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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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The Swiss Master Light® is a dental curing light that is designed for use in the photopolymerization of dental resins, activation of tooth whitening agents in bleaching procedures.

The Swiss Master Light® consists of a control unit with a handpiece connected to the Main Unit by a detachable handpiece cord. The handpiece contains the halogen light source and a light guide that directs light to the treatment area on the patient. The control unit provides power and cooling water to the handpiece and controls handpiece function.

Here's a breakdown of the acceptance criteria and study information for the Swiss Master Light® as derived from the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not specify a sample size for the test set.

The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin mentioned for the specific performance testing. However, given that the sponsor is in Switzerland and the filing is with the US FDA, it's possible testing occurred in either region.

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

The document does not provide any information regarding the number of experts used or their qualifications for establishing ground truth in the performance testing.

4. Adjudication Method for the Test Set

The document does not provide any information on the adjudication method used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as described in the provided summary. This document focuses on the device's technical performance rather than reader interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is an electromechanical device, a dental curing light, not an AI algorithm. Therefore, a standalone (algorithm only) performance study is not applicable and was not conducted. The "performance testing" described refers to the physical output and effect of the light itself.

7. Type of Ground Truth Used

The ground truth for the performance testing appears to be based on objective measurements of material polymerization and thermal effects. For example, the ability to "cure resin" would be assessed by laboratory tests measuring the degree of polymerization (e.g., hardness, depth of cure) and "without causing thermal damage to tissue" would involve temperature measurements or biological assays.

8. Sample Size for the Training Set

This is an electromechanical device, not an AI algorithm, and therefore does not have a "training set" in the context of machine learning.

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

As this is not an AI algorithm, the concept of a training set and its associated ground truth is not applicable.

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The EMS KERMIT® is an ultrasonic scaler which is intended for the following:

• Removing supra and subgingival calculus deposits and stains from the 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
• Preparing approximal cavities
• Cementing inlays and onlays
• Retrograde preparation of root canals

Ultrasonic Scaler

This document is a 510(k) Summary for a medical device called the EMS KERMIT®, an ultrasonic scaler. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data with specific acceptance criteria and detailed performance metrics as one might find in a Premarket Approval (PMA) application or a clinical trial report.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not present within this 510(k) Summary for the EMS KERMIT®.

Here's why and what can be inferred:

• 510(k) Submissions Focus on Substantial Equivalence: The primary goal of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a predicate device already on the market. This often relies on comparing technical specifications, materials, performance claims, and intended use rather than requiring new, extensive clinical trials to establish safety and effectiveness from scratch.
• "Acceptance Criteria" in 510(k): For a 510(k), "acceptance criteria" generally refer to the criteria used to determine if the new device performs as safely and effectively as the predicate device for its intended use. This might involve bench testing, engineering comparisons, or limited performance testing, but not typically the kind of detailed clinical study data often associated with AI/software devices.
• "Study that proves the device meets the acceptance criteria": In a 510(k), this is typically a "substantial equivalence" comparison, where the new device's features and performance are shown to be comparable to the predicate. The document lists predicate devices (EMS miniPiezon, Piezon Master 400, etc.) which means the applicant likely presented data or arguments showing the EMS KERMIT® performs similarly to these devices.

Based on the provided text, I cannot complete the table or answer the specific questions about acceptance criteria and study details because the information is not provided in this 510(k) Summary.

However, I can extract the relevant information about the device and its intended use, and explain the absence of the other requested data.

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

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

• Not provided in the 510(k) Summary. 510(k)s for mechanical devices like ultrasonic scalers often rely on bench testing, materials testing, and comparisons to predicate devices rather than clinical studies with large "test sets" in the context of AI. If any testing was done, the details are not in this summary.

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

• Not applicable/Not provided. This level of detail is typically associated with clinical studies for AI/software devices where ground truth needs to be established by multiple expert reviewers. For an ultrasonic scaler, performance verification would likely rely on engineering/bench testing and comparison to predicate device specifications.

