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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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The BDC 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 BDC dental unit is intended to supply air, water, vacuum and electrical power to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed in the dental operatory. The BDC dental unit consists of a patient chair, dentist element (tray table), assistant element (3-way syringe, high volume evacuator and saliva ejector), side cabinet support center, foot control, cuspidor and a dental operating light, which for patient to sit during the dental diagnosis, treatment and/or operation.

The provided text appears to be an FDA 510(k) clearance letter and summary for a dental unit. It describes a medical device (BDC Dental Unit) that is essentially a dental chair with integrated controls for air, water, vacuum, and electrical power for dental devices. The device's primary function is to serve as a base and power supply for other dental instruments used by trained dental professionals.

Based on the provided document, there is NO information about an AI/ML component or study involving acceptance criteria related to AI/ML device performance. The document focuses on establishing substantial equivalence to a predicate device (A-dec 500) through non-clinical testing of mechanical, electrical, software (non-AI), and biocompatibility aspects.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance for an AI/ML component.
2. Sample size and data provenance for an AI/ML test set.
3. Number and qualifications of experts for AI/ML ground truth.
4. Adjudication method for an AI/ML test set.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study for AI assistance.
6. Standalone (algorithm only without human-in-the-loop performance) study for an AI/ML component.
7. Type of ground truth for an AI/ML component.
8. Sample size for the training set (for AI/ML).
9. How ground truth for the training set was established (for AI/ML).

The document explicitly states: "Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Clinical testing has not been conducted on this product." This further reinforces that there was no study like the one you are asking for, especially not one involving human readers or AI performance metrics.

The "Software Verification and Validation Testing" section mentions: "The software for this device was considered as a 'BASIC' level of concern, since a failure or latent flaw in the software would not directly result in serious injury or death to the patient or operator." This implies standard software validation, not necessarily AI/ML model validation.

In summary, the provided text does not contain the information required to answer your prompt regarding acceptance criteria and studies for an AI/ML medical device. The device described is a conventional dental unit, and its clearance is based on substantial equivalence to a predicate device through standard non-clinical performance and safety testing.

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The Firstar Dental Unit is intended to serve as a base for ancillary dental devices and accessories by providing air, water, vacuum, and low voltage electrical power to hand-held dental instruments. The Firstar Dental Unit is intended for use by dental practitioners in a clinical environment.

The Firstar Dental Unit (also known as the delivery unit or delivery system) is a combination of dental equipment components used to carry, position, and control the devices used in the practice of dentistry. Delivery systems provide for hand pieces and other various accessories by delivering air, water, vacuum and low voltage electricity to the dentist during procedures. Depending on the configuration, it includes combinations of a Doctor Control Head (delivery head), Delivery System Foot Switch (sometimes referred to as a rheostat), Cuspidor, Side Box (Control Box), High Volume Evacuator (HVE), Saliva Ejector (SE), and an Air and Water Multifunction Syringe.

Air, water, vacuum, drainage, and electrical power utilities are delivered through the shut-off valves, pressure regulators, and electrical transformers located in the post mounted utility box. Subsequently, internal tubing delivers the air, water and vacuum to the control head and to the dental hand pieces and multifunction syringe. Low voltage electricity is delivered to the control head for operating items such as scalers, electric hand pieces and fiber optic light sources.

The Firstar Dental Unit is available in various configurations and mounting styles including dental chair mounted, mobile cart mounted, and wall mounted on a dental chair, the Firstar Dental Unit can be configured in two distinct styles - a pivot mounted unit which allows for ambidextrous access to the patient, and a post mounted unit which includes a side box located on one side of the dental chair that can mount a cuspitor (spittoon) on it. Despite the various applications, the key elements of the Dental Unit such as the internal plumbing, tubing, materials, power sources, utility connections, delivery head internal components, and overall operating principles remain the same.

The control head allows operators to place surgical equipment on top of the tray and it provides controls for hand piece water pressure, air pressure and electrical power. Additionally, controls for a Firstar Dental Chair are often integrated on the control head if the dental unit is configured to mount on a dental chair. If equipped, the cuspidor bowl allows 90 decrees ande rotation that provides access to collect the patient's saliva during dental treatment. The side box provides controls for the cuspidor cup fill, bowl rinse, air, and pressure regulators for the air and water quick disconnect outlets.

Various ancillary devices can be connected to the Firstar Dental Unit by means of standard ISO 9168-20 connections including but not limited to: pneumatic handpieces, electric micromotors and handpieces, air/water syringes, piezo or magnetostrictive dental scalers, curing lights, intraoral cameras, saliva ejectors, and high volume evacuators. 24VAC power supplied from the Junction Box Power Supply can be used to power electrically operated ancillary equipment such as electrical handpieces, dental does not manufacture the aforementioned devices except for the air/water syringes, saliva ejectors, and high volume evacuators.

