(275 days)
K3 is intended to supply power to and serve as a base for dental devices and accessories. This device includes a dental chair and is intended for use in the dental clinic environment and is designed for use by trained dental professionals, dentists and/or dental assistants.
A Dental Unit and Chair K3 (ver 1.2) is designed for dental treatment of children and adults. It is a dental treatment unit in accordance with IEC 80601-2-60. The 3-way syringe is a dental instrument in accordance with EN 1639. It aids the dental application in the mouth of the patient by supplying air, water or spray. This product is designed for use in dentistry only and may only be used by trained medical personnel. K3 is similar to other commercially available products based on the intended use, the technology used, the claims, the electrical power and performance characteristics. It is substantially equivalent in design, function and intended use to the predicate device.
The provided text describes a 510(k) premarket notification for a dental operative unit and accessories (device K3, version 1.2). The submission aims to establish substantial equivalence to a predicate device (K3, version 1.1).
It is important to note that this document does not describe acceptance criteria or a study proving the device meets those criteria in the typical sense of a diagnostic or AI-powered medical device. The K3 is a physical dental unit, not an AI or diagnostic device that would have performance metrics like sensitivity, specificity, or image analysis accuracy.
Instead, the document details non-clinical tests performed to demonstrate that K3 (ver 1.2) is safe and effective and substantially equivalent to its predicate. These tests focus on aspects like biocompatibility, cleaning/sterilization validation, electrical safety, electromagnetic compatibility, and software verification/validation.
Therefore, many of the requested points regarding acceptance criteria and studies (especially those related to AI, ground truth, expert readers, and sample sizes for diagnostic performance) are not applicable to this type of device submission.
Here's a breakdown of the relevant information from the document:
1. A table of acceptance criteria and the reported device performance
Since this is a physical dental operative unit, the "acceptance criteria" are compliance with various safety and performance standards rather than diagnostic accuracy metrics. The "reported device performance" is the conclusion that the device complies with these standards.
| Acceptance Criterion (Standard Compliance) | Reported Device Performance (Conclusion of Compliance) |
|---|---|
| Biocompatibility (ISO 10993-1, ISO 10993-5) | Components (upholstery, waterlines) tested for cytotoxicity and deemed compliant. |
| Cleaning and Sterilization (ISO 17665-1:2006, ISO 17665-2, ISO 16954:2015, ISO 19458:2006, ISO/TS 11080:2009) | 3-Way syringe components can withstand steam sterilization and achieve acceptable sterility. Waterlines validated for effective cleaning via microbiological simulation and physical & chemical tests. |
| Electrical Safety (EN/IEC 60601-1) | Complied with the standard. |
| Electromagnetic Compatibility (EMC) (EN/IEC 60601-1-2) | Complied with the standard. |
| Usability (EN/IEC 60601-1-6, EN/IEC 62366) | Usability testing was conducted in accordance with the standards. |
| Software Verification and Validation (FDA Guidance for Software in Medical Devices) | Software verification and validation testing were conducted; considered "moderate" level of concern. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for each test, but general statements like "Components of the K3" and "A representative sample of the 3-Way syringe components" are used. For standards compliance, the "sample" is typically the device itself or representative parts/units of the device.
- Data Provenance: The tests would have been performed by the manufacturer (OSSTEM IMPLANT Co., Ltd. located in Seoul, Korea) or accredited testing facilities on behalf of the manufacturer. The data is prospective in the sense that these tests were conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This is a physical dental unit, not a diagnostic device requiring expert interpretation of results to establish ground truth. Compliance with engineering, safety, and sterilization standards is assessed by qualified engineers and microbiologists, not medical experts establishing a "ground truth" for a medical condition.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As there's no ground truth established by human experts in the context of diagnostic performance, no adjudication method is relevant. Compliance with standards is typically a pass/fail determination based on objective measurements and testing protocols.
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
- Not Applicable. This is not an AI-powered or diagnostic device. No such study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical dental operative unit. It does not have a standalone algorithm for diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable in the traditional diagnostic sense. The "ground truth" for this device is the established safety and performance requirements codified in the cited international and national standards (e.g., IEC 60601-1, ISO 10993-1). The tests aim to demonstrate that the device's characteristics (e.g., electrical leakage, sterilization efficacy, material cytotoxicity) meet the predefined "truth" of these standards.
8. The sample size for the training set
- Not Applicable. This is not a machine learning or AI device that requires a "training set."
9. How the ground truth for the training set was established
- Not Applicable. As there is no 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.