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Dental Handpiece with models of SG200, SG200L, SA100L, SA100R, CA100L, and CA100R are intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, and restorations for polishing teeth.

In addition, Dental Handpiece with models of SG200, SG200L are also intended for implant surgery such as perforating the bone, tapping and threading procedures.

Dental Handpiece is designed for use by a trained professional in the field of general dentistry.

Dental Handpiece with models of SG200, SG200L, SA100L, SA100R, CA100L, and CA100R are intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, and restorations for polishing teeth.

In addition, Dental Handpiece with models of SG200, SG200L are also intended for implant surgery such as perforating the bone, tapping and threading procedures.

Dental Handpiece is designed for use by a trained professional in the field of general dentistry.

The proposed dental handpiece consists of the main body of a handpiece, which is used for transmitting a rotational force for the general dental treatments as well as accessory components. which are used for channeling water and air for further applications to the dental treatments. The torque transmitted from an electric micro-motor gets further transmitted to the joint part of Dental Handpiece. The rotational force is then decelerated according to the speed reducer of the gear to be transmitted to the head of the dental handpiece. The rotational force is transmitted under the permitted rotation mechanism.

The product is offered as an electrical-powered Dental Handpiece that is reusable and ergonomically shaped. The dental handpiece can be sterilized by the steam autoclave method. Through the tube and the electrical motor connected to a dental unit, the Dental Handpiece equipped with a handpiece connection according to ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors - ISO 3964:1982) receive the energy for the gear, the cooling water and air for cutting treatment. Dental burs and other attachments will be used with the proposed Dental Handpiece per ISO 1797:2017 (Dentistry - Shanks for rotary and oscillating instruments).

Dental Handpiece has been developed with a full range of surgical contra angle intended to be used in implantology. The contra angle-design, size and performance of the proposed Dental Handpiece conform to ISO 14457 (2017) "Dentistry -Handpieces and motors"

The six (6) product codes and models of Dental Handpiece are SG200L, SG200, CA100L, CA100R. SA100L. SA100R.The component names and functional descriptions for critical components of Dental Handpiece are provided in the table below.

The provided text describes a 510(k) premarket notification for a Class I dental handpiece, meaning it is seeking to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving a specific performance metric against acceptance criteria. Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, expert involvement, etc.) is not explicitly available in the provided document in the way it would be for a novel device undergoing clinical trials.

The document focuses on demonstrating that the new dental handpiece is substantially equivalent to existing predicate devices (SMARTmatic (K163239) and ANTHOGYR Contra angles and Handpieces (K093894)). Substantial equivalence is primarily proven by showing similar indications for use and technological characteristics, and by conforming to recognized standards.

Here's an analysis of the provided information relative to your request:

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

The document does not provide a table of acceptance criteria in the sense of specific thresholds for a novel device's performance metrics (e.g., a specific accuracy or sensitivity). Instead, it lists design verification and performance data tests that were conducted to confirm the device meets pre-determined design requirements and conforms to recognized standards. The "reported device performance" is generally stated as "favorable test results" or "demonstrates conformance."

Here's a table based on the information available, interpreting "acceptance criteria" as meeting the relevant standard and "reported device performance" as the outcome of the testing:

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The SMARTmatic handpieces are intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, restorations, and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry.

The SMARTmatic electrical-driven handpieces listed in the table below are dental handpieces for the use by a trained professional in the field of general dentistry. The devices are electricalpowered handpieces that are reusable and ergonomically shaped. The devices can be sterilized by the steam autoclave method. Through the tube and the electrical motor connected to a dental unit, the SMARTmatic handpieces equipped with a handpiece connection according to ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors - ISO 3964:1982) receive the energy for the gear, the cooling water and air for cutting treatment. Dental burs and other attachments will be used with the SMARTmatic handpieces per ISO 1797-1:2011 (Dentistry - Shanks for rotary instruments - Part 1: Shanks made of metals).

The request asks for a detailed description of acceptance criteria and the study proving the device meets these criteria. However, the provided document is a 510(k) premarket notification for a dental handpiece (SMARTmatic), which focuses on demonstrating substantial equivalence to a predicate device rather than on specific acceptance criteria and a detailed study proving performance against those criteria.

