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Intended Use: Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis.

Specific Indications:
1064 nm wavelength

• Tattoo Removal (dark ink: blue and black)
• Nevus of Ota
• Removal or lightening of hair with or without adjuvant preparation.
• Skin Resurfacing for Acne Scars and Wrinkles
• Benign cutaneous lesions, such as, but not limited to: striae and scars (excludes the 650nm wavelength)
• Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar (excludes the 650nm wavelength)

532 nm wavelength (nominal delivered energy of 585 nm and 650 nm with the Optional Multilite Dye Laser Handpiece)

• Tattoo removal (light ink: red, sky blue, green)
• Vascular lesions including but not limited to: port wine birthmarks, telangiectasias, spider angioma, cherry angioma, spider nevi
• Epidermal Pigmented lesions including but not limited to: cafe-au-lait birthmarks, solar lentiginos, senile lentiginos, Becker's nevi, Freckles, Nevus spilus
• Skin Resurfacing for Acne Scars and Wrinkles
• Benign cutaneous lesions, such as, but not limited to: striae and scars (excludes the 650nm wavelength)
• Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar (excludes the 650nm wavelength)

The entire laser unit and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. Laser energy produced within the device is delivered to the tissue by means of an articulated arm and a specially designed MultiSpot Handpiece (532 nm and 1064 nm) or optional Multilite Dye Laser Handpiece (650 nm and 585 nm). The user activates laser emission by means of a footswitch.

The RevLite Systems are designed to provide laser energy for use in a variety of dermatological procedures (see indications for use). The 532 nm and 1064 nm wavelengths and optional 650 nm and 585 nm wavelengths are absorbed by pigment and other chromophores within the skin to create the desired clinical effect. The laser incorporates very narrow laser pulses (5-20 ns) designed to apply higher peak power over a very short period to minimize the time to absorb heat into the tissue.

This 510(k) submission for the RevLite™ Q-Switched Nd:YAG Laser System is for a new indication for use and therefore does not include a study to prove acceptance criteria. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with acceptance criteria.

The provided document describes the device, its intended use, and compares it to predicate devices. It states under "Nonclinical Performance Data" and "Clinical Performance Data" that "None" were requested or provided at the time of this submission. The FDA's letter (K083899) confirms that the device was deemed "substantially equivalent" for the stated indications based on comparison to predicate devices, not on new performance data demonstrating specific acceptance criteria.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor can I describe study details like sample sizes, ground truth establishment, or expert adjudication, as this information is not present in the provided document.

Summary of unavailable information based on the provided document:

• A table of acceptance criteria and the reported device performance: Not provided. The submission states "None" for clinical performance data.
• Sample sized used for the test set and the data provenance: Not applicable, as no new clinical study data was presented.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method for the test set: Not applicable.
• 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 is a laser system, not an AI diagnostic device.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a laser system, not an algorithm.
• The type of ground truth used: Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

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The DERMASCULPT is intended for Dermatological procedures requiring incision, excision, coagulation and vaporization of soft tissue. The specific indications using the applicable handpieces are as follows: Skin resurfacing in the treatment of wrinkles and scar revision (including acne scars) with the non-fractionated handpiece. Removal of cutaneous skin lesions with the micron tip handpieces including epidermal nevi, actinic chellitis, keloids, verrucae, skin tags, anal tags, keratosis, scar revision, (including acne scars), benign tumors and cysts, superficial skin lesions and diagnostic biopsies. The DERMASCULPT with the fractionated scanner handpiece is intended/indicated for Dermatological procedures requiring coagulation of soft tissue and skin resurfacing.

The DermaSCULPT Er:YAG Laser System [DermaSCULPT] unit and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. The laser energy produced within the device is delivered to the tissue by means of Fiber Delivery System and specially designed Scanner, Handpieces, Tips and Adaptors. The user activates laser emission by means of a footswitch. The lamp power supply causes the flash lamp to light, causing the emission of an invisible infrared Er:YAG laser beam (2.94 microns). A visible white light pulsed beam from the flashlamp is used as an aiming beam. The laser beam passes through a partially reflecting mirror and then passes through the energy monitor, after which its power is measured. When all the pre-conditions have been satisfied and the READY button is pressed and the foot switch is depressed, the safety shutter opens and the laser beam is allowed into the delivery unit coupler. The electrical system is comprised of the laser power supply, the control unit, calibrator, control panel, key switch, emergency stop switch, and foot switch. The components of the laser power supply include a high voltage power supply and a high voltage trigger control board. The high voltage power supply uses the high voltage to illuminate the flashlamp. The control unit comprises a microprocessor board, accessory board and other components that it controls. The calibrator measures the transmittance of the fiber delivery unit. The handheld scanner module is an attachment to the fiber.

