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General Indications:

• Class I, II, III, IV and V cavity preparation
• Caries removal
• Hard tissue surface roughening or etching
• Enameloplasty, excavation of pits and fissures for placement of sealants
• • For use on adult and pediatric patients

Root Canal Hard Tissue Indications:

• Tooth preparation to obtain access to root canal
• Root canal preparation including enlargement
• Root canal debridement and cleaning

Root Canal Disinfection:

• Laser root canal disinfection after endodontic treatment

Endodontic Surgery (Root Amputation) Indications:

• 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).
• Apicoectomy - amputation of the root end.
• Root end preparation for retrofill amalgam or composite.
• Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex
  NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation.

Bone Surgical Indications:

• Cutting, shaving, contouring and resection of oral osseous tissues (bone)
• Osteotomy

Soft Tissue Indications including Pulpal Tissues*:
Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including:

• Excisional and incisional biopsies
• Exposure of unerupted teeth
• Fibroma removal
• Flap preparation incision of soft tissue to prepare a flap and expose the bone.
• 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
• Gingival incision and excision
• Hemostasis
• Implant recovery
• Incision and drainage of abscesses
• Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area during apical surgery
• Leukoplakia
• Operculectomy
• Oral papillectomies
• Operculectomy
• Oral papillectomies
• Pulpotomy
• Pulp extirpation
• Pulpotomy as an adjunct to root canal therapy
• Root canal debridement and cleaning
• Reduction of gingival hypertrophy
• Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex
  NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation.
• Soft tissue crown lengthening
• Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
• Vestibuloplasty

• For use on adult and pediatric patient

Laser Periodontal Procedures:

• Full thickness flap
• Partial thickness flap
• Split thickness flap
• Laser soft tissue curettage
• 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
• Removal of granulation tissue from bony defects
• Sulcular debridement (removal of diseased, inflamed or necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)
• Osteoplasty and osseous recontouring (removal of bone to correct osseous defects and create physiologic osseous contours)
• Ostectomy (resection of bone to restore bony architecture, resection of bone for grafting, etc.)
• Osseous crown lengthening
• Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage
• Waterlase MD Er,Cr:YSGG assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium)

The Waterlase MD Turbo Plus is a dental laser device indicated for incision, excision, removal, and specific dental therapies, such as root canal therapy and periodontal therapy. All indications for use submitted for the Waterlase® MD Turbo Plus have been previously cleared by the FDA and there are no new indications included for this device.

This K101658 510(k) submission for the Waterlase MD Turbo Plus does not contain specific acceptance criteria or a detailed clinical study demonstrating the device's performance against such criteria. Instead, it relies on substantial equivalence to previously cleared predicate devices.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria or report device performance in a formal table with metrics like sensitivity, specificity, accuracy, etc. The "performance" described is largely qualitative and comparative to predicate devices.

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

• Test Set Sample Size: Not explicitly stated. For the higher energy per pulse, it mentions "comparison of class II cavity preparations prepared at 600 mJ per pulse." For the new frequencies, it mentions "Gingivoplasties performed at the two new frequencies on pig jaw gingiva." No specific numbers of preparations or gingivoplasties are provided.
• Data Provenance: The document does not specify the country of origin. The test for gingivoplasty was performed on "pig jaw gingiva," indicating an in vitro or ex vivo animal model rather than human clinical data. The comparison of Class II cavity preparations suggests an in vitro or ex vivo setting as well, given the lack of clinical study details. The data is likely retrospective in the sense that it's a comparison to established performance of predicate devices, or bench/laboratory for the specific tests mentioned.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not performed. The submission explicitly states: "No clinical performance data is required for this submission." The equivalency is established through comparison to predicate devices and limited performance data (Class II cavity preparations and gingivoplasties on pig jaw gingiva), not through human reader studies.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

The Waterlase MD Turbo Plus is a physical dental laser device, not an algorithm. Therefore, a "standalone algorithm performance" study is not applicable. The performance data mentioned (cavity preparations, gingivoplasties) represents the device's direct physical interaction with tissue.

7. Type of Ground Truth Used:

• For the Class II cavity preparations, the "ground truth" implicitly refers to the established effectiveness and safety of the predicate device (Waterlase® MD Turbo) for this application. The new device's performance is compared to this established benchmark.
• For the gingivoplasties on pig jaw gingiva, the "ground truth" would be the observed clinical effect (e.g., successful tissue removal, absence of adverse effects) as assessed by technical or dental experts, compared to the expected outcome from predicate devices for a similar indication. This is a technical assessment rather than a diagnostic "ground truth" like pathology or clinical outcomes in a human patient.

8. Sample Size for the Training Set:

This is irrelevant as the Waterlase MD Turbo Plus is a physical device and not an AI/ML algorithm that requires a training set.

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

This is irrelevant as the Waterlase MD Turbo Plus is a physical device and not an AI/ML algorithm.

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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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