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PANA SPRAY Plus is a lubricant to be used during routine maintenance of dental and medical surgical handpieces after each patient use and prior to sterilization and is intended for use to clean and lubricate the dental and medical surgical handpieces.

PANA SPRAY Plus (PSP) is an alcohol-based general handpiece and air-motor lubricant. The lubricant is introduced into the handpiece through the air-drive pipe or the back end. PANA SPRAY Plus can be used for the maintenance of high speed handpieces, low speed handpieces, and air motors and should be used after each patient and prior to sterilization of handpiece and air motors. Additional testing has been conducted to support the claim for cleaning.

Here's an analysis of the provided text regarding the acceptance criteria and study for the "PANA SPRAY Plus" device.

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results typical of a device seeking de novo authorization or a PMA. As such, the information about "acceptance criteria" and "study that proves the device meets the acceptance criteria" will be interpreted in the context of a 510(k) submission, meaning it refers to non-clinical performance testing against established standards and comparisons to predicate devices to demonstrate equivalent performance and safety. There is no mention of a traditional "study" with a test set of patients or human readers.

Acceptance Criteria and Reported Device Performance

The "PANA SPRAY Plus" device is a lubricant for dental and medical surgical handpieces, with an added claim for cleaning. The acceptance criteria are benchmarked against performance of predicate devices and relevant ISO standards.

Detailed Study Information (Based on provided text)

Given that this is a 510(k) summary for a Class I device (lubricant/cleaner), the "study" described is primarily non-clinical, involving laboratory testing and comparison to predicate devices, rather than clinical trials with human subjects.

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

   • Cleaning Efficacy: The document states that "reprocessing/cleaning validation" was done "in accordance with FDA guidance." This typically involves testing a defined number of soiled devices, but the specific sample size for the cleaning test is not mentioned in this summary.
   • Biocompatibility: "Biocompatibility testing was conducted in accordance with ANSI/AAMI/ISO 10993-1." Specific sample sizes for cytotoxicity, sensitization, and irritation tests are not mentioned. These are typically in-vitro or animal studies.
   • Reliability & Durability: "Continues to meet all NAKANISHI, INC. internal requirements." The sample sizes for package vibration, unit drop, temperature testing, repeated usage, actual usage, and contra/turbine testing are not mentioned.
   • Functional Equivalence (ISO 14557): "Comparison testing was conducted using predicate K113674 to demonstrate performance equivalence for bur extraction force, eccentricity, noise level, and stopping torque." The sample size (number of handpieces tested, number of repetitions) for these comparisons is not mentioned.
   • Data Provenance: The testing was conducted by NAKANISHI, INC. (the manufacturer) or their contracted labs. The country of origin for the testing would likely be Japan or a region where Nakanishi Inc. operates, but it's not explicitly stated. The data is implicitly prospective as it was generated to support the 510(k) submission.

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

   • As this is non-clinical testing focused on physical performance, cleaning efficacy, and biocompatibility, the concept of "experts establishing ground truth for a test set" in the human diagnostic context isn't directly applicable. The "ground truth" for these tests is defined by the methods and acceptance criteria of the respective standards (e.g., FDA guidance for reprocessing, ISO 10993-1 for biocompatibility, ISO 14557 for handpiece performance).
   • Therefore, the "experts" involved would be those qualified to conduct and interpret these specific types of laboratory and engineering tests (e.g., microbiologists for cleaning validation, toxicologists for biocompatibility, mechanical engineers for functional performance). Their specific number and qualifications are not detailed in the summary.

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

   • None. This type of adjudication method is used in studies involving human interpretation or subjective assessments, typically for clinical endpoints or diagnostic accuracy. It is not relevant for the non-clinical performance and safety tests described here, where outcomes are quantitative measurements against defined standards.

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. An MRMC study is not applicable to this device. This device is a lubricant/cleaner, not an AI-powered diagnostic tool or a device that assists human readers.

