(266 days)
The Dental Unit is intended to supply power to and serve as a base for dental devices, and accessories. It is intended for use in the dental clinic /office environment and used by trained dentists and/or dental technicians and assistants. This product is attached with a dental chair.
The Integral dental unit is a dental treatment unit tested in accordance with IEC 80601-2-60. This product is used in dentistry only and may only be used by trained medical personnel and trained professionals in the field of general dentistry. The Integral dental unit consists of a dental chair, side box, dental light, instrument tray, 3-way syringe, strong suction, weak suction, cuspidor, x-ray film viewer, and the wired foot pedal. Optional accessories include ultrasonic scalers, curing lights, dental handpieces and dental electrical motor, which are to be purchased by the user. The dental operative unit is equipped with a dental light and water heater. The dental operative unit mainly relies on electricity, compressed air, water to achieve all functions. Various ancillary dental devices can be connected to the Integral dental unit which are attached by means of industry standard ISO connections. The ancillary dental devices include 3-way syringe, strong suction and weak suction vacuum instruments are manufactured by the Mipont Medical Equipment Co., Ltd. None of the Integral dental unit parts or accessories are provided sterile.
This document is a 510(k) clearance letter for "Integral Dental Units" (K242611). It primarily focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance and safety data, rather than clinical accuracy or AI performance.
Therefore, many of the requested sections related to acceptance criteria, MRMC studies, standalone AI performance, and AI-specific ground truth establishment cannot be fulfilled from this document as it does not describe AI-powered functionality or clinical accuracy testing for a diagnostic or AI-assisted system.
The "device" in this context is a dental operative unit, which is a piece of physical medical equipment, not an AI or software algorithm requiring clinical accuracy validation as typically seen in AI/ML medical devices.
Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:
Acceptance Criteria and Device Performance (Based on Non-Clinical Testing)
The "acceptance criteria" for this device are primarily met by demonstrating compliance with various national and international performance, safety, and quality standards, as well as showing substantial equivalence to existing predicate devices. The performance data presented are primarily in the context of electrical safety, EMC, usability, physical operation parameters, and biocompatibility.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a physical dental unit and not an AI-powered diagnostic device, the "acceptance criteria" are compliance with established standards and comparable specifications to predicate devices. There aren't specific accuracy metrics like sensitivity or specificity for a diagnostic algorithm.
| Acceptance Criteria Category | Specific Criteria (Standard & Parameter) | Reported Device Performance (Compliance/Value) |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1:2005+A1:2012+A2:2020 & ANSI AAMI ES60601-1:2005 + C1:2009 + A2:2010 + A1:2012 + A2:2021 | Compliance demonstrated by passing tests. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2:2014 /AMD1:2020 & IEC TR 60601-4-2:2016 | Compliance demonstrated by passing tests. |
| Basic Safety & Essential Performance | Compliance with IEC 60601-1-6:2010+A1:2013+A2:2020 (Usability) | Compliance demonstrated by passing tests. |
| Compliance with IEC 62366-1 Edition 1.0 2015-02 (Usability) | Compliance demonstrated by passing tests. | |
| Compliance with IEC 80601-2-60:2019 (Dental Equipment Specific) | Compliance demonstrated by passing tests. | |
| Compliance with ISO 7494-1:2018 (Stationary Dental Units/Chairs - General) | Compliance demonstrated by passing tests. | |
| Compliance with ISO 7494-2:2022 (Air, water, suction, wastewater systems) | Compliance demonstrated by passing tests. | |
| Compliance with ISO 9680:2021 (Operating lights) | Compliance demonstrated by passing tests. | |
| Software | Compliance with IEC 62304 (Software lifecycle processes for medical devices) | Compliance demonstrated; "Moderate" level of concern. |
| Biocompatibility | Compliance with ISO 10993-5:2019 (In vitro cytotoxicity) | Compliance demonstrated. |
| Compliance with ISO 10993-10:2021 (Skin sensitization) | Compliance demonstrated. | |
| Compliance with ISO 10993-23:2021 (Irritation) | Compliance demonstrated. | |
| Sterilization & Shelf Life/Packaging | Compliance with ISO 17665-1:2006 (Moist heat sterilization) | Compliance demonstrated. |
| Compliance with ASTM D4169-22 (Shipping Containers) | Compliance demonstrated. | |
| Dental Light Illuminance | ISO 9680: adjustable from 40000 lux (normal mode); 15000, 20000, 25000 lux (mixed light) | Meets specification. |
| Water Heater Temperature | Max. 40℃ storage; Avg. 33 ~ 35℃ water temp. | Meets specification. |
| Loading Capacity (Dental Chair) | 150kg | Meets specification. |
| Pressure of Water Supply | 200～400kPa | Meets specification. |
| Pressure of Air Supply | ≥550kPa | Meets specification. |
| Rate of Water Suction | Suction ≥ 1L/min; Saliva Ejector > 400mL/min | Meets specification. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of device performance testing. The "sample" here refers to the physical device units tested for compliance with standards. The document does not specify the number of units tested.
- Data Provenance: The tests are non-clinical, meaning they were likely performed in a laboratory or manufacturing setting. The manufacturer is Mipont Medical Equipment Co., Ltd. from China. The data provenance is from non-clinical bench and laboratory testing of the physical dental unit, not clinical data from patients.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not Applicable: This document describes non-clinical performance and safety testing of a physical medical device (dental unit), not an AI algorithm requiring expert-established ground truth for clinical accuracy.
4. Adjudication Method for the Test Set
- Not Applicable: As above, this pertains to clinical study design for AI algorithms, which is not described here.
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: The document states, "There was no clinical testing performed." This type of study is specifically for evaluating the impact of AI on human performance, which is not relevant to this device's clearance.
6. If a Standalone (i.e. algorithm only, without human-in-the loop performance) was done
- No: This device is a physical dental unit, not a standalone algorithm. The document explicitly states "There was no clinical testing performed."
7. The Type of Ground Truth Used
- For the non-clinical tests, the "ground truth" is defined by the specifications and requirements outlined in the referenced international standards (e.g., IEC, ISO, ASTM). The device is tested against these predefined, objective engineering and safety criteria. There is no "expert consensus" or "pathology/outcomes data" in the clinical sense for these types of non-clinical hardware tests.
8. The Sample Size for the Training Set
- Not Applicable: This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not Applicable: This device is not an AI/ML algorithm that requires a training set or associated ground truth.
§ 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.