(270 days)
The Integral Dental Unit is intended to supply power to and serve as a base for dental devices and accessories. This device includes a dental chair and is intended for use in the dental clinic environment and is designed for use by trained dental professionals, dentists and/or dental assistants.
The Integral Dental Unit (Model: YD-A4) is a dental operative unit specially designed and provided for a qualified dentist to be used in a professional clinic or hospital facility to carry out dental procedures.
Integral Dental Unit is intended to be used in a professional environment for dental diagnosis, treatment, or operation.
It includes a treatment chair, dentist element, assistant element and a dental light as offering several additional options and electronically-controlled chair movements with software and water/air unit functions.
The dental unit consists of an electronically operated dental chair and integrated control unit control for electricity, water and air supply to handpieces or some other dental instrument. The device is equipped with an instrument tray, pipes for water supply and tube air supply, a mouth lamp, a saliva aspirator, a spittoon, a three-way syringe, a film viewer, a foot switch and chair with driving motors and armrest.
The dental chair is intended to be used with dental hand pieces, cure light, ultrasonic scaler, camera system or other doctor stool, which is not provided by the manufacturer. The user will select the dental instruments and accessories with FDA clearance by themself. So, the device in the submission does not include these parts and accessories. The connector standard type complies with ISO 9168.
Basic parameters/use conditions/power supply specifications is as follows:
◆Noise ＜70 dBA
◆Base box Power supply: 115/230 Vac, 50/60Hz, single-phase 3core, protective grounding.
Power input: 380 VA
Water filter hole diameter: 15 kPa;
- water pumping rate＞80 mL/min
Strong saliva:
- vacuum degree >25 kPa;
- water pumping rate＞1000 mL/min
◆Instrument tray Rotating angle: >270º
Up-down moving range: >440mm
Max. Load: 85 Ra
◆Foot switch Tripping force: >10N and 25 000 repeats
◆Dental chair Power supply: 24 V dc Inside power supply
Loading capacity: 1323N (about 135 Kg)
Loading capacity of headrest: 300N (about 30Kg)
Moving range of headrest: 120mm
Range of backrest when going backwards: 90º~170º
Seat cushion's maximum height away from ground: 730mm
Seat cushion's minimum height away from ground: 450mm
Attachment
----- Amalgam separation device
It has a medical device product registration card
Attachment parameters are reflected in its operating instructions
◆Work space L: ≥3 000 mm; W: ≥2 000 mm; H: ≥2 500 mm
◆Environment for operation
Temperature: +5°C to +40°C
Relative humidity: 30% - 80%
Atmospheric pressure: 86kPa ~ 106kPa
The provided FDA 510(k) clearance letter pertains to the Integral Dental Unit, a Class I medical device. This device is an "Operative Dental Unit and Accessories" and is intended to supply power to and serve as a base for other dental devices and accessories, including a dental chair, for use by trained dental professionals in a dental clinic environment.
The document states that clinical performance testing was not performed for this device. As such, information regarding acceptance criteria derived from a clinical study, sample size for test sets (including data provenance, ground truth establishment, expert qualifications, and adjudication methods), MRMC studies, or standalone algorithm performance, and training set details are not provided in this submission.
Instead, the device's acceptance criteria are based on conformance to established international standards for electrical safety, electromagnetic compatibility, biocompatibility, software verification and validation, software life cycle processes, and general performance for stationary dental units and dental patient chairs.
Here's the information extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Category / Specific Parameter | Acceptance Criteria (Standard / Pre-defined Value) | Reported Device Performance (Reference to Standard Conformance) |
|---|---|---|
| Electrical Safety | IEC 60601-1:2012 | Complied with IEC 60601-1 |
| Electromagnetic Compatibility | IEC 60601-1-2:2014 | Complied with IEC 60601-1-2 |
| Biocompatibility | ISO 10993-1:2018 | Complied with ISO 10993-1 |
| Software Verification & Validation | FDA "Guidance for Premarket Submissions and for Software Contained in Medical Devices" | Complied with FDA Guidance |
| Software Life Cycle Processes | IEC 62304:2006+AMD1:2015 | Complied with IEC 62304 |
| Performance - General Requirements (Dental Unit & Patient Chair) | ISO 7494-1:2018 | Complied with ISO 7494-1 |
| Performance - Air, Water, Suction & Wastewater Systems | ISO 7494-2:2018 | Complied with ISO 7494-2 |
| Noise | 15 kPa | > 15 kPa |
| Saliva ejector - Weak saliva water pumping rate | > 80 mL/min | > 80 mL/min |
| Saliva ejector - Strong saliva vacuum degree | > 25 kPa | > 25 kPa |
| Saliva ejector - Strong saliva water pumping rate | > 1000 mL/min | > 1000 mL/min |
| Instrument tray - Rotating angle | > 270º | > 270º |
| Instrument tray - Up-down moving range | > 440mm | > 440mm |
| Instrument tray - Max. Load | 85 Ra | > 85 Ra |
| Foot switch - Tripping force | > 10N and 10N and 25 000 repeats | > 25 000 repeats |
| Dental chair - Power supply | 24 V dc Inside power supply | 24 V dc Inside power supply |
| Dental chair - Loading capacity | 1323N (about 135 Kg) | 1323N (about 135 Kg) |
| Dental chair - Loading capacity of headrest | 300N (about 30Kg) | 300N (about 30Kg) |
| Dental chair - Moving range of headrest | 120mm | 120mm |
| Dental chair - Range of backrest when going backwards | 90º~170º | 90º~170º |
| Dental chair - Seat cushion's maximum height away from ground | 730mm | 730mm (Predicate: 795±10mm) |
| Dental chair - Seat cushion's minimum height away from ground | 450mm | 450mm (Predicate: 365±10mm) |
| Work space - Length | ≥ 3 000 mm | ≥ 3 000 mm |
| Work space - Width | ≥ 2 000 mm | ≥ 2 000 mm |
| Work space - Height | ≥ 2 500 mm | ≥ 2 500 mm |
| Environment for operation - Temperature | +5°C to +40°C | +5°C to +40°C |
| Environment for operation - Relative humidity | 30% - 80% | 30% - 80% |
| Environment for operation - Atmospheric pressure | 86kPa ~ 106kPa | 86kPa ~ 106kPa |
| Air Pressure (Comparison to Predicate) | 0.6MPa～0.80 MPa | 0.6MPa～0.80 MPa (Predicate: 500kPa(min)/750kPa(max)) |
| Water Pressure (Comparison to Predicate) | 0.20 MPa ～0.40 MPa | 0.20 MPa ～0.40 MPa (Predicate: 250kPa(min)/600 kPa(max)) |
2. Sample size used for the test set and the data provenance
Not applicable. Clinical performance testing was not performed. The testing conducted was primarily engineering and bench testing against recognized standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically understood for clinical studies (e.g., expert interpretation of medical images) was not established. Performance was assessed against engineering specifications and international standards by relevant testing laboratories.
4. Adjudication method for the test set
Not applicable. No expert review or adjudication method was described as clinical performance testing was not performed.
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. No MRMC study was conducted as this device is an Integral Dental Unit, not an AI-assisted diagnostic or therapeutic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or AI system.
7. The type of ground truth used
The "ground truth" for this device's performance is based on conformance to international engineering and safety standards (e.g., IEC, ISO) and the device's adherence to its own design specifications and functional parameters. There is no clinical "ground truth" derived from patient outcomes or expert consensus in this submission.
8. The sample size for the training set
Not applicable. This is not an AI/Machine Learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/Machine Learning device.
§ 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.