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

   • The concept of "standalone performance" typically applies to AI algorithms. This device is a physical product (lubricant/aerosol) and does not involve an algorithm. Therefore, this question is not applicable.

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

   • The "ground truth" is defined by the established scientific and engineering standards and methods utilized for testing:
     • Cleaning Efficacy: Ground truth is linked to the reduction of simulated soil as measured by validated laboratory methods, as per FDA guidance.
     • Biocompatibility: Ground truth is determined by the presence/absence of toxicological responses as per ISO 10993 methods.
     • Functional Performance (ISO 14557): Ground truth is established by the quantitative measurements (e.g., force, RPM, noise level) compared against the specified limits and ranges within the ISO 14557 standard.

7. The sample size for the training set:

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

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

   • This question is not applicable as there is no training set for this type of device.

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The A-dec NLZ electric motor system is control unit that drives a direct current (DC) electric micromotor that is activated by means of a foot control. It is intended for use in general dental applications such as: cutting a tooth for cavity preparation, crown preparation, crown finishing, inlay, filing, prophylaxis and endodontic treatment, with use of a straight, right-angle ISO E-tvpe handpiece attachment of equal, gear-reducing, or gear-increasing speed.

The A-dec NLZ electric motor system is intended for use in general dental applications such as: cutting a tooth for cavity preparation, crown preparation, crown finishing, inlay, filing, polishing, prophylaxis and endodontic treatment, with use of a straight, right-angle or contra-angle ISO E-type handpiece attachment of equal, gear-reducing, or gear-increasing speed.

Control Unit, Motor and Motor Tubing are constituents of the A-dec NLZ electric motor system under this 510(k) application. The A-dec NLZ electric motor system is intended for use only with the A-dec 300 (K082985) or A-dec 500 (K032756) delivery system. The A-dec 300 (K082985) or A-dec 500 (K032756) delivery system offers operation modes for use with the A-dec NLZ electric motor system.

The Control Unit of the A-dec NLZ electric motor system is contained within the control head of the A-dec 300 (K082985) or A-dec 500 (K032756). The subject device acquires +24 VAC electrical power from the delivery system to the Control Unit. User can control the motor system through Touch Pad and Foot Controller of the delivery system. The control unit receives instructions such as motor rotation/stop, speed setting value, torque setting value, and LED turning ON/OFF from Touch Pad and Foot Controller. The Control Unit drives the Motor using instructed rotation speed and torque via Motor Tubing. The delivery system provides standard mode (range of rotation speed is 1,000 - 40,000 rpm) and endo mode (range of rotation speed is 100 - 5,000 rpm).

The Motor Tubing is connected to the Control Unit via a lead wire and air/water supply via tubing inside the control head of the delivery system. The other side of the Motor Tubing is attached to the Motor.

The provided document is a 510(k) summary for the A-dec NLZ Electric Motor System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the level of detail typically required to answer your specific questions regarding acceptance criteria and a detailed study proving performance, especially in the context of AI/ML devices or studies involving human readers and ground truth.

This document describes a traditional dental device (electric motor system), not an AI/ML device. Therefore, many of your questions, particularly those about AI/ML specific details like training sets, ground truth establishment for training data, MRMC studies, or standalone algorithm performance, are not applicable to the information provided.

Based on the available information, here's what can be extracted and what cannot:

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

The document states that the device was compliant with ISO 14457 and met the requirements of other standards. However, it does not provide a table with specific acceptance criteria (e.g., numerical thresholds for different performance metrics) and corresponding reported performance values for those criteria. It only provides a comparison table of features and ranges with the predicate device.

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

The document mentions "All A-dec NLZ electric motor system samples" for bench testing but does not specify a numerical sample size. It refers to "samples" being compliant, but no specific count is provided. There is no information about data provenance as this is a device performance test, not a data-driven clinical study.

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

Not applicable. This device is not an AI/ML product that would require expert-established ground truth for a test set in the same way. The "ground truth" for this device's performance would be objective measurements against engineering and safety standards.

