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

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

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

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

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

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

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

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

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

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

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

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

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

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

Therefore, I cannot fulfill your request to provide:

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

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

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The SD500 High Speed Handpiece Series is used by trained dental professionals for a variety of procedures including but not limited to caries and amalgam removal, restorative work and crown preparations.

The SD500 High-Speed Handpiece Series includes a fiber optic high speed handpiece, to be marketed as a SD500 Elite Handpiece and a non-fiber optic handpiece, to be marketed as a SD500 Pro Handpiece. Both the Elite and the Pro versions are available as lubefree or lubricated turbine handpieces. Each is a pneumatically driven handheld device with multiport water spray that is capable of reaching rotational speeds of 367,200 – 448,800 rpms at a recommended air pressure of 38 to 43 PSI. The series delivers a range of 39 - 50 watts of power providing .28 oz.-in. of stall torque at 43 psi. The handpieces are constructed of stainless steel, including the internal air and water tubes, which provide drive air to the turbine assembly and cooling water to the work site. The handpiece also uses PEEK in its construction. The handpieces incorporate either a lubefree ceramic bearing turbine assembly or a lubricated ceramic bearing turbine assembly. Both versions of the turbine assembly use a push button autochuck. The stainless steel and aluminum air driven turbine assembly provides rotation to the bur. The SD500 High-Speed Handpiece Series uses a quick disconnect coupler that allows easy connection to the dental line delivery tubing. This coupler allows for easy rotation of the handpieces when attached to the tubing. These couplers include both fiber optic and nonfiber optic versions with Type 3 or 2 connections. The fiber optic version uses LED technology to deliver the light to the handpiece. All couplers are autoclavable. The burs used with the SD500 High Speed Handpiece Series are ISO 1797-1, type 2 burs. Only burs with hardened, tempered steel shanks or carbide shanks should be used. All handpieces in this series incorporate RFID (radio frequency identification) technology. This passive RFID tag does not have a built-in energy source. The RFID tag will allow the practitioner to track the device within the office only if the practitioner has a separate reader. A reader will enable the practitioner to track such things as usage and maintenance.

This document describes a 510(k) premarket notification for the SD500 High Speed Handpiece Series. It is a submission for a dental handpiece, which is a Class I reserved device. As such, the information provided focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering and material characteristic comparisons and adherence to relevant industry standards, rather than clinical study results establishing diagnostic accuracy or comparative effectiveness with human readers.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies, organized according to your request:

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

The provided document doesn't explicitly state numerical "acceptance criteria" in the way one might see for a diagnostic device (e.g., "sensitivity > 90%"). Instead, the performance evaluation is based on meeting the requirements of recognized industry standards and demonstrating comparable performance to predicate devices. The "reported device performance" is largely described qualitatively or by reference to meeting these standards.

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

The document refers to "bench testing" and "test results" to demonstrate conformity with standards like ISO 14457 and IEC 60601-1.

• Sample Size: No specific numerical sample size is provided for these bench tests. This is typical for engineering performance testing of mechanical devices where testing is often done on a representative number of units to ensure consistency and compliance with specifications.
• Data Provenance: The tests were "conducted to evaluate the functional performance and safety." Given this is a 510(k) submission by DentalEZ Inc., located in Lancaster, Pennsylvania, USA, the testing was likely conducted in-house or by a contracted laboratory within the US or a region adhering to these international standards. The data is prospective as it was generated specifically for this submission.

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 product is a dental handpiece, not an AI or diagnostic imaging device. Therefore, the concept of "ground truth" and "experts used to establish ground truth" with qualifications like "radiologist with 10 years of experience" does not apply in the context of this submission. The performance of the device is assessed against engineering specifications and industry standards, not against expert interpretations of diagnostic outputs.

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

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human judgment (e.g., expert review of medical images). Since this submission pertains to a mechanical device and its performance against engineering standards, no adjudication method as described would be applicable or necessary. Performance is measured objectively through physical tests.

