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510(k) Data Aggregation
(120 days)
CLAROX plus (Model: VX-100)
CLAROX plus (Model: VX-100) is a portable general-purpose X-ray system that users can operate with one hand. The device uses a fixed X-ray tube current and voltage (kVp) and, therefore, is limited to taking diagnostic X-rays of extremities. It is intended to be used by a qualified and trained clinician on adult patients and pediatrics. It is not intended to replace a radiographic system with variable tube current and voltage (kVp), which may be required for full optimization of image quality and radiation exposure for different exam types.
VX-100 is a battery-operated, portable X-ray source designed for handheld operation. It is designed to produce diagnostic quality X-ray images. The VX-100 is designed for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams. Because of its low power output, the Clarox Plus (Model VX-100) is intended for exclusive use on body extremities. The functions of the VX-100 handheld system are supported by software (firmware). The device software is of Moderate level of concern and it is not based on the predicate software. The device uses a rechargeable battery to allow for the use of the VX-100 where transportation or use of other x-ray devices might be prohibitive due to the other device's size and/or lack of mobility. The VX-100 is an X-ray device with AC/DC adaptor. The handheld device features a main body (tube head), cone to limit the exposure range of the beam, cradle, and AC/DC adaptor. The power is supplied by a rechargeable Lithium-Ion battery core pack built into a main body. This facilitates portability of the device. A beam-limiting cone is mounted to the device before use. The tube voltage is adjustable from 70kV to 100kV. Tube current is fixed 1.0mA. The exposure time is also manually adjustable by the operators. This adjustment can be quickly accomplished through the user-friendly control panel. Control buttons, display, and an exposure button provide the primary operator interface. Exposures settings can be selected and displayed. The voltage and the exposure time varies based on patient type, detector type, and anatomical feature. Exposures can be completed using the exposure button. The VX-100 should be used with an X-ray detector, and the x-ray detector may be digital or analog, and it is not included in the VX-100 package.
The provided text pertains to a 510(k) premarket notification for a mobile X-ray system, CLAROX plus (Model: VX-100). This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not contain information about acceptance criteria or a study proving the device meets those criteria, especially not in the context of comparative effectiveness with human readers or standalone algorithm performance.
Specifically, the document states:
- "Clinical testing was not necessary for the VX-100, based on the nature of the device (an x-ray generator marketed without image detector). Adequate bench testing results should be sufficient in supporting our claim of substantial equivalence."
Therefore, the information requested for acceptance criteria and a study demonstrating device performance, as detailed in your prompt, is not available in the provided text. The document is concerned with regulatory clearance based on substantial equivalence through non-clinical performance and safety standards, rather than clinical efficacy against metrics like those used for AI/CAD devices.
If this were a device with AI components and clinical performance claims, the following information would be expected but is absent:
- A table of acceptance criteria and the reported device performance: This would typically show metrics like sensitivity, specificity, AUC, or detection rates for a specific task (e.g., detecting a condition) and the target values for these metrics.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set sample size or data provenance is mentioned as there was no clinical study.
- 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 there was no clinical study with a test set.
- Adjudication method (e.g. 2+1, 3+1, none) 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: No MRMC study was done, and no effect size is reported.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No standalone performance study was done or reported.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable, as there's no mention of an algorithm requiring a training set.
- How the ground truth for the training set was established: Not applicable.
The document primarily lists non-clinical performance data, referring to compliance with various IEC and ANSI standards related to medical electrical equipment, software, risk management, usability, and radiation protection for diagnostic X-ray equipment. This demonstrates basic safety and essential performance, but not clinical performance or efficacy in a diagnostic task.
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(57 days)
CLAROX
The CLAROX is indicated for use only by a trained and qualified dentist or dental technician for both adult and pediatric subjects as an extraoral diagnostic dental X-ray source to produce X-ray images using intraoral image receptors.
CLAROX is a battery-operated, portable dental X-ray source designed for handheld operation. It is designed to produce diagnostic quality X-ray images. The CLAROX is designed for use in a dental office. It can also be used in other similar environments (orthodontic office, general practitioner's office, hospital ward, etc.) where appropriate safeguards are implemented. The device uses a rechargeable battery to allow for the use of the CLAROX where transportation or use of other x-ray devices might be prohibitive due to ther device's size and/or lack of mobility. The CLAROX is an X-ray device with a AC/DC adaptor. The handheld device features a main body (tube head), Cone for sensor, Acryl shielding, cradle, and AC/DC adaptor.
