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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 PIEZON 250 is a device for delivering ultrasonic movement and irrigant to a stainless steel tip which is used by a dentist or dental hygienist. The indications for use are:

• Periodontal pocket lavage with simultaneous ultrasonic tip movement
• Scaling and root planing
• Removal of supra and subgingival calculus and stains from teeth

The proposed PIEZON 250 ultrasonic scaler is a modification of the previously cleared miniPiezon (K953026). The working instrument for the scaling function is the handpiece, which is connected to the control unit via a handpiece cord and mounted in a holder on the side of the control unit. In the proposed PIEZON 250, irrigating liguid is pumped to the handpiece from a 350ml (or 500ml) irrigating bottle by a peristaltic pump rather than from an external water supply. The flow rate of the irrigating liquid is adjusted via a rotating knob located on the side of the control unit. The PIEZON 250 is supplied with two handpieces - the Piezon handpiece LED (lightemitting diode) and the Piezon handpiece. The Piezon handpiece LED is identical to the Piezon handpiece LED described in K093000 for the Piezon Master 700 ultrasonic scaler (K093000) and contains 6 LEDs in the body of the handpiece and a light guide that is positioned under the nozzle. The Piezon handpiece is identical to the Piezon handpiece LED, except that the Piezon handpiece does not have LEDs or the light guide. All instruments compatible with the PIEZON 250 have been previously cleared (see 510(k) numbers referenced in Section 3).

The provided document describes a 510(k) submission for a device modification of the PIEZON 250 ultrasonic scaler. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than proving efficacy through clinical studies and acceptance criteria as would be the case for novel devices. Therefore, the information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically understood for new device validation, is largely not applicable in this context.

However, I can extract information related to the "non-clinical performance testing" which serves a similar function for device modifications.

Here's a breakdown of the available information:

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

The document does not explicitly state "acceptance criteria" in a quantitative table format with corresponding "reported device performance" as would be seen for a clinical trial or algorithm validation study. Instead, it refers to fulfilling "design inputs" and meeting "functional and performance requirements" through non-clinical testing.

The basis for substantial equivalence is listed as:

• Intended Use: Identical to predicate (dental and periodontal applications, scaling, root planing, removal of calculus and stains).
• Treatment Site: Identical to predicate (subgingival and supragingival).
• Function: Identical to predicate (ultrasonic scaling).
• Mechanism of Action: Identical to predicate (ultrasonic energy).
• Components: Mostly identical, with modifications in the control unit, handpieces, and irrigation system being the primary differences.

Implicit Acceptance Criteria (derived from the substantial equivalence claim and non-clinical testing summary):

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

• Sample Size for Test Set: Not applicable. The document states "No clinical testing was conducted for this submission." The evaluation relied on non-clinical performance testing and comparison to predicate devices, not a clinical test set.
• Data Provenance: Not applicable for a clinical test set. The non-clinical testing would typically be performed in a lab setting by the manufacturer (E.M.S. ELECTRO MEDICAL SYSTEMS S.A. in Switzerland).

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 as no clinical test set was used and no ground truth was established by experts in the context of a clinical study. The "ground truth" here is the established safety and effectiveness of the legally marketed predicate devices.

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

• Not applicable as no clinical test set was used.

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

• Not applicable. This is not an AI device, and no MRMC comparative effectiveness study was conducted.

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

• Not applicable. This is not an AI device.

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

• The "ground truth" in this context is the regulatory determination of safety and effectiveness for the predicate devices (miniPiezon and Piezon Master 700). The PIEZON 250 demonstrates substantial equivalence to these already cleared devices through non-clinical testing and comparison of technological characteristics.

8. The sample size for the training set

• Not applicable. This is not a machine learning/AI device, so there is no "training set."

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

• Not applicable. There is no training set for this type of device submission.

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The PIEZON 150 is a device for delivering ultrasonic movement and water to a stainless steel tip which is used by a dentist or dental hygienist. The indications for use are:
• Periodontal pocket lavage with simultaneous ultrasonic tip movement
• Scaling and root planning
• Removal of supra and subgingival calculus and stains from teeth
• Intended for use in dental and periodontal applications performed by an ultrasonic scaler.