The document provided is a 510(k) Pre-market Notification from the FDA for the Firstar Dental Unit. It describes the device, its intended use, and a comparison to a predicate device. However, it does not contain the detailed information about specific acceptance criteria, reported device performance data, sample sizes, ground truth establishment, or clinical study specifics that you are requesting.

The document only states:

• Non-Clinical and/or Clinical Tests Summary & Conclusions: "Non-Clinical verification and validation tests have been performed with regards to the intended use, requirement specifications and the risk management results. The non-clinical testing was performed to demonstrate verification testing in conformance with the acceptance criteria of test methods and recognized consensus standards shown below."
• Standards Applied:
  • IEC 80601-2-60:2019 Medical electrical equipment — Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment.
  • ISO 7494-1:2018 Dentistry Stationary dental units and dental patient chairs Part 1: General requirements.
  • ISO 7494-2:2015 Dentistry Dental units Part 2: Air, water, suction and wastewater systems.
  • ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
• Conclusion: "The test results demonstrate that the Firstar Dental Unit conforms with the relevant FDA-recognized consensus standards and guidance documents and meets the acceptance criteria. Therefore, the subject device, Firstar Dental Unit, is substantially equivalent to the predicate device."

Based on the provided document, I cannot fulfill your request for detailed information regarding acceptance criteria and study particulars because the document only states that non-clinical verification and validation tests were performed and met acceptance criteria based on recognized consensus standards, but it does not provide the specifics of those criteria or the study results.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for the test set or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for the test set.
5. Information about a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, effect size with or without AI-assistance.
6. Information if a standalone (algorithm only) performance study was done.
7. The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This document is a regulatory clearance letter, not a detailed study report. Such specific information would typically be found in the full 510(k) submission, which is not publicly available in this detail, or in a separate clinical study report.

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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 Dental Unit(model: Mare) 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 professional in the field of general dentistry. Dental Unit (model: Mare) consists of dental chair, arm dentist unit, assistant's unit, dental light, cuspidor, water unit, and multi-function foot control. It mainly relies on electricity, compressed air, water to achieve all functions. Various ancillary dental devices can be connected to the Dental Unit (model: Mare) which are attached by means of industry standard ISO connections. The ancillary dental devices include pneumatic handpieces, 3-way syringe, strong suction and weak suction vacuum instruments. The ancillary dental devices include 3-way syringe, strong suction and weak suction vacuum instruments are 510k clarence in the K142206. Based on Safety does not manufacture pneumatic handpieces, the pneumatic handpieces shall be purchased by the enduser. The recommended pneumatic handpieces are 510(k) clearance K170229 and K170236, which are held by GUANGDONG JINME MEDICAL TECHNOLOGY CO., LTD. None of the Dental Unit (model: Mare), parts or accessories are provided sterile.

This document is a 510(k) premarket notification for a dental unit, indicating it's primarily a regulatory submission for device clearance. It does not contain the detailed acceptance criteria and study results typically found in reports specifically designed to demonstrate device performance against such criteria for AI/ML devices.

The document discusses the substantial equivalence of the "Dental Unit: model Mare" to a predicate device (K142206). The "acceptance criteria" here refers to the compliance with recognized consensus standards for medical devices and the demonstration of safety and effectiveness through non-clinical testing.

Here's an attempt to extract the requested information based on the provided text, with the understanding that it's a regulatory submission and not a performance study report:

1. A table of acceptance criteria and the reported device performance

The "acceptance criteria" for a medical device in a 510(k) submission are typically compliance with recognized standards. The "reported device performance" is the statement that the device meets these standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document describes non-clinical testing against standards for a physical medical device (dental unit), not an AI/ML diagnostic or prognostic tool. Therefore, the concept of a "test set" in the context of data used for algorithm evaluation (as implied by the question) is not applicable here. The testing involves physical testing of the device itself to conform to engineering and safety standards. No information on data provenance (country, retrospective/prospective) is provided as it's not relevant for this type of 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 not an AI/ML device requiring expert-established ground truth for a test set. The "ground truth" is established by the specifications of the recognized consensus standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not an AI/ML device requiring adjudication of a test set.

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. This document explicitly states in Section 8: "There was no clinical testing performed." This is for a dental unit, not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical dental unit, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For this device, the "ground truth" is defined by the technical specifications and requirements outlined in the referenced international and national consensus standards (e.g., IEC 60601-1 for electrical safety, ISO 7494-1 for dental unit general requirements). Compliance with these standards is the ground truth for performance.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

Not applicable. This is a physical medical device, not an AI/ML model.