The provided text describes the DermaSCULPT Er:YAG Laser System, its intended use, and its comparison to predicate devices, but it does not contain details about a study that establishes acceptance criteria or proves the device meets those criteria with specific performance metrics.

The document is a 510(k) summary for a medical device which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance studies with acceptance criteria in the way you've described for AI/algorithm performance.

Therefore, I cannot provide the information requested in your bullet points as the provided document does not contain it. The "Nonclinical Performance Data" section states: "The review of the technical characteristics, indications for use, mechanism of action, and verification and validation information provided demonstrate that the DermaSculpt is substantially equivalent to its predicate device." and "Clinical Performance Data" states: "HOYA ConBio has established that the DermaSculpt performs as clinically intended and that no new issues of safety and effectiveness are introduced." These statements indicate that performance was reviewed for substantial equivalence, but they do not provide specific acceptance criteria or study results in the format you've requested.

If you have a document that describes specific studies with acceptance criteria for an AI/algorithm-based device, please provide that text.

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Intended Use:The V-Raser is intended for Incision, excision, ablation, vaporization and coagulation of soft tissue.

Specific Indications: Treatment of vascular lesions.

The V-RASER Diode System is a modified Diodent Micro 980. It will use similar specifications (laser medium, excitation method, fiber optic beam delivery, electrical requirements, physical specifications) as the Diodent Micro 980. The laser source of this device is a solid-state Gallium Aluminum Arsenide (GaAlAs) semiconductor diode. It produces invisible laser energy at the 980-nanometer wavelength. The delivery system consists of removable flexible HCS (hard clad silica) optical treatment fiber assembly connected to a lightweight, hand piece that has two different size end pieces (tips) to adjust the laser beam to specific spot sizes. Activation occurs when the operator enables the laser by a key switch, enters the Ready Mode and presses the footswitch. Releasing the footswitch suspends laser treatment. A color LCD and touch-screen display panel allows the operator to adjust or set the laser output level. The laser operates in a pulsed mode and will have a removable stainless steel end piece for establishing the proper focal length for the treatment. The hand piece will be manually attached (i.e., screwed on) to a connector to the fiber assembly. The spot size will be selected on the control panel and the software will calculate the treatment fluence accordingly.

The provided 510(k) summary for the V-RASER Diode Laser System does not contain information about acceptance criteria or a study proving the device meets them.

Instead, it's a premarket notification for a medical device seeking substantial equivalence to a predicate device. The document explicitly states:

• Nonclinical Performance Data: None
• Clinical Performance Data: None

Therefore, I cannot provide the requested information. This device was cleared based on its similarity to existing, legally marketed devices, rather than through a study demonstrating its performance against specific acceptance criteria.

The information regarding the training set, test set, ground truth, expert qualifications, and adjudication methods is typically found in clinical or performance studies, which were not submitted for this 510(k) application.

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For the incision, excision, ablation, vaporization, and hemostasis of oral soft tissue.

Examples:

Excisional and incisional biopsies 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 Leukoplakia Operculectomy Oral papillectomies Pulpotomy Pulpotomy as an adjunct to root canal therapy Reduction of gingival hypertrophy Reduction of bacterial level (decontamination) and inflammation Soft tissue crown lengthening Sulcular debridement (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)

Treatment of aphthous ulcers Vestibuloplasty Biopsy incision and excision Lesion (tumor) removal

For light activation for bleaching materials for teeth whitening For laser-assisted bleaching/whitening for teeth.

