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510(k) Data Aggregation
(266 days)
The Bluemoon is intended to polymerize resinous dental materials, restorative composite materials, and orthodontic brackets, bonding and sealing materials that are photopolymerized in the 385~515nm waveband of visible light.
The Bluemoon Dental Curing Light is an instrument for photopolymerizing dental materials and starting agents by irradiating them with visible light between 385-515nm wavelength. It offers four modes (HYPER, TURBO, LOW, and SOFT START) depending on the output intensity and irradiation time.
The FDA 510(k) clearance letter for the Bluemoon Dental Curing Light provides information on several aspects of device testing, but it does not detail acceptance criteria for all performance metrics, nor does it present the study in a format that directly addresses the specific questions about AI/human-in-the-loop and ground truth establishment for AI models. This device is a dental curing light, a hardware device, not an AI/ML software. Therefore, the concepts of "AI assistance," "human readers," "test set," "training set," "ground truth" as typically defined for AI/ML performance studies are not directly applicable here.
However, I can extract and interpret the provided information to answer the relevant questions as best as possible for a hardware medical device.
1. A table of acceptance criteria and the reported device performance
The document lists "Performance Data" which includes various properties and their corresponding values. These values can be interpreted as the acceptance criteria for those specific properties, and the implicit reported performance is that the device meets these criteria, as stated in the conclusion.
| Acceptance Criterion (Property) | Acceptance Value | Reported Device Performance |
|---|---|---|
| Irradiation time | SOFT START: 10 ± 1sLOW: 10 ± 1sTURBO: 5 ± 1sHYPER: 3 ± 1s | "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Bluemoon met the established specifications necessary for consistent performance according to its intended use." (Implicitly, the device met these times.) |
| Peak wavelength | Check that the wavelength maxima occur within 5% of 400 nm and 455 nm respectively.1) Purple: 400nm ± 5%2) Blue: 455nm ± 5% | "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Bluemoon met the established specifications necessary for consistent performance according to its intended use." (Implicitly, the device met these wavelength specifications.) |
| Polymerization strength measurement | ≥ 80 MPa | "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Bluemoon met the established specifications necessary for consistent performance according to its intended use." (Implicitly, the device achieved ≥ 80 MPa.) |
| Depth of cure | ≥ 2.0 mm | "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Bluemoon met the established specifications necessary for consistent performance according to its intended use." (Implicitly, the device achieved ≥ 2.0 mm.) |
| Light Probe temperature | ≤ 41 ℃ | "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Bluemoon met the established specifications necessary for consistent performance according to its intended use." (Implicitly, the device maintained ≤ 41 ℃.) |
| Energy-saving mode | 60 ± 2s | "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Bluemoon met the established specifications necessary for consistent performance according to its intended use." (Implicitly, the device functioned within 60 ± 2s for energy-saving mode.) |
| Turn off energy-saving mode | 1) Buzzer sounds once,2) LCD on | "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Bluemoon met the established specifications necessary for consistent performance according to its intended use." (Implicitly, the device demonstrated these behaviors.) |
| Auto power off | 10 minutes ± 2 seconds | "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Bluemoon met the established specifications necessary for consistent performance according to its intended use." (Implicitly, the device auto-powered off correctly.) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes "performance bench testing" but does not explicitly state the sample size (e.g., number of devices tested, number of dental material samples cured) for each test. Given it's a hardware device, the "test set" would refer to the units of the device and the materials it acts upon, rather than a dataset of clinical cases. The provenance of the data is not specified; however, the company is based in the Republic of Korea. The testing would be prospective (i.e., new tests conducted on the manufactured device) rather than retrospective clinical 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 a hardware dental curing light. "Ground truth" for this device is established by objective physical measurements (e.g., wavelength, power output, temperature, polymerization depth and strength measured by calibrated instruments) rather than expert interpretation of images or clinical findings. Therefore, no experts in the sense of trained clinicians interpreting data were used for establishing ground truth for the performance tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable to a hardware dental curing light. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical or image-based studies where expert consensus is required for ambiguous cases. The performance tests for this device involve objective 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. The Bluemoon is a dental curing light, not an AI-powered diagnostic or assistive tool. It does not involve "human readers" or "AI assistance."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The Bluemoon is a hardware device; there is no standalone algorithm to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance data listed (Irradiation time, Peak wavelength, Polymerization strength, Depth of cure, Light Probe temperature, Energy-saving mode, Auto power off), the "ground truth" is established through objective physical measurements using calibrated instruments and standardized test methods. For biocompatibility, the ground truth is established by the results of specific biocompatibility tests (Cytotoxicity, Skin Sensitization, Intracutaneous reactivity) conducted according to ISO 10993 standards.
8. The sample size for the training set
This question is not applicable. The Bluemoon is a hardware device and does not involve a "training set" in the context of machine learning or AI models. Its design and manufacturing process are validated through engineering principles and bench testing.
9. How the ground truth for the training set was established
This question is not applicable as there is no training set for this hardware device.
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(196 days)
rainbow Paste Stain SE is indicated for use as a veneering material for fixed prosthesis in crowns and bridges. This device is used in prosthetic dentistry by forming a porcelain veneer on to a ceramic substructure.
rainbow™ Paste Stain SE is a dental veneering material in paste form used for color staining and glazing of the surfaces of restorations such as porcelain-fused zirconia, full-contoured zirconia, or lithium disilicate. The intended use of general porcelain is to make artificial teeth (dental prosthesis) more similar with natural teeth. The subject device is pre-mixed paste form, which can help dental technicians exclude mixing process of porcelain powder and liquid.
