Search Results

Perio-Mate:
Perio-Mate is intended for the following application(s):
Removal of supragival/subgingival soft deposits and soft deposits on prostheses (including implant abutments).

Perio Mate Nozzle Tip:
Perio Mate Nozzle Tip is intended for the following application(s):
Removal of subgingival soft deposits and soft deposits on prostheses (including implant abutments).

The Perio Mate Nozzle Tip and Perio-Mate is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.

The Air Powered Tooth Polishing System includes the Perio-Mate, which consists of a handpiece and the Perio Mate Nozzle Tip, which is connected to the end of the Perio-Mate handpiece.

Perio-Mate is used to remove stains and deposits by spraying the polishing powder and water mixed by compressed air when connected with chair units through couplings or hoses to the treatment area. This device is a non-sterile state and intended to be cleaned and sterilized by end-users as a reusable device. This device to be used for supragingival purpose.

During subgingival treatment, Perio Mate Nozzle Tip is connected to the handpiece. The compressed air makes the tooth polishing agent in the Perio-Mate mixed and transfers it to the tip. The product is inserted in a periodontal pocket, sprays the tooth polishing agent/water to the treatment area in the subgingival area, and enables to remove the deposits from teeth surface or prostheses.

The provided text is a 510(k) summary for a dental device, the "Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)". It outlines the device's indications for use, technological comparison to predicate devices, and non-clinical tests performed to support substantial equivalence.

However, the document does not contain information regarding acceptance criteria or a study that proves the device meets those criteria in the way typically expected for performance claims related to effectiveness measured by clinical outcomes or diagnostic accuracy (e.g., sensitivity, specificity, accuracy, effect size with human readers).

The non-clinical tests mentioned are related to:

• Performance Test: Compliance with standards like ISO 20608:2018 (Dentistry - Powder jet handpieces and powders) and sterilization/reprocessing standards (ISO 17665-1, ISO 17664-1, ISO 17664-2), and FDA guidance documents related to dental handpieces and reprocessing. These tests confirm the device's functional and safety attributes, not direct clinical efficacy metrics.
• Biocompatibility Test: Compliance with ISO 10993-1:2018 and FDA guidance on biological evaluation for devices with limited contact with surface medical devices and breached or compromised surfaces. This ensures the material safety of the device.

Based on the provided text, the following points can be addressed:

1. Table of acceptance criteria and reported device performance:

   • Acceptance Criteria: The document refers to compliance with ISO standards (e.g., ISO 20608:2018 for powder jet handpieces and powders, various ISO standards for sterilization and biocompatibility) and FDA guidance documents. Specific numerical performance acceptance criteria (e.g., specific thresholds for removal efficiency of deposits, or clinical outcomes) are not detailed in this summary.
   • Reported Device Performance: The summary states that "The tests demonstrate compliance with the requirements of the following standards and guidance." and "The test results demonstrate compliance with the requirements of the following standards and guidance". It doesn't provide specific quantitative performance metrics beyond stating compliance with these standards.

2. Sample size used for the test set and the data provenance: Not applicable. The "tests" mentioned are non-clinical, primarily for engineering performance, biocompatibility, and reprocessing validation against international standards, not clinical studies with patients or image data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood in studies involving AI or clinical diagnostic accuracy is not relevant here as the tests are non-clinical.

4. Adjudication method for the test set: Not applicable for the non-clinical tests described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a dental handpiece, not an AI or diagnostic imaging device involving human readers.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical tests, the "ground truth" is defined by the requirements and test methods outlined in the cited ISO standards and FDA guidance documents (e.g., for sterilization efficacy, material compatibility, or functional parameters of the handpiece).

8. The sample size for the training set: Not applicable. This is a physical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided 510(k) summary focuses on demonstrating "substantial equivalence" to predicate devices through non-clinical testing for performance against recognized standards (engineering, sterilization, biocompatibility) rather than clinical efficacy studies with specific acceptance criteria that would yield metrics like sensitivity, specificity, or reader improvement.

