(86 days)
- Direct and Indirect Restorations: to etch enamel/dentin prior to bonding with ONE-Step and some other fifth generation adhesives for use with light-cured composite materials
- Indirect Restorations: when used with an adhesive, to seal a preparation when using a light-cured composite cement.
- Densensitization: when used in combination with adhesive, to treat hypersensitive and/or exposed root surfaces.
A two bottle (or unit dose container), no rinse self-etching primer for use with light cured dental adhesives.
The provided document is a 510(k) premarket notification for a dental adhesive device named "SIMPLE." The document primarily focuses on establishing "substantial equivalence" to a predicate device, Clearfil™ SE BOND.
However, the document does not contain specific details about acceptance criteria, a formal study protocol, or performance metrics in a way that would allow for a comprehensive table and detailed answers to all the questions posed.
Here's an analysis of the available information and what cannot be answered from this document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in terms of numerical performance targets (e.g., bond strength thresholds, success rates). Instead, it relies on a qualitative comparison to the predicate device for "significant performance characteristics."
| Characteristic | Acceptance Criteria (Implicit) | Reported Performance (SIMPLE) | Predicate Performance (Clearfil SE BOND) |
|---|---|---|---|
| Intended Use | Substantially equivalent to predicate | Designed to reduce steps in preparing dentin and enamel for composite adhesion | Designed to reduce steps in preparing dentin and enamel for composite adhesion |
| Product Description | Substantially equivalent to predicate | One clear yellow solution; One white slurry | Two clear solutions |
| Delivery System | Substantially equivalent to predicate | Two solutions in separate bottles or in a two-chamber unit dose package | Two solutions in separate bottles package |
| Biocompatibility | Non-toxic | Biocompatibility tested; cytotoxicity and acute oral toxicity found to be non-toxic | (Not explicitly stated for predicate in this summary, but implicitly acceptable) |
Important Note: The "acceptance criteria" here are inferred to be "substantially equivalent to the predicate device" for the listed characteristics. No quantitative thresholds are provided.
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 in the summary. The document mentions "Side by side comparisons of SIMPLE to the predicate device," but does not detail the nature of these comparisons, the sample sizes, or the study design (retrospective/prospective, country of origin).
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. The document does not describe a process for establishing ground truth as it would for image-based diagnostic devices or complex clinical trials. The evaluation seems to be based on product characteristics and biocompatibility testing rather than expert-adjudicated clinical outcomes for the "test set" in the sense of a diagnostic study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Given the nature of the "significant performance characteristics" described (intended use, product description, delivery system), a formal adjudication method as understood in clinical trials for diagnostic devices is unlikely to have been applied or documented in this summary.
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
An MRMC study is not applicable and not mentioned in this document. This typically applies to diagnostic devices where human readers interpret images or data, and AI assists in that interpretation. The "SIMPLE" device is a dental adhesive, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A "standalone algorithm" performance is not applicable and not mentioned. This device is a physical dental adhesive, not a software algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the "significant performance characteristics" discussed, the "ground truth" seems to be based on:
- Manufacturer specifications and composition: for product description and delivery system.
- Biocompatibility testing results: for non-toxicity.
- Intended use statements: For comparison of application.
There is no mention of pathology, expert consensus on clinical outcomes, or large-scale outcomes data being used to establish "ground truth" for the performance comparison described.
8. The sample size for the training set
This information is not provided. The concept of a "training set" doesn't directly apply here, as this isn't an AI/machine learning device. If interpreted broadly as "samples used for development and preliminary testing," that information is not detailed.
9. How the ground truth for the training set was established
As in point 8, the concept of a "training set" and its "ground truth" establishment in the context of AI/ML is not applicable to this dental adhesive device.
Summary of what the document indicates:
The document serves as a 510(k) summary demonstrating "substantial equivalence" of the "SIMPLE" dental adhesive to a legally marketed predicate device, Clearfil™ SE BOND. The primary evidence presented for this equivalence is a side-by-side comparison of intended use, product description, and delivery system, alongside biocompatibility testing results for "SIMPLE." It does not provide the detailed study protocols, sample sizes, expert qualifications, or quantitative performance metrics typically associated with the questions asked, particularly those relevant to AI/diagnostic device evaluation.