Given the provided text, there is no information about a study involving AI, human readers, or a medical device that diagnoses or analyzes conditions. The document is a 510(k) summary for a dental product called "rainbow Paste Stain SE," which is a veneering material for fixed prosthetics. The performance data presented refers to the physical and chemical properties of the material itself, not the performance of an AI algorithm or human readers.
Therefore, it is not possible to provide the requested information regarding acceptance criteria and a study proving the device meets them in the context of AI assistance, human reader improvement, or ground truth establishment for a diagnostic device.
The provided document discusses:
- Device Name: rainbow™ Paste Stain SE
- Intended Use: As a veneering material for fixed prosthesis in crowns and bridges.
- Acceptance Criteria for the material's properties: These are physical and chemical metrics like flexural strength, chemical solubility, appearance, and biocompatibility.
- Performance Data: Results of tests against these material-specific criteria.
There is no mention of:
- AI or software.
- Diagnostic capabilities.
- Human-in-the-loop performance studies.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Ground truth established by experts, pathology, or outcomes data in a diagnostic context.
- Training or test sets in the machine learning sense.
The acceptance criteria and performance data provided in the document relate to the physical and chemical properties of the dental paste itself, demonstrating its suitability as a dental material compared to a predicate device.
If you have a different document that details an AI medical device study, please provide that.
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(217 days)
rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono is used in the manufacture of a dental core through milling by machine followed by sintering.
rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono is a partially sintered dental ceramic made out of colored ZrO2(Y-TZP). rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono is milled into core (zirconia substructure) of artificial teeth and then is finally sintered in a furnace to harden the ZrO2.
rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono is fabricated by CAD/CAM or MAD/MAM machining processes. At the dental lab, the blanks are held to the milling machine which is used to machine to the final dental restoration. After machining steps, the dental restoration is fully sintered in the furnace to harden the ZrO2, and fitted to the patients as crowns and bridges.
rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono is available in numerous shapes and sizes in order to be compatible with multiple milling machines. According to the shapes, they are used for fabricating of each intended dental restoration, such as anterior crowns, posterior crowns, bridges
rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono is not for use or intended for use to fabricate the top-half of an abutment/titanium base and is for the fabrication of dental restorations only.
The provided text describes the 510(k) premarket notification for the "rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono" dental ceramic. This document is a regulatory submission to the FDA, demonstrating substantial equivalence to a legally marketed predicate device.
The information provided in the document focuses on the bench testing and biocompatibility testing performed on the device to establish its safety and performance characteristics, comparing it to a predicate device. It does not present a study related to AI or human reader performance/improvement, nor does it describe a ground truth establishment process involving experts or pathology for a test set. This is because the device is a dental material (porcelain powder for clinical use), not an AI-powered diagnostic or assistive tool.
Therefore, for the aspects related to AI/human reader studies, ground truth establishment, or MRMC studies, the requested information is not applicable to this specific device and the provided document.
Here's the breakdown of the information that is available in the document, framed by the acceptance criteria provided in your prompt, and noting where the requested information is not relevant to this type of device submission:
Device: rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono (Dental Ceramic)
1. Table of Acceptance Criteria and Reported Device Performance
The provided document details various performance tests, primarily mechanical and chemical, with their acceptance criteria and results.
| No. | Test Item | Acceptance Criteria (Bench Test) | Reported Device Performance (Result) |
|---|---|---|---|
| 1 | Visual | No impurities and No specific changes | Met established specifications |
| 2 | Size | Standard weight <±5% | Met established specifications |
| 3 | Package | No damage | Met established specifications |
| 4 | Uniformity | Uniform after sintering | Met established specifications |
| 5 | Freedom from extraneous materials | Free from extraneous materials | Met established specifications |
| 6 | Radioactivity | 238U Less than 1.0 Bq/g | < 1.0 Bq/g (also listed as < 1.0 in comparison table) |
| 7 | Flexural strength | More than 500 MPa | 807.1 MPa (comparison table) / Also "Met established specifications" |
| 8 | Linear thermal expansion | (10.7 ± 0.5) X 10^-6^ K^-1^ | 10.7 (comparison table) / Also "Met established specifications" |
| 9 | Chemical Solubility | Less than 100 µg/cm^2^ | 28.8 µg/cm^2^ (comparison table) / Also "Met established specifications" |
| Biocompatibility Tests | |||
| 1 | Cytotoxicity | None cytotoxicity | Pass |
| 2 | Sensitization | None sensitization | Pass |
| 3 | Irritation or intracutaneous reactivity | None irritation | Pass |
| 4 | Systemic toxicity (acute) | None systemic toxicity | Pass |
| 5 | Genotoxicity | No Toxicity | Pass |
| 6 | Subchronic toxicity | No Toxicity | Pass |
| 7 | Implantation | No Toxicity | Pass |
| 8 | Chronic toxicity | No Toxicity | Pass |
| 9 | Carcinogenicity | No Toxicity | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The exact sample size for each bench test (e.g., number of blocks tested for flexural strength) is not explicitly stated in the summary document. It states that "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono met the established specifications."
