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The PerioLase Nd: YAG Pulsed Dental Laser System is intended for use in laser surgery procedures for ablation, incision, excision, vaporization, and coagulation of soft tissues in specialties such as general and cosmetic dentistry, oral, maxillofacial, and cosmetic surgery, otolaryngology / ENT surgery, arthroscopy, dermatology and plastic surgery, gastroenterology, general surgery, gynecology, neurosurgery, ophthalmology, podiatry, pulmonary surgery, and urology.

Orophayrngeal / Dental Surgery

• Abscess incision and drainage
• Aphthous ulcers treatment
• Biopsies, incisional and excisional
• Excision and ablation of benign lesions and conditions
• Excision and vaporization of herpes simplex I and II
• Exposure of unerupted / partially erupted teeth
• Facilitation of subgingival calculus removal
• Fibroma removal
• Frenectomy
• Frenotomy
• Gingival incision and excision
• Gingival troughing for crown impressions
• Gingivectomy
• Gingivoplasty
• Hemostasis
• Hemostatic assistance
• Implant recovery
• Incision of infection when used with antibiotic therapy
• Laser-assisted new attachment procedure (cementum-mediated periodontal ligament no the root surface in the absence of long junctional epithelium)
• Laser-assisted uvulopalatoplasty (LAUP)
• Lesion (tumor) removal
• Leukoplakia
• Modification of the dentin surface, including increasing the mineral and decreasing the organic composition of the dentin surface, reducing bacteria on the dentin surface, improving the shear bond strength of composite resin, reducing the adhesive failure of composite resin, and removing demineralized dentin surfaces
• Operculectomy
• Oral papillectomy
• Periodontal regeneration - true regeneration of the attachment apparatus (new cementum, new periodontal ligament, and new alveolar bone) on a previously diseased root surface when used specifically in the LANAP® Protocol
• Pulpotomy
• 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 an adjunct treatment during root canal retreatment
• Removal of post-surgical granulations
• Selective ablation of enamel (first degree) caries removal
• 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 level or loss, and tooth mobility
• Tissue retraction for impression
• Vestibuloplasty

General Surgery
Open, laparoscopic, and endoscopic general surgery (ablation, vaporization, incision, and coagulation of soft tissue). All soft tissue is included, striated and smooth tissue, meniscus, mucous membrane, lymph vessels and nodes, organs and glands

• Appendectomy
• Cholecystecomy
• Debridement of decubitus ulcers
• Hemorrhoidectomy
• Hepatectomy
• Herniorrhaphy
• Lymphadenectomy
• Mastectomy
• Pancreatectomy
• Parathyroidectomy
• Partial nephrectomy
• Pelvic adhesiolysis
• Pilonidal cystectomy
• Removal of fibromas
• Removal of lesions
• Removal of polyps
• Removal of tumors
• Resection of lipoma
• Splenectomy
• Thyroidectomy
• Tonsillectomy
• Tumor biopsy

Endonasal Surgery
Endonasal surgery (ablation, vaporization, incision, and coagulation of soft tissue) including:

• Adenoidectomy
• Lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal tissues
• Tonsillectomy

Dermatology and Plastic Surgery
Dematology and plastic surgery (ablation, vaporization, excision, and coagulation of soft tissue) including:

• Debridement of decubitus ulcer
• Hemangiomas
• Lesions of skin and subcutaneous tissue
• Periungual and subungual warts
• Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemangiomae, warts, telangiectasiae, rosacea, venous lake, leg veins, and spider veins
• Plantar warts
• Port wine lesions
• Removal of tattoos
• Spider veins
• Telangiectasia
• Treatment of keloids
• Treatment of mild to moderate inflammatory acne vulgaris
• Treatment of wrinkles
• Venous lakes

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

• Matrixectomy
• Periungual and subungual warts
• Plantar warts
• Radical nail excision
• Neuromas

The PerioLase® MVP-7™ is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).

