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The HPR Cordless Hygiene Handpiece is a cordless prophylaxis handpiece featuring control buttons and equipped with a battery pack and a wireless foot control. It is designed for use with disposable prophylaxis angles in hygiene operatory to perform cleaning and polishing procedures on teeth surface and fillings.

The HPR Cordless Hygiene Handpiece is a cordless prophylaxis handpiece featuring control buttons and equipped with a battery pack and a wireless foot control.

The provided text is a 510(k) clearance letter from the FDA for a dental handpiece. It does not contain information about acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment for a medical device. These details are typically found in the 510(k) submission itself or in a summary of safety and effectiveness, which is not included in this document.

Therefore, I cannot extract the requested information from the given input.

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This "BASE290 LED Curing Light" is a dental curing unit utilizing visible light programmed for the polymerization of light curing materials in the wavelength range of 380-500 nm by dental professionals.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental curing light. It does not contain information about the acceptance criteria, study details, or performance metrics of a device, nor does it discuss ground truth, human experts, or AI.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

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The Maxima Electric System is intended to convert pneumatic output from a dental treatment center to electrical energy to drive an electric micro motor and to operate electrically- driven dental handpieces. This system is designed for use by a trained professional in the field of general dentistry.

Maxima Electric System is a system attached to dental system to operate Electricallydriven low speed handpieces. The common gear ratio is 1:1 and 1:5, the speed range is from 100 to 40,000 rpm. Software used on control box is to control speed, forward and reverse direction of the handpieces; turn on an off the cooling water and LED light. There are 3 memories for speed of common low speed handpieces can be save into the program. The air hose is connect the air and water from 4-hole standard handpiece hose from dental system to the control unit, the existing air pedal from dental system is to turn on and off and control speed by converting pneumatic from dental system to electrical energy to operate electric handpieces. The control box is power by a power supply AC/DC voltage 36 VDC. Maxima Electric System consists of the following components: 1-Control Unit 2-Motor Cable 3-Micromotor (Model ELM-B40S) 4-Accessories including the following a-Foot switch (optional) b-AC/DC Adapter c-AC cord A control unit, Motor Cable and a Micro-motor.

The provided document is a 510(k) Pre-Market Notification for the Maxima Electric System, a dental device. It does not describe a study involving an AI/ML algorithm or its performance criteria, but rather focuses on demonstrating substantial equivalence to a predicate device. Therefore, many of the requested fields cannot be filled based on the provided text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for the device's overall performance in a quantitative manner as one would for an AI/ML model. Instead, it demonstrates substantial equivalence to a predicate device by comparing technological characteristics and performance testing.

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

The document mentions "250 cycles of testing" for handpieces to compare Speed Vs Torque performance between the subject device and the predicate. It does not provide details on the number of handpieces tested, the specific testing parameters beyond "Speed Vs Torque," or the data provenance (e.g., country of origin, retrospective/prospective). This testing appears to be a bench test, not clinical data.

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

Not applicable. The ground truth, in this context, is derived from engineering specifications, industry standards (ISO), and the performance metrics of the predicate device, not direct expert interpretation of clinical data.

4. Adjudication method for the test set

Not applicable. This is not a study that uses human adjudication for a test set. Bench testing results are compared to established benchmarks or predicate 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

Not applicable. This device is a dental handpiece system, not an AI/ML diagnostic or assistive tool. No MRMC study was performed.

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

Not applicable. The device is hardware with embedded software for control, not a standalone algorithm in the context of AI/ML. The "software used on control box is to control speed, forward and reverse direction of the handpieces; turn on an off the cooling water and LED light." This is basic control software, not an AI algorithm.

