(51 days)
The UNICLINE MOBILE is an electrically powered, self-contained mobile dental operative unit intended to supply power to and serve as a base for other dental devices and instruments. The system is indicated for performing general dental procedures. The device is intended for operation and use in a clinical setting by legally qualified professionals.
The new UNICLINE MOBILE is an electrically powered, self-contained mobile dental operative unit consisting of a mobile cart, foot control, internal water supply containers, suction, and mobile patient chair. It contains a foot control that allows the dental professional to engage the features using only the foot. Instrument status is viewable in a single place using a multi-display feature. The instrument arms are spring balanced for ease of use and the extra long connection hoses have been designed for use in any position. The new UNICLINE MOBILE is designed to ensure patient comfort and safety in any of the chair positions. The handles, instrument support, and upholstery are easy to disassemble and clean. The unit uses compressed air and water, and includes a suction element. The cart contains the motors that operate the instrument connections. There are two movable arms that protrude from the top of the cart. One arm contains the optional OEM dental operating lamp that the dentist can position to light the area being worked on. The other arm supports an instrument table. The table contains five spring-loaded smaller arms, an instrument tray, and the instrument display. The new UNICLINE MOBILE spring-loaded arms connect with OEM dental instruments and provide power to them. Once connected, the display indicates whether the air and water spray are on, the time, and the speed of the active motor. The display also includes a timer for use with a light polymerization instrument. The dental professional uses the foot control to operate all functions and instruments of this dental operative unit. The unit was designed for mobility and ease of positioning. The cart is made of fire retardant medium density fiberboard (MDF) coated with paint and its two arms are made of anodized, lacquered aluminum. All selected materials are biocompatible. The chair is made with casted aluminum and imitation leather upholstery. Both the cart and chair contain wheels on one side to allow each piece to be positioned for optimal use of available floor space before connecting via the stabilizing plate.
The provided document is a 510(k) summary for the UnicLine Mobile dental operative unit. It focuses on demonstrating substantial equivalence to a predicate device, the Aseptico AMC 20 Mobile Dental System, rather than providing a detailed study proving the device meets specific acceptance criteria through clinical performance.
Therefore, many of the requested elements for a study proving acceptance criteria will not be present in this type of submission. The document mainly discusses compliance with recognized standards and a comparison of features with a predicate device.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of acceptance criteria with corresponding performance metrics in the way a clinical study would for efficacy. Instead, it demonstrates compliance with recognized non-clinical performance standards and compares its features to a predicate device.
| Acceptance Criteria (based on standards/comparison) | Reported Device Performance (Compliance/Similarity) |
|---|---|
| Non-Clinical Performance Data | |
| IEC 60601-1 (General safety) | Device complies with this standard. |
| IEC 60601-1-2 (EMC) | Device complies with this standard. |
| IEC 60601-1-6 (Usability) | Device complies with this standard. |
| IEC 62366 (Usability Engineering) | Device complies with this standard. |
| IEC 80601-2-60 (Dental equipment specific safety) | Device complies with this standard. |
| ISO 7494-2 (Water & air supply) | Device complies with this standard. |
| ISO 7494-1 (General requirements & test methods) | Device complies with this standard. |
| ISO 21530 (Resistance to chemical disinfectants) | Device complies with this standard. |
| ISO 6875 (Patient Chair) | Device complies with this standard. |
| Biocompatibility | |
| Direct patient contacting materials | Biocompatible (upholstery same as reference device K081699). |
| Indirect patient contacting materials | Comply with 21 CFR 177.2600. |
| Software | |
| FDA Guidance for Premarket Submission for Software | Software validated and complies with guidance. |
| IEC 62304 (Software life cycle) | Software validated and complies with this standard. |
| Comparison to Predicate Device | |
| Indications for Use | Similar - no new question of safety and effectiveness. |
| Product Code, Regulation Number, Name | Same. |
| Intended Users, Environment of Use | Same. |
| Protection Class, Degree of Protection | Same. |
| Power Supply | Similar - no new question of safety or effectiveness. |
| Frequency | Same. |
| Utility Supply | Same. |
| Electrical Safety, EMC, Display | Same. |
| Materials | Similar - no new question of safety or effectiveness (Fire retardant MDF. Aluminum vs. Stainless Steel, Aluminum, Plastic). |
| Dimensions, Weight | Similar - no new question of safety or effectiveness. |
| Features | Differences noted (optional lamp, instrument arm mounting to chair) but explained as not raising new questions of safety or effectiveness. |
| Air Pressure | Same. |
| Water Supply - Flow Rate | Same (0.15 liter/min). |
| Suction Connection - Flow Rate | Similar - no new question of safety or effectiveness (67.0 - 80.0 Liters/Min vs. 42.3 – 189.7 liters/min). |
The "study" that proves the device meets requirements is the set of non-clinical performance bench tests detailed above, which verified compliance with relevant IEC and ISO standards.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable in the context of this 510(k) summary. The "test set" for the non-clinical performance and engineering tests would be the device itself or components of the device. These tests are conducted on the manufactured product to verify design specifications and compliance with standards.
- Data Provenance: The tests are "Performance bench testing" which are conducted by the manufacturer, Heka Dental A/S (Denmark). The data would be prospective, as it's generated specifically for the submission.
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. For non-clinical performance and engineering tests against standards (e.g., electrical safety, EMC, material biocompatibility), the "ground truth" is adherence to the published specifications of those standards. This does not typically involve expert consensus on clinical cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 are used for clinical studies involving interpretation of medical images or patient outcomes, not for engineering bench tests.
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 device is a dental operative unit (hardware), not an AI-powered diagnostic or assistive tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a dental operative unit, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance tests, the "ground truth" is adherence to the specifications within the referenced international and national standards (e.g., IEC 60601-1, ISO 7494-2). For biocompatibility, it's compliance with 21 CFR 177.2600 and material equivalence to a known reference device. For software, it's compliance with FDA Guidance and IEC 62304.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.