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turbodent touch is intended for a complete supra-gingival and sub-gingival prophylaxis treatment. The prophylaxis treatment is obtained by the projection of water, air and appropriate dental prophylaxis powders, onto the tooth surface. The device removes dental plaque, soft deposits, and surface stains from pits, grooves, interproximal spaces, or smooth surfaces of teeth. turbodent touch is intended for the following oral prophylaxis procedures:

• Plaque removal for placement of sealants
• Surface preparation prior to bonding/cementation of inlays, onlays, crowns and veneers
• Surface preparation prior to placing composite restorations
• Effective plaque and stain removal for orthodontic patients
• Cleaning prior to bonding ortho brackets
• Cleaning implant fixtures prior to loading
• Stain removal for shade determination
• Plaque removal prior to fluoride treatment
• Plaque and stain removal prior to whitening procedures

The turbodent touch is also intended for use as an air-polisher in patients suffering from periodontal disease. The turbodent touch is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.

turbodent touch can be considered a functionally segmented version of the combi touch device (K231391), incorporating exclusively the air polishing functionality. It shares the main components, materials, and manufacturing processes as the combi touch, from which it is derived. The indication for use of turbodent touch is aligned with the air polishing indication of the combi touch.

The turbodent touch uses an operating principle based on the mechanical action of an accelerated powder jet, obtained thanks to compressed air. The kinetic energy imparted to the particles is almost completely dissipated in the impact against the dental surface, producing a delicate but effective cleaning action. The action is completed by a jet of water which, taking advantage of the depression created around the nozzle, is arranged in a bell-like shape surrounding the air and powder mixed flow. The water flow produces a double effect: continuous washing of the area treated from excess powder, and prevention of environmental dissemination of powder in the operating area.

In detail, the turbodent touch is mainly based on one polisher channel and it is equipped with three handpieces, AIR-POLISHING 90°, AIR-POLISHING 120° AND AIR-POLISHING PERIO (handpieces are already cleared, K231391). The device has a touch keyboard, displaying all selectable functions and the value scales that can be set by the user by simply gently pressing the finger at the chosen buttons.

The user-configurable settings include depressurization of the powder containers for safe removal, no powder cleaning mode and consequently the possibility of excluding water as well, circuit filling/rinsing, and air-polishing modes. For each selected air-polishing mode (PROPHY or PERIO), it is possible to choose different power levels (LOW, MEDIUM and HIGH) within a certain range preset by the manufacturer. The air-polishing action is activated by means of a foot pedal.

The irrigation system is completely external with irrigation tubing connecting the handpiece to the machine that has access to the external water network.

The turbodent touch is not intended to interact with other devices during use. About patient interaction, the SUBGINGIVAL PERIO TIPS (already cleared, K231391) attached to the terminal part of the handpiece AIR-POLISHING PERIO, enter into direct contact with the patient's body during use to allow the intended therapeutic functions to take place. These medical devices are supplied sterile and certified by external suppliers. Possible contact of the patient with the external part of the handpiece must be considered in the evaluation.

The production processes carried out internally at Mectron for processing the components of turbodent touch system are mainly assembly processes according to specific workflows and a dedicated production line.

The provided text describes the 510(k) clearance for the "turbodent touch" device, which is an air polishing unit for dental prophylaxis. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, especially not related to AI/ML performance.

The document details the device's function, comparison to a predicate device, and summaries of non-clinical testing (electrical safety, EMC, biocompatibility, software, performance, usability, distribution). Crucially, Section 9 explicitly states: "No clinical testing was conducted for this submission."

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the provided text lacks this information. The device is a physical dental instrument, not an AI/ML-driven diagnostic tool, and its clearance relies on substantial equivalence to a predicate, not on a performance study against specific acceptance metrics for AI output.

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Cleaning, polishing and restoring natural esthetics of tooth enamel.