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The BluTube@Dental Unit Water Purification Cartridge is for use on dental unit water lines attached to the dynamic dental instruments, i.e., high-speed handpiece, three-way airwater syringe and ultrasonic scaler. This cartridge in conjunction with currently recommended practices regarding sterilization and flushing of dental instruments reduces bacteria from the water supplied to the instruments to less than 200 CFU/mL, a level that will meet or exceed the current American Dental Association (ADA) recommendations for water quality.

BluTube® is a dental unit waterline purification cartridge intended for use at dental offices to reduce microbial bioburden in dental unit waterlines (DUWLs). BluTube® is placed in-line with the pick-up tube of the water supply bottle of a dental operative unit (DOU). Once installed, water flows into the device and through the iodinated resin chamber. Bacterial populations in the treated water are reduced through the antimicrobial action of iodine, which is released from the iodinated resin and into the treated water. Treated water expelled from BluTube® can be used as an irrigant/coolant for nonsurgical dental procedures and is appropriate for use in dental instruments like air/water syringes or high-speed handpieces.

The FDA 510(k) summary for the BluTube® Dental Unit Water Purification Cartridge (K232393) describes the acceptance criteria and the study that proves the device meets them. This device is intended to reduce bacterial populations in dental unit waterlines (DUWLs).

1. Table of Acceptance Criteria and Reported Device Performance

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The Forest Dental Units are intended to serve as a base for ancillary dental devices and accessories by providing air, water, vacuum, and low voltage electrical power to hand-held dental instruments. The Forest Dental Units are intended for use by dental practitioners to provide diagnostic treatment to dental patients in a clinical environment.

The Forest Dental Unit serves as a base for ancillary dental devices and accessories by providing air, water, vacuum, and low voltage electrical power to hand-held dental instruments. The controls are contained in a Doctor's Unit, Assistant's Instrumentation Unit, Duo Unit (both Doctor's and Assistant's Control) and Cuspidor and are configured in a variety of mounts. Additional accessory items include a pneumatic unit foot control, utility center (aka junction box) that houses a power supply and air/water regulators, hoses, trays, and mounting assemblies. The dental unit is supplied air and water from the utility connections through air/water regulators via the umbilical chase. The dental unit is supplied SELV-24VAC from the output of the power supply, also routed through the umbilical chase and terminated on an internal terminal strip.

This document is a 510(k) Premarket Notification for the "Forest Dental Unit," a Class I device. The submission aims to demonstrate substantial equivalence to a predicate device, the "SPIRIT – K143696" dental delivery unit manufactured by Pelton & Crane.

Here's an analysis of the provided information concerning acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal, explicit table of "acceptance criteria" in the traditional sense of measurable performance metrics with pass/fail thresholds. Instead, it relies on demonstrating equivalence to a predicate device and compliance with various standards. The "reported device performance" is largely communicated through declarations of compliance with these standards and the successful outcome of testing.

However, we can infer some "acceptance criteria" from the comparative table (Table 5.2) and the descriptions of testing performed.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in terms of patient data or a specific number of devices tested in a clinical trial setting. The evaluation is primarily based on:

• Engineering and Performance Testing: This involves testing physical devices (Forest Dental Unit models) against established standards (e.g., electrical safety, mechanical, biocompatibility, sterilization, cleaning, waterline disinfection). The number of individual units subjected to each specific test is not detailed, but it's implied that representative samples were tested to demonstrate compliance.
• Predicate Comparison: The comparison is made against the specifications and known performance of the Pelton & Crane Spirit 1500 (K143696) dental operative unit.

Therefore, the concept of "data provenance" (country of origin, retrospective/prospective) related to a patient-based test set is not applicable here as no clinical study with human subjects or patient data is described. The data provenance is from laboratory and engineering testing of the device components and systems.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not applicable. The "ground truth" for this type of submission is established by engineering standards, regulatory requirements, and the characteristics of the predicate device. There is no mention of experts being used to establish ground truth for a clinical test set, as no such clinical test set is described. The compliance with standards and the demonstration of substantial equivalence are likely evaluated by internal qualified personnel (engineers, quality assurance) and potentially third-party testing labs.

4. Adjudication Method for the Test Set

This information is not applicable, as there is no clinical test set with human subjects and associated interpretations that would require an adjudication method. The evaluation method relies on objective measurements against engineering standards and a direct comparison to the predicate device's specifications.

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

This information is not applicable. The Forest Dental Unit is a physical dental care delivery system, not an AI-powered diagnostic or therapeutic device that would involve "human readers" or AI assistance.