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The NLZ Built-in Motor System is indicated for use in the field of prophylaxis dentistry, restorative applications including cavity preparation and endodontic therapy, prosthodontics applications such as crown preparations.

The NLZ Built-in Motor System is a dental treatment system that is integrated and used in conjunction with dental chair units. It is composed of a motor system, a Multi-Pad, as well as a handpiece (optional) and cord that are compatible with different electric attachments The motor system has a control unit that works as an electric micromotor which can turn on or off and regulates the speed of the electric motor by the foot pedal of the dental unit. This product can be connected to dental units currently in use to add on a brushless electric micromotor with an LED light. Depending on the specifications of each chair unit manufacturers, the combination and operation method of the NLZ Built-in Motor System board, harness, and operation method will change.

This is a 510(k) summary for a dental handpiece and accessories, the NLZ Built-In Motor System. It outlines the regulatory process for marketing the device and demonstrates substantial equivalence to predicate devices, but does not describe or include details of an acceptance criteria table or specific studies that show the device meets acceptance criteria related to an AI device's performance.

Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets them, as the provided text pertains to a traditional medical device (a dental handpiece motor system) and its regulatory clearance process, not an AI/ML-enabled device. The document focuses on demonstrating the device's substantial equivalence through non-clinical performance and biocompatibility testing against established standards for dental medical devices.

Specifically, the document does not contain any of the following information relevant to an AI/ML device performance study:

• A table of acceptance criteria and reported device performance: No such table exists for AI performance metrics.
• Sample size for the test set and data provenance: No test set of data for an algorithm is mentioned.
• Number of experts used to establish ground truth and their qualifications: No expert review for ground truth is discussed.
• Adjudication method for the test set: Not applicable in this context.
• Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned.
• Standalone algorithm performance: The device is a physical dental motor system, not a standalone algorithm.
• Type of ground truth used: Not applicable for this type of device.
• Sample size for the training set: There is no AI model to train.
• How ground truth for the training set was established: Not applicable.

The performance testing listed focuses on:

• Motor performance
• Reprocessing (sterilization)
• Software (life cycle processes, which is about development and maintenance, not AI performance)
• Electrical safety
• Electromagnetic compatibility (EMC)
• Biocompatibility

These are standard non-clinical tests for physical medical devices to ensure safety and functionality, not AI performance.

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The Surgic Pro2 is intended for use in dental oral surgery and dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth.

The Surgic Pro2 consists of the Control Unit, the Foot Control, Motor and accessories. The Control Unit drives the Motors during procedures and is used to control the functions related to the Motor such as rotational direction. The Foot Control provides the user with "hands-free" control of the coolant flow, program selection, forward/reverse rotational direction, and speed during operation. Two models of the Motor with Motor cord are available, SGL80M Optic Motor. The SGL80M Optic Motor contains LED illumination of over 32,000 LUX. Each Motor is included with each series set in accordance to the client's specific needs and requirements.

The Surgic Pro2 is intended for use in dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth.

Features of this product are Bluetooth connectivity with a Foot Control, "Osseo 100+" ISQ measurement device *, and other company's products "iPad". The ISQ values measured by the "can be displayed on the Surgic Pro2 control unit. The "iPad" can display information on the control unit including ISQ values on the dedicated application for Surgic Pro2. The displayed information can be stored in the iPad.

• The ISQ value is measured by the Osseo100+ and the ISQ value displayed on the display of the SurgicPro2 connected via Bluetooth.

The product is provided unsterilized, and the motors are washed and sterilized at a medical institution, and used repeatedly. The product has no bio-contact components.

The provided text is an FDA 510(k) summary for a dental device called "Surgic Pro2." It outlines the device's technical specifications, intended use, and the non-clinical tests performed to demonstrate substantial equivalence to predicate devices. However, this document does not contain information about studies proving the device meets acceptance criteria related to AI/algorithm performance, multi-reader multi-case studies, or detailed ground truth establishment.

The non-clinical tests mentioned are primarily related to general device performance, reprocessing, software life cycle (general, not AI-specific), electrical safety, EMC, and cybersecurity. There is no mention of an AI/ML component or any performance metrics like sensitivity, specificity, or AUC that would typically be associated with AI application acceptance criteria for diagnostic or assistive devices.

