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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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The DCI Edge Dental Chair with operative unit is a device intended to position the patient in such a manner to provide to the dental practitioner visual and manual access to the oral cavity. This device should provide for the ergonomic necessities of most patients, both adults and children, throughout its range of movement. The device shall also be the means of supporting delivery systems for the purpose of standard dental procedures.

The DCI Edge Chair with Operative Unit is a dental chair with an operative unit attached. There are three main parts to the proposed device: a dental chair, dental light and dental chair has adjustable headrest, backrest, seat height and armrests. The dental chair unit consists of a floor box to which are attached a number of operative units: lights, cuspidor, cup filling device, control panel, and foot control. The instrument panel also includes a 3-way syringe and salvia ejector.

The provided documents describe a DCI Edge Dental Chair with Operative Unit (K151987), which is a medical device. However, the information provided does not contain acceptance criteria related to device performance in terms of diagnostic accuracy or a study proving it meets such criteria.

The context of this document is a 510(k) premarket notification for a Class I dental chair. Class I devices are generally low-risk and subject to general controls. The review process for such devices focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than extensive clinical efficacy or performance studies like those typically required for artificial intelligence (AI) or diagnostic devices.

Here's why the requested information cannot be fully provided based on the given text:

• Type of Device: A dental chair and operative unit is a mechanical device designed for positioning patients and supporting dental tools. It does not perform diagnostic functions, analyze data, or make clinical interpretations that would require metrics like sensitivity, specificity, accuracy, or a comparison to a "ground truth" derived from expert consensus or pathology.
• Regulatory Focus: The 510(k) summary (pages 3-5) and the FDA letter (pages 0-1) explicitly state the focus is on "substantial equivalence" to a predicate device (Foshion Chair Mounted Dental Unit K071353). This involves comparing intended use, technological characteristics, and safety standards, not diagnostic performance metrics.
• "Acceptance Criteria" in this context: For this device, "acceptance criteria" primarily relate to compliance with recognized performance standards for medical electrical equipment, biological evaluation, risk management, and usability engineering, as listed in Section 8 "Non Clinical Testing" (page 5). It does not refer to clinical performance metrics for diagnosis or prediction.
• "Study that proves the device meets the acceptance criteria": The "study" here is the non-clinical testing demonstrating compliance with the listed ISO/AAMI/IEC standards. This is a demonstration of safety and basic functionality, not clinical performance.

Therefore, many of the requested fields are not applicable to the information provided about this specific device.

However, I can extract the relevant information that is present in the document.

Summary of Information from the Document (where applicable):

Since the device is a dental chair and not an AI or diagnostic device, the requested table and many of the questions related to AI performance, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment are not applicable to this document.

1. Table of Acceptance Criteria and Reported Device Performance

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. The "testing" referred to is compliance with engineering and safety standards, not clinical performance testing with a "test set" of 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)

• Not Applicable. No ground truth for diagnostic or clinical performance was established, as this is a mechanical dental chair, not a diagnostic device.

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, 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-assisted diagnostic device.

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

• Not Applicable. This is not an algorithm. The software controls the chair's mechanical movements.

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

• Not Applicable.

8. The sample size for the training set

• Not Applicable. Training data for an AI algorithm is not relevant to this device.

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

• Not Applicable.

In conclusion, the provided documentation focuses on the safety and functional equivalence of a dental chair to existing products, rather than the performance metrics of a diagnostic or AI-driven device.

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The Foshion Chair Mounted Dental Unit is intended to supply power and serve as a base for dental devices and accessories. The product includes a dental chair, operating light, x-ray viewer, control panel, low and high speed turbine hand pieces, 3-way syringe and air foot control. The unit is intended for use in the dental office or clinic and is used by trained dentists and/or dental technicians and assistants.

The Foshion Chair Mounted Dental Unit is a dental operative unit attached to a dental chair. There are three main parts to the product: a dental chair, a dental unit, and a stool for the dentist. The dental chair has adjustable headrest, backrest, seat with extension for leg support, and armrests. The dental unit consists of a floor box to which are attached a number of operative units: light, x-ray viewer, cuspidor, cup filling device, control panel, instrument tray, and foot control. The instrument panel also includes a 3-way syringe, saliva ejector, air suction, and handpiece attachments

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets those criteria.

The document is a 510(k) summary for a dental unit, and it focuses on demonstrating substantial equivalence to a predicate device, rather than providing performance data against specific acceptance criteria.

The key points from the provided text are:

• Device Name: Foshion Chair Mounted Dental Unit
• Intended Use: To supply power and serve as a base for dental devices and accessories in a dental office or clinic.
• Technological Characteristics: Similar to the predicate device.
• Conclusion: "There are no significant differences between the Foshion Chair Mounted Dental Unit and the predicate device; therefore, the proposed device does not raise any questions regarding safety and effectiveness." and "The Foshion Chair Mounted Dental Unit, as designed, is as safe and effective as the predicate device. Comparisons have been made to a legally marketed predicate device, and the device is determined to be substantially equivalent to the referenced predicate device currently on the market."

This type of submission (510(k)) often relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than conducting new performance studies against specific, quantitative acceptance criteria. Therefore, the requested information (acceptance criteria, study details, sample sizes, ground truth, MRMC study, etc.) is not present in this document.

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THESE DENTAL CHAIRS ARE USED SO THAT THE PATIENTS AT THE DENTIST OFFICE MAY SIT ON THEM WHILE THE DENTIST IS PERFORMING ROUTINE DENTAL EXAMS. THESE CHAIRS DO NOT HAVE ANY INSTRUMENTS THAT MAY BE USED ON THE PATIENT.

Not Found

I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study proving the device meets them. The document is a 510(k) clearance letter from the FDA for dental chairs, and it primarily discusses the regulatory approval process and legal compliance rather than detailed performance study results.

The document mentions:

• Device Name: Optima Plus "E" Dental Chair, "A" Dental Chair, Excel Chair
• Indications For Use: "THESE DENTAL CHAIRS ARE USED SO THAT THE PATIENTS AT THE DENTIST OFFICE MAY SIT ON THEM WHILE THE DENTIST IS PERFORMING ROUTINE DENTAL EXAMS. THESE CHAIRS DO NOT HAVE ANY INSTRUMENTS THAT MAY BE USED ON THE PATIENT."
• Regulatory Class: I
• Product Code: KLC

However, it does not provide any of the specific study details you requested, such as:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Training set sample size.
9. Ground truth establishment for the training set.

This type of information would typically be found in a detailed premarket submission summary or a separate clinical/performance study report, not in the FDA clearance letter itself.

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Ask a specific question about this device