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Dental soft tissue indications: incision, vaporization, ablation, and coagulation of oral soft tissues including the following:

• · Gingival troughing for crown impression
• · Gingivectomy
• · Gingivoplasty
• · Gingival incision and excision
• · Hemostasis and coagulation
• · Excisional and incisional biopsies
• · Exposure of unerupted teeth
• · Fibroma removal
• · Frenectomy and frenotomy
• · 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 ulcers
• · Vestibuloplasty
• · Tissue retraction for impression

Laser periodontal indications including:
· Sulcular debridement (curettage, removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including: gingival bleeding index, probe depth, attachment loss, and tooth mobility).
· Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket.

The Ultrafast series (Ultrafast, Ultrafast Plus, and Ultrafast Lite) are cordless diode laser systems designed for a wide variety of dental soft tissue procedures. The products have three separate models under the model names: Ultrafast, Ultrafast Plus and Ultrafast Lite. They use solid-state laser diodes as sources of infrared radiation. The energy from the infrared radiation is delivered to the treatment site via a single-use fiber optic tip.

The product kit consists of a laser handpiece, laser goggles, charging stand, power adapter, laser shield, barrier sleeves, product warning labels and instructions for use. The laser handpiece is constructed from anodized aluminum and contains a single-use, disposable fiber optic tip and main body containing laser diode, main control and a rechargeable battery assembly. The main control houses the control circuitry with microprocessor and user interface to control and deliver the laser and a green aiming beam to guide the laser procedures. The charging stand allows for the placement of the handpiece in a holder with electrical connection to the power adapter as the source for charging the rechargeable battery.

Based on the wavelength and power of the laser diodes used, the kit can be preconfigured into three separate models:

The provided text, a 510(k) summary for the DentLight Inc. Ultrafast series dental lasers, describes the device's technical specifications and asserts its substantial equivalence to previously cleared predicate devices. It does not present a study with acceptance criteria and device performance data in the typical format of an AI/ML device performance study.

Instead, the document focuses on demonstrating that the Ultrafast series shares similar indications for use, technology, design, and performance characteristics with its predicates. The "performance testing" mentioned is related to non-clinical safety and design specifications, not clinical efficacy or diagnostic accuracy as would be relevant for an AI/ML-driven device.

Therefore, I cannot extract the information required for your request in the format you provided because the document describes a traditional medical device (dental laser) and its regulatory clearance process through substantial equivalence, not an AI/ML-driven device that would involve concepts like sensitivity, specificity, human reader performance, ground truth establishment by experts, or training/test sets for machine learning models.

The "acceptance criteria" for this device are implicitly tied to meeting the safety and performance standards demonstrated by the predicate devices and relevant IEC/ISO standards. The "study proving the device meets acceptance criteria" refers to non-clinical bench testing and compliance with those aforementioned standards.

Here's what can be inferred from the document regarding "acceptance criteria" and "performance" for a dental laser, but please note this is NOT an AI/ML performance study as you've outlined:

Based on the provided document, the "acceptance criteria" and "study proving the device meets acceptance criteria" are aligned with demonstrating substantial equivalence for a dental laser, not an AI/ML device.

1. Table of Acceptance Criteria and Reported Device Performance (as inferred for a laser device):

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

• Not applicable in the context of an AI/ML test set. The document describes non-clinical performance testing for optical, thermal, electrical, and mechanical safety, and biocompatibility. This typically involves testing of physical units of the device, not a "data set" in the AI/ML sense. Data provenance would be from internal lab testing.

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

• Not applicable. This relates to clinical data ground truth, which is not part of this 510(k) summary for a non-AI/ML device.

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

• Not applicable. This relates to clinical data adjudication, not applicable here.

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 a dental laser device, not an AI/ML product. MRMC studies are not relevant for this type of device clearance.

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

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

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

• Not applicable. For this device, "ground truth" equates to established engineering and safety standards (e.g., IEC, ISO) and the performance of the predicate devices. Performance is measured against these technical specifications and safety limits.

8. The sample size for the training set:

• Not applicable. This refers to machine learning training data, which is irrelevant for this traditional medical device.