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 MRMC comparative effectiveness study was done. This type of study is relevant for AI-powered diagnostic tools where human readers are involved in interpreting results, with or without AI assistance. The SD500 High Speed Handpiece Series is a direct therapy/procedural device, not a diagnostic or AI-assisted system.

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

No standalone algorithm performance study was done. This device does not involve any algorithms or AI for diagnostic or interpretive purposes. Its performance is entirely mechanical and physical.

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

As this is a mechanical device, the "ground truth" for its performance is established by:

• Compliance with Industry Standards: E.g., ISO 14457 (Dentistry Handpieces and Motors), IEC 60601-1 (Medical Electrical Equipment), ANSI/AAMI ST79, ISO 14937, ANSI/AAMI ST81 (for sterilization), FDA Guidance for "Reprocessing Medical Devices."
• Engineering Specifications: Meeting predefined rotational speed, power, and torque outputs.
• Material Compatibility: Use of materials with established safety profiles (Stainless steel, PEEK, Ceramic bearings) from existing industry knowledge.

These standards and specifications serve as the "ground truth" against which the device's physical and functional performance is measured.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI, and therefore, there is no "training set."

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

Not applicable. As there is no training set, there is no ground truth for it to be established.

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The Concentrix MX-AC High-Speed Handpiece is used by trained dental professionals for a variety of procedures including but not limited to caries and amalgam removal, restorative work and crown preparations.

The Concentrix MX-AC High-Speed Handpiece is a pneumatically driven, non-fiber optic, 2/3 line fixed backend handpiece that is capable of reaching rotational speeds of 302,000 rpms at a recommended air pressure of 32 PSI. The handpiece is constructed of stainless steel, including the internal air and water tubes which provide drive air to the turbine assembly and cooling water to the work site. The stainless steel and aluminum air driven turbine assembly provides spin to the bur and incorporates steel lubricated bearings and a push button autochuck. The burs used with the Concentrix MX-AC High Speed Handpiece are ISO 1797-1, type 2 burs. Only burs with hardened, tempered steel shanks or carbide shanks should be used.

This document is a 510(k) premarket notification for a dental handpiece, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, ground truth, and training sets for an AI/ML device is not applicable.

The document discusses the substantial equivalence of the Concentrix MX-AC High-Speed Handpiece to predicate devices. The "performance data" section outlines tests conducted to demonstrate functional performance and safety, but these are for the mechanical device itself, not an AI algorithm.

Here's a breakdown of the relevant information provided, while noting the requested AI-specific details are not present:

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

The document doesn't present a table with specific acceptance criteria and reported device performance in the way one might expect for a quantitative AI/ML study (e.g., sensitivity, specificity thresholds). Instead, it states that the device's functional performance and safety were evaluated against established international standards.

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

This information is not applicable. The performance data refers to physical testing of the device, not a data-driven test set for an algorithm.

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 is not applicable as there is no ground truth or expert review for an AI/ML device mentioned.

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

Not applicable.

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

Not applicable as this is not an AI/ML device.

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

Not applicable as this is not an AI/ML device.

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

Not applicable. The "ground truth" for this device's performance would be the physical measurements and observations of its mechanical and biological characteristics as defined by the referenced ISO/AAMI standards.

8. The sample size for the training set:

Not applicable as this is not an AI/ML device.

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

Not applicable as this is not an AI/ML device.

In summary, the provided document is a 510(k) summary for a physical medical device (dental handpiece), not an AI/ML product. Therefore, the specific questions related to AI/ML device studies, ground truth, and data sets are not relevant to this document. The device meets its acceptance criteria by conforming to established international standards for physical, mechanical, and biocompatibility performance.

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Titan 3 Low Speed Angle Attachments are used intraorally by trained dental professionals for drilling and preparation of dental cavities for restoration, such as fillings, as well as disking, cavity and crown preps, polishing, post and pin drilling and pin setting.

