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Ultrasonic Scaler is used to remove dental plaque from teeth and remove stains on teeth during dental cleaning.

A device intended for use during dental cleaning and periodontal (gum) therapy to remove adherent plaque and food debris from the teeth to reduce tooth decay, potential stains in the gingival groove, the back of the tooth and the tooth and associated gingival line. The electronic oscillation circuit generates ultrasonic frequency electric pulse wave, which is amplified to a certain intensity and conveyed to the transducer. The electrical energy is converted into mechanical energy, and the working head tool is stimulated to produce vibration of the same frequency, so as to achieve the purpose of crushing calculus and loosening tartar.

The provided text is a 510(k) summary for an Ultrasonic Scaler (K240707). It describes the device's substantial equivalence to a predicate device and outlines performance data. However, it does not contain the acceptance criteria or a study that proves the device meets those criteria in the context of AI/ML performance.

Instead, the document focuses on:

• Comparison of technological characteristics between the proposed device and a predicate device (K163414). This comparison highlights similarities and differences in design, operation controls, power supply, operating conditions, storage conditions, and electrical/EMC/biocompatibility standards.
• Performance data limited to biocompatibility testing and non-clinical testing of electrical safety and electromagnetic compatibility (EMC) according to various IEC standards.

Therefore, I cannot provide the requested information regarding acceptance criteria for an AI/ML device, its reported performance, sample sizes, ground truth establishment, or specific AI/ML study details, because this information is not present in the provided document.

The document discusses acceptance criteria and performance data for a physical medical device (ultrasonic scaler), not an AI/ML component.

If this was a misunderstanding and you were expecting information related to a traditional medical device's performance, please clarify. Otherwise, the requested AI/ML specific information is absent from this document.

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Ultrasonic Applications for:

• All sub-gingival and supra-gingival scaling and routine prophylaxis procedures.
• Periodontal therapy

The BioSonic US200 Ultrasonic Scaler is an ultrasonic scaling unit that is used in sub-gingival and supra-gingival scaling and routing prophylaxis procedures, and periodontal therapy. The BioSonic US200 Ultrasonic Scaler includes the main unit, handpiece, footswitch, removable sheath, and a selection of scaler inserts. This device generates high frequency waves that cause the tip of the scaler insert to vibrate at 25kHz or 30kHz depending on the scaler insert used.

The provided document is a 510(k) Premarket Notification for a medical device called the BioSonic US200 Ultrasonic Scaler, which is an ultrasonic scaling unit for dental procedures. It is a Class II device (Regulation Number 872.4850, Product Code ELC).

This document does not contain the specific acceptance criteria and detailed study results for a device that uses a test set for performance evaluation in the way typically expected for AI/ML-driven devices. This is because the BioSonic US200 Ultrasonic Scaler is a hardware device, not an AI/ML software device.

The "studies" referenced are non-clinical performance tests conducted to ensure safety and effectiveness in comparison to a predicate device, focusing on electrical and mechanical aspects, and material compatibility. There are no mentions of "test sets", "ground truth", "experts", "adjudication methods", "MRMC studies", or "standalone performance" in the context of assessing an algorithm's diagnostic or predictive capabilities.

Therefore, I cannot fulfill your request for items 1-9 based on the provided text, as those categories are not applicable to the type of device and submission described.

However, I can extract information about the type of tests performed and the general conclusion regarding acceptance criteria (though not specific numerical criteria for performance metrics).