The document primarily highlights the substantial equivalence of the SMARTmatic handpieces to the MASTERmatic LUX handpieces (K143465) based on intended use, technological characteristics, and performance data. It relies on conformance to various ISO standards and a guiding document for dental handpieces. The document does not contain information on:

• A specific table of acceptance criteria with reported device performance against numerical targets.
• Sample sizes for a test set or data provenance (as it's not a clinical study on diagnostic accuracy).
• Number of experts, their qualifications, or adjudication methods for ground truth.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance (as it's a mechanical device, not an AI algorithm).
• Sample size for a training set or how ground truth for a training set was established.

Therefore, many of the requested points cannot be extracted from this document as they are not relevant to a 510(k) submission for a dental handpiece.

However, I can extract information related to the performance data and "acceptance" from the perspective of substantial equivalence and adherence to recognized standards.

Here's the information that can be extracted and a clear indication of what is not present:

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

The document doesn't provide a table of acceptance criteria in the sense of specific numerical thresholds for performance metrics. Instead, it relies on conformance to international standards. The "Summary of the Technological Characteristics" table ([page 7] and [page 8]) compares the new device (SMARTmatic) to the predicate device (MASTERmatic LUX) across various design and technical specifications. The "acceptance criteria" here are effectively that the new device's characteristics are either the same as the predicate or, if different, that these differences do not raise new questions of safety or effectiveness, as demonstrated by non-clinical testing to relevant standards.

Summary of Technological Characteristics and Performance (as presented in the document):

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

• None stated directly. The document refers to "Performance bench testing according to international standards." This typically involves testing a defined number of device units or components, but the specific sample sizes are not provided in this summary.
• Data Provenance: Not explicitly stated, but the manufacturer is Kaltenbach & Voigt GmbH, based in Biberach, Germany. The tests are "Non-Clinical Test Data," indicating lab/bench testing, not data from human subjects. This would be considered prospective bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This information is for clinical studies or AI algorithm validation, not for a mechanical dental handpiece undergoing bench testing for substantial equivalence.

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

• Not applicable. This is for clinical studies/AI algorithm validation.

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

• Not applicable. This device is a mechanical dental handpiece, not an AI-assisted diagnostic tool.

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

• Not applicable. This is a mechanical device, not an algorithm. Bench testing was done for the device itself.

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

• For biocompatibility: Conformance to ISO 10993-1. The "ground truth" is that the materials used meet the specified biocompatibility standards.
• For mechanical performance (e.g., bur retention force, speed range, coupling dimensions): Conformance to relevant ISO standards (e.g., ISO 14457, ISO 1797-1, ISO 3964). The "ground truth" is whether the physical measurements and operational parameters of the device meet the requirements of these standards.
• For sterilization: Conformance to ISO 17665-1 and AAMI ANSI ST79. The "ground truth" is that the sterilization process specified for the device achieves the required sterility assurance levels.

8. The sample size for the training set

• Not applicable. This refers to AI/machine learning models.

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

• Not applicable. This refers to AI/machine learning models.

Summary of the Study (as described in the document):

The "study" described is a non-clinical performance bench testing program to demonstrate substantial equivalence to a legally marketed predicate device (MASTERmatic LUX K143465).

• Methodology: Performance bench testing according to international standards (listed below) and biocompatibility and sterilization studies.
• Standards utilized for performance verification:
  • ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors)
  • ISO 1797-1 (Dentistry - Shanks for rotary instruments - Part 1: Shanks made of metals)
  • ISO 7405 / ISO 10993-1 (Dentistry - Evaluation of biocompatibility of medical devices used in dentistry / Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system)
  • ISO 14457 (Dentistry - Handpieces and motors)
  • ISO 17665-1 (Sterilization of health care products - Moist heat - Part 1)
  • AAMI ANSI ST79 (Comprehensive Guide To Steam Sterilization And Sterility Assurance In Health Care Facilities)
  • Guidance for Industry and FDA Staff - Dental Handpieces - Premarket Notification [510(k)] Submissions.
• Conclusion: The tests demonstrated that despite some differences in technological characteristics (e.g., external vs. internal spray, presence/absence of fiber optics, speed range, specific chuck types, and minor dimensions), these differences do not raise new concerns regarding substantial equivalence to the predicate device. The SMARTmatic handpieces are deemed substantially equivalent based on intended use, indications, technological characteristics, principle of operation, features, and performance data derived from these non-clinical tests.
• Clinical Data: The document explicitly states: "Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Clinical testing has not been conducted on this product."

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The MASTERmatic LUX handpieces are intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, restorations, and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry.