The provided document is a 510(k) summary for the CLAROX dental X-ray system, which is an X-ray generator. It focuses on demonstrating substantial equivalence to a predicate device based on technical specifications and adherence to recognized standards, rather than clinical performance (e.g., diagnostic accuracy). Therefore, many of the requested sections related to clinical studies, ground truth, expert review, and MRMC studies are not applicable or not detailed in this document.
Here's an analysis of the provided text in relation to your request:
Acceptance Criteria and Study to Prove Device Meets Criteria:
The document does not specify "acceptance criteria" in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) for the CLAROX device itself. Instead, it demonstrates substantial equivalence to a predicate device (KaVo NOMAD Pro2 Handheld X-ray System) by comparing technological characteristics and showing compliance with international safety and performance standards.
The study that "proves the device meets acceptance criteria" is described as non-clinical testing and bench testing to demonstrate compliance with these standards and similar technological characteristics to the predicate device.
1. Table of acceptance criteria and the reported device performance
Since the "acceptance criteria" are not explicit performance metrics for diagnostic capability, but rather conformance to standards and comparable technical specifications, the table below will reflect the comparison between the subject device (CLAROX) and the predicate device (KaVo NOMAD Pro2) as presented in the document. The "reported device performance" refers to the specifications of the CLAROX device.
| Characteristic | Acceptance Criteria (Predicate Device Specification) | Reported Device Performance (CLAROX) |
|---|---|---|
| Indications for Use | "The KaVo NOMAD Pro 2 Handheld X-ray System is indicated for use only by a trained and qualified dentist or dental technician for both adult and pediatric subjects as an extraoral diagnostic dental X-ray source to produce X-ray images using intraoral image receptors." | "The CLAROX is indicated for use only by a trained and qualified dentist or dental technician for both adult and pediatric subjects as an extraoral diagnostic dental X-ray source to produce X-ray images using intraoral image receptors." |
| Body Size | 279mm(L) × 140mm(W) × 267mm(H) | 300mm(W) × 100mm(D) × 252mm(H) |
| Weight | 2.73kg | 1.5kg |
| Source to skin distance | 210mm | 200mm |
| Cone diameter | 60mm | 60mm |
| User Interface | Control buttons, display, and a trigger | control panel, control buttons, display, and an exposure button |
| Energy Source | Rechargeable 22.2 V DC Li-polymer battery core pack | Rechargeable 22.2 V DC Li-polymer battery core pack |
| Battery Capacity | 1.7 A-hr | 1.46 A-hr |
| Recharge capability | 70% remaining capacity after 300 cycles | 80% or above remaining capacity after 300 cycles |
| Exposure time | 0.02 - 1.0 seconds | 0.12 - 1.2 seconds |
| Timer Accuracy | ± (10% + 1ms) | Less than 5% or 20 ms |
| mA | 2.5 mA | 2.0 mA |
| kVp | 60 kVp | 70 kVp |
| Waveform | Constant Potential (DC) | Constant Potential (DC) |
| Compliance with Standards | - (Implicitly compliant with relevant standards) | AAMI ES60601-1; IEC 60601-1-2 (Ed. 4); IEC 60601-1-3; IEC 60601-2-65; ANSI AAMI IEC 62304:2006; EN ISO 14971:2019; ANSI AAMI IEC 62366-1:2015+AMD1:2020; IEC 60601-1-6 Ed. 3.1; IEC/EN 62133-2 Ed. 1.0 |
Note on Differences: While some specifications (e.g., weight, battery capacity, exposure time range, mA, kVp) differ, the document concludes that these differences do not raise new questions of safety or effectiveness and are within a range considered substantially equivalent for an extraoral X-ray source. For instance, the subject device has a lower weight and higher kVp compared to the predicate.
2. Sample size used for the test set and the data provenance
The document states, "Clinical testing is not necessary for the current submission, based on the device type (an x-ray generator) and based on the technological characteristics similar to the predicate system." Therefore, there is no test set of clinical images or patient data described in this submission. All testing was non-clinical (bench testing) to verify technical specifications and compliance with standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical test set with a ground truth established by experts was used.
4. Adjudication method for the test set
Not applicable, as no clinical test set was used.
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. The CLAROX device is an X-ray generator, not an AI-powered diagnostic tool. Its submission is based on substantial equivalence as an X-ray source, not on improving human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable, as the CLAROX is an X-ray generator, not an algorithm, and does not perform diagnostic interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical test set requiring ground truth for diagnostic accuracy was utilized. The "ground truth" in this context would implicitly be the validated specifications and performance of the predicate device and the requirements of the international standards.
