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510(k) Data Aggregation
(275 days)
EXACTA DENTAL DIRECT, INC
FixTemp ™ Cement is a dental luting agent indicated for:
- temporary cementation of provisional crowns and bridges,
- cementing of semi-permanent implants.
The Fixtemp Cement is designed as a luting cement for temporary dental applications. This dental cement having the active ingredients of zinc oxide does not include Eugenol. This lack of Eugenol does not reduce structural properties but allows a choice among healthcare professionals where Eugenol can cause objectionable results.
The provided text is for a 510(k) premarket notification for a dental cement called FixTemp Cement. This document primarily focuses on establishing substantial equivalence to a predicate device, not on presenting a detailed clinical study demonstrating the device's performance against specific acceptance criteria in a medical AI context. Therefore, much of the requested information regarding AI device studies (e.g., sample sizes for test/training sets, number of experts for ground truth, MRMC studies) is not applicable to this document.
However, the document does contain "acceptance criteria" in the form of performance characteristics used to demonstrate substantial equivalence to a predicate device.
Here's the information that can be extracted or inferred from the provided text, adapted to the request:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are the performance characteristics of the predicate device, which the FixTemp Cement aims to match or exceed.
| Acceptance Criteria (Predicate Device TempoCem K110759) | Reported Device Performance (FixTemp™ Cement) |
|---|---|
| Physical Properties (ISO 3107) | |
| Film Thickness: Less than 20 µm | Less than 20 µm |
| Setting Time: 4 min | Approx. 4 - 7 min |
| Compressive Strength: 8 MPa | More than 8MPa |
| Working Time: 1 minute | More than 1 min |
| Other Characteristics | |
| Compliance to standard: ISO3107 | ISO3107 |
| Container: double cartridge or syringe | double cartridge or syringe |
| Dispenser: injector / syringe | injector / syringe |
| Paste Ratio: 1:1 ? | 1:1 |
| Appearance: Homogeneous and smoothly consistent | Homogeneous and smoothly consistent |
| Storage: Room temperature, dry (15-25°C) | Room temperature, dry (15-25°C) |
| Indications for Use: Temporary cementation of crowns and bridges or provisional cementation of crowns and bridges on implant abutments | Indicated for luting of temporary dental prosthesis (crowns, inlays, onlays) (Note: The document also states "Same" for the predicate's full indications, indicating broad equivalence) |
| Intended Use: Temporary luting and cementation of temporary crowns and bridges | Temporary luting and cementation of temporary crowns and bridges |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document refers to "a series of factory tests" and "testing has confirmed this device meets its product specification," but does not provide details on sample sizes for these tests.
- Data Provenance: The tests are referred to as "factory tests," implying they were conducted by the manufacturer, Exacta Dental Direct, Inc. No information regarding country of origin of the data or whether it was retrospective/prospective is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This document describes performance testing of a dental cement, not an AI device requiring expert-established ground truth from images or other medical data. The ground truth for physical properties (like film thickness, setting time) would be based on standardized laboratory measurements.
4. Adjudication method for the test set
- Not applicable. See point 3. Performance is based on direct physical measurements against a standard (ISO 3107), not on human adjudication of classification or detection tasks.
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
- Not applicable. This document is for a dental cement, not an AI medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This document is for a dental cement, not an AI medical device.
7. The type of ground truth used
- The ground truth for the performance characteristics (e.g., film thickness, setting time, compressive strength, working time) is established by physical measurements based on recognized international standards (ISO 3107). These are objective, quantitative measurements.
8. The sample size for the training set
- Not applicable. This document does not describe the development of an AI model; therefore, there is no training set in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
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(259 days)
EXACTA DENTAL DIRECT, INC
FixTemp C&B ™ is a chemically catalyzed, highly filled, resin based restorative material used to fabricate temporary crowns and bridges.
The intended use of the FixTemp C&B "" is to form short and long term dental provisional prosthetics.
The FixTemp C&B *** is a Class II (nonexempt) device that is ideal suited as a dental acrylic to fabricate temporary crown and bridges.
FixTemp C&B "" provisional material is a two component, catalyst and base, material dispensed and mixed by a industry standard cartridge/static mixing tip combination. FixTemp C&B "" is intended for . use in both short and long term crown and bridge temporaries. The material is compatible with light cured composites for repair and characterization. FixTemp C&B "" contains methacrylate components and is radiopaque for easy radiographic identification.