The laser head consists of a flashlamp-pulsed Nd:YAG rod in an optical resonant cavity. The energy and the width of each laser pulse are determined by the size and shape of the current pulse through the flashlamp. The current pulse through the flashlamp is controlled by the flashlamp switching circuit. This circuit is based on a solid-state switch that sets the current level and pulse width according to the microprocessor controller. The rate at which the laser pulses are produced, the repetition rate or the pulses/second, is also determined by the microprocessorcontrolled switching circuit. The output energy of each laser pulse is measured by the internal energy monitor. This value is compared to the energy setting by the microcontroller and adjustments are made if necessary. The laser beam emitted from the laser head is coupled into a fiber-optic cable at the fiber port. The presence of the fiber-optic cable is detected by a sensor such that the laser will not fire if the fiber-optic cable is not in place. The laser aperture is at the distal tip of the fiber. The laser head is cooled by circulating water whose excess heat is removed by an air-water heat exchanger. The operator controls the laser through the touch screen display. The microcontroller handles all of the logic required to set the energy levels, pulse widths, and repetition rates for the laser output, monitors the output pulses to assure proper output energy, monitors all of the interlocks and sensors, and checks for proper operation of the switches, power supplies, and cooling system. Proper operation of the microcontroller is checked by an independent watchdog microprocessor. The system is designed such that no single fault can result in a system failure. All of the requirements of the laser safety standards of the CDRH as well as of the IEC 60825-1 standard are incorporated, including the remote interlock connector, the laser stop button, the key control, and the safety and manufacturer's labels.

This document describes a 510(k) premarket notification for the PerioLase Nd:YAG Pulsed Dental Laser System. It is a submission for substantial equivalence to legally marketed predicate devices, meaning it is not a new device requiring extensive new trials but rather an expansion of indications or minor modification to an already cleared device.

Therefore, the typical acceptance criteria and study information for a de novo device are not directly reported in this document in the same way. This submission primarily relies on comparing the device to existing predicate devices and showing that it shares similar technological characteristics and has equivalent intended uses.

However, new indications for use were added, and for these, clinical and laboratory data were provided.

Here's an analysis of the provided information based on your request:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in terms of performance metrics (sensitivity, specificity, accuracy) as would be seen for a diagnostic AI device. Instead, the acceptance criteria for this 510(k) submission are based on demonstrating substantial equivalence to predicate devices in terms of:

• Technological Characteristics: Wavelength, pulse energy, pulse width, repetition rate, average power, laser classification, intended use, aiming beam, output mode, laser medium, user interface, laser activation, beam delivery, soft tissue cutting method, electrical requirements, system dimensions, system weight, and cooling.
• Safety and Performance Standards: Conformance to applicable regulations and safety standards, particularly 21 CFR 1010 and 21 CFR 1040 for electrical safety and output characteristics.
• Indications for Use: The new indications are supported by human and animal studies, demonstrating the device's ability to perform these specific actions.

Table of Device Characteristics (excerpt from document):

New Indications for Use and Supporting Performance (from Section 7):

• Facilitation of subgingival calculus removal: Demonstrated by human and animal studies.
• Modification of the dentin surface: Demonstrated by human and animal studies, including:
  • Increasing the mineral and decreasing the organic composition of the dentin surface.
  • Reducing bacteria on the dentin surface.
  • Improving the shear bond strength of composite resin.
  • Reducing the adhesive failure of composite resin.
  • Removing demineralized dentin surfaces.

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

The document states: "Human and animal studies demonstrate the ability of a pulsed neodymium dental laser to remove subgingival calculus and modify the surface of dentin. The relevant clinical and laboratory reports are provided in Appendix B of this submission."

• Sample Size for Test Set: Not specified in the provided document. The exact number of human subjects or animals and detailed methodology for these studies are likely contained within "Appendix B," which is not available here.
• Data Provenance: Not explicitly stated as "country of origin" or "retrospective/prospective." The nature of "clinical and laboratory reports" suggests prospective studies for the new indications, but without Appendix B, this is an inference.

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

This information is not provided in the excerpt. For laser device performance studies related to tissue manipulation, "ground truth" would typically refer to objective measurements, histological analysis, or clinical outcomes assessed by qualified dental or medical professionals, but the details are missing.