- Data Provenance: The tests were conducted to support a submission to the U.S. FDA by Genoss Co., Ltd. from South Korea. The type of data is bench test data and biocompatibility test data, performed on the device material itself. This is not a human clinical study in the sense of retrospective or prospective patient data, but rather laboratory testing of a material.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Not Applicable. As this is a dental material, the "ground truth" for its performance is established through standardized laboratory testing (e.g., ISO 6872 for dental ceramics, ISO 10993 for biocompatibility) and direct physical/chemical measurements by qualified lab personnel. There is no concept of "experts establishing ground truth" in the diagnostic imaging sense for this device.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods are relevant for studies involving human interpretation (e.g., radiologists reviewing images). For physical and chemical material testing, the results are typically quantitative measurements or qualitative observations by laboratory technicians/scientists following established protocols, not subjective assessment requiring adjudication.
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 dental ceramic block, not an AI-powered device or software. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. Again, this is a physical dental material, not an algorithm or software. As such, the concept of "standalone algorithm performance" does not apply. The device's "performance" is its material properties and safety.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is established by international standards (e.g., ISO 6872 for dental ceramics, ISO 10993 for biological evaluation of medical devices). These standards define the accepted methodologies and criteria for testing the material's physical, chemical, and biological properties. The results of these tests, conducted according to the standards, serve as the evidence of the device's performance and safety.
8. The Sample Size for the Training Set
- Not Applicable. As this is a physical medical device (dental ceramic) and not an AI/Machine Learning model, there is no concept of a "training set" in the computational sense. The product development and manufacturing process involve R&D and quality control, but not data-driven machine learning training.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. There is no "training set" for this device, as it is not an AI/ML product.
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(67 days)
Bright MTA Sealer Plus is used for filling root canals.
Bright MTA Sealer Plus is a ready-to-use, injectable paste-like material for root canal filling, which is hardened and obturated after being injected into the root canal space. The product based on calcium silicate exhibits excellent biocompatibility as well as a low film thickness suitable for easy penetration of lateral and accessory canals.
The provided text describes the acceptance criteria and performance data for a medical device called "Bright MTA Sealer Plus." However, it is not an AI-driven device; it is a root canal filling material. Therefore, some of the requested information, such as details on AI acceptance criteria, expert ground truthing, MRMC studies, or training/test sets for an AI model, are not applicable and thus not present in the document.
The document primarily focuses on the biocompatibility and mechanical performance of the "Bright MTA Sealer Plus" in comparison to a predicate device.
Here's a breakdown of the available information based on your request, with an explanation for elements that are not applicable:
Device Name: Bright MTA Sealer Plus
Device Type: Root canal filling material (Non-AI device)
1. Table of Acceptance Criteria and Reported Device Performance
The closest information available is in the "Mechanical testing" section:
| No. | Items | Standard & Method | Acceptance Criteria | Result |
|---|---|---|---|---|
| 1 | Visual test | ISO 4049 Bare eyes | No alien substance and suitable for using the product | No alien substance and suitable for using the product |
| 2 | Capacity test | ISO 4049 Weight difference | Standard weight ± 5% | 1.50 % |
| 3 | Package test | ISO 4049 Bare eyes | No damages, cracks | The package was completely sealed, and there were no damages, cracks. |
| 4 | Extraneous matter test | ISO 4049 Bare eyes | No extraneous matter | No Extraneous Matter |
| 5 | Flow test | EN ISO 6876: 2012 5.2 | Diameter ≥ 17mm | 27mm |
| 6 | Setting time test | EN ISO 6876: 2012 5.4 | ≤ 360 min | Within 360min |
| 7 | Film thickness test | EN ISO 6876: 2012 5.5 | ≤ 50 μm | 30 μm |
| 8 | Radio-opacity test | EN ISO 6876: 2012 5.7 | More than 3mm | 4.6mm |
| 9 | Solubility test | EN ISO 6876: 2012 5.6 | ≤ 3% | 0.2% |
In addition, Biocompatibility testing was performed with the following acceptance criteria and evaluation:
| No. | Test | Standard & Method | Acceptance criteria | Evaluation |
|---|---|---|---|---|
| 1 | Cytotoxicity | EN ISO 10993-5 Agar diffusion assay | Non cytotoxic (Scale 0) | Scale 0 (Non cytotoxic) |
| 2 | Oral mucosal irritation | EN ISO 10993-23 | Irritation index 0 | Irritation index 0 |
| 3 | Skin Sensitization | EN ISO 10993-10 GPMT | Sensitization score and rate 0 | Sensitization score and rate 0 |
| 4 | Acute systemic toxicity | EN ISO 10993-11 Single dose | No Acute systemic toxicity | No Acute systemic toxicity |
| 5 | Systemic toxicity | EN ISO 10993-11 Pyrogen test | No abnormal signs and dead | No abnormal signs and dead |
| 6 | Genotoxicity | EN ISO 10993-3 Back mutation. | No back mutation regardless of the presence or absence of a metabolic activation system | No back mutation |
| Chromosomal aberration | No chromosomal aberration in CHL/IU cells | No chromosomal aberration in CHL/IU cells | ||
| 7 | Implantation | EN ISO 10993-6 Implantation | Biocompatible | Biocompatible |
| 8 | Sub-chronic toxicity | EN ISO 10993-11 Subchronic toxicity | No Subchronic toxicity | No Subchronic toxicity |
| 9 | Chronic toxicity | EN ISO 10993-11 Chronic toxicity | No chronic toxicity | No chronic toxicity |
| 10 | Carcinogenicity | EN ISO 10993-3 Carcinogenicity | No Carcinogenicity | No Carcinogenicity |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated in terms of number of samples/units tested for each mechanical or biocompatibility test, but the tests were performed on the device itself.
