(32 days)
VET-PREP is used to re-wet dried dentin following acid etching and drying of the prepared cavity.
WET-PREP is an aqueous solution of hydroxyethyl methacrylate. Hence, it is an aqueous re-wetting agent (dentin conditioner) that is applied to acid etching tooth structure, by the dentist following prior to application of a hydrophilic dentin adhesive such as ALL-BOND 2. The purpose of WET-PREP is to keep the dental cavity preparation adequately moist before the dentist restores the lost tooth structure.
The provided text describes the WET-PREP™ device, its intended use, and scientific rationale, but it does not contain the specific information required to complete all sections of your request regarding acceptance criteria and the detailed study proving device performance in the format you've outlined.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices and generally doesn't include the granular details of a full clinical or performance study report.
However, I can extract the information that is present and indicate where the requested information is missing.
Here's an attempt to answer your questions based only on the provided text, with clear indications of missing information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Implicit Acceptance Criteria (derived from text): | |
| Re-wet dried dentin and prevent desiccation prior to primer application. | WET-PREP significantly improved (greater than four-fold increase) the shear bond strength of air-dried dentin. "Desiccated dentin could be reconstituted so no significant difference could be found between treated teeth and those that were handled in a clinically acceptable fashion." |
| Not significantly interfere with the bonding mechanism of primer resins and the prepared tooth. | "There was no statistically significant difference (p=0.05, t=1.29) between the shear bond strength of WET-PREP treated teeth and those left untreated." |
| Improve shear bond strength compared to predicate HEMA-BENZ. | "WET-PREP treated teeth were found to have significantly greater shear bond strength when compared to HEMA-BENZ treated teeth (p=0.5 [sic, likely typo, should be <0.05 or similar], t=3.39)." |
| Explicit Acceptance Criteria: | Not explicitly stated in the provided text. The text describes observed performance but does not define pre-specified "acceptance criteria" with numerical thresholds. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for the test set: Not specified in the provided text.
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective).
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 and study described. The performance evaluation involved measuring shear bond strength, which is an objective measurement, not a subjective interpretation requiring expert consensus on "ground truth" in the way a diagnostic imaging study would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. As noted above, the evaluation involved objective shear bond strength measurements.
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. This is not an MRMC study. The device is a dental re-wetting agent, not an AI system or diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a chemical solution, not an algorithm. The performance was measured as a standalone effect of the chemical solution on material properties (shear bond strength).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" in this context is the objectively measured shear bond strength of the dental materials to the tooth structure. This is a direct physical measurement. The comparisons are against untreated teeth and teeth treated with a predicate device.
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI context where "training sets" are used. The study involves laboratory testing of a chemical product.
9. How the ground truth for the training set was established
- Not applicable, as there is no "training set" in the context of this device's evaluation. The ground truth (shear bond strength) for the performance evaluation was established by experimental measurement in a laboratory setting.
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BISCO, INC., 1500 W. Thorndale Ave., Itasca, IL 60143 510(k) submission for WET-PREP™
Image /page/0/Picture/1 description: The image shows a series of numbers and a letter. The numbers are 961822. The letter is K. The numbers and letter are written in a bold, black font.
510(k) SUMMARY As Required By the Safe Medical Devices Act of 1990
IDENTIFICATION OF THE LEGALLY MARKETED PREDICATE DEVICE
PREDICATE DEVICE Bisco DENTIN CONDITIONER™
DENTIN CONDITIONER is an aqueous solution of hydroxyethyl methacrylate (HEMA), and succinic acidhydroxyethyl methacrylate (SA-HEMA). The product was used at a time when acid etching dentin was unheard of. The product was intended to diffuse into the dentin smear layer and enhance the mechanical bond of subsequently applied bonding resins. The supporting hypothesis was sound in that aqueous solutions ought to easily penetrate the hydrophilic smear layer. After evaporation of the water solvent the acrylic monomers could then wet and bond to the relatively hydrophobic bonding resins (bis-GMA). Both the conditioners and bonding resins could polymerize together effecting a seal of the cut dentin.
