Search Results

For Model J6-126, J6-136:
The Dental Handpiece is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.
For Model SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L:
The Dental Handpiece is intended for cutting and grinding teeth, cavity preparations, tooth and crown preparations, finishing and trimming teeth and filling materials and removal of crowns and filling materials.

The Dental Handpiece is mainly composed of a machine head, handle, transmission shaft, and cartridge, and is designed to be attached to the drive via standard coupling which complies with ISO 3964 and hose connector which complies with ISO 9168. The head clamp accepts an instrument complying with ISO 1797-1. The handpieces are intended to be powered by air-powered or electric-powered, and they are also intended to provide optic series. They are intended to be provided non-sterile, so they must be sterilized prior to first use and sterilized after each subsequent use using steam sterilization (moist heat sterilization).

The provided document is a 510(k) Premarket Notification for a Dental Handpiece. This type of submission is focused on demonstrating substantial equivalence to a previously cleared device, rather than proving efficacy through clinical studies or setting and meeting specific acceptance criteria for performance as would be done for a novel device or a device requiring a PMA.

Therefore, the document does not contain the information requested regarding acceptance criteria and studies that prove the device meets those criteria in the context of diagnostic or actionable performance (e.g., accuracy, sensitivity, specificity for a diagnostic AI). The "acceptance criteria" discussed in this document refer to adherence to established safety and performance standards for dental handpieces, and "study" refers to non-clinical tests verifying compliance with these standards.

Here's why the requested information isn't available in this document:

• Device Type: A "Dental Handpiece" is a physical tool used for mechanical dental procedures (cutting, grinding, polishing). It's not a diagnostic device, an AI algorithm for image analysis, or a device that generates a patient-specific "result" that would require performance metrics like sensitivity or specificity.
• Regulatory Pathway (510(k)): The 510(k) pathway demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing design, materials, technological characteristics, and intended use, and running non-clinical tests to show adherence to relevant performance and safety standards. It generally does not require large-scale clinical trials or MRMC studies that would describe the kind of acceptance criteria you've outlined.
• No Clinical Testing: The document explicitly states: "Clinical testing was not included in the submission." This immediately tells us that there will be no data on human reader improvement with AI assistance, standalone algorithm performance, or ground truth established from clinical outcomes.
• "Ground Truth" irrelevant: For a dental handpiece, the concept of "ground truth" (e.g., for a diagnosis) is not applicable. Its "performance" is measured by its physical characteristics, safety, and ability to perform its mechanical function according to engineering standards.
• No AI component: There is no mention of an AI component in this device.

Based on the available document, I cannot fulfill your request as it pertains to a diagnostic/AI device. The document describes a traditional medical device (dental handpiece) and its regulatory clearance via a 510(k) pathway, which focuses on substantial equivalence and compliance with engineering and safety standards, not clinical performance metrics relevant to AI or diagnostic accuracy.

However, I can extract information related to the standards and non-clinical tests that were performed to demonstrate the device's adherence to established safety and performance requirements, which are the "acceptance criteria" in this context.

Summary of Acceptance Criteria and Device (Non-Clinical) Performance:

Here's why the other points of your request cannot be answered from this document:

1. Sample size used for the test set and data provenance: Not applicable in the context of diagnostic/AI performance. The "tests" are engineering and safety verification tests on physical units of the device. The provenance of the device under test would be "Guangdong JINME Medical Technology Co., Ltd., China."
2. Number of experts used to establish the ground truth... and qualifications: Not applicable. There is no diagnostic "ground truth" to establish for a dental handpiece.
3. Adjudication method: Not applicable.
4. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Explicitly stated "Clinical testing was not included in the submission." Therefore, no MRMC study, no human reader improvement data.
5. Standalone (i.e., algorithm only without human-in-the-loop) performance: Not applicable, as there is no algorithm component.
6. Type of ground truth used: Not applicable.
7. Sample size for the training set: Not applicable, as there is no AI or machine learning component that requires a training set.
8. How the ground truth for the training set was established: Not applicable, as there is no training set.

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The Dental Handpiece, Wireless Endodontic Handpiece, endoit, model no. (EH-C500) is 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.

Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) consists of a Main Body, connectable Contra Angle, Charging Cradle, and AC/DC Adapter. The Main Body of the handpiece is used for transmitting rotational force required in general dental treatment. The torque transmitted from a wireless electric micro-motor gets further transmitted to the joint part of the device. The rotational force is then decelerated according to the speed reducer of the gear which is transmitted to the head of the dental handpiece. The rotational force is transmitted under the permitted rotation mechanism.