4. Adjudication Method for the Test Set

This information is not provided in the excerpt. Since the primary evidence cited for the new indications are "human and animal studies" and "laboratory reports," the concept of "adjudication method" (like 2+1 or 3+1 consensus) as typically applied to image-based AI diagnostics might not be directly applicable or detailed in this kind of submission. If expert assessment of clinical outcomes was used, an adjudication method might have been employed, but this is not stated.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable to this device. The PerioLase Nd:YAG Pulsed Dental Laser System is a surgical laser, not an AI-powered diagnostic imaging system that assists human readers. Therefore, an MRMC study and effect size based on "human readers improve with AI vs without AI assistance" are not relevant for this device.

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

This is not applicable to this device. This is a physical laser device used by a human operator for surgical procedures, it is not an algorithm performing a task without human intervention.

7. The Type of Ground Truth Used

For the new indications (subgingival calculus removal, dentin surface modification), the ground truth would likely involve:

• Histology/Pathology: For assessing changes in dentin composition, bacterial reduction, and new attachment.
• Biomechanical Testing: For evaluating shear bond strength.
• Clinical Outcomes/Measurements: For confirming calculus removal, or other clinical improvements observed in human and animal studies.

The document refers to "human and animal studies" and "laboratory reports" (Section 7), implying that objective measurements and assessments were used to establish the efficacy for these new indications.

8. The Sample Size for the Training Set

This is not provided and is not applicable in the context of this device. The PerioLase laser system is not an AI/ML device that requires a "training set" in the computational sense. The "training" here refers to the development and optimization of the laser parameters and techniques, which is based on general scientific understanding, preclinical testing, and potentially iterative design improvements, not a machine learning training data set.

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

This is not applicable as the device is not an AI/ML product and thus does not have a "training set" in that context.

Ask a specific question about this device

The PerioLase Nd: YAG Pulsed Dental Laser System is to provide the ability to perform intraoral soft tissue dental, general, oral maxillofacial, and cosmetic surgery. The PerioLase is intended for ablating, incising, vaporization and coagulation of soft tissues using a contact fiber-optic delivery system. The following areas: general and cosmetic dentistry, otolary, arthroscopy, gastroenterology, general surgery, dermatology and plastic surgery, neurosurgery, gynecology, ophthalmology, and pulmonary general surgery. The following are the oropharyngeal indications for use for which the device will be marketed:

Oropharyngeal

• · Abscess incision and drainage
• · Aphthous ulcers treatment
• · Biopsies excision and incision
• · Crown lengthening
• · Hemostatic assistance
• Fibroma removal
• · Frenectomy
• · Frenotomy
• Gingival incision and excision
• · Gingivectomy
• Gingivoplasty
• · Operculectomy
• · Oral papillectomy
• · Tissue retraction for impression
• · Vestibuloplasty
• · Selective ablation of enamel (first degree) caries
• · Exposure of unerupted / partially erupted teeth
• · Implant recovery
• · Lesion (tumor) removal
• · Leukoplakia
• · Pulpotomy
• · Pulpotomy as adjunct to root canal therapy
• · Removal of filling material such as gutta-percha or resin as adjunct treatment during root canal retreatment

· Sulcular debridement (removal of diseased or in the periodontal pocket) to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment level and tooth mobility

· Laser-assisted new attachment procedure (cementum-mediated periodontal ligament 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 when used specifically in the LANAP® Protocol

The laser head consists of a flashlamp-pulsed Nd:YAG rod in an optical resonant cavity. The energy and the width of each laser pulse are determined by the size and shape of the current pulse through the flashlamp. The current pulse through the flashlamp is controlled by the flashlamp switching circuit. This circuit is based on a solid-state switch that sets the current level and pulse width according to the microprocessor controller. The rate at which the laser pulses are produced, the repetition rate or the pulses/second, is also determined by the microprocessorcontrolled switching circuit. The output energy of each laser pulse is measured by the internal energy monitor. This value is compared to the energy setting by the microcontroller and adjustments are made if necessary.

The laser beam emitted from the laser head is coupled into a fiber-optic cable at the fiber port. The presence of the fiber-optic cable is detected by a sensor such that the laser will not fire if the fiber-optic cable is not in place. The laser aperture is at the distal tip of the fiber. The laser head is cooled by circulating water whose excess heat is removed by an air-water heat exchanger.

