Search Results
Found 11 results
510(k) Data Aggregation
(3 days)
Denture Base Resin DT20
Denture Base Resin is a light-curable polymerizable resin intended to be used for the fabrication of full and partial removable dentures. Fabrication of denture base Resin requires a digital denture file, 3D printer and post-curing unit.
Denture Base Resin is a liquid light-curable material. The product should be used in combination with the 3D printer. Printer and resin must be optimized to each other in order to get complete and precise printed parts. The 3D printer and the post-curing unit of SHINING3D make use of a light source to polymerize the Denture Base Resin.
I am sorry, but the provided text does not contain information about the acceptance criteria and study that proves the device meets the acceptance criteria in the format you requested, as it pertains to a medical device's AI/algorithm performance.
The document is a 510(k) premarket notification for a Denture Base Resin (a material used for making dentures). It focuses on:
- Substantial Equivalence: Comparing the new resin to an existing predicate resin based on material composition, intended use, manufacturing process, and various performance and biocompatibility tests for dental materials.
- Non-Clinical Performance Tests: These tests are for the physical and biological properties of the resin material itself, such as mechanical properties according to ISO 20795-1, color stability according to ISO 7491, biocompatibility according to ISO 10993-1 and ISO 7405, and shelf-life.
- No Clinical Study: The document explicitly states, "No clinical study is included in this submission."
Therefore, I cannot provide a table of acceptance criteria and reported device performance related to AI/algorithm, nor can I answer questions about sample sizes for test sets, data provenance, ground truth establishment by experts, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not addressed in the provided text which describes a physical dental material, not an AI medical device.
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(126 days)
Denture Base Resin (PN-Denture (Red, White))
Denture Base Resin is a light-curable resin indicated for the fabrication of:
•individual and fixed permanent full single crowns, permanent partial crowns in front and posterior area
•denture bases
Denture Base Resin is intended exclusively for professional dental work.
The Denture Base Resin is an alternative to traditional heat cured and auto polymerization resins. The resins are available in two (2) different colors ( white, red). Denture Base Resin can be used with PioNext D Series. PioNext D Series printers include a 3D printing system that utilizes Digital Light Process (DLP) technology, with automatic feeding process, and a UV LED (405nm) curing process. The dental appliance is then cured in the PioNext UV-02 curing chamber and sent back to the dentist for try-in and final adjustment.
I'm sorry, but this document does not contain the information required to answer your request. The provided text is a 510(k) premarket notification letter from the FDA regarding a "Denture Base Resin" device.
It does not provide details about acceptance criteria or a study proving that an AI/software-based device meets these acceptance criteria. Instead, it focuses on dental resin material properties and non-clinical performance tests, not AI or software performance.
Therefore, I cannot provide:
- A table of acceptance criteria and reported device performance for an AI/software.
- Sample sizes used for test sets or data provenance for AI/software.
- Number of experts or their qualifications for establishing ground truth for AI/software.
- Adjudication methods for AI/software test sets.
- Information about MRMC comparative effectiveness studies or effect sizes for AI assistance.
- Standalone performance of an AI algorithm.
- Type of ground truth for an AI/software.
- Sample size for training sets for an AI/software.
- How ground truth was established for training sets for an AI/software.
The document discusses "Denture Base Resin" and its properties, and confirms its substantial equivalence to predicate devices based on non-clinical performance tests related to dimensional stability, color stability, translucency, flexural strength, freedom from porosity, and water solubility. There is no mention of AI, machine learning, or software performance evaluation in this context.
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(107 days)
Glidewell 3DP Denture Base Resin
Glidewell™ 3DP Denture Base Resin is a light-curable polymerizable resin intended to be used in conjunction with extraoral curing light equipment. Glidewell™ 3DP Denture Base Resin is indicated for the fabrication and repair, by additive manufacturing, of full and partial removable dentures and baseplates.