Here's what I can extract regarding the device's testing and intended performance from the document:

General Acceptance Criteria and Reported Device Performance (as inferred from the document):

• Frequency testing (e.g., verifying 25kHz or 30kHz operation).
• Power testing.
• Tip displacement testing.
• Insert extraction testing. |
  | Material Compatibility | Materials compatibility testing with cleaning and disinfecting agents was performed. |
  | Substantial Equivalence to Predicate | The device's indications for use are identical to the predicate. Technological characteristics are substantially equivalent with minor differences (mechanism to change modes, automatic frequency detection, removable autoclavable sheath) that "do not constitute a new intended use or raise different questions of safety and effectiveness compared with the predicate." This is the overarching acceptance criterion for 510(k) clearance. |

Why the other requested information cannot be provided from this document:

• 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 for a hardware device's non-clinical testing. "Test sets" in this context refer to electrical/mechanical measurements, not patient data.
• 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" usually refers to diagnostic accuracy in AI/ML, not the physical properties of an ultrasonic scaler.
• 4. Adjudication method (e.g. 2+1, 3+1, none) 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 for this hardware device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as it's not an algorithm-only device.
• 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, as this is not an AI/ML device that requires a training set.
• 9. How the ground truth for the training set was established: Not applicable.

This document solely concerns the FDA's 510(k) clearance of a traditional, non-AI medical device based on its physical and electrical performance and comparison to a predicate device.

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The ultrasonic scaler tips are intended for use by dental professionals to:

1. Remove supra and sub gingival calculus deposits and stain from the teeth;
2. Clean and irrigate root canals.

Ultrasonic scaler tips are an accessory to a piezoelectric ultrasonic handpiece and scaler unit. The devices are used during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of ultrasonic vibration and in various endodontic applications to prepare the teeth and/or root of the teeth for repair.
The models are GD1, GD2, GD4, GD5, GD6, PD1, PD3, PD4, PD4D, ED1. The Ultrasonic scaler tips are made from Stainless Steel 30Cr13 and the endo files are made of Nickel Titanium Alloy. The tips will be available in M3x0.6 internal thread.
GD series and PD series(except for PD4D) are used to remove calculus deposits from teeth; PD4D and ED1 are used for root canal indication.

The provided text is a 510(k) summary for "Ultrasonic Scaler Tips" and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance through a clinical or algorithmic study with a defined test set, ground truth experts, and statistical outcomes.

The document discusses:

• Device Description and Intended Use: The device is an accessory for professional dental use to remove calculus and stain, and to clean/irrigate root canals.
• Comparison to Predicate Devices: It details similarities and differences in product code, regulation, intended use, device description, operating principle, tip shapes, composition, coatings, interaction with other products, sterilization, and mechanism of treatment to establish substantial equivalence.
• Performance Data: It lists bench performance testing (biocompatibility, reprocessing validation, conformity to ISO standards like ISO 18397 and ISO 3630-5) conducted to support substantial equivalence.
• Absence of Clinical Data: Critically, it explicitly states, "The subject of this premarket submission, ultrasonic scaler tips, did not require clinical studies to support substantial equivalence."

Therefore, the information required to answer your detailed questions about acceptance criteria, test set, data provenance, number/qualifications of experts, adjudication, MRMC studies, standalone performance, and ground truth for training/test sets is not available in this document. This document describes a 510(k) pathway, which often relies heavily on bench testing and comparison to legally marketed predicate devices rather than novel clinical performance studies, especially for devices like scaler tips.

To directly answer your request based on the provided text:

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

The document doesn't provide specific numerical acceptance criteria or clinical performance metrics for the device itself (e.g., how effectively it removes calculus). Instead, it states that tests were conducted to demonstrate conformity to applicable clauses of ISO standards and that biocompatibility and reprocessing validation were performed. The "performance" is implicitly deemed acceptable if it meets these bench test standards and allows for substantial equivalence to predicates.

• ISO 18397 Dentistry Powered scaler
• ISO 3630-5 Dentistry Endodontic instruments Part 5: Shaping and cleaning instruments (Implicitly passed) |
  | Clinical Performance | Not Applicable / Not Required. "did not require clinical studies to support substantial equivalence." |

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: Not specified for any "test set" in the context of clinical performance data, as clinical studies were not required. For bench testing (biocompatibility, reprocessing, ISO conformity), sample sizes would be determined by the specific test protocols and standards, but are not detailed here.
• Data Provenance: Not specified, as clinical data was not used. The document pertains to a Chinese manufacturer (Guilin Refine Medical Instrument Co., Ltd.) seeking FDA clearance in the US, so any bench testing would likely have been conducted by or for the manufacturer.