The proposed angles are attached to a pneumatically driven low speed motor via the use of either a motor-to-angle adaptor (K960260) or 16:1 contra angle (preamendment). Air supplied to the motor (K960260) drives a gearing system through the adaptor or contra angle to the angle attachment. A torque multiplier can be used between the motor and motor-to-angle adaptor or contra angle to reduce the rpms from the motor while increasing the torque. A dental bur is inserted into the angle to perform the procedure.

There are four different angle styles that will marketed under the names Titan 3 LubeFree Angles, Titan 3 Lubricated Angles, and Five Star Prophy Angles with some variations within each style. The main differences between the styles of the proposed angles are in the mechanical chucking mechanism of the angle and prophy, the composition of the outside plating of the angle attachment and the lubrication that may be needed to maintain the attachment.

The angles are constructed of brass, which is chrome plated The internal drive gears are constructed of stainless steel.

The lubricated angles, consisting of a ball bearing manual latch angle, ball bearing auto latch angle, ball bearing auto chuck friction grip angle and a Prophy angle require daily lubrication using the recommended lubricant, Dentalube II, which is manufactured by StarDental (K070869).

The lubefree angles, consisting of a ball bearing manual latch angle, ball bearing auto latch angle, ball bearing auto chuck friction grip angle and a Prophy angle, are lubricated during the assembly process and require no further lubrication by the user.

All proposed angles are autoclavable.

This looks like a 510(k) premarket notification for a dental device, not an AI/ML device. The document describes a traditional medical device (dental handpiece attachments) and its comparison to a predicate device for substantial equivalence. Therefore, many of the requested categories for AI/ML device studies (like sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, etc.) are not applicable and are not present in this document.

However, I can extract the relevant information regarding acceptance criteria and the studies performed for this specific device.

Acceptance Criteria and Device Performance (as applicable to a non-AI/ML device):

Study Information (as applicable to a non-AI/ML device):

1. Sample sizes used for the test set and the data provenance: Not explicitly stated in this document for individual tests, as it's a traditional device submission. The "test set" would refer to the physical devices undergoing testing. The provenance is from DentalEZ, Inc., StarDental Division, Lancaster, PA, USA. The testing is prospective for the specific devices being submitted.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For this type of device, "ground truth" refers to physical measurements and adherence to engineering and performance standards, not expert interpretations of data.

3. Adjudication method for the test set: Not applicable. Performance is measured against objective engineering and regulatory standards, not expert adjudication.

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: Not applicable, as this is not an AI device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI device.

6. The type of ground truth used:

   • Functional/Performance: Metrological measurements of RPMs and operational characteristics against established engineering specifications and the predicate device's performance.
   • Biocompatibility: Material specifications and compliance with known biocompatible materials.
   • Sterilization: Results from sterilization validation cycles against microbiology standards (e.g., achieving sterility assurance level).
   • Mechanical: Physical inspection, material analysis, and functional tests (e.g., torque, durability).
   • Risk Analysis: Compliance with the methodology outlined in ISO14971:2012.

7. The sample size for the training set: Not applicable, as this is not an AI/ML device. There is no "training set" in the context of an algorithm.

8. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

Overall Study Conclusion:

The document explicitly states: "Based upon the comparison of technological characteristics, demonstrated through bench testing and intended use, the Titan 3 Low Speed Angle Attachments are substantially equivalent to the predicate devices."

Specific Studies/Tests Mentioned:

• Performance testing: In accordance with ISO 14457:2012 Dentistry – Handpieces and motors.
• Sterilization validation: In accordance with ANSI/AAMI ST79:2010 & A4:2013, AAMI/ANSI/ISO 14937:2009, and ANSI/AAMI ST81:2004 (R2010).
• Risk analysis: Developed using ISO14971:2012.
• Bench testing: Implied for comparison of technological characteristics.

