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The commercial market for my dental products is solely going to be in the dental laboratory/dental office industry. Methyl methacrylate monomer and polymer is used to form a hard acrylic plastic during the fabrication of dental appliances.

Orthodontic and Dental laboratories:
a. to be used by qualified dental/orthodontic technicians trained in the fabrication of orthodontic and pedodontic, fixed and removable appliances.
b. trained in the proper use, precautions and hazards of dental resins
c. the actual fabrication of these dental devices must first be preceded by an authorized prescription for such a device, by a licensed dental practitioner.
Dental Offices/Clinics
a. to be used by qualified dentists/dental assistants trained in the fabrication of orthodontic, pedodontic fixed and removable appliances.
b. to be used by qualified dentists/dental assistants trained in the proper use, precautions and hazards of dental resins
c. to be used under the direct supervision of a licensed dental practitioner

Device Description

Jet Acrylic Liquid-Monomer, Ortho Jet Powder Trade Name: Polymer, Plastic

AI/ML Overview

The provided text is a 510(k) summary for a dental resin product (Jet Acrylic Liquid-Monomer, Polymer, Plastic) and does not contain information about acceptance criteria or a study proving device performance in the way typically found for medical devices with measurable performance metrics (e.g., diagnostic accuracy, precision).

Instead, this submission focuses on demonstrating substantial equivalence to a predicate device based on chemical composition and historical use, particularly regarding the dyes and pigments. The "study" mentioned is a "non-clinical test" comparing the physical characteristics and performance of the proposed device's monomers and polymers to control samples.

Therefore, many of the requested categories cannot be directly extracted from this document as they are not applicable to this type of regulatory submission or the nature of the evaluation described.

Here's a breakdown of the information that can be inferred or directly stated, along with explanations for the missing categories:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Physical Characteristics and Performance: Consistent with or equal to other commercially marketed monomers and polymers.	"The none clinical tests, simple as they were, appeared to show results that represented equal performances between the TESTER samples and the CONTROL samples."
Toxicity of Dyes/Pigments: Percentages allowable for maintaining safe FDA levels of toxic ingredients; levels of toxic substances acceptable and not a threat to public safety.	"All solvent dyes used, were used at percentages that were allowable for maintaining safe FDA levels of toxic ingredients. The same also applies for the use of the dry synthetic dye pigments used to tint the polymers. Therefore, all pigments used, were used, where levels of toxic substances were acceptable and regarded as not to be a threat to public safety."
No immediate or short-term side effects: Physical wearing of dental appliances.	"The physical wearing of dental appliances by family members showed no immediate or short terms side affects from any of the new polymers or monomers."
Leach Testing (Dyes/Pigments): Dyes/pigments would not leach out of the cured methyl methacrylate resin.	Stated by FDA in a conversation: "I was told that the dyes/pigments would not leach out of the cured methyl methacrylate resin." (This was not a test performed by the submitter but an FDA assertion).
Chemical Structures: Provided for review.	"The chemical structures that I was able to obtain are included for that part of your review. The chemical structures that I was unable to obtain are of proprietary property and can be obtained upon request from the dye/pigment manufacturer(s)."

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: Not specified. The description refers to "TESTER samples and the CONTROL samples" without quantifying them.
Data Provenance: Not specified. The "physical wearing of dental appliances by family members" suggests anecdotal feedback, likely domestic (USA) and prospective in nature, but this is not a formal study. The "none clinical tests" are also not detailed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The evaluation appears to be based on comparative physical characteristics and safety assessments rather than expert-adjudicated clinical outcomes in a formal test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable/Not specified. There is no mention of a formal adjudication process for interpreting results.

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 MRMC or AI-assisted study was performed or is relevant to this device type and submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a material-based device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the physical characteristics appears to be implicitly established by comparing to "other currently manufactured and distributed denture based resins" and "commercially marketed monomers and polymers."
For toxicity, the "ground truth" is adherence to "allowable for maintaining safe FDA levels of toxic ingredients" and the FDA's statement regarding leaching.
"Outcomes data" is highly informal, based on "physical wearing of dental appliances by family members."

8. The sample size for the training set

Not applicable. This type of submission refers to material properties and safety rather than a machine learning model with a training set.

9. How the ground truth for the training set was established

Not applicable for the same reason as above.

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