Therefore, I cannot fulfill your request for information regarding AI acceptance criteria and a study proving the device meets these criteria based on the provided text. The text does not describe such a study or an AI component.

To directly address your request given the provided text's limitations, here's what I can extract and what I cannot:

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

The document mentions validation and verification testing against various standards and guidance documents. These are the "acceptance criteria" for the general device performance and safety. The "reported device performance" is simply that the "results of the exit [sic] the requirements of the following standards and guidance."

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

• Not specified. The document does not provide details on the sample sizes for the performance tests, only lists the standards against which they were tested. Data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned for these non-clinical tests.

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

• Not applicable/Not specified. For the non-clinical tests mentioned (e.g., electrical safety, sterilization), "ground truth" as it applies to clinical data review by experts is not relevant. The conformity to standards would be assessed through engineering and quality testing, not expert clinical review.

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

• Not applicable/Not specified. This is relevant for clinical studies with expert reviewers, not for the type of non-clinical device performance and safety testing described.

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

• No evidence of an MRMC study. The document describes a traditional 510(k) pathway for a dental handpiece system, focusing on substantial equivalence based on technical characteristics and non-clinical performance (safety, reprocessing, software lifecycle, etc.), not a comparative effectiveness study involving human readers or AI assistance.

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

• Not applicable. The device described (Surgic Pro2) is a dental surgical system with a micromotor, handpieces, and control unit. While it has software and Bluetooth connectivity (e.g., to display ISQ values from another device), it is not an AI/algorithm-only device for diagnosis or image analysis. Its software controls mechanical functions, not an independent interpretive algorithm.

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

• Not applicable/Compliance with standards. For the non-clinical tests performed, the "ground truth" is typically defined by the specified parameters and limits within the engineering standards (e.g., specific electrical leakage limits, torque values, sterilization parameters).

8. The sample size for the training set:

• Not applicable. This device is not described as having an AI/ML component that would require a training set.

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

• Not applicable. As above, no AI/ML training set is indicated.

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Air Motor is intended for the following application(s): Driving the handpiece for the tooth restoration, prophylaxis, and root canal preparation.

The air motor converts the compressed air supplied from the dental unit into rotary motion. The rotation is transmitted to instruments for tooth restoration, prophylaxis, and root canal preparation connected to straight and geared angle handpieces.

The provided document is a 510(k) premarket notification for a dental air motor. The core of this document is a comparison of the subject devices (Air Motor FX204 M4 and Air Motor M205) against predicate devices to demonstrate substantial equivalence, rather than a clinical study evaluating the device against acceptance criteria in the typical sense of AI/ML performance.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" for AI/ML devices are not applicable in this context. The document focuses on performance testing to demonstrate safety and effectiveness for a mechanical device.

However, I can extract the information relevant to how the device's technical specifications and performance were evaluated against established standards and predicate devices.

Here's a breakdown of the relevant information from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical thresholds in a table format for each specific performance metric in the way you might see for an AI algorithm (e.g., AUC > 0.90). Instead, the acceptance criterion for this 510(k) submission is to demonstrate "substantial equivalence" to legally marketed predicate devices by showing that the subject devices perform similarly and meet relevant safety and performance standards.

The closest we have to "reported device performance" and "acceptance criteria" are the comparison tables (Table 1 for FX204 M4 and Table 2 for M205) and the "Judgement" column, which indicates if the subject device is "Same," "Similar," or "Different" to the predicate. For "Different" or "Similar" aspects, further testing or justification is provided to demonstrate that the difference does not raise new questions of safety or effectiveness.

Below are tables summarizing the key performance and safety aspects evaluated and how the subject device's performance compared to the predicates, along with the implicit "acceptance criteria" through this comparison.