The operator controls the laser through the touch screen display. The microcontroller handles all of the logic required to set the energy levels, pulse widths, and repetition rates for the laser output, monitors the output pulses to assure proper output energy, monitors all of the interlocks and sensors, and checks for proper operation of the switches, power supplies, and cooling system. Proper operation of the microcontroller is checked by an independent watchdog microprocessor. The system is designed such that no single fault can result in a system failure.

All of the requirements of the laser safety standards of the CDRH as well as of the IEC 60825-1 standard are incorporated, including the remote interlock connector, the laser stop button, the key control, and the safety and manufacturers labels.

The document describes a 510(k) premarket notification for the PerioLase Nd:YAG Pulsed Dental Laser System. It focuses on establishing substantial equivalence to a predicate device and provides clinical data to support a new clinical outcome claim related to periodontal regeneration.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, the primary "acceptance criteria" for this 510(k) submission appear to be demonstrating substantial equivalence to a predicate device and providing histologic evidence for a new clinical outcome claim.

• Wavelength (1.064 microns / 1064 nm)
• Laser medium (Nd:YAG)
• Beam delivery system type (optical fiber)
• Laser activation method (footswitch)
• Power source (conventional AC power)
• Type of aiming beam
• Cooling system
• Intended Uses (general and cosmetic dentistry, otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology and plastic surgery, neurosurgery, gynecology, urology, ophthalmology, and pulmonary surgery, specifically Oropharyngeal indications)
• Power, pulse duration, energy per pulse, and repetition rate (20-300mJ pulse energy, 100-650µsec pulse width, 10-100Hz repetition rate, 6W max average power)
  (Source: Section 5) |
  | Safety and Performance Standards Conformance | - Evaluated via verification and validation tests and inspections for conformance to applicable regulations and safety standards.
• Tested for electrical safety and output characteristics to meet design criteria for essential performance.
• Safety features and functions operate correctly.
• Satisfies performance requirements specified in 21 CFR 1010 and 21 CFR 1040.
• Designed to comply with applicable federal and international safety and performance standards.
  (Source: Section 6) |
  | New Clinical Outcome Claim: Periodontal Regeneration | Evidence of true periodontal regeneration (new cementum, periodontal ligament, and alveolar bone with inserting Sharpey's fibers) on previously diseased root surfaces.
• 5 out of 10 evaluated sites (50%) demonstrated regeneration coronal to the notch.
• 3 of these regenerating teeth also showed new bone, ligament, and cementum within furcations. (Source: Section 7) |

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

• Sample Size for Clinical Study (Test Set):
  • Patients: 8 patients
  • Teeth: 12 treated teeth were scheduled for extraction, with 10 available for microscopic evaluation after splintering of 2 teeth during histological preparation.
  • Sites: 10 sites were evaluated.
• Data Provenance: The study was a prospective human histological study. The country of origin of the data is not specified in the provided text.

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)

The document does not specify the number of experts or their specific qualifications used to establish the ground truth (histological evaluation) for the test set. It only states that "en bloc biopsy extractions were evaluated histologically."

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

The document does not specify an adjudication method for the histological evaluation. It simply states that the biopsies "were evaluated histologically."

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a laser system, not an AI-assisted diagnostic or imaging tool involving human readers. Therefore, there is no information on human reader improvement with or without AI assistance.

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

This question is not applicable. The PerioLase Nd:YAG Pulsed Dental Laser System is a physical laser device used by a human operator (dentist/surgeon), not an algorithm or AI system. Its performance is inherent to the device's physical operation, not an "algorithm-only" performance measurement.

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

For the new clinical outcome claim (periodontal regeneration), the ground truth was pathology (histological evidence). Specifically, it involved the microscopic evaluation of en bloc biopsy extractions to identify new bone, periodontal ligament, and cementum on previously diseased root surfaces.

8. The sample size for the training set

The document does not describe the development of an algorithm or AI model, thus there is no "training set" in the context of machine learning. The study described is a clinical study for a physical device.

