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FREEPRINT® splintmaster is a light-curable resin intended to be used in conjunction with extra-oral curing light equipment. FREEPRINT® splintmaster is indicated for the fabrication, by additive manufacturing, of orthodontic and dental objects such as mouthguards, splints, and repositioners.

The Subject device is a light-cured methacrylate-based resin used in 3D printers to produce dental mouthguards, nightguards, splints, and repositioners. The Subject device is a viscous solution consisting of methacrylate-based resins, photo initiators and pigment.

The Subject device is used by a dental professional (dentist or dental technician) for the additive Computer-Aided Manufacturing (CAM) of dental mouthguards, nightguards, splints, and repositioners. There are two models of the Subject device which are referred to as FREEPRINT® splintmaster flex and FREEPRINT® splintmaster taff with slightly different material properties for either a more flexible or rigid final product.

The Subject device resin is used within a validated manufacturing workflow to create the intended dental device. Dental devices fabricated using the Subject device are one-time use, prescription-only devices.

The provided text describes a 510(k) premarket notification for a medical device called FREEPRINT® splintmaster. However, it does not contain the specific information required to answer your detailed questions about acceptance criteria and the study proving the device meets them.

The document is a clearance letter from the FDA, stating that the device is substantially equivalent to legally marketed predicate devices. It discusses:

• Indications for Use: What the device is intended for (fabrication of orthodontic and dental objects like mouthguards, splints, and repositioners).
• Device Description: It's a light-cured methacrylate-based resin used in 3D printers.
• Equivalence to Marketed Devices: Comparison of the subject device with predicate devices (GR Splint Resin System, KeyPrint KeySplint Soft, KeyPrint KeySplint Hard) in terms of indications for use and technological characteristics.
• Non-Clinical Performance Testing: Mentions that physical property testing was performed to ISO 20795-2, and biocompatibility testing was done to ISO 10993 standards. It also states that "Non-clinical performance testing of the Subject device met the acceptance criteria for each validation and test described above."

Missing Information:

Crucially, the document explicitly states:

• "No clinical or animal testing data is included in this submission."
• It does not provide a table of acceptance criteria, specific performance numbers for the device against those criteria, or details regarding the methodologies for setting ground truth, expert qualifications, sample sizes for test or training sets, MRMC studies, or standalone performance.

**Therefore, I cannot fulfill your request for: **

1. A table of acceptance criteria and the reported device performance: This detailed information is not present. The document only broadly states that the device met acceptance criteria for non-clinical tests.
2. Sample sizes used for the test set and the data provenance: Not specified, as clinical data was not included. "Test set" here refers to non-clinical chemical and mechanical tests, not a clinical dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as ground truth typically refers to clinical diagnosis or outcomes, which were not part of this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for non-clinical material testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Explicitly stated "No clinical or animal testing data is included."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, this is a material (resin) for dental manufacturing, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as it's not a diagnostic device or AI. The "ground truth" for the material is its physical and chemical properties as measured by ISO standards.
8. The sample size for the training set: Not applicable, as no AI model was described requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided FDA document is a clearance letter for a 3D printing resin based on engineering and material property testing, rather than an AI/diagnostic device that would typically involve the detailed study information you are asking for.

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FREEPRINT® crown is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces.

The FREEPRINT® crown material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations.

Fabrication of FREEPRINT® crown requires a computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer, and post-cure unit.

The Subject device is a light-cured methacrylate-based resin used in 3D printers for the production of temporary or permanent dental restorations such as crowns and bridges, inlays, veneers and full crown restorations including occlusal surfaces. The Subject device is used by a dental technician for the CAD/CAM manufacturing of temporary dental restorations.

Restorations fabricated using the Subject device are one-time use, prescription-only devices. The Subject device is a viscous solution consisting of methacrylate-based resins, photo initiators and pigments.

Commonly used dental CAD software is used by dental professionals to virtually design a fixed indirect restoration and generate an industry-standard "STL" 3D dataset which reflects the intended shape and contour. The Subject resin is used within a validated manufacturing workflow to create the intended restoration. The Subject device is available in a variety of optional shades to reproduce the intended tooth shade of the restoration. Methacrylates are known materials, commonly used in the dental industry for fixed and removable prosthetic devices due to their physical-chemical, mechanical, and biocompatible properties.

The Subject device is intended to be sold by the bottle and used with compatible hardware in computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer, and post-cure unit.

The provided document describes the FDA 510(k) premarket notification for the FREEPRINT® crown device, which is a light-cured methacrylate-based resin for 3D printing dental restorations. The document focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical performance testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the FREEPRINT® crown are primarily based on meeting the requirements of recognized international standards for dental materials. The reported device performance is compared against these standards and against predicate/reference devices.

