(10 days)
Arges Imaging Contrast is indicated as a coating medium for optical impressions. It aids in intraoral topographical recordings of prepared and unprepared teeth and their surroundings.
The Arges Imaging Contrast Spray is a pigment suspension in ethanol with a fluorinated hydrocarbon propellant. The Arges Imaging Contrast Spray is a coating medium which is applied to teeth and surrounding areas. A 3D impression of the coated dentition is taken using a commercially available CAD/CAM system. Upon completion of the impression scan, the patient's mouth if rinsed and suctioned to remove the Arges Imaging Contrast Spray.
The provided text describes a medical device called "Arges Imaging Contrast Spray" and its 510(k) submission. However, it does not include detailed information about acceptance criteria, a specific study proving the device meets those criteria, or most of the other requested elements. This submission focuses on demonstrating substantial equivalence to a predicate device (CEREC Opti Spray) rather than providing extensive performance data against specific, quantitative acceptance criteria.
Here's an analysis based on the information available in the text, with significant gaps for the parts not provided:
Acceptance Criteria and Device Performance Study Analysis
The provided 510(k) summary for the "Arges Imaging Contrast Spray" focuses on establishing substantial equivalence to a predicate device, the CEREC Opti Spray (K080882). As such, it does not present a typical study design with explicit, quantitative acceptance criteria and detailed performance results in the way one might expect for a novel high-risk device or an AI/software as a medical device.
Instead, the "acceptance criteria" are implicitly met by demonstrating that the device has comparable technological characteristics, indications for use, and performance to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this 510(k) submission, explicit quantitative acceptance criteria for performance are not provided. The document states that the device "performed as intended with acceptable results" which points to qualitative assessment and comparison rather than specific numerical thresholds.
| Acceptance Criterion (Implicitly derived from predicate comparison) | Reported Device Performance (from text) |
|---|---|
| Biocompatibility | "biocompatible for its intended use" |
| Dimensional verification | "performed as intended with acceptable results" |
| Functional testing | "performed as intended with acceptable results" |
| Substantial equivalence in: | "substantially equivalent in intended use, principal of operation and technological characteristics" |
| - Indications for Use | "same technological characteristics" and "Substantially Equivalent To" predicate |
| - Basic design/configuration | "same technological characteristics" and "Substantially Equivalent To" predicate |
| - Where used | "same technological characteristics" and "Substantially Equivalent To" predicate |
| - Target population | "same technological characteristics" and "Substantially Equivalent To" predicate |
| - Delivery method | "same technological characteristics" and "Substantially Equivalent To" predicate |
2. Sample size used for the test set and the data provenance
Not provided. The document mentions "Bench testing, including dimensional verification and functional testing" but does not specify sample sizes for these tests or the provenance of any data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. This type of information is typically relevant for studies involving human interpretation (e.g., imaging studies). For a coating medium, ground truth would likely be established through physical measurements or chemical analyses rather than expert consensus on diagnostic interpretations. The document does not mention any expert involvement in establishing "ground truth" for the testing performed.
4. Adjudication method for the test set
Not applicable/Not provided. Similar to point 3, adjudication methods are usually applied in human-based evaluations (e.g., clinical trials or reading studies). This information is not relevant or provided for the bench testing described.
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 is not an AI/software as a medical device. The device is a contrast spray. Therefore, an MRMC study is not relevant and was not conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/software as a medical device.
7. The type of ground truth used
The document states "Bench testing, including dimensional verification and functional testing was completed". This implies that the ground truth for these tests would be objective physical or chemical measurements/specifications (e.g., coating thickness, spray uniformity, material properties) rather than expert consensus, pathology, or outcomes data. However, the specific type of ground truth is not explicitly detailed. For biocompatibility, the ground truth would be established by the principles of ISO 10993-1, which involves standardized biological assessments.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that would require a training set.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning or AI device.
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).