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 test set requiring expert ground truth was performed or required for this 510(k) submission.

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

• Not applicable. No clinical test set requiring adjudication was performed or required.

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 tip, not an AI-powered diagnostic or assistive tool. No MRMC study or AI assistance is mentioned or relevant to its function.

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

• Not applicable. This device is an ultrasonic scaler tip, not an algorithm.

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

• Not applicable. No clinical ground truth was established or used, as no clinical studies were performed. Ground truth for the bench tests would refer to the validated methods and accepted reference standards of the specific physical, chemical, and mechanical tests conducted.

8. The sample size for the training set

• Not applicable. No training set for an algorithm was used or mentioned.

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

• Not applicable. No training set for an algorithm was used or mentioned.

In summary: The provided document is a 510(k) clearance letter and summary for an ultrasonic scaler tip, which falls under Class II medical devices. For such devices, particularly accessories, the FDA often relies on bench testing and substantial equivalence to existing predicate devices rather than requiring extensive clinical trials or AI-specific performance studies. The questions you've asked are highly relevant for AI/software as a medical device (SaMD) clearances, but not for this specific type of physical device and its associated 510(k) pathway.

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TTBIO EVOCLEAN Ultrasonic Scaler is designed for use during dental cleaning and periodontal debridement of periodontal diseases.

TTBIO EVOCLEAN Ultrasonic Scaler consists of an ultrasonic generator, a handpiece, a power supply, a foot pedal and other minor accessories. There are two models of TTBIO EVOCLEAN Ultrasonic Scaler, one is EVOCLEAN and the other is EVOCLEAN+. The specifications of these two models are almost the same; the major difference is the connection type, fix and plug in, between the handpiece and main unit. TTBIO EVOCLEAN Ultrasonic Scaler uses ultrasonic energy to generate mechanical micro-vibration of the available inserts to perform the dental procedures defined in its intended use. TTBIO EVOCLEAN Ultrasonic Scaler is a multi-frequency available device which is compatible with 25 KHz or 30 KHz inserts. The system will automatically detect the insert oscillation frequency, need not to operate it manually. The handpiece is connected directly to the device's ultrasonic generator, from which it receives the functional drive signals, search and locate the resonant frequency of the insert, which varies according to the insert in use.

The provided text is a 510(k) summary for a medical device called the TTBIO EVOCLEAN Ultrasonic Scaler. It does not contain information about an AI-powered device or a study involving human readers and AI assistance for diagnostic purposes. Instead, it details the substantial equivalence of an ultrasonic scaler to a predicate device, focusing on non-clinical performance and testing. Therefore, I cannot generate a response that includes acceptance criteria and a study proving an AI device meets those criteria based on the provided text.

Specifically, the document focuses on the following:

• Device identification: TTBIO EVOCLEAN Ultrasonic Scaler (K201317)
• Regulatory classification: Class II, Product Code ELC
• Intended Use: Dental cleaning and periodontal debridement.
• Comparison to predicate device (BONART ART-M3II Ultrasonic Scaler UNITS WITH ACCESSORIES, K052028): Demonstrates substantial equivalence through detailed comparisons of indications for use, contraindications, components, materials, treatment mechanism, power, frequency, etc.
• Non-clinical testing: Refers to testing according to ISO18397:2016, cleaning validation, biocompatibility evaluation (ISO 10993-1), software verification/validation, and electrical safety/EMC testing (IEC 60601-1-2:2014 and ANSI/AAMI ES60601-1:2005/(R)2012 & A1:2012).
• Absence of clinical testing: Explicitly states "No clinical testing was conducted for this submission."

Since the request is about acceptance criteria and a study for an AI device and the provided text is for an ultrasonic scaler with no AI component, I cannot fulfill the request directly.