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The station of the state of the contract and the same of the many of the comments of the comments of
JAN 1 7 2002
Image /page/0/Picture/2 description: The image shows a handwritten string of characters. The string appears to be "KO133519". The characters are written in black ink on a white background. The handwriting is somewhat messy, but the characters are still legible.
Section 5-1
Image /page/0/Picture/4 description: The image shows the logo for BISCO, a company specializing in adhesive and composite technology. The logo consists of a series of interconnected hexagons, each containing a letter that spells out "BISCO". Below the logo, the text "Specialist In Adhesive and Composite Technology" is written in a smaller font. The logo is black and white and appears to be a scan of a printed document.
Bisco, Inc. 1100 W. Irving Park Road Schaumburg, Il 60193 Telephone: (847) 534-6146 Fax: (847) 534-6396 Contact: Stephen D. Smith, Regulatory Affairs Manager
Brenders Science as Virg
SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 190 and 21 CFR par 807.92
Trade Name: Common Name: Classification name:
No Rinse Self-Etching Primer Resin Tooth Bonding Agent Class II per 21 CFR 872.3200
Description of Applicant Device:
A two bottle (or unit dose container), no rinse self-etching primer for use with light cured dental adhesives.
SIMPLE
Intended uses of Applicant Device:
- Direct and Indirect Restorations: to etch enamel/dentin prior to bonding with ONE ● STEP® for use with light-cured composite materials
- Indirect Restorations: when used with an adhesive, to seal a preparation when using a . light-cured composite cement
- Desensitization: when used in combination with adhesivo, to treat hypersensitive and/or 8 exposed root surfaces.
Predicate Devices: Clearfil™ SE BOND K990040 (clearance date of 2/4/99)
Siguificant Performance Characteristics:
| SIMPLE | Clearfil SE BOND | |
|---|---|---|
| Intended Use: | Designed to reduce steps inpreparing dentin and enamelfor composite adhesion | Designed to reduce steps inpreparing dentin and enamelfor composite adhesion |
| ProductDescription: | One clear yellow solutionOne white slurry | Two clear solutions |
| DeliverySystem: | Two solutions in separatebottles or in a two-chamberunit dose package. | Two solutions in separatebottles package. |
Side by side comparisons of SIMPLE to the predicate device Clearfil SE BOND clearly demonstrates that the applicant device is substantially equivalent to the legally marketed devices. The ingredients of Simple were biocompatibility tested, cytotoxicity and acute oral toxicity, and were found to be non-toxic.
It is concluded that the information supplied in this submission has proven the safety and efficacy of SIMPLE.
Stephen D. Smith Manager of Regulatory Affairs
Tel: 1-800-BISDENT or 847 534-6146 Fax: 847 534-6396
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Image /page/1/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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and a wavy line representing the body.
Public Health Service
JAN 1 7 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Stephen D. Smtih Manager of Regulatory Affairs Bisco, Incorporated 1100 West Irving Park Road Schaumburg, Illinois 60193
Re: K013519
Trade/Device Name: Simple Regulation Number: 872.3200 Regulation Name: Resin Dentin Bonding System Regulatory Class: II Product Code: KLE Dated: October 17, 2001 Received: October 23, 2001
Dear Mr. Smith:
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. Smith
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
Timothy A. Ulatowski
Timo Directo 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 1 of Sec. 2
K013519 510(k) Number (if known):
Device Name: SIMPLE
ר
Indications For Use:
-
Direct and Indirect Restorations: to etch enamel/dentin prior to bonding with ONE-Step and some other fifth generation adhesives for use with light-cured composite materials
-
Indirect Restorations: when used with an adhesive, to seal a preparation when using a light-cured composite cement.
-
Densensitization: when used in combination with adhesive, to treat hypersensitive and/or exposed root surfaces.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Susan Riisa
'Division Sign-Off) Division of Dental, Infection Control, ୍ General Hospital D - - General Hospital Devices - 013319
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.