The proposed PIEZON 150 ultrasonic scaler is a modification of the previously cleared miniPiezon (K953026). The working instrument for the scaling function is the handpiece, which is connected to the control unit via a handpiece cord and mounted in a holder on the side of the control unit.

The PIEZON 150 connects to an external water supply and delivers water via the connected handpiece. The power of ultrasonic vibrations is adjusted via a power knob on the top of the control unit. The flow rate of the irrigating liquid is adjusted via a rotating knob located on the side of the control unit.

The PIEZON 150 is supplied with two handpieces - the Piezon Handpiece LED (lightemitting diode) or the Piezon Handpiece. The Piezon Handpiece LED is identical to the Piezon Handpiece LED described in K093000 for the Piezon Master 700 ultrasonic scaler (K093000) and contains 6 LEDs in the body of the handpiece and a light guide that is positioned under the nozzle. The Piezon Handpiece is identical to the Piezon Handpiece LED, except that the Piezon Handpiece does not have LEDs or the light guide. All instruments compatible with the PIEZON 150 have been previously cleared (see 510(k) numbers referenced in Section 3).

The modifications made to the miniPiezon to produce the PIEZON 150 include:
• Shape and contours of the control unit redesigned to accommodate the finger-tip power control, improve aesthetics, facilitate cleaning, and enhance ergonomics
• Use of a potentiometer for power regulation via the power control knob to improve ultrasonic power control.
• One operating mode with a Standard power range (0-100% power) for scaling procedures and a Perio range (0-37.5% power) for periodontal procedures
• Supported handpieces (Piezon Handpiece (FT-215#) and Piezon Handpiece LED (FT-223#)
• Ultrasonic generator upgraded to EJ-110. the Light command, Motor/Solenoid valve command and Pedal command have been added.

The provided document is a 510(k) summary for a medical device modification, specifically for the PIEZON 150 ultrasonic scaler. It states that no clinical testing was conducted for this submission. Instead, substantial equivalence was determined based on non-clinical performance testing and comparison to predicate devices.

Therefore, the requested information regarding acceptance criteria derived from a study proving the device meets those criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, cannot be extracted from this document, as these types of studies were not performed or reported for this submission.

Here's a summary of what can be gathered, addressing the relevant points from your request:

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

The document states: "Non-clinical performance testing demonstrates that all design inputs for the PIEZON 150 were satisfied by the design outputs, that the device meets electrical safety and electromagnetic compatibility requirements, and functional and performance requirements."

While the document generally states that "functional and performance requirements" were met, it does not explicitly list quantitative acceptance criteria for these functional performance aspects, nor does it provide specific "reported device performance" metrics against such criteria in a measurable way beyond stating they were satisfied.

The comparison table (sections 3 and 4 of the input) highlights the technological characteristics of the proposed device and predicate devices, which implicitly defines the expected performance by showing similarity. For instance:

The "reported device performance" essentially aligns with the characteristics of the predicate devices, and any noted "improvements" (like the potentiometer for power regulation) are presented as enhancing an already acceptable functionality.

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. No clinical test set data was used. Non-clinical performance testing was conducted, but details on sample sizes or data provenance for these engineering tests are not provided.

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 clinical studies requiring expert ground truth were conducted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical studies requiring adjudication were conducted.

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 ultrasonic scaler, not an AI-based diagnostic tool, and therefore MRMC studies are not relevant. No such study was conducted.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No clinical studies requiring ground truth were conducted. Substantial equivalence was based on non-clinical performance and comparison to predicate devices, implying that the established safety and efficacy of the predicate devices serve as the "ground truth" for the modified device's expected performance.

8. The sample size for the training set
Not applicable. No algorithm training was performed for this hardware device.

9. How the ground truth for the training set was established
Not applicable. No algorithm training was performed and therefore no ground truth for a training set was established.