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The ultrasonic scaler is intended to:

1. Remove supra and sub gingival calculus deposits and stain from the teeth;
2. Carry out periodontal pocket lavage with simultaneous ultrasonic tip movement;
3. Clean and irrigate root canals

The Ultrasonic scaler employs piezoelectric technology to produce a steady power. It is composed of a control unit housing a generator that produces piezo-electric vibrations. The working instrument for the ultrasonic scaler is the handpiece, which is connected to the control unit via a handpiece cord. A scaling tip specific to a particular procedure is attached to the end of the handpiece. The ultrasonic scaler models VET-W3 and VST-W3 connect to an external water supply and delivers water via connected handpiece.
Ultrasonic scaler consists of main generator, VE and VS handpiece, optional scaler tips (G series, P series, E series), power adapter and foot switch;
The main part is as follows:

1. Power adapter: DC 24V, input frequency: 3-20W
2. Main engine: The main engine is the major part of the circuit control, including ultrasonic pulse circuit, modulator circuit and oscillatory circuit. It is used for converting the ultrasonic oscillatory signal to ultrasonic mechanical oscillatory signal by magnifying and improving the vibrating frequency.
3. Handpiece: It mainly converts the signal from circuit,which will drive the ultrasonic scaler tips vibrating.
4. Scaler tip: The scaler tip is used to remove the calculus and plague by vibrating on the teeth surface.

This document describes a 510(k) premarket notification for an Ultrasonic Scaler, which is a dental device. The request asks for details related to acceptance criteria and a study proving the device meets those criteria, typically found in submissions for Artificial Intelligence (AI) or machine learning (ML) enabled medical devices.

However, the provided text does NOT describe an AI/ML-enabled device or a study designed to evaluate its performance against specific acceptance criteria for AI/ML outputs.

The document states:

• "Clinical evaluation is not applicable for the proposed device." (Page 6)
• The comparison is primarily focused on technological characteristics and bench testing against existing standards (IEC, ISO), not clinical performance metrics related to AI/ML.
• The device is an "Ultrasonic Scaler" for removing calculus and stain, periodontal pocket lavage, and root canal cleaning. This is a mechanical device, not described as having any AI or ML components.

Therefore, many of the requested points, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the loop performance)," "number of experts used to establish ground truth," and "sample size for training set," are not applicable to the content of this 510(k) submission.

Based on the provided text, I can only address how the device's equivalence and safety were established, not how an AI/ML component meets specific performance criteria.

Summary of Device Acceptance (for a non-AI/ML device based on this 510(k)):

The acceptance of the "Ultrasonic Scaler" (Models VET-W3, VST-W3, VET-1, VST-1) is based on demonstrating substantial equivalence to a legally marketed predicate device (Nanning Baolai Medical Instruments Co., Ltd.'s Ultrasonic scaler P7, K140233) rather than proving performance against specific AI/ML acceptance criteria.

The acceptance involves showing the proposed device has the same intended use, similar product design, same sterilization conditions, and comparable technological characteristics as the predicate device. Bench testing against recognized international standards was conducted to support safety and performance.

1. Table of acceptance criteria and reported device performance:

1. Remove supra and sub gingival calculus deposits and stain from the teeth;
2. Carry out periodontal pocket lavage with simultaneous ultrasonic tip movement;
3. Clean and irrigate root canals. | Same as predicate device. |
   | Technological Characteristics (similar to predicate) | Working Principle: Piezoelectric effect (same as predicate)
   Sterilization: Handpiece: autoclaved 135°C/0.22MPa; Scaler tip: autoclaved high temp/pressure (same as predicate)
   Operating Conditions: Temp 5-40℃, RH 30-80%, Pressure 50-106kPa (same as predicate)
   Storage Conditions: Temp -10-+50℃, RH ≤ 80%, Pressure 50-106kPa (same as predicate) | Key technological aspects are similar. |
   | Power Supply (meet safety standards) | Input voltage: 30VDC 50HZ; Output power: 3-20W. (Predicate: 24VDC 1.5A 50HZ, 3-20W) | Slight difference in input voltage, but both meet IEC 60601-1. |
   | Safety and Performance Standards Compliance | IEC 60601-1:2006+A1:2012 (Electrical safety)
   IEC 60601-1-2:2007 (EMC)
   IEC 61205:2001 (Measurement & declaration of output characteristics)
   ISO 10993-5:2009 (Biocompatibility - cytotoxicity)
   ISO 10993-10:2010 (Biocompatibility - irritation/sensitization) | All listed standards were used for non-clinical bench testing. |
   | Software Level of Concern | Moderate (same as predicate) | Addressed as "Moderate." (Details on software testing not provided in text). |

