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The intended use of DPA is for polishing and cleaning teeth.

Plastic one-piece housing (external casing) with 1 internal drive shaft and a spindle installed and aligned at right angle (90 degree) with each other. The tip of spindle is fitted with rubber prophy cup for cleaning and polishing teeth. A small amount of food-grade grease is added between the drive shaft and the spindle as lubrication. The disposable prophylaxis angle is available in a soft cup and firm cup format, which differ in the material used to form the cup. The Medicom and Practicon brands differ in logo and packaging, but utilize the same design.

This FDA 510(k) clearance letter pertains to a Disposable Prophy Angle, a dental device, not an AI/ML medical device. Therefore, much of the requested information regarding AI/ML device testing (e.g., sample size for test set, data provenance, expert ground truth, MRMC study, training set details) is not applicable to this document.

However, I can extract the relevant information regarding performance criteria and testing for this device.

Acceptance Criteria and Study for Disposable Prophy Angle (K240950)

This document describes the 510(k) clearance for a Disposable Prophy Angle, a dental handpiece accessory used for polishing and cleaning teeth. The device is not an AI/ML medical device, and thus, many of the typical AI/ML study parameters are not applicable.

The submission demonstrates substantial equivalence to predicate devices by meeting recognized performance requirements through non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

The documentation references compliance with a specific industry standard for performance.

Note: The specific numerical values or thresholds for "temperature rise" and "vibration" are not provided in this summary but would be detailed in the full test reports submitted to the FDA.

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

Not Applicable (N/A). This is a hardware dental device. The testing described is non-clinical performance testing (temperature rise, vibration) based on engineering specification compliance, not an AI/ML model evaluated on a test set of data. The "test set" would refer to the physical samples of the device and its components. The document doesn't specify the number of units tested, only that "all models of the device (soft cup and firm cup)" were tested.

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

Not Applicable (N/A). Ground truth based on expert review is specific to AI/ML or diagnostic image analysis. For this device, "ground truth" refers to established engineering standards (ANSI ADA Specification No. 85) and comparative performance against a predicate device.

4. Adjudication method for the test set

Not Applicable (N/A). Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among multiple human readers in AI/ML or diagnostic studies. This is a non-clinical, hardware performance test.

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 (N/A). This is not an AI/ML device; therefore, an MRMC study and analysis of human reader improvement with AI assistance are irrelevant.

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

Not Applicable (N/A). This is not an algorithm or software device.

7. The type of ground truth used

The "ground truth" (or basis for acceptance) for this device's performance testing is:

• Established engineering standards: Specifically, "ANSI ADA Specification No. 85, Part I: Disposable Prophy Angles, section 5.5."
• Comparative equivalence: Demonstration of "equivalent performance to the predicate device" for temperature rise and vibration.

8. The sample size for the training set

Not Applicable (N/A). This is a hardware device; there is no training set for an AI/ML model.

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

Not Applicable (N/A). There is no training set for an AI/ML model.

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The Star E900 Handpiece Series are intended to be used for general dentistry by trained dental professionals. The intended use of the respective handpieces is dependent on the gear ratio.

Star E900 1:5 Handpiece: the removal of decayed matter, cavity and crown preparations, the removal of fillings and surface finishing of tooth and restoration surfaces.

Star E900 1:1 Handpiece: Cavity preparations, caries excavation, endodontic applications, processing of tooth and restoration surfaces.

Star E900 5:1 Handpiece: Cavity preparations, caries excavation, endodontic applications, processing of tooth and restoration surfaces.

Star E900 1:1 Straight Handpiece: prophylaxis treatment, crown preparations, polishing of tooth and restoration surfaces

The Star E900 Handpiece Series are reusable contra-angle handpieces, driven by an ISO 3964 compliant electric micro-motor or air driven motor, that are intended for use by trained dental professionals in the field of general dentistry. The Star E900 1:5, 1:1 and 5:1 handpieces are designed for general applications to prepare dental cavities for restoration. The Star E900 1:1 Straight Handpiece is designed for prophylaxis treatment, crown preparations, polishing finishing of tooth and restoration surfaces.