The laser source of the DioDent Micro 810/980 is a solid-state Gallium Aluminum Arsenide (GaAlAs) semiconductor diode. It produces invisible laser energy at the 810-nanometer or 980nm wavelength. The delivery system consists of an autoclavable flexible treatment fiber threaded through a lightweight, autoclavable hand piece. Activation occurs when the operator enables the laser and presses the footswitch. Releasing the footswitch suspends laser treatment. The footswitch can function as an on/off switch. A color touch-screen display panel allows the operator to adjust or set laser output level with minimal effort. The laser can operate in continuous wave or pulse mode.

The provided text is a 510(k) summary for the HOYA ConBio DioDent Micro 810/980 Dental Laser System. It focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than proving performance against specific acceptance criteria through clinical studies. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth establishment is not present in this document.

Here's an analysis of the provided text in response to your questions:

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

This document does not provide a table of acceptance criteria or reported device performance based on a dedicated study designed to meet specific metrics. The 510(k) pathway relies on demonstrating substantial equivalence to a predicate device.

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

There is no mention of a test set sample size or data provenance because no clinical or non-clinical performance study against specific acceptance criteria was conducted or necessary for this 510(k) submission. The submission explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None".

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 test set or ground truth establishment process is described for performance evaluation.

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

Not applicable, as no 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 device is a dental laser, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not mentioned.

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

Not applicable. This device is a dental laser, not a standalone algorithm.

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

Not applicable, as no ground truth for performance evaluation was established in the context of this 510(k) summary. The submission relies on the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable, as this device is not an AI/ML algorithm that requires a training set.

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

Not applicable, as no training set was used.

Summary of Device Rationale from the Provided Text:

The basis for market clearance for the DioDent Micro 810/980 Dental Laser System is the demonstration of substantial equivalence to legally marketed predicate devices:

• SIROLaser by Sirona Dental Systems (K053161)
• DioDent II Dental Laser System by HOYA ConBio (K050274)
• Twilight Diode Laser System by BioLase Technologies (K991994)

The submission states that the DioDent Micro 810/980 is "equivalent in operating parameters, physical characteristics, and intended uses" to these predicate devices. The only noted difference among the equivalent devices is that the DioDent II (one of the predicates) is explicitly cleared for teeth whitening. The DioDent Micro 810/980's intended use also includes teeth whitening, implying it also aligns with the specified predicate for that particular indication.

Therefore, the "acceptance criteria" in this context are primarily regulatory – meeting the criteria for substantial equivalence under 21 CFR 878.4810 for a Class II medical device, which does not require new clinical performance studies if equivalence to a predicate device is adequately demonstrated.

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The RevLite O-switched Nd: YAG Laser System is indicated for Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis.

Specific Indications

1064 nm wavelength:

Tattoo Removal: Dark Ink: (Black & Blue)

Nevus of Ota

Removal or lightening of unwanted hair with or without adjuvant preparation.

Skin resurfacing procedures for the treatment of acne scars and wrinkles

532 nm wavelength (nominal delivered energy of 585nm and 650 nm with the Optional Multilite Dye Laser Handpiece):

Tattoo Removal: Light Ink (Red, Sky Blue, Green)

Treatment of Vascular Lesions including, but not limited to:

• . Prot wine birthmarks
• Telangiectasias .
• Spider angioma .
• Cherry angioma .
• Spider nevi .

Treatment of Pigmented Lesions including, but not limited to:

• Café-au-lait bithmarks .
• Solar lentiginos .
• Senile lentiginos .
• Becker's nevi .
• Freckles .
• Nevus spilus .

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

The RevLite System with LCD Panel laser unit and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. Laser energy produced within the device is delivered to the tissue by means of an articulated arm and a specially designed MultiSpot Handpiece or optional Multilite Dye Laser Handpieces. The user activates laser emission by means of a footswitch. The RevLite System incorporates 2 very narrow laser applications designed to apply more energy over a larger spot size at the same fluence level, enabling the physician to treat a larger area more rapidly.

The provided K063834 RevLite Q-Switched Laser System did not include any clinical performance data or studies. The submission explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: none".

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer any of the subsequent questions related to a study, as no such study is described in this document.

The FDA's decision was based on a comparison to an equivalent device (RevLite C6 Q-Switched Nd: YAG Laser System - K063112) in terms of indications for use, technical specifications, operating performance features, and general design features, rather than on new performance data for this specific submission.