The scientific concept on which this device is based is the principle that ethoxylated Bis-GMA is a multifunctional acrylates and inorganic fillers as silinated barium glass and silinated silicic acid to form a suitable structure for a short and long term crown and bridge temporaries. This device functions by providing a dental material to short and long term dental provisional prosthetics.
The provided text is a 510(k) summary for a dental device called "FixTemp C&B". This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving performance against acceptance criteria for a new AI/software device.
Therefore, many of the requested elements for an AI/software device are not applicable to this submission. This is a traditional medical device submission, not a software as a medical device (SaMD) submission.
Here's a breakdown of the requested information based on the provided text, highlighting what is not applicable:
Acceptance Criteria and Device Performance for FixTemp C&B
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (from ISO 10993/ASTM Standards where stated) | Reported Device Performance (FixTemp C&B) |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity | Not cytotoxic (based on Agar Diffusion Test, Din EN ISO 10993-5, using L929 mouse fibroblasts). | Met criteria of the test and was found to be non-cytotoxic. |
| Sensitization | Did not induce sensitization (based on modified Guinea Pig Maximization Test (GMPT), ASTM F720-81). | Did not induce any sensitization. |
| Genotoxicity | Non-mutagenic (based on Ames test, with or without metabolic activation). | Fixtemp C&B (extract) was non mutagenic in the Ames test either with or without metabolic activation. |
| Carcinogenicity | Not required if negative genotoxicity/cytotoxicity and low exposure. | Not conducted as not thought necessary due to extraordinarily low exposure levels and negative genotoxicity and cytotoxicity tests, conforming to general plastics testing procedures. |
| Implantation | Not required if contact only with hard/surface soft tissues (DIN EN ISO 10993). | Not conducted as material only comes into contact with oral hard tissues and the surface of oral soft tissues when used as prescribed. |
| Acute Systemic Toxicity | Not explicitly obligatory per DIN EN ISO 10993; components with >3% content have low acute oral toxicity and are generally used in dental materials. | Not specifically evaluated. Components with >3% have very low acute oral toxicity and are approved for use in dental materials by FDA. |
| Inhalation Toxicity | Not required if practically no volatile compounds and not used as aerosol (FDA G95-1 memo). | Not thought useful and not conducted as it contains practically no volatile compounds and is not used as an aerosol. |
| Functional/Other | ||
| Radiopacity | (Implicitly, to allow easy radiographic identification) | Contains methacrylate components and is radiopaque for easy radiographic identification. |
| Suitability for Use | Form suitable structure for short and long-term crown and bridge temporaries. | Provides a dental material to short and long term dental provisional prosthetics. |
| Compatibility | Compatible with light cured composites for repair and characterization. | Compatible with light cured composites for repair and characterization. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided text. For biocompatibility tests, sample sizes are typically standardized by the test methods (e.g., number of cell cultures, animals) but specific numbers are not given here.
- Data Provenance: Not explicitly stated but implied to be from laboratory bench testing. No mention of country of origin or whether clinical (retrospective/prospective) data was used, as this is a material science device, not a data-driven AI device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This is a material testing submission. "Ground truth" in the context of expert consensus is relevant for diagnostic AI systems, not for biocompatibility testing of dental materials. Biocompatibility results are based on objective laboratory measurements and biological responses defined by standards.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations in diagnostic studies, particularly in AI performance validation. This is not relevant to chemical and biological material testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Applicable. An MRMC study is designed to evaluate human reader performance, often with and without AI assistance, in interpreting medical images or data. This is irrelevant for a dental material (Crown & Bridge Temporary resin).
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- Not Applicable. There is no algorithm or software component described that would require a standalone performance study.
7. Type of Ground Truth Used
- Laboratory Test Results / Standardized Biological Responses: The "ground truth" for the device's performance is established by the results of standardized biological and chemical tests (e.g., cytotoxicity assays, sensitization tests, genotoxicity assays) performed according to international standards (e.g., ISO 10993 parts, ASTM F720-81). These tests provide objective measures of the material's interaction with biological systems.
8. Sample Size for the Training Set
- Not Applicable. There is no "training set" as this is a medical device clearance based on material properties and substantial equivalence, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point 8.
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