The Star E900 Handpiece Series feature an ISO 3964 compliant handpiece coupling connecting them to an electric micro-motor controlled by an electric control unit or air driven motor connected to a dental delivery unit. The control unit or delivery unit supplies energy to the handpiece which powers the gears within the handpieces. Depending on the applications, the handpieces have a maximum drive speed of 8,000 to 200,000 RPM's.

These handpieces are ergonomically shaped and have glass rod fiberoptics to illuminate the oral cavity during procedures. In addition, the handpieces have multi-port water spray. The exception to the fiber optics and water spray features is the Star E900 1:1 Straight Handpiece. This handpiece does not contain any fiberoptics nor does it have water spray capabilities.

All the handpieces in the Star E900 Handpiece series are composed of stainless steel and PEEK. They can be autoclaved.

The Star E900 Handpieces use only burs with hardened, tempered steel shanks or carbide shanks which are ISO 1797 compliant.

All handpieces in this series incorporate RFID (radio frequency identification) technology. This passive RFID tag does not have a built-in energy source. The RFID tag will allow the practitioner to track the device within the office only if the practitioner has a separate reader. The RFID reader will enable the practitioner to track such things as usage and maintenance.

The handpieces, with the exception of the Star E900 1:1 Straight Handpiece, incorporate a temperature sensor to be used in the service of the device, by trained service personnel, to access excessive heat in the handpiece, indicative of mechanical failure. This feature is not accessible to the practitioner.

The provided text is a 510(k) premarket notification for a medical device (DentalEZ, Inc., StarDental Division's Star E900 Handpiece Series). This document describes the device and its equivalence to legally marketed predicate devices, but it does not contain acceptance criteria or study results in the format you requested for AI/algorithm performance.

The document describes bench tests conducted to evaluate the functional performance and safety of the device against standards like ISO 14457:2017 and IEC 60601-1:2020. It also mentions biocompatibility testing leveraged from a reference device and sterilization/cleaning validation. However, these are evaluations of the physical medical device itself, not an AI or algorithm.

Therefore, I cannot fulfill your request to provide:

• A table of acceptance criteria and reported device performance (for an AI/algorithm).
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study results.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This document is for a traditional dental handpiece, not a device that utilizes AI or an algorithm that would have "ground truth" or "training sets" in the context of your request.

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X65L / X65 / M65

General Cutting Straight is intended for the following application(s):

Caries removal, cavity and crown preparation, removal of dental restorations (fillings and prostheses), finishing and polishing of teeth and dental restorations.

FX65 / FX65m / EX-5B

General Cutting Straight is intended for the following application(s):

Caries removal, cavity and crown preparation, removal of dental restorations (fillings and prostheses), finishing and polishing of teeth and dental restorations. Using a prophy angle, prophylaxis treatment of the surface of teeth and dental restorations.

The General Cutting Straight is a prescription-only dental straight handpiece used by qualified dental healthcare professionals in general dentistry. The General Cutting Straight includes six models: X65L, X65, M65, FX65m, FX65, and EX-5B. The General Cutting Straight conforms to ISO 14457 and is driven by an ISO 3964-compliant electric or air motor. The General Cutting Straight achieves its intended use in conjunction with an ISO 1797-compliant rotary instrument or a prophy angle that conforms to either ANSI ADA Standard No. 85-2004 (R2009) or ISO 14457. The General Cutting Straight is composed mainly of stainless steel, titanium, or aluminum, depending on the model, and is reusable, requiring cleaning and steam sterilization. The accessories of the General Cutting Straight include the Bur Stopper, Bur Stopper Puller, and E-Type Spray Nozzle. The General Cutting Straight is lubricated with the PANA SPRAY Plus [K163486] using the E-Type Spray Nozzle.