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The 430 Torque High-Speed Handpiece Series are used by trained dental professionals for a variety of procedures including but not limited to caries and amalgam removal, restorative work and crown preparation.

The 430 Torque High-Speed Handpiece Series consists of a fiber optic high speed handpiece, marketed as a SWL and a non-fiber optic handpiece, marketed as a SW handpiece. Each is a pneumatically driven hand- held device that is capable of reaching rotational speeds of 350,000 to 450,000 rpms at a recommended air pressure of 38-43 PSI. The series delivers on average up to 20 watts of power providing .269 oz.-in. of stall torque. The handpieces are constructed of stainless steel, including the internal air and water tubes which provide drive air to the turbine assembly and cooling water to the work site. The stainless steel and aluminum air driven turbine assembly provides spin to the bur, and incorporates lubefree ceramic bearings (K905155) and a push button autochuck. The rotor is larger than the rotor of the predicate, yielding a higher cutting torque. The fiber optics in the SWL version of the handpiece are lead-free, multi-core glass rod that transmit light from the fiber optic swivel coupler to the oral cavity. The 430 Torque High-Speed handpiece Series can be assembled to quick disconnect couplers that are ISO Type 3 and ISO Type 2 connections, available as fiber optic or non-fiber optic versions, using a halogen bulb or LED technology. All couplers are autoclavable with the exception of the LED coupler that incorporates the electronics internally.

This looks like a 510(k) summary for a dental handpiece, and not a study on a medical device that uses artificial intelligence or machine learning. Therefore, most of the requested information (acceptance criteria, sample sizes, ground truth establishment, expert qualifications, MRMC studies) is not applicable.

However, I can extract the relevant performance data and mention the standards used for testing.

1. Table of Acceptance Criteria and Reported Device Performance

For dental handpieces, the "acceptance criteria" are generally compliance with recognized consensus standards for safety and performance. The document doesn't explicitly state quantitative acceptance criteria in a pass/fail format, but rather demonstrates compliance with a standard and compares performance metrics to predicate devices.

Notes on the Table:

• The proposed device (430 Torque High-Speed Handpiece Series) demonstrates improved performance (higher power, higher rotational speed, higher stall torque) compared to its predicates, while still being considered substantially equivalent.
• The "acceptance criteria" are implied by meeting or exceeding the performance of the predicate devices and complying with relevant international standards for safety and performance (e.g., sterilization, risk management, performance standards for dental handpieces).

2. Sample size 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 document refers to "Performance testing ... in accordance with ISO 14457:2012 Dentistry – Handpieces and motors" and "Sterilization validation...". These are bench tests, and the sample size or specific data provenance (country, retrospective/prospective) are not detailed within this 510(k) summary. Given the nature of a 510(k) submission for a mechanical device, the data would typically be generated during product development and testing, likely by the manufacturer, Dentalez, Inc. (USA).

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 is not applicable as this is a mechanical dental device and not an AI/ML diagnostic or prognostic device requiring expert ground truth for image or data interpretation. The "ground truth" for this device's performance is established through objective physical measurements according to specified ISO standards.

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

This is not applicable for the same reasons as point 3.

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 is not applicable as this is a mechanical dental device and not an AI/ML device.

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

This is not applicable as this is a mechanical dental device and not an AI/ML device.

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

The "ground truth" for this device's performance is objective physical measurements (e.g., rotational speed, power, stall torque) and compliance with recognized consensus standards (e.g., ISO 14457:2012 for performance, ANSI/AAMI ST79:2010 for sterilization, ISO 14971:2012 for risk analysis).

8. The sample size for the training set

This is not applicable as this is a mechanical dental device and does not involve a "training set" in the context of AI/ML.

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

This is not applicable as this is a mechanical dental device and does not involve a "training set."

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The Concentrix High-Speed Handpieces are used by trained dental professionals for a variety of procedures including but not limited to caries and amalgam removal, restorative work and crown preparations.