Glidewell™ 3DP Denture Base Resin, is a light-curable resin intended to be used in conjunction with extraoral curing light equipment. Glidewell™ 3DP Denture Base Resin is indicated for the fabrication and repair, by additive manufacturing, of full and partial removable dentures and baseplates. Glidewell™ 3DP Denture Base Resin, is a light-cured methacrylic material with photo initiators that form a polymer during 3D printing. Glidewell™ 3DP Denture Base Resin is printed using digital light processing (DLP). The DLP printer and resin are optimized to each other in order to achieve complete and precise printed parts. The light source provided by the DLP printer (405nm wavelength), and the post-curing light box polymerize the resin which forms a hardened denture base. Once cured, Glidewell™ 3DP Denture Base Resin has the mechanical property that meets the performance criteria for Type 4: Light-activated materials as defined in the FDA-recognized consensus standard ISO 20795-1:2013 Dentistry - Base polymers - Part 1: Denture base polymers, including flexural strength, flexural modulus, water sorption and water solubility.
The subject device, Glidewell™ 3DP Denture Base Resin, has the same formulation and manufacturing process as the predicate device, Glidewell™ 3DP Denture Base Resin (K213765), which contains silver sodium hydrogen zirconium phosphate. In vitro studies on the subject device, Glidewell™ 3DP Denture Base Resin, demonstrated a reduction in the following microorganisms: Streptococcus mutans, Streptococcus mitis, Staphylococcus aureus, Escherichia coli, Klebsiella pneumonia, Candida albicans, Candida glabrata, Candida tropicalis, MRSA (Methicillin Resistant Staphylococcus aureus), VRE (Vancomycin Resistant Enterococcus).
Here's an analysis of the provided text, focusing on the acceptance criteria and the study proving the device meets them, presented in the requested format.
It's important to note that this document is a 510(k) Summary, which is a regulatory submission for medical devices. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical trial results. Therefore, some information typically found in a full clinical study report (like detailed sample sizes for training sets or expert qualifications for ground truth) may not be explicitly stated for components not directly studied in this submission. The "study" described herein refers primarily to the in vitro antimicrobial testing.
Acceptance Criteria and Device Performance
Glidewell™ 3DP Denture Base Resin is a Class II device (Product Code EBI, Regulation Number 21 CFR 872.3760). The primary focus of the additional testing in this 510(k) submission (K241493) seems to be the antimicrobial properties of the resin, as its physical properties are stated to be identical to the predicate device (K213765).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category/Metric | Acceptance Criteria (Target/Threshold) | Reported Device Performance (Result) | Study Type/Standard |
|---|---|---|---|
| Physical Properties | |||
| Flexural Strength | Meets ISO 20795-1:2013 for Type 4 | Meets standard (same as predicate) | ISO 20795-1:2013 |
| Flexural Modulus | Meets ISO 20795-1:2013 for Type 4 | Meets standard (same as predicate) | ISO 20795-1:2013 |
| Water Sorption | Meets ISO 20795-1:2013 for Type 4 | Meets standard (same as predicate) | ISO 20795-1:2013 |
| Water Solubility | Meets ISO 20795-1:2013 for Type 4 | Meets standard (same as predicate) | ISO 20795-1:2013 |
| Antimicrobial Properties (In Vitro) | |||
| Viable Count Reduction - Short-term | >99.9% reduction compared to control | >99.9% reduction for all 10 tested microorganisms (Streptococcus mutans, Streptococcus mitis, Staphylococcus aureus, Escherichia coli, Klebsiella pneumonia, Candida albicans, Candida glabrata, Candida tropicalis, MRSA, VRE) | ASTM E2180-07 |
| Viable Count Reduction - Long-term (Accelerated aging to 3 years) | >99.9% reduction compared to control | >99.9% reduction for S. mutans and C. albicans | ASTM E2180-07 & ASTM F1980-16 (modified) |
| Viable Count Reduction - Long-term (Real-time aging up to 6 months) | Significantly higher levels compared to control | Significant reduction for S. mutans and C. albicans | ASTM E2180-07 |
| Biofilm Formation/Growth Reduction | >90% reduction for S. mutans; >70% reduction for C. albicans | Achieved (>90% for S. mutans, >70% for C. albicans) | ASTM E2647-13 (modified) |
| Biocompatibility | Meets applicable endpoints | Biocompatible (per ISO 10993-1:2018 and ISO 7405:2018) | ISO 10993-1:2018, ISO 7405:2018 |
| Printer Compatibility | Printing accuracy & orientation validated for additional model | Asiga PRO 4K validated | Internal Validation |
2. Sample Sizes Used for the Test Set and Data Provenance
- Antimicrobial Tests (Test Set): The specific number of samples (replicates) used for each microorganism in the in vitro tests (ASTM E2180-07 and ASTM E2647-13) is not explicitly stated in this summary. These are typically material tests on prepared resin samples, not patient-derived data.
