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The Integral Dental Unit 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.

The Integral Dental Unit (Model: YD-A4) is a dental operative unit specially designed and provided for a qualified dentist to be used in a professional clinic or hospital facility to carry out dental procedures.

Integral Dental Unit is intended to be used in a professional environment for dental diagnosis, treatment, or operation.

It includes a treatment chair, dentist element, assistant element and a dental light as offering several additional options and electronically-controlled chair movements with software and water/air unit functions.

The dental unit consists of an electronically operated dental chair and integrated control unit control for electricity, water and air supply to handpieces or some other dental instrument. The device is equipped with an instrument tray, pipes for water supply and tube air supply, a mouth lamp, a saliva aspirator, a spittoon, a three-way syringe, a film viewer, a foot switch and chair with driving motors and armrest.

The dental chair is intended to be used with dental hand pieces, cure light, ultrasonic scaler, camera system or other doctor stool, which is not provided by the manufacturer. The user will select the dental instruments and accessories with FDA clearance by themself. So, the device in the submission does not include these parts and accessories. The connector standard type complies with ISO 9168.

Basic parameters/use conditions/power supply specifications is as follows:

◆Noise ＜70 dBA

◆Base box Power supply: 115/230 Vac, 50/60Hz, single-phase 3core, protective grounding.
Power input: 380 VA
Water filter hole diameter: 15 kPa;

• water pumping rate＞80 mL/min

Strong saliva:

• vacuum degree >25 kPa;
• water pumping rate＞1000 mL/min

◆Instrument tray Rotating angle: >270º
Up-down moving range: >440mm
Max. Load: 85 Ra

◆Foot switch Tripping force: >10N and 25 000 repeats

◆Dental chair Power supply: 24 V dc Inside power supply
Loading capacity: 1323N (about 135 Kg)
Loading capacity of headrest: 300N (about 30Kg)
Moving range of headrest: 120mm
Range of backrest when going backwards: 90º~170º
Seat cushion's maximum height away from ground: 730mm
Seat cushion's minimum height away from ground: 450mm

Attachment
----- Amalgam separation device
It has a medical device product registration card
Attachment parameters are reflected in its operating instructions

◆Work space L: ≥3 000 mm; W: ≥2 000 mm; H: ≥2 500 mm

◆Environment for operation
Temperature: +5°C to +40°C
Relative humidity: 30% - 80%
Atmospheric pressure: 86kPa ~ 106kPa

The provided FDA 510(k) clearance letter pertains to the Integral Dental Unit, a Class I medical device. This device is an "Operative Dental Unit and Accessories" and is intended to supply power to and serve as a base for other dental devices and accessories, including a dental chair, for use by trained dental professionals in a dental clinic environment.

The document states that clinical performance testing was not performed for this device. As such, information regarding acceptance criteria derived from a clinical study, sample size for test sets (including data provenance, ground truth establishment, expert qualifications, and adjudication methods), MRMC studies, or standalone algorithm performance, and training set details are not provided in this submission.

Instead, the device's acceptance criteria are based on conformance to established international standards for electrical safety, electromagnetic compatibility, biocompatibility, software verification and validation, software life cycle processes, and general performance for stationary dental units and dental patient chairs.

Here's the information extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

Not applicable. Clinical performance testing was not performed. The testing conducted was primarily engineering and bench testing against recognized standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth as typically understood for clinical studies (e.g., expert interpretation of medical images) was not established. Performance was assessed against engineering specifications and international standards by relevant testing laboratories.

4. Adjudication method for the test set

Not applicable. No expert review or adjudication method was described as clinical performance testing was not performed.

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. No MRMC study was conducted as this device is an Integral Dental Unit, not an AI-assisted diagnostic or therapeutic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is not an algorithm or AI system.

7. The type of ground truth used

The "ground truth" for this device's performance is based on conformance to international engineering and safety standards (e.g., IEC, ISO) and the device's adherence to its own design specifications and functional parameters. There is no clinical "ground truth" derived from patient outcomes or expert consensus in this submission.

8. The sample size for the training set

Not applicable. This is not an AI/Machine Learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/Machine Learning device.

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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.

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.

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