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

• Not applicable.

In summary, the provided text is a regulatory filing for a dental laser device, demonstrating substantial equivalence through non-clinical testing against established safety standards and comparison to predicate devices' specifications, not an AI/ML device requiring clinical performance studies with human readers, ground truth from experts, or training/test datasets.

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Source of illumination for curing photo-activated dental restorative materials and adhesives.

Fusion Plus Curing Light is a portable dental LED curing light system. It provides a source of illumination for polymerization of photo-activated dental materials. The principle of operation is the same as the predicate devices: illumination for polymerization or curing of photo-activated dental materials. It uses our patented Fusion optical technology in combination with high-power LED to deliver high efficiency and high-power curing light.

The system consists of a curing handpiece, a charging stand, 100 barrier sleeves, light shields, a power adapter, and instructions for use. The handpiece is constructed of aluminum and consists of a main control, a light head, and a rechargeable battery assembly. The main control houses the control circuitry with microprocessor and user interface consisting of LCD display and two control buttons. A mode button selects operation timer and two curing modes: plasma or pulse mode. A ON/OFF button activates and deactivates the light. The handpiece is non-sterile utilizing the barrier sleeves for infection control. Similar to the predicate devices, the light shield and curing cap absorb emitted light and perform the function of eye protection. The charging stand allows for the placement of the handpiece in a holder with electrical connection to the power adapter as the source for charging the rechargeable battery. FUSION Plus has an interchangeable LED light head. Depending on the light head connected with the main control or added later, the kit can be configured in three options:

Trade Name: FUSION Plus, LED Peak Wavelength (nm): 395-480
Trade Name: FUSION Plus Standard, LED Peak Wavelength (nm): 440-480
The instructions for use detail the use of each head in curing of dental materials.

The DentLight FUSION Plus Curing Light is a dental LED curing light system designed for the polymerization of photo-activated dental restorative materials and adhesives. The manufacturer asserts its substantial equivalence to the predicate device Valo (K083647) by Ultradent Products Inc. and the reference device FUSION (K052593) by DentLight Inc., based on similarities in indications for use, technology, and performance test results.

Below is a detailed breakdown of the acceptance criteria and the study proving the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided document does not specify a separate "test set" in the context of human data or image data for the FUSION Plus Curing Light. The non-clinical performance testing involved evaluating the device's functionality and performance directly, rather than using a dataset of clinical cases. The data provenance is essentially from the internal testing conducted by the manufacturer, DentLight Inc.

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

Not applicable. This device is a dental curing light, a physical device, not an AI or diagnostic tool that requires expert-established ground truth from clinical cases. The testing focused on the physical and electrical properties of the device.

4. Adjudication Method for the Test Set:

Not applicable, as no ground truth requiring adjudication was established from clinical or imaging data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI assistance:

Not applicable. This device is a dental curing light and does not involve AI assistance for human readers or interpretation of medical images.

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

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

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

Not applicable in the conventional sense. The "ground truth" for this device's performance is established by direct measurement of its physical and electrical characteristics against established industry standards and the performance of predicate devices. For instance, optical irradiance and spectral irradiance are directly measured and compared.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical medical device, not an AI model that requires a training set.

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

Not applicable. As there is no training set for an AI model, there is no ground truth to establish for it.

Study Proving Device Meets Acceptance Criteria:

The study that proves the FUSION Plus Curing Light meets its acceptance criteria is a series of non-clinical performance tests conducted by DentLight Inc. These tests were performed to evaluate the device's functionality, performance, safety, and substantial equivalence to the predicate devices. The study was guided by the FDA's "Dental Curing Lights – Premarket Notification [510(k)] Submissions" guidance document.

The non-clinical tests included:

• Device performance: This category covered specific technical parameters such as optical irradiance, spectral irradiance, curing time, curing modes and safety controls, and heat management.
• Software and hardware verification and validation: This ensured that the device's internal systems operate correctly and reliably.
• Risks to health and traceability analysis: This involved assessing potential hazards and ensuring the device's components and manufacturing processes are traceable.
• Electrical safety and electromagnetic compatibility (EMC): The device was tested for compliance with relevant electrical and safety standards, specifically IEC 60601-1, IEC 60601-1-2, and ANSI/ADA 48-2.