8. The sample size for the training set
Not applicable. This device is an X-ray generator, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
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(197 days)
MAZIC Claro CAD and MAZIC Claro Press
MAZIC Claro Press is an all-ceramic system for the creation of Occlusal veneers Thin Veneers Veneers Inlays Onlays Crowns in the anterior and posterior region 3-unit bridges in the anterior region 3-unit bridges in the premolar region up to the second premolar as the terminal abutment Crown, splinted crown or 3 unit bridge up to the second premolar placed on top of an implant abutment.
MAZIC Claro CAD is a CAD/CAM machinable glass ceramic based on lithium disilicate for the preparation of full ceramic crowns, inlays, onlays and full ceramic 3-unit anterior bridges.
The MAZIC Claro Press, dental glass ceramic ingot, is to make dental restorative prosthesis such as inlays, onlays, veneers, crowns and bridges. Having a variety of shade, the user can choose a suitable color that matches the natural teeth of the patient. The prosthesis can be made through regular press process.
The MAZIC Claro CAD, dental glass ceramic block, is to make dental restorative prosthesis such as inlays, onlays, veneers and crowns. Having a variety of shade, the user can choose a suitable color that matches the natural teeth of the patient. The prosthesis can be made through milling procedure by dental CAD/CAM.
This document describes the acceptance criteria and the study proving the device meets those criteria for the MAZIC Claro CAD and MAZIC Claro Press dental materials.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for both MAZIC Claro CAD and MAZIC Claro Press are based on conformance to ISO 6872: Dental ceramic. The reported device performance indicates that both devices conform to this standard for the specified physical and chemical properties.
| Acceptance Criterion (Standard) | MAZIC Claro Press Performance | MAZIC Claro CAD Performance |
|---|---|---|
| Uniformity (ISO 6872) | Conforms | Conforms |
| Freedom from extraneous materials (ISO 6872) | Conforms | Conforms |
| Flexural strength (ISO 6872) | Conforms | Conforms |
| Chemical solubility (ISO 6872) | Conforms | Conforms |
| Radioactivity (ISO 6872) | Conforms | Conforms |
| Linear thermal expansion coefficient (ISO 6872) | Conforms | Conforms |
| Glass transition temperature (ISO 6872) | Conforms | Not explicitly listed for CAD, but general conformance implied |
| Biocompatibility (ISO 10993-5, -10, -11, -3) | Confirmed (see tests below) | Confirmed (see tests below) |
2. Sample Size and Data Provenance
The document does not explicitly state the sample sizes used for the non-clinical performance tests or the data provenance (country of origin, retrospective/prospective). The tests were conducted according to ISO standards, implying controlled laboratory conditions.
3. Number and Qualifications of Experts for Ground Truth
Not applicable. This submission is for dental materials, and the "ground truth" is established through standardized physical, chemical, and biocompatibility testing, not through expert radiological or clinical interpretation of images.
4. Adjudication Method
Not applicable, as this is for material testing, not diagnostic performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a diagnostic device that involves human readers.
6. Standalone (Algorithm Only) Performance
Not applicable. This is for dental materials, not an algorithm. The performance is based on the material's inherent physical and chemical properties.
7. Type of Ground Truth Used
The ground truth used for these devices is established by international standards for dental ceramics and biocompatibility:
- ISO 6872 (Dental ceramic) for physical and chemical properties.
- ISO 10993 (Biological evaluation of medical devices) for biocompatibility.
8. Sample Size for the Training Set
Not applicable. There is no "training set" in the context of material performance testing for these dental ceramics. The material itself is the subject of the performance tests.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for these dental materials. The "ground truth" for evaluating the device's performance is the adherence to the established parameters and limits defined in the ISO 6872 and ISO 10993 standards. The performance tests are designed to measure these parameters directly.
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(391 days)
CLARO
The CLARO is indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.
The CLARO is a portable handheld intense pulse light (IPL) device powered by a rechargeable battery. The CLARO uses a Xenon flash lamp which delivers pulses of light with a wavelength range from 400-1100 nm at Imsec pulse duration and a fluence of 6 J/cm2. The spot size of the CLARO is 1cm2.