- Physical Properties: Not explicitly stated as the data for the subject device is leveraged from the predicate device (K213765), implying prior testing was performed for the predicate.
- Data Provenance: The studies are in vitro laboratory tests conducted by the manufacturer or their contracted labs. The provenance is internal to the manufacturer (Prismatik Dentalcraft, Inc.) and is retrospective as it supports a 510(k) submission. No country of origin for data generation is specified beyond the company's location in Irvine, California, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not Applicable. For these in vitro material and microbiology tests, "ground truth" is established by the standardized methods themselves (e.g., cell counts, optical density measurements, mechanical property testing according to ISO standards). This is not equivalent to establishing ground truth for AI algorithms based on expert interpretation of medical images. The tests measure objective physical and biological properties.
4. Adjudication Method for the Test Set
- Not Applicable. As these are in vitro laboratory tests measuring objective properties, an adjudication method among experts (like 2+1 or 3+1 for image reviews) is not relevant.
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 device is a denture base resin, not an AI software intended to assist human readers (e.g., radiologists). Therefore, an MRMC comparative effectiveness study is not relevant to this submission. The summary explicitly states: "Clinical studies have not been conducted to demonstrate that the presence of silver sodium hydrogen zirconium phosphate in Glidewell™ 3DP Denture Base Resin results in improved clinical outcomes."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a material (resin) device, not an algorithm.
7. The Type of Ground Truth Used
- For Antimicrobial Tests: Ground truth is established by quantitative microbial culture methods (viable plate counts) as per ASTM E2180-07 and ASTM E2647-13. The "control samples of regular denture without antimicrobial agent" serve as the baseline for comparison.
- For Physical Properties: Ground truth is established by standardized mechanical testing procedures as per ISO 20795-1:2013.
- For Biocompatibility: Ground truth is established by standardized biological evaluation tests per ISO 10993-1:2018 and ISO 7405:2018.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" in the context of this device because it is a physical material, not an AI/ML algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for an AI/ML algorithm.
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(59 days)
Denture Base Resin
Denture Base Resin is used for the fabrication of removable dentures.
The Denture Base Resin mainly consist of denture base resin (powder), polymethyl methacrylate (PMMA), methyl methacrylate, ethylene glycol dimethacrylate, titanium dioxide, ferric oxide, iron oxide yellow and ferric tetroxide. The resin block is milled using the CAD/CAM technique to form the removable dentures. The product combines the prosthetic denture teeth with the denture base.
The provided document is a 510(k) premarket notification for a medical device called "Denture Base Resin." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical effectiveness or safety through new clinical trials. Therefore, the information typically requested in your prompt regarding AI/ML device performance (e.g., acceptance criteria for a specific AI metric, human-in-the-loop performance, large test sets, expert ground truth adjudication) is not applicable to this submission.
This document describes a traditional dental material. The performance data presented are for material properties, not an AI/ML algorithm.
Here's why many of your detailed questions cannot be answered by this document:
- AI/ML Device: This is not an AI/ML device. It's a physical material used for fabricating dentures.
- Acceptance Criteria for AI Performance: The acceptance criteria are for physical material properties as defined by ISO standards, not for AI metrics like sensitivity, specificity, AUC, or F1-score.
- Sample Size for Test Set (AI): There's no AI test set. Instead, there are samples of the material tested for its physical and chemical properties.
- Data Provenance (AI): Not applicable. The "data" are laboratory measurements of material properties.
- Experts for Ground Truth (AI): Not applicable. Ground truth for material properties is established through standardized laboratory testing methods.
