(320 days)
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
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance/Compliance |
|---|---|---|
| Risk Management | ISO 14971 (Second Edition 2007-03-01) - Medical devices Application of risk management to medical devices. | Complies |
| Biocompatibility | AAMI ANSI ISO 10993-1:209/(R) 2013 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. | Complies |
| Electrical Safety | ANSI/AAMI ES60601-1:2005/(R)2012 (with C1:2009 (R)2012 and A2:2010/(R)2012) - Medical Electrical Equipment—Part 1: General requirements for basic safety and essential performance. | Complies |
| EMC | ISO 60601-1-2:2007 - Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility-Requirements and test. | Complies |
| Usability Engineering | IEC 62366 Edition 1.1 - Medical devices - Application of usability engineering to medical devices. | Complies |
| Dental Equipment Specific | IEC 80601-2-60:2012 - Medical electrical equipment Part 2-60: Particular requirements for basic safety and essential performance of dental equipment. | Complies |
| Software "Level of Concern" | Moderate level of concern for software controlling chair movement (slow, preprogrammed, limited by sensors/hard stops). | Software described as pre-programmed and activated by button, moves slowly, limited by stop sensors and mechanical hard stops to prevent exceeding pre-programmed range. |
| Substantial Equivalence | Demonstrated equivalence to predicate device (K071353) in intended use, material composition, fundamental scientific technology, principles of operation, and basic design. | Stated as demonstrated by DCI, ITL. |
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.
§ 872.6250 Dental chair and accessories.
(a)
Identification. A dental chair and accessories is a device, usually AC-powered, in which a patient sits. The device is intended to properly position a patient to perform dental procedures. A dental operative unit may be attached.(b)
Classification. Class I. The dental chair without the operative unit device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.