The MASTERmatic LUX electrical-driven handpieces - MASTERmatic LUX M25 L, MASTERmatic LUX M20 L, MASTERmatic LUX M10 L, MASTERmatic LUX M07 L, MASTERmatic LUX M29 L, MASTERmatic LUX M05 L are dental handpieces for the use by a trained professional in the field of general dentistry. The devices are electrical-powered handpieces that are reusable and ergonomically shaped, and provided with a fiber optic light system. The devices can be sterilized by the steam autoclave method. Through the tube and the electrical motor connected to a dental unit, the MASTERmatic LUX handpieces equipped with a handpiece connection according to ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors - ISO 3964:1982) receive the energy for the gear, the cooling water and air for cutting treatment through pouring holes and light for illumination the operation area. Dental burs and other attachments according to ISO 1797-1 (Dentistry - Shanks for rotary instruments - Part 1: Shanks made of metals - ISO 1797-1:2011) will be used with the MASTERmatic LUX handpieces.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states: "Non-Clinical Test Data". This indicates that the testing was bench testing and not performed on human subjects. Therefore, there is no "test set" in the context of patient data, nor is there any provenance related to country of origin for such data. The testing was conducted according to international standards for dental gear-driven handpieces.

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

This section is not applicable. The device underwent "Non-Clinical Test Data" (bench testing) and "Clinical testing has not been conducted on this product." Therefore, there was no human expert adjudication for a clinical ground truth.

4. Adjudication method for the test set

This section is not applicable. As no clinical studies were performed that required expert adjudication, no adjudication method 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

This section is not applicable. No MRMC study was conducted, as no clinical studies were performed and the device is a dental handpiece, not an AI-assisted diagnostic tool.

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

This section is not applicable. The device is a dental handpiece and does not involve an algorithm or AI. Performance was assessed through non-clinical bench testing.

7. The type of ground truth used

The ground truth used for performance verification was based on compliance with established international standards for dental devices (bench testing outcomes). This includes:

• ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors)
• ISO 1797-1 (Dentistry - Shanks for rotary instruments)
• ISO 10993-1 (Biological evaluation of medical devices - Biocompatibility)
• ISO 14457 (Dentistry - Handpieces and motors)
• ISO 17665-1 (Sterilization of health care products - Moist heat)

8. The sample size for the training set

This section is not applicable. There is no mention of a training set as this is a physical medical device, not a machine learning model.

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

This section is not applicable. There is no training set mentioned or implied in the provided document.

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RDT3 Handpiece Head is a reciprocating dental handpiece attachment intended for use in root canal preparations using the Self Adjusting File, SAF (K092933) (ReDent Nova LTD., Ra'anana Israel).

RDT3 is a reciprocating vertical vibrating handpiece attachment and is capable of providing the SAF with an impact movement of approximately 0.4 mm and up to 5,000 rpm drive speed required for conducting endodontic treatment. Low torque (max 9.5 ar cm) rotation motion is integrated in order to ease insertion of the file into the root canal. The file is attached to the RDT3 head via friction grip.

The provided document describes a 510(k) premarket notification for the REDENT NOVA's RDT3 Handpiece Head. It focuses on demonstrating substantial equivalence to a predicate device through technological characteristics and performance testing. However, it does not include information about a clinical study involving human or even simulated patients, nor does it involve AI, expert consensus for ground truth, or statistical measures like sensitivity, specificity, or AUC typically associated with device performance in diagnostic or prognostic applications.

The acceptance criteria and "study" described are engineering and material performance tests.

Here is the information based on the provided text, recognizing the limitations of its scope regarding "acceptance criteria" in a clinical sense:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" for each test with pass/fail values. Instead, it states that tests were carried out in accordance with ISO 7785-2 and an in-house test, and for all of them, the device "functioned as intended" and "results observed were as expected." This implies that the RDT3 met the implied performance standards of the ISO standard and the internal test.

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

The document does not specify exact sample sizes for the performance tests (e.g., how many handpieces were tested for chuck friction grip or corrosion). The tests are described as in vitro engineering and material tests, not tests on clinical data. No information on data provenance (country of origin, retrospective/prospective) is provided, as it's not applicable to these types of tests.

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

Not applicable. The ground truth for these engineering tests would be derived from the objective measurements and standards set forth in ISO 7785-2, not from expert consensus or clinical evaluation.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a dental handpiece head, a mechanical device. The submission does not involve AI or human readers, and therefore no MRMC study was conducted.

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

Not applicable. This device is a mechanical handpiece head, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for these performance tests is based on the standards and methodologies outlined in ISO 7785-2 and presumably a documented internal specification for the in-house Sodium Hypochlorite Exposure test.