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

• Not applicable for AI/ML performance testing.
• The device underwent bench testing against international standards (IEC, ISO). This typically involves testing a few representative units to confirm compliance with electrical safety, EMC, performance characteristics, and biocompatibility. The specific number of units tested is not detailed in this summary, but it would not be a "sample size" in the context of AI/ML validation with a large dataset.
• Data provenance for such tests would be from the manufacturer's internal testing labs, likely in China (based on submitter's address). These are prospective tests performed to demonstrate compliance.

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

• Not applicable. This device is not an AI/ML device requiring human expert annotation for ground truth. Ground truth for this device is based on physical measurements of device characteristics against engineering and safety standards.

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

• Not applicable. There was no human reader/adjudication involved in establishing ground truth for performance of this mechanical device.

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, this was not done. This is a mechanical dental device, not an AI/ML tool designed to assist human readers.

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

• Not applicable. This is not an algorithm. Device performance was assessed via bench tests.

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

• For this type of device, "ground truth" is typically defined by established engineering standards and specifications. For example, electrical safety is confirmed by measuring parameters against limits set in IEC 60601-1, and biocompatibility is assessed by testing against ISO 10993 standards. It's objective measurement against a known reference, not human expert consensus on diagnostic image interpretation.

8. The sample size for the training set:

• Not applicable. This device does not use an AI/ML training set.

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

• Not applicable. This device does not have a training set or associated ground truth.

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The ultrasonic scaler is intended to:

1. Remove supra and sub gingival calculus deposits and stain from the teeth;
2. Carry out periodontal pocket lavage with simultaneous ultrasonic tip movement;
3. Clean and irrigate root canals.

Ultrasonic scaler employs piezoelectric technology to produce a steady power. It is composed of a control unit housing a generator that produces piezo-electric vibrations. The working instrument for the ultrasonic scaler is the handpiece, which is connected to the control unit via a handpiece cord. A scaling tip specific to a particular procedure is attached to the end of the handpiece. The ultrasonic scaler connects to an external water supply and delivers water via connected handpiece.

The provided text is related to the FDA 510(k) premarket notification for an Ultrasonic Scaler P7. This document is a regulatory submission demonstrating substantial equivalence to a predicate device, not a study proving device performance against specific acceptance criteria in a clinical context with human interaction.

Therefore, many of the requested categories for a study proving acceptance criteria cannot be extracted from this document, as it focuses on demonstrating safety and efficacy through non-clinical testing and comparison to an already approved device.

Here's the information that can be extracted and a clear indication of what cannot be found in this type of document:

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

This document does not present acceptance criteria in a tabulated format for clinical performance or a direct measure of human improvement with AI. Instead, it lists the non-clinical tests performed to demonstrate safety and performance equivalent to the predicate device.

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

• Sample size for test set: Not applicable in this context. The testing described is non-clinical bench testing and biocompatibility. For these types of tests, "sample size" would refer to the number of units tested, which is not specified in the summary document. It's not a clinical study involving patients or a test set of data like images.
• Data provenance (country of origin, retrospective/prospective): Not applicable for the non-clinical tests described. The tests were performed to international standards (IEC, ISO, AAMI/ANSI). The manufacturing country is China.

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

Not applicable. This document describes non-clinical testing and regulatory equivalence, not a clinical study with expert-established ground truth.

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

Not applicable, as this is not a study involving expert adjudication of clinical cases.

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. This is not an AI/software device, and no MRMC study was conducted or reported.

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

Not applicable. This is a physical medical device, not an algorithm.