Based on the provided FDA 510(k) summary, the device in question is a Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500). This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a clinical study of AI performance. Therefore, many of the typical acceptance criteria and study details for AI/ML-driven medical devices (e.g., Sensitivity, Specificity, MRMC studies, ground truth establishment for images) are not applicable here.

This device is not an AI/ML-driven diagnostic or therapeutic device. It is a traditional medical device (a dental handpiece). The "acceptance criteria" and "study" described in the document relate to engineering and performance testing to ensure the device meets established safety and performance standards for dental handpieces, and demonstrates substantial equivalence to predicate devices.

Here's an attempt to answer your questions based on the provided text, while noting where AI/ML-specific criteria are not relevant:

Acceptance Criteria and Device Performance for the Dental Handpiece, Wireless Endodontic Handpiece, endoit (Model EH-C500)

This device is a dental handpiece, and its acceptance criteria are primarily related to its mechanical, electrical, and material safety and performance, rather than diagnostic accuracy as would be the case for an AI/ML algorithm. The "study" described is a series of engineering design verification and validation tests, along with biocompatibility testing.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a non-AI device, the acceptance criteria are not typically expressed as traditional metrics like sensitivity, specificity, or AUC. Instead, they are related to compliance with recognized standards and successful completion of pre-defined engineering tests. The document states that "The favorable test results of the proposed device which confirmed to meet the FDA recognized standards as well as ISO standard demonstrate that the proposed Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) retains the substantially equivalent profile in safety and essential performance of medical electrical equipment as the predicate (K220577) Dental Handpiece model CA160L and predicated (K123582) Endo A Class."

Here's a summary of the types of criteria and the general performance statement:

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

• Sample Size: Not explicitly stated as a number of "cases" or "patients" as would be for an AI study. The testing for this device involves:
  • Biocompatibility: Likely conducted on samples of device materials, not a "test set" of patients. The document references testing done on a previous predicate device (K192809) which results were applied.
  • Design Verification and Validation: This typically involves testing a certain number of manufactured units of the device (e.g., several units tested for rotational speed, noise, durability, etc.). The exact number is not specified in the summary but would be detailed in the full test reports.
  • Electrical/EMC Testing: This would be conducted on device units in specialized labs.
• Data Provenance: Not applicable in the sense of patient data origin. The testing is laboratory and bench testing of the physical device and its materials. This is effectively "prospective" testing of the new device's engineering performance.

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

• Not applicable. For this type of device, "ground truth" is established by engineering specifications, recognized industry standards (e.g., ISO, IEC), and scientific principles, not by expert interpretation of clinical data or images. The "ground truth" is that the device must meet the specified performance parameters (e.g., a certain rotational speed, torque, noise level) and safety requirements (e.g., electrical safety, material biocompatibility). These are verified through objective measurements and accepted testing methodologies.

4. Adjudication Method for the Test Set

• Not applicable. As there are no human interpretations of data (e.g., images) that require consensus, there is no need for an adjudication method. Test results are objective measurements against established engineering and safety thresholds.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size

• No. This is not an AI/ML diagnostic device, so an MRMC study comparing human reader performance with and without AI assistance is not relevant or performed for this type of 510(k) submission.

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

• No. This is a hardware medical device with an electromechanical function, not a software algorithm. Therefore, "standalone algorithm-only performance" is not a relevant concept for this product. The device's "standalone performance" is its ability to meet its engineering and safety specifications on its own, which is what the various design verification tests confirm.

7. The Type of Ground Truth Used

• Engineering Specifications and Recognized Standards: The "ground truth" is defined by the requirements outlined in the relevant ISO and IEC standards (e.g., ISO 14457 for handpieces and motors, IEC 60601-1 for electrical safety, ISO 10993-1 for biocompatibility) and the manufacturer's own pre-defined design requirements for functional performance (e.g., rotational speed range, noise limits). Successful completion of tests against these standards constitutes meeting the "ground truth."

8. The Sample Size for the Training Set

• Not applicable. This device does not use an AI/ML algorithm that requires a "training set" of data.

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

• Not applicable. As there is no AI/ML algorithm or training set, this question is not relevant.

