(147 days)
Boyd delivery systems are intended for use by Dental Professionals for effective treatment of patients.
The Boyd Delivery Unit is a Dental Operative Unit that provides the dentist with primary requirements for a dental operatory. The delivery system is designed to be used as an interface device to connect the dental operatory hand instruments to the appropriate supply utility such as air, water suction, drain and electricity. It functions as a system management device that provides a method of operating various hand instruments from a single control input device. The unit is furnished with controls that allow the dentist or operator to set the air pressure and water flow to the hand pieces and the syringe in the delivery head. The unit is of a stackable design providing a base for dental tools and accessories. Assistant's instrumentation delivery system, water heater, and the cuspidor are all features that this unit can offer.
This 510(k) summary describes a traditional device submission and does not include an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, and AI-specific metrics is not present in the provided text. The document is for a dental operative unit and focuses on substantial equivalence to predicate devices based on design and intended use, rather than performance metrics derived from a study.
The FDA 510(k) clearance process for this type of device does not typically require performance studies with the level of detail requested for AI/ML products. Instead, it relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device.
Here's an breakdown of the available information, noting the absence of AI/ML-specific details:
1. Table of Acceptance Criteria and Reported Device Performance:
Not applicable in the provided context. The submission focuses on comparing features and intended use to predicate devices, not on quantitative performance metrics or specific acceptance criteria met through a study.
2. Sample Size for Test Set and Data Provenance:
Not applicable. There is no mention of a "test set" in the context of a performance study. The comparison is feature-based against existing commercial products.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. "Ground truth" is typically relevant for diagnostic or classification tasks, which are not described for this device.
4. Adjudication Method:
Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. No MRMC study was conducted or mentioned, as this is not an AI/ML device.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. This is not an algorithm-only device.
7. Type of Ground Truth Used:
Not applicable.
8. Sample Size for the Training Set:
Not applicable. There is no mention of a training set as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
Summary of Device Comparison (from the provided text, which serves as the "study" for substantial equivalence):
The provided text includes a "Comparison of device to marketed device" table. This table serves as the primary "study" or justification for substantial equivalence for this type of medical device submission. It outlines various features of the Boyd Delivery Unit and compares them to three predicate devices (a-dec, DentalEZ, Marus Dental).
Acceptance Criteria (Implicitly based on comparison):
The implicit acceptance criterion for this 510(k) submission is substantial equivalence to existing legally marketed predicate devices. This means the Boyd Delivery Unit must be shown to be as safe and effective as the predicate devices, with no new questions of safety or effectiveness raised.
Reported Device Performance (as demonstrated by comparison):
The table highlights the following for the Boyd Industries, Inc. device:
- Mounting unit: Cabinet (matches a-dec, DentalEZ, Marus Dental)
- Instruments Available: High-speed handpiece hookup, low-speed handpiece hookup, 3-way syringe, saliva ejector, high volume evacuation with solids collector (matches or is very similar to all predicates)
- Activation: Master off/on valve, handpiece toggle switch and foot control. This is similar to DentalEZ, and differs slightly from a-dec (which lacks "master off/on valve" in the description) and Marus Dental (which has "Automatic activation for each handpiece"). The differences are not presented as raising new safety or effectiveness concerns, but rather as variations in control mechanisms common to such devices.
- Cleaning: Air flush system. This is a point of difference with the predicates, which use "Water flush." The applicant implicitly argues this difference does not impact substantial equivalence or raise new safety/effectiveness questions, likely because both are established cleaning methods for dental units.
- Water System: Self contained. Similar to a-dec, and one option for DentalEZ, while Marus Dental uses "City hook up."
Conclusion of the FDA Letter ({2} and {3}):
The FDA reviewed the submission and determined that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. This indicates that the comparison presented in the table was sufficient to demonstrate that the device met the implicit acceptance criterion of being as safe and effective as the predicates.
§ 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.