The ß-Powder system is comprised primarily of ßtricalcium phosphate. X-ray diffraction methods were used to identify the crystalline structure. These studies showed that the main constitutent of the device is ßtricalcium phosphate with a small amount of hydroxyapatite, but no other contaminants. Inductively coupled plasma/mass spectroscopy was used for cadmium (Cd) and lead (Pb) analyses, and atomic absorption spectrophotometry was used for mercury (Hg) and arsenic (As). The levels of these harmful elements were below 0.5 ppm

The provided text is a 510(k) summary for a medical device (B-Powder) and a clearance letter from the FDA. This type of documentation focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through extensive clinical studies.

Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, etc.) is not present in the provided text.

Here's why and what can be extracted:

• No Acceptance Criteria or Performance Reporting: The 510(k) process for this device (B-Powder) establishes that it is "substantially equivalent" to already marketed devices. This means the manufacturer did not have to conduct new clinical trials to prove efficacy or safety against specific performance metrics, but rather demonstrate that its characteristics and intended use are similar enough to existing, cleared devices.
• Focus on Material Composition and Intended Use: The summary focuses on the material composition (beta-tricalcium phosphate with some hydroxyapatite) and its intended use (polishing/prophy powder) being similar to predicate devices.
• Analytical Testing, Not Clinical Studies: The "studies" mentioned (X-ray diffraction, ICP/MS, atomic absorption spectrophotometry) are analytical tests to characterize the material, not clinical performance studies. These tests confirm the material content and the absence of harmful elements, but they don't assess clinical outcomes like cleaning effectiveness or polishing quality in a human population.
• MRMC, Standalone Performance, Ground Truth, Training Set: These concepts are typically relevant for AI-powered diagnostic or prognostic devices that perform classifications or measurements. The B-Powder is a physical dental material, so these types of studies are not applicable.

In summary, based only on the provided text, I cannot fill in the table or answer the specific questions about acceptance criteria, study details, expert ground truth, or AI study specifics because this information is not part of a 510(k) submission for this type of device.

The document states: "Compliance with Performance Standards: No performance standards are applicable." This directly indicates that there aren't formal quantitative acceptance criteria for this device that would be proven by a performance study.

Here's what I can extract and explain based on the provided text, addressing the spirit of your request where possible by highlighting what was not done or not required for this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
No test set or clinical study data is reported as part of this 510(k) submission. The evaluation was based on material characterization and comparison to predicate devices, not clinical performance testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. No ground truth establishment by experts for a test set was required or mentioned for this type of device submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication was used or mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a dental polishing powder, not an AI-powered diagnostic tool. MRMC studies are not relevant to its evaluation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a dental polishing powder, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The basis for clearance was "substantial equivalence" to legally marketed predicate devices, not performance against an independently established clinical ground truth. The "ground truth" implicitly relies on the established safety and effectiveness of the existing predicate devices.

8. The sample size for the training set
Not applicable. There was no "training set" for this device, as it is a material and not an algorithm.

9. How the ground truth for the training set was established
Not applicable. As above, no training set or ground truth in the context of an algorithm's development was relevant or established for this submission.

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The KaVo RONDOflex® plus 360 Handpiece is intended for the: preparation for fissure sealing by cleaning, opening, and extending the fissures; creation of micro-mechanical retention for adhesive restorations on enamel and dentine with subsequent acid etch technique; preparation-of small carious defects; removal of deep discolorations in the enamel; cleaning and removal of adhesive residues from bridges, crowns, etc.; and, preparation of adhesive surfaces of brackets.

This submission is for a modification of a device system cleared under K002708, KaVo Corund Handpiece 2013. The modification is in the form of adding dental water to the stream.

The RONDOflex plus 360 is an air abrasion system in which alumina particles are accelerated to high speed in an air jet in order to remove material from the tooth surface.

The provided text describes a 510(k) summary for the KaVo RONDOflex® plus 360 Handpiece, which is a modification of an existing device. The device is being submitted for substantial equivalence to predicate devices, and as such, the "acceptance criteria" discussed are largely related to demonstrating that the modified device performs as safely and effectively as the predicate devices, with no new questions of safety or effectiveness.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission for a modified device seeking substantial equivalence, the "acceptance criteria" are implicitly met by demonstrating that the new device shares the same indications for use and has comparable technical characteristics (e.g., abrasive material, sterilization methods) to the predicate devices. The "reported device performance" is essentially that it operates within the specified technical data and its indications for use are the same as the primary predicate.

