(105 days)
The INTEGO Family of Dental Treatment Units with accessories is intended to supply power to and serve as a base for dental devices and accessories. Each unit includes a dental chair. The units are intended for use in the dental clinic environment and are used by trained dentists and/or dental assistants.
The MOTOR BL ISO E is used to drive rotating and oscillating straight and contra-angle handpieces in connection with the dental treatment units for endodontic and general dental purposes.
The SPRAYVIT E multifunctional syringe is used for dental treatment with unheated air and unheated water. The SPRAYVIT E multifunctional syringe is also used to illuminate the preparation field.
The INTEGO family dental treatment unit is a dental operating system. INTEGO and INTEGO pro dental treatment units constitute the INTEGO Family. These are the successors of C8+. Components and functional principles are taken over or widely derived from this C8+. The units include a patient chair, foot control, dentist element and a water unit. The units may also include an assistant element, a cuspidor a dental operating light, and a monitor.
The design concept of the INTEGO treatment unit is similar to commonly available treatment units.
The dimensions of the components, their movements and shapes are designed for ergonomic treatment; i.e. the dentist and, where applicable, the assistant can perform their treatments in a healthy working posture.
Surfaces are smooth to enable easy cleaning and disinfecting. This simplifies, in line with detachable parts and barriers as well as simple maintenance routines, efficient infection control.
The operating concept is designed to make treatments easy and intuitive to prevent mal-operations and provide an unimpeded workflow. Depending on the selected foot control and user interface version, a significant portion of functions can be operated hands-free to improve infection control and treatment workflow.
Styling and colors were selected under aesthetic aspects.
The provided text is a 510(k) Summary for the Sirona Dental Systems INTEGO Family and Accessories. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with acceptance criteria and device performance in the way a clinical study for a novel device would.
Therefore, many of the requested elements (like sample size, number of experts, adjudication method, MRMC studies, standalone performance with metrics like AUC, sensitivity, specificity, ground truth type for test/training sets) are not applicable in this regulatory context, as it's a submission for a Class I device based on substantial equivalence, not a new high-risk device requiring extensive clinical validation.
However, I can extract information related to the device's adherence to relevant standards and its demonstrated equivalence.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the device's compliance with various national and international standards. The "Reported Device Performance" is stated by the manufacturer to be substantially equivalent to the predicate devices and compliant with these standards. Since this is a substantial equivalence submission, specific numerical performance metrics (e.g., sensitivity, specificity, accuracy) are not provided in the document for the device itself against a specific acceptance criterion.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Compliance with ISO 7494-1 (Dental units - General requirements) | Device complies with ISO 7494-1:2011 |
| Compliance with ISO 7494-2 (Dental units - Water and air supply) | Device complies with ISO 7494-2:2003 |
| Compliance with ANSI/AAMI ES60601-1 (Electrical equipment safety) | Device complies with ANSI/AAMI ES60601-1:2005/(R)2012 and amendments |
| Compliance with IEC 60601-1-2 (EMC) | Device complies with IEC 60601-1-2 Ed 3:2007 |
| Compliance with IEC 60601-1-6 (Usability) | Device complies with IEC 60601-1-6 Ed 3.0 2010 |
| Compliance with IEC 62304 (Software lifecycle processes) | Device complies with IEC 62304:2006 (for moderate concern software) |
| Compliance with IEC 62366 (Usability engineering) | Device complies with IEC 62366 Ed 1.1 2014 |
| Compliance with IEC 62471 (Photobiological safety) | Device complies with IEC 62471:2006 |
| Compliance with ISO 14457 (Handpieces and Motors) | Device complies with ISO 14457:2012 |
| Compliance with ISO 7405 (Biocompatibility) | Device complies with ISO 7405:2008 |
| Compliance with ISO 15223-1 (Medical Device Symbols) | Device complies with ISO 15223-1:2012 |
| Compliance with ISO 10993-10 (Irritation and Skin Sensitization) | Device complies with ISO 10993-10:2010 |
| Compliance with EN 1717 (Protection against water pollution) | Device complies with EN 1717:2000 |
| Compliance with DIN 6856-3 (Radiological film viewing boxes) | Device complies with DIN 6856-3 |
| Compliance with ISO 6875 (Dental patient chair) | Device complies with ISO 6875:2011 |
| Compliance with ISO 9680 (Dentistry - Operating lights) | Device complies with ISO 9680:2007 |
| Compliance with ISO 11143 (Amalgam separators) | Device complies with ISO 11143:2008 |
| Compliance with ISO 13485 (Quality management systems) | Device complies with ISO 13485:2003 |
| Compliance with ISO 21530 (Resistance to chemical disinfectants) | Device complies with ISO 21530:2004 |
| Compliance with IEC 80601-2-60 (Dental equipment) | Device complies with IEC 80601-2-60:2012 |
| Compliance with ISO 17664 (Sterilization of medical devices) | Device complies with ISO 17664:2004 |
| Compliance with ISO 21531 (Graphical symbols for dental instruments) | Device complies with ISO 21531:2009 |
| Compliance with ISO 3964 (Dental handpieces – Coupling dimensions) | Device complies with ISO 3964:1982 |
| Compliance with DIN EN ISO 10993-5 (In vitro cytotoxicity) | Device complies with DIN EN ISO 10993-5:2009 |
| Substantial Equivalence to Predicates | "Sirona INTEGO family is as safe and as effective to perform its intended use and is substantially equivalent to the predicate devices." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable. This document describes a 510(k) submission for a Class I dental operative unit, not a device requiring clinical performance testing with test sets in the typical sense (e.g., for diagnostic accuracy). The evaluation is primarily based on compliance with recognized consensus standards and comparison of technological characteristics to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. See point 2. The evaluation relied on "an evaluation using relevant literature and a critical appraisal of the Dental Treatment Unit and accessories by a medical professional." The number and specific qualifications of this medical professional are not detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. See point 2.
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. This is not an AI/CADe/CADx device. No MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithmic device in the AI sense.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable in the traditional clinical validation sense. The "ground truth" for this type of submission is the established performance and safety demonstrated by predicate devices and the requirements set forth in the referenced consensus standards.
8. The sample size for the training set
- Not Applicable. This is not an AI/machine learning device that uses a "training set."
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 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.