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The intended use of DPA is for polishing and cleaning teeth.

Plastic one-piece housing (external casing) with 1 internal drive shaft and a spindle installed and aligned at right angle (90 degree) with each other. The tip of spindle is fitted with rubber prophy cup for cleaning and polishing teeth. A small amount of food-grade grease is added between the drive shaft and the spindle as lubrication. The disposable prophylaxis angle is available in a soft cup and firm cup format, which differ in the material used to form the cup. The Medicom and Practicon brands differ in logo and packaging, but utilize the same design.

This FDA 510(k) clearance letter pertains to a Disposable Prophy Angle, a dental device, not an AI/ML medical device. Therefore, much of the requested information regarding AI/ML device testing (e.g., sample size for test set, data provenance, expert ground truth, MRMC study, training set details) is not applicable to this document.

However, I can extract the relevant information regarding performance criteria and testing for this device.

Acceptance Criteria and Study for Disposable Prophy Angle (K240950)

This document describes the 510(k) clearance for a Disposable Prophy Angle, a dental handpiece accessory used for polishing and cleaning teeth. The device is not an AI/ML medical device, and thus, many of the typical AI/ML study parameters are not applicable.

The submission demonstrates substantial equivalence to predicate devices by meeting recognized performance requirements through non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

The documentation references compliance with a specific industry standard for performance.

Note: The specific numerical values or thresholds for "temperature rise" and "vibration" are not provided in this summary but would be detailed in the full test reports submitted to the FDA.

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

Not Applicable (N/A). This is a hardware dental device. The testing described is non-clinical performance testing (temperature rise, vibration) based on engineering specification compliance, not an AI/ML model evaluated on a test set of data. The "test set" would refer to the physical samples of the device and its components. The document doesn't specify the number of units tested, only that "all models of the device (soft cup and firm cup)" were tested.

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

Not Applicable (N/A). Ground truth based on expert review is specific to AI/ML or diagnostic image analysis. For this device, "ground truth" refers to established engineering standards (ANSI ADA Specification No. 85) and comparative performance against a predicate device.

4. Adjudication method for the test set

Not Applicable (N/A). Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among multiple human readers in AI/ML or diagnostic studies. This is a non-clinical, hardware performance 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 (N/A). This is not an AI/ML device; therefore, an MRMC study and analysis of human reader improvement with AI assistance are irrelevant.

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

Not Applicable (N/A). This is not an algorithm or software device.

7. The type of ground truth used

The "ground truth" (or basis for acceptance) for this device's performance testing is:

• Established engineering standards: Specifically, "ANSI ADA Specification No. 85, Part I: Disposable Prophy Angles, section 5.5."
• Comparative equivalence: Demonstration of "equivalent performance to the predicate device" for temperature rise and vibration.

8. The sample size for the training set

Not Applicable (N/A). This is a hardware device; there is no training set for an AI/ML model.

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

Not Applicable (N/A). There is no training set for an AI/ML model.

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Bonart dental hand piece is used for removing carious material, cavity and crown preparations, finishing tooth preparations, reducing hard tooth structures, restorations.

Bonart Dental Handpieces (ART), Disposable Prophy Angle (PERFORMANCE)

The provided text is a 510(k) summary from the FDA for Bonart Dental Handpieces (ART) and Disposable Prophy Angle (PERFORMANCE). It is a letter of substantial equivalence and does not contain details about acceptance criteria, study methodologies, or performance results. This document is a regulatory approval, not a scientific study report.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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This Device is to be used by a Dentist or A Dental Hygienist for cleaning procedures on teeth.

Disposable Prophy Angle

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets such criteria.

The document is an FDA 510(k) clearance letter for a device called "Disposable Prophy Angle Project's 020,021." This letter confirms that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices.

The letter explicitly states that the FDA's issuance of a substantial equivalence determination "does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies." It focuses on regulatory compliance rather than performance data or study results.

Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

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The Premium Plus Disposable Prophy Angle Model 3399 is intended to be attached to a low speed dental handpiece and used by professional dentists and dental hygienists for polishing and cleaning the surface of teeth. The Premium Plus Disposable Prophy Angle is intended for single use, thus eliminating the possibility of cross contamination. It is intended to be used for a single patient and should be discarded after each patient.

Not Found

I apologize, but this document is a 510(k) clearance letter from the FDA for a dental device (Premium Plus Disposable Prophy Angle). It does not contain information about the acceptance criteria or a study that proves the device meets acceptance criteria in the context of an AI/ML-based medical device.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for training and test sets. This document is not relevant to those types of inquiries for AI/ML devices.

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The DR Disposable Prophy Angle is a device intended to be attached to a low speed dental handpiece and used by professional dentists and dental hygienists for polishing and cleaning the surface of teeth. The DR Disposable Prophy Angle is intended for single use, thus eliminating the possibility of cross contamination.

