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Dental Soft Tissue Indications for: Incision, excision, vaporization, ablation and coagulation of oral soft tissues. including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications: Excisional and incisional biopsies, Exposure of unerupted teeth, Fibroma removal, Frenectomy, Frenotomy, Gingival troughing for crown impressions, Gingivectomy, Gingivoplasty, Gingival incision and excision, Hemostasis and coagulation, Implant recovery, Incision and drainage of abscess, Leukoplakia, Operculectomy, Oral papillectomies, Pulpotomy, Pulpotomy as an adjunct to root canal therapy, Reduction of gingival hypertrophy, Soft tissue crown lengthening, Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa, Vestibuloplasty, Tissue retraction for impression. Laser Periodontal procedures, including: Laser soft tissue curettage, Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket, Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility.)

The iLase™ dental soft tissue laser is a surgical device designed for a wide variety of dental soft tissue procedures. It is capable of storing up to twelve soft tissue procedure settings. The iLase™ uses a solid state laser diode as a source of invisible infrared radiation. The energy is delivered to the treatment site via the ezTip® a single-use fiber optic tip assembly. Several types of ezTips® are available for use with the iLase™ to perform different procedures. The iLase™ is a Class II medical laser device and is sold only to licensed practitioners. The iLase™ system consists of two elements: I. The handpiece contains the laser diode, the replaceable fiber optic ezTip®, removable shroud, a microprocessor, control program, memory, integrated finger switch, organic LED (OLED) display, and rechargeable battery. The handpiece delivers laser energy, under user control, to the treatment site. II. The battery charger is used for charging and storing the handpiece. Discharged batteries are placed in receptacles in the charging station where they are automatically recharged. The charging station is furnished with a low voltage power supply.

The provided text does not contain information about acceptance criteria and a study proving the device meets those criteria. The document is a 510(k) summary statement for the iLase™ dental diode laser, focusing on demonstrating substantial equivalence to predicate devices rather than presenting performance study results against specific acceptance criteria.

The document includes:

• Device description
• Indications for use
• Contraindications
• A conclusion of substantial equivalence
• An official FDA letter confirming clearance

It explicitly states: "Substantial equivalency for the iLase™ has been determined through comparison to previously cleared dental diode lasers." This indicates that the regulatory clearance was based on similarity to existing devices, not on a new clinical performance study with defined acceptance criteria.

Therefore, I cannot provide the requested table or answer the questions related to sample size, ground truth, expert opinions, or MRMC studies, as this information is not present in the provided text.

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The ezlase™ diode system emits energy in the near- infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a 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.

The ezlase™ diode laser system, was cleared for dental soft tissue indications under KQ61898 and K083069. The system uses a Gallium Aluminum Arsenide (GaAlA) and/or an Indium Gallium Arsenide Phosphorus (InGaAsP) solid state laser diode to emit infrared laser energy which is transmitted via a flexible fiberoptic cable to a handpiece that emits the energy to the targeted site. A visible light is emitted at the same time to visually identify the treatment location.

This document, K083595, describes a Special 510(k) Summary Statement for the Biolase Technology, Inc. ezlase™ diode laser system. The purpose of this 510(k) is to expand the current indications for use to include therapeutic indications.

Acceptance Criteria and Device Performance:

The document does not explicitly state "acceptance criteria" in a quantitative performance metric table as might be found for a diagnostic device. Instead, the justification for the expanded indications relies on substantial equivalence to already cleared predicate devices. The "performance" being demonstrated is that the ezlase™ meets the same therapeutic claims as these predicates.

Study Details:

This submission is a Special 510(k) for expanding indications based on substantial equivalence to existing cleared devices, not a clinical trial demonstrating novel performance against new, specific acceptance criteria through a newly conducted study. Therefore, many of the typical elements of a standalone clinical study are not applicable or explicitly provided in this document.

1. Sample size used for the test set and the data provenance: Not applicable. This submission doesn't describe a new clinical test set. The basis for approval is substantial equivalence to previously cleared devices.

2. 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 new clinical test set described in this document. The "ground truth" for the predicate devices would have been established during their respective clearances, but details are not provided here.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a laser system for therapeutic use, not an AI-assisted diagnostic tool involving human readers.

5. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable. The "performance" assessment is based on the functional and claims equivalence to predicate devices, not a standalone algorithm's performance.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the purpose of this 510(k) submission, the "ground truth" or evidence of effectiveness for the therapeutic indications is derived from the prior FDA clearance of the predicate devices with identical (or very similar) Indications for Use. This implicitly relies on the data and "ground truth" (likely clinical study outcomes or established physiological effects) that supported the original clearances of those predicate devices.

7. The sample size for the training set: Not applicable. This document does not describe a machine learning algorithm requiring a training set.