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

Not applicable. This concept applies to human expert review for establishing ground truth, which is not relevant 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

Not applicable. This is not an AI-assisted device. No MRMC study was mentioned or implied.

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

Not applicable. This is not an algorithm, but a physical electric motor system.

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

For the performance tests mentioned (bench testing, electrical safety, EMC, biocompatibility, backflow, extractables), the "ground truth" is established by the specified international and national standards (e.g., ISO 14457, IEC 60601-1, IEC 60601-1-2, ISO 10993 series) and FDA guidance documents. Compliance is determined by objective measurements meeting the criteria set forth in these standards.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that uses a "training set."

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

Not applicable. This is not an AI/ML device.

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The Primado 2 is an AC-electrically powered 10tal surgical system that is intended for cutting, drilling, sawing, and otherwise manipulating soft tissue, bone, bone, bone cement, prosthesis, implant, and other bone related tissue in a variety of surgical procedures, including but not limited to Cranial (Craniofacial), ENT, Endoscopic / Arthroscopic / Arthroscopic, Neuro, Orthopedic, Spinal, and General surgical procedures.

The Primado2 consists of the Control Unit, the Foot Control (optional) and various handpieces for use with specific motors. Available Motors include Slim, High Torque, Micro Bone Saw, and Wire Pin Driver. Each motor series has handpieces or attachments specific to that series. Burs, drills, blades (saws), and rasps are available for use with specific handpieces / attachments. Handpieces and attachments are available for cranial surgery, trephination, oral surgery, and craniotomy. Sagittal, reciprocating, and oscillation saw blades are available, including for intra oral use.

The control unit drives the motors during procedures and is used to control the functions related to that motor such as speed and rotational direction. Two motors can be connected to the control unit at one time for asynchronous use. The control unit also incorporates the irrigation pump and controls the irrigation functions.

The foot control is an optional additional user interface. The foot control is available as a single or multi control. The single foot control has one button that can be programmed. The multi foot control has three buttons that can be programmed. The features available for allocation to the buttons include Foot Control ON/OFF, A/B Control Switching, Speed Control, Reverse Rotation, Irrigation ON/OFF, Flush, and Disable.

The provided text describes a surgical system, the "Primado2 Total Surgical System," and its performance testing. However, the document does not contain specific acceptance criteria or a study that rigorously proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, accuracy, or other quantitative measures. The document is a 510(k) summary for a medical device submission to the FDA, focusing on substantial equivalence to predicate devices and compliance with safety and electrical standards.

Here's an analysis based on the information provided and what is missing:

The device is the Primado2 Total Surgical System. Its intended use is "for cutting, drilling, sawing, and otherwise manipulating soft tissue, hard tissue, bone, bone cement, prosthesis, implant, and other bone related tissue in a variety of surgical procedures."

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

   Acceptance Criteria (Stated/Implied)	Reported Device Performance
   Compliance to internal functional specifications (including software)	Demonstrated that the device is safe and effective.
   Compliance to FDA Guidance for Software Contained in Medical Devices (verification/validation, traceability to software requirements and risk hazards)	Documentation provided; testing confirmed compliance.
   Compliance to relevant voluntary safety standards (IEC 60601-1, IEC 60601-1-2) for Electrical safety and Electromagnetic Compatibility	Testing confirmed compliance.
   Compliance to applicable standards for biocompatibility and sterilization	Evaluations and validations performed to demonstrate compliance.
   Substantial equivalence to predicate devices (K083112, K040369, K040300, K081475, K053526)	Stated that the device is substantially equivalent based on similarities in primary intended use, principles of operation, functional design, and established medical use.

   Note: The document does not report specific quantitative performance metrics for the device's surgical capabilities beyond general statements of "safe and effective" and compliance with standards. There are no sensitivity, specificity, or accuracy figures typical of diagnostic or AI-driven devices.