The DR Disposable Prophy Angle is a dental device that consists of a pair of gears, a turning spindle and a drive spindle enclosed in a plastic housing, that connects to a low speed dental handpiece. The turning spindle has a prophylaxis cup attached to the end which holds dental tooth polishing paste.

Here's an analysis of the provided text regarding the DR Disposable Prophy Angle, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantitative acceptance criteria for the DR Disposable Prophy Angle. Instead, it relies heavily on demonstrating substantial equivalence to a predicate device (Oral-B Disposable Prophy Angle W/Prophy Cup, K932990) by comparing various characteristics.

The "acceptance criteria" can be inferred as matching or being equivalent to the predicate device in the following categories:

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

The provided text does not describe an explicit test set or sample size for testing the DR Disposable Prophy Angle. The submission is a 510(k) Premarket Notification, which often relies on demonstrating substantial equivalence to a legally marketed predicate device rather than extensive new clinical trials or performance studies for low-risk devices like this.

There is no mention of "country of origin of the data" or whether data was "retrospective or prospective" because an independent study with a test set, in the traditional sense, was not the primary basis of this submission. The comparison is based on the characteristics of the devices.

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

This information is not applicable as there was no explicit "test set" and "ground truth" derived from expert consensus described in the submission for performance evaluation. The "ground truth" for the predicate device's characteristics would have been established during its own regulatory review, or by industry standards and common knowledge for such a device.

4. Adjudication Method for the Test Set

This information is not applicable as no test set requiring adjudication is described.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described in this submission. This type of study is more common for diagnostic imaging AI devices, not for a mechanical dental instrument like a prophy angle.

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

This question is not applicable as the device is a mechanical dental instrument and does not involve any algorithms or artificial intelligence.

7. The Type of Ground Truth Used

The "ground truth" implicitly used for this 510(k) submission is the established performance and safety characteristics of the predicate device, based on its prior market clearance (K932990) and general industry understanding of dental prophy angles. The argument is that the new device shares the "same intended use, performance and safety characteristics" as the predicate.

8. The Sample Size for the Training Set

This question is not applicable as the device does not involve algorithms or AI that would require a training set.

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

This question is not applicable for the same reason as #8.

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ProAngle™ disposable prophy angle is a device intended to polish and clean the surface of teeth. It should be attached to a low speed handpiece for operation.

ProAngle™ disposable prophy angle is a device used for polishing and cleaning the surface of teeth. It consists of a pair of gears, a turning spindle and a drive spindle which can connect the low speed handpiece. The turning spindle has a prophylaxis cup on it for polishing or cleaning teeth.

The provided text is a 510(k) summary for a dental device, the "ProAngle™ disposable prophy angle." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria for device performance in the way a clinical trial for a diagnostic AI device would.

Therefore, many of the requested categories for a clinical study with acceptance criteria simply do not apply to this type of submission.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding specific performance, the document describes the device's function: "It consists of a pair of gears, a turning spindle and a drive spindle which can connect the low speed handpiece. The turning spindle has a prophylaxis cup on it for polishing or cleaning teeth." The intended use is "for polishing and cleaning teeth." No specific quantitative performance metrics (e.g., polishing efficiency, wear resistance, noise levels) are provided or required for this type of submission focused on substantial equivalence to a well-established device type. |

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

This information is not applicable and not provided in the 510(k) summary. A 510(k) for a Class I device like this typically relies on a comparison to a predicate device and adherence to general controls, not on a new clinical study with a test set of patients or data. The "test set" in this context is the comparison between the new device's design/function and the predicate device's design/function.

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. No "ground truth" establishment by experts in a clinical study context is described or required for this 510(k) submission focused on substantial equivalence of a general dental tool. The "ground truth" for the predicate device's safety and effectiveness would have been established historically through its prior marketing and use.

4. Adjudication Method for the Test Set

This information is not applicable. No adjudication method is described as there isn't a "test set" in the context of a clinical performance study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable. This device is a manual dental tool, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study and AI-related effect sizes are entirely irrelevant.

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

This information is not applicable. The device is a physical dental tool, not an algorithm, so a standalone algorithm performance evaluation is not relevant.

7. The Type of Ground Truth Used

This information is not applicable in the context of a clinical "ground truth" from pathology or outcomes data. The "ground truth" for this 510(k) is the established safety, effectiveness, and intended use of the predicate device (Allpro, Inc., Disposable prophy angle) as determined by its prior marketing clearance. The new device is simply confirming it matches this established "ground truth."

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" for an algorithm or a clinical study mentioned in this 510(k) submission.

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

This information is not applicable. As there is no training set mentioned, the method for establishing its ground truth is also not mentioned.

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The device is a plastic disposable attachment for use in conjunction with a slow speed handpiece, used during the professional prophylaxis treatment of patient's teeth by a dentist or hygienist.

Our disposable prophylaxis angle is intended as a single use device used by a Dental Professional, either a Dentist or a Dental Hygienist to assist in the cleaning process of patient's teeth. It is intended for a single patient and should be discarded after each patient.

