(273 days)
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.
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.