- Data Provenance: The document implies in-house testing performed by or for Genoss Co., Ltd. The country of origin for the company is South Korea. The studies are assumed to be prospective tests on newly manufactured samples of the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is not an AI device that requires expert-established ground truth for image interpretation or diagnosis. The ground truth for this device's performance is derived from standardized physical and biological material testing.
4. Adjudication method for the test set
- Not Applicable. As this is not an AI device involving human interpretation, there is no need for an adjudication method for a test set. The results are based on objective measurements from standardized tests.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No. An MRMC study is relevant for AI systems that assist human readers in tasks like radiological interpretation. This device is a material, not an AI system, so an MRMC study would not be performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm or AI system. Its performance is inherent to its physical and chemical properties.
7. The type of ground truth used
- The ground truth for this device's performance is based on objective measurements from internationally recognized standards (ISO and EN ISO) for dental materials and biocompatibility. For example, specific diameters for flow, time limits for setting, weight differences, and qualitative assessments of physical appearance and biological reactions are used as the "ground truth" against which the device's performance is measured. It's not expert consensus, pathology, or outcomes data in the traditional sense of diagnostic AI.
8. The sample size for the training set
- Not Applicable. This is not an AI device that undergoes machine learning training.
9. How the ground truth for the training set was established
- Not Applicable. As it's not an AI device, there is no training set or associated ground truth establishment process.
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(353 days)
Impression of inlay, onlay crown, and bridge preparation
- Crown, bridge impression
- Inlay and onlay impression
- Functional impression
- Denture impression
- Study model impression
Bright Impress impression material is a fast-set of addition-reaction silicone elastomer (Vinyl polysiloxane)-based material for dental professionals, consisting of five types (Light, Medium, Heavy, Bite and Putty) with superior hydrophilicity, dimensional accuracy, high tensile strength, and resistant to deformation. It is designed for versatile impression techniques of crowns, bridges, orthodontics and implants.
The document is a 510(k) Summary for the dental impression material "Bright Impress" by Genoss Co., Ltd. It compares the characteristics of Bright Impress to a predicate device, HySil Impression Materials, and presents performance and biocompatibility data.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document provides extensive tables for both biocompatibility and performance for each variant of "Bright Impress" (Light, Medium, Heavy, Putty, Bite). I will consolidate and present a representative sample, focusing on the "Performance Data" which directly addresses how the device meets physical/mechanical acceptance criteria. The "Biocompatibility Data" also uses "Acceptance Criteria" and "P/F" (Pass/Fail) results.
Comprehensive Table of Acceptance Criteria and Reported Device Performance
| Category | Item | Acceptance Criteria | Reported Performance (Bright Impress - Light) | Reported Performance (Bright Impress - Medium) | Reported Performance (Bright Impress - Heavy) | Reported Performance (Bright Impress - Putty) | Reported Performance (Bright Impress - Bite) |
|---|---|---|---|---|---|---|---|
| Biocompatibility (All variants) | |||||||
| Cytotoxicity | None cytotoxicity | Pass | Pass | Pass | Pass | Pass | Pass |
| Sensitization | None sensitization | Pass | Pass | Pass | Pass | Pass | Pass |
| Irritation/ Intracutaneous Reactivity | None irritation/intracutaneous reactivity | Pass | Pass | Pass | Pass | Pass | Pass |
| Systemic Toxicity (acute) | None systemic toxicity | Pass | Pass | Pass | Not reported for Heavy | Pass | Pass |
| Oral Mucosa Irritation | None irritation (Heavy) | Pass | Not reported for Light/Medium/Putty/Bite | Not reported for Light/Medium/Putty/Bite | Pass | Not reported for Light/Medium/Putty/Bite | Not reported for Light/Medium/Putty/Bite |
| Performance | |||||||
| Visual | No substance material | Pass | Pass | Pass | Pass | Pass | Pass |
| Volume/Capacity | Size error of Standard Size < ±5% | Pass | Pass | Pass | Pass | Pass | Pass |
| Package | No damage | Pass | Pass | Pass | Pass | Pass | Pass |
| Color | Contrasting color of base and catalyst | Pass | Pass | Pass | Pass | Pass | Pass |
| Consistency | ≥ 36mm (Light) | 42.7mm | 31mm~41mm (Reported: 39.0mm) | ≤ 35mm (Reported: 27.0mm) | ≤ 35mm (Reported: 26.0mm) | Not applicable for Bite | |
| Working Time | ≥ 120 sec (Light) | 126sec | ≥ 90 sec (Reported: 117sec) | ≥ 60 sec (Reported: 112sec) | ≤ 30 sec (Reported: 30sec) | ≤ 30 sec (Reported: Pass) | |
| Detail Reproduction | 20µm reproduction without interruption (Light/Medium) 50µm reproduction without interruption (Heavy) 75µm reproduction without interruption (Putty) | Pass (20µm) | Pass (20µm) | Pass (50µm) | Pass (75µm) | Not reported for Bite | |
| Compatibility with Gypsum | 50µm reproduction without interruption (Light/Medium/Heavy) 75µm reproduction without interruption (Putty) | Pass | Pass | Pass | Pass | Not reported for Bite | |