Plastic disposable item comprising a housing (body) that holds two plastic shafts aligned at 90 degrees (right angle) to each other that rotate a cup or brush.

Plastic one-piece housing (outer body) holding 2 internal shafts aligned at 90 degree (right angle) to each other. Tip fitted with a rubber cup or brush to clean teeth.

This document describes the St. George Technology, Inc. Perfection Plus Disposable Prophy Angles and their substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the way it would for AI/ML performance. Instead, the testing described appears to be for mechanical and functional evaluation of the device.

• Sample Size: Not explicitly stated. The document mentions "extensively tested in in-vitro environments."
• Data Provenance: The tests were conducted in "in-vitro environments," meaning in a laboratory setting, rather than on human subjects or with clinical data. The country of origin for the data is not specified beyond St. George Technology, Inc. being a US-based company. The data is retrospective in the sense that it evaluates the manufactured device.

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

This information is not applicable. The study is a non-clinical performance evaluation of a medical device, not an AI/ML study requiring expert ground truth for classification or diagnosis.

4. Adjudication Method for the Test Set

This information is not applicable for this type of non-clinical device performance study.

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

No. This document describes a non-clinical performance study of a physical medical device (disposable prophy angles), not an AI/ML system. Therefore, an MRMC study and the concept of human readers improving with AI assistance are not relevant.

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

No. This document pertains to a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this study is the observed performance characteristics of the predicate device and the St. George Technology device under defined in-vitro testing conditions. This includes measurements of fit, wear, duration of performance, strength, and durability. It is based on objective, quantifiable physical properties rather than expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

This information is not applicable. This is a medical device performance study, not an AI/ML study that uses a "training set."

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

This information is not applicable. As stated above, there is no "training set" in the context of this device performance study.

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For one time use as part of a professionally administered prophylaxis treatment, to clean and polish teeth.

The device is a disposable dental prophylaxis angle which consists of a plastic body integrally formed with a drive mechanism, and a rubber cup that attaches to a retention knob or stud on the angle. The prophy angle has a slot for connecting the angle to a dental handpiece, which powers the prophy angle. The drive shaft of the prophy angle allows the rubber prophy cup to rotate.

The provided text describes a 510(k) premarket notification for a dental prophylaxis angle. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with explicit acceptance criteria and performance metrics. Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in the given document.

However, based on the information provided, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

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

This document does not describe a clinical "test set" in the context of typical algorithm evaluation. The safety assessment relied on a retrospective review of existing Medical Device Records (MDRs).

• Sample Size: Over 200 MDRs filed with CDRH between 1992 and 1996 for prophy angles. This is not a direct test set for the Pro-Flex™ device itself, but rather a review of adverse events for similar devices.
• Data Provenance: The MDRs were "filed with CDRH" (Center for Devices and Radiological Health), implying a national/international scope as reported to the FDA in the USA. The data is retrospective.

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

Not applicable. The safety assessment involved a review of adverse event reports, not an expert panel establishing ground truth for a test set in a typical clinical study.

4. Adjudication Method for the Test Set

Not applicable. There was no explicit "adjudication method" for a test set. The review involved an analysis of reported incidents in MDRs.

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 medical device (dental prophylaxis angle), not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance is irrelevant.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the safety assessment, the "ground truth" was based on reported adverse events and malfunctions documented in Medical Device Records (MDRs). For the effectiveness, the claim of "substantial equivalence" implies that the new device is functionally identical to the predicate device, which is presumably safe and effective based on its prior market clearance.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is a physical medical device following a 510(k) pathway, not an AI/machine learning model.

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

Not applicable. No training set was used.

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The TWISTT.M. (Recioprocating Disposable Prophy Angle) is indicated for teeth cleaning/ polishing.

TWIST RECIPROCATING DISPOSABLE PROPHY ANGLE

This is a 510(k) clearance letter for a medical device called the "Twist Reciprocating Disposable Prophy Angle." This document primarily deals with regulatory approval based on substantial equivalence to a predicate device, rather than providing detailed performance study data against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and ground truth establishment is not present in this type of regulatory document.

However, based on the provided text, I can infer the following:

1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The letter states that the FDA "reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976." This implies that the 'acceptance criteria' were met through a demonstration of substantial equivalence to a legally marketed predicate device, rather than through specific performance metrics outlined in this letter.

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. 510(k) summaries might sometimes contain summaries of performance data, but this specific clearance letter does not.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable/provided in the document. The device is a "Reciprocating Disposable Prophy Angle" which is a dental instrument, not an AI-assisted diagnostic tool that would typically involve a multi-reader multi-case study with human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided in the document. This device is a physical dental instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided in the document. For a physical device like this, performance testing might involve mechanical durability tests, biocompatibility tests, or efficacy studies for teeth cleaning/polishing, but the details of such tests or their 'ground truth' are not in this letter.

8. The sample size for the training set
This information is not provided in the document.

9. How the ground truth for the training set was established
This information is not provided in the document.

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