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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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The AIRFLOW Prophylaxis Master combines the functions of an ultrasonic scaler and air-polishing unit within a single chassis. The AIRFLOW Prophylaxis Master is intended for use in the following dental applications:

• · Removing supra and subgingival calculus deposits and stains from teeth
• · Periodontal pocket lavage with simultaneous ultrasonic tip movement
• · Scaling and root planing
• · Releasing crowns, bridges, inlays, and posts as well as condensing gutta percha
• Plugging for amalgam condensation
• Amalgam burnishing
• · Preparing, cleaning and irrigating root canals
• · Cavity preparation
• · Cementing inlays and onlays
• · Retrograde preparation of root canals

The AIRFLOW Prophylaxis Master is intended for use in the cleaning and polishing of teeth by the projection of water, air, and dental 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.

The AIRFLOW Prophylaxis Master can be used for the following cleaning 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 fixture prior to loading
• · stain removal for shade determination
• · plaque removal prior to fluoride treatment
• · plaque and stain removal prior to whitening procedure

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

The AIRFLOW One is intended for use in the cleaning and polishing of teeth by the projection of water, air, and dental 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.

The AIRFLOW One can be used for the following cleaning procedures:

• · plaque removal for placement of sealants
• · surface preparation prior to bonding/cementation of inlays, 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 fixture prior to loading
• · stain removal for shade determination
• · plaque removal prior to fluoride treatment
• · plaque and stain removal prior to whitening procedure

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

The EMS AIRFLOW Prophylaxis Master is a dental device that combines the functions of an ultrasonic scaler and air-polishing unit within a single chassis. The proposed device consists of a control unit, hoses, handpiece cords for the two handpieces and a foot pedal which can be wired or wireless. There are two repositories on the control unit: one for the irrigation liquid container or the waterline cleaner container and the other one for one of both air-polishing powder chambers supplied with the device.

The AIRFLOW Prophylaxis Master is supplied with the Piezon Handpiece LED for performing ultrasonic scaling functions. The proposed device is compatible with EMS instruments legally marketed for ultrasonic scaling procedures.

The AIRFLOW Prophylaxis Master is also supplied with the AIR-FLOW Handpiece and optionally with the PERIO-FLOW Handpiece and the PERIO-FLOW Nozzles marked for performing air-polishing procedures. The proposed device is compatible with the AIR-FLOW CLASSIC new formula (sodium bicarbonate), AIR-FLOW SOFT (glycine), AIR-FLOW PERIO (glycine) and AIR-FLOW PLUS (Erythritol) prophylaxis powders.

The AIRFLOW Prophylaxis Master is supplied with accessories for attaching and removing instruments and nozzles from the handpieces.

The EMS AIRFLOW One is the same device as the EMS AIRFLOW Prophylaxis Master without the ultrasonic scaling function. Therefore, the description of the AIRFLOW Prophylaxis Master is also applicable to the AIRFLOW One, except the part related to the ultrasonic scaling function.

This document describes the non-clinical performance testing for the EMS AIRFLOW Prophylaxis Master and EMS AIRFLOW One devices to establish substantial equivalence to a predicate device.

Here's the requested information:

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

The document does not explicitly provide a table of acceptance criteria with corresponding performance results. Instead, it refers to compliance with a list of regulatory standards. The reported device performance is that the devices passed these compliance tests, thereby confirming they are "safe and effective for the indications for use."

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

The document does not specify the sample size for any test sets. The tests are non-clinical performance tests, likely involving units of the device rather than patient data. No information on data provenance (country of origin, retrospective/prospective) is provided, as these are not relevant for non-clinical device performance testing against engineering standards.

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 is not applicable as no clinical studies with expert ground truth establishment are reported. The "ground truth" here is compliance with established engineering and safety standards.

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

This is not applicable as no clinical studies requiring adjudication are reported. The testing involves standardized procedures for demonstrating compliance with engineering standards.

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 MRMC comparative effectiveness study was done. This device is a physical dental instrument, not an AI-assisted diagnostic tool involving human readers.

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

This is not applicable. The device is a physical dental instrument, not an algorithm.

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

The "ground truth" for the non-clinical performance testing is compliance with the requirements outlined in the listed international and national standards (e.g., ISO 14971, ANSI/AAMI ES60601-1, IEC 60601-1-2, etc.).

