(27 days)
The AcuCam Concept IVF"T Digital Dental Intraoral Camera System is a dental imaging system intended for use by health professionals in taking intraoral and extraoral images of dental anatomy.
The DENTSPLY International, Gendex Division AcuCam Concept IVf"" Digital Dental Intraoral Camera System is an imaging device that is intended for use in taking intraoral and extraoral images. The DENTSPLY International, Gendex Division AcuCam Concept IVF™™ Digital Dental Intraoral Camera System is comprised of the following main components: Docking station (wall mounted, or counter top), Handpiece assembly with monocoil cable. Optional components: Video monitor, Printer.
The provided text does not contain detailed acceptance criteria or a specific study that proves the device meets those criteria in a quantitative manner as typically expected for modern medical device submissions. Instead, it describes a 510(k) summary for the AcuCam Concept IVF™T Digital Dental Intraoral Camera System, focusing on demonstrating substantial equivalence to predicate devices rather than proving specific performance metrics against pre-defined acceptance criteria through a standalone study.
However, based on the information provided, we can infer some aspects and highlight what is missing.
1. Table of Acceptance Criteria and Reported Device Performance
No specific quantitative acceptance criteria or device performance metrics are explicitly stated in the provided document. The document primarily focuses on demonstrating "Safety and Effectiveness" through a list of general testing and analysis types, and then concludes substantial equivalence to predicate devices.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| (No specific quantitative criteria provided) | Performance testing to meet product specifications |
| Software testing to validate software design/performance | |
| Effective clinical image exposures | |
| Hazard analysis including risk level and solution | |
| Same indications for use as predicate devices |
Detailed Explanation of What is Missing:
A typical acceptance criteria table would include quantifiable targets (e.g., image resolution, magnification accuracy, color fidelity, illumination uniformity, signal-to-noise ratio, software error rates, cybersecurity penetration test results, etc.) and specific test outcomes directly demonstrating that these targets were met. The document only lists general categories of testing performed.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of an algorithm or AI model, nor does it provide a sample size or data provenance (country of origin, retrospective/prospective).
- Sample Size for Test Set: Not applicable or not specified.
- Data Provenance: Not applicable or not specified.
Explanation: The device is an intraoral camera system, not an AI/algorithm-based diagnostic device. Therefore, the concept of a "test set" for algorithm evaluation isn't relevant in the context of this 510(k) submission. "Effective clinical image exposures" are mentioned, but no details on the number of images or patients are given.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the device is an imaging system and not an AI/algorithm that requires expert consensus for ground truth establishment.
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable.
4. Adjudication Method
This information is not applicable as the device is not an AI/algorithm that would typically involve an adjudication process for its output.
- Adjudication Method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted or reported. The device is a direct imaging tool, not an AI-assisted diagnostic aid that would improve human reader performance.
- MRMC Study Conducted: No.
- Effect Size of Human Readers with/without AI: Not applicable.
6. Standalone Performance Study
A standalone performance study was conducted, but the results are not quantitatively detailed. The "performance testing to meet product specifications" and "software testing to validate software design / performance" are forms of standalone testing. However, no specific metrics or results are provided in the summary.
- Standalone Study Conducted: Yes, implied by "Performance testing to meet product/specifications" and "Software testing to validate software design / performance."
- Results: Not quantitatively specified in the provided summary.
7. Type of Ground Truth Used
The concept of "ground truth" (e.g., pathology, outcomes data) as it pertains to evaluating diagnostic algorithm accuracy is not directly applicable here. For an imaging device, the "ground truth" implicitly refers to the accuracy and fidelity of the captured image in representing the actual dental anatomy. This is assessed through physical performance tests and user observation ("effective clinical image exposures").
- Type of Ground Truth: Not explicitly stated in the AI/diagnostic algorithm sense. For an imaging system, it would be the accurate visual representation of the actual dental anatomy, assessed through engineering and clinical performance evaluations.
8. Sample Size for the Training Set
This information is not applicable as the device is not an AI/algorithm that uses a "training set."
- Sample Size for Training Set: Not applicable.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable.
- How Ground Truth for Training Set was Established: Not applicable.
Summary of the Study (as described in the document):
The document describes the submission of a 510(k) Premarket Notification for the AcuCam Concept IVF™T Digital Dental Intraoral Camera System. The "study" described is essentially the process of demonstrating substantial equivalence to legally marketed predicate devices.
Key components of this demonstration include:
- Performance testing: To ensure the device meets its own product specifications. Specific metrics or results are not provided.
- Software testing: To validate the design and performance of the software. Specific details are not provided.
- Effective clinical image exposures: Implies some form of clinical evaluation of the images produced, but no case numbers or outcomes are detailed.
- Hazard analysis: To identify and mitigate risks.
- Comparison to predicate devices: The core argument for substantial equivalence is based on the device sharing "the same indications for use, similar materials, design, operational, and functional features" as the established predicate devices (Gendex AcuCam Concept IV, Vistacam Omni and Vistacam Omni (IC), and Ultracam).
The conclusion from these activities is that the device is "safe and effective when used as labeled" and "Substantially Equivalent" to the predicate devices. This type of submission does not typically include a detailed, quantitative clinical study report with specific acceptance criteria and performance metrics for novel AI algorithms, but rather focuses on demonstrating that the new device operates similarly and safely to existing, legally marketed devices.
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.