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The PIEZON® 707 BIK and PIEZON® BIK LED is intended for use for the following indications:

Scaling

• Removal of supragingival calculus
• Removal of stains

Endo

• Preparation, cleaning and irrigation of root canals
• Condensing gutta-percha
• Removal of crowns, bridges and restorations

Restorative

• Preparation of cavities
• Cementation of restorations
• Condensing of amalgams

Periodontics

• Scaling and root planing
• Periodontal therapy

The PIEZON® 707 BIK and PIEZON® BIK LED is an ultrasonic scaling unit consisting of an ultrasonic generator supplied with a Piezon Handpiece and scaling instruments. The PIEZON® 707 BIK and PIEZON® BIK LED are supplied with the Piezon Handpiece EN-061 and Piezon Handpiece LED EN-060, respectively. The PIEZON® 707 BIK and PIEZON® BIK LED ultrasonic generator is designed for installation into a dental chair.

The ultrasonic generator produces piezo-electric vibrations (ultrasonics) for water or dry work instruments. The appropriate instrument for a particular application is screwed onto the handpiece supplied with the scaling unit prior to beginning the procedure. The power control is handled via the potentiometer or the chair main control. The water control is handled via the handpiece or the chair main control. The treatment is carried out by placing the instrument tip onto the tooth surface according to the Operating Instruction for the instrument selected.

The provided text describes the regulatory clearance for the PIEZON® 707 BIK and PIEZON® BIK LED ultrasonic scaler. It states that no clinical testing was conducted to support this submission, and therefore, an AI/algorithm-specific acceptance criteria and study proving its meeting of those criteria in a MRMC or standalone manner are not applicable.

The submission focuses on demonstrating substantial equivalence to a predicate device (Satelec SP Newtron Module, K033764) through non-clinical performance testing.

Here's the information parsed from the document based on your request, with an emphasis on what is not applicable due to the nature of the submission (device, not AI/ML):

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

The document does not explicitly state "acceptance criteria" in a quantitative, threshold-based manner typical for AI/ML performance. Instead, it indicates that "all design inputs... were satisfied by the design outputs" and that "the device met the predetermined acceptance criteria" based on non-clinical tests.

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

Not applicable. This was non-clinical performance and safety testing of a physical device, not an AI/ML algorithm's performance on a data test set. The testing was performed on the device itself, integrated with a dental chair and handpiece.

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. Ground truth as typically defined for AI/ML performance evaluation (e.g., derived from expert consensus on medical images) is not relevant here. The "ground truth" for this device's performance would be engineering specifications and safety standards.

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

Not applicable. No expert adjudication process for a data test set was 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. No clinical testing, and specifically no MRMC comparative effectiveness study was performed or described. This device is an ultrasonic scaler, not an AI-assisted diagnostic tool. The submission explicitly states: "No clinical testing was conducted to support this submission."

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

Not applicable. This device is a physical medical device (ultrasonic scaler), not an AI algorithm. Its performance is measured by its physical operation and adherence to engineering and safety standards, not as a standalone algorithm.

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

For the non-clinical performance testing of the ultrasonic scaler, the "ground truth" was based on:

• Engineering specifications: The design inputs and predetermined performance specifications for the device's electrical, mechanical, and functional characteristics.
• International standards: Compliance with standards like IEC 60601-1 (electrical safety) and IEC 60601-1-2 (electromagnetic compatibility).

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no concept of a "training set" for an algorithm.

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

Not applicable. As there is no training set, this question is not relevant.

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The AIR-FLOW MASTER PIEZON combines the functions of an ultrasonic scaler and airpolishing unit within a single chassis. The AIR-FLOW MASTER PIEZON is intended for use in the following dental and periodontal 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 AIR-FLOW MASTER PIEZON 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 AIR-FLOW MASTER PIEZON 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 AIR-FLOW MASTER PIEZON is also intended for use as an air-polisher in patients suffering from periodontal disease. The AIR-FLOW MASTER PIEZON 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 PIEZON 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 the base control unit, hoses and connectors for two handpieces, and a foot control containing a four-position switch. There are two mounts on the top of the base unit, one for an irrigation liquid container and the other for one of the two air-polishing chambers supplied with the device.