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This air-powered dental handpiece is intended for removal of carious material, cavities and crown preparations, removal of filings, processing of tooth, restoration of surfaces and as a surgical tool for third molar removal procedures. It is designed for use by a trained professional in the field of general dentistry.

The TRAUS Air Dental handpieces are air driven dental handpieces for the use by a trained dental professional. The devices are air-powered handpieces that are reusable and designed accordance with international standard. The devices can be sterilized by the prevacuum steam autoclave methods that have been validated. Through the coupling connected to a dental unit, the proposed dental handpiece receive air for functionality of the high-speed turbine. They also receive cooling water for cutting through one port and light for illumination through another port.

Using in combination with dental unit chair, it is possible to use by installing the instrument at air handpiece according to purpose. It is possible to change the rotation speed by adjusting the flowing air.

The provided document is a 510(k) premarket notification for a dental handpiece (TRAUS Air Dental Handpiece) and does not contain information about acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML medical device.

The document discusses the substantial equivalence of the TRAUS Air Dental Handpiece to a predicate device (Maxima PRO 45L) based on technical characteristics and non-clinical performance data. It explicitly states: "No clinical performance testing was performed."

Therefore, I cannot provide the requested information, such as:

1. Table of acceptance criteria and reported device performance: This document does not establish performance criteria in the way an AI/ML device study would (e.g., sensitivity, specificity, AUC). Instead, it compares the technical specifications and operational principles of the new device to a predicate device.
2. Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance: These are all concepts relevant to clinical or AI/ML performance studies, which were explicitly stated as "not performed."
3. Type of ground truth: Not applicable as it's a mechanical device with no AI component requiring ground truth.
4. Sample size for training set, how the ground truth for the training set was established: Not applicable as there is no training set for an AI/ML model.

The "Non-clinical Performance Data" section (page 6) details bench tests conducted to ensure conformity to ISO standards (ISO 14457, ISO 17665-1, ISO 9168) and demonstrate substantial equivalence. These are engineering and sterilization validation tests, not performance studies as typically understood for AI/ML devices.

In summary, the provided text describes a 510(k) submission for a conventional dental handpiece, and thus does not contain the information requested about acceptance criteria and a study for an AI/ML driven device.

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Dental Handpiece with models of CA160, and CA500L 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.

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

Dental Handpiece with the model CA160, CA160L and CA500L consists of the main body of the handpiece, which is used for transmitting rotational force for the general dental treatments. The torque transmitted from a wired 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 which is transmitted to the head of the dental handpiece. The rotational force is transmitted under the permitted rotation mechanism.

Model CA160, CA160L and CA500L can be connected to spray adapter (accessory component) which is used for channeling water and air for further applications to the dental treatments. The only difference between model CA160 and CA160L is that the CA160L has lighting function.

The provided text is a 510(k) summary for a dental handpiece. It details the device's equivalence to a predicate device but does not describe an AI medical device or a study involving AI performance metrics like sensitivity, specificity, or reader studies. Instead, it focuses on the engineering and biocompatibility testing of a physical dental instrument.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance for an AI model, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these concepts are not applicable to the content provided.

The document discusses the following types of tests for the dental handpiece:

Design Verification & Performance Data:

• Appearance Test
• Operation Test
• Rotational Speed Test
• Noise Test
• Spray Test
• Light Test
• Serviceable Year/Shelf-Life Test

Biocompatibility Testing (applicable from the predicate device):

• ISO MEM Elution Using L-929 Mouse Fibroblast Cells (GLP)
• ISO Guinea Pig Maximization Sensitization Test (GLP 2 Extracts)
• ISO Intracutaneous Irritation Test (GLP 2 Extracts)
• ISO Materials Mediated Rabbit Pyrogen (GLP)
• ISO Acute Systemic Injection Test (GLP 2 Extracts)

The document concludes that the proposed device is substantially equivalent to the predicate device based on these tests and that no new questions of safety or effectiveness are raised.