This document describes the 510(k) summary for the "General Cutting Straight" dental handpiece. It details its intended use, technological characteristics, and comparison to a predicate device. However, this document does not contain information about a study proving the device meets specific performance acceptance criteria beyond general statements that it met applicable tests from ISO 14457:2017.

The device in question, "General Cutting Straight," is a dental handpiece, which is a mechanical device. The clearance is based on substantial equivalence to a predicate device, not on clinical performance data from an AI or imaging-based diagnostic system. Therefore, the specific questions related to AI/imaging device performance (e.g., sample sizes for test and training sets, expert consensus, MRMC studies, ground truth establishment) are not applicable to this submission type.

Here’s a breakdown of why many of your specific requests cannot be fulfilled from the provided document:

• Type of Device: This is a Class I basic mechanical dental instrument (a handpiece), not an AI/imaging diagnostic device. Substantial equivalence for such devices typically relies heavily on non-clinical performance testing (e.g., safety, mechanical function, biocompatibility) and comparison of specifications to a legally marketed predicate, rather than human-in-the-loop clinical efficacy studies with ground truth derived from expert consensus on images.
• Regulatory Pathway: This is a 510(k) submission for a Class I device. Clinical data is often not required for Class I devices, especially when substantial equivalence can be demonstrated through non-clinical means. The document explicitly states: "Clinical testing was not required as the differences from the predicate device are minor and non-clinical testing is believed to be sufficient for a determination of substantial equivalence of the General Cutting Straight."

Given the nature of the device and the provided document, here's what can be extracted and why other questions are not applicable:

Acceptance Criteria and Device Performance (as far as provided for this mechanical device type):

The document states that NAKANISHI INC. conducted performance testing in accordance with ISO 14457:2017 "Dentistry - Handpieces and motors" and that "All acceptance criteria for the applicable tests were met."

However, the specific quantitative acceptance criteria and the numerical results of the "reported device performance" are not detailed in this summary. The summary only provides qualitative confirmation of compliance with the standard.

Answers to Specific Questions in the Context of this Mechanical Device 510(k):

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

   • As shown above, the document states general compliance with ISO standards (ISO 14457:2017 for performance, ISO 10993-1:2018 for biocompatibility, ISO 17665-1:2006 for reprocessing). Specific quantitative acceptance criteria or numerical performance data are not provided in this 510(k) summary. The "acceptance criteria" listed are the qualitative statements of meeting the standards.

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

   • Not Applicable. This is a mechanical device, not an AI/imaging diagnostic device that uses "test sets" of patient data in the way you are implying for AI algorithm validation. Performance testing was likely conducted on a sample of manufactured devices, but the size and specifics are not provided in this summary. Data provenance (country of origin of data, retrospective/prospective) is not relevant for this type of mechanical device testing.

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

   • Not Applicable. Ground truth in the context of expert review of images is not relevant for a mechanical dental handpiece. The "ground truth" for this device is its mechanical functionality, safety (biocompatibility), and ability to be reprocessed, which are assessed through engineering and laboratory tests, not human image interpretation.

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

   • Not Applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations, typically in imaging studies. This is not applicable to the performance testing of a mechanical 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:

   • Not Applicable. This is a mechanical device, not an AI-assisted diagnostic tool. MRMC studies are designed for evaluating diagnostic AI systems in conjunction with human readers.

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

   • Not Applicable. This is a mechanical device; there is no "algorithm" to be evaluated in a standalone manner.

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

   • For this mechanical device, "ground truth" pertains to its engineering specifications, material properties, and functionality under test conditions. This is established through laboratory testing against predefined engineering and biocompatibility standards, not through expert consensus on clinical images or pathology findings.

8. The sample size for the training set:

   • Not Applicable. This is a mechanical device; there is no "training set" in the context of machine learning or AI.

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

   • Not Applicable. As there is no training set for this type of device, ground truth establishment for a training set is not pertinent.