7. The type of ground truth used

The "ground truth" for this submission is based on:

• Engineering Specifications and Standard Compliance: Adherence to standards like ISO 14971, ISO 17665-1, ISO 17665-2, ISO 10993-1, ISO 10993-5, IEC 60601-1, IEC 60601-1-2, ISO 14457, IEC 60601-1-6, IEC 63266, and IEC 80601-2-60.
• Predicate Device Performance: Direct comparison of technological characteristics and performance data (Speed Vs Torque) to a legally marketed predicate device (ELECTROtorque TLC4893 with INTRAmatic KL 702).

8. The sample size for the training set

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

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

Not applicable. This device does not involve an AI/ML algorithm or a training set.

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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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The U-Type Contra Angles and U-Type Sectional Contra Angles are used to mount on U-Type Nose Attachments and powered by either low speed air motors or electric micro motors. These U-Types are intended for removing carious material, cavity and crown preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth.

U-Type contra angles and U-Type sectional contra angles are used to mount on U-Type Nose Attachments and powered by either low speed air motors or low speed electric motors. These U-Type Contra Angle Attachments are gear 1:1 to the low speed air motors or low speed electrical motors. As results, they transmit the same speed and torque from the connected air motors or electric motors.

This document is a 510(k) Premarket Notification for Henry Schein/Handpiece Headquarters U-Type Contra Angles and U-Type Sectional Contra Angles. The primary purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a numerical or target performance format. Instead, the demonstration of equivalence is based on a direct comparison of technological characteristics and performance (specifically heat generation and speed capabilities) between the new device and the predicate device. The "conclusion" section states that the non-clinical tests did not raise any safety or efficacy concerns and that the device is substantially equivalent based on these comparisons.

The following table summarizes the comparative performance presented in Attachment 8 (H1-Summary table of comparing the technological characteristics between the subjects to predicate devices):

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

• Sample Size: The document does not explicitly state the numerical sample size for the test set used in the "in-house" comparison testing. It simply refers to "these U-type contra angles" and "predicate devices."
• Data Provenance: The testing was conducted "in house per ISO 7785-2:1995 (section 7 of this 510(k))." This indicates the data was generated internally by the manufacturer, rather than being from a specific country of origin or being retrospective/prospective clinical data involving patients.

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

This information is not applicable and not provided in the document. The study is a benchtop comparative performance study of mechanical devices, not a clinical study requiring expert interpretation of medical images or patient outcomes.

4. Adjudication method for the test set:

Not applicable. This was a direct comparative measurement of physical characteristics and performance based on a standard (ISO 7785-2:1995). No adjudication method is described or required for this type of test.

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

Not applicable. This is a 510(k) submission for dental handpiece attachments, which are mechanical devices, not AI/software as a medical device.

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

Not applicable. This is about mechanical dental devices, not an algorithm.

7. The type of ground truth used:

The "ground truth" for this engineering comparison study was established by objective physical measurements based on the requirements of ISO 7785-2:1995, which pertains to dental handpieces. The predicate device's characteristics and performance values served as the benchmark for comparison.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI-based device, so there is no training set.

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

Not applicable. There is no training set.

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The Dental Handpiece Cleaner and Lubricant is intended to be used during routine maintenance in order to lubricate and clean air-powered Dental Handpieces (including low speed and high speed) and Dental air motors after each patient use and prior to sterilization.

The Dental Handpiece Lubricant is intended to be used during routine maintenance in order to lubricate air-powered Dental Handpieces (including low speed and high speed) and Dental air motors after each patient use and prior to sterilization.

Dental Handpiece Cleaner and Lubricant (Spray & Clean Handpiece Cleaner & Lubricant, Maxima Handpiece Cleaner & Lubricant, and EZcare Handpiece Cleaner & Lubricant), This is an aerosol product that is used during routine maintenance. It contains two major components, which are Mineral oil and Isopropyl Alcohol. The product lubricates and cleans dental handpieces and air motors when sprayed directly into the air drive tube. It lubricates and cleans out contamination from all internal parts, such as the bearings, gears and auto chucks.