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

This information is not applicable, as the device is not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this submission is multi-faceted and derived from:

• Engineering Standards: Compliance with recognized international and national standards (e.g., ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 80601-2-60, ISO 7494-1, ISO 7494-2, ISO 14971, IEC 62366, ISO 10993-1, ISO 10993-5, ISO 17655-1, ISO 16954). The pass/fail criteria for these tests define the "ground truth" for performance and safety.
• Predicate Device Specifications: The detailed characteristics and performance of the legally marketed predicate device (Pelton & Crane Spirit 1500, K143696) serve as a benchmark for substantial equivalence.
• Biocompatibility/Material Safety: EPA standards for drinking water and established ISO standards for biocompatibility (e.g., cytotoxicity, irritation) define the "ground truth" for material safety.

8. The Sample Size for the Training Set

This information is not applicable. The Forest Dental Unit is a physical medical device, not a machine learning or AI model, and therefore does not involve a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no training set for this device.

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The Vanguard 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.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA for a dental unit. It does not contain any information about acceptance criteria or a study proving that an AI/ML device meets those criteria.

The document solely focuses on:

• Device: Vanguard Dental Unit
• Regulation Number: 21 CFR 872.6640 (Dental Operative Unit and Accessories)
• Regulatory Class: Class I
• Product Code: EIA
• FDA Determination: Substantially equivalent to legally marketed predicate devices.
• Indications for Use: To supply power to and serve as a base for dental devices and accessories, intended for use in dental clinics/offices by trained personnel, and attached to a dental chair.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for an AI/ML device.

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Evogue Dental Unit series are intended for the Dentists, and Dental assistants for traditional and normal patient treatment procedures in the dental operatory.

This product is an active therapeutic device intended to administer or exchange energy of electric, air and water for the exclusive use for diagnoses, treatments and relative procedures of dentistry, and its characteristic is not in a potentially hazardous way between such energy and human body, taking account of the nature, the density and site of application of the energy. The product must be operated or handled by the qualified dentists or by dental staffs under the supervision of the dentist. Such dentists or dental staffs should instruct and/or assist the patients to approach to and leave from the product. Patients should not be allowed to operate or handle the product unless he/she is so instructed. The air unit system uses compressed air to drive air motor and air scaler. The new Evogue Dental Unit is air unit system. The function and components used for Evogue Dental Unit are very similar to X-Calibur unit (Belmont Model 2000 Series, K000799). Though the Evogue Dental Unit is typical air system, it does have upgrade ability to use micro motor with external touch pad (MX2 Optima) and integrated type electric scaler (Cavitron). The foot control regulates drive air to the active handpiece to control the rotation speed of turbine and air motor. Also controls the frequency of air scaler. It provides an air signal that activates air coolant and water coolant flow. The foot control is equipped with a wet/dry toggle to turn the water coolant on or off.

Here's an analysis of the provided text regarding the Evogue Dental Unit, focusing on the acceptance criteria and the study that proves the device meets those criteria:

Based on the provided document, there is no study that proves the device meets specific performance acceptance criteria in the traditional sense of a clinical or analytical performance study.

The document is a 510(k) Premarket Notification, which primarily focuses on demonstrating substantial equivalence to a previously marketed predicate device. This means the manufacturer is asserting their new device is as safe and effective as a legally marketed device and does not require a new Pre-Market Approval (PMA) process.

Instead of a study proving a device meets performance criteria, the document refers to performance standards applied, which are international standards (ISO and IEC) that the device should comply with or was tested against to ensure its safety and basic functionality.

Therefore, many of your requested points will either be "Not Applicable" or inferable from the context of a 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by Applied Standards):

Summary of Device Performance (from the 510(k) perspective):

The Evogue Dental Unit is represented as having the same intended use and technology characteristics as the predicate device (Belmont Unit, Model 2000 Series). The conclusion drawn by the manufacturer is that the "proposed device is substantially equivalent to the noted predicate," implying that its performance is comparable and acceptable for the given indication based on compliance with the listed performance standards and the comparison of features.

Detailed Answers to Your Specific Questions:

1. A table of acceptance criteria and the reported device performance:

   • See the table above. The "acceptance criteria" here are the requirements outlined in the cited international standards (IEC 60601-1-2, ISO 7405, ISO 7494-1, ISO 7494-2, ISO 9168, ISO 14457) and the stated "intended use." The "reported device performance" is a general affirmation that the device meets these standards and functions equivalently to the predicate. Specific quantitative performance metrics are not provided in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not Applicable (N/A) / Not provided. This document does not describe a clinical or performance study with a "test set" in terms of patient data or a specific number of units tested to achieve a statistical outcome. The testing performed would have been against the cited engineering/material standards, typically involving a representative number of units or materials for compliance testing, but the specifics are not detailed in this 510(k) summary. The data provenance would be from internal testing by the manufacturer, likely in Japan (country of origin of Takara Belmont Corporation, LTD).