| Linear Dimensional Change | ≤ 1.5% (All except Bite for specific value) | 0.15% | 0.18% | 0.0% | 0.07% | ≤ 1.5% (Reported: Pass) | |
| Elastic Recovery | ≥ 96.5% (Light/Medium/Heavy/Putty) | 98.48% | 99.18% | 99.00% | 97.98% | Not reported for Bite | |
| Strain in Compression | 2.0 | 2.54% | 2.26% | 1.7% | 1.06% | Not reported for Bite | |
| Minimum Residence Time in Mouth | ≤ 90sec (Bite) | Not applicable for Light/Medium/Heavy/Putty | Not applicable for Light/Medium/Heavy/Putty | Not applicable for Light/Medium/Heavy/Putty | Not applicable for Light/Medium/Heavy/Putty | ≤ 90sec (Reported: Pass) | |
| Hardness | ≥ 20HD (Bite) | Not applicable for Light/Medium/Heavy/Putty | Not applicable for Light/Medium/Heavy/Putty | Not applicable for Light/Medium/Heavy/Putty | Not applicable for Light/Medium/Heavy/Putty | ≥ 20HD (Reported: Pass) | |
| Flexural Strength | ≥ 8.0N (Bite) | Not applicable for Light/Medium/Heavy/Putty | Not applicable for Light/Medium/Heavy/Putty | Not applicable for Light/Medium/Heavy/Putty | Not applicable for Light/Medium/Heavy/Putty | Pass | |
| Recovery after Deformation | < 0.1mm (Bite) | Not applicable for Light/Medium/Heavy/Putty | Not applicable for Light/Medium/Heavy/Putty | Not applicable for Light/Medium/Heavy/Putty | Not applicable for Light/Medium/Heavy/Putty | < 0.1mm (Reported: Pass) |
Important Note: The document often states "Pass" for certain criteria in the performance tables where a specific numerical result might be expected (e.g., Working Time for Bright Impress - Bite, Flexural Strength for Bright Impress - Bite). This indicates that the device met the specified quantitative acceptance criteria, even if the exact number isn't explicitly shown in that particular table. The "Technological Characteristics" section comparing to the predicate does provide specific numbers for some of these.
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not explicitly state the sample sizes used for the performance and biocompatibility tests. It lists "Report No." for biocompatibility tests, suggesting external lab reports, but these reports are not provided. For performance, it lists Method (e.g., ISO 4823, DIN 13903) which implies standardized testing procedures that would define sample sizes, but the actual numbers of samples tested are not given.
- Data Provenance: The manufacturer is Genoss Co., Ltd., located in Suwon-si, Gyeonggi-do, Korea, South. The document doesn't specify if the testing was done in Korea or elsewhere. The studies appear to be prospective bench tests and biocompatibility assessments conducted to demonstrate equivalency for regulatory clearance, rather than retrospective or prospective clinical studies on human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to the type of study described. The document outlines bench testing (physical and mechanical properties) and biocompatibility testing of a medical device material. The "ground truth" here is established by adherence to international standards (ISO, DIN) and objective measurements using laboratory equipment, not by human expert consensus on clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for image interpretation or diagnosis where multiple readers provide opinions, and a consensus process is needed to establish ground truth. The studies described are bench tests and biocompatibility assessments, which rely on objective measurements and established protocols.
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 is not applicable. This document describes the clearance of a dental impression material, not an AI-powered diagnostic device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is a material, not software or an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the tests performed is based on:
- International Standards: Adherence to established ISO (International Organization for Standardization) and DIN (Deutsches Institut für Normung) standards for dental materials, which define methods and acceptance criteria for properties like consistency, working time, dimensional change, elastic recovery, and detail reproduction.
- Objective Laboratory Measurements: Data obtained from quantitative measurements in a laboratory setting (e.g., electronic scale for volume, specific instruments for consistency, hardness, flexural strength).
- Biocompatibility Protocol Compliance: Results from standardized biological tests (e.g., Cytotoxicity, Sensitization, Irritation) following ISO 10993 guidelines, indicating the material's interaction with biological systems.
Essentially, the ground truth is objective scientific measurement and compliance with established performance and safety standards.
8. The sample size for the training set
This is not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."
9. How the ground truth for the training set was established
This is not applicable as there is no training set for this type of device.
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(313 days)
- Base/liner
- Pit & Fissure sealant
Bright Flow is a light-cured flowable composite resin. It comprises two different types of flowability (Low Flow and High Flow) and 9 shades depending on the intended use, which enables aesthetic and durable outcomes for anterior and posterior composite restorations.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device Name: Bright High Flow
Manufacturer: GENOSS Co., Ltd.
The provided document describes the performance bench testing and biocompatibility testing conducted to demonstrate that the Bright High Flow device meets its acceptance criteria. No clinical study or MRMC effectiveness study is mentioned, as this device appears to be a dental material.