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

The document does not explicitly mention a "test set" in the context of clinical trials or specific performance testing against ground truth. The submission is based on comparison to predicate devices and internal validation studies. There is no information provided about the sample size for these internal validation studies or their data provenance (e.g., country of origin, retrospective/prospective).

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

Not applicable. This 510(k) submission primarily relies on demonstrating substantial equivalence to predicate devices through technical comparisons and internal validation. There is no mention of a ground truth established by experts for a specific test set.

4. Adjudication Method for the Test Set

Not applicable. As there is no mention of an external test set requiring expert ground truth, no adjudication method is described.

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

Not applicable. This device is an air abrasion handpiece for dental procedures, not an AI-assisted diagnostic or therapeutic tool for which MRMC studies would typically be conducted.

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

Not applicable. This is a physical medical device (handpiece), not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The term "ground truth" as typically used in the context of AI or diagnostic device evaluation is not directly applicable here. The device's safety and effectiveness are established by:

• Comparison to legally marketed predicate devices: The "ground truth" implicitly relies on the established safety and effectiveness of the predicate devices cleared by the FDA.
• Internal validation studies: These studies would typically verify that the device meets its design specifications and performs as intended, likely using engineering and performance metrics relevant to an air abrasion device (e.g., consistency of abrasive flow, pressure, sterilization efficacy). The specific nature of these "internal validation studies" (what they tested and how performance was measured) is not detailed in the provided text.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

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

Not applicable. As there is no training set mentioned, no ground truth establishment for a training set is relevant.

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The ProSmile Air Polisher is intended for removing deposits, plaque, and staining on all visible tooth surfaces as well as in fissures and interdental areas. The ProSmile is also intended for the following prophylactic applications:

• cleaning teeth prior to scaling
• cleaning teeth prior to fluoridation
• cleaning teeth prior to bleaching
• cleaning teeth prior to using bonding materials .

The ProSmile consists of the handpiece, ProSmile Prophylaxis Powder, the powder jet nozzle, test card, and hose coupling. The components that are integral to the C8+ Dental Operative Unit and used during ProSmile operation are the powder chamber. powder chamber venting button, water regulator, air/powder regulator, and foot control. The ProSmile is a pneumatically operated device that is offered with two powder jet nozzles.

The provided text describes a 510(k) submission for the Sirona Dental Systems ProSmile Air Polisher and Prophylaxis Powder. It outlines the device's intended use, description, and basis for substantial equivalence to a predicate device.

However, the document does not contain specific acceptance criteria or a detailed study proving the device meets performance criteria beyond a general statement about functional testing and risk analysis.

Therefore, I cannot provide the requested information in the format specified because the necessary details are not present in the given text.

Here's why and what information is available:

Missing Information:

• Specific Acceptance Criteria: The document does not list quantitative or qualitative acceptance criteria for the device's performance (e.g., a specific percentage of plaque removal, a certain level of stain reduction, or a maximum abrasion level).
• Detailed Study Data: While it states "Functional testing" was conducted and "results confirmed that the ProSmile is safe and effective," no details of this functional testing are provided. This includes:
  • Reported Device Performance: No specific metrics or results are given.
  • Sample Size: No information on the number of subjects, teeth, or procedures used in any test.
  • Data Provenance: No mention of the origin of data (e.g., clinical trials, in-vitro experiments, country of origin).
  • Experts for Ground Truth: No mention of experts, their qualifications, or their role in establishing ground truth.
  • Adjudication Method: Not applicable as there's no expert assessment described.
  • MRMC Comparative Effectiveness Study: No such study is mentioned. The comparison is primarily structural and functional similarity to a predicate device.
  • Standalone Performance: No specific standalone performance metrics are provided.
  • Type of Ground Truth: Not described as there's no detailed study.
  • Training Set Sample Size: No training set is mentioned, as this appears to be a device performance evaluation (design verification/validation), not an AI/algorithm-based diagnostic device.
  • Ground Truth for Training Set: Not applicable.