- Adjudication Method (AI): Not applicable.
- MRMC Study (AI): Not applicable. This refers to human reader performance with/without AI assistance for diagnostic tasks, which is irrelevant here.
- Standalone Performance (AI): Not applicable.
- Type of Ground Truth (AI): For this device, "ground truth" refers to the measured physical and chemical properties of the material against established standards (e.g., ISO, FDA guidance).
- Training Set (AI): Not applicable. This device is not developed using machine learning.
- Ground Truth for Training Set (AI): Not applicable.
Based on the provided document, here's what can be extracted regarding the "acceptance criteria" (which are performance specifications for the material) and its "study" (which are non-clinical bench tests):
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the relevant ISO standards (ISO20795-1: 2013, ISO 4049: 2019, ISO 7491: 2000) and the comparison to the predicate device. The performance data demonstrate compliance with these standards and substantial equivalence.
| Item | Acceptance Criterion (Implicit: Meet relevant ISO standards and be similar to predicate) | Reported Device Performance (Denture Base Resin) | Predicate Device Performance (IvoBase CAD for Zenotec) |
|---|---|---|---|
| Ultimate flexural strength | > Predicate's Performance (or within acceptable range to prove SE) and meet ISO standards | 87 Mpa | 82 Mpa |
| Flexural modulus | > Predicate's Performance (or within acceptable range to prove SE) and meet ISO standards | 2340 Mpa | 2032 Mpa |
| Residual methyl methacrylate monomer | ≤ Predicate's Performance (or within acceptable range to prove SE) and meet ISO standards | 1.29% | 1.34% |
| Sorption | ≤ Predicate's Performance (or within acceptable range to prove SE) and meet ISO standards | 23.64 µg/mm³ | 19.48 µg/mm³ |
| Solubility | ≤ Predicate's Performance (or within acceptable range to prove SE) and meet ISO standards | 0.25 µg/mm³ | 0.65 µg/mm³ |
| Maximum stress intensity factor for materials with improved impact resistance | > Predicate's Performance (or within acceptable range to prove SE) and meet ISO standards | 2.89 MPa m¹ᐟ² | 2.35 MPa m¹ᐟ² |
| Total fracture work | > Predicate's Performance (or within acceptable range to prove SE) and meet ISO standards | 1609 J/m² | 1411 J/m² |
| Biocompatibility | Pass all required biocompatibility tests (ISO 10993-1) for surface device, permanent contact (>30 d) with mucosal membrane | Passed (Cytotoxicity, Sensitization, Irritation, Acute systemic toxicity, Subchronic systemic toxicity, Implantation, Material-mediated pyrogenicity, Genotoxicity) | Passed (Assessed as equivalent) |
| Other Performance Bench Tests | Meet all design specifications and relevant ISO standards (Surface characteristics, Shape capability, Colour, Colour stability, Translucency, Freedom from porosity, Bonding to synthetic polymer teeth) | Complies with ISO standards | Complies with ISO standards |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact sample sizes for each bench test conducted (e.g., how many specimens for flexural strength). It generally states that "Performance testing were conducted to verify that the subject device met all design specifications." Specific sample sizes would be detailed in the full test reports, which are not part of this summary.
- Data Provenance: The tests are non-clinical bench tests performed in a laboratory setting, presumably by the manufacturer (Aidite (Qinhuangdao) Technology Co., Ltd) or a contracted lab. The country of origin for the data is implicitly China, as the manufacturer is based there. The data are retrospective in the sense that they were collected prior to the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is not an AI/ML device requiring expert interpretation for ground truth. The "ground truth" for material properties is established through standardized and validated laboratory testing procedures as per ISO standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This concept applies to human reader studies often seen with diagnostic AI/ML devices, not material property testing.
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, an MRMC comparative effectiveness study was not done. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is derived from standardized laboratory measurement methods as described in the cited ISO standards (e.g., ISO20795-1 for denture base polymers, ISO 4049 for polymer-based restorative materials, ISO 7491 for color stability) and biocompatibility testing according to ISO 10993-1. Comparison is also made to the performance characteristics of the predicate device.