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

   This information is not provided in the document. The testing described is verification/validation to internal specifications, software requirements, and safety standards, rather than a clinical trial with 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 (e.g. radiologist with 10 years of experience)

   This information is not provided. The device is a surgical system, and the reported testing is about its functional, electrical, and safety performance, not about assessing clinical outcomes against expert-established ground truth in a diagnostic context.

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

   This information is not provided. Adjudication methods are typically relevant for studies involving human interpretation or clinical outcomes, which are not detailed 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

   This information is not provided. An MRMC study is not relevant for this type of device (a surgical tool) and the type of performance testing described. The device is not an AI-driven assistive tool for readers.

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

   This information is not provided and is not applicable. This device is a surgical system, requiring human operation, not a standalone algorithm.

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

   This information is not provided and largely not applicable in the context of the reported performance testing. The "ground truth" for the device's performance appears to be its ability to meet engineering specifications, safety standards, and functional requirements. For example, for "electrical safety," the ground truth would be conformance to IEC 60601-1.

8. The sample size for the training set

   This information is not provided. The device is not described as involving machine learning or AI that would require a "training set."

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

   This information is not provided and is not applicable, as there is no mention of a "training set" or AI/machine learning components in the device description.

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The Nakanishi iProphy mobile is a cordless prophylaxis handpiece for use with disposable prophylaxis angles in hygiene operatory to perform cleaning and polishing procedures on teeth.

The iProphy mobile is a cordless prophylaxis system consisting of an electric motor driven handpiece and an AC powered battery charger (stand). The handpiece utilizes commercially available disposable, single use Disposable Prophy angles (DPA). The handpiece features on-board user controls for power, on/off, and speed with indicators for battery charging, battery life, and speed selection. The iProphy mobile is to be used with disposable handpiece sleeves.

The provided text describes the iProphy mobile, a cordless prophylaxis system, and its FDA 510(k) summary. However, it does not contain the detailed acceptance criteria or a specific study proving the device meets those criteria in the format requested.

The document focuses on demonstrating substantial equivalence to a predicate device (Dentsply Midwest RDH Freedom Cordless System) based on:

• Intended use: Both are cordless prophylaxis handpieces for cleaning and polishing teeth.
• Principles of operation: Both use disposable prophylaxis angles.
• Functional design: Both are handpieces with user controls.
• Established medical use.

Instead of specific quantitative acceptance criteria and a study demonstrating their achievement, it mentions general compliance with standards and internal specifications.

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

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information for Acceptance Criteria: The document does not provide specific quantitative acceptance criteria such as speed ranges, battery life, torque, or safety thresholds (e.g., maximum temperature rise, noise levels, vibration). It generally states compliance with 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: Not specified. The document mentions "Tests were performed which demonstrated that the device is substantially equivalent to the predicate device. Tests included verification/validation testing to internal functional specifications, including software." This refers to internal product development testing rather than a clinical study with a specific patient sample size.
• Data Provenance: Not specified. The testing seems to be internal to the manufacturer (Nakanishi, Inc. in Japan) for engineering verification and validation.

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

• Not applicable. This device is a dental handpiece, not an AI/diagnostic software that requires expert ground truth for a test set. The validation is based on engineering and safety standards.

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

• Not applicable. This device is a dental handpiece, and its validation involves engineering and safety testing, not expert adjudication of diagnostic outcomes.

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 physical dental device, not an AI-assisted diagnostic tool.

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

• Not applicable. This is a physical dental device, not an algorithm. The device itself is "standalone" in that it performs its function when operated, but this is a different context than AI software.

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

• Ground Truth Type: For a physical device like this, "ground truth" refers to compliance with established engineering standards (e.g., IEC 60601-1, ISO 11498) and the device's ability to meet its functional specifications (e.g., maintain set speed, indicate battery life). There isn't an "expert consensus" or "pathology" type of ground truth for a mechanical and electrical device's performance in this context.

8. The sample size for the training set

• Not applicable. This is a physical device, not a machine learning algorithm that requires a training set.