Note: For several parameters (Depth of Cure, Surface Finish, Flexural Strength, Water Sorption, Water Solubility), the document explicitly states that the FREEPRINT® crown meets the requirements of the listed ISO standards, but for some, it also provides specific values for the subject device or for the predicate/reference devices. The table above uses the explicitly stated acceptance thresholds where given.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes (number of specimens) used for each non-clinical test (e.g., flexural strength, water sorption, biocompatibility). It states that "Physical property testing was performed on the Subject device to ISO 4049:2019...and ISO 10477:2018." These standards typically define the number of test specimens required for various mechanical and physical property evaluations.

Data Provenance: The data is primarily from non-clinical laboratory testing ("Non-clinical Performance Testing") conducted to support the substantial equivalence claim. The country of origin for the testing itself is not explicitly stated, but the manufacturer is DETAX GmbH, located in Germany, suggesting the testing might have been conducted there or in labs compliant with international standards. The document also mentions comparative material property testing performed with a "Reference device," implying some form of internal or contracted testing. This is retrospective data, as it was collected before the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This device is not an AI/Software as a Medical Device (SaMD) that diagnoses or interprets medical images, so the concept of "ground truth" established by experts in a clinical context (e.g., radiologists) is not applicable here. The "ground truth" for this device, which is a dental material, is defined by the objective, quantifiable physical, chemical, and biological properties measured against established international standards (ISO). The "experts" involved would be the material scientists, engineers, and chemists who conducted and interpreted the laboratory tests according to the specified standard operating procedures and test methods. Their specific number and qualifications are not detailed in this FDA letter, but it's presumed they possess the necessary expertise to perform these standardized tests.

4. Adjudication Method for the Test Set

Not applicable. Since the "ground truth" is defined by objective physical and chemical measurements against ISO standards for material performance, there is no need for an adjudication method as would be used in expert consensus for clinical image interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This document explicitly states: "The performance of methacrylate-based polymer resins in the clinical environment has been well established. No clinical or animal testing data is included in this submission." Therefore, an MRMC study, which is a type of clinical study, was not performed. The device is a dental material, not an AI or imaging device where MRMC studies are typically relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an AI algorithm. Its performance is measured directly by its physical, chemical, and biocompatibility properties when fabricated into a dental restoration.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on objective measurements of material properties according to established international consensus standards (ISO standards) for dental restorative materials. These include:

• Physical properties (e.g., flexural strength, water sorption, water solubility, depth of cure, surface finish).
• Chemical characterization of its composition.
• Biocompatibility testing results (cytotoxicity, sensitization, irritation, etc.).

8. The Sample Size for the Training Set

Not applicable. This is a material, not a machine learning algorithm, so there is no concept of a "training set" for an AI model. For material development, batches are produced and tested, but this is part of quality control and R&D, not an "AI training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set in the context of an AI model. For the material's development and evaluation, the "ground truth" or acceptable parameters are set by the performance requirements outlined in the relevant ISO standards (e.g., ISO 4049, ISO 10477, ISO 10993 series). These standards represent an international consensus on the minimum performance and safety requirements for such dental materials.

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FREEPRINT denture is a light-cured resin indicated for the fabrication of all types of denture bases, for instance full and partial removable dentures. FREEPRINT denture is intended for continuous use in the oral environment, exclusively for professional dental work. FREEPRINT denture can be used in combination with a stereolithographic 3D printer using a 3D-printer is not part of the device.

FREEPRINT denture is a light-cured one-component materials for the Digital Light Processing (DLP)-printing of denture base products. It is stored in 500 and 1000ml HDPE bottles. This Product is a liquid photo-curable material that is polymerized, by the photo-initiator contained in the resin. This device can be manufactured with 3D stereolithographic printer with 385nm wavelength light source. Curing in a 3D printer is related to the conditions of the printer equipment and is typically 100µm in thickness. FREEPRINT denture products are post cured with a xenon flashlight, in a nitrogen atmosphere.

The provided text describes a 510(k) premarket notification for a dental device called "FREEPRINT denture." It focuses on bench testing and biocompatibility studies to demonstrate substantial equivalence to a predicate device, rather than the performance of an AI/ML-based device that would typically involve a test set, ground truth experts, and MRMC studies.

Therefore, the requested information regarding acceptance criteria and a study proving an AI device meets these criteria cannot be fully extracted or answered from the provided document. The document describes a physical medical device (denture resin), not an AI/ML system.

However, I can extract the details about the performance testing and acceptance criteria as described for this physical device.

Here's an interpretation based on the provided text, acknowledging it's for a physical product and not an AI/ML device:

Device: FREEPRINT denture (light-cured resin for denture bases)

Type of Study: Bench testing and biocompatibility testing to demonstrate substantial equivalence to a predicate device. No clinical tests were performed.

