(77 days)
Snowpost & Snowlight posts are indicated for use wherever root canal posts are required Showpost & Showingin posts are mellor and/or where known metal allergies are of concern.
Not Found
The provided 510(k) summary (K012354) for the Snowpost & Snowlight devices describes acceptance criteria and a study to demonstrate substantial equivalence to predicate devices, but does not describe an AI/ML device or its performance criteria. The device in question is a physical dental product (glass fiber composite root canal post).
Therefore, I cannot fulfill the request to describe the acceptance criteria and study that proves an AI device meets acceptance criteria based on this document. The information requested regarding AI/ML device performance, sample sizes for training/test sets, ground truth establishment, expert adjudication, MRMC studies, and standalone performance is not applicable to this 510(k) submission.
However, I can extract the information relevant to the actual device described in the 510(k):
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No evidence of cytotoxic response (per ISO 10993-5 "Biological evaluation of medical devices - Tests for Cytotoxicity: in vitro methods") | "ISO 10993-5 ... was conducted and shows no evidence of a cytotoxic response." |
| Material suitable for root canal posts (per ISO 3597-2-94 Three-point Bending Standard mechanical tests) | "Mechanical tests were conducted in conformance with ISO 3597-2-94 Three-point Bending Standard results showed the material to be suitable for root canal posts." The specific bending strength values or acceptance thresholds are not provided in this summary, only that "results showed the material to be suitable". |
| Substantial equivalence to predicate devices for intended use and technological characteristics | The primary purpose of this 510(k) is to demonstrate substantial equivalence. The FDA concurred with this determination, allowing the device to be marketed. The equivalence is based on similar intended use (retention for reconstruction of non-vital teeth) and technological characteristics, with minor material and dimensional changes from the predicate. |
Regarding the other points requested (which are for AI/ML devices):
- 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, this is a physical medical device.
- 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): Not applicable.
- 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.
- 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): Not applicable. The "ground truth" here is the performance against ISO standards.
- 8. The sample size for the training set: Not applicable. There is no AI model.
- 9. How the ground truth for the training set was established: Not applicable.
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OCT 1 0 2001
K 012354
510(k) Summary (As Required by 21 C.F.R. §807.92)
| Submitted by: | Craig BrunsVice PresidentDanville Materials, Inc.2021 Omega Dr.San Ramon, CA 94583Phone 925 838-7940Fax 925 838-0944e-mail: cbruns@daneng.com | |
|---|---|---|
| Date of summary | July 20, 2001 | |
| Device name | Snowpost & Snowlight | |
| Common name | Glass fiber composite root canal post | |
| Classification names | Regulation Number972.3810 | Classification NameDental root canal post |
| Predicate Device | The modified device is substantially equivalent to the previously cleared BiscoUM Aesthetic Post (K945370), Coltene ParaPost Fiber White (K000311),Jeneric/Pentron FibreKor Post (K983266), and Harald Nordin Glassix post(K003221) devices. | |
| Modifications | The primary differences are minor changes to the material and dimensions. | |
| Intended Use | The modified device has the same intended use as the legally marketedpredicate devices herein referenced. The Snowpost & Snowlight compositeposts are intended for use by dentists to give retention for reconstruction ofnon-vital teeth. | |
| TechnologicalCharacteristics | The modified device has the same technological characteristics as the legallymarketed predicate device mechanically supporting reconstruction. | |
| Testing | ISO 10993-5 "Biological evaluation of medical devices - Tests forCytotoxicity: in vitro methods" was conducted and shows no evidence of acytotoxic response. Mechanical tests were conducted in conformance with ISO3597-2-94 Three-point Bending Standard results showed the material to besuitable for root canal posts |
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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol often associated with medicine and healthcare.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 0 2001
Mr. Craig R. Bruns Vice President Danville Materials, Incorporated 2021 Omega Drive San Ramon, California 94583
Re: K012354
Trade/Device Name: Snowpost & Snowlight Regulation Number: 872.3810 Regulation Name: Root Canal Post Regulatory Class: I Product Code: ELR Dated: July 18, 2001 Received: July 25, 2001
Dear Mr. Bruns:
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 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.
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Page 2 - Mr. Bruns
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
K. Watoust
Timothy A Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page / of /
K012354 510(k) Number:
Device Name: Snowpost & Snowlight
Indications for use:
Snowpost & Snowlight posts are indicated for use wherever root canal posts are required Showpost & Showingin posts are mellor and/or where known metal allergies are of concern.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96) (Division Sign-Off) Division of Dental, Infection Control, and General Hospita 510(k) Number _
§ 872.3810 Root canal post.
(a)
Identification. A root canal post is a device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be cemented into the root canal of a tooth to stabilize and support a restoration.(b)
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 the limitations in § 872.9.