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
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(203 days)
Glidewell 3DP Denture Base Resin
Glidewell™ 3DP Denture Base Resin is a light-curable polymerizable resin intended to be used in conjunction with extraoral curing light equipment. Glidewell™ 3DP Denture Base Resin is indication and repair, by additive manufacturing, of full and partial removable dentures and baseplates.
Glidewell™ 3DP Denture Base Resin is a light-cured resin for the fabrication of removable 3DP denture bases, including full and partial dentures, fabricated in a professional dental setting. The resin is compatible with DLP printers utilizing wavelengths of 405nm and is offered in G1 (standard pink), G3 (medium pink) and G4 (dark pink) shades formulated to match gingival tissue.
Here's a breakdown of the acceptance criteria and the study information for the Glidewell™ 3DP Denture Base Resin, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (from ISO 20795-1: 2013 for Type 4 Light-activated materials) | Reported Device Performance (Glidewell™ 3DP Denture Base Resin) | P-value/Statistical Significance (if available) |
|---|---|---|---|
| Flexural Strength | > 65 MPa | > 65 MPa | Not specified |
| Flexural Modulus | > 2000 MPa | > 2000 MPa | Not specified |
| Water Sorption |
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(184 days)
Pac-Dent Denture Base Resin
Pac-Dent Denture Base resin is a light-curable resin indicated for fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heat-curable and auto polymerizing resins.
Pac-Dent Denture Base resin is a light-curable resin.
The provided text is a clearance letter from the FDA for a dental device, specifically a "Pac-Dent Denture Base Resin." It does not contain information about the acceptance criteria or a study proving that an AI/ML device meets those criteria. The document is strictly a regulatory clearance for a physical medical device (denture resin), not a software or AI-driven device.
Therefore, I cannot answer the questions regarding acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, or MRMC studies for an AI/ML device, as this information is not present in the provided text.
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(94 days)
Denture base resin
Smiletone® (denture base resin) is a thermoplastic resin that is intended to be used in fabrication of removable full and partial dental prosthesis, as well as occlusal splints and night guards. The product is based on a compounded mixture of polyamide and pigments.
Smiletone® is a thermoplastic material to be used for removable full or partial dental prosthesis. The product is based on a compounded mixture of Polyamide and pigments. Smiletone® is classified as 'Type 3-thermoplastic blank or powder' by EN ISO 20795-1[2013].
The provided document describes the 510(k) premarket notification for the Smiletone® denture base resin, not a device with AI or machine learning components. Therefore, many of the requested categories related to AI/ML device studies (such as multi-reader multi-case studies, effect size of AI assistance, expert qualifications for ground truth, adjudication methods, and training/test set sample sizes for algorithms) are not applicable.
However, the document does contain information about performance testing and acceptance criteria for the material.
Here's a summary of the available information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list "acceptance criteria" with numerical thresholds against which the device performance is reported. Instead, it states that "All test results were satisfactory" and indicates "Pass" for each test against various standards. The acceptance criteria are implied to be meeting the requirements of the specified standards (e.g., EN ISO 20795-1, ISO 10993 series).
