(84 days)
The Mare Dental Operative Unit and Accessories is intended for use in general dental applications by providing the dental practitioner a user interface to control operation of the dental chair and attached dental devices.
The system delivers air, water, and electricity to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed in the dental office.
The Mare Dental Operative Unit provides connections for five pneumatically operated instruments. The unit can supply air, water and electricity, which may include an air water syringe, high and low speed handpiece, electric motors, ultrasonic scalers, and dental curing lights, these accessories are not part of the unit.
The unit provides automatic instrument selection by means of a five way pneumatic valve located in each instrument hanger assembly. The automatic selection takes place when a static air pressure signal is removed from the top of a diaphragm located in the handpiece control block. The Mare Dental Operative Unit consists of the following components:
- l. Patient Treatment Chair: It has two controls; a foot control and a digital pad in the instruments console for all chair positions, auto return system, preset position, emergency stop system and electric cup filler. The entire Mare features an articulating, detachable headrest.
- II. Cuspidor with Water Unit: The ceramic bowl, cup fillers and the bowl irrigator are detachable. The Mare features a swivel ceramic bowl.
- III. Dental Light: The Unit features a lamp with two intensity settings.
- IV. Instruments Console: Features an instruments auto selection system and a master digital control.
- V. Rolling Chair: Height adjustable backrest and inclination setting.
This document describes a 510(k) premarket notification for the "Mare Dental Operative Unit" (K041458). It's important to understand that 510(k) clearances are based on demonstrating "substantial equivalence" to a predicate device, not necessarily extensive clinical studies proving new safety and efficacy as typically seen with pharmaceuticals or novel high-risk medical devices.
Therefore, the study information requested regarding acceptance criteria, sample sizes, expert adjudication, MRMC studies, and ground truth establishment is generally not applicable (N/A) for this type of device and submission. The focus of the 510(k) is on comparing technical specifications and intended use against existing legally marketed devices, along with adherence to relevant electrical and quality management standards.
However, I can extract the information that is provided regarding design specifications and compliance with standards, which serve as the "acceptance criteria" for substantial equivalence in this context.
Here's a breakdown based on the provided text, addressing your points where possible:
Acceptance Criteria and Device Performance for Denimed Electrónica Mare Dental Operative Unit (K041458)
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are primarily based on demonstrating substantial equivalence to predicate devices (Sirona Dental Systems C8+ Dental Operative Unit, K032543, and Spirit S1 Dental Operative Unit, K962071) in terms of intended use, technological characteristics, and material composition, as well as compliance with relevant safety standards.
| Acceptance Criteria Category | Specific Criteria/Standard Adhered To | Reported Device Performance (Mare Dental Operative Unit) | Basis for Performance Claim |
|---|---|---|---|
| Intended Use Equivalence | Same as predicate devices: supply power to and serve as a base for dental devices and accessories, conveniently position dynamic instruments, deliver air, water, and electricity for dental procedures. | Meets: Intended use is identical to predicate devices. | Stated in "Intended Use" section and confirmed by FDA. |
| Technological Characteristics Equivalence | Similar components, design, characteristics, and mode of operation as predicate devices (e.g., chair, instrument board, cuspidor, dental light, footswitches). | Meets: Includes a patient treatment chair, cuspidor with water unit, dental light, instruments console, and rolling chair. These are generally comparable to predicate devices. | Stated in "Technological Characteristics and Substantial Equivalence" section. |
| Material Equivalence | Use of common dental industry materials like PVC, polyurethane tubing, stainless steel, painted steel, anodized/plated alloy compounds, ABS plastics. | Meets: Utilizes these materials, stating they are "substantially equivalent to Spirit S1 Operative Unit." | Stated in "Technological Characteristics and Substantial Equivalence" section. |
| Mechanical Safety | Features like safety fuses, manual and pneumatic shut-off valves for air/water lines. | Meets: "Safety fuse on the bottom of the unit, as an industry standard." "Air and water lines have both manual shut off valves and pneumatically controlled automatic shut off valves." | Stated in "Technological Characteristics and Substantial Equivalence" section. |
| Electrical Safety Standard | IEC 60601-1/14-12-2000 | Meets: "The Mare unit successfully passed the electrical safety tested per IEC 60601-1/14-12-2000 standards, which meets the safety requirements for medical electrical systems." | Compliance Testing. |
| Quality Management System Standard | DNV ISO 9002:2000 | Meets: "The Mare unit successfully passed, the DNV (Det Norske Veritas) ISO 9002: 2000 which meets the Quality Management System Standards." | Certification/Audit. |
| European Test Standards (ETS) | Adherence to applicable ETS. | In Progress: "The Mare unit is currently being tested for the ETS (European Test Standards)." | Stated status of testing. (Note: This was "in progress" at the time of the submission, but its inclusion implies an intent to meet this as a benchmark.) |
| Technical Specifications | Comparable operational parameters for voltage, frequency, water pressure, air pressure, air consumption, water consumption. | Meets: Comparative table shows Mare specifications are within generally comparable ranges or provide options (e.g. 110/220V) that subsume predicate specifications. |
- Voltage: 110 or 220 Volts (vs 110 Volts for Spirit S1)
- Frequency: 50 or 60Hz (vs 50 Hz for Spirit S1)
- Water Pressure: 40 psi Kg/cm2
- Air Pressure: 5 bar or 80psi (same as Spirit S1)
- Air Consumption: 100 L/min (comparable to Spirit S1's "100 min")
- Water Consumption: 3L/m (comparable to Spirit S1's "2 m") | Comparative table provided in section "Technological Characteristics and Substantial Equivalence." |
Study Information Details
Given this is a 510(k) submission for a Class I dental operative unit based on substantial equivalence, the types of detailed studies typically associated with novel or high-risk devices (e.g., clinical trials with large sample sizes, expert adjudication of medical image interpretation, MRMC studies) are not applicable (N/A) here. The device is a "base for dental devices and accessories" and aims to provide user control, not to diagnose or treat conditions itself in a way that requires complex clinical efficacy data.
Therefore, for points 2 through 9, the answer is largely N/A with explanations of why.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
N/A. This submission does not involve a "test set" in the sense of clinical data or patient samples. The "testing" referred to is engineering and safety compliance testing (e.g., electrical safety according to IEC 60601-1). Data provenance is from internal company testing and certification bodies for these technical standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. No ground truth for a clinical "test set" was established by experts. Substantial equivalence relies on technical specifications, intended use comparison, and adherence to recognized standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. No clinical "test set" requiring adjudication 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
N/A. MRMC studies are used for diagnostic aids, particularly those involving human interpretation of images or data, often in the context of AI assistance. This device is a dental operative unit, not an AI-powered diagnostic tool, so an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This device does not have a standalone algorithm component whose performance would be assessed without human input. It is a physical dental unit operated by human practitioners.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
N/A. The "ground truth" for this submission are the established engineering standards (like IEC 60601-1 for electrical safety), quality management standards (ISO 9002:2000), and the technical specifications and intended use of the legally marketed predicate devices. The device's performance against these technical specifications and standards constitutes its "truth" for substantial equivalence.
8. The sample size for the training set
N/A. This device is not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
N/A. This device is not an AI/ML algorithm that requires a "training set."
§ 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.