8. The sample size for the training set

This is not applicable. The device is a physical dental instrument, not an AI/machine learning model that requires a training set.

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

This is not applicable, as there is no training set for this type of device.

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· Professional cleaning of teeth: Removal of subgingival and supragingival plaque-biofilm and stains

· Professional cleaning of teeth including patients with dentin hypersensitivity

· Treatment of dentin hypersensitivity by blockage of the dentin tubules

· Can also be used in the presence of fixed orthodontic devices (brackets), restorative and prosthetic materials, and implants

· For maintenance in periodontitis therapy after completion of initial treatment - when using standard devices - for gingival pockets up to 5 mm in depth

· For maintenance in perimplantitis therapy after completion of initial treatment - when using standard devices - for gingival pockets up to 5 mm in depth

Clean & More is classified as airbrush (21 C.F.R. § 872.6080) because it is a powder to be used with air polishing devices in the professional tooth cleaning.

Clean & More is a prophylactic powder for gentle and professional sub- and supragingival cleaning of teeth, including the removal of plaque-biofilm and stains, using commercially available air polishing devices.

Clean & More is a glycine based air polishing powder containing functionalized tri-calcium phosphate, a substance which blocks open dentin tubules on the tooth surface, thereby contributing to a reduction in dentin hypersensitivity.

Here's an analysis of the acceptance criteria and study information for the "Clean & More" device, based on the provided document:

The document (K151748) describes a 510(k) premarket notification for "Clean & More," a prophylactic powder for professional tooth cleaning. The primary purpose of the submission is to demonstrate substantial equivalence to predicate devices, rather than establishing de novo acceptance criteria. Therefore, the "acceptance criteria" for the device are largely implied by its performance being equivalent to the predicate devices and demonstrating safety and efficacy for its stated Indications for Use.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) summary demonstrating substantial equivalence, formal, quantitative acceptance criteria are not explicitly stated in the same way they would be for a direct performance claim against a specific standard. Instead, the "acceptance criteria" are implied by the requirement for the new device to perform equivalently to its predicate devices in various aspects.

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

• Clinical Study Test Set:
  • Sample Size: A total of 40 subjects were enrolled.
  • Data Provenance: The document does not explicitly state the country of origin for the clinical study. It was conducted "according to ISO 14155:2011 - Good Clinical Practice (GCP)," which suggests international standards were followed. It is a prospective study, as subjects were enrolled, treated, and followed up at specific intervals (10 days, 4 weeks, 3 and 6 months).
• Non-Clinical (In vitro) Test Set:
  • Sample Materials: Bovine enamel, composite materials, bovine dentin, zirconia surfaces, and titanium surfaces.
  • Data Provenance: Not specified, but generally in vitro studies are conducted in a controlled lab environment. This data is prospective in the sense that the experiments were designed and executed to test the device.

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

• Clinical Study:
  • Dentin Hypersensitivity: Ground truth for hypersensitivity was "predetermined hypersensitivity on at least two teeth determined by air blast and tactile scoring." The document does not specify the number or qualifications of the experts (e.g., dentists, hygienists) who performed these initial assessments or subsequent evaluations.
• Non-Clinical (In vitro) Studies:
  • The "ground truth" for these studies is the experimental measurement and comparison to the predicate device's performance. Experts would include the researchers conducting the tests and analyzing the data, but no specific number or qualifications are provided.

4. Adjudication Method for the Test Set

• Clinical Study: Not explicitly stated. The determination of "predetermined hypersensitivity" and subsequent assessment of "incidence and degree of dentinal hypersensitivity" would imply a clinical evaluation, but no multi-reader adjudication method (like 2+1 or 3+1) is mentioned. "Air blast and tactile scoring" are common methods, and typically, the assessing clinician's findings serve as the "ground truth" for that individual.
• Non-Clinical (In vitro) Studies: Not applicable in the same way as clinical adjudication. Data analysis of measurements and observations (e.g., Keyence microscope observation, statistical evaluation) would be the method to determine "truth."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not explicitly done or mentioned.
  • The clinical study focused on the effectiveness of Clean & More in reducing dentin hypersensitivity in a cohort of patients. It describes the device's performance, not a comparison of human readers with and without AI assistance.
  • The non-clinical studies were direct comparisons of material properties and performance between the new device and its predicate, not involving human readers' diagnostic accuracy.

