Module in therapy: Temporary relief of minor muscle/joint pain, stiffness, arthritis pain, muscle spasm, sprains/strains, muscular back pain; temporary increase in local blood circulation; temporary relaxation of muscle.
• 980 nm Diode Laser: Gingival troughing, crown lengthening, gingivoplasty, coagulation, hemostasis of donor site, implant recovery/uncovery, soft tissue curettage, sulcular debridement, biopsy, frenectomy, operculectomy, exposure of unerupted teeth, pulpotomy, treatment of aphthous ulcers, excision of lesions, light activation for bleaching; Surgical applications in dermatology, dentistry, gastroenterology, general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, ophthalmology, pulmonology, thoracic surgery.
• 445 nm Diode Laser: Incision/excision, vaporization, ablation, hemostasis, and coagulation of soft tissue.
  (These indications are explicitly stated as "same indications for use" with predicate devices in the Statement of Substantial Equivalence) |
  | Similar Technological and Design Characteristics | - Energy Source: Diode (matches predicates)
• Wavelengths: 810 nm, 980 nm, 445 nm (matches predicates)
• Power Output (Examples): Up to 8 W (810 nm system), Up to 1.5 W (810 nm module), Up to 12 W (980 nm), Up to 4 W (445 nm) (compared favorably to predicate ranges)
• Pulse Width (Examples): 20 μs to 30 s, CW (810 nm); 100 μs to 60 s, CW (980 nm) (similar to predicates, sometimes different ranges but functionally equivalent for intended use)
• Repetition Rate (Examples): CW, 0.1 Hz to 200 Hz (similar to predicates, sometimes different ranges but functionally equivalent)
• Delivery System: Contact and non-contact handpieces connected via fiber (matches predicates)
• User Interface: Touch screen control (matches most recent predicates)
• Aiming Beam: Laser diode (650 nm or 532 nm;

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Er: Y A G 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 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 curettage;
• · Laser removal of porcelain and ceramic crowns and veneers;
• · Flap preparation incision of soft-tissue to prepare a flap and expose the bone;
• · Cutting bone to prepare a window access to the apex (apices) of the root(s);
• · Root-end preparation for retrofill amalgam or composite;
• · Full thickness flap;
• · Partial thickness flap:
• · Split thickness flap;
• · Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket;
• · Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining junctional epithelium; · Excisional and incisional biopsies;
• · Flap preparation incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions);
• · Frenectomy and frenotomy;
• · Gingival troughing for crown impressions;
• · Gingivectomy:
• · Gingivoplasty;
• Implant recovery:
• · Root canal debridement and cleaning;
• · Soft tissue crown lengthening;
• · Laser root canal disinfection after endodontic treatment;

Er:Y AG laser (2940 nm wavelength) in dermatology and other surgical areas:
The LightWalker Er: YAG laser is intended for surgical incision/excision, 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, gingivectomy;
  · Uvulopalatoplasty by laser resurfacing
  · 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;
• · Podiatry Indications: Warts, plantar verrucae, large mosaic verrucae, matrixectomy;
• · Ophtalmology Indications: Soft tissue surrounding the eye;
  · 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, valvar lesions, polyps and familial polyps of the colon;
  · Dermatological procedures requiring resurfacing of soft tissue with Fotona FS-01 fractionated handpiece.

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 toothmobility):
• · Tissue retraction for impression;
• Treatment of aphtous ulcers:
• · Vestibuloplasty;
  · Laser assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium);
  · Periodontal regeneration of the attachment apparatus (new cementum, new periodontal ligament, and new alveolar bone) on a previously diseased root surface.

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, hemangiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins;

• Treatment of wrinkles:
• · Treatment of mild to moderate inflammatory acne vulgaris;
• · General surgery indications: surgical incision, 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, and coagulation of soft tissue) including. Matrixectomy, Periungual and subungual warts. Plantar warts, Radical nail excision, 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 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.
*Note: Permanent hair reduction is defined as the long-term, stable redction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

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 diode aiming beam is combined with both therapeutic laser beams. The combined therapeutic and aiming beams are guided through an articulated arm to an optical handpiece (in the case of the Er: YAG laser), or, in the case of the Nd:YAG laser, through an optical fiber delivery system to an optical handpiece or to the bare fiber distal end. The Er:YAG laser is intended to be used for incision/excision, cutting, ablation, vaporization and coagulation of soft and hard tissue in dentistry, dermatology and other surgical areas. The Nd:YAG laser is intended to be used for various intra oral treatments in dentistry, and for various surgical and aesthetic applications in dermatology and other surgical areas.

The provided text describes a 510(k) premarket notification for the Fotona LightWalker Laser System Family, which is a medical laser system. The document focuses on establishing substantial equivalence to predicate devices and does not detail specific acceptance criteria or a study that evaluates the device's performance against such criteria in the context of clinical outcomes or diagnostic accuracy. Instead, the "acceptance criteria" discussed are related to regulatory compliance and safety standards, and the "study" is a non-clinical summary of verification and validation tests.