| Test Title | Test Standard | Reported Device Performance (Acceptance Criteria Implicitly Met) |
|---|---|---|
| Dentistry - Medical devices for dentistry - Materials testing | EN 1641 (2010) | Pass |
| Accelerate aging test | ASTM F1980 (2002) | Pass |
| Visual Inspection | Performance test Guidance of dental materials (KFDA 2014) | Pass |
| Capacity test | Performance test Guidance of dental materials (KFDA 2014) | Pass |
| Packaging (Visual Inspection) test | Performance test Guidance of dental materials (KFDA 2014) | Pass |
| Surface characteristics test | EN ISO 20795-1 | Pass |
| Shape characteristics test | EN ISO 20795-1 | Pass |
| Color test | EN ISO 20795-1 | Pass |
| Color Stability test | EN ISO 20795-1 | Pass |
| Translucency test | EN ISO 20795-1 | Pass |
| Freedom from porosity test | EN ISO 20795-1 | Pass |
| Bonding to synthetic polymer teeth test | EN ISO 20795-1 | Pass |
| Residual Monomer test | EN ISO 20795-1 | Pass |
| Sorption test | EN ISO 20795-1 | Pass |
| Solubility test | EN ISO 20795-1 | Pass |
| Ultimate flexural strength test | EN ISO 20795-1 | Pass |
| Genotoxicity test: BACTERIAL REVERSE MUTATION STUDY (AMES) | ISO 10993-3 & OECD 471 Bacterial Reverse Mutation Test | Pass |
| Cytotoxicity Test (Agar diffusion test) | ISO7405:2008 | Pass |
| Acute Systemic Toxicity Test | ISO 10993-11 | Pass |
| Maximization Sensitization Test (LLNA-BrdU) | ISO 10993-10 & OECD 442B:2010 | Pass |
| Oral mucosa irritation test | ISO10993-10:2010 Annex B.3 | Pass |
Note on Physical Properties (Specific Values from Predicate Comparison):
While not explicitly stated as "acceptance criteria" for Smiletone, the comparison table ([6]) provides specific physical property values for Smiletone and its predicates. For Smiletone:
- Flexural strength: 68 ± 2 MPa
- Flexural modulus: 1389 ± 35 MPa
- Water absorption: 30.7 ± 0.2 µg/mm²
- Water solubility: 0.33 ± 0.1 µg/mm²
These values would implicitly need to meet certain ranges or be comparable to the predicates as part of the overall demonstration of substantial equivalence.
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for each of the physical, chemical, and biological tests. It states that tests were performed according to standards (e.g., ISO, ASTM, OECD, KFDA guidance), which typically include requirements for sample size and testing methodology.
The data provenance is not explicitly stated in terms of country of origin of the data, but the testing appears to have been conducted based on international standards (ISO, ASTM, OECD) and a Korean FDA (KFDA) guidance, suggesting either international or Korean testing laboratories. The KFDA guidance implies the reporting entity and potentially the data origin is from Korea. The tests are prospective in the sense that they were conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a material testing study, not an AI/ML device requiring clinical expert ground truth for interpretation.
4. Adjudication method for the test set
Not applicable. This is a material testing study.
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 material testing study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a material testing study.
7. The type of ground truth used
The "ground truth" for the material testing is based on objective measurements and compliance with established international and national standards for denture base resins (e.g., EN ISO 20795-1 for physical properties, ISO 10993 series and OECD guidelines for biocompatibility). The results are quantitative measurements or qualitative observations (e.g., visual inspection) evaluated against predefined specifications within the standards.
8. The sample size for the training set
Not applicable. This is a material testing study, not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a material testing study.
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(88 days)
YAMAHACHI DENTURE BASE RESINS
Yamahachi Denture Base Resins is intended for fabrication or repair of the denture base.
Yamahachi Denture Base Resins is supplied in powder and liquid form. The powder is primarily a polymer of polymethyl methacrylate (PMMA) beads with small quantities of initiator and color pigments. The liquid is primarily the monomer methyl methacrylate (MMA) with small quantities of a cross-linking agent and activator.
To fabricate the denture base, the powder and liquid materials are mixed together and stirred to create a dough state that is packed or poured into a mold, saddle, or core. The resin then cures either through heat application (water bath, rapid immersion, or microwave oven) or a self-curing process (pressure vessel or via quick-setting).
While heat-cure resins are generally used to fabricate denture bases, self-cure acrylics are most often indicated for repair and relining of the dentures. The subject device includes three heat-cure resins (Basis, Basis HI, and Basis Twin Cure) and two self-cure resins (Basis Flow and Re-Fine Bright).
I am unable to answer most of your questions as this document is a 510(k) summary for a denture base resin, not an AI/ML medical device. Therefore, many of the requested fields, such as "sample size used for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," and "standalone performance," are not applicable.
However, I can provide the following information based on the document:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are established by the ISO 20795-1 standard for denture base polymers. The reported device performance is compared against the minimums/maximums set by this standard.