The Concentrix High-Speed Handpieces are pneumatically driven, hand-held devices used by trained dental professionals to perform a variety of dental procedures.
The Concentrix MX is a non-fiber optic, 2/3 line fixed backend handpiece with a steel bearing manual chucking turbine. The Concentrix PX is a non-fiber optic, 2/3 line fixed backend handpiece with a steel bearing, push button autochuck turbine. The Concentrix FX is a non-fiber optic, 3/4 line fixed backend handpiece with a steel bearing, push button autochuck turbine. The Concentrix SX is a fiber optic, swivel handpiece with a steel bearing, push button autochuck turbine.

This document describes a 510(k) Premarket Notification for the DentalEZ, Inc. Concentrix High-Speed Handpiece Series. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics in the typical sense of a diagnostic or AI-powered device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set information) are not applicable to this type of regulatory submission, as it is not an AI/diagnostic device.

The "acceptance criteria" here are effectively the criteria for demonstrating substantial equivalence to the predicate device.

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

For a 510(k) submission for a dental handpiece, "acceptance criteria" are implied by demonstrating that the new device has the same technological characteristics, intended use, and performance as the predicate device, or that any differences do not raise new questions of safety and effectiveness.

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

Not applicable. This is a 510(k) submission for a mechanical dental instrument, not a diagnostic or AI device that relies on a test set of patient data. The "study" here is a comparison to a predicate device based on engineering and design characteristics.

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. Ground truth for a diagnostic test set is not relevant to this device. The assessment is based on engineering evaluations and comparison to the predicate device characteristics.

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

Not applicable. This concept is for diagnostic studies with human readers.

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.

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

Not applicable. This is not an algorithm or AI device.

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

Not applicable. The "ground truth" for this submission is the performance and safety profile of the legally marketed predicate device (Star Dental 430 Series High Speed Handpiece, K960719), as established through its prior clearance and market history. The substantial equivalence relies on demonstrating that the new device is as safe and effective as this predicate.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

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The StarCare Handpiece Maintenance Unit is intended for the internal cleaning, i.e purging of old lubricant, and the lubrication of air-driven high speed handpieces, electric micromotor attachments and turbines used in dentistry.

StarCare Handpiece Maintenance Unit should be used only after the handpieces have been externally cleaned and prior to sterilization.

The StarCare Handpiece Maintenance Unit is used for the cleaning, i.e. purging of old lubricant, and lubrication of lubricated high speed handpieces, electric micromotor attachments and handpiece turbines. The unit consists of two connections for high speed handpieces, one connection for electric micromotor attachments and one connection for handpiece turbine cleaning. The unit supplies cleaner and lubricant to the connection only when a high speed handpiece or electric micromotor attachment is present. The handpiece turbine cleaning function is independent of the high speed handpiece and electric micromotor attachment cleaning and lubrication function.

Two reservoirs within the unit supply the cleaner and lubricant to the individual stations. These reservoirs are clearly marked regarding the contents of the reservoir. The cleaner and lubricant are delivered to the high speed handpiece and electric micromotor attachment connection via tubes controlled by the activation of magnetic valves. The liquid is dispensed by pressurized air to the high speed handpiece and electric micromotor attachment.

The StarCare Handpiece Maintenance Unit is a device used for the cleaning and lubrication of dental handpieces. The provided text is a 510(k) summary, which outlines the device's characteristics and its equivalence to predicate devices, rather than a study report detailing performance against acceptance criteria. Therefore, much of the requested information regarding specific acceptance criteria, study design, and performance metrics for the StarCare Handpiece Maintenance Unit is not directly available within this document.

However, based on the information provided, we can infer some aspects and highlight what is missing.

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document does not provide quantifiable acceptance criteria (e.g., "removes X% of old lubricant," "lubricates sufficiently to extend handpiece life by Y%," or specific technical performance metrics for cleaning/lubrication efficacy). Performance is generally described in terms of its intended function and similarity to predicate devices, not through specific test results against defined criteria.

