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K5 is intended to supply power to and serve as a base for dental devices and accessories. This product is intended for use by dentist and dental assistance to assist dental treatment of patients for adjusting the position of the patient seat, operating the instruments, and supplying water into the oral cavity through a water line in dental clinical environments.

The K5 Cart, K5 Mount and K5 Swing are designed for dental treatment and are intended for dental use only and are intended for use by trained medical personnel only.

These devices consist of a foot controller, headrest, backrest, seat, armrest, doctor table, unit, dental light, auxiliary table and doctor stool.

These are an AC-powered dental operative unit with accessories, intended to supply power to and serve as a base for other dental devices. 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 unit functions.

The provided FDA 510(k) clearance letter and summary for the K5 Cart, K5 Mount, K5 Swing devices (K251491) indicate that these devices are Class I Dental Operative Units and Accessories. Class I devices are generally considered to be low-risk and often demonstrate substantial equivalence through non-clinical testing rather than extensive clinical studies.

The document extensively compares the proposed devices to a predicate device (K5, K233805) to establish substantial equivalence. It does not describe specific acceptance criteria in terms of performance metrics with numerical thresholds for the device's function as a whole. Instead, it relies on compliance with recognized consensus standards and a detailed comparison of technological characteristics.

Therefore, many of the requested details about acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity, or improvement over human readers) are not applicable or not explicitly stated in this type of 510(k) submission for a Class I mechanical device. The "acceptance criteria" here are primarily met by demonstrating compliance with safety and performance standards relevant to dental operative units and showing that any differences from the predicate device do not raise new questions of safety or effectiveness.

Here's an analysis based on the provided document, addressing the points where information is available and noting where it's not applicable for this type of device and submission.

Acceptance Criteria and Device Performance

As a Class I dental operative unit, the "acceptance criteria" are primarily established by compliance with recognized electrical safety, electromagnetic compatibility, and performance standards for dental equipment, along with demonstrating that any differences from a predicate device do not introduce new safety or effectiveness concerns. The performance is assessed qualitatively through compliance with these standards and by direct comparison of functionalities and specifications with the predicate device.

Table of Acceptance Criteria and Reported Device Performance

Study Details

It's important to differentiate that this 510(k) submission is for a mechanical/electrical dental operative unit, not an AI/software as a medical device (SaMD). Therefore, many of the questions related to AI performance metrics, clinical study design for accuracy/sensitivity, expert readers, and ground truth establishment (common for imaging AI) do not apply to this clearance. The "study" here is primarily a series of non-clinical tests and a detailed comparison to a predicate device.

1. Sample sizes used for the test set and the data provenance:

• Test Set Sample Size: Not applicable in the context of typical AI/imaging studies. Performance was demonstrated through compliance with recognized standards (IEC 60601-1, IEC 60601-1-2, IEC 80601-2-60, IEC 60601-1-6, ISO 7494-1, ISO 7494-2) and direct engineering measurements and comparisons. This involved testing the physical device(s).
• Data Provenance: Not applicable in the sense of patient data. The testing involves engineering and safety evaluations of the manufactured devices.

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

• Not applicable. The device is a dental operative unit, not an AI diagnostic tool requiring expert-established ground truth from medical images. Compliance with engineering standards and functional specifications constitutes the "ground truth" for this device type.

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

• Not applicable. This is not a study involving human reader adjudication of diagnostic outputs.

4. 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 diagnostic or assistive device for human readers.

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

• Not applicable, as it's not an algorithm-based device in the diagnostic sense. The device performs its intended functions independently (e.g., moving chair, supplying water/air, powering instruments).

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

• For this device, "ground truth" is established by:
  • Compliance with recognized consensus standards: e.g., IEC 60601-1 (Electrical Safety), IEC 60601-1-2 (EMC), ISO 7494-1 (Dental Units), ISO 7494-2 (Dental Chairs).
  • Engineering specifications and measurements: Verifying that the device meets its design specifications for things like air pressure, water pressure, chair movement ranges, and patient load.

7. The sample size for the training set:

• Not applicable. This is not a machine learning/AI device requiring a training set.

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

• Not applicable. No training set is used.

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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 dental delivery system is a device intended to support the instruments used by the dental practitioner, delivering those instruments to an accessible position during a dental procedure. This device may control and be the means of delivering compressed air, water, vacuum and low voltage electricity to a variety of instruments commonly used in dental practice.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a Dental Delivery System Series 5 and 5 Plus.

This document does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The 510(k) letter primarily addresses the substantial equivalence of the device to legally marketed predicates and outlines regulatory requirements. It does not delve into specific performance metrics, clinical study design, or ground truth establishment for a medical device that relies on diagnostic performance (like an AI algorithm).