Information Present (but not directly answering the full request):

• Intended Use: Removing deposits, plaque, and staining, and for prophylactic applications (cleaning prior to scaling, fluoridation, bleaching, bonding).
• Basis for Substantial Equivalence: Visual and operational similarity to the EMS Air Flow Handy 2 Air Polisher and Powder (K022119). Both use a mixture of water, air, and powder for dental cleaning.
• Performance Testing Mentioned: "The appropriate design verification and design validation activities were conducted to address the potential risks identified in the Hazard Analysis. These activities included electrical safety testing, electromagnetic compatibility testing, and functional testing. The results confirmed that the ProSmile is safe and effective for its intended use." This is a high-level summary without any specifics.

In summary, the provided document is a 510(k) summary focused on demonstrating substantial equivalence to a predicate device through general design and safety testing, rather than a detailed clinical or performance study report with specific acceptance criteria and detailed performance metrics.

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The PrepAir is intended for the cutting and preparation of all classes of cavity restorations; removal of composite resin fillings; surface roughening of enamel, dentin, metals and composite surfaces prior to adhesive resin bonding; preparation of pits and fissures prior to sealing; cleaning and removal of cements and adhesives from bridges and crowns prior to re-cementation; and preparation of adhesive surfaces of orthodontic bands and brackets to increase retention.

The PrepAir is a dental airbrush using aluminum oxide to prepare all classes of cavity prior to restoration.

This document is a 510(k) Summary of Safety and Effectiveness for a dental airbrush device called PrepAir. It primarily focuses on demonstrating substantial equivalence to previously marketed predicate devices, rather than presenting a study with specific acceptance criteria and performance data in the format requested.

Therefore, many of the requested sections cannot be directly extracted from the provided text as they relate to a different type of study (e.g., performance testing with acceptance criteria, human reader studies, or detailed ground truth establishment), which is not present in this 510(k) submission.

Here's an analysis based on the information available in the document, noting what cannot be provided:

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

This information is not present in the provided 510(k) summary. The document focuses on demonstrating substantial equivalence based on intended use, device description, and comparison to predicate devices, rather than presenting a performance study against specific, quantified acceptance criteria.

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

This information is not present. No specific test set or data provenance is detailed for performance evaluation, as the submission relies on substantial equivalence to predicate devices.

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)

This information is not present. There is no ground truth establishment described for a test set in this document.

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

This information is not present. No test set or adjudication method is described.

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

This information is not present. This device is a physical dental airbrush, not an AI or imaging diagnostic tool. Therefore, an MRMC study or AI assistance is not applicable.

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

This information is not present. This device is a physical tool, not an algorithm.

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

This information is not present. Ground truth is not relevant in the context of this 510(k) submission, which focuses on substantial equivalence for a physical device.

8. The sample size for the training set

This information is not present. No training set is mentioned as this is not an AI/algorithm-based device.

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

This information is not present. Ground truth for a training set is not applicable here.

Summary of what is available from the document:

• Device Name: PrepAir
• Intended Use: For cutting and preparation of all classes of cavity restorations; removal of composite resin fillings; surface roughening of enamel, dentin, metals, and composite surfaces prior to adhesive resin bonding; preparation of pits and fissures prior to sealing; cleaning and removal of cements and adhesives from bridges and crowns prior to re-cementation; and preparation of adhesive surfaces of orthodontic bands and brackets to increase retention.
• Predicate Devices: PrepStart by Danville Engineering (K970589), PrepTech by Prep Technology Corp (K974655), AirDent by Air Techniques (K981564), and Rondoflex by Kavo America (K002708).
• Regulatory Conclusion: The FDA determined the device is "substantially equivalent" to legally marketed predicate devices, meaning it meets the requirements for marketing without a full Pre-Market Approval (PMA) application, based on its similarity in intended use and technological characteristics to devices already on the market.

