(53 days)
CMP's Flex-Star V is used for the fabrication of partial or full removable dentures, as well as occusal splints and night guards. It is to be used only by professional dental practitioners who make or repair dentures for patients
Flex-Star V is used for the fabrication of partial or full removable dentures, as well as occusal splints and night guards.
Here's an analysis of the provided text regarding acceptance criteria and study information:
Based on the provided document, which is a 510(k) premarket notification letter from the FDA, the device in question is a "Denture Relining, Repairing, or Rebasing Resin" called "Flex-Star V."
This type of FDA correspondence, specifically a 510(k) clearance, does not typically contain detailed information about specific acceptance criteria or the study data that "proves" the device meets those criteria in the way a clinical trial report would. Instead, a 510(k) submission generally relies on demonstrating "substantial equivalence" to a legally marketed predicate device. This means showing that the new device has the same intended use and technological characteristics as a predicate device, or different technological characteristics that do not raise new questions of safety and effectiveness.
Therefore, the requested information elements related to detailed study design, sample sizes, expert qualifications, and specific performance metrics cannot be found within this FDA clearance letter.
However, I can extract what limited information is available and explain why other requested details are absent:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance (Implied by Substantial Equivalence) |
|---|---|
| Safe for dental use | Equivalent safety profile to predicate devices. |
| Effective for its intended use (fabrication of partial/full removable dentures, occlusal splints, night guards) | Equivalent effectiveness for its intended use compared to predicate devices. |
| Biocompatible (not explicitly stated but a general requirement for dental materials) | Biocompatibility equivalent to predicate devices. |
| Meets predicate device specifications (e.g., strength, durability, aesthetics) | Performance characteristics (including physical and chemical properties) are substantially equivalent to predicate devices. |
Explanation: In a 510(k), specific numerical performance criteria and their corresponding results are generally not published in the clearance letter itself. Instead, the FDA reviews the manufacturer's submission which would have contained this data, demonstrating that the Flex-Star V performs as safely and effectively as a legally marketed predicate device. The letter states the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified in this document.
- Data Provenance (country of origin, retrospective/prospective): Not specified in this document.
Explanation: The letter does not detail the specific studies performed for the 510(k) submission, let alone the sample sizes or provenance of the data used in those studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
Explanation: This information would be specific to clinical or performance testing, which is not detailed in this FDA clearance letter.
4. Adjudication method for the test set:
- Adjudication Method: Not specified.
Explanation: Similar to the above, this pertains to study design not present in this document.
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:
- MRMC Study: No, this device is a dental resin, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers improving with AI is irrelevant and was not conducted.
Explanation: This category doesn't apply to a denture repair/rebase resin.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance Study: No, this device is a material, not an algorithm.
Explanation: This category doesn't apply to a denture repair/rebase resin.
7. The type of ground truth used:
- Type of Ground Truth: For a dental material, "ground truth" would typically relate to established physical, chemical, and biological performance standards (e.g., strength, water absorption, biocompatibility, bond strength to other materials, wear resistance) rather than expert consensus on images or pathology. This would be established through laboratory testing (e.g., ISO standards for dental materials) and potentially non-clinical in vitro/in vivo studies.
Explanation: The relevant "ground truth" for a dental resin would be its adherence to material science specifications and biocompatibility, not clinical outcomes in the same way a diagnostic device would. These would be assessed through lab tests.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable in the context of this type of device and 510(k) submission.
Explanation: "Training set" implies machine learning or AI, which is not relevant for a dental resin.
9. How the ground truth for the training set was established:
- How Ground Truth for Training Set was Established: Not applicable.
Explanation: This question is not applicable to the device described.
In summary: The provided document is an FDA 510(k) clearance letter for a medical device (a dental resin). It confirms that the device is "substantially equivalent" to predicate devices, allowing it to be marketed. However, it does not contain the detailed study protocols, acceptance criteria, or performance data that would be found in a comprehensive study report for a diagnostic AI or imaging device. The questions posed are largely designed for diagnostic/AI devices, not for a material such as a dental resin.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 9 2007
Mr. Devon O. Howe President and Chief Executive Officer CMP Industries LLC 413 North Pearl Street Albany, New York 12207-1311
Re: K072402
Trade/Device Name: Flex-Star V Regulation Number: 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: August 24, 2007 Received: August 27, 2007
Dear Mr. Howe:
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 includerequirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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- Mr. Howe
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sytte L. Michael Davis
Chiu Lin, Ph.D. Director Division 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
510(k) Number (if known): K072402
Device Name: Flex-Star V Indications for Use:
CMP's Flex-Star V is used for the fabrication of partial or full removable dentures, as well as occusal splints and night guards. It is to be used only by professional dental practitioners who make or repair dentures for patients
AND/OR
Prescription Use × (21 CFR Part 801 Subpart D) Over-The-Counter Use (21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Quane
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K072462
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§ 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.