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

Not applicable. For the non-clinical tests, "ground truth" is established by the specifications and standards outlined (e.g., electrical safety standards, biocompatibility thresholds). The "ground truth" for showing equivalence is the performance characteristics of the predicate device.

8. The sample size for the training set

Not applicable. This is a physical device, not a machine learning model requiring a training set.

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

Not applicable.

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This product is intended only for dental clinic /dental office use. This device generates ultrasonic waves intended for use in dental applications such as scaling, root canal treatment, periodontal and cavity preparation.

The Varios 370 is a compact, portable control unit powered by the iPiezo® engine. The product comes with a wide range of tip inserts, which can be attached at the distal end of the Varios 2 Handpiece transducer and vibrates at ultrasonic frequencies of 28 to 32 KHz. The Varios 370 LUX features twin LED lights, assuring generally clearer vision and easier identification of the treatment area.

This report does not contain information about the acceptance criteria and the study proving the device meets those criteria from an AI/ML perspective. The document is a 510(k) summary for an ultrasonic scaler (Varios 370 / Varios 370 Lux) and focuses on regulatory compliance, outlining the device's description, intended use, technological characteristics, and a summary of testing against applicable industry standards (e.g., electrical safety, biocompatibility, sterilization).

Here's a breakdown of what is provided, and why it doesn't align with the requested AI/ML-centric information:

What is provided in the document:

• Device: Varios 370 / Varios 370 Lux (Ultrasonic Scaler)
• Intended Use: Dental clinic/office use for applications like scaling, root canal treatment, periodontal and cavity preparation using ultrasonic waves.
• Summary of Testing: The document states the device underwent "design validation, including software validation" as required by 21 CFR 820.30(g) and was tested in accordance with several standards:
  • IEC 60601-1 (Electrical Safety)
  • UL 60601-1 (Electrical Safety)
  • IEC 60601-1-2 (Electromagnetic Compatibility)
  • ISO 10993-1 (Biocompatibility)
  • ISO 22374 (Dental handpieces Electrical-powered scalers and scaler tips)
  • AAMI/ANSI/ISO 17665-1 (Sterilization)
• Predicate Device: K031421 – Nakanishi Varios 350 / Varios 350 Lux, to which the current device is considered "substantially equivalent."
• Conclusion: Substantial equivalence is based on similarities in primary intended use, principles of operation, design rationale, test results, and performance.

Why this doesn't fit the requested AI/ML acceptance criteria study:

The provided document describes a traditional medical device (an ultrasonic scaler) and its regulatory submission. It does not mention any AI or Machine Learning components. Therefore, there are no AI/ML acceptance criteria, no studies on algorithm performance, no discussions of training or test sets, no data provenance related to AI, no ground truth establishment for AI, and no MRMC studies or standalone algorithm performance metrics.

To answer your specific questions based on the absence of AI/ML in this document:

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

   • Acceptance Criteria (for regulatory submission): The device successfully met the requirements of the standards listed (IEC 60601-1, UL 60601-1, IEC 60601-1-2, ISO 10993-1, ISO 22374, AAMI/ANSI/ISO 17665-1) and successfully underwent design validation, including software validation, as per 21 CFR 820.30(g). Performance was also deemed similar to the predicate device.
   • Reported Device Performance (for AI/ML): Not applicable, as there is no AI/ML component.

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 for AI/ML. The device's performance was likely evaluated through engineering tests (e.g., electrical safety, EMC, vibration frequency, biocompatibility tests) rather than a clinical "test set" in the context of data analysis for AI.

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 for AI/ML. Ground truth, in this context, would relate to the physical and functional specifications of the device meeting its design intent and safety standards, rather than expert interpretation of data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for AI/ML.

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, as there is no AI component.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as there is no AI component.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): The "ground truth" for this device would be defined by the technical specifications, performance standards, and safety requirements outlined in the referenced IEC/ISO/UL standards. For example, for electrical safety, the ground truth is whether the device adheres to leakage current limits. For biocompatibility, it's whether the materials are non-toxic.