Conclusion:

The provided document is a 510(k) summary, which is a premarket submission to FDA to demonstrate that a device is "substantially equivalent" to a legally marketed predicate device. This process typically focuses on comparing the new device's intended use, technological characteristics, and safety/effectiveness data to a predicate, rather than detailing a specific study with quantitative acceptance criteria and performance metrics unique to the new device in the way requested for an AI/algorithm-based product. Therefore, the information requested regarding acceptance criteria, sample sizes, expert ground truth, and study design is not contained within this specific type of regulatory document.

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FOR PIT AND FISSURE SEALANTS. PREPARATION REMOVAL AND RESICRATION OF COMPOSITS . CAVITY PREPARATION. CLEANING, POLISHING AND STAIN REMOVAL,

Not Found

The provided FDA letter for K024105, "Velopex Aquacut Fluid Abrasion Unit," does not contain any information about acceptance criteria or a study proving the device meets said criteria.

The letter is a 510(k) clearance letter, which focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed performance study results against specific acceptance criteria.

Therefore, I cannot answer the questions regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for either the test or training sets, as this information is not present in the provided document.

The document only states the "Indications For Use" which are:

• FOR PIT AND FISSURE SEALANTS. PREPARATION
• REMOVAL AND RESTORATION OF COMPOSITES.
• CAVITY PREPARATION.
• CLEANING, POLISHING AND STAIN REMOVAL.

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Cutting and Preparation of tooth structure, both enamel and dentin for all classes of cavity preparations. Removal of composite restorations. For roughening and/or etching of tooth surfaces, enamel, dentin, and dental restorations for adhesive restorative procedures.

Indications for use are identical to Microetcher AP/PrepStar™ by Danville Engineering Inc.

For Use by Dentists Only.

Not Found

I apologize, but the provided text only contains an FDA 510(k) clearance letter for the "Groman PrepMaster™" device. This letter primarily focuses on the regulatory approval and substantial equivalence to a predicate device.

It does not contain any information regarding specific acceptance criteria, study designs, sample sizes, expert qualifications, or performance metrics that would be necessary to answer your questions about the device's performance study.

Therefore, I cannot provide the requested table or describe the study that proves the device meets acceptance criteria based on the given input.

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Clinpro™ Prophy Powder is intended for use in dental polishing units. The air polishing unit produces a stream of water, air and Clinpro Prophy Powder to clean and polish tooth surfaces.
Cleaning, polishing and restoring the natural esthetics of tooth enamel

Clinpro Prophy Powder is classified as a class II medical device because it is a device intended for use during dental cleaning and periodontal therapy to remove deposits and stains from teeth (Ultrasonic Scaler, 21 C.F.R. § 872.4850). Clinpro Prophy Powder is intended for use in dental polishing units. The air polishing unit produces a stream of water, air and Clinpro Prophy Powder to clean and polish tooth surfaces.

The provided text describes a 510(k) summary for a dental cleaning powder, Clinpro™ Prophy Powder, and its substantial equivalence determination by the FDA. However, it does not contain the information required to populate the requested table and answer the questions related to acceptance criteria, device performance, and study details for an AI/software device.

The document discusses:

• Device Name: Clinpro™ Prophy Powder
• Classification: Class II medical device, Ultrasonic Scaler (21 C.F.R. § 872.4850), later identified as Airbrush (21 CFR 872.6080)
• Intended Use: Cleaning, polishing, and restoring the natural aesthetics of tooth enamel; specifically for use in dental polishing units to produce a stream of water, air, and powder to clean and polish tooth surfaces.
• Predicate Device: New Prophy Powder by Dentsply (K014188)
• Conclusion: The submitter believes the device is substantially equivalent to the predicate device and that performance and biocompatibility data provide evidence that safety and effectiveness requirements are met.

There is no mention of:

• Acceptance criteria in terms of metrics (e.g., sensitivity, specificity, accuracy).
• Reported device performance values for such metrics.
• Any clinical study, test set, training set, or ground truth details.
• AI/software components, human readers, or comparative effectiveness studies.