Here's a breakdown of the acceptance criteria and study information for the CLARO device, based on the provided text:
CLARO Device Performance Study Summary
1. Acceptance Criteria and Reported Device Performance
The provided document describes studies primarily focused on usability and self-selection for Over-The-Counter (OTC) use, rather than clinical efficacy studies with specific performance metrics like sensitivity or specificity for acne treatment. The acceptance criteria relate to the ability of users to understand labeling and operate the device correctly for OTC use.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Self-Selection | Percentage of participants able to properly self-select themselves using the box labeling | Study 1: 98.3% |
| Study 2: 95% | ||
| Device Operation | Percentage of participants able to correctly use the device by reading the User's Guide (without assistance) | Study 1 (without final labeling): 86.4% |
| Study 1 (with final labeling): 97.2% | ||
| Study 2 (with final labeling): 93% | ||
| Study 3 (with final labeling): 100% |
2. Sample Size and Data Provenance
The provided document outlines the following sample sizes and provenance details:
- Test Set Sample Sizes:
- Self-Selection Study 1: 61 subjects
- Usability Study 1: 59 subjects (from Self-Selection Study 1)
- Self-Selection and Usability Study 2: 165 subjects
- Usability Study 3: 19 subjects
- Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission for OTC clearance, these would most likely be prospective usability and self-selection studies conducted in a controlled environment.
3. Number and Qualifications of Experts for Ground Truth
The document does not specify the number or qualifications of experts used to establish ground truth for the usability and self-selection studies. For these types of studies, "ground truth" would typically be defined by whether participants followed instructions and operated the device as intended, assessed by study administrators or observers rather than medical experts.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method (e.g., 2+1, 3+1) for the test sets. This is expected given the nature of usability and self-selection studies, where the primary assessment is direct observation of user behavior compared to predefined correct actions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The studies described are usability and self-selection studies for OTC device use, not clinical comparative effectiveness studies involving human readers (e.g., radiologists) and AI assistance.
6. Standalone (Algorithm Only) Performance Study
No, a standalone (algorithm only) performance study was not done. The CLARO is a physical device, and the described studies evaluate user interaction and understanding of labeling, not an algorithm's performance in isolation. The device itself is "identical in all technological respects" to a previously cleared prescription device (K080638), suggesting its standalone efficacy was previously established for a similar indication.
7. Type of Ground Truth Used
For the usability and self-selection studies, the "ground truth" was based on:
- Observed user behavior: Whether participants correctly followed instructions for self-selection from labeling.
- Observed device operation: Whether participants correctly operated the device based on the User's Guide.
This is a form of empirical observation and adherence to instructions, rather than expert consensus, pathology, or outcomes data related to an underlying medical condition.
8. Sample Size for the Training Set
The document does not mention a training set in the context of these usability and self-selection studies. These studies were intended to test the device and its labeling, not to train an algorithm or model.
9. How Ground Truth for the Training Set Was Established
As no training set is mentioned in the context of these studies, this question is not applicable.
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(195 days)
CLARO
The CLARO is indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.
The CLARO is a portable handheld device that uses light energy from the blue to infra-red spectrum emitted by a Xenon flash lamp. The device is powered by a rechargeable battery. CLARO is intended to be a prescription device which will be used both in the doctor's office and in the home environment for the treamment of mild to moderate acne.
The provided text, a 510(k) summary for the CLARO device, does not contain specific acceptance criteria or details of a study proving the device meets particular performance metrics.
Instead, it states:
"Performance testing will be performed which will demonstrate compliance with IEC 60601-1-1 and IEC 60601-1-2. Testing was submitted which showed that the user was able to use the device in the home-use environment."
This indicates that general safety and essential performance standards (IEC 60601-1-1 and -1-2) would be addressed, and a user study demonstrated home-use feasibility. However, no specific performance criteria related to acne treatment efficacy, clinical outcomes, or comparative performance are detailed, nor are the results of any such study presented in this document.
Therefore, I cannot provide the requested information. The document focuses on regulatory submission and substantial equivalence to predicate devices, not on detailed performance study results against specific acceptance criteria for efficacy.
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(77 days)
CLAROS NANO DENTAL LASER SYSTEM
Dental 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, Frenectomy, Frenotomy, Gingival troughing for crown impressions, Gingivectorny, Gingivoplasty, Gingival incision and excision, Hemostasis and coagulation, Implant recovery, Incision and drainage of abscesses, Leukoplakia, Operculectomy, Oral papillectornies, 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, and Vestibuloplasty. Laser Periodontal Procedures: Laser soft tissue curettage, Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket, Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium, 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). Tooth Whitening: Laser assisted whitening/bleaching of teeth, Light activation for bleaching materials for teeth whitening.