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

• Not applicable. This is a physical device, not a machine learning algorithm that requires a training set.

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

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

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

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

What is provided in the document:

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

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

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

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

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

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

2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for AI/ML. The device's performance was likely evaluated through engineering tests (e.g., electrical safety, EMC, vibration frequency, biocompatibility tests) rather than a clinical "test set" in the context of data analysis for AI.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable for AI/ML. Ground truth, in this context, would relate to the physical and functional specifications of the device meeting its design intent and safety standards, rather than expert interpretation of data.

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

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as there is no AI component.

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

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

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

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

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TI-MAX Z45 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, and removal of crowns and filling materials.

The Ti-MAX Z45 is a contra-angle dental handpiece which is powered by either an air-motor or electronic-micromotor for use in general dentistry. The TI-MAX Z45 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 Tr-MAX Z45 transmits rotational force from the motor to the gears through a clutch, and then the rotation force reaches the chuck and the dental bur receives the rotation force. The dental bur is able to cut and grind teeth and dentures using the rotation force.

The provided text describes a 510(k) summary for a dental handpiece, the TI-MAX Z45. This document focuses on demonstrating substantial equivalence to predicate devices through various comparisons and bench testing. It does not contain information about clinical studies with human readers or AI algorithms for diagnostic purposes. Therefore, many of the requested categories related to clinical studies and AI performance cannot be addressed.

Here's the information that can be extracted from the provided text, primarily focusing on the acceptance criteria and the study performed:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the TI-MAX Z45 are based on compliance with the international standard ISO 7785-2, which is also used for the predicate devices.

The text also provides specific performance characteristics, although these are not explicitly labelled as "acceptance criteria" but rather as "performance" metrics within the comparison table:

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

The document states that "All TI-MAX Z45 samples were compliant with ISO 7785-2". However, the exact sample size for the bench testing is not specified in the provided text.
The data provenance is from bench testing performed by the manufacturer, NAKANISHI, INC., a company located in Japan. The study is not a clinical study involving patient data and therefore the terms "retrospective or prospective" do not apply in the usual sense.

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

Not applicable. The "ground truth" for this device's acceptance was established through compliance with an engineering standard (ISO 7785-2) via bench testing, not through expert clinical interpretation of data.

4. Adjudication Method for the Test Set

Not applicable. This was bench testing against a standard, not a clinical study requiring adjudication of expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document describes the regulatory submission for a physical dental handpiece, not an AI software or a diagnostic tool that would typically involve human readers and comparative effectiveness studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This is a hardware device (dental handpiece), not an algorithm or software. Therefore, standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance regarding safety and effectiveness was established by compliance with the international standard ISO 7785-2. This is an engineering/performance standard for dental handpieces.

8. The Sample Size for the Training Set

Not applicable. This is a hardware device, not an AI or machine learning model that requires a training set.

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

Not applicable. As above, this is a hardware device and does not involve a training set as understood in the context of AI development.

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

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

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

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

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

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

2. Sample Size for the Test Set and Data Provenance

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

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

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

4. Adjudication Method for the Test Set

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

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

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

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

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

7. The Type of Ground Truth Used

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

8. The Sample Size for the Training Set

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

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

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

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The Ti-Max X450 is an air-powered dental handpiece with intended use of being a surgical tool for impacted third molar removal and periodontal procedures for which a conventional handpiece would be used.

The. Ti-Max X450 is intended for use with a friction grip bur that conforms to ISO 1797-1 standard. Recommended supply air pressure is between 0.22 and 0.30 MPa, which results in high-speed bur rotation (approximately 380,000 to 450,000 RPM).

The Ti-Max X450 air-powered high-speed dental handpiece capable of reaching rotational speeds of 380,000 to 450,000 revolutions per minute. The device includes non-optic, fiber-optic, and LED models. All models have a 45 degree back angle. Models are available to connect directly to the couplings of specific brands.