1. Table of Acceptance Criteria and Reported Device Performance
Biocompatibility Testing
| No. | Test | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| 1 | Cytotoxicity | None cytotoxicity | Pass |
| 2 | Irritation | None oral irritation | Pass |
| 3 | Sensitization | None sensitization | Pass |
| 4 | Acute systemic | None systemic toxicity | Pass |
| 5 | Genotoxicity | None genotoxicity | Pass |
| 6 | Implantation | Biocompatible | Pass |
| 7 | Chronic toxicity | No chronic toxicity | Pass |
Performance Bench Testing
| No. | Items | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| 1 | Visual | No impurities and No specific changes | Pass |
| 2 | Capacity | Capacity error of; Standard Capacity < ± 5% | Pass |
| 3 | Package | No damage | Pass |
| 4 | Sensitivity to Ambient Light | Must be physically uniform | Pass |
| 5 | Depth of Cure | More than 1.5 mm | Pass |
| 6 | Shade | Must be shade uniform | Pass |
| 7 | Color Stability | Color should be stable | Pass |
| 8 | Flexural Strength | More than 80 MPa | Pass |
| 9 | Water Sorption | Less than 40 µg/mm³ | Pass |
| 10 | Solubility | Less than 7.5 µg/mm³ | Pass |
| 11 | Radio-opacity | More than the same thickness of aluminum (More than Al) | Pass |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes used for each test. The tests are bench tests and biocompatibility tests, not studies involving human subjects or patient data. The provenance of the data (country of origin, retrospective/prospective) is not specified beyond the fact that the manufacturer is based in Korea and the testing was conducted according to international standards (ISO).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The evaluations are based on standardized laboratory tests (ISO standards) rather than expert interpretation of clinical data. There is no mention of experts establishing ground truth for a test set in the context of this device's evaluation.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving human interpretation or subjective assessments, which are not detailed for this device. The evaluation relies on objective measurements against defined standards.
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 comparative effectiveness study was done. This device is a dental material (flowable composite resin) and its evaluation is based on material properties and biocompatibility, not AI assistance for human readers.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
This information is not applicable. The device is a dental material, not an algorithm, so "standalone performance" in the context of AI is irrelevant. Its performance is measured directly through physical and chemical property tests.
7. The type of ground truth used
The ground truth used for the performance evaluations are international consensus standards (ISO 10993 for biocompatibility and ISO 4049 for dental polymer-based restorative materials). These standards define the acceptable range or threshold for specific material properties.
8. The sample size for the training set
This information is not applicable. As the device is a material, there is no "training set" in the context of machine learning. The manufacturing process and material formulation are developed based on established dental material science principles.
9. How the ground truth for the training set was established
This information is not applicable, as there is no "training set" for this type of device. The "ground truth" for developing the material is derived from scientific knowledge, material engineering, and performance requirements for dental restorative materials, as codified in relevant ISO standards.
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(280 days)
- Direct bonding for light-cured composites to tooth surface
- Bonding of dual-cured core build up composites to tooth surface
- Intraoral repair of composite, PFM and ceramic restoration using cements
- Sealing of tooth preparation for indirect restoration
Bright Bond Universal is a light-cured dental adhesive that combines etching, priming, and bonding functions in a single bottle solution. It provides strong and durable bonds between dentin/enamel and light-curable direct/indirect restorative materials.
The provided text describes the acceptance criteria and performance data for a dental bonding agent, "Bright Bond Universal," in the context of its 510(k) premarket notification to the FDA. The study presented here is a bench testing study, not a clinical study involving human patients or multi-reader studies. Therefore, many of the requested details about human expert involvement, MRMC studies, and patient data provenance are not applicable to the information contained in this document.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance was evaluated against a set of physical and chemical specifications for a dental bonding agent and biocompatibility standards.
| No. | Test | Method | Acceptance Criteria | Reported Device Performance | Pass/Fail |
|---|---|---|---|---|---|
| 1 | Cytotoxicity | ISO 10993-5 | None cytotoxicity | - | Pass |
| 2 | Irritation | ISO 10993-10 | None oral irritation | - | Pass |
| 3 | Sensitization | ISO 10993-10 | None sensitization | - | Pass |
| 4 | Acute systemic toxicity | ISO 10993-11 | None systemic toxicity | - | Pass |
| 5 | Genotoxicity | ISO 10993-3 | None genotoxicity | - | Pass |
| 6 | Implantation | ISO 10993-6 | Biocompatible | - | Pass |
| 7 | Chronic toxicity | ISO 10993-11 | No chronic toxicity | - | Pass |
| 1 | Visual test | Bare eyes | No impurities and No specific changes | No impurities and No specific changes | - |
| 2 | Capacity test | Weight difference | Capacity error of; Standard Capacity ± 5 % | 2.75 % | - |
| 3 | Package test | Bare eyes | No damage | No damages, cracks | - |
| 4 | Film Thickness | ISO 4049:2009 7.5 | ≤ 50 µm | 2 µm | - |
| 5 | Sensitivity to Ambient Light | ISO 4049:2009 7.9 | Must be physically uniform | Homogeneous | - |
| 6 | Depth of Cure | ISO 4049:2009 7.10 | ≥ 1.5 mm | 3.0 mm | - |
| 7 | Bonding Strength (Dentin) | ISO 29022:2013 7 | ≥ 8 MPa | 16 MPa | - |
| 8 | Bonding Strength (Enamel) | ISO 29022:2013 7 | ≥ 8 MPa | 14 MPa | - |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify exact sample sizes for each bench test. However, these tests are typically conducted on a sufficient number of material samples to ensure statistical validity for the specific test (e.g., multiple specimens for bonding strength, multiple replicates for biocompatibility assays).
- Data Provenance: The tests were conducted by GENOSS Co., Ltd. (South Korea). The data is from laboratory bench testing of the physical properties and biocompatibility of the bonding agent. It is inherently "prospective" in the sense that the tests were specifically performed to demonstrate the device's characteristics for regulatory submission. It does not involve patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The "ground truth" for these tests is established by industry-standardized test methods (e.g., ISO standards) and measurable physical/chemical properties, not by human expert opinion or interpretation of images. The results are quantitative measurements.