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The RevLite Q-Switched Nd: YAG Laser System is indicated for Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology, Dermatology, Dermand General Surgical Procedures for Coagulation and Hemostasis.

Specific Indications:

1064 nm wavelength:

Tattoo Removal: Dark Ink: (Black & Blue)

Nevus of Ota

Removal or lightening of unwanted hair with or without adjuvant preparation.

Skin resurfacing procedures for the treatment of acne scars and wrinkles

532 nm wavelength (nominal delivered energy of 585nm and 650 nm with the Optional Multilite Dye Laser Handpiece):

Tattoo Removal: Light Ink (Red, Sky Blue, Green)

Treatment of Vascular Lesions including, but not limited to:

• port wine birthmarks
• . telangiectasias
• spidcr angioma
• . cherry angioma
• spider nevi

Treatment of Pigmented Lesions including, but not limited to:

• . cafe-au-lait birthmarks
• . solar lentiginos
• . senile lentiginos
• Becker's nevi
• Freckles
• Nevus spilus ◆

Skin resurfacing procedures for the treatment of acne scars and wrinkles

The RevLite System laser unit and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. Laser energy produced within the device is delivered to the tissue by means of an articulated arm and a specially designed MultiSpot Handpiece or optional Multilite Dye Laser Handpieces. The user activates laser emission by means of a footswitch. The RevLite System incorporates 2 very narrow laser applications designed to apply more energy over a larger spot size at the same fluence level, enabling the physician to treat a larger area more rapidly.

This 510(k) summary for the RevLite Q-Switched Nd: YAG Laser System does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The document states:

• "Nonclinical Performance Data: None"
• "Clinical Performance Data: none"

This means no studies were submitted to demonstrate performance against specific acceptance criteria. The clearance for this device was based on substantial equivalence to predicate devices (Focus Medical NaturaLase 1064 2 Joule Laser System and MedLite C6 Q-Switched Nd: YAG Laser System) in terms of "indications for use, technical specifications, operating performance features, and general design features," rather than new performance data.

Therefore, I cannot provide the requested information.

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For use in dermatology for all currently approved indications for the Medlite C-Series Nd: YAG Laser Systems and MultiSpot Handpiece.
Tattoo Removal
Nevus of Ota
Hair Removal
Vascular Lesions
Dermal Pigmented Lesions
Epidermal Pigmented Lesions
Laser Resurfacing for Acne scars and wrinkles
Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology

The Compression Tool and Handpiece Attachment Accessories are intended to be used to assist and enhance the procedure of treating dermatological conditions The Compression Tool and Handpiece Attachment Accessories are additional accessories designed to accompany the currently offered MedLite MultiSpot Handpiece. The purpose for these accessories are purely for a cosmetic end to help reduce undesirable purpura while treating with the Medlite C Series lasers.

The provided text describes a 510(k) submission for the "HOYA ConBio Compression Tool and Handpiece Accessories for use with MedLite™ C Series Q-Switched Nd: YAG Laser Systems". This submission is for accessory devices to an already approved laser system, aimed at reducing purpura during dermatological treatments.

Based on the content of the provided 510(k) summary and FDA letter, the primary focus is on substantial equivalence to predicate devices, rather than establishing new performance criteria through clinical studies with acceptance criteria, ground truth, or statistical analysis typically associated with AI/software devices. The devices in question are physical accessories (a compression tool and handpiece attachment), not a software or AI device that would have performance metrics like sensitivity, specificity, or AUC.

Therefore, many of the requested categories for AI/software device evaluation are not applicable here.

Here's a breakdown of the information that is available or can be inferred:

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

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics (e.g., sensitivity, specificity). The acceptance criteria for this type of submission would primarily revolve around demonstrating that the device is substantially equivalent to legally marketed predicate devices in terms of intended use, technological characteristics, and safety and effectiveness. This often involves engineering bench testing and potentially limited human factors evaluations for new accessories, rather than clinical efficacy studies with specific performance targets.
• Reported Device Performance: The submission states that the purpose of the accessories is "purely for a cosmetic end to help reduce undesirable purpura while treating with the Medlite C Series lasers." The "performance" is implicitly deemed acceptable by virtue of its substantial equivalence to the predicate device, which also aims to manage purpura. No specific numerical performance results (like "purpura reduction by X%") are provided.

