(141 days)
It is intended for the permanent cementation of ceramic (including zirconia), composite and metal-based posts, crowns, bridges, veneers, inlays and onlays.
TotalC-Ram is permanent, radio-opaque dual cured (auto/photopolymerizable) self-etch and self-adhesive resin cement.
The provided document is a 510(k) premarket notification for a dental cement called "TotalC-RAM." It outlines the device's characteristics and compares it to predicate devices to demonstrate substantial equivalence to legally marketed devices.
This document does not describe a study involving AI/ML medical devices based on imaging data or other complex data types that would require acceptance criteria related to accuracy, sensitivity, specificity, or human reader performance. Therefore, most of the requested information (points 1-9) about acceptance criteria, test sets, expert ground truth, MRMC studies, standalone performance, and training sets is not applicable to this document.
Here's why and what information can be extracted:
- This is a review for a dental cement (TotalC-RAM), which is a physical material used in dental procedures.
- The comparison is based on physical and mechanical properties (e.g., shear bond strength, flexural strength, solubility, working time, setting time, film thickness, shelf life) and chemical composition.
- Section 11, "Brief Description of Performance and Biocompatibility Testing," explicitly states that the submission is an Abbreviated 510(k) and relies on conformity with guidance documents and recognized consensus standards (like ISO standards for dental materials).
- Section 12, "Clinical Performance Data," explicitly states: "Not applicable. Clinical performance testing has not been performed for the subject device." This confirms that there was no human reader study, no ground truth established by experts interpreting imaging, and no AI performance metrics.
Therefore, it is impossible to populate the requested table and answer the specific questions (1-9) as they pertain to the evaluation of an AI-based system's performance. The information requested is relevant for software-based medical devices, especially those that analyze medical images or other clinical data to provide diagnostic or prognostic insights.
To directly address your request, here's what can be inferred or stated based on the document's content, acknowledging the mismatch in context:
1. A table of acceptance criteria and the reported device performance
The "acceptance criteria" here are not in terms of AI performance metrics (like sensitivity/specificity) but rather the physical and mechanical properties being comparable to predicate devices or meeting ISO standards. The document doesn't explicitly state quantitative acceptance criteria for each property for the purpose of a performance study, but rather lists the measured performance of the device and compares it to predicates. The "acceptance" is that these values are within a range considered safe and effective, and contribute to substantial equivalence.
| Property | Subject Device Performance (TotalC-RAM) | Predicate TotalCem Performance | Predicate DentoCem Performance | Implicit "Acceptance Criteria" (Substantial Equivalence/ISO Standards) |
|---|---|---|---|---|
| Chemical Composition | UDMA, Bis-GMA, TEGDMA (Matrix); Barium Glass, Fumed Silica (Fillers) | Same as Subject Device | Same as Subject Device | Compatible with predicate, safe and effective materials as per standards. |
| Delivery | Automix | Automix | Automix | Functionally similar to predicates. |
| Curing Method | Light/Self-Cure | Light/Self-Cure | Light/Self-Cure | Functionally similar to predicates. |
| Radiopacity | Yes | Yes | Yes | Visible on X-rays, similar to predicates. |
| Shear Bond Strength to Zirconia (MPa) | 11.2 | 2.8 | 3.8 | Demonstrated higher values than predicates, which supports its specific indication for zirconia cementation. While higher here, it's still considered substantially equivalent for the broader dental cement category. |
| Flexural Strength (MPa) | 125.5 | 170 | 151 | Within acceptable range for dental cements, meeting ISO 4049 requirements. |
| Solubility (µg/mm3) | LOW | LOW | LOW | Low enough to meet ISO standards, indicating stability. |
| Working time at 22°C (min) | 4.5 | 4 | 2.5 | Within a practical range for dental procedures, similar to predicates. |
| Setting time at 37 °C (min) | 2.5 | 3 | 4 | Within a practical range for dental procedures, similar to predicates. |
| Film thickness (µg/mm3) | 10 | 10 | 10 | Thin enough for effective seating of restorations, meeting ISO standards. |
| Shelf life (Years) | 2 | 2 | 2 | Standard shelf life for such materials. |
Note: The "acceptance criteria" for a physical dental cement are primarily whether its properties fall within established ranges defined by international standards (e.g., ISO 4049, ISO 9917-1) and whether it is "substantially equivalent" to predicate devices, meaning it performs similarly and does not raise new questions of safety or effectiveness. The increased shear bond strength for zirconia is highlighted as a performance advantage, but not as a strict "acceptance criterion" that it must surpass predicates.
2. Sample size used for the test set and the data provenance: Not Applicable. This is a material properties comparison, not a data-driven AI study. Laboratory tests are performed on material specimens.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not Applicable. Ground truth for material properties is established through standardized laboratory testing, not expert consensus on interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not Applicable.
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. No human readers or AI assistance involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not Applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for material properties is established through standardized laboratory testing methods as outlined by ISO standards (e.g., measuring flexural strength, solubility, bond strength under controlled laboratory conditions).
