(45 days)
SMH Flex "S" is intended for the laboratory fabrication of dental prosthesis including the repair and relining of complete and/or partial dentures, occlusal splints, night guards, tooth positioners, snoring and sleep apnea devices, and other appliances as prescribed.
The submitted device SMH Flex "S" is a pre-mixed acrylic resin for use in the laboratory fabrication of dental prosthesis such as the repair and relining of complete and/or partial dentures, dental appliances including, occlusal splints, night guards, tooth positioners, snoring and sleep apnea devices.
The provided 510(k) summary for the SMH Flex "S" device does not contain the detailed information necessary to answer all aspects of your request regarding acceptance criteria and a study proving the device meets those criteria, particularly in the context of AI-driven medical devices. Much of the request asks about elements common in studies for AI/ML performance (e.g., sample size for test sets, ground truth establishment, MRMC studies), which are not relevant to this traditional material device.
However, I can extract the information that is present and explain why other parts are not applicable.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance
The "acceptance criteria" for a material device like SMH Flex "S" are typically defined by demonstrating substantial equivalence to a predicate device through comparative testing of its physical, chemical, and biological properties, rather than specific performance metrics like sensitivity, specificity, or AUC as one might see for diagnostic AI. The document confirms that specific tests were performed, and the results "support the safety and effectiveness."
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criterion (Test Performed) | Reported Device Performance |
|---|---|
| Mechanics | Not explicitly detailed, but implied to be similar to predicate. |
| Water Absorption & Solubility | Not explicitly detailed, but implied to be similar to predicate. |
| Rest Monomer Concentration | Not explicitly detailed, but implied to be similar to predicate. |
| Biocompatibility | - L929 Mem Elution Test: Non Cytotoxic- Intracutaneous Injection Test: Non Irritant- Kligman Maximization Test: Non Sensitivity |
| Opaque Factor | Not explicitly detailed, but implied to be similar to predicate. |
| Density & Consistency | Not explicitly detailed, but implied to be similar to predicate. |
2. Sample size 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 in the 510(k) summary. For material characterization and biocompatibility tests, specific sample sizes (e.g., number of specimens for mechanical testing, number of animals for in-vivo biocompatibility tests, replicates for in-vitro assays) would have been used, but these details are not disclosed in this summary. Data provenance information like country of origin or retrospective/prospective status is also not applicable or not provided for these types of bench and in-vitro/in-vivo physical property tests.
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 question is not applicable to the type of device (dental resin) and the tests performed. "Ground truth" as a concept for expert consensus or pathology is typically used for diagnostic or imaging devices where human interpretation is involved. For material characteristic or biocompatibility tests, the "ground truth" is derived from standardized laboratory procedures and measurements.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This question is not applicable for the reasons stated above. Adjudication methods are relevant for expert review processes, which are not described for this device's evaluation.
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:
This question is not applicable. SMH Flex "S" is a dental resin, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and "human readers improving with AI" are entirely irrelevant to its evaluation.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
This question is not applicable. The device is a material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's evaluation is based on standardized laboratory measurements and accepted scientific principles for material properties and biocompatibility testing standards (e.g., ISO standards for cytotoxicity, irritation, sensitization).
8. The sample size for the training set:
This question is not applicable. The device is a material, not a machine learning model, so there is no "training set" in the AI/ML context.
9. How the ground truth for the training set was established:
This question is not applicable for the reasons stated above.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" in this context is a series of laboratory tests and analyses comparing SMH Flex "S" to its predicate devices (Talon & Revere, Ivocap Elastomer) and conducting specific biocompatibility assays.
- Study Design: Comparative testing and in-vitro/in-vivo biocompatibility assays. The comparison focused on "Technological Characteristics Compared with Predicate Device: Mechanics, Water Absorption & Solubility, Rest Monomer Concentration, Biocompatibility, Opaque Factor and Density & Consistency."
- Key Findings: The device demonstrated non-cytotoxic, non-irritant, and non-sensitizing properties in the specific biocompatibility tests. The summary concludes that "the similarity in composition between SMH Flex "S" and the predicate we coincided that the performance data and biocompatibility results, supports the safety and effectiveness of SMH Flex "S" for the indicated uses."
- Conclusion for 510(k): The FDA determined the device to be "substantially equivalent" to legally marketed predicate devices, meaning it meets the necessary safety and effectiveness standards for its intended use.
In essence, for a material such as dental resin, the "acceptance criteria" are met by demonstrating that the new device has similar characteristics and performs comparably to already approved, predicate devices, and that it is shown to be biocompatible through standard biological tests. The concept of "ground truth" and specific sample sizes for clinical studies (as would be relevant for diagnostic devices) are not presented in this type of 510(k) submission summary for a material.
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K073040
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.
Submitter Information: SMH BioMaterial AG
DEC 1 3 2007
Date Summary Prepared: 10th October 2007
Contact Persons: Ashley Truitt
Device Name:
Trade Name(s): SMH Flex "S" Classification Name: Denture resin, relining, repairing or rebasing resin Panel: Dental Product Code: EBI
Predicate Device Information:
| Device Name | Manufacturer | 510(k) Reference |
|---|---|---|
| Talon & Revere | Comfort Acrylics | K071245 |
| Ivocap Elastomer | Ivoclar Vivodent GmbH | K896130 |
Device Description:
The submitted device SMH Flex "S" is a pre-mixed acrylic resin for use in the laboratory fabrication of dental prosthesis such as the repair and relining of complete and/or partial dentures, dental appliances including, occlusal splints, night guards, tooth positioners, snoring and sleep apnea devices.
Intended Use:
SMH Flex "S" is intended for the laboratory fabrication of dental prosthesis including the repair and relining of complete and/or partial dentures, occlusal splints, night guards. tooth positioners, snoring and sleep apnea devices, and other appliances as prescribed
Technological Characteristics Compared with Predicate Device Mechanics, Water Absorption & Solubility, Rest Monomer Concentration, Biocompatibility, Opaque Factor and Density & Consistency.
SMH Flex "S" was also evaluated as follows: L929 Mem Elution Test - Non Cytotoxic Intracutaneous Injection Test -- Non Irritant Kligman Maximization Test - Non Sensitivity
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Performance Test Data and Conclusions:
We conclude that the similarity in composition between SMH Flex "S" and the predicate we concided that the performance data and biocompatibility results, supports the safety and effectiveness of SMH Flex "S" for the indicated uses.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES (USA)" around the perimeter. Inside the circle is a stylized image of three human figures facing to the right, represented by curved lines.
DEC 1 3 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SMH BioMaterial AG C/O Ms. Ashley Truitt Consultant Sonomed, Incorporated 3537 Teasley Lanc Denton, Texas 76210
Re: K073040
Trade/Device Name: SMH Flex "S" Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Codes: EBI and MOC Dated: October 10, 2007 Received: October 29, 2007
Dear Ms. Truitt:
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.
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 vour 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- Ms. Truitt
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 vours.
Sylette Y. Michauds
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 K073040 510(k) Number (if known):
Device Name: SMH Flex "S"
Indications for Use:
SMH Flex "S" is intended for the laboratory fabrication of dental prosthesis including the repair and relining of complete and/or partial dentures, occlusal splints, night guards, tooth positioners, snoring and sleep apnea devices, and other appliances as prescribed.
Prescription Use XX (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Swam
§ 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.