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BB Base 3D printing resin for denture base, developed by ENLIGHTEN MATERIALS Co., Ltd., is a light-cured resin indicated for the fabrication of full removable denture bases in dental laboratories. It is an alternative to traditional heat-cured, light-cured or light-cured denture base resins. BB Base 3D printing resin for denture base should be used exclusively by dental professionals. Fabrication of denture bases with BB Base 3D printing resin for denture base requires a computer-aided and manufacturing (CAD/CAM) system including the following; optical impression system, design software (CAD software), stereolithographic additive printer, and post-cure unit.

BB Base is a photosensitive resin intended to fabricate removable dentures in a CAD/CAM additive printing process. The BB Base 3D printing resin for denture base is a viscous solution of the following compounds: methacrylate-based resins, a photoinitiator that activates between 385nm to 405 nm light, and pigments. It comes in one size, one kilogram per bottle. It is a Type 4 (light-activated) acrylic resin as classified ISO20795-1. The material is used in a 3D printer, which prints the shape determined by a 3D stereolithographic drawing. After printing, the printed product is placed in a UV-light curing box for final polymerization. 3D printer is not included with the device.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

Device Name: BB Base 3D printing resin for denture base
Predicate Device: Dentca Denture Base II (K162044)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are largely based on the ISO 20795-1 standard for "Dentistry - Base polymers - Part 1: Denture base polymers" and comparisons to the predicate device.

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AA temp temporary restoration 3D printing photoreactive resin is a light-curable polymerizable resin to fabricate, by additive manufacturing, temporary crowns or bridges. The fabricated temporary crowns or bridges are an alternative to preformed temporary crowns or bridges and require digital models of crowns or bridges, a stereolithographic additive printer, and curing light equipment.

AA temp is a photosensitive resin intended for use to fabricate temporary crowns and bridges using CAD/CAM additive printing process. The AA temp polymer is a viscous solution of the following compounds: methacrylate-based resins, a photoinitiator that activates between 385nm to 405 nm light, and pigments. It comes in one size, one kilogram per bottle. It is compliant to the requirements defined in ISO 10477-2018 for Type 2 Class 2 materials. The material is used in a 3D printer, which prints the shape determined by a 3D stereolithographic drawing. After printing, the printed product is placed in a UV-light curing box for final polymerization. 3D printer is not included with the device.

The provided document describes the FDA 510(k) clearance for the "AA temp temporary restoration 3D printing photoreactive resin." This device is a light-curable polymerizable resin used to fabricate temporary crowns or bridges via additive manufacturing (3D printing). The clearance is based on demonstrating substantial equivalence to a predicate device (K102776, "e-DENT TEMPORARY RESIN and EXTRA-ORAL CURING SYSTEM").

However, the provided text does not contain detailed information about acceptance criteria or a specific study proving the device meets those criteria in the way typically expected for an AI/ML medical device.

The document focuses on the physical and chemical properties of the resin, its biocompatibility, and compliance with ISO standards, which is standard for material-based medical devices. It compares the proposed device to a predicate device based on these physical properties and indications for use.

Here's an attempt to answer your questions based only on the provided text, while acknowledging the limitations for an AI/ML context:

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

For material-based devices like this resin, acceptance criteria are generally established against relevant ISO standards or engineering specifications. The document indicates adherence to ISO standards as performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide details on sample sizes for the physical property tests (Flexural Strength, Water Absorption, Solubility) or for the biocompatibility tests. It only states that these tests were conducted. The "Non-clinical performance testing" and "Bench Testing" sections directly relate to these tests. Given the nature of material testing, these would typically be lab-based experiments.

• Test Set Sample Size: Not specified.
• Data Provenance: Not specified, but given the manufacturer is in Taiwan, it's likely the testing was performed there or by an accredited lab. These are bench tests, not patient data.
• Retrospective/Prospective: These are laboratory bench tests and not applicable to human data.

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 this type of device and testing. The ground truth for material properties is established by physical and chemical test results, not expert interpretation in the medical imaging sense.

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

This question is not applicable to the non-clinical bench testing of a material.

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 such study was conducted or is relevant for this device. This is a material (resin) for 3D printing temporary dental restorations, not an AI/ML diagnostic or assistive device that would involve human readers.

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)

For the physical and chemical properties, the ground truth is the quantitative measurements obtained from standardized laboratory tests according to ISO standards (e.g., flexural strength in MPa, water absorption in µg/mm³, solubility in µg/mm³). For biocompatibility, the ground truth is the outcome of specific biological assays (e.g., cell viability for cytotoxicity, skin reaction for sensitization).

8. The sample size for the training set

This question is not applicable, as there is no "training set" for this type of material device. The resin itself is the product; it does not involve AI/ML models that require training data.

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

This question is not applicable, as there is no training set.

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