The AIR-FLOW MASTER PIEZON 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 AIR-FLOW MASTER PIEZON is also supplied with the AIR-FLOW Handpiece and PERIO-FLOW Handpiece for performing air-polishing procedures. The proposed device is compatible with the AIR-FLOW CLASSIC (sodium bicarbonate), AIR-FLOW SOFT (glycine), and AIR-FLOW PERIO (glycine) prophylaxis powders.

The AIR-FLOW MASTER PIEZON is supplied with accessories for attaching and removing instruments and nozzles from the handpieces and containers for storage and sterilization of the reusable components and accessories.

Here's an analysis of the provided text regarding the EMS AIR-FLOW MASTER PIEZON, focusing on acceptance criteria and supporting studies, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

• Intended Use
• Operational Characteristics
• Functional Technological Characteristics | Demonstrated through direct comparison and testing of integrated functionalities. The device fulfills prospectively defined design and performance specifications. |

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

The document describes non-clinical performance testing against established standards. These involve engineering and laboratory tests, not tests on a "test set" in the sense of patient data. Therefore, notions of sample size and data provenance (country of origin, retrospective/prospective) are not applicable in the context of this submission. The testing was performed on the device itself and its components.

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

This information is not applicable as the study involved non-clinical performance testing against pre-defined engineering and medical device standards, not clinical diagnostic accuracy or efficacy requiring expert ground truth in the traditional sense. The "ground truth" here is the adherence to the specifications outlined in the standards.

4. Adjudication Method for the Test Set

This is not applicable as the evaluation involved non-clinical performance testing against established standards. There was no "test set" requiring adjudication by clinicians for diagnostic accuracy or outcome.

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 was conducted. This device is an ultrasonic scaler and air-polishing unit, not an AI software or diagnostic tool that assists human readers.

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

No standalone algorithm performance study was done. This device is a physical dental instrument, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the compliance with recognized international and national consensus standards for medical device safety, electrical safety, electromagnetic compatibility, and sterilization/reprocessing. These standards define objective, measurable criteria for performance.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical dental instrument, not an AI model requiring a training set.

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

This is not applicable as there was no training set.

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The BONART CO., LTD. ART Ultrasonic Scaler is intended for use during dental cleaning and periodontal therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.

The Bonart ART-P3 comes equipped with a turbo mode and can be operated in scaling or perio mode functions. The Bonart ART Ultrasonic Scaler ART-P3 is equipped with water adjustment and power adjustment. The unit is operated by a footswitch and comes complete with a handpiece. The handpiece is compatible with EMS ,SATELEC and Bonart tips.

The provided document is a 510(k) premarket notification for the ART Ultrasonic Scaler ART-P3. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than independent performance studies to meet acceptance criteria in the same way a de novo or PMA submission might.

Therefore, the information you're looking for regarding acceptance criteria and a study proving the device meets them, especially in the context of AI/algorithm performance, multi-reader studies, and ground truth establishment, is not present in this document. The document describes a traditional medical device (ultrasonic scaler), not an AI-powered diagnostic or therapeutic device.

Here's why each point you requested cannot be addressed from this document:

1. Table of acceptance criteria and reported device performance: This document explicitly states in section 14.8 that "The Bonart ART Ultrasonic Scaler ART-P3 was subjected to performance bench testing in accordance with applicable industry and clinical standards. Physical performance studies were conducted to verify that the Bonart ART Ultrasonic Scaler ART-P3 conformed to all emission and immunity standards in accordance with EN and IEC regulations. Results of the testing showed that the Bonart ART Ultrasonic Scaler ART-P3 performs as intended." However, it does not provide specific quantitative acceptance criteria (e.g., in terms of sensitivity, specificity, accuracy, F1-score) or reported device performance metrics against those criteria. It only states that the device "conformed" and "performs as intended."

2. Sample size used for the test set and the data provenance: Not applicable. This device is not an AI/algorithm that uses test sets or data. The "performance bench testing" mentioned would refer to engineering and electrical safety tests, not data-driven human performance or AI performance tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no mention of "ground truth" or expert review in the context of this device being an ultrasonic scaler.

4. Adjudication method for the test set: Not applicable.

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 not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.

8. The sample size for the training set: Not applicable. There is no AI model to train.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) premarket notification for a physical medical device (ultrasonic scaler). The "performance data" described refers to compliance with safety and electrical standards through bench testing, not to the kind of clinical performance or AI algorithm validation you're asking about.

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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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