In summary, the provided document is a 510(k) clearance letter and summary for a basic mechanical dental handpiece. It confirms compliance with relevant mechanical and biocompatibility standards but does not detail the specific quantitative results of the performance tests or involve the types of studies (e.g., clinical imaging trials, AI algorithm validation) that would address most of your specific questions.

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FX15 / FX15m / FX25 / FX25m
FX Contra is intended for the following application(s): Caries removal, cavity and crown preparation, removal of dental restorations (fillings and prostheses), finishing and polishing of teeth and dental restorations.

FX57 / FX57m
FX Contra is intended for the following application(s): Prophylaxis treatment of the surface of teeth and dental restorations.

The FX Contra includes six models: FX15, FX15m, FX25, FX25m, FX57, and FX57m. The FX Contra handpieces are reusable contra-angle handpieces, driven by an ISO 3964 compliant electronic micromotor or air motor, that are intended for use in a healthcare facility/hospital setting by a trained health care professional in the field of general dentistry. The FX Contra handpieces are designed for general applications to prepare dental cavities for restorations (FX15/FX15m/FX25/FX25m) and for prophylactic teeth cleaning (FX57/FX57m).

The FX Contra handpieces feature ISO 3964 compliant handpiece coupling connecting them to a dental unit through either a micromotor or an air motor. By these means the handpieces receive the energy for the gear for dental treatment. The maximum drive speed is 40,000 min-1 for FX15, FX15m, FX25, and FX25m; and 20,000 min-1 for FX57 and FX57m. The maximum rotation speed is 10,000 min-1 for FX15 and FX15m; 40,000 min-1 for FX25 and FX25m; and 5,000 min-1 for FX57 and FX57m.

The FX Contra handpieces are composed mainly of stainless steel and aluminum and can be sterilized in a steam sterilizer (autoclave).

The provided text describes a 510(k) summary for the Nakanishi Inc. FX Contra dental handpieces. However, it does not include detailed acceptance criteria or a specific study proving the device meets those clinical performance acceptance criteria in the format requested. The document focuses on regulatory compliance, non-clinical performance testing (bench testing, sterilization, cleaning, biocompatibility), and a comparison to a predicate device to establish substantial equivalence.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what is explicitly not present:

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

• Not present in the document. The document states that "The product's conformance with applicable international and internal standards was verified in the course of bench testing" and "Tests were performed on the subject device including verification/validation testing to internal functional specifications which demonstrated that the device is substantially equivalent." However, specific numerical acceptance criteria (e.g., minimum torque, maximum vibration) and the corresponding measured performance values are not provided.

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

• Not present in the document. The document mentions "bench testing" and "verification/validation testing to internal functional specifications," but it does not specify sample sizes for these tests or the data provenance.

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 / Not present. This type of information is typically relevant for studies involving human interpretation or clinical endpoints. Since this document describes non-clinical performance testing for a dental handpiece, there's no mention of experts establishing a "ground truth" for a test set in the conventional sense of diagnostic or AI-driven medical devices.

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

• Not applicable / Not present. Similar to point 3, this is relevant for studies involving human readers and interpretations, which are not described here.

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. The document explicitly states: "Clinical Testing: Clinical testing was not required as non-clinical testing is believed to be sufficient for a determination of substantial equivalence of the FX Contra handpieces." Therefore, no MRMC study or AI assistance evaluation was performed as per this document.

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

• Not applicable. This device is a dental handpiece, not an algorithm or AI-driven system.

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

• Not applicable / Not present in a clinical sense. For the non-clinical tests mentioned (sterilization, performance to ISO standards, cleaning, biocompatibility), the "ground truth" would be the specifications and requirements defined by the respective standards. However, actual data points or methods for confirming these are not detailed.

8. The sample size for the training set

• Not applicable. 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 is not an AI/ML device that requires a training set.