PREDICATE DEVICE (cont). HEMA-BENZ™
HEMA-BENZ is functionally and chemically similar to DENTIONER noted above. The product is intended to perform identical service but HEMA-BENZ is also referred to as a desensitization. " it occurs at all, is due to the indirect effect of enhanced wetting of subsequent applications of primer resins. I hat is, reduction of sensitivity is due to the enhanced seal provided by the primers, the enhancement of the seal occurs through improved wetting provided by the products in question.
DESCRIPTION OF APPLICANT DEVICE WET-PREP™
WET-PREP is an aqueous solution of hydroxyethyl methacrylate. Hence, it is an aqueous re-wetting agent (dentin conditioner) that is applied to acid etching tooth structure, by the dentist following prior to application of a hydrophilic dentin adhesive such as ALL-BOND 2. The purpose of WET-PREP is to keep the dental cavity preparation adequately moist before the dentist restores the lost tooth structure.
It is well known that ALL-BOND 2 and similar hydrophilic primer resin systems are most effective when applied to moist dentin as in the so-called wet technique'. Some dentists have had difficulty determining exactly how wet to leave the dentin prior to application of hydrophilic primers. Brief drying with an air syringe prior to primer application often leads to desiccation of dentin with resultant collapse of collagen fibers. Collapsed collagen presents an effective barrier to penetration of primers.
Using the WET-PREP technique, the dentist can dry the cavity preparation following acid etching to assess the degree of enamel etching without fear of affecting the primer bond. The dentist simply re-wets with WET-PREP prior to application of the hydrophilic primer. WET-PREP precludes asking the familiar question, .10w wet is wet?"
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INTENDED USES OF APPLICANT DEVICE
VET-PREP is used to re-wet dried dentin following acid etching and drying of the prepared cavity. Following etching the dentist typically air dries the etched enamel to check that a chalky-white appearance is present indicating that etching has occurred. At this point the dentin and enamel are too dry for effective penetration of subsequently applied primers. Hydrophilic primers will not effectively penetrate the dried collagen layer. If the primer is unable to penetrate through collagen an effective seal will not occur and postoperative sensitivity is likely to result.
If WET-PREP is applied prior to application of the primers, it will effectively re-wet the collapsed collagen and allow for penetration of the hydrophilic primers through the moist collagen network. Enhancement of penetration of primers will improve the seal the restorative material makes with the prepared tooth. Since it is well known that microleakage is the predominant reason for post-operative sensitivity it is reasonable to assume an increase in sensitivity ought to result from the use of these products.
SCIENTIFIC CONCEPTS and SIGNIFICANT PERFORMANCE CHARACTERISTICS
WET-PREP ia an aqueous solution of hydroxyethyl methacrylate (approx. 35%) with a small amount (<0.5%) of sodium fluoride and benzalkonium chloride. This solution has the ability to easily penetrate etched dentin and enamel and will help to prevent desiccation of the etched surface prior to application of primer resins. That is, after the etched enamel/dentin is dried to determine the quality of the dentist can re-wet the cut tissue with WET-PREP without concern for desiccation. The HEMA solution will keep the cut surface moist until application of hydrophilic primers.
it was found that WET-PREP significantly improved (greater than four fold increase) the shear bond strength of air dried dentin. This is a good indication of the product's efficacy. Desiccated dentin could be reconstitued so no significant difference could be found between treated teeth and those that were handled in a clinically acceptable fashion.
It was found that there was no statistically significant difference (p=0.05, t=1.29) between the shear bond strength of WET-PREP treated teeth and those left untreated. This was taken as an indication that WET-PREP did not significantly interfere with the bonding mechanism of the primer resins and the prepared tooth. However, WET-PREP treated teeth were found to have significantly greater shear bond strength when compared to HEMA-BENZ treated teeth
(p=0.5, f=3.39).
James L. Sandrik
James L. Sandrik, Ph.D Bisco, Inc. Itasca, IL 60143
May 8, 1996
§ 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.