Heat-Cure Acrylics (Basis, Basis HI, Basis Twin Cure):
| Acceptance Criteria (ISO 20795-1) | Reported Device Performance (Subject Devices) | Reported Device Performance (Predicate Devices) |
|---|---|---|
| Flexural Strength: 65 MPa Minimum | Basis: 84.3 MPa; Basis HI: 87 MPa; Basis Twin Cure: 81.0 MPa | Veracril: 70.8 MPa; Veracril HI: 88.1 MPa; Ez-cryl: 70.5 MPa |
| Flexural Modulus: 2,000 MPa Minimum | Basis: 2,067 MPa; Basis HI: 2,178 MPa; Basis Twin Cure: 2,299 MPa | Veracril: 5,300 MPa; Veracril HI: 5,804 MPa; Ez-cryl: 5,700 MPa |
| Impact-Resistance: Min 1.9 MPa m^(1/2) | Basis/Basis TC: Not Applicable; Basis HI: > 2.26 MPa m^(1/2) | Veracril/Ez-cryl: Not Applicable; Veracril High Impact: 3.1 MPa m^(1/2) |
| Residual Monomer: Maximum 2.2% | Basis: 0.4%; Basis HI: 0.7%; Basis Twin Cure: 0.2% | Veracril: 0.98%; Veracril HI: 1.88%; Ez-cryl: 0.80% |
| Sorption: Max 32 ug/mm3 | Basis: 10.7 ug/mm3; Basis HI: 22.8 ug/mm3; Basis Twin Cure: 22.4 ug/mm3 | Veracril: 18.1 ug/mm3; Veracril Hi: 14.5 ug/mm3; Ez-cryl: 19.1 ug/mm3 |
| Solubility: Max 1.6 ug/mm3 | Basis: 0.6 ug/mm3; Basis HI: 0.4 ug/mm3; Basis Twin Cure: 0.2 ug/mm3 | Veracril: 0.8 ug/mm3; Veracril HI: 0.9 ug/mm3; Ez-cryl: 0.72 ug/mm3 |
| Classification (ISO 20795-1:2008): Type 1 Class 1 or Type 5 | Basis & Basis HI: Type 1 Class 1; Basis Twin Cure: Type 5 | Veracril & Veracril HI: Type 1 Class 1; EZ-cryl: Type 5 |
Self-Cure Acrylics (Basis Flow, Re-Fine Bright):
| Acceptance Criteria (ISO 20795-1) | Reported Device Performance (Subject Devices) | Reported Device Performance (Predicate Devices) |
|---|---|---|
| Flexural Strength: 60 MPa Minimum | Basis Flow: 80.1 MPa; Re-Fine Bright: 73.8 MPa | Vertex Self Curing: 68 MPa; Vertex Castavaria: 79MPa |
| Flexural Modulus: 1,500 MPa Minimum | Basis Flow: 1,657 MPa; Re-Fine Bright: 1,529 MPa | Vertex Self Curing: 2,028 MPa; Vertex Castavaria: 2,316 MPa |
| Residual Monomer: Maximum 4.5% | Basis Flow: 4.2%; Re-Fine Bright: 3.3% | Vertex Self Curing: 3.76%; Vertex Castavaria: 3.91% |
| Sorption: Max 32 ug/mm3 | Basis Flow: 18.8 ug/mm3; Re-Fine Bright: 15.8 ug/mm3 | Vertex Self Cure: 20.3 ug/mm3; Vertex Castavaria: 23.2 ug/mm3 |
| Solubility: Max 8.0 ug/mm3 | Basis Flow: 1.8 ug/mm3; Re-Fine Bright: 2.3 ug/mm3 | Vertex Self Cure: 1.8 ug/mm3; Vertex Castavaria: 1.8 ug/mm3 |
| Classification (ISO 20795-1:2008): Type 2 Class 2 or Type 2 Class 1 | Basis Flow: Type 2 Class 2; Re-Fine Bright: Type 2 Class 1 | Vertex SC: Type 2 Class 2; Vertex Castavaria: Type 2 Class 1 |
Summary of Device Performance: The document explicitly states: "All Physical Properties within specification" for both heat-cure and self-cure acrylics, and "All Physical Properties within specification" (duplicate entry) for self-cure acrylics. This indicates that the subject devices (Yamahachi Denture Base Resins) met all the specified acceptance criteria from ISO 20795-1.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the exact sample sizes used for each physical property test. It refers to "Bench tests were performed on the subject device in conformity with ISO 20795-1." This standard would dictate the required sample sizes for each test.
