Search Results
Found 1 results
510(k) Data Aggregation
(216 days)
-Restoration of Class III, Class V, smaller Class IV
-Repair of resin, porcelain, and acrylic temporary materials
-Undercut blockout
The subject device is a light-curved complex resin for aesthetic restoration for both anterior and posterior parts, which is used for restoration that requires aesthetics through decay and damage in a form of paste with unpolymerized dimethacrylate monomer, inorganic filler, and photoinitiators mixed. The subject device is packaged with the following: Syringe, Disposable Tip, Protective Cap, Shade Sheet
Here's a breakdown of the acceptance criteria and the study information for the DiaFil Flow device, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary for DiaFil Flow (K192284) primarily demonstrates substantial equivalence through non-clinical performance data and comparison to a predicate device. The "acceptance criteria" are therefore framed around adherence to harmonized standards and showing similar properties to the predicate.
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance | Comments |
|---|---|---|---|
| Non-Clinical Performance | ISO 4049:2009 (Dentistry - Polymer-based restorative materials) | Conformance demonstrated | Subject device conforms to this standard. |
| Non-Clinical Performance | ISO 7405:2008 (Dentistry – Evaluation of biocompatibility of medical devices used in dentistry) | Conformance demonstrated | Subject device conforms to this standard. |
| Non-Clinical Performance | ISO 10993-1:2009 (Evaluation and testing within a risk management process) | Conformance demonstrated | Subject device conforms to this standard. |
| Non-Clinical Performance | ISO 10993-2:2006 (Animal welfare requirements) | Conformance demonstrated | Subject device conforms to this standard. |
| Non-Clinical Performance | ISO 10993-3:2014 (Tests for genotoxicity, carcinogenicity and reproductive toxicity) | Conformance demonstrated | Subject device conforms to this standard. |
| Non-Clinical Performance | ISO 10993-5:2009 (Tests for in vitro cytotoxicity) | Conformance demonstrated | Subject device conforms to this standard. |
| Non-Clinical Performance | ISO 10993-6:2016 (Tests for local effects after implantation) | Conformance demonstrated | Subject device conforms to this standard. |
| Non-Clinical Performance | ISO 10993-10:2010 (Tests for irritation and skin sensitization) | Conformance demonstrated | Subject device conforms to this standard. |
| Non-Clinical Performance | ISO 10993-11:2017 (Tests for systemic toxicity) | Conformance demonstrated | Subject device conforms to this standard. |
| Non-Clinical Performance | ISO 10993-12:2012 (Sample preparation and reference materials) | Conformance demonstrated | Subject device conforms to this standard. |
| Equivalence to Predicate | Indications for Use | "The subject device has the same indications for use as the predicate device. The indications for use of the subject device is more simplified than the predicate device." | Considered equivalent. |
| Equivalence to Predicate | Main Raw Materials | "The main compositions are similar... DiaFil Flow and the predicate device are substantially equivalent through Biological Safety Assessment Report. (#BSA-2018-14)" | Considered equivalent despite not being exactly the same. |
| Equivalence to Predicate | Mechanical Properties (Curing Time) | 20 seconds (same as predicate) | Considered equivalent. |
| Equivalence to Predicate | Mechanical Properties (Photopolymerization Type Resin) | Light-cured (same as predicate) | Considered equivalent. |
| Equivalence to Predicate | Shelf Life | 3 years (same as predicate) | Considered equivalent. |
| Equivalence to Predicate | Biocompatibility | Biocompatible (same as predicate) | Considered equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a distinct "test set" in terms of discrete samples for performance evaluation beyond conformity to standards. The evaluation is primarily based on bench testing against harmonized standards and a comparison to a predicate device. No specific number of items tested for each characteristic (e.g., strength, wear) is provided in the summary.
- Data Provenance: The studies are described as "non-clinical performance data" and "non-clinical bench testing." This implies internal laboratory testing conducted by the manufacturer, DiaDent Group International, located in Cheongju-si, Chungcheongbuk-do, Republic of Korea. The data is retrospective in the sense that it was generated for the 510(k) submission, not as a continuous monitoring process.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- The summary does not mention "experts" in the context of establishing ground truth for a test set in the way one might for an AI/device diagnostic study. This is a dental material, and the "ground truth" is established by adherence to the objective criteria laid out in international standards (e.g., ISO for dental materials, ISO 10993 for biocompatibility). There is no mention of human expert consensus or radiologists in this context.
4. Adjudication Method for the Test Set
- No adjudication method is described, as the evaluation is based on objective measurements against harmonized standards, not on subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance) is relevant for diagnostic imaging devices. DiaFil Flow is a dental restorative material, and its evaluation focuses on material properties and biocompatibility, not diagnostic performance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable/Not done. This device is a physical material, not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply. The performance evaluated is the physical and chemical properties of the material itself.
7. Type of Ground Truth Used
- The "ground truth" for the non-clinical performance data is defined by the specifications and acceptable ranges/pass criteria within the referenced harmonized ISO standards (e.g., ISO 4049 for material properties, ISO 10993 series for biocompatibility). These standards define objective, measurable physical, chemical, and biological endpoints. The "Biological Safety Assessment Report (#BSA-2018-14)" also contributed to establishing the safety ground truth.
8. Sample Size for the Training Set
- Not applicable/Not provided. This is not an AI/machine learning device that would require a "training set" in the conventional sense. The "training" for a material like this involves formulation development and manufacturing process controls, not data-driven algorithm training.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As a dental restorative material, the concept of a "training set" and associated ground truth establishment for a training set does not apply.
Ask a specific question about this device
Page 1 of 1