8. How the ground truth for the training set was established: Not applicable.

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This device may be used for the following indications:

• Light activation for bleaching materials for teeth whitening
• Laser-assisted whitening/bleaching of teeth

The exlase™ dental diode laser system is currently used to perform various and The system uses advanced laser technology to dealer with a many and the Samment works of the Mas An Indium Gallium Arsenide Phosphorus solid-state laser diode emits infrared laser energy to the various oral soft tissues targeted during procedure. This energy is transmitted via a flexible fiberoptic cable to the handpiece that emits the energy to the targeted tissue site. A visible light is emitted at the same time to visually pinpoint the treatment location. The power output and pulse width may be adjusted to specific user requirements.

The provided document is a 510(k) summary for the ezlase™ dental diode laser system, seeking to expand its indications for use to include teeth whitening. This type of regulatory submission often focuses on demonstrating substantial equivalence to predicate devices rather than presenting novel clinical study data with detailed acceptance criteria and performance metrics in the way a new, high-risk device might.

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

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

The document does not explicitly define specific performance-based acceptance criteria for teeth whitening (e.g., a certain percentage improvement in shade, or a specific safety profile outcome) that the ezlase™ device was tested against. Instead, the "acceptance criteria" appear to be based on the principle of substantial equivalence to already cleared predicate devices for the same indications.

• Acceptance Criteria (Implied): Substantial equivalence to predicate devices for the indications of "Light activation for bleaching materials for teeth whitening" and "Laser-assisted whitening/bleaching of teeth," demonstrated by similar principles of operation, technology, and intended use as devices already cleared by the FDA for these indications.
• Reported Device Performance: The document states, "The indications requested by this 510(k) are the same as those previously cleared by the FDA for other equivalent devices. Substantial equivalency for the ezlase™ has been determined through comparison to previously cleared devices." This implies that the device's performance for the new indications is considered to be on par with the cleared predicate devices, without providing specific quantifiable performance metrics for the ezlase™ itself for these new indications.

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

The document does not report any specific test set sample size or data provenance (e.g., country of origin, retrospective/prospective) because it relies on a substantial equivalence comparison rather than new clinical trials demonstrating performance for the expanded indications. The existing predicate devices' clearance likely involved relevant data, but that data is not presented here as a "test set" for the ezlase™ in this 510(k).

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

This information is not applicable or not provided in the document. As no new clinical study data with a specific 'test set' was presented for these expanded indications, there's no mention of experts establishing ground truth for such a set. The "ground truth" for substantial equivalence is based on the regulatory history and scientific understanding of the predicate devices.

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

This information is not applicable or not provided in the document, as no specific test set requiring adjudication of outcomes is presented for the ezlase™ device for the expanded indications.

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

This information is not applicable. An MRMC study is relevant for diagnostic devices often involving human interpretation of images, especially when comparing AI assistance. The ezlase™ is a therapeutic laser device for teeth whitening, not a diagnostic imaging tool. Therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant in this context. There is no AI component mentioned in the device description.

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

This information is not applicable. The ezlase™ is a physical laser device operated by a human clinician, not a standalone algorithm.

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

The concept of "ground truth" in this 510(k) is primarily centered on regulatory precedent and established safety/efficacy of predicate devices. The "truth" is that the predicate devices have been deemed safe and effective for these indications by the FDA. The submission argues that the ezlase™ is substantially equivalent to these devices, implying its performance will be similar. No new direct "ground truth" measurements (like specific outcomes data for a clinical trial) are presented for the ezlase™ for these expanded indications.

8. The sample size for the training set

This information is not applicable or not provided. Since the submission relies on substantial equivalence and does not describe a machine learning algorithm, there is no "training set."

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

This information is not applicable or not provided for the same reasons as #8.

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Dental Soft Tissue Indications for: Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications: - Excisional and incisional biopsies - Exposure of unerupted teeth - A Fibroma removal - A Frenectomy - V Frenotomy - A Gingival troughing for crown impressions - ア Gingivectomy - ア Gingivoplasty - ﺗﯜ Gingival incision and excision - ﺮ Hemostasis and coagulation - ア Implant recovery - ア Incision and drainage of abscess - ア Leukoplakia - ﺮ Operculectomy - ア Oral papillectomies - > Pulpotomy - ア Pulpotomy as an adjunct to root canal therapy - ﻟﻠﺘﺮ Reduction of gingival hypertrophy - Soft tissue crown lengthening A - A Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa - A Vestibuloplasty Laser Periodontal procedures, including: - A Laser soft tissue curettage - A Laser removal of discased, inflamed and necrosed soft tissue within the periodontal pocket - A Sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility.)