Therefore, based solely on the provided text, it is impossible to answer the questions regarding acceptance criteria and the study that proves the device meets them. The device described (Dental Delivery System Series 5 and 5 Plus) is a physical piece of dental equipment, not a diagnostic algorithm or AI software for which the requested performance metrics and study details would be relevant.

To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data for a diagnostic device, or a clinical study report.

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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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Luvis Chair 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 Luvis Chair (LC700C) includes a chair used by dentists to provide seating for patients during dental procedures. It is designed to position the patient during treatment. The chair consists of a seat, backrest, and armrests that can be adjusted to accommodate the patient's position. Additionally, it may feature a headrest to offer additional support. Dental unit chairs come equipped with various tools and attachments, including dental lights, suction devices, and air- water syringes. The chair's controls are usually located within reach of the dentist, allowing for quick adjustments during the procedure. The Luvis Chair is intended to supply power to and serve as a base for dental devices and accessories.

This document is a 510(k) Premarket Notification for a dental chair (Luvis Chair LC700C). However, it does not contain acceptance criteria or a study proving the device meets acceptance criteria in the manner requested.

Instead, it asserts substantial equivalence to a predicate device based on similar intended use, principles of operation, and technological characteristics. It lists various standards the device complies with for safety, performance, and biocompatibility.

Therefore, I cannot populate the table and answer the questions as requested because the specific information about acceptance criteria and detailed study results (like sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies) are not present in this 510(k) summary.

The document indicates that "the conducted tests, as well as all verification and validation activities, demonstrate that the design specifications and technological characteristics of the Luvis Chair (LC700C) meet applicable requirements and standards." It also states, "The subject device had been subjected to the applicable safety and performance testing before release to ensure the device meets all its specifications." However, it does not provide the specific acceptance criteria (e.g., "device must perform with X% accuracy for Y function") or the detailed results of these tests for comparison or to be presented in a table format.

Summary of what is present:

• Device Name: Luvis Chair (LC700C)
• Intended Use: To supply power to and serve as a base for dental devices and accessories. It includes a dental chair for use in a dental clinic environment by trained dental professionals.
• Predicate Device: Osstem Implant Co., Ltd. K3 (K183347)
• Reference Device: MeqaGen Implant Co., Ltd. N2 (K211556)
• Testing Conducted (Non-Clinical Test Summary):
  • Thermal, electrical, mechanical safety & Electromagnetic Compatibility (compliance with ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 80601-2-60)
  • Software Validations (basic documentation level, moderate level of concern, designed and developed according to a software development process, verified, and validated)
  • Biocompatibility (in vitro cytotoxicity test, oral mucosa irritation test, skin sensitization test; in accordance with ISO 10993-1 and ISO 7405)
  • Performance Test (in accordance with IEC 80601-2-60, ISO 7494-1, ISO 7494-2)
  • Cleaning and Sterilization Validation (in accordance with FDA guidance for reprocessing, ISO 17665-1, ISO TS 17665-2, ISO 16954, ISO 19458)
• Conclusion: The device meets applicable requirements and standards, and the differences from predicate devices do not raise new questions of safety and effectiveness.

Missing Information (and why it's missing from this document):

The request for a detailed table of acceptance criteria vs. reported performance, sample sizes for test/training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types are typical for AI/ML-enabled devices or those requiring specific performance metrics (e.g., diagnostic accuracy). This document is for a dental chair, which is a Class I medical device. For such devices, "acceptance criteria" are usually defined by compliance with recognized electrical safety, mechanical safety, biocompatibility, and performance standards (like the ISO and IEC standards listed). The "study" proving it meets these is often a series of engineering tests and validations against those standards, rather than clinical trials or AI performance evaluations with detailed ground truth analysis as would be done for a diagnostic or image analysis device.

Therefore, the requested information (points 1-9) in the format of specific performance metrics is not applicable or not provided in this regulatory submission for a dental chair.

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K5 is intended to supply power to and serve as a base for dental devices and accessories. This product includes a dental chair. The dental treatment unit is intended for use in the dental clinic environment and is used by trained dentists and/or dental assistants.

A Dental Unit and Chair K5 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. K5 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 medical device, the K5, which is a dental operative unit and accessories, including a dental chair. It is a 510(k) submission to the FDA. However, the document does not contain acceptance criteria or a study that proves the device meets those criteria in the context of performance metrics like sensitivity, specificity, accuracy, or reader performance with or without AI assistance.

The document focuses on demonstrating substantial equivalence to a predicate device (K3, K183347) based on indications for use, technological characteristics, and compliance with various safety and performance standards.

Here's a breakdown of the requested information based on the provided text, highlighting where information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not present in the document. The document discusses compliance with safety standards and functional equivalence to a predicate device, but it does not specify quantitative acceptance criteria for features like diagnostic accuracy, sensitivity, or specificity, nor does it provide a table of reported device performance against such criteria. The device is a dental operative unit, not an AI/diagnostic software, so these types of performance metrics are not applicable in this context.

