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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.

• Bur extraction force
• Eccentricity
• Noise level
• Stopping torque
  All results were reported as "in compliance with ISO 14557." (This implies that the measured values for these parameters for PANA SPRAY Plus were within the acceptable ranges defined by ISO 14557 and comparable to the predicate.) |
  | Safety and Efficacy (General) | "The test results indicate that PANA SPRAY Plus is substantially equivalent to the predicate devices and does not raise new questions of safety or efficacy." |

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 contra-angle handpieces are used to hold and drive burr instruments for the purposes of rotary processing. The handpieces are intended for dental applications in endodontics and for root canal measurement and are used by trained dental personnel in dental practices and laboratories. The T1 Spray is intended to be used to clean and lubricate dental handpieces.

Endo 6:1 is a contra-angle handpiece which is adapted to dental electric motors or dental air motors with the ISO 3964 interface. It is reusable and it does not have a fiber optic light system.
T1 LINE ENDO 6 L contra-angle handpiece is equipped with a fiber optic light system. It is also adapted to dental electric motors or dental air motors with the ISO 3964 interface. It is reusable.
SIRONiTi APEX contra-angle handpiece is adapted to dental electric motors with the ISO 3964 interface. It is reusable. SIRONiTi APEX is equipped with a torque limitation function. Once a set torque has been reached, a gold plated magnetic coupling prevents jamming of the file in the root canal by retro-rotation.
T1 Spray is the lubricant used for maintenance and cleaning of the drive channels of the handpieces.

The provided text is a 510(k) Summary for dental handpieces. This document focuses on demonstrating substantial equivalence to predicate devices based on design, function, and performance standards, rather than proving a device meets specific acceptance criteria based on clinical study performance of an AI-powered device.

Therefore, many of the requested categories for AI/clinical study performance (such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and how ground truth was established) are not applicable to the information contained in this type of submission.

The document does not describe the acceptance criteria and a study proving the device meets those criteria in the context of an AI-powered medical device and its performance against a specific clinical outcome. Instead, it demonstrates compliance with recognized performance standards for dental handpieces.

However, I can extract the relevant information regarding the performance standards and a general conclusion of equivalency:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not applicable for a 510(k) submission of this type of device. The compliance is based on meeting engineering and biocompatibility standards, not on clinical performance evaluations with a specific test set of patients/data. The "study" mentioned is conformity to existing standards, which implicitly involves testing the device against those standards.

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 clinical performance is not established here. The document mentions "An evaluation using relevant literature and a critical appraisal of the handpieces by a medical professional have been performed," but this is for overall assessment, not for establishing ground truth on a specific test set for an AI algorithm.

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

• Not applicable.

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

• No. This is not an AI-powered device.

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

• No. This is not an AI-powered device.

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

• Not applicable. For this type of device, "ground truth" relates to the device successfully meeting the specifications outlined in the various ISO/DIN/AAMI standards (e.g., sterilization effectiveness, biocompatibility, mechanical performance as per ISO 14457).

8. The sample size for the training set:

• Not applicable. This is not an AI-powered device.

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

• Not applicable. This is not an AI-powered device.

Summary of the study that proves the device meets the acceptance criteria (from the text):

The device's performance is demonstrated through its compliance with a list of recognized national and international performance standards (listed in the table above). These standards cover aspects such as mechanical performance, biocompatibility, risk management, sterilization, labeling symbols, and quality management systems. The document states: "The Sirona Dental System T1 LINE Endo 6 L, ENDO 6:1 and SIRONiTi Apex contra-angle handpieces comply with the following performance standards." Additionally, "An evaluation using relevant literature and a critical appraisal of the handpieces by a medical professional have been performed." This implies that testing and evaluation against these standards were conducted to ensure the devices meet the specified requirements for safety and performance. The conclusion drawn is that "Based on a comparison of intended use, indications, principal of operations, features and technical data, the Sirona Dental Systems T1 LINE ENDO 6 L, ENDO 6:1 and SIRONiTi APEX are similar in design and function to the Predicate Devices. Therefore, the subject device is substantially equivalent to the predicate device."

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The Maxima XTEND Handpiece Maintenance System is intended for cleaning and lubrication of dental Handpieces including air turbines, air motors and air driven scalers prior to sterilization.

