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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 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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The Dental Unit with Chair is intended to supply power to and serve as a base for dental devices and accessories. It is intended for use in the dental clinic/office environment and used by trained dentists and/or dental technicians and assistants. This product is attached with a dental chair.

The proposed device Dental Unit with Chair S2310 is a well equipped with two hands operation dental unit, which 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 device is modification device to Dental Unit with Chair S2318 (K080438). It and the existed device share the same intended use, similar configuration, safety and performance.

The proposed device consists of connection box, assistant holder, foot control, telescopic tray arm, instrument tray and operating light.

The provided text describes a 510(k) submission for a Dental Unit with Chair (Model S2310) and does not contain detailed information about acceptance criteria or a study proving that a device meets those criteria in the context of AI/ML performance.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device (Dental Unit with Chair S2318, K080438) through non-clinical bench testing and comparison of specifications.

Therefore, many of the questions regarding acceptance criteria, study design, sample size, ground truth, and expert involvement for AI/ML performance cannot be answered from the provided text.

Here's an analysis based on the information available:

Acceptance Criteria and Device Performance (as presented in the document)

The "acceptance criteria" in this context are implicitly met if the proposed device's performance aligns with relevant safety and technical standards and is substantially equivalent to the predicate device.

The study that proves the device meets the acceptance criteria is the non-clinical bench testing comparing the proposed device to the predicate device and assessing compliance with various international standards. The document states: "Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards..."

Information Not Applicable or Not Provided in the Document:

The following information is typically relevant for AI/ML-driven medical devices but is not present in this submission, as it concerns a traditional medical device (Dental Unit with Chair) and not an AI/ML algorithm.

2. Sample size used for the test set and the data provenance: Not applicable. This was a physical device undergoing bench testing, not an AI/ML model evaluated on a data set.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth as understood in AI/ML (e.g., expert labels on images) is not a concept for this type of device submission. Compliance with standards and functional tests determined "truth."
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done...: Not applicable. This type of study evaluates human performance with and without AI assistance, which is not relevant for a dental unit.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this submission was successful adherence to established engineering standards (e.g., IEC, ISO) and the functional specifications of the predicate device, demonstrated through bench testing.
8. The sample size for the training set: Not applicable. This device does not use a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes a 510(k) submission for a conventional medical device (Dental Unit with Chair) where "acceptance criteria" are met through compliance with established safety and performance standards and demonstrating substantial equivalence to a legally marketed predicate device via non-clinical bench testing. It does not involve AI/ML technology, and therefore, the related questions for AI/ML device evaluation are not addressed.

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The Dental Unit with Chair is intended to supply power to and serve as a base for dental devices and accessories. It is intended for use in the dental clinic/office environment and used by trained dentists and/or dental technicians and assistants. This product is attached with a dental chair.

The applicant device of Dental Unit with Chair contains 6 types: S2300, S2305, S2308, S2315, S2318 and S2320. All of these types follow the same design principle and intended use, and comply with ISO7494-1, ISO7494-2 and ISO6875. The connection of these types complies with ISO9168.

All of these types of applicant device consist of similar components with similar function and different appearance, these components include: main box, connection box, assistant holder, foot control, telescopic tray arm, instrument tray, operating light.

The provided text is for a 510(k) summary for a "Dental Unit with Chair" (K080438). This type of device is a Class I product, and the submission primarily focuses on demonstrating substantial equivalence to a predicate device based on common design principles, adherence to recognized standards, and safety considerations. It does not involve a study proving performance against specific acceptance criteria in the way a medical imaging AI or diagnostic device would.

Therefore, many of the requested categories (like sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, etc.) are not applicable to this type of regulatory submission. The "acceptance criteria" here are compliance with recognized standards and demonstration of substantial equivalence.

Here's a breakdown based on the available information:

Acceptance Criteria and Device Performance for K080438 (Dental Unit with Chair)

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not Applicable. This is a hardware device submission focused on compliance with recognized standards and substantial equivalence, not performance against clinical test data. No specific "test set" in the context of clinical or algorithmic performance data was used.

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

• Not Applicable. See point 2. Ground truth in the context of clinical data is not relevant here. Compliance with standards is assessed through engineering tests and documentation.

4. Adjudication method for the test set:

• Not Applicable. See point 2.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. This device is a dental unit and chair, not an AI or diagnostic tool that would involve human readers or image interpretation.

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

• Not Applicable. This is a hardware device, not an algorithm.

7. The type of ground truth used:

• Engineering Standards and Predicate Device Characteristics: The "ground truth" for this submission is based on the requirements of recognized international and national standards (ISO, IEC, FDA guidance) and the specifications/performance of a previously cleared predicate device.

8. The sample size for the training set:

• Not Applicable. See point 2.

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

• Not Applicable. See point 2.

Summary Explanation:

This 510(k) submission (K080438) for a "Dental Unit with Chair" is a Class I medical device. For such devices, particularly those that are not complex diagnostic tools or AI-driven, the regulatory pathway primarily involves demonstrating substantial equivalence to an existing legally marketed predicate device. This demonstration is achieved by showing that the new device has the same intended use, similar design principles, and, crucially, complies with relevant recognized national and international consensus standards for safety and effectiveness (e.g., ISO, IEC).

The "study that proves the device meets the acceptance criteria" in this context refers to the manufacturer's internal testing and documentation verifying that the device (and its components, including software where applicable) meets the specifications outlined in the standards (e.g., electrical safety, biocompatibility, mechanical properties) and aligns with the design and features of the predicate device. There is no clinical trial, performance study with patient data, or AI algorithm validation involved.

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