For Air Motor, FX204 M4 (model without spray) - (Based on "DEVICE AND PREDICATE COMPARISON TABLE-1")

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

• Sample Size for Test Set: The document mentions "Statistical calculation of sample size" under performance testing, but does not provide specific numbers for units tested for each type of test. The nature of these tests (e.g., drop test, reprocessing resistance, water leakage, vibration, sterilization validation) typically involves testing a representative sample of devices, but the exact number isn't quantified in the provided text.
• Data Provenance: Not explicitly stated, however, the applicant is "NAKANISHI INC." based in "700 Shimohinata Kanuma Tochigi, 322-8666, Japan". It's highly probable the testing was conducted in Japan or through certified testing facilities used by the manufacturer. The data would be prospective in the sense that these tests are performed on the manufactured devices to ensure they meet specifications.

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

• This concept typically applies to clinical studies or studies involving human interpretation (e.g., radiology expert review for AI algorithms). This submission is for a mechanical dental device.
• The "ground truth" here is compliance with engineering standards (e.g., ISO 14457 for dental handpieces), safety standards (e.g., ISO 10993 for biocompatibility), and the performance characteristics of the predicate devices.
• No "experts" in the sense of clinical reviewers establishing ground truth for individual cases are mentioned. Instead, the evaluations are based on technical testing by qualified personnel in accredited laboratories.

4. Adjudication Method for the Test Set

• Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation or subjective assessments, often in AI/ML performance evaluation where ground truth is based on expert consensus.
• This is not applicable here as the evaluation is based on objective measurements against engineering standards and comparison with predicate device specifications.

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

• Not applicable. This is a submission for a mechanical dental motor, not an AI/ML diagnostic or assistive device that would involve human readers interpreting cases.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable. This device does not involve a software algorithm in the context of an AI/ML device requiring this type of performance evaluation.

7. Type of Ground Truth Used

• The "ground truth" for this submission is primarily technical specifications/performance derived from engineering standards (e.g., ISO 14457, ISO 10993) and comparison to the known and established safety and effectiveness of legally marketed predicate devices.
• For example, passing ISO 14457 test methods indicates the device performs as expected for a dental handpiece. Biocompatibility is "ground-truthed" by adherence to ISO 10993.

8. Sample Size for the Training Set

• Not applicable. This is a mechanical device, not an AI/ML algorithm that requires a "training set."

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

• Not applicable, as there is no "training set" for this type of device.

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The Titanium Turbine is intended for the following applications:

Caries removal, Cavity and crown preparation, Removal of dental restorations (fillings and prostheses), Finishing of teeth and dental restorations (preparation/adjustment).

The Titanium Turbine is an air-driven dental handpiece used by qualified dental professionals. The Titanium Turbine is connected to a dental unit via a coupling and uses supplied compressed air to rotate a dental bar attached to its tip at a high speed (380.000-450.000 min-') to enable dental treatment.

Titanium Turbine is mainly made of titanium and can be reused by reprocessing. This device is equipped with a Clean Head System that reduces suck-buck into the head and exhaust line, thereby reducing cross-contamination of the air lines. Titanium Turbine is also equipped with a quick stop system that reduces the time required to stop rotation, thereby improving oral cavity safety, and reducing suck-buck.

The provided text describes the 510(k) premarket notification for a dental handpiece called "Titanium Turbine." It details the device's characteristics, its comparison to predicate devices, and the performance testing conducted to demonstrate substantial equivalence.

However, the information requested regarding acceptance criteria and a study proving the device meets the acceptance criteria (specifically related to AI/algorithm performance and human reader studies) is not present in the provided document. This document pertains to a Class I dental handpiece, which is a mechanical device, not an AI or algorithm-driven medical device. Therefore, the concepts of sensitivity, specificity, MRMC studies, human-in-the-loop performance, and ground truth establishment for AI models are not applicable to the information given.

The document focuses on demonstrating substantial equivalence to predicate dental handpieces based on:

• Mechanical and operational characteristics: Head size, weight, head angle, rotation speed, torque, noise level, chuck design, bur type, power, device features (Clean Head System, Quick Stop System).
• Material properties: Coating (DURAGRIP vs. Sand blasting finish/Plasmatec coating), direct/indirect patient contacting materials (Titanium vs. Stainless Steel).
• Sterilization and lubrication: Methods and compatible products.
• Performance testing against established standards: ISO 14457:2017 ("Dentistry Handpieces and motors") and ISO 17665-1:2006 ("Sterilization of health care products - Moist heat").
• Biocompatibility testing: According to ISO 10993-1:2018.