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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 EMS Piezon® Master 600 is an ultrasonic scaler 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 proposed Piezon® Master 600 is a modification of the Piezon® Master 400. The modified Piezon® Master 600 consists of the main scaler unit (including a peristaltic pump for irrigant delivery), hoses and connectors for two handpieces, a foot control containing a four-position switch, and two bottles for holding irrigation liquids. The Piezon® Master 600 is supplied with one of a number of optional Instrument Systems (containing a Universal handpiece and scaling instruments), a flat key, and a torque tool (CombiTorque) for attaching instruments to the handpiece.

This document is a 510(k) summary for a medical device (EMS Piezon® Master 600) and does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a specific study proving device performance. This type of submission is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than a full clinical trial report with detailed performance metrics.

However, I can extract the information that is present and highlight what is missing based on your request.

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

• Specific quantitative acceptance criteria (e.g., maximum leakage current, specific EMC levels).
• Detailed quantitative performance data (e.g., cleaning efficiency, scaling precision, time to complete tasks for new applications, vibration characteristics, efficacy rates for specific procedures). The document mentions "enhanced ultrasonic performance" but doesn't provide metrics.

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

This document does not provide a sample size for a test set in the context of clinical or performance data. The "performance testing" referred to (electrical safety, EMC, design control) are engineering and regulatory compliance tests, not typically clinical studies involving patient data.

Missing Information:

• Sample size for any test set involving performance on human or animal subjects.
• Data provenance (country of origin, retrospective/prospective).

3. Number of Experts and their Qualifications for Ground Truth

This document does not describe the establishment of a ground truth by experts in the way you've outlined for clinical studies. The performance testing mentioned refers to engineering and design verification.

Missing Information:

• Number and qualifications of experts for ground truth.

4. Adjudication Method for the Test Set

This document does not describe any adjudication method for a clinical test set, as no such test set is detailed.

Missing Information:

• Adjudication method.

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

This document does not mention or describe a MRMC comparative effectiveness study. The device is an ultrasonic scaler, suggesting a focus on mechanical performance rather than image interpretation by human readers.

Missing Information:

• Information on MRMC study or AI-assisted improvement for human readers.

6. Standalone (Algorithm Only) Performance Study

The device is a physical ultrasonic scaler, not an AI algorithm. Therefore, a "standalone algorithm only" performance study is not applicable in this context.

7. Type of Ground Truth Used

For the engineering and design verification tests mentioned, the "ground truth" would be established by engineering standards, regulatory requirements, and internal design specifications. For example, electrical safety is judged against a standard like IEC 60601-1, and EMC against relevant IEC or national standards. These are not "expert consensus, pathology, or outcomes data" in the typical clinical sense.

8. Sample Size for the Training Set

This document does not refer to a training set as would be used for an AI/machine learning algorithm. The development of this physical medical device would involve design, prototyping, and iterative testing, but not a "training set" in that context.

Missing Information:

• Sample size for a training set.

9. How Ground Truth for the Training Set Was Established

As there is no mention of a training set for an AI algorithm, this information is not applicable.

Summary of what the document does provide regarding performance and acceptance:

The document describes the device as a modification of a predicate device (Piezon® Master 400). The modifications aimed to enhance procedural flexibility and ease of use, and included "enhanced ultrasonic performance." The basis for substantial equivalence is that these modifications do not alter the general intended use or fundamental scientific technology. New applications (cavity preparation, cementation, retrograde root canal preparation) are covered by equivalence to another predicate device (EMS KERMIT®) which was previously cleared for those uses.

Performance testing was conducted as part of design verification and validation activities. These included:

• Electrical safety testing
• Electromagnetic compatibility testing (EMC)
• Completion of Design Control Checklists to ensure all design requirements were fulfilled.

The results of these engineering/regulatory compliance tests "confirm that the modified EMS Piezon® Master 600 is safe and effective for the indicated dental and periodontal cleaning, preparatory, and restorative procedures." The FDA's substantial equivalence determination implies these tests met the necessary acceptance criteria for the device to be marketed.

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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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