(214 days)
The Dental Unit is intended to supply power to and serve as a base for dental devices; and accessories. It is intended for use in the dental clinic /office environment and used by trained dentists and/or dental technicians and assistants. This product is attached with a dental chair.
The proposed devices Dental Unit are well equipped dental unit, which are intended to supply power to and serve as a base for dental devices and accessories. They are intended for use in the dental clinic/office environment and used by trained dentists and/or dental technicians and assistants. The products are attached with dental chair.
The proposed devices include two models. U300 and U500. Both of the two models mainly consist of instruments, instrument arm tray, cabinet group, operation light arm, assistant position, pedal switch, and patient chair.
The provided document is a 510(k) summary for a medical device called "Dental Unit." It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of document typically focuses on comparing the new device to existing ones based on technical specifications and safety standards, rather than clinical performance or diagnostic accuracy studies.
Therefore, the information regarding acceptance criteria and a study to prove the device meets these criteria is limited to non-clinical tests and compliance with safety and performance standards. There is no mention of studies involving human subjects, AI assistance, expert ground truth, or MRMC comparative effectiveness studies.
Here's the information extracted from the document:
1. A table of acceptance criteria and the reported device performance:
The document presents a comparison table between the proposed device (Dental Unit U300, U500) and the predicate device (Dental Unit with Chair S2310) across several technical characteristics and standards. The "acceptance criteria" can be inferred as compliance with the listed standards and achieving similar technical specifications to the predicate device.
| Item | Acceptance Criteria (Predicate) | Reported Device Performance (Proposed) |
|---|---|---|
| Product Code | EIA | EIA |
| Regulation No. | 21 CFR 872.6640 | 21 CFR 872.6640 |
| Class | 1 | 1 |
| Intended Use | Supply power to and serve as a base for dental devices; and accessories. Intended for use in dental clinic/office environment by trained dentists/technicians/assistants. Attached with a dental chair. | Same as predicate. |
| Operating Light | Halogen | LED |
| Connection Joint | Comply with ISO9168 | Comply with ISO9168 |
| Water Heating | Yes | No |
| Operation Method | Control Panel / Assistant Control Panel / Foot Controller | Control Panel / Assistant Control Panel / Foot Controller |
| Power Supply | 110V | 110V |
| Frequency | 50/60Hz | 50/60Hz |
| Power (with dental chair) | 900VA | 400VA |
| Pressure of Water Supply | 200 kPa ~ 400 kPa | 0.2MPa-0.4MPa (200 kPa - 400 kPa) |
| Pressure of Air Supply | ≥550 kPa | 0.55MPa (550 kPa) |
| Dental Chair Loading Capacity | 135Kg | 200kg |
| Dental Chair Movement Range (Chair) | 420-820 MM | 390mm-740mm |
| Dental Chair Movement Range (Backrest) | 0°~80° | 1°~70° |
| Dental Chair Movement Range (Headrest) | 200MM | 150mm |
| Accessories can be attached to the device | Handpiece / Scaler / Curing Light / Syringe | Handpiece / Scaler / Curing Light / Three-way-Syringe |
| Performance Standards | Comply with ISO7494-1, ISO7494-2 and ISO6875 | Comply with ISO7494-1, ISO7494-2 and ISO6875 |
| Rate of Water Suction (Suction) | ≥ 1L/min | 1 L/min |
| Rate of Water Suction (Silva Ejector) | > 750mL/min | 750ml/min |
| Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 |
| Patient Contact Material | PU, PVC, Polyamide, ABS, Stainless steel | Armrest: PU, Leather for patient chair: PVC, Syringe: Stainless steel, Tubes: TPU |
2. Sample size used for the test set and the data provenance:
The document describes non-clinical tests conducted to verify that the proposed device met design specifications and was substantially equivalent. It lists several international standards to which the device was tested for compliance (e.g., IEC 60601-1, IEC 60601-1-2, ISO7494-1, ISO7494-2, ISO 6875, ISO 10993-5, ISO 10993-10).
- Sample size: Not applicable in the context of clinical test sets as no clinical study is mentioned. The tests were likely performed on a limited number of device units (e.g., prototypes or production samples).
- Data provenance: Not explicitly stated as it's not a clinical data set. The tests were conducted by the manufacturer or accredited testing laboratories as part of verifying compliance with standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The "ground truth" for the non-clinical tests is established by the specified requirements of the international safety and performance standards themselves. There is no mention of experts establishing ground truth in a clinical sense.
4. Adjudication method for the test set:
Not applicable. This concept applies to clinical studies where different expert opinions on a case need to be resolved. For non-clinical device testing, the outcome is typically a pass/fail against a specific standard or specification.
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:
No, an MRMC comparative effectiveness study was not done. The device is a "Dental Unit," which is a physical piece of equipment for dental procedures, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
No, a standalone performance study in the context of an algorithm or AI was not done. The device is a traditional dental unit.
7. The type of ground truth used:
For the non-clinical tests, the "ground truth" is defined by the technical specifications outlined in the international standards (e.g., IEC 60601-1 for electrical safety, ISO7494-1 for general dental unit requirements, ISO 10993 for biocompatibility). The device either complies with these standards or it does not.
8. The sample size for the training set:
Not applicable. This device is not an AI/ML algorithm 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.