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

Not applicable, as there is no training set mentioned or implied for an AI/algorithm-based device.

Ask a specific question about this device

The following are the oral-pharngeal indications for use for which the device will be marketed: Abscess Incision and Drainage Apthous Ulcers Treatment Biopsies Excision and Incision Crown lengthening Hemostatic assistance Fibroma Removal Frenectomy Frenotomy Gingival Incision and Excision Gingivectomy Gingivoplasty Operculectomy Oral Papillectomy Tissue retraction for Impression Vestibuloplasty. Selective ablation of enamel (first degree) caries Exposure of unerupted / partially erupted teeth Implant recovery Lesion (tumor) removal Leukoplakia Pulpotomy Pulpotomy as adjunct to root canal therapy Removal of filling material such as gutta percha or resin as adjunct treatment during root canal re-treatment Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) to improve clinical indices including gingival index, gingivaltooth mobility tooth mobility.

The PerioLase Nd: YAG Dental Laser System is to provide the ability to perform intraoral soft tissue dental, general, oral maxillo-facial and cosmetic surgery. The PerioLase is intended for ablating, incising, excising, vaporization and coagulation of soft tissues using a contact fiber optic delivery system. The device will be used in the following areas: general and cosmetic dentistry otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, gynecology, urology, ophthalmology and pulmonary surgery. The following is the additional oral-pharngeal indication for use for which the device will be marketed: Laser assisted new attachment procedure (cementum-mediated periodontal ligament new- attachment to the root surface in the absence of long junctional epithelium.)

The PerioLase is a FR Nd:YAG laser producing laser emission at 1064nm with variable pulse durations (100-650µsec). The laser consists of two interconnected sections: The cabinet which houses the laser head, the power supply, the cooling system and the microprocessor with control panel; and the fiber optic delivery system.

Here's an analysis of the provided documents to extract the requested information about acceptance criteria and the supporting study for the PerioLase Dental Laser:

Acceptance Criteria and Study Details for PerioLase Dental Laser (K030290)

The provided documents primarily focus on the regulatory submission (510(k)) for the PerioLase Dental Laser, specifically regarding its re-affirmation and an additional indication for use. While they describe the device's technical specifications and intended uses, they do not explicitly state quantitative "acceptance criteria" in the form of specific performance metrics (e.g., minimum accuracy, sensitivity, specificity values) or the overall results of a study that directly "proves" the device meets these criteria in a tabulated format as one might expect for a diagnostic or AI-driven device.

The main "acceptance" being sought and granted here is the substantial equivalence to a predicate device and the addition of a new indication for use, supported by clinical performance data. The FDA's 510(k) clearance process focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving it meets pre-defined quantitative acceptance criteria in a highly detailed, algorithmic performance report.

However, based on the information provided, we can infer and construct aspects of the "acceptance criteria" and the "study that proves the device meets the acceptance criteria" in the context of this regulatory submission.

1. Table of Acceptance Criteria and Reported Device Performance

As noted, explicit quantitative acceptance criteria for device performance (like sensitivity/specificity for a diagnostic) are not provided in the typical format. However, we can interpret the regulatory approval as meeting the following implicit criteria for its intended use and safety/efficacy:

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

• Test Set (for LANAP Indication): The summary states, "The new clinical outcome claim is based on human histological and radiographic data from a controlled prospective University-based clinical study."
  • Sample Size: The exact sample size for this prospective clinical study is not provided in the given documents.
  • Data Provenance: The data is described as "human histological and radiographic data" from a "controlled prospective University-based clinical study." This indicates it's human clinical data, prospective in nature, and collected at a university setting. The country of origin is not explicitly stated, but given the US-based submission, it's highly likely to be a US university or institution collaborating with one.

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

• This information is not provided in the documents. For a histological and radiographic study, experts (e.g., oral pathologists, periodontists, radiologists) would typically interpret the data, but the number and qualifications are not detailed.

4. Adjudication Method for the Test Set

• This information is not provided in the documents. While a "controlled clinical study" would imply rigorous methods, the specific adjudication process (e.g., 2+1, 3+1, none) is not mentioned.

