(32 days)
The Dental Unit with Chair 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
Yoboshi dental units with chairs are driven by imported low-voltage DC motor with imported air spring auxiliary balance to keep a safe and stable operation of equipment and low noise. With two pieces of NSK high speed H.P and one piece of NSK lowspeed H.P, it is easy and credible for working. The single-form seamless leather cushion provides comfort for the patient to sit and for the doctor to clean and disinfect more easily. It is applicable for the dental clinic. The unit is composed of integral ceramic spittoon, air-controlled balanced instrument-arm, newlydesigned cold light.
The models include A8000, A8000-I, A8000-II. All of these types follow the same design principle and intended use, and comply with ISO7494-1:2004, ISO7494-2:2003. The hose connectors of these types comply with ISO9168:1991. The air-motors of these types comply with ISO13294: 1997. Dental patient chair complies with ISO 6875:1995.
All of these types of applicant devices consist of similar components with similar function and different appearance, these components include:
- Electric pedal switch ●
- Control key for mouth lamp
- Wash cuspidor
- Gargle water control
- Pedal switch
- Handrail
- Backrest
- Headrest
- Cuspidor
- Rising pipe
- Lamp arm
- Operation light
- Seat cushion for child
The K103550 submission for the Yoboshi Dental Unit with Chair describes a traditional 510(k) submission, indicating that the device's safety and effectiveness are established by demonstrating substantial equivalence to a predicate device. This type of submission relies on comparative data rather than a de novo clinical study with specific acceptance criteria and performance metrics for the new device alone.
Therefore, the information typically found in an AI/software device submission regarding detailed acceptance criteria, a standalone study proving those criteria, expert ground truth adjudication, MRMC studies, or training set details is not present in this document.
Instead, the submission focuses on demonstrating that the Yoboshi Dental Unit with Chair (Models A8000, A8000-I, A8000-II) is substantially equivalent to the legally marketed predicate device, the North West Medical Instrument (Group) Co., Ltd. Dental Unit with Chair, Model: S2300 (K080438).
Here's an analysis of the provided information, addressing the requested points where applicable, and highlighting what is not available due to the nature of this 510(k) submission type:
1. Table of Acceptance Criteria and Reported Device Performance
This type of information is generally not found in a traditional 510(k) submission for a physical medical device like a dental unit, especially when demonstrating substantial equivalence. The "acceptance criteria" here implicitly refer to meeting the recognized standards and having comparable specifications to the predicate device.
| Category | "Acceptance Criteria" (Implicit) | Reported Device Performance (Compliance) |
|---|---|---|
| Effectiveness | Compliance with relevant ISO standards for dental units and chairs. | Complies with: |
- ISO 7494-1:2004
- ISO 7494-2:2003
- ISO 9168:1991
- ISO 6875:1995
- ISO 13294:1997 |
| Safety | Compliance with relevant IEC standards for medical electrical equipment. | Complies with: - IEC 60601-1
- IEC 60601-1-2 |
| | Compliance with biocompatibility standards (for applied materials). | Complies with: - ISO 11138-1:2006 (for BI material)
- ISO 11737-1:2006 (for disposable anesthesia channel)
- ISO 10993-5 & -10 (for Single-use anesthesia tube) |
| | Software Validation (if applicable). | In compliance with FDA Guidance for Content of Pre-Market Submissions for Software Contained in Medical Devices. |
| Comparison to Predicate | Same classification, indications, intended use, similar product design, technical, biological, and safety specifications. | Verified as "Substantially Equivalent" to predicate device K080438. Differences (e.g., optional video system) do not raise new questions of safety or effectiveness. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. This submission relies on engineering and performance testing against recognized standards, and a comparison to a predicate device, not a "test set" of clinical data in the context of an AI algorithm.
- Data Provenance: Not applicable. The "data" here refers to test results against international standards and design specifications, not country-of-origin specific clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device is a physical dental unit, not an AI algorithm that requires expert consensus for ground truth on a test set of images or patient data. Its performance is assessed against engineering standards and comparison to a predicate device.
4. Adjudication method for the test set
- Not applicable for the reasons stated above.
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 device. An MRMC study is irrelevant for a dental operative unit.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI device or software algorithm in that context. The "software validation" mentioned relates to any embedded software controlling basic functions of the dental unit, not a standalone AI diagnostic or assistive tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the typical AI/diagnostic sense. The "ground truth" for this device's safety and effectiveness is established by its adherence to internationally recognized performance and safety standards (e.g., ISO, IEC) and by demonstrating substantial equivalence to a previously cleared device.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning device.
Summary of the Study/Evidence:
The "study" demonstrating that the Yoboshi Dental Unit with Chair meets acceptance criteria for 510(k) clearance is not a clinical trial or AI performance study. Instead, it is a Substantial Equivalence (SE) determination based on:
- Compliance with Recognized Standards: The device was tested and found to comply with a comprehensive set of international standards for dental equipment, medical electrical equipment, biocompatibility, and hose connectors (ISO 7494-1:2004, ISO 7494-2:2003, ISO 9168:1991, ISO 6875:1995, ISO 13294:1997, IEC 60601-1, IEC 60601-1-2, ISO 11138-1:2006, ISO 11737-1:2006, ISO 10993-5 & -10).
- Comparison to a Predicate Device: A detailed comparison was made between the Yoboshi Dental Unit (A8000, A8000-I, A8000-II) and the predicate device (North West Medical Instrument (Group) Co., Ltd. Dental Unit with Chair, Model: S2300, K080438). The applicant asserted, and the FDA agreed, that the devices share the same classification information, indications for use, intended use, and similar product design, technical specifications, biological specifications, and safety specifications. The differences (e.g., optional video system) were deemed not to raise new questions of safety or effectiveness.
- Software Validation: Any embedded software within the device underwent validation in compliance with FDA guidance.
The FDA's letter (K103550) confirms the substantial equivalence determination, allowing the device to be marketed.
§ 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.