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

• Yes, in spirit, the clinical and non-clinical studies can be considered standalone performance for the device itself.
  • The in vitro tests directly assessed the physical and chemical performance of the Clean & More powder. This is an "algorithm only" type of test in the sense that it's the device's inherent performance being measured.
  • The clinical study evaluated the direct effect of the Clean & More treatment on patients' dentin hypersensitivity relief. This is the "standalone" performance of the therapeutic intervention itself; it's not assessing a diagnostic algorithm or a human reader's interpretation.

7. The Type of Ground Truth Used

• Clinical Study: The ground truth for dentin hypersensitivity was established by expert clinical assessment (air blast and tactile scoring) of pre-existing hypersensitivity and subsequent changes after treatment. This effectively represents a clinical outcome and patient-reported state (pain level).
• Non-Clinical (In vitro) Studies: The ground truth was based on objective laboratory measurements of physical properties (e.g., surface roughness, abrasion levels, plaque removal efficiency) using scientifically accepted methods and instrumentation.

8. The Sample Size for the Training Set

• The document does not explicitly mention a "training set" because this product is a physical dental device (prophylactic powder), not a software algorithm that requires machine learning training data. The studies conducted are for performance validation, not for training an AI model.

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

• As there is no mention of a "training set" in the context of an AI/ML algorithm for this device, this question is not applicable. The device's formulation and design would be based on prior scientific research and development, not on a machine learning training process.

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• Removal of subgingival and supragingival plaque; can also be used in the presence of permanent orthodontic apparatus (brackets) and implants
• For maintenance in periodontitis therapy after completion of initial treatment, for gingival pockets up to 5 mm in depth only
• For maintenance in periimplantitis therapy after completion of initial treatment, for gingival pockets up to 5 mm in depth only
  Calculi and tartar cannot be removed with Clinpro Prophy Powder.

Clinpro TM Prophy Powder is classified as airbrush (21 C.F.R. § 872.6080) because it is a powder to be used with air polishing devices in the professional tooth cleaning. As the predicate devices Air-N-Go® Perio Powder (K110379) and Air-Flow® Perio Powder (K092289), Clinpro Prophy Powder is a glycine based air polishing powder to be used with air polishing devices in the professional tooth cleaning.

The provided text is a 510(k) summary for a dental device (Clinpro Prophy Powder) and does not describe acceptance criteria for a study or a study proving that a device meets such criteria in the format requested.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on indications for use, performance characteristics, and biocompatibility. It does not contain a typical "acceptance criteria" table or details of a clinical study designed to quantitatively prove the device meets specific performance thresholds with a defined "test set" or "training set" as would be expected for a diagnostic or AI-based device.

Here's an breakdown of why the requested information cannot be extracted from the provided text, and what information is available:

Information NOT available in the document:

• A table of acceptance criteria and the reported device performance: The document compares characteristics to predicate devices but does not list specific numerical acceptance criteria (e.g., Sensitivity > X%, Specificity > Y%) or quantifiable performance metrics like a standalone study would.
• Sample size used for the test set and the data provenance: There is no mention of a specific test set, its size, or its origin.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No information about expert adjudication for a test set.
• Adjudication method for the test set: Not applicable as no specific test set or expert review process is described.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: This is a dental powder, not an AI diagnostic device. MRMC studies are not applicable.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for this device type.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): While it mentions "in vitro and in vivo studies" and "clinical literature review," it doesn't specify a rigorous ground truth establishment process for a performance study.
• The sample size for the training set: Not applicable for this type of submission.
• How the ground truth for the training set was established: Not applicable.

What the document does provide, in relation to device evaluation:

The evaluation conducted for this 510(k) submission primarily relies on:

• Comparison to predicate devices: The manufacturer argues "substantial equivalence" based on similar materials, indications for use, and a literature review of glycine-based air-polishing powders.
• Biocompatibility testing: This was carried out against "FDA & internationally recognized guidelines."
• In vitro and in vivo investigations: The document states that "Results of in vitro and in vivo investigations using Clinpro Prophy Powder and glycine based air-polishing powder (i.a.) published in numerous literature show that Clinpro Prophy Powder is substantially equivalent to the predicate device with regard to the performance of the product." However, it does not provide details of specific studies, their methodologies, sample sizes, or numerical results.
• Clinical literature review: The document states, "The overall conclusion, based also on the clinical literature review, is that Clinpro Prophy Powder is suitable and safe for its intended use."