Therefore, I cannot fulfill the request as the provided text is for a physical dental cleaning powder undergoing a 510(k) submission, not an AI/software device evaluation.

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For use with all DENTSPLY® Cavitron™ Prophy-Jet® Systems and DENTSPLY® Cavitron-Jet™ Systems for cleaning, polishing and restoring the natural esthetics of tooth enamel.

NEW PROPHY POWDER is for use in DENTSPLY dental air polishing units. When the air polishing unit is in the JET mode, it produces a spray mixture of air, water, and powder to clean, polish and restore the natural esthetics of tooth enamel. NEW PROPHY POWDER is a new formulation and is for use with all DENTSPLY® Cavitron™ Prophy-Jet® Systems and DENTSPLY® Cavitron-Jet™ Systems. NEW PROPHY POWDER will be offered in two size bottle/closure for sampling and an 8-oz. bottle/closure as standard). The bottles will have a wide mouth for easy dispensing and be packaged as six bottles per shipper.

The provided text (K014188) is a 510(k) summary for a "NEW PROPHY POWDER" device. It outlines the device's description, intended use, and technological characteristics, especially regarding its safety and biocompatibility. However, it does not contain any information about acceptance criteria, specific performance studies to meet those criteria, sample sizes, expert involvement, ground truth establishment, or comparison with human readers.

The document states: "We believe that the prior use of the components of NEW PROPHY POWDER in the legally marketed predicate device, the performance data provided, and the biocompatibility data provided support the safety and effectiveness of NEW PROPHY POWDER for the indicated William."

This indicates that the submission relies on:

1. Prior use of components: The ingredients in the new powder have been used in previously marketed devices and found safe for dental use.
2. Performance data: While mentioned, no details about this "performance data" or how it was collected and what it demonstrated are provided in the summary. It's likely related to the powder's ability to clean and polish, but specific metrics and comparison to acceptance criteria are absent.
3. Biocompatibility data: The summary explicitly states, "NEW PROPHY POWDER has been evaluated and passed biocompatibility testing for cytotoxicity, acute oral toxicity, irritation, and sensitization." This is the only "study" mentioned with a clear outcome.

Without specific performance study details, it is impossible to complete the requested table and answer the detailed questions about the study design, sample sizes, expert involvement, or adjudication methods.

Therefore, based only on the provided text, I can infer the following about acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Biocompatibility: Not specified in the summary. Biocompatibility tests usually involve in vitro or animal models, not human "test sets."
• Performance Data: Not specified.
• Data Provenance: Not specified.

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

• Not applicable as no such study with a "test set" and "ground truth" established by experts is described for this device in the provided text. The assessment mainly relies on material properties and comparison to predicate devices.

4. Adjudication method for the test set:

• Not applicable for the reasons stated above.

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

• Not applicable. This device is a dental powder, not an AI or imaging diagnostic device.

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

• Not applicable. This device is a dental powder, not an algorithm.

7. The type of ground truth used:

• Biocompatibility: Lab-based assays (e.g., cell cultures for cytotoxicity, animal models for toxicity/irritation/sensitization).
• Component Safety: Historical use of components in legally marketed devices or established safety profiles.
• Performance: Unspecified "performance data" – likely involved qualitative or quantitative assessment of cleaning/polishing efficacy, but the ground truth method is not detailed.

8. The sample size for the training set:

• Not applicable. This device is a dental powder, not a machine learning model that requires a training set.

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

• Not applicable.

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The JETPOLISHER airpolishing unit is intended to be used to remove stubborn stains, plaque and soft debris. Device applications: Routine polishing especially hard to reach areas, polishing prior to enamel etching and bonding techniques, and prior to bonding orthodontic bands and brackets

Not Found

I apologize, but this document is a 510(k) clearance letter from the FDA for a dental device called "JetPolisher." It primarily concerns the regulatory approval process and does not contain information about acceptance criteria or a specific study proving the device meets those criteria. The letter confirms substantial equivalence to a predicate device and outlines regulatory compliance requirements.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth, or expert qualifications as they are not present in the provided text.

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