The Claros nano Dental Laser System is a variant of the Claros Dental Laser System. It is a portable laser that uses a gallium aluminum arsenide 810 nm diode laser module to provide optical energy via a contact fiber optic delivery system. Claros nano is used for multiple soft tissue, periodontal, and teeth whitening applications. The Claros nano Dental Laser System is comprised of the following main components: a light/ laser system console (including software, a display panel and controls); delivery devices; one or more handpieces; and protective eye wear.
The provided text covers a 510(k) summary for the Claros nano Dental Laser System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria for the device itself in terms of clinical effectiveness metrics.
Therefore, many of the requested sections (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth details, training set size and ground truth) are not available in the provided text.
Here's a summary of what can be extracted or inferred from the text:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated as performance metrics tied to specific values. Instead, the primary "acceptance criterion" for 510(k) clearance is demonstrating substantial equivalence to existing legally marketed devices.
- Reported Device Performance: The device is stated to comply with several international and US standards related to medical electrical equipment safety, laser safety, and radiation control.
| Acceptance Criteria (Implied for 510(k)) | Reported Device Performance (Compliance) |
|---|---|
| Substantial Equivalence to Predicate Devices | - Shares same/similar indications for use |
| - Shares same/similar principles of operation | |
| - Shares same/similar overall technical and functional capabilities | |
| - Does not raise new safety or effectiveness issues | |
| Compliance with relevant standards | - IEC 60601-1:1988+A1:1991+A2:1995 |
| - IEC 60601-2-22:1995 | |
| - IEC 60825-1:1993+A1:1997+A2:2001 | |
| - 21 CFR 1040.10 and 1040.11 |
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable / Not Provided. The submission is focused on technical specifications and substantial equivalence, not a clinical trial with a defined test set for performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable / Not Provided. There is no mention of a test set with ground truth established by experts.
4. Adjudication Method for the Test Set
- 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
- No. This is a hardware device (laser system), not an AI-powered diagnostic or assistance tool. Therefore, an MRMC study related to human reader improvement with AI assistance is irrelevant and not performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided. As noted above, this is a laser and not an algorithm.
7. The Type of Ground Truth Used
- Not Applicable / Not Provided. There is no mention of ground truth in the context of device performance in the provided text.
8. The Sample Size for the Training Set
- Not Applicable / Not Provided. This is a hardware device submission, not a machine learning algorithm.
9. How the Ground Truth for the Training Set was Established
- Not Applicable / Not Provided. This is a hardware device submission, not a machine learning algorithm.
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(142 days)
CLAROS DENTAL LASER SYSTEM
Dental 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, Frenectomy, Frenotomy, Gingival troughing for crown impressions, Gingivectorny, Gingivoplasty, Gingival incision and excision, Hemostasis and coagulation, Implant recovery, Incision and drainage of abscesses, Leukoplakia, Operculectormy, 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, and Vestibuloplasty. *For use on adult and pediatric patients. Laser Periodontal Procedures: Laser soft tissue curettage, Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket, Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium, 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). Tooth Whitening: Laser assisted whitening/bleaching of teeth, Light activation for bleaching materials for teeth whitening.
The Claros Dental Laser System is a portable laser that uses a gallium aluminum arsenide 810 nm diode laser module to provide optical energy via a contact fiber optic delivery system. Claros is used for multiple soft tissue. periodontal, and teeth whitening applications. The Claros Dental Laser System is comprised of the following main components: a light/ laser system console (including software, a display panel and controls); delivery devices: one or more handpieces; key cards for security; and protective eve wear.
The provided text is a 510(k) summary for the Claros® Dental Laser System. It focuses on establishing substantial equivalence to a predicate device by comparing indications for use, principles of operation, and technical capabilities.
Crucially, the document does not contain information about acceptance criteria, device performance metrics (such as sensitivity, specificity, accuracy), or any studies that would prove the device meets such criteria.
The "Performance Data" section only lists compliance with various electrical and laser safety standards (IEC 60601-1, IEC 60601-2-22, IEC 60825-1, 21 CFR 1040.10 and 1040.11, and the European Medical Device Directive 93/42/EEC). These are general safety and performance standards for laser devices, not clinical efficacy or diagnostic performance metrics.
Therefore, I cannot provide the requested information from the given text.
To answer your specific questions, based solely on the provided text:
- A table of acceptance criteria and the reported device performance: Not available.
- Sample size used for the test set and the data provenance: Not available.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not available.
- 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 available. This device is a surgical laser, not an AI-powered diagnostic or assistive tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available. This device described is a physical laser system, not an algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not available.
- The sample size for the training set: Not available.
- How the ground truth for the training set was established: Not available.
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