(243 days)
Diplomat dental operative units are self-contained dental treatment units that contain vacuum system and water supply and separate compressor placed outside the dental unit. These dental operative units are designed to provide air, water, vacuum and electricity to operate various dental hand-pieces, accessories and attachments, and to serve as a base for other dental devices and accessories. Diplomat dental operative units are offered with or without attached dental chairs. When supplied with a dental chair, the chair is intended to properly position a patient to perform different dental procedures. Diplomat dental operative units are to be operated and used by dentists and other legally qualified professionals, and are intended for use to provide general dental restorative care and hygiene procedures in both traditional dental office settings applications by or under the supervision of a licensed dentist or a hygienist if permitted by applicable law.
Diplomat dental operative units are modern, ergonomically designed, dental systems offered in a wide range of models depending on the specific end user requirements. Diplomat dental operative units are AC-powered devices that are intended to supply power to, and serve as a base for, other dental devices and accessories - such as hand-pieces, operating lights, curing lights, ultrasonic instruments, hygiene instruments, etc. - and deliver electric, air, water and vacuum power to them. Diplomat dental operative units are offered either with the patient dental chair or as a free-standing unit without the chair for those end-users with existing patient chairs that they want to use.
This document is a 510(k) summary for Diplomat Dental Operative Units. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for a new, innovative device feature. Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not explicitly present in the provided text.
Based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not present explicit acceptance criteria in the typical sense of quantitative targets for performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the "acceptance criteria" are implied by the demonstration of Substantial Equivalence to a legally marketed predicate device. This means the Diplomat Dental Operative Units are considered acceptable if they are as safe and effective as the predicate device (Sirona C8+Dental Operative Unit).
The table provided in the document compares various features of the Diplomat Dental Operative Units to the C8+Dental Operative Unit:
| Features | Diplomat Dental Operative Units | C8+Dental Operative Unit | Substantially Equivalent |
|---|---|---|---|
| 510(k) | Pending | K032543 | |
| Models | Adept Models: DA 380, DA 370, DA | ||
| 170, DA 130, DA 110; | |||
| Consul Models: DC 350, DC 310, DC | |||
| 180, DC 170 and DC orthodontic; and | |||
| Lux Models: DL 320, and DL 210 | Multiple versions | Similar | |
| Product Code | EIA | EIA | Same |
| Regulation Number | 872.6640 | 872.6640 | Same |
| Regulation Name | Unit, Operative, Dental | Unit, Operative, Dental | Same |
| Place of Use | Dental clinic | Dental clinic | Same |
| Intended Users | Dentists; assistants and hygienists | Dentists; assistants and hygienists | Same |
| Power Supply | 110V/(230 VAC) | ||
| 50/60 Hz | 110V/115V/127V/(230 VAC) | ||
| 50/60 Hz | Similar | ||
| Utility Supply | Compressed air and water | Compressed air and water | Same |
| Protection Class | Class 1 equipment | Class 1 equipment | Same |
| Degree of Protection | Type B of applied parts | Type B of applied parts | Same |
| Installation | Professionally installed; available | ||
| with chair and cart mounted | |||
| options. | Professionally installed; not available | ||
| with chair and cart mounted options. | Same | ||
| Air Pressure | $450 kPa/800 kPa$ (min./max.) | $550 kPa/750 kPa$ (min./max.) | Similar |
| Water Pressure | $300 kPa/600 kPa$ (min./max.) | $250 kPa/600 kPa$ (min./max.) | Similar |
| Electrical Safety | IEC 60601-1 | IEC 60601-1 | Same |
| EMC | EN 60601-1-2 | ||
| ISO 7494-1 | IEC 60601-1-2 | Similar | |
| Performance | Diplomat dental operative units | ||
| are self-contained dental | |||
| treatment units that contain | |||
| vacuum system and water supply | |||
| and separate compressor placed | |||
| outside the dental unit. These | |||
| dental operative units are designed | |||
| to provide air, water, vacuum and | |||
| electricity to operate various | |||
| dental hand-pieces, accessories | |||
| and attachments, and to serve as a | |||
| base for other dental devices and | |||
| accessories. Diplomat dental | |||
| operative units are offered by with | |||
| or without attached dental chairs. | |||
| When supplied with a dental chair, | |||
| the chair is intended to properly | |||
| position a patient to perform | |||
| different dental procedures. | The C8 + Dental Operative Unit with | ||
| accessories are intended to supply | |||
| power to and serve as a base for dental | |||
| devices and accessories. This product | |||
| includes a dental chair. The unit is | |||
| intended for use in the dental clinic | |||
| environment and used by trained | |||
| dentists and/or dental technicians and | |||
| assistants. The C8 + Dental Operative | |||
| Unit is offered wilt the optional Sivision | |||
| 3, an intraoral camera system intended | |||
| to provide the dentist and patient with | |||
| intraoral video images to view the | |||
| condition of the teeth and oral cavity. | Similar | ||
| Statement of | |||
| Intended Use | Diplomat dental operative units are to be operated and used | ||
| by dentists and other legally | |||
| qualified professionals, and are | |||
| intended for use to provide general | |||
| dental restorative care and hygiene | |||
| procedures in both traditional | |||
| dental office settings applications | |||
| by or under the supervision of a | |||
| licensed dentist or a hygienist if permitted by applicable law. | |||
| Similar |
The "reported device performance" is the conclusion that the Diplomat Dental Operative Units are "Substantially Equivalent" to the predicate device, meaning they perform similarly and do not raise new questions of safety or effectiveness. This is based on the comparison of features, intended use, and technological characteristics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "Clinical Data: Not applicable to this 510(k) submission." This indicates that no human patient or clinical test set was used to evaluate the device's performance in a clinical setting for this submission. The evaluation was based on Non-Clinical Data - Device Bench Testing in accordance with international standards. Therefore, there is no sample size for a "test set" in the context of clinical data.
The device testing was likely performed by the manufacturer, DIPLOMAT DENTAL, s.r.o. in Slovak Republic, Slovakia. This would be the provenance of the non-clinical data.
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)
Since no clinical data or human test set was used, there were no experts establishing ground truth for such a set. The "ground truth" for non-clinical bench testing would be the compliance with engineering standards by the testing entity, and possibly by third-party laboratories.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set was used.
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 submission for a dental operative unit (a piece of equipment), not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable, as this 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 data, the ground truth would be the physical and electrical properties and performance characteristics of the device measured against the specifications outlined in the international standards (IEC 60601-1, EN 60601-1-2, ISO 7494-1). This is a form of engineering/technical ground truth.
8. The sample size for the training set
Not applicable, as this is not a machine learning or AI device. The "training" in this context would be the design and manufacturing processes based on engineering principles and regulatory standards.
9. How the ground truth for the training set was established
Not applicable, as this is related to software/AI development. For this device, the "ground truth" for its design and manufacturing (analogous to a training set for an algorithm) would be the established engineering specifications, safety standards, and performance requirements for dental operative units as defined by the relevant international standards (IEC, EN, ISO) and regulatory bodies (FDA). The manufacturer's internal quality control procedures and adherence to these standards would ensure the "ground truth" of the manufactured units.
§ 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.