4. Adjudication Method for the Test Set
This is not applicable. The tests involve objective measurements (e.g., weight difference, film thickness, bonding strength in MPa, observation of cell viability or tissue reaction), rather than subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. This type of study is relevant for AI/radiology devices where human readers interpret medical images. This document describes a dental material, not an imaging device or an AI algorithm for image interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. This is not an AI algorithm. The performance described is the inherent performance of the dental bonding material itself.
7. The Type of Ground Truth Used
The ground truth used for these tests is based on:
- Standardized Test Methods: Specific ISO standards (e.g., ISO 10993 for biocompatibility, ISO 4049 and ISO 29022 for physical properties) define how the tests are performed and how results are interpreted.
- Quantitative Measurements: Performance is measured against predetermined quantifiable thresholds (e.g., MPa for bonding strength, µm for film thickness, visual assessment of impurities).
- Biocompatibility Endpoints: For biocompatibility, the ground truth is established by the absence of adverse biological responses as defined by the ISO 10993 series of standards.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" as this is not an AI/machine learning model. The device's formulation and manufacturing processes are likely developed through research and development, but there isn't a "training set" of data in the AI sense.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no training set.
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(268 days)
OSTEON III is intended for use as a bone grafting material to fill, augment or reconstruct periodontal or oral/maxillofacial defects.
- Periodontal/infrabony defects
- Ridge augmentation
- Extraction Sites(implant preparation/ placement)
- Sinus lifts
- Cystic cavities
This product is a synthetic osteoconductive bone graft substitute composed of hydroxyapatite (HA) and beta-tricalcium phosphate (ß-TCP). This product presents an interconnected porous structure, similar to that human cancellous bone. This product is available as irregular shape particle of size 0.2~2.0mm. It is sterilized by gamma-radiation.
The provided text is a 510(k) summary for a medical device called OSTEON III. It describes the device's characteristics and compares it to predicate devices to demonstrate substantial equivalence, but it does not provide the details requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.
Specifically, the document does not contain any information about:
- A table of acceptance criteria and reported device performance for clinical endpoints. It has a table comparing technological characteristics (composition, physical properties) to predicate devices, and lists biocompatibility and performance bench tests conducted, but not acceptance criteria for clinical outcomes.
- Sample size used for a test set or data provenance for a clinical study. The document only references non-clinical testing.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
- Standalone (algorithm only) performance. (This device is a bone grafting material, not a software algorithm).
- Type of ground truth used for a clinical study.
- Sample size for a training set. (Again, this relates to an algorithm, which OSTEON III is not).
- How ground truth for the training set was established.
The document focuses on demonstrating substantial equivalence to legally marketed predicate devices based on:
- Intended Use and Indications for Use: OSTEON III is for bone grafting to fill, augment, or reconstruct periodontal or oral/maxillofacial defects, similar to its predicates.
- Technological Characteristics: Comparison of main materials (HA and β-TCP), device design (interconnected porous structure), composition, and physical properties (porosity, pore size, particle size, Ca/P ratio, crystallinity).
- Biocompatibility Testing: A list of ISO 10993 tests performed (Cytotoxicity, Sensitization, Pyrogenicity, Intracutaneous reactivity, Systemic toxicity, Subchronic toxicity, Genotoxicity-Ames, Genotoxicity-Micro nucleus, Implantation, Genotoxicity-Chromosomal aberration, Endotoxin (LAL)). The results are stated as showing the materials are non-toxic and non-sensitizing.
- Performance Bench Testing: A list of engineering tests like Visual Test, Size, Capacity, Density, Trace Elements, Ca/P ratio, Crystalline phase Composition, Crystallinity, Morphology & Surface Characteristics, Water Solubility, Elution Test (pH, Pb), Potassium permanganate consumed, Ultraviolet rays absorption spectrum, Resorption, Particle size distribution, Compressive strength, Shear and Elastic modulus. The document states "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the OSTEON III met the established specifications necessary for consistent performance according to its intended use."
In summary, the provided document is a 510(k) summary for a bone grafting material, not a clinical study report for an AI/software device. Therefore, it does not contain the information requested in your prompt regarding clinical acceptance criteria, study design, or expert consensus details.
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(182 days)
rainbow™ LS Block can be used for manufacturing Crown, Veneer, Inlay and Onlay.
rainbow™ LS Block is a dental ceramic made out of Lithium disilicate. rainbow™ LS Block is milled into cores of teeth and then is fired in a furnace to harden the Li2Si2O3. Then, the core is layered with porcelain to make a finished tooth.
The provided information describes the acceptance criteria and performance data for a dental ceramic device named "rainbow™ LS Block," submitted for 510(k) premarket notification. The study primarily relies on bench testing and biocompatibility testing to demonstrate substantial equivalence to a predicate device (IPS e.max CAD).
Here's the breakdown of the information that can be extracted from the document, organized according to your requested points.