The ezlase™ 10W dental diode laser system may be used to perform various dental soft tissue applications. The system uses advanced laser technology to incise, excise, vaporize, coagulate and ablate intraoral soft tissues. An Indium Gallium Arsenide Phosphorus solid-state laser diode emits infrared laser energy to the various oral soft tissues targeted during a procedure. This energy is transmitted via a flexible fiberoptic cable to the handpiece that emits the energy to the targeted tissue site. A visible light is emitted at the same time to visually pinpoint the treatment location. The power output and pulse width may be adjusted to specific user requirements.

This document does not describe an acceptance criteria or a study that proves the device meets specific acceptance criteria.

Instead, this document is a 510(k) summary statement for the Biolase ezlase™ 10W dental diode laser system. It focuses on demonstrating substantial equivalence to previously cleared predicate devices (ezlase™ K061898 and Twilight™ K991994) for its stated indications for use.

Here's why the requested information cannot be extracted from this document:

• No Acceptance Criteria or Performance Data: The document lists the device's indications for use and describes its technology but does not provide any quantitative metrics, thresholds, or performance targets that the device must meet (i.e., acceptance criteria). Consequently, there is no "reported device performance" to compare against such criteria.
• No Study Described: The document explicitly states, "There are no new indications requested for this device in this Special 510(k). Substantial equivalency for the ezlase™ 10W has been determined through comparison to previously cleared devices." This indicates that no new clinical study was conducted or is being presented as part of this submission to demonstrate the device's efficacy or safety. The approval is based on its similarity to existing, cleared devices.

Therefore, since no study is presented, the subsequent questions about sample size, data provenance, experts, adjudication, MRMC studies, standalone performance, ground truth, and training set information are not applicable to this document.

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Incision, excision, vaporization, ablation and coagulation of oral soft tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications: Excisional and incisional biopsies Exposure of unerupted teeth Fibroma removal Frenectomy Frenotomy Gingival troughing for crown impressions Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis and coagulation Implant recovery Incision and drainage of abscess Leukoplakia Operculectomy Oral papillectomies Pulpotomy Pulpotomy as an adjunct to root canal therapy Reduction of gingival hypertrophy Soft tissue crown lengthening Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa. Vestibuloplasty Laser Periodontal procedures, including: Laser soft tissue curettage Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility.)

The EZLase™ dental diode laser system may be used to perform various soft tissue dental applications. The system uses advanced laser technology to incise, excise, vaporize, coagulate and ablate intra-oral soft tissues. A Gallium Aluminum Arsenide (GaAlAs) and/or an Indium Gallium Arsenide Phosphorous solid-state laser diode emit infrared laser energy to the various oral soft tissues targeted during procedure. This energy is transmitted via a flexible fiberoptic cable to the handpiece that emits the energy to the targeted tissue site. A visible light is emitted at the same time to visually pinpoint the treatment location. The power output and pulse width may be adjusted to specific user requirements.

This document is a 510(k) summary for the EZLase™ dental diode laser, which seeks substantial equivalence to already cleared devices. It does not contain a study demonstrating the device meets specific acceptance criteria in the way a clinical trial for a new therapeutic or diagnostic device would.

Instead, the submission for the EZLase™ dental diode laser relies on demonstrating substantial equivalence to predicate devices. This means that the device is shown to be as safe and effective as a legally marketed device that is not subject to PMA (Premarket Approval). The "acceptance criteria" here are met by proving this substantial equivalence, rather than by achieving specific performance metrics against a defined ground truth in a new clinical study.

Therefore, many of the requested sections (like sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size, and how training set ground truth was established) are not applicable to this type of regulatory submission in the way they would be for a novel diagnostic AI algorithm.

Here's a breakdown based on the provided text, focusing on how substantial equivalence is demonstrated:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable in this context. This 510(k) submission relies on demonstrating substantial equivalence to existing legally marketed predicate devices, not on a new clinical study with a test set of patient data to prove effectiveness. The "data provenance" would refer to the existing regulatory clearances for the predicate devices.

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

• Not Applicable. No new ground truth needed to be established for this submission as it relies on substantial equivalence.

4. Adjudication method for the test set

• Not Applicable. No new test set requiring adjudication was performed.

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 surgical laser, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies are not relevant to its regulatory submission.

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

• Not Applicable. This is a hardware device (surgical laser), not an algorithm.

7. The type of ground truth used

• "Ground truth" here is embodied by the established safety and effectiveness of the predicate devices cleared by the FDA. The premise of a 510(k) is that if a new device is substantially equivalent to an already cleared device, then it is also safe and effective. The FDA's initial clearance of the predicate devices would have relied on various forms of evidence, potentially including clinical data, performance testing, and literature review, but not necessarily for this new device's submission.

8. The sample size for the training set

• Not Applicable. This is not a machine learning or AI device that requires a training set.

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

• Not Applicable. As per point 8.

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