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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 TRAUS Dental Handpieces, TRAUS CRB46LN and TRAUS CRB46NN are intended for a wide range of dental procedures including:

A. Implant placement , including

• 1. Preparation of the osteotomy site
• 2. Bone contouring , osteoplasty
• B. Periodontal surgeries
• 1. Bone contouring & alveoplasty around living teeth
• 2. Removal of exostosis
• C. Bone grafting
• 1. Preparation of the donor site (for e.g. symphysis and ascending rames etc.)
• 2. Harvesting autogen living bone
• 3. Sinus elevation & grafting of alveolar sockets

D. Removal and sectioning of teeth and teeth bone for e.g. impacted third molars and complicated extractions

The TRAUS Dental Handpieces; TRAUS CRB46LN and TRAUS CRB46NN are gear driven hand-held dental handpieces with Gear Ratio of 20:1. They can be driven by torque adjustable electrical motors for surgery treatment. They are attached to drive via ISO 3964 coupling. The head clamp accepts instrument complying with ISO 1797-1. They have contra-angle attachment intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.

The provided text is an FDA 510(k) Premarket Notification for a dental handpiece. It details the device's indications for use, technological characteristics, and comparison to a predicate device to establish substantial equivalence.

However, the document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/human-in-the-loop performance study.

The "studies" mentioned are:

• Biocompatibility testing (following ISO standards) to ensure material safety.
• Bench testing (to ISO 14457) to ensure mechanical performance and compliance.
• Sterilization validation (following FDA guidance, ASTM, and ISO standards) to confirm effective reprocessing.

These are standard engineering and safety tests for a medical device like a dental handpiece, not performance studies assessing diagnostic accuracy or human performance with or without AI assistance. The device in question is a physical dental instrument, not a software algorithm for diagnostic image analysis.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets them in the context of AI/human-in-the-loop performance, as the provided text does not contain this information for this type of device.

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The Strong Dental Handpiece, ACL(B)-46EP is intended for wide range of dental procedures, including:

A. Implant placement, including

• 1. Preparation of the osteotomy site
• 2. Bone contouring, osteoplasty
• B. Periodontal surgeries
• 1. Bone contouring & alveoplasty around living teeth
• 2. Removal of exostosis
• C. Bone grafting
• 1.Preparation of the donor site (for e.g. symphysis and ascending rames etc.)
• 2. Harvesting autogen living bone
• 3. Sinus elevation & grafting of alveolar sockets

D. Removal and sectioning of teeth and teeth bone for e.g. impacted third molars and complicated extractions.

Not Found

The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria.

The document is a 510(k) clearance letter from the FDA for a medical device called "STRONG Dental Handpieces". It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general controls provisions of the Act that the manufacturer must comply with. It also includes an "Indications for Use" section for the device.

Therefore, I cannot provide the requested information based on the given input.

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The STRONG Dental Handpieces, ACL(B)-611, ACL(B)-631, ACL(B)-651 and ACL(B)-04C are intended for a wide range of dental procedures including:

• A. Implant placement, including
• 1. Preparation of the osteotomy site
• 2. Bone contouring, osteoplasty

B. Periodontal surgeries

• 1. Bone contouring & alveoplasty around living teeth

2. Removal of exostosis

C. Bone grafting

• 1. Preparation of the donor site (for e.g. symphysis and ascending rames etc.)
• 2. Harvesting autogen living bone
• 3. Sinus elevation & grafting of alveolar sockets

D. Removal and sectioning of teeth bone for e.g. impacted third molars and complicated extractions

The STRONG Dental Handpieces; ACL(B)-611, ACL(B)-621, ACL(B)-631, ACL(B)-65| and ACL(B)-04C are gear driven hand-held dental handpieces with Gear Ratio of 20:1, 16:1, 64:1, 32:1 and 1:1. They can be driven by torque adjustable electrical motors for surgery treatment. They are attached to drive via ISO 3964 coupling. The head clamp accepts instrument complying with ISO 1797-1. They have contra-angle attachment intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.

Here's an analysis of the acceptance criteria and supporting study for the "STRONG Dental Handpieces" based on the provided FDA 510(k) summary (K171436):

1. Table of Acceptance Criteria and Reported Device Performance:

The document for the "STRONG Dental Handpieces" focuses on demonstrating substantial equivalence to a predicate device (K143418) rather than defining specific, quantitative acceptance criteria for de novo performance. The acceptance criteria are implicitly that the new device meets the same performance and safety standards as the predicate, as evidenced by similar technical specifications and successful bench testing against relevant standards.