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

This information is not applicable in the context of AI/diagnostic software. The document describes non-clinical testing for areas like biocompatibility, cleaning validation, electrical safety, electromagnetic compatibility, and software verification/validation. These tests do not involve a "test set" of clinical data for performance evaluation in the way an AI algorithm would.

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

This information is not applicable. The device is a dental operative unit, and its evaluation focuses on safety, functionality, and compliance with engineering standards, not on diagnostic performance or interpretation by experts to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable. As there is no "test set" of clinical data for diagnostic performance requiring expert interpretation, no adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices, particularly AI-powered ones, to assess how human readers' performance changes with AI assistance. The K5 is a dental operative unit, not a diagnostic AI tool.

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 K5 is a physical dental unit with electronics and software for controlling its functions, not an AI algorithm intended for standalone performance evaluation in a diagnostic capacity.

7. The Type of Ground Truth Used

This information is not applicable in the context of diagnostic accuracy. The "ground truth" for the K5 device's evaluation is primarily based on:

• Compliance with recognized standards (e.g., IEC 60601-1 for electrical safety, ISO 10993-1 for biocompatibility).
• Functional performance (e.g., chair movement, fluid delivery, suction) as designed and tested against specifications.

8. The Sample Size for the Training Set

This information is not applicable. There is no mention of a "training set" in the context of machine learning or AI algorithms because the K5 is a dental operative unit, not an AI-driven diagnostic or analytical tool.

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

This information is not applicable for the same reasons as point 8.

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N2 is intended to supply power to and serve as a base for dental devices and accessories. This 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 N2 is a dental treatment unit in accordance with IEC 80601-2-60 and designed for dental treatment of children and adults. 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.

The N2 is an AC-powered dental operative unit with accessories, intended to supply power to and server as a base for dental devices and accessories by providing air, water, vacuum and low voltage electrical power to dental instruments and dental handpieces. 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 unit functions.

The subject device has three types, Cart type, Mount type and Continental type which consists of chairs, unit, table, seat, stool, 3-way syringe, monitor arm, foot control and console.

The N2 dental operative unit is primarily evaluated against safety and performance standards for dental equipment and medical electrical equipment. As such, the acceptance criteria and study designs differ significantly from those for AI-powered diagnostic or prognostic devices.

Here's an analysis of the provided information, structured to address your specific points where applicable, and noting where the information is not relevant to this type of device:

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

For the N2 dental operative unit, the "acceptance criteria" are compliance with established international and FDA-recognized standards for electrical safety, electromagnetic compatibility, biocompatibility, cleaning/sterilization validation, and software validation. The reported device performance is that it complied with 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)

For this type of device, "test set" and "data provenance" don't apply in the way they do for AI/diagnostic devices. The evaluation of N2 relies on bench testing and compliance with recognized standards.

• Bench Testing: This involves testing the physical device and its components in a controlled laboratory environment against specified parameters (e.g., electrical measurements, pressure limits, temperature control, mechanical movements). The "sample size" would typically be a representative number of units from a production batch or prototypes. The document doesn't specify the exact number of units tested for each standard, but it's understood to be sufficient for demonstrating compliance.
• Data Provenance: This is not relevant. The testing is performed in accordance with international standards, and the results are primarily engineering and performance measurements, not patient data.

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)

This is not applicable to the N2 device. "Ground truth" in the context of diagnostic performance (e.g., presence/absence of a disease) is established by expert consensus, pathology, or outcomes data. For a dental operative unit, the "ground truth" is adherence to engineering specifications and safety standards, which is verified through objective measurements and test procedures, not expert interpretation of clinical data.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies where human readers interpret medical images or data and their decisions need to be reconciled to establish a consensus ground truth. For equipment like N2, compliance is determined by passing objective tests against defined standards, not by human interpretation.

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 is not applicable. The N2 is a dental operative unit (a piece of hardware for dental procedures), not an AI-assisted diagnostic or therapeutic device that would involve human readers or image interpretation. Therefore, an MRMC study is completely irrelevant.

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

This is not applicable. The N2 device is not an algorithm. Its "standalone performance" is its ability to function safely and effectively as a dental operative unit, which is demonstrated through component testing, system integration testing, and compliance with the listed standards. The software components are for controlling the unit's functions, not for standalone diagnostic or analytical tasks.

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

As mentioned in point 3, the concept of "ground truth" in the context of expert consensus, pathology, or outcomes data is not applicable to this device. The "truth" for this device's safety and effectiveness is its conformance to established engineering and medical device standards through objective measurements and validated processes.

8. The sample size for the training set

This is not applicable. "Training set" refers to data used to train machine learning models. The N2 device is a hardware unit with embedded software for control; it does not utilize machine learning in its described function.

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

This is not applicable for the same reasons as point 8.

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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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