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. This is a hardware accessory (compression tool and handpiece attachment) for a laser system, not a software or AI device that would typically rely on a "test set" of data or patient images for performance evaluation in the context of sensitivity/specificity. The evaluation would have been engineering/bench testing for safety and functionality.

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. See point 2. Ground truth is not established in the same way for a physical accessory as it would be for an AI diagnostic device.

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

• Not Applicable. See point 2.

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 device, and therefore, an MRMC study is not relevant.

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

• Not Applicable. This is a physical accessory to a laser system, not an algorithm.

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

• Not Applicable. The evaluation of these accessories likely focused on their mechanical fit, durability, and ability to apply compression without adverse effects, rather than a diagnostic ground truth. Safety and performance conformity to standards and predicate device characteristics would be the "ground truth" for this type of submission.

8. The sample size for the training set

• Not Applicable. This is a hardware accessory and does not involve AI training.

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

• Not Applicable. See point 8.

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The VersaWave Dental Er:YAG Laser System is intended for
Hard Tissue General Indications*:

• Class I, II, III, IV and V cavity preparation .
• Carries 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 .
  Bone Surgical Indications
• Cutting, shaving, contouring and resection of oral osseous tissues (bone) .
• . Osteotomy
  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 . Removal of pathological nesues (rom around the apex. Note: Any tissue growth (i.e. tissues (1.6. grandiaren besions) must be submitted to a qualified laboratory for histopathological evaluation.
  Laser Periodontal Procedures
• Full thickness flap .
• Partial thickness flap .
• Split thickness flap .
• Laser soft tissue curettage .
• Laser son ubsed of our and of the . periodontal pocket
• perfouontal pother
  Removal of highly inflamed edematous tissue affected by bacteria penetration of the . pocket lining and 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)
• gingi rai otooming masti, master, many of bone to correct osseous defects and . create physiological osseous contours)
• Ostectomy (resection of bone to restore bony architecture, resection of bone for . grafting, etc.)
• Osseous crown lengthening .
  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 the unerupted . teeth (hard and soft tissue impactions)
• Frenectomy and frenotomy .
• Gingival troughing for crown impressions .
• Gingivectomy .
• . Gingivoplasty
• Gingival incision and excision .
• Hemostasis and coagulation .
• Implant recovery ●
• Incision and drainage of abscesses .
• Incision and drainage of periapical abscesses .
• Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area . during apical surgery
• . Leukoplakia
• Operculectomy .
• Oral papillectomies .
• Pulpotomy .
• . Pulp extirpation
• Pulpotomy as an adjunct to root canal therapy .
• Reduction of gingival hypertrophy .
• Removal of pathological tissues (i.e. cysts, neoplasm, abscess) and hyperplastic . tissues (i.e. granulation tissue). Note: any tissue growth (i.e., cyst, neoplasm or other tissues (f.c. grandration aboratory for histopathological evaluation.
• Root canal debridement and cleaning .
• Soft tissue crown lengthening .
• Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa .
• Vestibuloplaty .
  *For use on adult and pediatric patients

Not Found

The provided document, K041710, is a 510(k) summary for the VersaWave Dental Er:YAG Laser System. It focuses on establishing substantial equivalence to existing predicate devices based on operating parameters, physical characteristics, and intended uses. Crucially, the document explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None." This means there is no study described within this document that proves the device meets any specific acceptance criteria beyond being substantially equivalent to legally marketed devices.

Therefore, I cannot fulfill the request to provide:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
• Information on a standalone performance study.
• The type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document indicates that the VersaWave Dental Er:YAG Laser System was cleared based on its substantial equivalence to other dental laser systems already on the market, not on new performance data demonstrating its ability to meet specific acceptance criteria.

The "Comparison" section explicitly states: "The VersaWave Dental Er: YAG Laser System, the DELight Er: YAG Laser System, the WaterLase, Millennium Dental Laser System, and the Premier Centauri Dental Laser System are equivalent in operating parameters, physical characteristics, and intended uses." This comparison is the basis for the 510(k) clearance, not a new study with acceptance criteria.

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