(71 days)
GrandTEC is intended for the following applications:
- Stabilisation of teeth:
- After orthodontic treatment
- After periodontal treatment
- For support in treating trauma:
- For immobilising and splinting avulsed and loosened teeth
- Fragment anchoring after fracture
- For the reinforcement/fabrication of provisional bridges made from composite and provisional C & B material
- For temporary treatment after extraction and replacement of a missing tooth with the use of a plastic tooth
- For the temporary or semi-permanent treatment of a tooth space with the use of an extracted natural tooth
- For temporary treatment after placing an implant during the osseointegration of the implant
Not Found
The provided document is an FDA 510(k) clearance letter for the device GrandTEC, which is a denture relining, repairing, or rebasing resin. This type of document typically focuses on establishing substantial equivalence to a predicate device based on performance testing for material properties and an assessment of indications for use. It does not contain information about clinical studies involving human readers, AI algorithms, or ground truth establishment in the context of diagnostic performance.
Therefore, an exhaustive response to your query based solely on the provided text is not possible, as it does not detail acceptance criteria related to diagnostic performance or a study demonstrating such performance for an AI device.
However, I can extract the relevant information that is present and explain why other requested information is not available in these documents:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or reported device performance in the context of an AI/diagnostic algorithm. For a device like GrandTEC (denture resin), acceptance criteria would typically relate to physical and chemical properties (e.g., strength, biocompatibility, polymerization shrinkage, water absorption) and the reported performance would be the results of laboratory tests against these criteria. This information is not included in the provided FDA clearance letter, which summarizes the decision rather than detailing the full technical review.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. It would be relevant for a diagnostic study, but not for the type of material testing likely performed for GrandTEC.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. Ground truth establishment is critical for diagnostic performance studies, which are not described here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are relevant for resolving discrepancies in expert opinions in diagnostic studies.
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
No such study is mentioned or implied in the document. An MRMC study is specific to evaluating the clinical impact of an AI-assisted diagnostic device, which is not what GrandTEC is.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No such study is mentioned. This would be relevant for an AI algorithm's performance, not a dental resin.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided. For a dental resin, the "ground truth" for its performance would be defined by standardized material testing methods.
8. The sample size for the training set
This information is not provided. This is relevant for AI model development, not for a dental resin's material properties.
9. How the ground truth for the training set was established
This information is not provided. This is relevant for AI model development, not for a dental resin's material properties.
Summary of what can be extracted from the provided text:
- Device Name: GrandTEC
- Regulation Number/Name: 21 CFR 872.3760, Denture Relining, Repairing, or Rebasing Resin
- Regulatory Class: II
- Product Code: EBI
- Indications for Use:
- Stabilisation of teeth (after orthodontic treatment, after periodontal treatment)
- For support in treating trauma (immobilizing and splinting avulsed and loosened teeth, fragment anchoring after fracture)
- For the reinforcement/fabrication of provisional bridges Made from composite and provisional C & B material
- For temporary treatment after extraction and replacement of a missing tooth with the use of a plastic tooth
- For the temporary or semi-permanent treatment of a tooth space with the use of an extracted natural tooth
- For temporary treatment after placing an implant during the osseointegration of the implant
- Prescription Use: Yes
The document is an FDA clearance letter indicating that GrandTEC has been found substantially equivalent to predicate devices for its stated indications for use. It does not provide the technical details of the testing performed.
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Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is written in a simple, sans-serif font and is horizontally aligned. The words are evenly spaced, and the overall appearance is clean and professional.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Contro} Room -WO66-G609 Silver Spring. MD 20993-0002
Dr. T. Gerkensmeier Regulatory Affairs Voco GMBH Anton-Flettner-Strasse 1-3 Cuxhaven Germany D-27472
001 2 9 2010
Re: K102347
Trade/Device Name: GrandTEC Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: August 13, 2010 Received: August 19, 2010
Dear Dr. Gerkensmeier:
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.
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Page 2- Dr. Gerkensmeier
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers. International and Consumer Assistance 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 yours.
for
Anthony D. Watson, B.S., M.S., M.B.A. Director Director of Anesthesiology, General Hospital,
Infection Control and Dental Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
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Indications for Use Statement
| 510(k) Number: | K10-2347 | OCT 29 2010 |
|---|---|---|
| Device Name: | GrandTEC |
Indications for Use:
GrandTEC is intended for the following applications:
- Stabilisation of teeth:
- After orthodontic treatment
- After periodontal treatment
- For support in treating trauma:
- For immobilising and splinting avulsed and loosened teeth
- Fragment anchoring after fracture
- For the reinforcement/fabrication of provisional bridges made from composite and provisional C & B material
- For temporary treatment after extraction and replacement of a missing tooth with the use of a plastic tooth
- For the temporary or semi-permanent treatment of a tooth space with the use of an extracted natural tooth
- For temporary treatment after placing an implant during the osseointegration of the implant
| Prescription Use X | OR | Over-The-Counter Use _ |
|---|---|---|
| ---------------------- | ---- | ------------------------ |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rusper
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Significal Canadael, Dontal Devices Division of Anesthesions go
Infection Control, Dental Devices
1702347 510(k) Number: _______________________________________________________________________________________________________________________________________________________________
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.