4. Adjudication method for the test set

• Not applicable/Not provided. See the explanation for point 3.

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

• Not applicable. The EMS KERMIT® is a physical medical device (ultrasonic scaler), not an AI or software-as-a-medical-device (SaMD) that assists human readers. Therefore, an MRMC study related to AI assistance would not be relevant.

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

• Not applicable. The EMS KERMIT® is a physical medical device, not an algorithm.

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

• Not applicable/Not provided in this summary. For a physical device, "ground truth" often relates to measured physical properties, successful removal of calculus in in-vitro models, or comparison against established predicate device performance. Specific "ground truth" in the clinical AI sense is not relevant here.

8. The sample size for the training set

• Not applicable. The EMS KERMIT® is a physical device, not an AI model that requires a training set.

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

• Not applicable. See the explanation for point 8.

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The EMS Surface Mount Scaler is an ultrasonic scaler and is intended for the removal of supra and subgingival calculus deposits and stains from the teeth; periodontal pocket lavage with simultaneous ultrasonic tip movement; and scaling and root planing.

The EMS Surface Mount Scaler consists of a control unit housing containing the ultrasonic generator, a dental handpiece, scaler instrument, and torque wrench. The Scaler is designed to operate in conjunction with the office dental unit. The control unit housing is mounted under the control head of the dental unit and is connected to the water supply, hanger air supply, pneumatic foot switch, and electrical supply of the dental unit. The Scaler ultrasonic power and water flow are simultaneously activated by pressing the dental unit foot switch. Power output and water flow can be adjusted using the knobs on the front of the Scaler. The Scaler handpiece is designed to be placed in the dental unit's handpiece hanger when not in use.

The provided 510(k) summary for the EMS Surface Mount Scaler does not contain specific acceptance criteria or a detailed study proving the device meets them. This type of regulatory submission often focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive performance studies with predefined acceptance criteria as would be expected for novel devices or AI/software as a medical device (SaMD).

However, I can extract information related to the device and its intended use, and then explain why the requested study-related details are not present in this document format.

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in the document.
• Reported Device Performance: Not explicitly stated in terms of quantitative metrics or a performance study. The document asserts that the device is "substantially equivalent" to a predicate device, implying similar performance.

Why this table cannot be fully completed from the provided text:
The 510(k) summary focuses on demonstrating substantial equivalence to a legally marketed predicate device (EMS miniPiezon Ultrasonic Scaler, K953026). For devices like ultrasonic scalers, substantial equivalence is often established by demonstrating similar technological characteristics, intended use, and safety/effectiveness profiles to a predicate device, rather than through a new, extensive clinical performance study with predefined acceptance criteria. Testing for such devices typically involves verifying basic functionality, electrical safety, biocompatibility, and sterilization, which are not detailed in this public summary.

Regarding the other requested information, it is not present in this 510(k) summary because the nature of this submission (510(k) for an ultrasonic scaler) does not typically require such detailed clinical study information as would be seen for complex diagnostic devices or AI/SaMD.

Here's a breakdown of why each point is not addressed:

• 2. Sample sized used for the test set and the data provenance: Not applicable. No "test set" in the context of a performance study is described. The demonstration of equivalence relies on comparing the device's design and intended use to the predicate.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" or expert review process is described as part of a performance study.
• 4. Adjudication method for the test set: Not applicable. No test set requiring adjudication 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 is an ultrasonic scaler, not an AI/diagnostic imaging device that would involve human readers or AI assistance for image interpretation.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical ultrasonic scaler, not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth for a performance study is described.
• 8. The sample size for the training set: Not applicable. The device does not involve machine learning or AI with a "training set."
• 9. How the ground truth for the training set was established: Not applicable. The device does not involve machine learning or AI.