Topics of "studies evaluated to substantiate performance and safety":

• Removal of subgingival bacterial load in supportive periodontal therapy
• Root debridement
• Use on contaminated implant material
• Professional oral hygiene treatment of patients with orthodontic appliances (effects on plaque index (PI) and gingival bleeding)
• Gingival tissue effects
• Abrasiveness of air-polishing

In conclusion, this document describes a 510(k) submission for a dental prophy powder asserting substantial equivalence to existing devices, supported by general statements about in vitro/in vivo studies and a clinical literature review, rather than a detailed report of a specific device performance study with predefined acceptance criteria.

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The EMS AIR-FLOW MASTER is intended for patients suffering from periodontal disease and peri-implantitis.

The EMS AIR-FI.OW MASTER is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.

The EMS AIR-FLOW MASTER is a dental air-polishing unit containing an operating unit, air pressure powered handpiece cords, powder chambers, an AIR-FLOW MASTER AIR-FLOW handpiece and a PERIO-FLOW handpiece, AIR-FLOW CLASSIC, SOFT and PERIO Prophylaxis powder, multifunction footpedal and connections for external water and air supply. The EMS AIR-FLOW MASTER is a modification of the EMS AIR-FLOW MASTER STANDARD that was cleared for marketing as K073284 for cleaning of teeth using a specially designed nozzle to deliver a mixture of water, air, and dental powders to a treatment site. The proposed EMS AIR-FLOW MASTER is supplied with a flexible thermoplastic nozzle that is used for subgingival cleaning of periodontal pockets.

The provided text describes a 510(k) summary for the EMS AIR-FLOW MASTER device. However, it does not contain detailed information regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, or adjudication methods in the manner typically expected for a detailed study report.

The text primarily focuses on:

• Device description and intended use: Detailing what the device is and what it's used for (non-surgical removal of subgingival plaque in pockets up to 5mm).
• Technological characteristics and substantial equivalence: Comparing the new device to a predicate device and explaining why it is substantially equivalent.
• Testing performed: Stating that electrical safety, electromagnetic compatibility, performance testing, and clinical data were provided.

Therefore, I cannot fulfill all aspects of your request as the specific information is not present in the provided text.

Here's a breakdown of what can be extracted and what is missing:

1. Table of acceptance criteria and reported device performance:

Specific numerical acceptance criteria (e.g., minimum plaque removal percentage, maximum adverse event rate) and detailed performance metrics are not provided.

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

• Sample size for test set: Not specified. The document only mentions "clinical data" was provided.
• Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

• Number of experts: Not specified.
• Qualifications of experts: Not specified.

4. Adjudication method for the test set:

• Not specified.

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 MRMC study is mentioned. This device is an air-polishing unit, not an AI diagnostic tool that requires human readers.

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

• This is not applicable as the device is a physical dental tool, not an algorithm.

7. The type of ground truth used:

• For a device like this, ground truth would typically refer to the clinical assessment of plaque removal and pocket depth reduction by a dental professional. However, the exact methodology for establishing this "ground truth" in the clinical data is not detailed.

8. The sample size for the training set:

• Not applicable/Not specified. This is a physical device, and the concept of a "training set" as used in AI/machine learning does not apply in this context unless referring to product development and testing cycles, which are not detailed here.

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

• Not applicable/Not specified for the reasons above.

In summary: The provided document is a 510(k) summary, which is a regulatory filing. While it states that performance testing and clinical data were provided, it does not offer the granular detail regarding study design, acceptance criteria, sample sizes, or ground truth establishment that you are requesting. Such details would typically be found in the full study report, not in this summary document.

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The AIR-FLOW MASTER STANDARD is an air-polishing unit intended for use in the cleaning and polishing of teeth by the projection of water, air, and dental 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.

The device can also be used for the following cleaning 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 fixture prior to loading
• stain removal for shade determination
• plaque removal prior to fluoride treatment
• plaque and stain removal prior to whitening procedure

The AIR-FLOW MASTER STANDARD is an air-polishing unit containing an operating unit, air/water pressure powered handpiece cords, powder chambers, AIR-FLOW handpieces, prophylaxis powders, multifunction footpedal and connections for external water and air supply. The operating unit of the AIR-FLOW MASTER STANDARD regulates the water and air/powder flow and selection of the prophylaxis powder chamber (Working Mode). The multifunction footpedal controls the operation of the AIR-FLOW handpieces. Upon installation, the AIR-FLOW MASTER STANDARD operating unit is connected to the external water and air supply.