The conclusion drawn from these tests was that, based on similarities in indications for use and technology, coupled with the results from the performance testing, the FUSION Plus Curing Light is substantially equivalent to the predicate devices. The listed performance values in the table above demonstrate that the FUSION Plus Curing Light performs within acceptable ranges established by the predicate devices, and in some cases, exceeds them (e.g., Pulse/High curing optical intensity). Compliance with relevant IEC and ANSI/ADA standards confirms its safety and electromagnetic compatibility.

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Dentlight Oral Exam Light Kit is indicated to be used by a dentist and physician for illumination to aid visualization during oral procedures and as an adjunct to enhance the visualization for oral examination of mucosal abnormalities and oral lesions.

Dentlight Oral Exam Light Kit is a rechargeable-battery-powered cordless unit designed for illumination and examination for dental and physician's office on any procedures which require a small homogenous and well-defined spot and natural tissue reflectance and fluorescence visualization of healthy and abnormal tissue.

Dentlight Oral Exam Light Kit consists of a cordless unit with interchangeable light head (White and Violet), custom adaptable Fluorescence Loupe Filters and Filter Caps, Charging Stand, Power Adapter, and Patient Protective Eyewear Goggle.

This document is a 510(k) summary for the Dentlight Oral Exam Light Kit. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study with acceptance criteria in the way a clinical trial for an AI diagnostic device would.

Therefore, much of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating AI or diagnostic tools, is not present in this document.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the provided text. The document refers to "Performance Testing and Compliance" but does not define specific acceptance criteria or report quantitative results against them. The testing listed is:

• Optical Power Testing
• Optical wavelength
• Beam Quality
• Illumination and Fluorescence Image

The document states, "The Dentlight Oral Exam Light Kit is designed to comply with electrical safety... and will comply with electrical safety requirement established by IEC 60601-1-2." This is a compliance statement rather than a performance acceptance criterion.

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

This information is not provided. As this is a submission for a physical medical device (an examination light) rather than a diagnostic algorithm, the concept of a "test set" in the context of data for an algorithm is not applicable. The performance testing mentioned (optical power, wavelength, beam quality, illumination, and fluorescence image) would have been conducted on the device itself.

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/not provided. The device is an illumination tool to aid visualization, not a diagnostic tool that produces a "result" needing ground truth establishment by experts in a study context. Its intended use is to "enhance the visualization for oral examination of mucosal abnormalities and oral lesions," meaning human clinicians still interpret the visual information.

4. Adjudication method for the test set

This information is not applicable/not provided.

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/not provided. The device is not an AI system. While a clinical study could be performed to assess if the device improves human visualization and diagnosis, this document does not present such a study.

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

This information is not applicable/not provided. This is not an algorithm.

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

This information is not applicable/not provided.

8. The sample size for the training set

This information is not applicable/not provided. This is not an AI algorithm requiring a training set.

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

This information is not applicable/not provided. This is not an AI algorithm requiring a training set.

Summary of what the document does provide regarding performance and equivalence:

• Device Type: The Dentlight Oral Exam Light Kit is a rechargeable, cordless unit for illumination and enhanced visualization of oral tissue abnormalities using fluorescence and/or reflectance.
• Intended Use: To provide illumination to aid visualization during oral procedures and as an adjunct to enhance the visualization for oral examination of mucosal abnormalities and oral lesions.
• Substantial Equivalence Claim: The device is claimed to be substantially equivalent to three predicate devices (Velscope K070523, Sapphire O/E K073483, Identafi 3000 K090135) in intended use and operation. All use fluorescence and/or reflectance for enhanced tissue visualization.
• Technological Characteristics Comparison:
  • Predicate K070523: 120V AC powered metal halide light, views fluorescence via filtered lens.
  • Predicate K073483: 120V AC powered Xenon plasma arc light, views fluorescence via filtered lens.
  • Predicate K090135: AA-battery-powered low power LED, views fluorescence through a broadband polarized filter glass, selectable wavelength (polarized white and amber LED).
  • Proposed Device: Uses LED light source in multiple wavelength spectra for illumination/excitation, offers two illumination modalities and one common detection/viewing mechanism.
• Claimed Advantages of Proposed Device: Magnified high contrast filter for detection/viewing, increased light intensity from "new reason LED" for improved clarity, improved portability with cordless hands-free or wand operation, benefits in size and weight for patient operations and counter space.
• Performance Testing Listed: Optical Power Testing, Optical wavelength, Beam Quality, Illumination and Fluorescence Image. (No results or acceptance criteria are given).
• Compliance: Designed to comply with electrical safety requirements established by IEC 60601-1-2.