Therefore, the requested information elements related to device performance (e.g., accuracy, sensitivity, specificity), ground truth, sample sizes for test and training sets, expert qualifications, adjudication methods, and MRMC studies are not applicable to this document as it does not present a clinical performance study of this nature.

Here's the information that can be extracted based on the provided text, primarily focusing on the regulatory and technical aspects:

1. Table of Acceptance Criteria and Reported Device Performance

As this document does not present a clinical performance study with acceptance criteria for metric-based performance (e.g., sensitivity, specificity, accuracy), the "acceptance criteria" here refer to compliance with safety and performance standards. The "reported device performance" refers to the device meeting these standards.

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

• Not Applicable. The document describes a substantial equivalence submission based on non-clinical testing and comparison to predicate devices, not a clinical study with a "test set" of patient data.

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

• Not Applicable. No experts were used to establish ground truth for a clinical test set as no such study is described.

4. Adjudication method for the test set:

• Not Applicable. No test set or related adjudication process 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. No MRMC study or AI component is mentioned. This is a laser device cleared for surgical procedures.

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

• Not Applicable. This device is a laser system, not an algorithm. Its operation inherently involves a human operator and it does not have "standalone" performance in the context of an algorithm.

7. The type of ground truth used:

• Not Applicable. The "ground truth" for this regulatory submission is compliance with established safety and performance standards for medical devices and establishing substantial equivalence based on technical characteristics and intended use. No clinical ground truth (e.g., pathology, outcomes data) is presented in this document.

8. The sample size for the training set:

• Not Applicable. This document does not describe a machine learning algorithm or a training set.

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

• Not Applicable. This document does not describe a machine learning algorithm or a training set.

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The StarWalker Laser System Family is indicated for:

1064 nm wavelength in Q-switched mode:

-Removal of dark (black, blue, brown) tattoo ink

-Treatment of nevus of ota

-Treatment of common nevi

-Removal and lightening of unwanted hair

-Skin resurfacing procedures for the treatment of acne scars and wrinkles

-Treatment of melasma

-General dermatology indications: Incision, excision, ablation and vaporization of soft tissue

1064 nm wavelength in long pulse 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 benign pigmented and benign vascular lesions, such as, but not limited to,

port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins

-Coagulation and hemostasis of soft tissue

-Treatment of wrinkles

-Treatment of mild to moderate inflammatory acne vulgaris

1064 nm wavelength in PICO mode:

-Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple

-Benign pigmented lesions removal for Fitzpatrick Skin Types I-IV

-Treatment of acne scars in Fitzpatrick Skin Types II-V

-Treatment of wrinkles as well as benign pigmented lesions in Fitzpatrick Skin Types I-IV

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

-Red, tan, purple and orange tattoo ink removal

-Sky blue (light) tattoo ink removal

-Green tattoo tattoo ink removal

-Treatment of benign pigmented lesions including, but not limited to: cafe-au-lait birthmarks, solar lentigines, senile lentigines, senile lentigines, Becker's nevi, freckles, common nevi, nevus spilus

-Treatment of benign vascular lesion including, but not limited to: port wine birthmarks, telangiectasias, spider angioma, cherry angioma, spider nevi

-Seborrheic Keratosis

-Treatment of post-inflammatory hyperpigmentation

-Skin resurfacing procedures for the treatment of acne scars and wrinkles

-Removal of epidermal pigmented lesions

532 nm wavelength in long pulse mode:

-Incision, ablation vaporization, coagulation and hemostasis of vascular lesions and soft tissue in various surgical areas. All soft tissue is included, such as skin, cutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.

-The treatment (hemostasis, color lightening, blanching, reduction of lesion size) of the benign vascular lesions (Angiomas, Hemangiomas, Telangiectasia)

532 nm wavelength in PICO mode:

-Tattoo removal in Skin Types I - III

-Treatment of benign pigmented lesions in Fitzpatrick Skin Types I-IV

The Fotona StarWalker Laser System Family is based on the previously cleared Fotona StarWalker Laser System Family (K171227).The device 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: Y AG 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 nm or a 650 nm wavelength, correspondingly. The user activates laser emission by means of a footswitch. All handpieces are equipped with sensors for automatic detection of a handpiece type and the spot size.

The provided text is a 510(k) premarket notification for a medical device, specifically a laser system. It details the device's indications for use, technological characteristics, and comparison to predicate devices, along with the non-clinical tests performed.

However, the document states "Clinical Summary: Not Applicable." This means that no clinical studies were performed, and therefore, there is no information regarding acceptance criteria for device performance based on human reader studies, an AI algorithm's standalone performance, ground truth establishment, or sample sizes related to clinical data.

The document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and adherence to relevant safety and performance standards (EN, IEC, ISO).

Therefore, I cannot provide the requested information, particularly points 1 through 9, as they pertain to clinical studies that were explicitly stated as "Not Applicable" in this submission.

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