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The intended use of the Lotus Prophy Angle is for polishing and cleaning teeth.

Lotus 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.

Lotus Prophy Angle is intended for single use only and is provided aseptic in sealed packaging to be prevent contamination.

The provided text is a 510(k) summary for the Lotus Prophy Angle, a Class I medical device (dental handpiece and accessories). This type of device is a physical tool and does not involve AI, software, or algorithms that would require the creation of a ground truth, training data, or a test set as described in your request. The acceptance criteria and performance studies are focused on physical characteristics and safety, not diagnostic accuracy or AI performance.

Therefore, many of the requested fields are not applicable to this type of device. I will address the applicable parts of your request based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

| Acceptance Criteria (from ANSI/ADA Specification No. 85-1 for Disposable Prophy Angles) | Reported Device Performance |
|------------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Speed | Performance details not provided. Tested to meet ANSI/ADA Spec No. 85-1 for Disposable Prophy Angles. | Specific quantitative acceptance criterion is not detailed in this document, but implied compliance with ANSI/ADA Spec No. 85-1. |
| Load | Performance details not provided. Tested to meet ANSI/ADA Spec No. 85-1 for Disposable Prophy Angles. | Specific quantitative acceptance criterion is not detailed in this document, but implied compliance with ANSI/ADA Spec No. 85-1. |
| Temperature Rise | Performance details not provided. Tested to meet ANSI/ADA Spec No. 85-1 for Disposable Prophy Angles. | Specific quantitative acceptance criterion is not detailed in this document, but implied compliance with ANSI/ADA Spec No. 85-1. |
| Vibration Analysis | Performance details not provided. Tested to meet ANSI/ADA Spec No. 85-1 for Disposable Prophy Angles. | Specific quantitative acceptance criterion is not detailed in this document, but implied compliance with ANSI/ADA Spec No. 85-1. |

Study Details (as per document):

The document states: "The subject Lotus Prophy Angle is identical in every way to the previously cleared ProAngle™ Disposable Prophy Angle (K030603). Therefore, all previous testing performed on the ProAngle™ Disposable Prophy Angle is applicable to the subject device. The following confirmatory testing was performed on the subject device in accordance with ANSI/ADA Specification No. 85-1 - Disposable Prophy Angles: Speed, Load, Temperature Rise, and Vibration Analysis."

This implies that instead of full, new performance studies demonstrating quantitative measurements, the primary "proof" of meeting acceptance criteria relies on substantial equivalence to a predicate device (ProAngle™ Disposable Prophy Angle, K030603) and confirmatory testing to verify this equivalence.

Based on the provided document, the following points are largely N/A (Not Applicable) or cannot be determined for the reasons explained:

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

• N/A. This device is a physical dental instrument, not an AI/software device that uses data for a "test set" in the context of diagnostic performance. The "testing" mentioned refers to physical performance characteristics. The document does not specify sample sizes for these physical tests or data provenance beyond stating compliance with a standard.

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)

• N/A. This concept is not applicable to a physical dental prophy angle. There is no diagnostic "ground truth" to establish by experts for this type of device.

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

• N/A. Adjudication methods are used to establish ground truth in diagnostic studies, which is not relevant for this physical device.

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

• N/A. This is a physical device, not an AI system. MRMC studies are not applicable.

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

• N/A. This is a physical device, not an algorithm.

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

• N/A. As mentioned, "ground truth" as it pertains to diagnostic accuracy is not relevant for a physical dental instrument. The "truth" here is compliance with engineering standard specifications.

8. The sample size for the training set

• N/A. There is no "training set" for a physical device in the AI/machine learning sense.

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

• N/A. See point 8.

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The MIDWEST® RDH Freedom® Cordless Prophy System with SmartMode™ is a high-performance cordless prophylaxis handpiece with an optional wireless foot pedal for use with NUPRO Freedom® disposable prophy angles in a hygiene operatory to perform cleaning and polishing procedures on teeth.

The proposed device, MIDWEST® RDH Freedom® Cordless Prophy System with SmartMode™ Technology, is a cordless handpiece which is intended for use by a dental clinician during dental cleaning and polishing procedures. The proposed device, MIDWEST® RDH Freedom® Cordless Prophy System with SmartMode™ Technology, is comprised of an electric motor-driven prophylaxis cordless handpiece (consisting of an inner module and outer sheath), a direct current (DC) powered charging base for cordless handpiece, cradle for cordless handpiece, direct current (DC) power supply and cord, and uses proprietary disposable prophy angles (DPAs). The proposed device, MIDWEST® RDH Freedom® Cordless Prophy System with SmartMode™ Technology, uses a USB mini connector to provide battery charging power to the charging base for the cordless handpiece and operates using Bluetooth low energy (BLE) wireless radio frequency. An optional wireless foot pedal is sold separately.

This document describes the Dentsply Sirona MIDWEST® RDH Freedom® Cordless Prophy System with SmartMode™ Technology (K160825), a dental handpiece used for cleaning and polishing teeth. The submission compares this new device to a predicate device, the MIDWEST® RDH Freedom® Cordless System (K110753).

Acceptance Criteria and Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data. It does not explicitly state acceptance criteria in a quantitative, pass/fail manner for features beyond "Pass," but rather compares performance to the predicate device and internal Dentsply Professional test methods.

Study Information:

1. Sample Size used for the test set and the data provenance:
   The document does not specify exact sample sizes for the non-clinical performance tests. It mentions "multiple professional evaluations with typodonts" for the clinical performance section, but does not quantify the number of typodonts or treatments. The data provenance is internal to DENTSPLY Professional ("DENTSPLY Professional Internal Test Method"). The studies are effectively prospective as they were conducted to test the performance of the proposed device. The country of origin is not explicitly stated but can be inferred as the US, given the FDA submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   The document states that "Professional evaluations were conducted considering the proposed device intended use, users, and use environments. All studies were completed by practicing registered dental hygienists." The number of dental hygienists is not specified, nor are their exact qualifications beyond "practicing registered dental hygienists."

3. Adjudication method for the test set:
   The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for the non-clinical or clinical performance evaluations. The results are presented as "Pass" based on internal test methods, implying a direct comparison to pre-defined technical specifications or successful operation.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
   No MRMC comparative effectiveness study was done. This device is a dental handpiece, not an AI-powered diagnostic tool, so such a study would not be applicable. The "SmartMode™ Technology" refers to an automated control mechanism based on force applied, not an AI feature involving human "readers" or diagnostic improvement.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   The non-clinical performance tests described, particularly those for SmartMode™ functionality, speed, and torque, represent a form of standalone performance evaluation of the device's automated capabilities. These tests verify the device's technical specifications and how it responds to various inputs (e.g., applied force, different DPAs).

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the non-clinical tests, the "ground truth" is based on internal engineering specifications and standards (e.g., "meet specifications," "acceptable per design specifications," "fluid does not accumulate"). For the "clinical human factor validations," the "ground truth" seems to be the absence of "unacceptable risks or unacceptable use related hazards related to SmartMode™ Technology" as assessed by practicing registered dental hygienists. This implies an expert assessment of performance and safety on typodonts.

7. The sample size for the training set:
   Not applicable. This is a medical device clearance, not an AI model requiring a training set. The "SmartMode™ Technology" is described as a control mechanism, not a learned AI algorithm.

8. How the ground truth for the training set was established:
   Not applicable, as there is no training set for an AI model.

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