Summary of what is provided:

• Device Name: EMS Surface Mount Scaler
• Intended Use: Removal of supra and subgingival calculus deposits and stains from the teeth; periodontal pocket lavage with simultaneous ultrasonic tip movement; and scaling and root planing.
• Predicate Device: EMS miniPiezon Ultrasonic Scaler (K953026)
• Technological Characteristics Comparison: The document states "The Surface Mount Scaler is substantially equivalent to the EMS miniPiezon ultrasonic scaler. Both devices are intended to be used for the removal of calculus deposits and stains from the teeth. The devices use the same ultrasonic generator and handpiece. The main difference between the devices is that the miniPiezon is a stand-alone ultrasonic scaler while the Surface Mount Scaler works in conjunction with the office dental unit. Minor differences in the user interface, and in the power, air, and water supplies, do not raise new questions of safety and effectiveness, leading to a conclusion of substantial equivalence." This comparison serves as the basis for establishing that the device meets safety and effectiveness expectations, drawing upon the known performance of the predicate device.

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The Swiss OrthoClast® is used for the removal of bone cement during implant revision surgery.

The EMS Swiss OrthoClast® system consists of a pressure regulator/control unit, pneumatic footswitch, handpiece, chisels of various sizes and shapes, a hollow drill and extractor for removal of the cement tip, and the Orthoscope. The Swiss OrthoClast® uses simple pneumatic and ballistic principles to fragment bone cement. A pressure pulse generated by the pressure regulator/control unit causes a moveable projectile in the handpiece to be driven forward to strike the proximal end of the chisel. The impact generates a shock wave along the chisel, which leads to a small, high-speed excursion of the chisel tip. The distal end of the chisel is held in contact with the targeted cement. Repetitive shock waves result in fragmentation of the bone cement. A short tip excursion period followed by a longer rest period prevents the build-up of heat in the fragmentation site. Direct vision into body cavities, such as the femoral cavity, is facilitated using the Orthoscope.

The provided document is a 510(k) summary for the Swiss OrthoClast®, a powered orthopedic surgical instrument used for the removal of bone cement during implant revision surgery. It describes the device, its intended use, and performance testing conducted. However, it does not include specific quantitative acceptance criteria or detailed results like the "reported device performance" typically associated with a table. Instead, it broadly states that tests "confirmed that the Swiss OrthoClast® met the design objectives."

Therefore, I cannot populate a table with specific acceptance criteria and reported performance for each test from this document. I will extract the information that is present and indicate when information is not available.

Here's the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided document. The document mentions "tests" retrospectively but does not provide details on the number of samples (e.g., number of chisels tested, number of in vitro cement models).
• Data Provenance: Not specified. It's likely from in vitro laboratory testing given the test types, but the location (country of origin) and whether it's retrospective or prospective are not mentioned.

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

This section is not applicable to the provided document. The performance tests ("Maximum excursion and velocity of the Swiss OrthoClast® chisel tips," "Handpiece and chisel longevity," "In vitro cement fragmentation efficiency," "Orthoscope temperature elevation") are engineering/physical performance tests, not clinical evaluations that require expert adjudication or ground truth establishment in the traditional sense for diagnostic devices.

4. Adjudication method for the test set

Not applicable. The tests are mechanical/physical performance tests, not image interpretation or diagnostic evaluations requiring adjudication.

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 is a surgical instrument, not a diagnostic or AI-assisted device. Multi-reader multi-case studies and AI comparative effectiveness are not relevant to this type of device and were not conducted or mentioned.

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

Not applicable. This is a manually operated surgical instrument; an "algorithm only" performance study is not relevant.

7. The type of ground truth used

Not applicable in the typical sense of pathology or outcomes data for diagnostic devices. The "ground truth" for these engineering tests would be derived from physical measurements (e.g., actual excursion/velocity, remaining useful life, temperature readings, successful cement fragmentation).

8. The sample size for the training set

Not applicable. This is a physical device, not a machine learning algorithm that requires a training set.

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

Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment.

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