Summary of available information related to performance testing:

The device is the FX Contra dental handpiece.

The document indicates that the device's substantial equivalence largely relies on non-clinical performance testing and a comparison to a predicate device (SciCan GmbH SANAO Dental Handpieces, K132356).

Performance Testing Mentioned:

• Sterilization Validation: Conformance to AAMI/ANSI/ISO 17665-1:2006 "Sterilization of Health Care Products - Moist Heat - Part 1: Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices."
• Performance (General): Conformance to ISO 14457:2017 "Dentistry - Handpieces and Motors." (Specific parameters or acceptance criteria from this standard are not detailed, nor are the measured results).
• Cleaning Validation: Compliance with "Guidance for the Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff."
• Biocompatibility Testing: Selected in accordance with AAMI/ANSI/ISO 10993-1: 2018 and FDA Guidance Use on International Standard ISO 10993. This included:
  • Cytotoxicity per ISO10993-5
  • Sensitization per ISO10993-10
  • Irritation per ISO10993-10
  • Acute Systemic Toxicity per ISO 10993-11
  • Pyrogenicity per ISO 10993-11

Conclusion from the document:

NAKANISHI INC. considers the FX Contra handpieces to be substantially equivalent to the predicate device based on similarities in primary intended use, principles of operation, functional design, and established medical use, supported by the non-clinical testing. Clinical testing was deemed not required.

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Products intended for professional use only. Used in general dentistry for restoration procedures.
Lares Research Smoothdrive 1:5 contra angle handpiece is intended for professional use only. The device is used in general dentistry for restoration procedures.

The Lares Research Smoothdrive 1:5 contra angle is a high-speed dental handpiece which is driven by an electrical motor. The device is designed to be connected to ISO 3964 compatible electric motors operating between 0 and 40,000 rpm. The device has a 1:5 speed increasing transmission (identified by the industry standard red ring) which translates to a working end speed of 0 to 200,000 rpm. The device has a push button chucking system is designed to allow convenient bur changing for ISO 1797 type 3 burs.

The requested information is not available in the provided text. The document is an FDA 510(k) clearance letter for a dental handpiece, focusing on substantial equivalence to predicate devices rather than detailed performance studies with acceptance criteria, sample sizes, expert ground truth, or comparative effectiveness with AI.

The document states:

• "No clinical field trials have been conducted with the Lares Research Smoothdrive 1:5 contra angle handpiece." (Page 4)
• "Performance tests were conducted in-house at Lares Research with production samples of the Smoothdrive 1:5 contra angle. The contra angle motor connection, speed, sound, temperature and chucking mechanism were all evaluated during validation testing. Validation testing concluded the device meets all of the applicable consensus standards." (Page 4)

Without further details on the "applicable consensus standards" and the specific results of the validation testing, the acceptance criteria and detailed study information cannot be extracted.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria with the provided information.

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The intended use of the Lotus Prophy Angle is for polishing and cleaning teeth.

Lotus Prophy Angle is a device used for polishing and cleaning the surface of teeth. It consists of a pair of gears, a turning spindle and a drive spindle which can connect the low speed handpiece. The turning spindle has a prophylaxis cup on it for polishing or cleaning teeth.

Lotus Prophy Angle is intended for single use only and is provided aseptic in sealed packaging to be prevent contamination.

The provided text is a 510(k) summary for the Lotus Prophy Angle, a Class I medical device (dental handpiece and accessories). This type of device is a physical tool and does not involve AI, software, or algorithms that would require the creation of a ground truth, training data, or a test set as described in your request. The acceptance criteria and performance studies are focused on physical characteristics and safety, not diagnostic accuracy or AI performance.