8. The sample size for the training set: Not Applicable. This product is not an AI/ML device.
9. How the ground truth for the training set was established: Not Applicable. This product is not an AI/ML device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 14, 2017
Itena Clinical % Louis-Paul Marin President Lok North America Inc. 2025 Rue Michelin Laval, H7L 5B7 CANADA
Re: K162960
Trade/Device Name: TotalC-RAM Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA Dated: December 19, 2016 Received: December 27, 2016
Dear Louis-Paul Marin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
| Indications for Use |
| Form Approved: OMB No. 0910-0120 |
|---|
| Expiration Date: January 31, 2017 |
| See PRA Statement below. |
| 510(k) Number (if known) | |
|---|---|
| Device Name | TOTALC-RAM |
| Indications for Use (Describe) | It is intended for the permanent cementation of ceramic (including zirconia), composite and metal-based posts, crowns, bridges, veneers, inlays and onlays. |
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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| FORM FDA 3881 (8/14) | Page 1 of 1 |
|---|---|
| ---------------------- | ------------- |
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Abbreviated 510(k) Summary
| 1. | Name/Address of Submitter: | Itena Clinical |
|---|---|---|
| 2. | Contact Person: | Louis-Paul MarinLOK North America Inc.Phone: (514) 928-5546Email: marin.lp@lok-corporation.com |
- October 12th, 2016 3. Date Summary Prepared:
- Devices Names: TotalC-Ram 4.
-
- Device Classification: II, 21 CFR 872.3275
-
- Common name: Dental Cement
-
- Classification Product Code: EMA
- Predicate Devices: 8.
| TotalCem | K121804 |
|---|---|
| DentoCem | K121804 |
9. Devices Description:
TotalC-Ram is permanent, radio-opaque dual cured (auto/photopolymerizable) self-etch and self-adhesive resin cement. The following table shows the significant technological characteristics for the subject device and indicates the following similarities and differences with the predicate devices:
| ChemicalComposition: | Subject Device | PredicatesTotalCem | PredicatesDentoCem |
|---|---|---|---|
| Matrix: | UDMA | UDMA | UDMA |
| Bis-GMA | Bis-GMA | Bis-GMA | |
| TEGDMA | TEGDMA | TEGDMA | |
| Fillers | Barium Glass | Barium Glass | Barium Glass |
| Fumed Silica | Fumed Silica | Fumed Silica |
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| Physical/Mechanical | Subject Device | Predicates | Predicates |
|---|---|---|---|
| Properties: | TotalCem | DentoCem | |
| Delivery | Automix | Automix | Automix |
| Curing Method | LightSelf-Cure | LightSelf-Cure | LightSelf-Cure |
| Radiopacity (% Al) | Yes | Yes | Yes |
| Shear Bond Strength toZirconia (MPa) | 11.2 | 2.8 | 3.8 |
| Flexural strength (MPa) | 125.5 | 170 | 151 |
| Solubility (µg/mm3) | LOW | LOW | LOW |
| Working time at 22°C (min) | 4.5 | 4 | 2.5 |
| Setting time at 37 °C (min) | 2.5 | 3 | 4 |
| Film thickness (µg/mm3) | 10 | 10 | 10 |
| Shelf life (Years) | 2 | 2 | 2 |
| Shear Bond Strength toZirconia (MPa) | 11.2 | 2.8 | 3.8 |
TotalC-Ram is similar to the predicate devices in that they are all auto-mixing, dualcuring, radio-opaque, self-etch and self-adhesive resin cements to be used for permanently cementing restorations such as posts, crowns, bridges, inlays and onlays.
The subject device and the predicate devices have substantially equivalent physical and mechanical properties. As depicted above, the values for the shear bond strength between the subject device and zirconia demonstrate significantly higher values for the subject device. The indication for use for TotalC-Ram mentions specifically the use for ceramics cementation (including zirconia). The differences in the indications for use affect neither the intended use nor substantial equivalence.
TotalC-Ram is different from the predicate devices in that it contains the same key biocompatible ingredients, but in different proportions. The differences in the indications for use affect neither the intended use nor substantial equivalence.
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10. Indication for Use:
The device is intended for the permanent cementation of ceramic (including zirconia), composite and metal-based posts, crowns, bridges, veneers, inlays and onlays. Below is a comparison of the indications for use of the subject device and the predicates:
| Subject Device(Shade DentinBase) | Predicate DeviceTotalCem | Predicate DeviceDentoCem | |
|---|---|---|---|
| Indication for use: | for the permanentcementation ofceramic (includingzirconia), compositeand metal-basedposts, crowns,bridges, veneers,inlays and onlays | for the cementation ofposts, crowns,bridges, inlays andonlays. | intended forpermanentcementation of:crowns andbridges, inlays,onlays, posts andcores, ceramiccrowns, Marylandbridges andveneers;implant prosthesis;orthodonticattachments;amalgamrestorations;veneering ofalloys; andcompositerestorations. |
The indication for use for TotalC-Ram mentions specifically the use for ceramics cementation (including zirconia) as this device demonstrate significantly higher shear bond strength values when used for ceramic cementations. The differences in the indications for use affect neither the general intended use nor substantial equivalence.
Brief Description of Performance and Biocompatibility Testing: This 11. submission is an Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications". In support of this, Itena Clinical has provided information to establish substantial equivalent to the predicates and demonstrate conformity with FDA's guidance document entitled Dental Cements - Premarket Notification. August 1998 and the following recognized consensus standards:
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- ISO 4049 - Dentistry - Dentistry -- Polymer-based restorative materials;
- ISO 7405 Dentistry dentistry evaluation of biocompatibility of medical ● devices used in dentistry;
- ISO 9917-1 Dentistry-- water-based cements part 1: powder/liquid acid-base ● cements; and
- . ISO 10993-5 - Biological evaluation of medical devices - part 5: tests for in vitro cytotoxicity.
TotalC-Ram meets or surpasses requirements set forth therein, notably as regards flexural strength, solubility, film thickness and radiopacity.
12. Clinical Performance Data
Not applicable. Clinical performance testing has not been performed for the subject device.
- Conclusion Drawn: Based on a comparison of intended use and indications for use, physical properties and chemical composition. Itena Clinical concludes that the subject device is substantially equivalent to the predicates (respectively, TotalCem and DentoCem (K121804)).
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.