Therefore, I cannot populate the requested table and study details as they are outside the scope of this FDA submission for a mechanical dental device.

Summary regarding the absence of requested information:

• No AI/Algorithm Component: The device, "Titanium Turbine," is a mechanical dental handpiece. It does not involve any artificial intelligence, machine learning algorithms, or image analysis components.
• Acceptance Criteria: The "acceptance criteria" for this device are its compliance with recognized performance standards (ISO 14457, ISO 17665-1) and biocompatibility standards (ISO 10993-1), and demonstrating substantial equivalence to predicate devices based on its physical and functional characteristics. These are not performance metrics like sensitivity/specificity for AI.
• Study Proving Acceptance: The "study" proving acceptance is the series of non-clinical performance and biocompatibility tests conducted according to the listed ISO standards. No clinical study was required for this 510(k).
• Irrelevant Metrics: All the specific points requested (sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set ground truth establishment) are relevant to the validation of AI/ML-based medical devices, not mechanical devices like a dental handpiece.

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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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The Stainless Turbine is intended for the following applications: Caries removal, Cavity and crown preparation, Removal of dental restorations (fillings and prostheses), Finishing of teeth and dental restorations (preparation/adjustment). The coupling is intended for the following applications: A connection device to transfer energy (air, water, light) required for handpieces.

The Stainless Turbine handpieces are air driven dental handpieces for use by a trained professional in the field of general dentistry. The handpieces are air-powered, high-speed dental handpieces capable of reaching rotational speeds of 325,000 to 450,000 revolutions per minute. Handpiece models include fiber optic, LED, and non-optic lighting. The handpiece models are available to connect directly to NAKANISHI INC. manufactured couplings. Available handpiece models include the S-Max M Series, Pana-Max Plus Series, Pana-Max Plus2 Series, and the S-Max pico Series. The Stainless Turbine couplings are connection devices used to attach the dental unit to the Stainless Turbine handpieces. Available coupling models include the Glass Fiber Rod Series, LED Series, and No Light Irradiation Series.

The provided text describes a 510(k) premarket notification for a dental handpiece and its accessories, referred to as the "Stainless Turbine." The submission aims to demonstrate that this new device is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as separate targets but are implied through the comparison with predicate devices and claims of conformance to ISO standards. The performance characteristics of the proposed Stainless Turbine and the predicate/reference devices are presented in Tables 1 and 2 of the document.

2. Sample size used for the test set and the data provenance
The document states: "Tests were performed on the handpieces including verification/validation testing to internal functional specifications which demonstrated that the device is substantially equivalent to FDA cleared devices." However, it does not provide any specific sample sizes for the test set or details about the data provenance (e.g., country of origin, retrospective or prospective). It simply refers to "bench testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The testing appears to be functional and engineering-based (bench testing) rather than involving human experts for ground truth establishment.

4. Adjudication method for the test set
This information is not provided in the document, as the testing described is primarily technical and quantitative, not involving clinical 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
This information is not applicable to this device. The Stainless Turbine is a mechanical dental handpiece, not an AI-powered diagnostic or assistive tool for human readers/clinicians. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable to this device, as it is a mechanical dental tool and not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the technical performance characteristics (rotation speed, torque, noise level, pressure), the "ground truth" or reference for comparison appears to be the specifications and performance of legally marketed predicate and reference devices, as well as conformance to international standards (e.g., ISO 1797-1, ISO 9168, ISO 14457:2012). For sterilization, the ground truth is conformance to ISO 17665-1:2006. For biocompatibility, it's ISO 10993-1:2018 and FDA guidance. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for verification of this type of device.

8. The sample size for the training set
This information is not applicable to this device, as it is a mechanical device and not an algorithm or AI system that requires a "training set."