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):

   • N/A. This is not a study requiring expert-established ground truth on diagnostic or clinical outcomes. The "ground truth" for the device's safety and effectiveness relies on its compliance with established engineering and biocompatibility standards, and its functional similarity to a predicate device. This typically involves engineers and quality control personnel.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • N/A. Adjudication methods like 2+1 or 3+1 are used in clinical trials to resolve discrepancies in expert interpretations of medical data. This type of study was not conducted for this 510(k) submission.

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:

   • N/A. This device (a dental operative unit) is not an AI-powered diagnostic tool, and no MRMC study was performed. The concept of "human readers improving with AI assistance" is entirely irrelevant to this device submission.

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

   • N/A. This device does not involve an algorithm that performs tasks independently. It's a manual dental unit operated by humans (dentists, hygienists, assistants).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • The "ground truth" for this 510(k) submission is primarily based on:
     • Compliance with recognized international standards (engineering, electrical safety, biocompatibility, mechanical function). This is established through laboratory testing.
     • Demonstration of substantial equivalence to a predicate device. This is established through a feature-by-feature comparison and by confirming the new device shares the same fundamental technology and intended use as the predicate.
     • Manufacturer's internal testing and quality control data to ensure the device meets its design specifications and the applied standards.

8. The sample size for the training set:

   • N/A. This device is not an AI/machine learning device that requires a "training set."

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

   • N/A. As there is no training set, this question is not applicable.

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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 proposed devices Dental Unit are well equipped dental unit, which are intended to supply power to and serve as a base for dental devices and accessories. They are intended for use in the dental clinic/office environment and used by trained dentists and/or dental technicians and assistants. The products are attached with dental chair.

The proposed devices include two models. U300 and U500. Both of the two models mainly consist of instruments, instrument arm tray, cabinet group, operation light arm, assistant position, pedal switch, and patient chair.

The provided document is a 510(k) summary for a medical device called "Dental Unit." It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of document typically focuses on comparing the new device to existing ones based on technical specifications and safety standards, rather than clinical performance or diagnostic accuracy studies.

Therefore, the information regarding acceptance criteria and a study to prove the device meets these criteria is limited to non-clinical tests and compliance with safety and performance standards. There is no mention of studies involving human subjects, AI assistance, expert ground truth, or MRMC comparative effectiveness studies.

Here's the information extracted from the document:

1. A table of acceptance criteria and the reported device performance:

The document presents a comparison table between the proposed device (Dental Unit U300, U500) and the predicate device (Dental Unit with Chair S2310) across several technical characteristics and standards. The "acceptance criteria" can be inferred as compliance with the listed standards and achieving similar technical specifications to the predicate device.

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

The document describes non-clinical tests conducted to verify that the proposed device met design specifications and was substantially equivalent. It lists several international standards to which the device was tested for compliance (e.g., IEC 60601-1, IEC 60601-1-2, ISO7494-1, ISO7494-2, ISO 6875, ISO 10993-5, ISO 10993-10).

• Sample size: Not applicable in the context of clinical test sets as no clinical study is mentioned. The tests were likely performed on a limited number of device units (e.g., prototypes or production samples).
• Data provenance: Not explicitly stated as it's not a clinical data set. The tests were conducted by the manufacturer or accredited testing laboratories as part of verifying compliance with standards.

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

Not applicable. The "ground truth" for the non-clinical tests is established by the specified requirements of the international safety and performance standards themselves. There is no mention of experts establishing ground truth in a clinical sense.

4. Adjudication method for the test set:

Not applicable. This concept applies to clinical studies where different expert opinions on a case need to be resolved. For non-clinical device testing, the outcome is typically a pass/fail against a specific standard or specification.

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, an MRMC comparative effectiveness study was not done. The device is a "Dental Unit," which is a physical piece of equipment for dental procedures, not an AI-powered diagnostic or assistive tool for human readers.

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

No, a standalone performance study in the context of an algorithm or AI was not done. The device is a traditional dental unit.

7. The type of ground truth used:

For the non-clinical tests, the "ground truth" is defined by the technical specifications outlined in the international standards (e.g., IEC 60601-1 for electrical safety, ISO7494-1 for general dental unit requirements, ISO 10993 for biocompatibility). The device either complies with these standards or it does not.

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.

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