8. The sample size for the training set: Not applicable, as there is no AI/ML component.

9. How the ground truth for the training set was established: Not applicable, as there is no AI/ML component.

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This device, Varios 970 / Varios 970 Lux, an electronic scaler, is intended for use with an appropriate tip for following use: Scaling, Perio, Implant Maintenance, Endodontic, Retrograde Endo, Restorative (for ・ Minimal Intervention/ Finishing/Trimming/ Polishing/Caries of Dentin), Prosthetics (Condensation / Loosening / Plugging)

Varios 970 is a stand-alone ultrasonic scaler device powered by the iPiezo® engine. The Varios 970 consists of the Varios 970 Control Unit, two independent 400 mL irrigation bottles, handpiece, and a wide range of tip inserts. The tip inserts, when attached at the distal end of the handpiece transducer, resonate at ultrasonic frequencies of 28 -32 kHz. The 400 mL bottles each can carry different solutions with independent pumps. The Varios 970 LUX features twin LED lights that last longer, are more durable, and generate less heat than halogen bulbs.

The provided text is a 510(k) summary for the NSK Varios 970 / Varios 970 Lux Ultrasonic Scaler. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and expert-adjudicated ground truth.

Therefore, an exhaustive response to all specific points regarding acceptance criteria, study details, expert involvement, and ground truth establishment, as typically expected for studies proving AI device performance, cannot be fully provided based solely on the given extract. This document describes a medical device's regulatory submission, not the results of a specific clinical performance study for an AI algorithm.

However, I can extract and infer information relevant to what would be the "acceptance criteria" and the "study" in the context of a 510(k) submission for a non-AI medical device, which relies heavily on demonstrating equivalence to an already legally marketed product.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (ultrasonic scaler), the "acceptance criteria" revolve around demonstrating that the new device operates similarly and safely to the predicate device, especially in terms of fundamental performance characteristics and compliance with electrical safety and EMC standards.

2. Sample Size for the Test Set and Data Provenance

• Test Set Sample Size: The document does not specify a "sample size" in terms of patient data or clinical cases for a performance study. For a traditional medical device like an ultrasonic scaler demonstrating substantial equivalence, the "test set" primarily refers to the device itself being subjected to engineering verification and validation tests rather than a cohort of patients.
• Data Provenance: The 'data' mentioned refers to the results of engineering tests (electrical safety, EMC, sterilization). This data would be generated in a lab setting by the manufacturer (Nakanishi, Inc. in Japan). It is not retrospective or prospective in the clinical sense.

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

• This is not applicable in the context of this 510(k) submission for an ultrasonic scaler. Ground truth establishment by clinical experts is typically required for diagnostic or AI-driven devices where interpretation of medical data is central. For an ultrasonic scaler, performance is evaluated against engineering specifications and safety standards, not against "ground truth" established by radiologists or other clinical experts for comparative diagnostic accuracy.

4. Adjudication Method for the Test Set

• This is not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in expert interpretations to establish a definitive ground truth in a clinical study. As explained above, this 510(k) relies on engineering and performance testing against objective standards and comparison to a predicate device, not on interpreting medical images or data.

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

• No, an MRMC comparative effectiveness study was not done. Such studies are relevant for evaluating the impact of an AI diagnostic aid on human reader performance, typically in interpreting medical images. This 510(k) is for a physical medical device (an ultrasonic scaler), not a diagnostic AI.

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

• No, this is not an AI device, so the concept of a "standalone" or "algorithm only" performance study is not applicable. The device itself is a standalone physical instrument.

7. The Type of Ground Truth Used

• Not applicable in the AI context. For this device, the "ground truth" for performance is effectively defined by:
  • Compliance with specific engineering and safety standards (e.g., ISO, IEC for electrical safety, EMC, sterilization).
  • Demonstrated functionality (generating ultrasonic frequencies, irrigation, operating modes) matching the predicate device.
  • The predicate device itself (Varios 75) serving as the benchmark for "acceptable" performance and safety.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI device, so there is no "training set."