- Data Provenance: The device manufacturer is Yamahachi Dental Manufacturing Co. in Japan. The testing was conducted in conformity with ISO 20795-1, which is an international standard. The specific country where the bench tests were performed is not explicitly stated, but it can be inferred to be associated with the manufacturer or a certified testing facility accredited to ISO standards. The tests are non-clinical bench tests, not clinical studies, so the terms "retrospective or prospective" do not directly apply in the same way they would for patient data. These are laboratory measurements.
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. The "ground truth" for the performance of these materials is established by the ISO 20795-1 standard, which defines standardized test methods and acceptance values for physical and chemical properties of denture base polymers. These are objective measurements determined in a laboratory setting, not subjective interpretations by human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods are typically used in clinical studies or expert reviews where there is subjective assessment or disagreement amongst human readers. The tests performed are objective, standardized physical property 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
This question is not applicable. This device is a denture base resin, not an AI-powered diagnostic or assistive medical device. No human readers or AI assistance are involved in its intended use or performance evaluation as described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This device is a physical material (resin), not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance criteria is defined by the ISO 20795-1 international standard for denture base polymers. This standard specifies scientifically validated benchmarks and test methodologies for physical properties like flexural strength, flexural modulus, impact resistance, residual monomer, sorption, and solubility. These are objective, measurable physical and chemical properties, not subjective assessments.
8. The sample size for the training set
This question is not applicable. This device is a physical material, not an AI/ML model that requires a training set. The term "training set" is relevant to machine learning, not the testing of physical properties of denture resins.
9. How the ground truth for the training set was established
This question is not applicable for the reasons mentioned in point 8.
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POLYSTAR 79 DENTURE BASE RESIN
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MODIFICATION TO TRUBYTE DENTURE BASE RESIN SYSTEM
The Trubyte® Denture Base Resin System is indicated for:
- Fabrication of dentures, appliances and prostheses
- Repair of dentures, appliances and prostheses
- Relining of denture surfaces
The TRUBYTE® DENTURE BASE RESIN SYSTEM is composed of five resin formulations: a denture baseplate resin, contour resin, clear resin, clear resin, and resilient resin. The finished denture base is constructed from a laminate of these resins that are light cured. These new materials bypass the usual "lost wax" process and allow the dentist and technician to develop a trial denture that will become the final denture. It will not be necessary to fabricate a mold or "invest" the trial denture.
This document is a 510(k) Pre-market Notification for the Trubyte® Denture Base Resin System. It's a regulatory submission to the FDA, not a study report detailing performance against acceptance criteria in the way a clinical trial or algorithm validation study would.
Therefore, the requested information elements (acceptance criteria table, sample sizes, expert ground truth, adjudication, MRMC study, standalone performance, training set details) cannot be extracted from the provided text.
Here's why and what information can be inferred:
Key Takeaways from the Document:
- Device Type: Trubyte® Denture Base Resin System (a light-cured resin system for dentures).
- Regulatory Pathway: 510(k) Pre-market Notification, indicating a claim of substantial equivalence to a predicate device.
- Predicate Device: Trubyte® Denture Base Resin System (K011560), implying the new system is an update or variant of an already cleared device.
- Basis for Equivalence:
- The components of the new resin system have been used in legally marketed devices or found safe for dental use.
- Biocompatibility testing (cytotoxicity, mutagenicity, irritation, sensitization) was performed on the resilient resin (uncured and cured) and passed. This is the closest the document comes to experimental "acceptance criteria" and "performance."
- Intended Use: Fabrication, repair, and relining of dentures, appliances, and prostheses. These are the same as the predicate device.
Why the Requested Information Cannot Be Provided from This Document:
- Acceptance Criteria & Reported Performance Table: The document states that the resilient resin passed biocompatibility testing. It does not list specific numerical acceptance criteria (e.g., cytotoxicity index
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