Search Results
Found 1 results
510(k) Data Aggregation
(110 days)
· As structural reinforcement for fabricating and/or repairing removable prostheses (dentures) and removable implant supported dentures (ISDs)
· As reinforcement for temporary and/or permanent plastic/composite partial and full crowns and bridges.
· As reinforcement for customized splints used to immobilize teeth which may be required for orthodontia, periodontia, traumatology and any dental activity requiring bonding of natural teeth.
Fiber Force is a system of light-cured resin pre-impregnated E-glass fibers used for reinforcement in a variety of applications in dentistry. All formats of Fiber Force use specially treated E-glass fibers that impregnated in resin using an industrialized process that ensures homogeneity with the acrylic or composite resin interface material.
The provided 510(k) summary for the Fiber Force products (K102207) does not contain typical acceptance criteria and a study design in the way one would describe for a diagnostic or AI-driven device. This submission is for a material used in dentistry, a Class II device, and relies on substantial equivalence to a predicate device rather than performance criteria from a clinical trial.
Instead of clinical performance metrics like sensitivity, specificity, or AUC, the "acceptance criteria" here relate to the material properties and biocompatibility. The "study" proving it meets these criteria is a set of tests to demonstrate these properties and show they are comparable to or safe for the intended use, consistent with the predicate device.
Here's the information broken down based on your request, with an emphasis on how it applies to this specific type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a material science and biocompatibility assessment for substantial equivalence, the "acceptance criteria" are implied by the standards and tests performed, and "reported device performance" refers to the results of those tests demonstrating compliance.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Absence of cytotoxicity. | In vitro cytotoxicity test performed according to NF EN ISO 10993-5 showed no sign of cell lysis or toxicity (reduction of cellular density lower than 25%). The extract satisfied test requirements. Positive and negative controls were compliant. |
| Biocompatibility: Absence of irritation or sensitization. | Initial evaluation tests considered for clinical application included sensitization, intradermal irritation. Toxicological risk study concluded it's improbable to cause unacceptable health risk. (Acknowledged risks of irritation for non-polymerized resin with practitioners' fingers, and mechanical irritation from airborne glass fibers, are mitigated by precautions). |
| Biocompatibility: Absence of subchronic/subacute toxicity. | Initial evaluation tests considered subchronic and subacute toxicity. Toxicological risk study concluded it's improbable to cause unacceptable health risk. |
| Material Homogeneity. | "Fiber Force use specially treated E-glass fibers that impregnated in resin using an industrialized process that ensures homogeneity with the acrylic or composite resin interface material." |
| Chemical Composition Equivalence/Safety. | Chemical components (E-glass, UDMA, TEGDMA, camphorquinone, Ethyl-4-(dimethylamino)-benzoate, pigments) are common in dentistry, have long-standing safe use, or are universally accepted (e.g., pigments in food/cosmetics). Components are identical to those in other safely marketed products (e.g., Postec, Precipost, Vectris, TETRIC EVO CERAM, VARIOLINK II). |
| Effective Polymerization. | Formulation optimized to achieve effective polymerization, minimizing leaching of soluble products. (Implied by chemical composition working like comparable products). |
| Safety in use | Identified risks (irritation/sensitization from non-polymerized resin, mechanical irritation from glass fibers) are addressed by stating precautions in instructions for use (gloves, goggles, mask, grinding under water/surgical aspiration). |
| Equivalence to Predicate Device (everStick/everStick Net). | "The indications for use, material, form factor, performance, and safety characteristics between Fiber Force and the predicate device are the same." "Has the same chronological characteristics as the predicate device since both have same indications for use, similar polymer composition and same working technique." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a number of "cases" in the typical sense.
- For the in vitro cytotoxicity test, a "tested product extract" was used. The number of samples for this test (e.g., number of replicates, number of batches tested) is not specified.
- For the biological evaluation, the "medical device and its many applications" (implying the material itself) were evaluated against standards. This is a material characterization and risk assessment, not a study with a traditional "test set sample size."
- Data Provenance: The document does not specify country of origin for the in vitro tests, but the company is Canadian (Synca Marketing Inc., Quebec, Canada). The biological evaluation is based on ISO standards. The in vitro cytotoxicity test was "performed by an outside agency," but the agency's location is not specified. All tests described are retrospective in the sense that they are laboratory tests on the finished product or its components, not prospective clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of submission typically does not involve establishing ground truth through expert consensus on a test set of clinical images or patient data. The "ground truth" for the material's properties and safety is established by adherence to recognized international standards (ISO 10993-5, ISO 7405) and chemical analysis. The assessment of toxicological risks was done, but the number and qualifications of individuals performing this assessment are not mentioned.
4. Adjudication Method for the Test Set
Not applicable. There is no human adjudication process described for the material's performance in the context of this 510(k). The tests are laboratory-based, with predefined pass/fail criteria according to standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a diagnostic device or an AI-assisted tool where human reader performance is measured. The device is a material for dental use.
6. Standalone Performance Study (Algorithm Only)
Not applicable. This is not an algorithm or software device. The documented tests evaluate the intrinsic properties of the material.
7. Type of Ground Truth Used
The "ground truth" for this submission relies on:
- Biocompatibility Standards: Specifically ISO 10993-5 for cytotoxicity and general principles of ISO 10993 for biological evaluation.
- Chemical Purity/Composition: Data on the chemical components and their known safety profiles.
- Predicate Device Characteristics: The established safety and effectiveness of the legally marketed predicate device (everStick/everStick Net) serve as a benchmark for "substantial equivalence."
- Industry Knowledge/Literature: References to other existing dental products with similar components and their established safety (e.g., TETRIC EVO CERAM, VARIOLINK II, Postec, Precipost, Vectris).
8. Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a "training set." The product developmental process involves material selection, formulation, and manufacturing, which are informed by material science principles and existing knowledge, rather than data training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
Ask a specific question about this device
Page 1 of 1