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The EVO 450 series is the air-powered dental handpiece which is used by trained dental professionals for removal of carious material, cavities, crown preparations and as a surgical tool for impacted third molar removal and periodontal procedures.

The EVO 450 series High Speed Handpieces are similar to other high-speed dental handpieces currently on the US dental market in design, function, and intended use. The devices are air-powered handpieces that are reusable, ergonomically shaped, and are provided both with and without a fiber optic light system. Several models could be connected to couplings of manufacturers including TTBIO, KaVo, NSK Mach, Sirona, and Star. Others could be connected to hose connectors type 2 or type 3 according to ISO 9168:2009 Dental handpieces-Hose connectors for air driven dental handpieces. The EVO 450 series High Speed Handpieces will be supplied with water, air and light through the tube and the coupling of a dental treatment unit. For proper operation, make sure that the supply of cooling air is dry, clean and uncontaminated. Make sure that air is not emitted in the direction of the bur. After each patient use, disinfect the tubing waterlines including the handpiece waterlines by flushing with cleaning water to prevent cross-contamination according to handpiece waterlines disinfection procedure of main dental unit.

This looks like a submission for a 510(k) premarket notification for a medical device. The document states that the EVO 450 series High Speed Handpieces are substantially equivalent to the predicate device, Maxima PRO2 45L (K141576). It does not contain information about the acceptance criteria or a study that proves the device meets the acceptance criteria in the format you requested, specifically regarding AI/algorithm performance.

The provided document describes a medical device (dental handpiece), not an AI/ML powered device. As such, the concept of "acceptance criteria" and "study proving the device meets the acceptance criteria" as typically applied to AI/ML devices (e.g., performance metrics like sensitivity, specificity, AUC compared to a pre-defined threshold) is not present here.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device, which is the regulatory pathway for this type of medical device. This involves comparing the new device to a legally marketed predicate device in terms of:

• Intended Use: Both devices are high-speed, air-powered dental handpieces for specific dental procedures.
• Technological Characteristics: Comparison of physical attributes, materials, operating principles, and performance specifications.
• Safety and Effectiveness: Demonstrated through compliance with recognized standards and non-clinical testing.

Here's an analysis of the provided information in relation to your questions, noting the context of a non-AI medical device:

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

   • Acceptance Criteria (Implicit for Substantial Equivalence): The implicit acceptance criteria here are that the proposed device (EVO 450 series) is substantially equivalent to the predicate device (Maxima PRO2 45L) in terms of safety and effectiveness, based on similar intended use and technological characteristics. This is demonstrated through direct comparison and adherence to standards.
   • Reported Device Performance: The "Summary Table of Substantial Equivalence" on pages 4 and 5 directly compares the proposed device's characteristics against the predicate device. This serves as the reported performance, showing that the device's specifications (e.g., speed, operation pressure, materials) are comparable or within acceptable ranges relative to the predicate and relevant standards.

   Table of Comparison (derived from the document):

   Descriptive Information	Proposed Device (EVO 450 series)	Predicate Device (Maxima PRO2 45L K141576)	Comparison/Comment
   Indication for use	Removal of carious material, cavities, crown preparations, surgical tool for impacted third molar removal and periodontal procedures.	Removal of carious material, cavities and crown preparations, removal of filings, processing of tooth, restoration of surfaces and as a surgical tool for third molar removal procedures.	Substantially similar.
   Principle of operation	Air-powered turbine, cooling water, optional light system.	Air-powered turbine, cooling water, light system.	Identical mechanism.
   Water ports	Four	One	Differs but does not raise new safety or effectiveness questions.
   Fiber optics	With and without fiber-optic glass rod built-in light system	With built-in light system	Option for both, similar technology.
   Light intensity on input side	N/A	Approx. 25000 Lux	Not directly comparable, but presence of light system is noted.
   Head Dimensions	Φ10.5×H12.5mm	Φ12.5×H14.6mm	Slight dimensional difference, but within a functional range.
   Type of chuck	Push button locking chuck	Identical	Identical.
   Materials of body of the device	Stainless steel	Stainless steel	Identical.
   Bur retention force	Up to 24 N-cm	Identical	Identical (implied, as no difference noted).
   Operation pressure	2.0-3.0 bar	2.75±0.1 bar	Overlapping range.
   Speed	360,000~440,000 rpm	380,000~420,000 rpm	Overlapping range.
   Conformance with standards for shank	Ø1.59mm~1.60 mm	Identical	Identical (implied, as no difference noted).
   Head angle	45-degree	Identical	Identical.
   Compliance to Standards	ISO 14457:2017, ISO 9168:2009	ISO 14457:2012, ISO 9168:2009	Both comply with relevant standards (new device with updated version for one).
   Sterilization Method	Steam Autoclave (Moist Heat)	Steam Autoclave (Moist Heat)	Identical.
   Sterilization Standard	ISO 17665-1:2006	ISO 17665-1:2006	Identical.

2. Sample sized 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 and not provided in the context of a 510(k) submission for this type of device. The "testing" refers to non-clinical bench testing and adherence to standards, not a patient-based test set or clinical trial data collection.

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. This device is not an AI/ML diagnostic tool requiring expert ground truth for image or data interpretation. Performance is assessed through engineering specifications and compliance with standards.

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

   • Not applicable. There is no "test set" in the sense of clinical cases or data requiring adjudication.

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 document is for a dental handpiece, not an AI-assisted diagnostic or therapeutic 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 algorithm.

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

   • Not applicable in the context of an AI/ML algorithm. For this device, "ground truth" relates to engineering specifications verified through testing and adherence to established industry standards (e.g., ISO for dental handpieces, sterilization, biocompatibility).

8. The sample size for the training set

   • Not applicable, as this is not an AI/ML algorithm development.

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

   • Not applicable, as this is not an AI/ML algorithm development.

In summary: The provided document is a 510(k) summary for a conventional medical device (a dental handpiece). It focuses on demonstrating substantial equivalence to a predicate device through comparison of features and adherence to non-clinical performance standards. It does not involve AI/ML technology, and therefore, the questions related to AI/ML specific acceptance criteria, study design, and ground truth establishment are not addressed or applicable in this context.

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