Dental Handpiece Lubricant: Maxima Handpiece Lubricant contains mineral oil that drops directly into the air drive tube of the dental handpiece. When the user operates the handpiece, the pressure of air in the air drive tube will deliver the oil into the handpiece to lubricate the bearings, gears, and auto chucks.

The provided document is a 510(k) premarket notification for dental handpiece cleaners and lubricants. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than establishing new acceptance criteria and proving performance against them in the same way a de novo device might.

Here's an analysis based on the document, addressing the requested points where applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't define specific quantitative "acceptance criteria" in the traditional sense for a new device's performance benchmarks. Instead, it relies on demonstrating that the subject devices perform comparably to a legally marketed predicate device. The "acceptance criteria" are implicitly that the subject device's performance in the specified tests is equivalent to or better than the predicate device's performance, allowing it to meet its design performance requirements.

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

The document does not specify the sample size used for the test set (i.e., the number of handpieces or test iterations). It simply states that "performance testing... was conducted on the subject devices and the predicate device."

The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) for a device like this, it is likely that the testing was conducted prospectively by the manufacturer or a contracted lab.

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

This type of information is generally not relevant for 510(k) submissions of accessories like handpiece lubricants. The "ground truth" here is objective physical and mechanical measurements of handpiece performance, not subjective expert assessment of clinical outcomes or images. Therefore, no experts were used in this capacity.

4. Adjudication Method for the Test Set:

Not applicable, as the "ground truth" is based on objective measurements, not expert consensus requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-assisted interpretation devices where human reader performance is a key metric. This device is a maintenance product for dental equipment.

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

Not applicable. This device is not an algorithm or an AI system. It is a physical product (lubricant). Performance is evaluated based on its effect on the mechanical function of dental handpieces.

7. The Type of Ground Truth Used:

The ground truth for the non-clinical testing was based on objective physical and mechanical measurements. Specifically, the test evaluated:

• Bur extraction force
• Concentricity
• Noise level
• Torque

These are measurable performance specifications for dental handpieces, which are expected to be maintained or improved by the lubricants.

8. The Sample Size for the Training Set:

Not applicable. This device is 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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This HHC-Push button air turbine is intended for use with the Midwest Tradition Handpiece in replacement of Midwest Tradition's original turbine.

The Dental Handpiece with the HHC- replacement turbine is used by authorized persons in the practice of dentistry.

The HHC-replacement turbine is used in the Midwest Tradition High Speed Dental Handpiece, which is intended for removing carious material, cavity preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth.

The HHC-Push button air turbine is a complete air turbine which will be offered as replacement turbine for Midwest Tradition original turbine.

High pressured air directly impacts the blade pockets of the impeller through an air intake tube located inside the handpiece body, which causes the air turbine to rotate at a high speed. The dental cutting bur connects to the turbine's shank (spindle), which rotates at the same speed as the impeller. Cooling water flows through an inlet water tube at high pressure and blows out at an angle near the dental cutting bur to reduce temperature at cutting area.

Acceptance Criteria and Device Performance Study for HHC-Push Button Replacement Turbine

This document outlines the acceptance criteria and the study that demonstrates the HHC-Push button replacement turbine’s performance, based on the provided 510(k) summary (K100389).

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the HHC-Push button replacement turbine are established through direct comparison to a predicate device, the NSK- Replacement Turbine for Midwest Tradition Handpiece Products of NSK NAKANISHI INC. (K971774). The study aimed to demonstrate substantial equivalence by meeting or exceeding the predicate's performance specifications.

Summary of Device Performance: "The HHC-Push button air turbine performance tests were carried out to evaluate it against the predicate device. In all instances the HHC-Push button air turbine functioned as intended, results observed were as expected, and was determined to have comparable performance and safety as compared to the predicate."