Therefore, many of the requested fields are not applicable to this type of device. I will address the applicable parts of your request based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

| Acceptance Criteria (from ANSI/ADA Specification No. 85-1 for Disposable Prophy Angles) | Reported Device Performance |
|------------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Speed | Performance details not provided. Tested to meet ANSI/ADA Spec No. 85-1 for Disposable Prophy Angles. | Specific quantitative acceptance criterion is not detailed in this document, but implied compliance with ANSI/ADA Spec No. 85-1. |
| Load | Performance details not provided. Tested to meet ANSI/ADA Spec No. 85-1 for Disposable Prophy Angles. | Specific quantitative acceptance criterion is not detailed in this document, but implied compliance with ANSI/ADA Spec No. 85-1. |
| Temperature Rise | Performance details not provided. Tested to meet ANSI/ADA Spec No. 85-1 for Disposable Prophy Angles. | Specific quantitative acceptance criterion is not detailed in this document, but implied compliance with ANSI/ADA Spec No. 85-1. |
| Vibration Analysis | Performance details not provided. Tested to meet ANSI/ADA Spec No. 85-1 for Disposable Prophy Angles. | Specific quantitative acceptance criterion is not detailed in this document, but implied compliance with ANSI/ADA Spec No. 85-1. |

Study Details (as per document):

The document states: "The subject Lotus Prophy Angle is identical in every way to the previously cleared ProAngle™ Disposable Prophy Angle (K030603). Therefore, all previous testing performed on the ProAngle™ Disposable Prophy Angle is applicable to the subject device. The following confirmatory testing was performed on the subject device in accordance with ANSI/ADA Specification No. 85-1 - Disposable Prophy Angles: Speed, Load, Temperature Rise, and Vibration Analysis."

This implies that instead of full, new performance studies demonstrating quantitative measurements, the primary "proof" of meeting acceptance criteria relies on substantial equivalence to a predicate device (ProAngle™ Disposable Prophy Angle, K030603) and confirmatory testing to verify this equivalence.

Based on the provided document, the following points are largely N/A (Not Applicable) or cannot be determined for the reasons explained:

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

• N/A. This device is a physical dental instrument, not an AI/software device that uses data for a "test set" in the context of diagnostic performance. The "testing" mentioned refers to physical performance characteristics. The document does not specify sample sizes for these physical tests or data provenance beyond stating compliance with a standard.

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)

• N/A. This concept is not applicable to a physical dental prophy angle. There is no diagnostic "ground truth" to establish by experts for this type of device.

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

• N/A. Adjudication methods are used to establish ground truth in diagnostic studies, which is not relevant for this physical 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

• N/A. This is a physical device, not an AI system. MRMC studies are not applicable.

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

• N/A. This is a physical device, not an algorithm.

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

• N/A. As mentioned, "ground truth" as it pertains to diagnostic accuracy is not relevant for a physical dental instrument. The "truth" here is compliance with engineering standard specifications.

8. The sample size for the training set

• N/A. There is no "training set" for a physical device in the AI/machine learning sense.

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

• N/A. See point 8.

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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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The SURGmatic S15 L Pro handpiece is intended for:

• Oral, jaw and facial surgery
• Tooth extraction procedures
• Root resection
• Osteotomy
• Removal of carious material
• Tooth, cavity and crown preparations
• Processing of fillings

The SURGmatic S15 L Pro is for use by a trained professional in the field of general dentistry and/or oral surgery.

The electrical-driven SURGmatic S15 L Pro handpieces in accordance with 21 CFR § 872.4200 (dental handpieces and accessories) designed for use by a trained professional in the field of general dentistry only. The device is an electrically driven handpiece that is reusable and provided with a fiber optic light system. The electrical motor includes the light source and the SURGmatic S15 L Pro handbiece is provided with a fiber optic light transmitter to transport the light to the bur side. DIN EN ISO 14457 requlates the minimum illuminance. The dental handpieces can be sterilized in a steam sterilizer (autoclave). SURGmatic handpieces equipped with a handpiece connector in accordance with ISO 3964 are connected to a treatment unit by means of a hose and the electrical motor and receive the energy for the gear, cooling water and air for conservative dental treatment as well as the light for illumination of the operation area through corresponding output openings. Burs in accordance with ISO 1797-1 must be used with the SURGmatic handpieces. Based on the INTRAmatic connection that meets the ISO 3964 standard, the SURGmatic handpieces fit with any electrical dental motor which is produced in accordance to this standard. The SURGmatic handpieces interact with the patient through a rotating bur with the patient teeth according to the intended use.