Prior to use, the prophylaxis powder is loaded into the powder chamber and the chamber fixed to the operating unit. The AIR-FLOW handpiece is inserted into the air pressure powered handpiece cord and a powder nozzle is attached to the end of the AIR-FLOW handpiece. The operating unit is switched on and the air/powder flow and the Working Mode are adjusted on the control panel. When the operating unit is switched on, the powder chambers are under pressure. Air enters the powder chamber of the operating unit where it mixes with the prophylaxis powder. The air/powder mixture leaves the powder chamber and enters the handpiece cord. When the multifunction footpedal is pressed, the air pressure of the handpiece cord is activated and allows the air/powder mixture to be delivered to the AIR-FLOW handpiece for treatment. The air/powder mixture exits the distal end of the AIR-FLOW handpiece through the powder nozzle where it is enveloped by a water spray and directed onto the tooth surface.

This 510(k) summary describes a dental device, the AIR-FLOW MASTER STANDARD, which is an air-polishing unit. The submission aims to demonstrate substantial equivalence to a previously cleared device, the AIR-FLOW S2 (K900709). The information provided does not include a comparative study with a detailed breakdown of acceptance criteria and device performance in the way a clinical trial or AI device study would. Instead, it focuses on demonstrating that modifications to a predicate device do not alter its fundamental safety and effectiveness.

Here's an analysis based on the provided text, addressing the requested points where possible, and noting where information is not present in this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present specific quantitative acceptance criteria or detailed in-vitro/in-vivo performance data in a table format for the device's cleaning and polishing efficacy. Instead, the "acceptance criteria" are implied by successful completion of various engineering and safety tests, and the performance is assumed to be substantially equivalent to the predicate device.

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

• Sample Size: Not specified in the document. The testing mentioned (electrical safety, EMC, biocompatibility, functional testing) typically involves engineering samples of the device itself rather than a clinical "test set" of patients or data, as this is a physical device and not an AI/software product requiring patient data for performance evaluation in the same way.
• Data Provenance: Not applicable in the context of patient data. The provenance of the engineering and safety tests would be the testing laboratories, likely in the country of manufacture (Switzerland for EMS Electro Medical Systems SA). The testing is prospective for the new device.

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

This information is not applicable and not provided. The "ground truth" for a physical device like an air-polisher is its ability to perform its function (e.g., deliver air, water, and powder effectively, maintain safety standards). Experts involved would be engineers, safety specialists, and biocompatibility experts, not typically a panel establishing "ground truth" in the way a medical image interpretation study would.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for subjective assessments or when independent expert review is needed for ground truth establishment (e.g., reading medical images). For physical device testing, the criteria are objective, and the results are typically directly measured and compared against specifications.

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

No. An MRMC study is not relevant for this type of physical dental device. MRMC studies are typically employed for diagnostic devices and algorithms, often involving human readers (e.g., radiologists, pathologists) interpreting medical images or data, with and without AI assistance, to assess the impact of the AI on human performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. This is a physical device, an air-polishing unit, not a software algorithm. Therefore, "standalone" algorithm performance is not a concept applicable to this submission. While it mentions "controlling software," this software controls the physical operation of the device, not performs a diagnostic or analytical function independently of human operation.

7. The Type of Ground Truth Used

The "ground truth" for this device is derived from:

• Engineering Specifications: The device must meet predefined specifications for air/water pressure, powder delivery, power consumption, etc.
• Safety Standards: Compliance with electrical safety, EMC, and biocompatibility standards.
• Functional Performance: Demonstration that the device effectively performs its mechanical functions as intended (e.g., mixing and delivering the air/powder/water mixture).
• Predicate Device Equivalence: The ultimate "ground truth" for this 510(k) is that it is substantially equivalent to a legally marketed predicate device that has already been deemed safe and effective. The burden is to show the new device meets the same performance and safety expectations as the predicate.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI algorithm in the context of needing a "training set" of data to learn from. The "training" for such a device involves product design, development, and engineering, which are not based on data sets in this way.

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

Not applicable, as there is no "training set" in the context of AI/ML algorithms. The design and engineering process for a physical device involves meeting established engineering principles, safety standards, and performance specifications through iterative design and testing.

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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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