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

• Test Set Description: The studies involved "ACL(B)-611, ACL(B)-62l, ACL(B)-63l, ACL(B)-65l and ACL(B)-04C samples."
• Sample Size: The exact number of samples tested for each model in the bench tests is not specified in the provided document. It states "samples were compliant," implying multiple units were tested per model.
• Data Provenance:
  • Country of Origin: Korea (Saeshin Precision Co., Ltd. is based in Republic of Korea; Biocompatibility testing done by Korea Testing & Research Institute).
  • Retrospective or Prospective: The testing appears to be prospective bench testing specifically conducted for this 510(k) submission to demonstrate compliance. Biocompatibility data leverages previous clearance (K092412) for similar materials, which would be considered retrospective in terms of the initial material assessment, but the application to the current device is part of the prospective submission.

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

• This document describes testing for a Class I dental handpiece, not an AI/Software as a Medical Device (SaMD) that typically involves expert ground truth for interpretation.
• Therefore, there is no mention of experts establishing ground truth in the context of interpretation for image analysis or clinical diagnosis. The "ground truth" for this device's performance is established by direct measurement and compliance with engineering and biocompatibility standards.
• Experts involved would typically be in engineering, materials science, and microbiology for the bench and sterilization testing, but their specific number and qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set:

• Not applicable for this type of device and testing. Adjudication methods like "2+1" are relevant for clinical studies where multiple human readers interpret data, and discrepancies need to be resolved, often in the context of AI performance evaluation. This document describes bench testing against defined standards.

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

• No MRMC study was done. This type of study is typically performed for diagnostic imaging AI algorithms to compare human reader performance with and without AI assistance. The "STRONG Dental Handpieces" are mechanical devices, and such a study is not relevant to their evaluation.

6. Standalone Performance Study (Algorithm only):

• Not applicable. This device is a mechanical dental handpiece, not an algorithm or software. The performance described is for the physical device itself.

7. Type of Ground Truth Used:

• The "ground truth" for this device's acceptance is based on:
  • Engineering Standards: Compliance with ISO 14457:2012 for dental handpieces, and ISO 3964, ISO 1797-1 for coupling and shank conformity.
  • Biocompatibility Standards: Compliance with ISO 10993-1, ISO 10993-5, ISO 10993-10.
  • Sterilization Standards: Compliance with FDA Guidance for Reprocessing, ASTM F2314, ISO 15883-5, ISO 17665-1, ISO 17665-2.
  • Direct Measurement: Technical specifications for revolution, gear ratio, weight, size, torque, etc., are directly measured and compared against the predicate and design specifications.

8. Sample Size for the Training Set:

• Not applicable. This device is a mechanical product, not a machine learning model, 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, this question is not relevant.

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Bonart dental hand piece is used for removing carious material, cavity and crown preparations, finishing tooth preparations, reducing hard tooth structures, restorations.

Bonart Dental Handpieces (ART), Disposable Prophy Angle (PERFORMANCE)

The provided text is a 510(k) summary from the FDA for Bonart Dental Handpieces (ART) and Disposable Prophy Angle (PERFORMANCE). It is a letter of substantial equivalence and does not contain details about acceptance criteria, study methodologies, or performance results. This document is a regulatory approval, not a scientific study report.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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The STRONG Dental Handpieces. ACL(B)-03C and ACL(B)-03F. are intended for a wide range of dental procedures including:

A. Implant placement, including

• 1. Preparation of the osteotomy site
• 2. Bone contouring, osteoplasty
     B. Periodontal surgeries
• 1. Bone contouring & alveoplasty around living teeth
• 2. Removal of exostosis
     C. Bone grafting
• 1. Preparation of the donor site (for e.g. symphysis and ascending rames etc.)
• 2. Harvesting autogen living bone
• 3. Sinus elevation & grafting of alveolar sockets
     D. Removal and sectioning of teeth and teeth bone for e.g. impacted third molars and complicated extractions

The STRONG Dental Handpieces; ACL(B)-03C and ACL(B)-03F are gear driven handheld dental handpieces with Gear Ratio of 1:1. They can be driven by torque adjustable electrical motors for surgery treatment. They are attached to drive via ISO 3964 coupling. 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.

The provided document describes a 510(k) premarket notification for the STRONG Dental Handpieces (models ACL(B)-03C and ACL(B)-03F). The intention is to demonstrate substantial equivalence to a predicate device (K100192).

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

Key Takeaway: This submission is for a medical device (dental handpieces), not for an AI/ML powered device. Therefore, many of the typical questions regarding AI/ML study design, such as information about training sets, test sets, ground truth establishment by experts, adjudication methods, and MRMC studies, are not applicable here. The evaluation focuses on non-clinical bench testing and biocompatibility to prove substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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