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

For a physical material like dental resin, acceptance criteria are typically defined by recognized standards (like ISO) and relate to physical, chemical, and biological properties.

Proof of Meeting Acceptance Criteria:
"Performance testing confirmed the FREEPRINT denture demonstrated performance to the acceptance criteria referred to ISO 20795-1."
"Biocompatibility testing...The results showed that the insolubility is in compliance with the requirements of the standard. There is no evidence that hazardous effects will arise by leachable ingredients/contaminants."

2. Sample sized used for the test set and the data provenance

• Sample Size: Not explicitly stated for each specific test (e.g., how many samples were tested for water sorption). The document generally states "Bench testing was carried out."
• Data Provenance: Not explicitly stated for test samples (e.g., country of origin). The device manufacturer is DETAX GmbH & Co.KG. in Germany, implying testing likely occurred in a similar region. The studies are retrospective in the sense that they are conducted on manufactured samples of the device and its components, not involving patient data.

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

This question is not applicable as the document describes a physical dental material, not an AI/ML device requiring expert interpretation of images or data to establish ground truth. "Ground truth" in this context refers to measurements against established standards for material science.

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

Not Applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in interpreting medical images for AI/ML development. For material performance testing, results are typically objective measurements against a standard.

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. This is a physical device, not an AI/ML system. No human readers or interpretations of results in the context of an MRMC study are mentioned.

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

Not Applicable. This is a physical device, not an algorithm.

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

The "ground truth" for this device's performance relies on established international standards (e.g., ISO 20795-1 for dental base polymers, ISO 10993 series for biocompatibility), and the objective measurements of the material's properties against the specifications within these standards.

8. The sample size for the training set

Not Applicable. This is a physical dental material, not an AI/ML device that requires a training set. The material is manufactured and tested according to specified processes and properties.

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

Not Applicable. As there is no training set for an AI/ML model, this question does not apply.

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FREEPRINT temp is indicated for the fabrication of temporary dental restorations in conjunction with extra-oral curing light equipment. Duration is less than 30 days in oral environment.

FREEPRINT temp is a family of light-cured-component materials for the Digital Light Processing (DLP)-printing of temporary Crowns & Bridges (C&B) material. It is stored in 500 and 1000ml HDPE bottles. It contains materials with colours of A1, A2, and A3 based on the shade guide. This Product is a liquid photo-curable material that is polymerized by UV laser at 385nm. It can be used to make a tooth model with a photo-curable polymer that is cured by ultraviolet light. The liquid UV curing resin is cured at a specific wavelength (385nm) by the photo-initiator contained in the resin. This device can be manufactured with 3D stereolithographic printer with 385nm wavelength lightsource. Curing in a 3D printer is related to the conditions of the printer equipment and is typically 50µm in thickness. Output resolution ranges from 34µm to 75µm on the x, y axis.

I am sorry, but based on the provided text, there is no information about a study that uses AI or machine learning, or medical image analysis. This document is a 510(k) premarket notification for a dental resin called FREEPRINT temp, used for fabricating temporary dental restorations.

The document discusses the device's indications for use, technological characteristics, and comparison to a predicate device. It also mentions performance testing (against ISO standards) and biocompatibility testing, but these are standard tests for physical materials and do not involve AI or medical image analysis.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance related to AI/ML.

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Used for fabricating long-term soft denture relinings by direct or indirect application.

Not Found

This FDA document is a clearance letter for a dental device, "Mollosil Plus," classifying it as substantially equivalent to existing predicate devices. It does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot provide the requested information based on the provided text. The document is a regulatory approval, not a performance study report.

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DETAX implantlink® semi is designed for the temporary luting of implant-retained restorations. Requires no separating agents. Luted restorations can be removed. with standard devices (i.e. Crown Butler, Corona Fix).

Not Found

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a dental cement. The letter explicitly states it is a review of the notification and a determination of substantial equivalence.

This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies. It is a regulatory approval letter, not a study report.

Therefore, I cannot fulfill your request for details on the acceptance criteria and the study that proves the device meets them based on the provided text.

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Material for making temporary crowns and bridges, self curing, fast setting, bis-acrylic-composite 2:1

Not Found

I apologize, but the provided text is a 510(k) clearance letter from the FDA for a dental material called "Tempofit," and a statement of indications for use.

This document does not contain any information about:

• Acceptance criteria for a device.
• A study that proves a device meets acceptance criteria.
• Any of the specific details requested in your prompt (sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details, etc.).

The letter is simply an FDA approval notice indicating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory classifications and general controls, but not performance study details.

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