(92 days)
This device is intended for delivery of general restorative dental care for those who cannot visit the dental office.
The UNIPORT has been designed to provide ease in set-up and transportation as well as good dental care. Reliable air supply being an utmost necessity, it has 9.8 L of air storage supplied by a 3/4 hp compressor to maintain pressure during daily practice. For ease in set-up, take-down, and transport, the UNIPORT is truly self-contained - all components are mounted in a lightweight unitized cabinet with wheels. The cabinet, a shell containing the operational components, is made of food grade polyethylene for durability; its smooth exterior is easy to wipe down and disinfect between operations. While the outside of the UNIPORT appears different to others, the actual operating components are similiar to those used in dental clinics around the nation.
This document is a 510(k) summary for the UNIPORT Mobile Dental Operative Unit, dated April 21, 2004. It focuses on demonstrating substantial equivalence to a predicate device, the A-dec PAC I Portable Unit.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are based on the comparison of features and intended use between the applicant's device (UNIPORT) and the legally marketed predicate device (A-dec PAC I Portable Unit). The "performance" is a direct feature-by-feature comparison demonstrating equivalence or superiority.
| Acceptance Criteria (Predicate Device Features) | Reported Device Performance (UNIPORT Features) |
|---|---|
| Manual control for two handpieces | Manual control for two handpieces |
| Oil collection system | Oil collection system |
| Autoclavable syringe | Autoclavable syringe |
| Wet/dry foot control | Wet/dry foot control |
| Self-contained water system | Self-contained water bottle |
| 1/2 hp 120 or 240 VAC compressor | 3/4 hp 110 or 220 VAC compressor (Superior) |
| 4 liters of air storage | 9.8 liters of air storage (Superior) |
| Air filter regulator with moisture separator | Air filter/dryer |
| Air saliva ejector | HV and saliva ejector vacuum with individual actuation (Superior) |
| Fixed-height mobile stand 33" x 21-1/2" x 21" | One-piece molded plastic case 36-3/4" x 19-7/8" x 20-3/4" (Different form factor, similar function) |
| Duplex electrical outlet | Power bar for accessories |
| Intended for general restorative dental care to those unable to visit the dental office. | Intended to provide general restorative dental care to those who are unable to visit the dental office. |
2. Sample Size Used for the Test Set and Data Provenance
This document describes a comparison study against a predicate device, not a performance study with a distinct "test set" in the sense of clinical trial data. The "sample" here constitutes the features and specifications of the two devices being compared.
- Sample Size: N/A (not applicable in the context of clinical data). The comparison is between two devices.
- Data Provenance: The data is derived from the design specifications and features of the UNIPORT device and the A-dec PAC I Portable Unit. This is internal company data for the UNIPORT and publicly available or known specifications for the predicate device. It is a retrospective comparison of device specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not explicitly stated as part of this 510(k) summary. The "ground truth" for this type of submission is the legally marketed status and established features of the predicate device, and the engineering specifications of the new device. Product developers and engineers would have been involved in defining the UNIPORT's features.
- Qualifications of Experts: Not specified. However, the FDA's review process (which resulted in the letter of substantial equivalence) involves experts in dental devices.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This is a comparison of product specifications against pre-existing predicate device specifications, not an assessment requiring expert consensus on clinical findings. The FDA's review serves as the ultimate "adjudication" in determining substantial equivalence.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This submission is for a Class I dental operative unit and relies on substantial equivalence of features, not clinical effectiveness studies requiring MRMC analysis.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance Study: No, a standalone performance study as described (e.g., for an AI algorithm) was not performed. This device is electro-mechanical and its performance is assessed by its specifications and function, not an algorithm's output.
7. The Type of Ground Truth Used
- Ground Truth: The "ground truth" for this 510(k) submission is the established design, performance specifications, and intended use of the legally marketed predicate device (A-dec PAC I Portable Unit), as well as the engineering specifications of the new UNIPORT device. The FDA validates the claim of substantial equivalence based on this comparison.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. There is no machine learning or AI component requiring a training set mentioned in this document.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable, as there is no training set involved.
§ 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.