2. Sample Size and Data Provenance

• Sample Size for Test Set: The document states that "100 inspection using ONMI gauge" was performed for bur extraction force, implying a sample size of 100 units for this specific test. For other parameters, specific sample sizes are not explicitly mentioned, but the comparison implies testing was conducted on a sufficient number of units to establish equivalence.
• Data Provenance: The study was conducted by Handpiece Headquarters as part of their 510(k) submission. The data is retrospective, generated specifically for showing substantial equivalence to a legally marketed device. The country of origin of the data is not explicitly stated, but it can be inferred to be the United States, given the FDA submission.

3. Number of Experts and Qualifications for Ground Truth

• Experts: Not applicable. This study does not involve human expert interpretation of data to establish ground truth. It is a performance study comparing engineering specifications and functional output.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This study does not involve human adjudication. The performance metrics are objective and measurable engineering parameters.

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

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is typically used for diagnostic devices involving human interpretation of medical images or data. The HHC-Push button replacement turbine is a dental handpiece component, and its effectiveness is determined by its mechanical and operational performance, not by diagnostic accuracy or human interpretation.

6. Standalone (Algorithm Only) Performance Study

• Standalone Performance Study: Not applicable. This device is a mechanical component, not an algorithm. Its performance is inherent to its design and manufacturing, evaluated through direct physical and functional testing.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this study is based on engineering specifications and established performance standards for dental handpiece turbines, as exemplified by the predicate device. The performance of the subject device was compared directly to these objective, measurable parameters.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How Ground Truth for the Training Set was Established

• Ground Truth for Training Set: Not applicable, as there is no training set for this device.

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The Straight Attachment and Contra Angle Sheath attachments are used with a Low Speed Dental Handpiece that is intended for removing carious material, cavity and crown preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth. These attachments are used by authorized persons in the practice of dentistry.

The Straight Attachment or the Contra Angle sheath is used to connect between the low-speed air-driven motor and the handpiece head. (1 to 1)

This 510(k) submission (K092053) for the Henry Schein Maxima-M Straight Attachment & Contra Angle Sheath does not contain a study or detailed acceptance criteria for device performance.

Instead, it relies on demonstrating substantial equivalence to predicate devices. This means that the device is considered safe and effective because it is similar in design, materials, and intended use to devices already on the market. In such cases, a detailed performance study with specific acceptance criteria is typically not required, as the safety and effectiveness are established through comparison rather than de novo testing.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not applicable. There is no mention of a "test set" in the context of a performance study for this device. The submission focuses on a comparison to predicate devices, not on direct performance testing of the new device.

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

• Not applicable. As no performance study with a test set generating new data was conducted, there were no experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set:

• Not applicable. No test set or associated adjudication was performed.

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

• No. The document does not describe an MRMC study. The comparison is made at a device level (similarity of design, materials, intended use) rather than assessing human reader performance.

6. Standalone (Algorithm Only) Performance Study:

• Not applicable. This device is a mechanical dental attachment; therefore, an "algorithm only" performance study is irrelevant.

7. Type of Ground Truth Used:

• Not applicable/Implicit. The "ground truth" in this context is the regulatory acceptance and established safety/effectiveness of the predicate devices. The new device leverages this existing regulatory record by demonstrating its similarity.

8. Sample Size for the Training Set:

• Not applicable. This is a hardware device; machine learning or AI models with training sets are not involved.

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

• Not applicable. As above, no training set or associated ground truth establishment process is relevant for this type of device.

Summary of the Study (or lack thereof):

The "study" in this 510(k) submission is a comparison to predicate devices (MIDWEST STRAIGHT ATTACHMENT-K792445 and NSK CONTRA ANGLE SHEATH-K962540). The applicant, Handpiece Headquarters, asserts that the Henry Schein Maxima-M Straight Attachment & Contra Angle Sheath is substantially equivalent to these legally marketed devices based on:

• Device Description: Both the proposed device and the predicate devices are described as connecting between a low-speed air-driven motor and a handpiece head (1 to 1 ratio).
• Intended Use: The intended use statement for the Henry Schein Maxima-M Straight Attachment & Contra Angle Sheath is identical in function to what would be expected of the predicate devices: "removing carious material, cavity and crown preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth."
• Safety and Effectiveness: The conclusion explicitly states: "The Straight Attachment & Contra Angle Sheath are as safe and effective as the predicate devices as cited above."