9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.

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The P300 Attachment is intended to be used with electric and pneumatic surgical instruments and cutting accessories for cutting, drilling, removal, and shaping of bone in the procedures of: Neuro, Spine, Orthopedic, and General Surgery.

NSK Sterile Cutting Accessory(ies) is for single use only. This device is intended for use, in conjunction with P300 Attachment, in cutting, drilling, removal, and shaping of bone in the procedures of: Neuro, Spine, Orthopedic, ENT, Maxillofacial, and General Surgery.

The P300 Attachment is a powered bone cutting and drilling instruments designed to be used with the Primado2 Total Surgical System (K132264), which provides mechanical power to the attachment. The P300 Attachment is comprised of two families: Standard Attachment 300 and Slim Attachment 300. The Standard Attachment 300 and Slim Attachment 300 consist of angled and straight types of attachments with varying lengths. The Standard Attachment 300 is an attachment to the Primado2 Total Surgical System that can be in either a straight or angled configuration and comes in 5 different tube lengths, ranging from 12 mm to 79 mm. Accessories compatible with the Standard Attachment 300 include 52 NSK Sterile Cutting Accessories, a STD Attachment Beak, and 4 Irrigation Nozzles. The Slim Attachment 300 consists of 2 parts, a Slim Attachment Hub that comes in 2 configurations (straight or angled) and a Slim Tube that comes in 8 configurations and varies in tube lengths from 110 mm to 240 mm, and can be straight, curved, or angled. Accessories compatible with the Slim Attachment 300 include 49 NSK Sterile Cutting Accessories, a Slim Tube Beak and a Slim Tube Hood, and 2 Irrigation Nozzles. The Standard Attachment 300 and Slim Attachment 300 share the same Cleaning Tools for automated cleaning, manual cleaning, and purging. For both the Standard Attachment 300 and the Slim Attachment 300, the length of the bur can be adjusted in six levels. Both the Standard and Slim attachments include a non-slip surface etching on the grip. The attachments consist of stainless steel, polytetrafluoroethylene, Copper-Beryllium Alloy, fluorocarbon rubber, and PEEK.

Here's an analysis of the acceptance criteria and study information for the P300 Attachment and NSK Sterile Cutting Accessories, based on the provided FDA 510(k) summary:

This device is not an AI/ML device, but a surgical attachment. Therefore, most of the requested AI/ML specific criteria (sample size for test set, data provenance, number of experts, adjudication, MRMC study, standalone performance, training set size and ground truth establishment for training set) are not applicable.

Acceptance Criteria and Reported Device Performance

The device appears to be a traditional medical device (Powered Simple Cranial Drills, Burrs, Trephines, and Their Accessories), and the FDA 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing, rather than a clinical study with traditional acceptance criteria for diagnostic performance metrics (e.g., sensitivity, specificity, AUC).

The acceptance criteria are implied by the successful completion of specific non-clinical tests and demonstrations of compliance with relevant standards. The "performance" section describes the results of these tests, which effectively serve as the reported device performance meeting the implicit acceptance criteria of the standards and internal specifications.

Study Information

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

   • Sample Size: Not applicable. The "test set" in this context refers to samples used for non-clinical bench testing (e.g., cell cultures, animal models for biocompatibility, physical device units for functional testing). Specific numbers for these types of samples are not provided in the summary. For example, for the "Acute Systemic Toxicity Test," it mentions "mice" but not the count. The biocompatibility testing selected "worst-case representative models" (Slim Attachment 300, specific bur/nozzle models) for evaluation.
   • Data Provenance: The manufacturing site for NAKANISHI INC. is listed as Kanuma, Tochigi 322-8666 Japan. The tests would likely have been conducted by or for the manufacturer. The FDA 510(k) summary does not specify the country of origin for the testing facilities, but it typically aligns with the manufacturer's region or accredited labs. All testing is prospective in nature, as it's conducted specifically for demonstrating the safety and effectiveness of the device being submitted.