8. The Sample Size for the Training Set

Not applicable. This is a mechanical device, not an AI or machine learning model, so there is no training set in the typical sense.

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

Not applicable, as there is no training set.

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ANTHOGYR's fully autoclavable contra-angles Implantology « Impulsion » are devices intended for a wide range of dental procedures including: Implant surgery such as perforating the bone, tapping and threading procedures This range can be used with special accessories like depth stop.

ANTHOGYR has developed a full range of surgical contra angle intended to be used in implantology. The name of the range is « Impulsion » . ANTHOGYR Contra angles design, size and performance conform to NF EN ISO 7785-2 "Dental Handpieces -Part 2: Straight and geared angle handpieces".

The provided document describes a Special 510(k) for a modification to Anthogyr Dental Contra-Angles. This type of submission is typically for minor changes to a legally marketed device and often relies on conformance to recognized consensus standards rather than extensive clinical studies.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

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

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

The document does not report any specific test set sample size or data provenance for human-involved studies. The performance data section refers to conformance with recognized consensus standards, implying that the device was tested against the requirements of these standards. The nature of these standards (e.g., mechanical testing, material analysis, risk management processes) would dictate the "sample size" and "provenance" in a manufacturing and testing context, but this information is not detailed here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided in the context of this device. The regulatory submission relies on conformance to engineering and material standards, not diagnostic or clinical expert review of a "test set" in the way an AI algorithm might.

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

This information is not applicable and not provided. No expert adjudication method is described, as the evaluation is based on conformance to established standards.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted and is not relevant to this type of device (dental contra-angles). This is a hardware device, not an AI or diagnostic software.

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

This concept is not applicable to a dental contra-angle device. There is no algorithm or AI component in this device.

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

The "ground truth" for this device is defined by the requirements and specifications within the referenced international and national standards. For example, for mechanical properties, the ground truth would be the defined acceptable limits and test methods in ISO 7785-2. For material composition, it would be the specifications in ISO 7153-1. These are established engineering and quality standards, not clinical "ground truth" derived from patient data or expert consensus in a diagnostic sense.

8. The sample size for the training set

This information is not applicable and not provided. This device is not an AI/ML product and does not have a "training set."

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

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

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The INTRA Lux Head 3 LDSY reciprocating dental handpiece attachment is intended for use in root canal preparations using hand-held endodontic files.

The INTRA Lux Head 3 LDSY reciprocating dental handpiece attachment is for use by a trained professional in general dentistry. The device is attached to air-powered or electrical handpieces. The reciprocating dental handpiece attachment is re-usable and ergonomically shaped, and can be sterilized by the steam autoclave method.

The provided text is related to a 510(k) submission for a dental handpiece attachment. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, the document does not contain any information about acceptance criteria or a study that proves the device meets such criteria.

The 510(k) summary focuses on demonstrating substantial equivalence based on design, application, and function compared to existing legally marketed devices, rather than presenting a performance study with defined acceptance criteria.

Therefore, I cannot provide the requested table and details because the information is not present in the given text. The document is primarily a regulatory submission for premarket notification, not a report detailing a clinical or technical performance study.

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The Elite low speed air motor with Elite "E" contra-angle is to power various attachments which helps the dental clinician perform various dental procedures, removing carious material and excess filling material, cavity and crown preparation, root canal preparations, restoration and polishing teeth.

The Medidental high speed handpiece is an air-powered dental handpiece which helps the dental clinician perform various dental procedures such as removing carious material and excess filling material, cavity and crown preparation, root canal preparations, restoration and polishing teeth.

The Elite low speed air motor with Elite "E" contra-angle is to power various attachments which helps the dental clinician perform various dental procedures, removing carious material and excess filling material, cavity and crown preparation, root canal preparations, restoration and polishing teeth.

The Medidental high speed handpiece is an air-powered dental handpiece which helps the dental clinician perform various dental procedures such as removing carious material and excess filling material, cavity and crown preparation, root canal preparations, restoration and polishing teeth.

This is a 510(k) premarket notification for a dental handpiece, not an AI/ML medical device. Therefore, the requested information about acceptance criteria, study details, expert involvement, MRMC study, standalone performance, ground truth, and training set is not applicable.