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

• No, a MRMC comparative effectiveness study is not explicitly mentioned or implied. The study described focuses on the device's clinical outcome efficacy (histological and radiographic data) for the LANAP procedure, not a comparison of human reader performance with and without AI assistance. This device is a laser for surgical procedures, not a diagnostic imaging aid.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• This question is not applicable in the context of this device. The PerioLase Dental Laser is an energy-based surgical instrument, not an AI algorithm. Its performance is measured by its clinical efficacy in a human-operated surgical context, not as a standalone algorithm.

7. The Type of Ground Truth Used

• For the new indication (LANAP), the ground truth was established by human histological and radiographic data.
  • Histology: This implies microscopic examination of tissue samples, which is a gold standard for assessing tissue changes, inflammation, and new attachment formation.
  • Radiography: This implies imaging (e.g., X-rays) to assess bone levels and other periodontal structures.
  • Outcomes Data: The ultimate "ground truth" for a clinical outcome claim like LANAP is the demonstrated successful clinical outcome (cementum-mediated periodontal ligament new attachment to the root surface), as evidenced by these objective measures.

8. The Sample Size for the Training Set

• This information is not applicable and not provided. As the PerioLase is a medical device (laser), not an AI/machine learning algorithm, there is no "training set" in the sense of data used to train a model. The "training" for the device would involve engineering development, bench testing, and potentially pre-clinical studies, but not a data training set.

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

• This information is not applicable and not provided for the same reasons as point 8.

Ask a specific question about this device

The PerioLase Nd: YAG Dental Laser System is to provide the ability to perform intraoral soft tissue dental. general, oral maxillo-facial and cosmetic surgery. The PerioLase is intended for ablating, incising. excising. vaporization and coagulation of soft tissues using a contact fiber optic delivery The Sevice will be used in the following areas: general and cosmetic dentistry sy stem. otolary ngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, gynecology, urology, ophthalmology and pulmonary surgery. The following are the additional oral-pharngeal indications for use for which the device will be marketed:

• . Selective ablation of enamel (first degree) caries
• Exposure of unerupted / partially crupted teeth
• Implant recovery ●
• l.esion (tumor) removal .
• Leukoplakia .
• Pulpotomy
• Pulpotomy as adjunct to root canal therapy
• Romoval of filling material such as gutta percha or resin as adjunct treatment during root canal re-treatment
• Sulcular debridement (removal of diseased or inflamed soft tissue in the periodonal pecket) to improve clinical indiccs including gingival bleeding index, probe depth, attachment level and tooth mobility

The following are the oral-pharngeal indications for use for which the device will be marketed: Abscess Incision and Drainage

Apthous Ulcers Treatment Biopsies Excision and Incision Crown lengthening Hemostatic assistance Fibroma Removal Frencctomy Frenotomy Gingival Incision and Excision Gingivectority Gingivoplasty Operculectomy Oral Papillectomy Tissue retraction for Impression Vestibuloplasty. Selective ablation of enamel (first degree) caries Exposure of unerupted / partially erupted teeth Implant recovery Lesion (tumor) removal Leukoplakia Pulpotomy Pulpotomy as adjunct to root canal therapy Removal of filling material such as gutta percha or resin as adjunct treatment during root canal retreatment

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 level and tooth mobility

The PerioLase is an Nd:YAG laser producing laser emission at 1064nm. The laser consists of two interconnected sections: The cabinet which houses the laser head, the power supply, the cooling system and the microprocessor with control panel; and the fiber optic delivery system.

The provided document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document is a 510(k) summary and FDA clearance letter for the PerioLase Dental Laser System. It focuses on demonstrating substantial equivalence to pre-existing legally marketed predicate devices, rather than presenting a study proving a device meets specific performance metrics.

Specifically, the "Clinical Performance Data" section explicitly states "N/A" (Not Applicable), and the "Summary Basis of Equivalence" states, "The PerioLase is essentially identical to the InPulse Laser System. The indications for use and intended uses are also identical. There are no new safety issues." This indicates that the clearance was based on similarity to already approved devices, not new clinical performance data or studies defining and meeting specific acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided text.

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