Maxima XTEND Handpiece Maintenance System is a complete automatic dispensing system for cleaning: lubrication and purging old oil for dental handpieces prior to sterilization cvcles.

User can use push button kev pad to select time for purqing lubricant into handpiece including 15 seconds, 20 seconds, and 30 seconds. In addition, there are 11 adjustable settings for the amount of lubricant into the handpiece; user can choose the amount of lubricant to purge into handpieces accordingly. The system can maintenance up to 3 handpieces at the same time, and an unique chuck care nozzle to lubricate chucks in dental turbines.

Service Maxima XTEND Handpiece maintenance system is capable to operate with aerosol lubricant can with or without compressed-air supply. Air pressure will deliver Lubricant directly through internal parts of handpieces and contra angles by the controlling of software to open and close magnetic valves. The system will purge all the excess lubricant. The provided linen pads and removable trays on front side and bottom of the system will absorb the excess liquid of lubricant.

Lubricant uses for the Maxima Handpiece Maintenance System is aerosol spray can "Maxima Handpiece Cleaner & Lubricant" has been previous cleared with 510(k) # K113674

The Maxima XTEND Handpiece Maintenance System contains following main components:

• Main case 1
• Rear case
• Front door module
• 4 PCBA board
• 5 Power supply
• 6 Adapters module
• 7 LCM Module
• 8 Oil supply module
• Solenoid valve
• 10 Rear components module
• 11 Back plate cover
• 12 Top cover
• 13 Veneer (Bright Blue)
• 14 Oil trav
• 15 Rotation motor module

The provided document describes the Maxima XTEND Handpiece Maintenance System, a device for cleaning and lubricating dental handpieces. The document is a 510(k) premarket notification to the FDA, asserting substantial equivalence to a predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the traditional sense of a pass/fail metric for device performance against specific thresholds. Instead, it presents a comparison table of features with a predicate device and then discusses performance testing to demonstrate similarity.

Comparison Table (based on features and "performance testing" section):

Study Proving Acceptance Criteria:

The study proving the device meets the functional "acceptance criteria" (i.e., that it effectively cleans and lubricates handpieces without degrading performance) is described as "product testing results in attachment 3" (which is not included in the provided text).

The document states: "Based on product testing results in attachment 3: there are no significant changes in performance of testing handpieces after 250 cycles of testing by using Maxima XTEND and STAMATIC 31 Handpiece Maintenance Unit. The performance of these handpieces including speed, torque bur extraction force and concentricity which do not change significantly compared from the beginning of the test to the end result of the performance testing. The lubrication performance of Maxima XTEND Handpiece Maintenance System on the testing handpieces is similar to lubrication performance of the STATMATIC 31 Handpiece Maintenance Unit on the testing handpieces."

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

• Sample Size: The document mentions "testing handpieces" and "250 cycles of testing." It does not specify the number of individual handpieces tested. It only refers to "these handpieces" in a general sense.
• Data Provenance: Not explicitly stated, but it would be prospective testing conducted by the manufacturer ("Handpiece Headquarters"). No country of origin for the data is mentioned, but the company is based in Placentia, CA, USA.

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

Not applicable. The performance testing appears to be objective, measuring physical parameters of the handpieces (speed, torque, bur extraction force, concentricity) directly, rather than relying on expert assessment of an outcome.

4. Adjudication Method for the Test Set

Not applicable, as ground truth was established by direct measurement of physical properties, not by expert consensus.

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

No. This is not an MRMC study. The study compares the performance of the device itself to a predicate device, not human reader performance with or without AI assistance.

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

Yes, this is essentially a standalone (device-only) performance study, comparing the Maxima XTEND Handpiece Maintenance System's effect on handpieces to that of the predicate device. There is no human intervention in the operation being evaluated beyond starting the device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for the performance study was based on objective physical measurements of dental handpiece performance parameters:

• Speed
• Torque
• Bur extraction force
• Concentricity

The baseline measurements "from the beginning of the test" served as the initial ground truth for each handpiece, against which "the end result of the performance testing" was compared after 250 cycles.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical cleaning and lubrication system, not an AI or algorithm-based device 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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