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

• Not applicable. As there is no training set for an AI algorithm, no ground truth needed to be established for it.

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The Lakong 2200 Ultrasonic Scaler is intended for use during dental cleanings and periodontal therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.

Not Found

This document is a 510(k) clearance letter from the FDA for the Lakong 2200 Ultrasonic Scaler. It indicates that the device has been found substantially equivalent to a predicate device. However, this document does not contain the acceptance criteria, reported device performance, or details of a study proving the device meets acceptance criteria.

The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with specific performance acceptance criteria for devices like an ultrasonic scaler, which is in a lower risk class (Class II).

Therefore, I cannot provide the requested information from the given input. The document is too limited to answer the specific questions about acceptance criteria and detailed study information.

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This device generates ultrasonic vibrations intended for ultrasonic procedures: 1.) General Supra and Subgingival scaling applications; 2.) Periodontal debridement for non-surgical treatment of Periodontal diseases.

The Swerv Magnetostrictive Ultrasonic Scaler is a portable stand alone scaler, handpiece and foot control. The Swerv Magnetostrictive Ultrasonic Scaler operates at 25 kHz and accepts voltage inputs between 100-240V. The available power output is segmented into two over zones to assist the user in selecting the recommended power setting for a selected ultrasonic insert. The power and water controls of the Swerv' Scaler are located in the control unit. The Swerv2 Magnetostrictive Ultrasonic Scaler plugs into an ordinary electrical outlet and converts the AC current into high frequency electro-mechanical vibrations. The Swerv3 Scaler features a patented switching mechanism to support the use of either 25 kHz or 30 kHz inserts. Therefore, the scaling system accepts both Hu-Friedy 25 kHz and 30 kHz Ultrasonic Inserts.

The provided text describes a 510(k) summary for the Hu-Friedy Swerv Magnetostrictive Ultrasonic Scaler System. It details the device, its intended use, and technological characteristics, along with evidence of its performance and substantial equivalence to predicate devices. However, the document does not contain the level of detail typically found in a clinical study report or a comprehensive validation study that would outline acceptance criteria and specific study results in the structured format requested.

Therefore, it is not possible to fully answer all aspects of your request based on the provided text. I will extract the information that is present and indicate where information is missing.

Acceptance Criteria and Device Performance for Swerv Magnetostrictive Ultrasonic Scaler System

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific quantitative acceptance criteria are not explicitly stated. The performance is described in qualitative and comparative terms.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified. The document mentions "in-house testing" and "analysis of frequency and stroke data" but does not give specific numbers of tests or samples.
• Data Provenance: The testing was "in-house testing" conducted by Hu-Friedy and "EMC and Safety testing conducted by Underwriters Laboratories." The data appears to be retrospective as it was collected as part of the device development and submission process. The country of origin of the data is implicitly USA, as Hu-Friedy MFG. CO. INC. is located in Chicago, IL, USA.

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

• This information is not provided in the document. The document describes engineering and performance testing, not a study involving experts establishing ground truth for a test set in a clinical context.

4. Adjudication Method for the Test Set

• This information is not provided. The type of testing described (engineering performance, EMC, safety) typically does not involve adjudication in the clinical sense.

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

• No, an MRMC comparative effectiveness study is not mentioned in the document. The study described focuses on the device's technical specifications and safety/efficacy relative to predicate devices, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

• This is not applicable as the device described is a physical medical device (ultrasonic scaler), not a software algorithm with standalone performance.

7. Type of Ground Truth Used

• The ground truth for the performance claims appears to be based on engineering specifications and established regulatory standards. For "frequency and stroke data," it was compared to "predicated devices in the market" and compliance with "ISO 22374 requirements." For "EMC and Safety testing," it demonstrated "compliance with the international requirements."

8. Sample Size for the Training Set

• This is not applicable as the device is hardware, not an AI algorithm requiring a training set in the conventional sense. The "in-house testing" mentioned would be more akin to validation/verification testing.

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

• This point is not applicable as there is no mention of a training set for an AI algorithm.

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