The electrical motor rotates with an idle speed of 40.000 1/min and the gear ratio of the SURGmatic S15 L Pro instrument amounts to 1:5 (exactly 1:4,71).

The bur is held in the rotating head drive with the help of a collet and can be released by a push-button mechanism. DIN EN ISO 14457 requlates the minimum extraction force of the bur.

The provided document is a 510(k) premarket notification for a dental handpiece (SURGmatic S15 L Pro). Unlike submissions for AI/ML-driven medical devices that involve complex algorithms and require extensive performance studies, this document focuses on demonstrating substantial equivalence to existing predicate devices based on common technological characteristics, intended use, and adherence to established international standards.

Therefore, many of the questions regarding acceptance criteria and performance studies in the context of AI/ML or diagnostic devices (e.g., sample size for test sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance) are not applicable to this type of device submission.

The document primarily relies on non-clinical bench testing against recognized industry standards to demonstrate that the new device performs comparably to its predicates and meets safety and performance requirements.

Here's an attempt to answer the questions based on the information available in the document, highlighting where the requested details are not relevant to this type of device:

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

The document does not present specific "acceptance criteria" in the format of quantitative thresholds for device performance against a particular medical outcome, as might be seen for an AI diagnostic tool. Instead, acceptance is demonstrated by adherence to established international standards for dental handpieces and by demonstrating substantial equivalence to predicate devices in typical performance characteristics.

The "reported device performance" is implicitly demonstrated through the device complying with the standards listed. The acceptance criteria are the criteria outlined in these standards.

The document states: "Performance bench testing according to international standards for Dental Handpieces has been conducted to determine conformance..." and lists the standards. This implies that the device met the requirements of these standards.

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 specified in terms of patient or clinical samples, as this was a non-clinical, bench-testing submission. The "test set" would refer to the physical units of the device tested in the lab. The document describes "Comparative performance testing of the functions of the Proposed device compared to the cleared stand-a-lone device," which implies a sample of devices tested. The exact number is not provided.
• Data provenance: Not explicitly stated regarding origin or type (retrospective/prospective), as it's non-clinical bench testing. The manufacturer, KaVo Dental GmbH, is based in Germany.

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 a dental handpiece, "ground truth" as it relates to diagnostic accuracy or clinical outcomes is not established by human experts in the same way as for an AI/ML algorithm. Performance is assessed against engineering specifications and international standards through bench testing.

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

• Not Applicable. Adjudication methods are typically for resolving discrepancies in expert interpretations (e.g., ground truth for image-based diagnostics), which is not relevant for this 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

• Not Applicable. This is a mechanical dental instrument, not a diagnostic AI/ML system, and therefore, MRMC studies are not relevant.

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

• Not Applicable. This is a standalone mechanical device. The concept of "algorithm only" or "human-in-the-loop" performance does not apply. The device's "standalone" performance is assessed by its ability to meet the non-clinical performance standards.

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

• Type of Ground Truth: For a dental handpiece, the "ground truth" for performance relates to engineering specifications and international standards. For example, bur extraction force must meet a minimum specified in DIN EN ISO 14457; light illumination must meet DIN EN ISO 14457. Biocompatibility is "ground-truthed" by adherence to ISO 10993 series. There isn't a "pathology" or "outcomes data" ground truth in the same sense as for a diagnostic device.

8. The sample size for the training set

• Not Applicable. 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. Not an AI/ML device.

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The General Cutting Contra Handpiece is powered by either an air-motor or electronic micromotor for use in general dentistry. The device is intended for cutting and grinding teeth, cavity preparations, tooth and crown preparations, finishing and trimming teeth and filling materials.