The provided document describes the substantial equivalence determination for:

• Trade Name: Elite Low Speed Air Motor with Elite "E" Contra-angle, Medidental High Speed Handpiece
• Common Name: Air-powered Low Speed Handpiece, E Type contra-angle, Air-powered High Speed Handpiece
• Classification Name: Handpiece, Air-Powered Dental
• Product Code: EFB (later listed as EFA in the FDA letter, which could be a typo or an update)

The device is intended to power various attachments for dental procedures such as removing carious material, excess filling material, cavity and crown preparation, root canal preparations, restoration, and polishing teeth.

The device was found substantially equivalent to the predicate device:

• Predicate Device: High & Low Speed Handpiece, with E-Type contra-angle (K073652) manufactured by NAKAMURA MAGNIFIER CO., LTD.

The FDA's review for such devices typically focuses on comparing the new device's technological characteristics and performance to a legally marketed predicate device to ensure it is as safe and effective. This generally involves mechanical and performance testing relevant to its function as a dental handpiece, such as speed, torque, vibration, noise, and compatibility with attachments, but not AI/ML-specific metrics.

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The STRONG Implant Handpieces, ACL-411, ACL(B)-411, ACL-421, ACL(B)-421, ACL-431, ACL-(B)-431, ACL-451 and ACL(B)-451, are devices intended for a wide range of dental procedures including:

• Endodontic surgeries, such as root canal preparations
• Implant surgery such as perforating the bone, tapping and threading procedures
• General dentistry such as removing carious material, cavity and crown preparation, finishing tooth preparations, restorations and polishing teeth

The STRONG Implant Handpieces; ACL-411. ACL(B)-41I. ACL-421. ACL(B)-421. ACL-431. ACL-(B)-431. ACL-451 and ACL(B)-451. are gear driven hand-held dental handpieces with transmission ratio of 20:1, 16:1, 32:1 and 64:1. They can be driven by torque adjustable electrical motors for surgery treatment. They are attached to drive via ISO 3964 counling. A Saline inigation system for surgery treatment is integral to the STRONG Implant Handpieces. The head clamp accepts instrument complying with ISO 1797-1. They have contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.

This document is a 510(k) summary for the Saeshin STRONG Implant Handpieces, seeking clearance from the FDA. It does not include information about acceptance criteria or a study proving the device meets those criteria, as it's a submission for substantial equivalence based on a predicate device, not a performance study against specific criteria.

Therefore, I cannot extract the requested information from the provided text. The document focuses on demonstrating that the STRONG Implant Handpieces are "substantially equivalent" to a legally marketed predicate device (ANTHOGYR Contra Angles and Handpieces, K040674) based on intended use, technology, claims, material composition, and performance characteristics, rather than reporting on a standalone study with defined acceptance criteria.

The 510(k) process for this type of device typically involves demonstrating equivalence through comparisons of technical features, materials, and intended use, often citing compliance with recognized standards (like ISO 3964 and ISO 1797-1 as mentioned) without necessarily requiring a separate performance study with acceptance criteria as would be performed for novel devices or AI/software-as-a-medical-device (SaMD) clearances.

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ANTHOGYR's fully autoclavable contra-angles Implantology "MontBlanc" and ANTHOGYR's fully autoclavable contra-angles "MontBlanc" are devices intended for a wide range of dental procedures including:
Implant surgery such as perforating the bone, tapping and threading procedures
General dentistry such as removing carious material, cavity and crown preparation, finishing tooth preparations, restaurations and polishing teeth.

ANTHOGYR has developed a full range of surgical contra angle intended to be used in implantology. The name of the range is "MontBlanc". ANTHOGYR Contra angles design, size and performance conform to NF EN ISO 7785-2 Dental Handpieces -Part 2: Straight and geared angle handpieces".
ANTHOGYR has developed a full range of general dentistry contra angle intended to be used in general dentistry. The name of the range is "MontBlanc". ANTHOGYR Contra anales design, size and performance conform to NF EN ISO 7785-2 "Dental Handpieces - Part 2: Straight and geared anale handbieces".

The provided text describes a 510(k) premarket notification for "ANTHOGYR DENTAL CONTRA-ANGLES." This document focuses on demonstrating substantial equivalence to predicate devices and adherence to recognized standards, rather than presenting a study with specific acceptance criteria and detailed device performance metrics in the format requested.

Therefore, much of the requested information regarding acceptance criteria, specific study details, and performance data from a clinical or extensive bench study is not available within this document. The submission relies on compliance with established international standards for dental handpieces and risk management.