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

• Sample Size: Not specified. This 510(k) summary does not describe a clinical or performance study with a defined test set of units or handpieces.
• Data Provenance: Not applicable, as no specific performance data from a "test set" is presented. The document focuses on technological comparison to predicate devices, not primary performance data.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Those Experts

• Not applicable. This is not a study involving expert-established ground truth. The demonstration of safety and effectiveness relies on substantial equivalence to existing predicate devices, rather than a new clinical or performance study requiring expert adjudication of outcomes.

4. Adjudication Method for the Test Set

• Not applicable. There is no described test set or adjudication process in this document.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed or described in this 510(k) summary. This type of study is typical for diagnostic imaging devices involving human readers, which is not the nature of the StarCare Handpiece Maintenance Unit.

6. Standalone (Algorithm Only) Performance Study

• Not applicable. This device is a mechanical unit, not an algorithm. Therefore, no standalone algorithm performance study would be relevant or discussed. The device's performance is intrinsically linked to its physical operation and interaction with the dental handpieces.

7. Type of Ground Truth Used

• Not applicable. For this type of device and submission, "ground truth" in the sense of expert consensus, pathology, or outcomes data is not utilized to demonstrate equivalence. The "ground truth" for a 510(k) submission generally refers to the established safety and effectiveness of the predicate devices to which the new device is compared. The claim is that the new device is "substantially equivalent" in its performance, intended use, and technological characteristics to devices already cleared for market.

8. Sample Size for the Training Set

• Not applicable. There is no "training set" for this device, as it is a mechanical unit, not an AI/ML algorithm or a diagnostic tool that learns from data.

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

• Not applicable, for the same reasons as point 8.

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The Prophy Star 3 Hygiene Handpiece is a low speed, pneumatically driven, hand-held device intended for use by trained dental professionals for performing dental prophylaxis.
The prophy handpiece is used by trained dental professionals to perform dental prophylaxis.

The Prophy Star 3 Hygiene Handpiece is a low speed, pneumatically driven, hand-held device intended for use by trained dental professionals for performing dental prophylaxis. The handpiece uses either an ISO standard Doriot style reusable Prophy angle or a ISO standard Doriot style disposable angle. The Prophy Star 3 Hygiene Handpiece is a Lube Free handpiece requiring no lubrication.

The provided text describes a 510(k) premarket notification for a dental handpiece, the Prophy Star 3 Hygiene Handpiece. It focuses on establishing substantial equivalence to a predicate device based on intended use, technology, and design.

However, the document does not contain information related to acceptance criteria, a specific study proving device performance against acceptance criteria, or any of the detailed aspects of a clinical or performance study as requested in the input.

Therefore, I cannot provide the requested table and detailed information about acceptance criteria and study particulars for the Prophy Star 3 Hygiene Handpiece based on the given text.

The document is a regulatory approval letter from the FDA (June 15, 2007) and a 510(k) summary (May 21, 2007). These types of documents typically attest to substantial equivalence based on comparisons to existing devices and adherence to general safety and performance standards, rather than presenting detailed multi-reader multi-case studies or standalone algorithm performance data.

Here's what I can infer from the available information, but it does not address the specific questions about acceptance criteria or a dedicated performance study:

• Device: Prophy Star 3 Hygiene Handpiece
• Intended Use: For use by trained dental professionals for performing dental prophylaxis.
• Predicate Device: StarDental Prophy Star II Hygiene Handpiece Micro Motors PHP 100 Prophy Handpiece (K896877)
• Basis for Substantial Equivalence: Same intended use, similar technology and design, same means of operation, and used for the same procedures. Improvements were made to enhance handpiece performance while maintaining safety. This implies that the new device is expected to perform at least as well as the predicate device.

Without a performance study or clinical trial section in the provided text, I cannot answer the specific quantitative questions.

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