The subject modified General Cutting Contra Handpiece (modified Ti-Max Z Series: Z10L, Z15L, Z25L, Z85L, Z95L) is a contra-angle dental handpiece powered by either an air-motor or electronic-micromotor for use in general dentistry. The modified General Cutting Contra 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 modified General Cutting Contra Handpiece transmits rotational force from the motor to the gears through a clutch. The allowable maximum speed for the motor is 40,000 min-1. Then the rotation force reaches the chuck and the dental bur receives the rotation force. The dental bur cuts and grinds teeth using the rotation force. The rotation speed varies depending on the gear ratios as follows: Z95L 1:5 Increasing, Z85L 1:5 Increasing, Z25L 1:1 Direct Drive, Z15L 4:1 Reducing, Z10L 16:1 Reducing. The modified General Cutting Contra Handpiece feature fiber optic providing illumination to the cutting area. The subject of this Special 510(k) submission is an addition of the Switching Valve that allows to alternate between two types of water spray options: water spray (water + air) and water jet (water only) to the cleared device [K182999] to reduce the area of irrigation water splattering. This alternation is enabled using the Wrench accessory that has been previously cleared as a part of K121901. The coating material for the exterior of the handpiece has been changed from DURACOAT (Ti+MRK-T) to DURAGRIP (Ti+CrN). The coating material was previously used in the exterior of the nano Series of the predicate General Cutting Contra Handpiece [K182999] and has been cleared by FDA in 2019. The original submission [K182999] included four series of contra handpieces: the S-Max M Series, the Ti-Max X Series, the Ti-Max Z Series, and the Ti-Max nano Series. The proposed modification applies solely to the Ti-Max Z series. The following models will be affected by this change: Z10L, Z15L, Z25L, Z85L, Z95L. The modified models are marked with "SW" on the neck on the handpiece. The models that were cleared under the original General Cutting Contra Handpieces submission are not impacted by the present submission.

The provided document is a 510(k) premarket notification for a dental handpiece. It describes modifications to an existing device and compares it to predicate devices to demonstrate substantial equivalence. However, it does not contain the detailed information necessary to answer all parts of your request, which primarily focuses on clinical study data, acceptance criteria related to performance metrics, and human-in-the-loop assessments for AI/ML devices.

This document is for a Class I dental handpiece, which is a physical mechanical device, not an AI/ML powered device that would typically involve acceptance criteria like accuracy, sensitivity, specificity, or studies with expert adjudications and MRMC designs.

Here's a breakdown of what can and cannot be answered based on the provided text:

What can be extracted (and interpreted for context):

The document primarily focuses on demonstrating substantial equivalence for a modified physical medical device (a dental handpiece) to a previously cleared predicate device. For such devices, acceptance criteria often revolve around engineering performance, material compatibility, and safety standards rather than clinical performance metrics like those for AI/ML.

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

The document mentions "applicable technical standards, internal specifications, and FDA guidance documents" were used. It also states:

What cannot be answered from the provided text:

The following points are typically relevant to AI/ML or diagnostic devices that rely on data for performance metrics (e.g., sensitivity, specificity, AUC). Since this document is for a physical dental handpiece, these concepts don't directly apply in the way you've framed them.

2. Sample sizes used for the test set and the data provenance: Not applicable. Performance testing for a mechanical device would involve engineering tests (e.g., torque, speed, durability, material testing) rather than a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no "ground truth" in the clinical data sense for a mechanical device's direct performance. Adherence to engineering specifications and safety standards are the benchmarks.
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. This device is not an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of an AI/ML algorithm. For this device, the "ground truth" for performance would be established engineering specifications, material standards, and safety requirements.
8. The sample size for the training set: Not applicable. There is no "training set" for a mechanical device.
9. How the ground truth for the training set was established: Not applicable.

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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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