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

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

• Acceptance Criteria: The acceptance criteria are implicitly defined by compliance with the referenced international standards. The document states that "ANTHOGYR Contra angles design, size and performance conform to NF EN ISO 7785-2 Dental Handpieces -Part 2: Straight and geared angle handpieces." Other standards listed (ISO 14971, ISO 15223, ISO 13402, ISO 3964, ISO 5832-1, ISO 13485, NF EN ISO 1797-1, NF EN ISO 17664, NF EN ISO 17665-1) also serve as acceptance criteria for various aspects like risk management, labeling, resistance to autoclaving/corrosion, coupling dimensions, and material properties.
• Reported Device Performance: The document generally states that the devices conform to these standards. It does not provide specific quantitative performance metrics (e.g., torque values, RPMs, durability cycles, temperature ranges, or specific sterilization effectiveness rates) from a dedicated study that would allow a direct comparison to numerical acceptance thresholds.

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

• This information is not provided in the document. The submission refers to compliance with standards, implying that testing was conducted according to the methodologies prescribed within those standards, but doesn't specify the sample sizes or data provenance for each test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This information is not applicable/provided. The submission is not for an AI/diagnostic device that requires expert ground truth establishment for a test set. It's for a dental handpiece, where ground truth would relate to physical and mechanical properties measurable against defined standards.

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

• This information is not applicable/provided. As above, this type of adjudication is typically for subjective assessments in AI or diagnostic studies, not for the objective physical/mechanical testing implied by compliance with ISO standards for a dental handpiece.

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

• This information is not applicable/provided. This is a medical device for general dental and implantology procedures (contra-angles), not an AI-assisted diagnostic or imaging system.

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

• This information is not applicable/provided. This is a mechanical dental instrument, not an algorithm or AI system.

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

• The "ground truth" for this device would be the specifications and requirements stipulated by the referenced international standards (e.g., specific dimensions, material compositions, resistance levels, torque outputs, sterilization efficacy as defined by the standards). These are objective, measurable criteria, not subjective expert assessments or pathology findings.

8. The sample size for the training set

• This information is not applicable/provided. This is not an AI/machine learning device that requires a training set.

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

• This information is not applicable/provided. As above, this is not an AI/machine learning device.

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ANTHOGYR's fully autoclavable contra-angles Implantology "MontBlanc" Control are devices intended for a wide range of dental procedures including: Implant surgery such as perforating the bone, tapping and threading procedures This range can be used with special accessories like depth stop.

ANTHOGYR has developed a full range of surgical contra angle intended to be used in implantology. The name of the range is "MontBlanc". ANTHOGYR Contra angles design, size and performance conform to N.F. EN ISO 7785-2 "Dental Handpieces -Part 2: Straight and geared angle handpieces: ".

This document describes a Special 510(k) submission for a modification to existing ANTHOGYR dental contra-angles. The information provided focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone study with detailed acceptance criteria and performance data for a novel AI/software device.

Therefore, many of the requested sections regarding AI/software performance will be marked as "Not Applicable" or "Information Not Provided," as this submission does not pertain to such a device.

Here's an analysis of the provided text based on your request:

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

Explanation: The acceptance criteria are primarily based on conformity to recognized international and national standards for dental handpieces and medical device quality management. The reported performance is a general statement that the device "conforms" to these standards. There are no numerical performance metrics or specific test results detailed in this summary.

2. Sample size 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. This submission describes a modification to a mechanical medical device (dental contra-angle), not a software or AI device that would typically have a "test set" in the context of diagnostic performance. Technical aspects are evaluated against engineering standards.
• Data Provenance: Not Applicable. The data provided refers to conformity with manufacturing and performance standards, not to clinical data or AI model output.

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)

• Number of Experts: Not Applicable. Ground truth as typically understood for AI/software devices (e.g., diagnostic labels) is not relevant here. Compliance with engineering standards is verified through testing and certifications, not expert annotation of a test set.
• Qualifications of Experts: Not Applicable.

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

• Adjudication Method: 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

• MRMC Study: No. This is a mechanical device, not an AI-assisted diagnostic tool.

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

• Standalone Performance: Not Applicable. This is not an algorithm.

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

• Type of Ground Truth: The "ground truth" for this type of device is compliance with established engineering and safety standards (e.g., ISO, NF EN standards) for mechanical performance, material properties, and quality systems. This is verified through testing procedures outlined within those standards, often conducted by manufacturers or certified testing bodies, rather than clinical outcomes or pathology data.

8. The sample size for the training set

• Sample Size for Training Set: Not Applicable. This is not an AI/machine learning device; there is no training set.

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

• Ground Truth for Training Set: Not Applicable.

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