2. 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 is a non-clinical submission for a surgical instrument. "Ground truth" in the context of expert consensus, as might be used for AI diagnostic devices, is not a concept applied here. The "truth" is established by adherence to recognized international and national standards (e.g., ISO, ASTM, ANSI/AAMI) for material safety, reprocessing, and sterilization, verified through laboratory testing.

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

   • Not applicable. Adjudication methods are typically relevant for clinical studies or studies involving human interpretation of data where consensus is needed to establish ground truth for a diagnostic outcome. This submission relies on objective physical, chemical, and biological testing results.

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

   • No. This is a non-clinical submission for a mechanical surgical instrument. MRMC studies are used for evaluating the performance of AI/CADe diagnostic devices in conjunction with human readers.

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

   • No. This device does not have an algorithm or AI component.

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

   • For this device, the "ground truth" is defined by established scientific and engineering principles, as articulated in national and international standards (e.g., ISO 10993 for biocompatibility, ISO 17664/17665/ANSI/AAMI ST79 for reprocessing, ISO 11137-2 for sterilization). Compliance with these standards, demonstrated through specific laboratory tests (e.g., cytotoxicity assays, sensitization tests, pyrogenicity tests, material characterization), serves as the evidence that the device is safe and performs as intended.

7. The sample size for the training set:

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

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

   • Not applicable, as there is no training set for an AI/ML algorithm.

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Oral Surgery Contra is for oral surgery. This device is driven by an electronic micromotor for oral surgery and dental implant. This device aims to transfer the rotation of the power source with various gear ratios, and moves instruments such as a surgical bur to cut the maxillary/mandibular bone during oral surgery treatment.

The Ti-Max Series Oral Surgery Contra handpieces, X-SG93L, X-SG93 and X-SG25L, are contra-angle handpieces that are intended for use by a clinician in a healthcare facility/hospital setting for oral surgery and preparation for dental implant operation. The subject handpieces are available in two options: 1) fiber optic glass (X-SG93L and X-SG25L) or 2) non-optic (X-SG93). The Oral Surgery Contra handpieces are driven by a micromotor, thereby rotating surgical burs at different transmission gear ratios, to cut the maxillary/mandibular bone during oral surgery and preparation for dental implant surgery. The maximum rotational speeds of the handpieces are as follows: 120,000 min-1 for the X-SG93L and X-SG93 models; 40,000 min-1 for the X-SG25L model. The maximum rotation speed depends on the transmission gear ratios as follows:

• X-SG93L and X-SG93: ISO 1797 Type 3 FG burs (φ1.59 - 1.6 mm)
• X-SG25L: ISO 1797 Type 1 CA burs (φ2.334 - 2.35 mm).
  The Oral Surgery Contra handpieces are a prescription-only device.

This document describes a 510(k) premarket notification for the "Oral Surgery Contra" device. It is a submission for substantial equivalence based on comparisons to predicate and reference devices, and no clinical studies were conducted that prove device meets acceptance criteria.

Here's an analysis based on the provided text:

No clinical studies were performed. The document explicitly states: "Clinical testing was not required for a determination of substantial equivalence of the Oral Surgery Contra." Therefore, there is no information in the provided text regarding acceptance criteria for device performance based on clinical outcomes, nor any study proving the device meets such criteria through clinical data.

The "Summary of Performance Testing" section mentions "verification/validation testing to internal functional specifications" and conformance to various ISO standards (AAMI/ANSI/ISO 17665-1:2006 for sterilization, ISO 14457:2012 for handpieces and motors, and AAMI/ANSI/ISO 10993-1: 2018 for biocompatibility). These are bench tests and evaluations, not clinical studies involving patients or expert review of clinical images/data.

Therefore, since no clinical study was performed, the following requested information cannot be provided from the text:

1. A table of acceptance criteria and the reported device performance: Not applicable for clinical performance.
2. Sample sized used for the test set and the data provenance: Not applicable as there was no test set from a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method 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 a mechanical 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 device is a mechanical handpiece, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, this document describes a regulatory submission relying on substantial equivalence to predicate devices and bench testing, rather than novel clinical performance studies.

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