In essence, this 510(k) submission relies on demonstrating that the Dentlight Oral Exam Light Kit has similar technological characteristics and the same intended use as already-marketed (predicate) devices, supported by general performance testing and electrical safety compliance, rather than proving a specific diagnostic accuracy against defined criteria in a clinical study as would be expected for a novel AI diagnostic device.

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The FUSION Curing Light is a dental curing light that is intended for photopolymerization of dental resins, restorative composite materials, and orthodontic brackets, bonding, and sealing that are photo-polymerized in the 440 – 480 nm wavelength range.

The DentLight's FUSION Curing Light is a battery-powered cordless unit designed for curing VLC materials whose initiator systems are sensitive to light in the 440-480nm wavelength range of the visible spectrum. The unit is based on blue LED (light emitting diode) technology for light generation in the desired wavelength and Li-Ion rechargeable batteries.

The FUSION Curing Light includes:

• A handpiece with a focusing lens focusing light emitted from a single LED probe tip and controlled by built-in control electronics
• · A detachable rechargeable battery unit
• · A base unit that plugs into main power as the handpiece stand
• · An eye shield and disposable cap at probe tip
• · Disposable disinfectant barrier sleeves on the probe tube

The provided text describes the 510(k) summary for the FUSION Curing Light, which is a dental curing light. It discusses its intended use, technological characteristics, and performance testing. However, it does not contain specific acceptance criteria or detailed study results that would allow for a table of acceptance criteria versus reported device performance, or many of the other requested details for an AI/device study.

The document is a regulatory submission for a physical medical device, not an AI/ML-based device. Therefore, a significant portion of the requested information (e.g., sample size for AI, ground truth establishment, MRMC studies, standalone algorithm performance) is not applicable or present.

Here's what can be extracted based on the provided text, and where the requested information is not available:

Acceptance Criteria and Study Information for FUSION Curing Light

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific numerical acceptance criteria for performance tests. It lists the types of tests conducted but does not provide the threshold values for success or the quantitative results achieved. Therefore, a complete table cannot be generated.

Notes:

• The document states that the "major difference between the proposed FUSION Curing Light and the predicate curing lights is the intensity of the light power delivered, the longer range of curing distance, size and weight." It also notes that "The increased light intensity of the proposed FUSION Curing Light allows the resin curing and tooth whitening agent activation to be conducted at faster speed. The longer range of curing distance enables more flexibility for operators." This implies performance benefits in these areas compared to predicates, but without quantitative acceptance criteria or results.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified. The document states "The following testing was conducted to evaluate the functionality performance..." but does not detail the number of units tested or specific samples used for each test.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified.

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

• Not Applicable. This device is a physical dental curing light, not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth for a test set.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

• Not Applicable. As per point 3.

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

• No. This is not an AI-assisted device. MRMC studies are not relevant to this type of regulatory submission.

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

• Not Applicable. This is a physical device, not an algorithm.

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

• Not Applicable. For a physical curing light, "ground truth" would relate to measurable physical properties (e.g., light spectrum, power output, curing depth/hardness of resin), which are evaluated through standard industrial test methods. The document does not specify the exact methods or comparator "ground truth" materials/standards used for the resin curing tests, but it would be based on recognized dental material testing protocols.

8. The Sample Size for the Training Set

• Not Applicable. This device does not involve a "training set" in the context of AI/ML.

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

• Not Applicable. As per point 8.

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