Search Results

ProFil: Direct anterior & posterior restorations, Core Build ups, Splinting. ProFil Flow: Class III, V & smaller Class IV restorations, Base/liner in Class I & Class II restorations, Repair resin, porcelain & acrylic temporary materials, Pit & fissure sealant, Undercut blockout, Restoration of minimally invasive cavity preparations.

The ProFil Composites are light cured restorative micro hybrid composite resins for use in both posterior and anterior restorations. The restoratives are available in a variety of tooth colored shades and are packaged in syringes and capsules.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a dedicated table format with corresponding reported performance values. Instead, it describes a "Summary of Physical Tests" and then presents a "Similarity of Technological properties to predicate devices" table to establish substantial equivalence.

However, based on the context, the implicit acceptance criteria for the ProFil Composites are that their physical properties and technological characteristics are comparable to or within acceptable ranges of the predicate devices.

Implicit Acceptance Criteria and Reported Device Performance (as inferred from the document):

2. Sample Size Used for the Test Set and the Data Provenance

The document mentions "data from bench testing" but does not provide specific details on the sample sizes used for these tests. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for these bench tests.

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 and not provided in the document. The study described is bench testing of material properties, not a clinical study requiring expert assessment of outcomes or images for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document. As stated above, this was bench testing of material properties, not a study involving human readers or clinical outcomes 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

This information is not applicable and not provided in the document. The device in question is a dental composite material, not an AI-powered diagnostic or assistive device for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable and not provided in the document. The device is a dental material, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the bench tests would be the measured physical and chemical properties of the materials themselves, determined by standardized laboratory methods, and then compared to the established properties of the predicate devices. It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not applicable and not provided in the document. There is no mention of a "training set" as this is not a machine learning or AI-driven device.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided in the document, as there is no training set mentioned or implied.

Summary of the Study Proving Substantial Equivalence:

The study proving the device meets its implicit acceptance criteria is a series of bench tests that evaluated various physical properties of the ProFil Composites (Compressive Strength, Flexural Strength, Surface Hardness, Water sorption, Polymerization shrinkage, Diametral Tensile Strength, Flexural Modulus, Radiopacity, Water solubility). The results of these bench tests were compared to those of three predicate devices: GrandiO, Unifil Flow, and Filtek Supreme Ultra Flowable.

The document emphasizes that "the information provided in this 510(k) submission shows that the ProFil Composites are substantially equivalent" to the predicate devices in terms of intended use, indications for use, composition, physical properties, and technological characteristics. The table comparing technological properties (Table 2) highlights the shared components and mechanisms (e.g., photoinitiator system, resin matrix type, silane-treated fillers, bonding method, polymerization process) as a key part of establishing this equivalence. The prior use of these components in legally marketed predicate devices is cited to support the safety and effectiveness without requiring additional biocompatibility testing of the final formulation.

Ask a specific question about this device