The provided text describes a 510(k) summary for a dental handpiece, the Ti-Max X450, and mentions its conformance with technical standards and internal specifications through bench testing. However, it does not include specific acceptance criteria, detailed study data, or information about AI/algorithm performance.

Therefore, many of the requested sections about acceptance criteria, study details, expert involvement, and AI performance cannot be answered from the provided text.

Here's a breakdown of what can be extracted and what cannot:

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

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

• Not explicitly stated. The document mentions "bench testing" but does not provide details on sample size or data provenance. The submitter is Nakanishi, Inc. from Japan.

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 explicitly stated. This device is a dental handpiece, not an AI or diagnostic device that requires expert ground truth for its performance evaluation in this context. Performance is based on physical characteristics and standards.

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

• Not applicable / Not explicitly stated. Adjudication methods are typically relevant for diagnostic or AI studies involving human interpretation. This document describes physical device performance.

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 document is for a dental handpiece, not an AI or diagnostic device. There is no mention of MRMC studies or AI assistance.

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

• No. This document is for a dental handpiece, not an algorithm.

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

• Not applicable in the AI/diagnostic sense. The "ground truth" for this device's performance is established by technical standards and internal specifications (e.g., ISO 1797-1, ISO 9168) and directly measured physical properties (RPM, torque, dBA).

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI model that requires a training set.

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

• Not applicable. As above, no training set for an AI model is involved.

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The Ti-Max X Turbine Series is an air-powered dental handpiece intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.

The Ti-Max X Turbine is an air-powered high-speed dental handpiece capable of reaching rotational speeds of 300,000 to 450,000 revolutions per minute. The device includes non-optic, fiber-optic, and LED models. Models are available to connect directly to the couplings of specific brands.

The provided document is a 510(k) premarket notification for a dental handpiece, the Ti-Max X Turbine. It focuses on establishing substantial equivalence to a predicate device based on similarities in intended use, principles of operation, functional design, and established medical use. It does not contain information on acceptance criteria for a performance study, nor does it present the results of such a study.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a study proving the device meets acceptance criteria.

The document states:
"The Ti-Max X Turbine was developed and is produced under consideration of all applicable technical standards, internal specifications, and FDA guidance documents. The product's conformance with applicable international and internal standards was verified in the course of bench testing."

This indicates that bench testing was performed to demonstrate conformance to relevant standards, but no specific performance metrics, acceptance criteria, or a detailed study report are included in this 510(k) summary.

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This product is a cordless motor handpiece system intended for tightening and loosening an abutment screw to fix and remove the abutment on a dental implant in prosthodontic treatment.

The Cordless Prosthodontic Screwdriver with Torque Calibration System consists of the cordless motor handpiece, the contra angle head, and the quick charger. The motor handpiece and the contra angle head are connected via a proprietary coupling. The dental professional can select various settings such as: ON/OFF; forward/reverse; speeds of 15, 20, or 25 rpms; and torque settings between 10 and 40 N·cm.

The provided text is a 510(k) summary for the Nakanishi iSD900 Cordless Prosthodontic Screwdriver with Torque Calibration System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed information requested regarding specific acceptance criteria for performance, a study proving those criteria were met, sample sizes for test/training sets, expert qualifications, ground truth establishment, or comparative effectiveness studies.

The "Performance Testing" section states: "The iSD900 Prosthodontic Screwdriver was developed and is produced under consideration of all applicable technical standards and internal specifications. The product's conformance with the applicable technical standards and internal specifications was verified in the course of bench testing and software validation testing."

This statement indicates that performance testing was conducted, but it does not provide the specific results, acceptance criteria, or methodology that would allow for filling out the requested table and details. This document is a regulatory submission summary, not a detailed study report.

Therefore, I cannot provide the requested information based solely on the text provided. The document explicitly states that performance was "verified in the course of bench testing and software validation testing" with "applicable technical standards and internal specifications," but it doesn't detail what these standards or specifications were, nor the results of those tests.

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