The FDA's letter (Page 3 of the document) confirms that the FDA "reviewed your Section 510(k) premarket notification of intent to market the device... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This determination signifies that the FDA accepted the applicant's argument of substantial equivalence, meaning no new clinical or performance studies were required for this specific filing.

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The Dental Handpiece is used by authorized persons in the practice of dentistry.

This Handpiece is intended for removing carious material, cavity preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth.

The canister handpiece is a complete dental handpiece that includes the turbine (push button & a screw type). The handpiece is fully functional and is being offered in a 4 hole version.

High pressured air directly impacts the blade pockets of the impeller through an air intake tube located inside the handpiece body, which causes the air turbine to rotate at a high speed. The dental cutting bur connects to the turbine's sharik (spindle), which rotates at the same speed as the impeller. Cooling water flows through an inlet water tube at high pressure and blows out at an angle near the dental cutting bur to reduce temperature at cutting area.

This document is a 510(k) summary for the Henry Schein/HHC/SCORE Canister Handpiece, indicating a premarket notification for a dental device. The primary finding is that the device is "substantially equivalent" to a predicate device. This type of submission relies on demonstrating equivalence rather than conducting new clinical studies with established acceptance criteria and detailed performance reporting.

Therefore, the information typically found in a study proving a device meets acceptance criteria (like detailed performance metrics, sample sizes, ground truth establishment, MRMC studies, etc.) is not present in this document.

Here's an analysis based on the provided text, highlighting the absence of the requested clinical study data:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable/Not provided.
The document states: "The canister handpiece is as safe and effective as the predicate device as cited above." This is a statement of substantial equivalence, not a report of specific performance metrics against pre-defined acceptance criteria from a clinical study. No specific quantitative or qualitative acceptance criteria are listed, and no detailed performance data (e.g., accuracy, precision, durability, success rates) are reported.

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

Not applicable/Not provided.
Since no new clinical study demonstrating performance against acceptance criteria was conducted or reported, there is no test set sample size or data provenance information. The basis for equivalence is a comparison of design and functional principles with existing predicate devices.

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

Not applicable/Not provided.
No test set requiring expert ground truth establishment is mentioned.

4. Adjudication Method for the Test Set

Not applicable/Not provided.
No test set requiring adjudication is mentioned.

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

Not applicable/Not provided.
No MRMC study was conducted or reported. The document focuses on device design and intended use equivalence, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Not applicable/Not provided.
This device is a mechanical dental handpiece, not an AI algorithm. Therefore, a standalone performance study in the context of an algorithm is irrelevant.

7. Type of Ground Truth Used

Not applicable/Not provided.
There is no "ground truth" mentioned in the context of a clinical performance study. The ground truth for this submission is the established safety and effectiveness of the predicate devices.

8. Sample Size for the Training Set

Not applicable/Not provided.
No training set is mentioned as this is a physical device, not a machine learning model.

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

Not applicable/Not provided.
As there is no training set for an algorithm, this question is not relevant.

Summary of Device Rationale from the Document:

The basis for market clearance for the Henry Schein Canister Handpiece is substantial equivalence to an already legally marketed predicate device (SUPER-AIR S & SUPER-AIR U Handpiece Models manufactured by PENG LIM ENTERPRISE CO., Ltd.).

The document describes the device and its intended use, then states: "The canister handpiece is as safe and effective as the predicate device as cited above." This implies that by being similar in design, function, and intended use to a device already deemed safe and effective, no new, extensive clinical studies demonstrating specific performance against novel acceptance criteria were required for this 510(k) submission.

The "study" in this context is the comparison against the predicate device, not a clinical trial.

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