(26 days)
The EVO 700 series High Speed Handpieces are designed for removing carious material, reducing hard tooth structure, cavity preparation and finishing tooth preparations/ restorations. The devices are only for dental handpieces treatment and used by a trained person in the field of dentistry.
EVO 700 series high speed handpiece, on the scope of 21 CFR 872.4200 Dental handpiece and accessories, product code EFB, is a modification from TTBIO's own legally market predicate device, EVO 500 series high speed handpiece, which is legally marketed on the US dental market per 510(k) clearance, No. K141183.
EVO 700 series high speed handpiece is air-powered dental handpiece that is reusable and ergonomically designed. The handpiece is connected to a dental tubing which delivers driving air, cooling air and water to the cutting bur area. Optional fiber optics deliver light to the cutting area.
This device is to be connected to dental unit and operated by qualified professional (dentist) in the clinic. EVO 700 series high speed handpiece can be connected to couplings that manufactured by TTBIO, KaVo® or NSK®. It is designed in accordance with FDA Recognized Consensus Standards of device-specific guidance document, ISO 14457:2017 Dentistry - Handpieces and motors to ensure its safety and effectiveness and follows ISO 13485:2016 Medical devices – Quality management systems – Requirements for requlatory purpose regarding to the internal design change control procedure to complete the device design steps.
EVO 700 series high speed handpiece is supplied as non-sterile and can be sterilized by gravity-displacement method, at 132°C for 15 minutes and drying for 30 minutes, and dynamic-air-removal (prevacuum) method, at 134°C for 4 minutes and drying for 15 minutes.
The provided text is a 510(k) summary for the EVO 700 series High Speed Handpiece. This document is a premarket notification for a medical device seeking substantial equivalence to a predicate device, not a report of a study proving the device meets specific performance acceptance criteria through clinical trials or comprehensive algorithmic validation studies.
The document primarily focuses on demonstrating that the new device (EVO 700 series) is substantially equivalent to a previously cleared predicate device (EVO 500 series) based on similar indications for use, principle of operation, and technological characteristics.
Therefore, the information requested in your prompt regarding acceptance criteria, study design, sample sizes, expert ground truth establishment, MRMC studies, standalone performance, and training set details for AI/ML validation studies is not present in this document. This document is for a Class I dental handpiece, which typically does not require extensive clinical or AI/ML performance studies for 510(k) clearance, especially when demonstrating substantial equivalence to an existing predicate.
The "study" referenced in the document is effectively the comparison of the new device to the predicate device and verification that it meets relevant consensus standards (ISO 14457:2017, ISO 9168:2009, ISO 14971:2019, ISO 10993-1:2018).
Here's a breakdown of what is available and why the requested information is absent:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria (Implied): The acceptance criteria are implicitly that the EVO 700 series handpiece's characteristics (e.g., rotation speed, drive air pressure, bur retention force) are either identical or appropriately justified as similar to the predicate device and comply with relevant international standards (ISO 14457:2017).
- Reported Device Performance: The table on page 4-5 compares the subject device (EVO 700 series) to the predicate device (EVO 500 series) across various technical specifications. There are no performance metrics reported in terms of clinical outcomes or diagnostic accuracy, as this is a mechanical dental tool.
- Example from the document's comparison table (page 4-5):
Characteristic Acceptance Criteria (Predicate) Reported Performance (Subject Device) Rotation speed (rpm) T≥300,000, M≥350,000 T: 300,000 360,000, M: 350,000430,000Drive air pressure (bar) 2.6~3.0 2.6~3.0 Bur retention force Up to 24 N-cm Up to 24 N-cm Device standard ISO 14457:2012, ISO 9168:2009 ISO 14457:2017, ISO 9168:2009
- Example from the document's comparison table (page 4-5):
2. Sample size used for the test set and the data provenance
- Not applicable/Not provided. This is a comparison of device specifications and compliance with standards, not a clinical study or AI/ML performance test on a specific dataset. "Test set" in the context of AI/ML validation studies is not relevant here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. No "ground truth" to establish in the AI/ML sense. The "truth" is established by engineering specifications and compliance with recognized standards.
4. Adjudication method for the test set
- Not applicable/Not provided.
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 mechanical device, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a mechanical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the AI/ML sense. The "ground truth" for this device's safety and effectiveness is established through adherence to engineering standards (ISO 14457:2017, ISO 9168:2009) and the results of specific tests for biocompatibility (ISO 10993-1:2018) and risk management (ISO 14971:2019).
8. The sample size for the training set
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
Summary of what the document does describe as its "study":
The study to prove the device meets acceptance criteria is primarily a comparison and verification study based on engineering standards and design control activities.
- Comparison to Predicate: The document explicitly compares the EVO 700 series to the predicate EVO 500 series across numerous parameters (indications for use, principle of operation, rotation speed, pressures, bur dimensions, etc.).
- Compliance with Standards:
- ISO 14457:2017 Dentistry - Handpieces and motors: The device's design and performance are stated to be in accordance with this standard to ensure safety and effectiveness. The document addresses manufacturing tolerances for rotation speed as per the standard (Analysis 2).
- ISO 9168:2009: Also cited as a standard the device complies with.
- ISO 13485:2016 Medical devices – Quality management systems: Followed for internal design change control.
- ISO 14971:2019 Medical devices - Application of risk management to medical devices: Used for identifying and evaluating risks through Failure Modes and Effects Analysis (FMEA).
- ISO 10993-1:2018 Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process: Used to confirm biocompatibility of materials (specifically PEEK).
- Sterilization Validation: The document mentions the specified sterilization parameters (gravity-displacement and dynamic-air-removal methods) imply that these parameters have been validated to ensure the device can be properly sterilized for reuse.
In essence, for this Class I medical device, "acceptance criteria" are met by demonstrating substantial equivalence to a cleared predicate and compliance with relevant, recognized international consensus standards for safety and performance of dental handpieces. No clinical trial or AI/ML validation study, as detailed in your prompt, was conducted or required for this type of device clearance.
§ 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.