(27 days)
- Anterior and posterior restorations.
- Indirect restorations for Inlays, onlays and veneers.
Any-Com Flow is a composite resin material designed for use in anterior and posterior restorations. It is composed of an enhanced zirconia filler, and all shades of the material are radiopaque. It is conveniently packaged in a syringe with a wide caliber. Dentists can dispense the material using their own instruments and apply it to the tooth.
The product offers a wide range of options with a total of 9 shades available. Dentists can select shades such as A1, A2, B1, B2, etc., based on the desired brightness, yellowness, and darkness that match the patient's natural teeth.
After the appropriate tooth pretreatment process for the selected shade, Any-Com Flow is applied to the teeth using enclosed tip and in the appropriate amount. Once applied, it is permanently bonded to the tooth structure by using a photopolymerizer owned by the dentist for photocuring.
This document is a 510(k) clearance letter for a dental composite resin called "Any-Com Flow". It establishes substantial equivalence to a predicate device, "Any-Com". The information provided primarily focuses on the device's technical specifications and a comparison to its predicate, rather than a clinical study evaluating its real-world performance against specific acceptance criteria in a human population.
Therefore, it is impossible to fully answer all aspects of your request as this document does not contain information about:
- A study that proves the device meets specific acceptance criteria in a clinical setting with human subjects.
- Clinical test set sample sizes, data provenance, expert panels, adjudication methods, MRMC studies, or specific efficacy criteria that would be relevant for devices that provide diagnostic or prognostic outputs.
- Training set sample sizes or how their ground truth was established, as this is not an AI/ML device relying on such training.
However, I can extract the acceptance criteria and reported performance based on the non-clinical testing conducted to demonstrate substantial equivalence, which is the focus of this 510(k) application. This non-clinical testing adheres to international standards (ISO 4049 and ISO 10993).
Here's the information extracted and formatted to answer your request as much as possible given the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (from ISO 4049, implied) | Reported Device Performance (Any-Com Flow) | Predicate Device Performance (Any-Com) |
|---|---|---|---|
| Curing Depth | Not explicitly stated in the document, but ISO 4049 defines requirements. | 2.2 (mm, implied) | 1.7-3 (mm, implied) |
| Water Absorption | Not explicitly stated in the document, but ISO 4049 defines limits. | 30 | 29 |
| Solubility | Not explicitly stated in the document, but ISO 4049 defines limits. | 0.6 | 0.7 |
| Flexural Strength | Not explicitly stated in the document, but ISO 4049 defines minimums. | 125 | 101 |
| Radiopacity | Not explicitly stated in the document, but ISO 4049 defines minimums (e.g., equivalent to aluminum). | 1.35 | 1.60 |
| Biocompatibility | Conformed to ISO 10993 (implied passing all relevant tests) | Yes (conformed to ISO 10993-5, 10, and 11) | Yes |
| Curing Time (600-1000 mW/㎠) | No explicit criteria, but consistency with predicate is key for SE. | 20 sec | 20 sec |
| Curing Time (1000-1200 mW/㎠) | No explicit criteria, but consistency with predicate is key for SE. | 10 sec | 10 sec |
| Adherence to ISO 4049 | Full conformance to ISO 4049 standard. | Conformed to ISO 4049 | Conformed to ISO 4049 |
Notes on Acceptance Criteria: The document states that the performance tests were conducted "in accordance with ISO 4049" and biocompatibility tests "in accordance with ISO 10993." For a 510(k) submission, the "acceptance criteria" are implied to be that the device successfully meets all relevant requirements and limits defined by these international standards for dental restorative materials and biocompatibility, respectively, and that its performance is substantially equivalent to the predicate device. The exact numerical limits from the ISO standards are not provided in this 510(k) summary.
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the exact sample sizes used for each non-clinical performance test (e.g., how many specimens were tested for flexural strength). These details would typically be found in the full test reports referenced in the submission, not the summary.
- Data Provenance: The tests were conducted by MEDICLUS Co., Ltd., which is based in the Republic of Korea. The testing is non-clinical (laboratory-based) rather than patient-derived data, so there is no "country of origin of the data" in the sense of patient demographics. The tests are "retrospective" in the sense that they were conducted for this specific submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable. The "test set" here refers to physical samples of the dental material, and the "ground truth" is established by direct measurement against known ISO standards and methods, not by expert consensus (e.g., no radiologists or other medical professionals are involved in interpreting results for material properties like flexural strength).
4. Adjudication method for the test set
- This information is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used for interpreting complex clinical data or images by multiple experts. For material property testing, results are quantitative measurements against an established standard, not subjective interpretations requiring adjudication.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or screening devices that assist human readers (e.g., radiologists interpreting images). Any-Com Flow is a dental restorative material, not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. Any-Com Flow is not an algorithm or an AI device. The "performance" refers to the physical and chemical properties of the material itself.
7. The type of ground truth used
- The "ground truth" for the non-clinical performance tests is based on direct physical and chemical measurements against the specified methodologies and requirements of ISO 4049 (for dental polymer-based restorative materials) and ISO 10993 (for biological evaluation of medical devices). This is akin to established scientific and engineering standards for material properties.
8. The sample size for the training set
- This information is not applicable. Any-Com Flow is a dental material, not a machine learning model. Therefore, there is no "training set."
9. How the ground truth for the training set was established
- This information is not applicable, as there is no training set for this device.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.