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
The document provides a table summarizing the performance data, including criteria and results, primarily from bench testing and biocompatibility.
| No. | Items | Criteria | Reported Device Performance (Result) | Standard |
|---|---|---|---|---|
| Biocompatibility Testing | ||||
| 1 | Cytotoxicity | None cytotoxicity | None cytotoxicity | ISO 10993-5 |
| 2 | Sensitization (Local Lymph Node Assay) | None sensitization | None sensitization | ISO 10993-10 |
| 3 | Oral mucosa irritation | Less than stimulus threshold | Minimal irritation | ISO 10993-10 |
| 4 | Acute systemic toxicity | None acute Systemic toxicity | None acute Systemic toxicity | ISO 10993-11 |
| 5 | Genotoxicity (Ames, Micronucleus) | None genotoxicity | None genotoxicity | ISO 10993-3 |
| Performance Bench Testing | ||||
| 1 | Visual | No impurities and No specific changes | No impurities and No specific changes | ISO 6872 |
| 2 | Size | Size error of; Standard Size < ±5% | (C-type) W 0.03%, L 3.90%, H 0.21% | ISO 6872 |
| (Disk type) W 3.42%, L2.36%, H 0.07% | ISO 6872 | |||
| 3 | Package | No damage | No damage | ISO 6872 |
| 4 | Uniformity | Uniform | Uniform | ISO 6872 |
| 5 | Freedom from extraneous materials | Not Freedom from extraneous materials | Not Freedom from extraneous materials | ISO 6872 |
| 6 | Radioactivity | 238U Less than 1.0 Bq/g | 238U: < 0.00628 Bq/g | ISO 6872 |
| 7 | Chemical solubility | Less than 100 $ \mu $g/cm² | Solubility: 12 $ \mu $g/cm² | ISO 6872 |
| 8 | Flexural strength | More than 100MPa | Average: 370MPa | ISO 6872 |
| 9 | Linear thermal expansion ($10^{-6}K^{-1}$) | 9.95($\pm0.5$) $X 10^{-6}K^{-1}$ | Average: 9.95 $X 10^{-6}K^{-1}$ | ISO 6872 |
| 10 | Glass-transition temperature | Less than 579$\pm20$ °C | 579 °C | ISO 6872 |
Study Details
2. Sample size used for the test set and the data provenance
The document indicates that the evaluation was based on bench testing and biocompatibility testing. It does not specify a "test set" in the context of clinical data or images. The sample sizes for the specific tests (e.g., number of samples for flexural strength, chemical solubility) are not explicitly stated in this summary but are implied to be sufficient for compliance with the referenced ISO standards.
The data provenance is from GENOSS Co., Ltd., a company based in Korea (1F, Gyeonggi R&DB Center / 226, 2F, GSBC, 105 Gwanggyo-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, Korea). The study appears to be retrospective in the sense that it's a summary of completed lab tests rather than a prospective clinical trial.
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 to this study. The ground truth for this device (a dental material) is established through physical and chemical property measurements and standardized biological tests, not through expert consensus on medical images or clinical outcomes.
4. Adjudication method for the test set
This question is not applicable. There is no "test set" requiring human adjudication as this is not a diagnostic AI device or a clinical outcome study. The tests are benchtop measurements guided by ISO standards.
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 is a submission for a dental material (porcelain block) and does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. There is no algorithm or AI component mentioned for this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device is based on standardized physical, chemical, and biological measurements specified by international standards like ISO 6872 (dental ceramics) and ISO 10993 (biological evaluation of medical devices). For example:
- Flexural strength: Measured in MPa against a standard criterion.
- Chemical solubility: Measured in $ \mu $g/cm² against a standard criterion.
- Biocompatibility: Assessed against criteria like "None cytotoxicity," "None sensitization," etc., based on established biological assays.
8. The sample size for the training set
This question is not applicable. This submission is for a physical dental material, not a machine learning or AI device that would require a "training set."
9. How the ground truth for the training set was established
This question is not applicable as there is no training set for this type of device.
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(120 days)
OSTEON II is intended for use as a bone grafting material to fill, augment or reconstruct periodontal or oral/maxillofacial defects.
- Periodontal/Infrabony defects
- Ridge augmentation
- Extraction sites (implant preparation/placement)
- Sinus lifts
- Cystic cavities
This product is a synthetic osteoconductive bone graft substitute composed of hydroxyapatite (HA) and beta-tricalcium phosphate (B-TCP). This product presents an interconnected porous structure, similar to that of human cancellous bone. This product is available as irregular shaped particles of size 0.2~2.0 mm. It is supplied sterile by gamma irradiation.
The provided document describes the OSTEON II device, a synthetic bone grafting material. It outlines the device's characteristics, indications for use, and performance data for biocompatibility and bench testing. However, it does not include specific acceptance criteria or a study designed to demonstrate that the device meets those criteria, especially in terms of diagnostic performance or clinical effectiveness.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device (OSTEON) based on similar materials, indications for use, and design.
Here's an breakdown of the information that is available and what is missing based on your prompt:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| ISO Cytotoxicity | Met standards |
| ISO Pyrogenicity | Met standards |
| ISO Intracutaneous reactivity | Met standards |
| ISO Ames | Met standards |
| ISO Systemic toxicity | Met standards |
| ISO Sensitization | Met standards |
| ISO Implantation | Met standards |
| ISO Micro-nucleus | Met standards |
| Performance Bench Testing: | |
| -Ca/P ratio | Met established specifications |
| -Crystalline Phase Compositions | Met established specifications |
| -Porosity | Met established specifications |
| -Water Solubility Test | Met established specifications |
| -Density | Met established specifications |
| -Crystallinity Value | Met established specifications |
Missing: The document does not provide numerical acceptance criteria for any of these tests (e.g., "Cytotoxicity score must be < X"). It states that the tests were "completed" and "results show that the materials... are non-toxic and non-sensitizing" and "All test results demonstrate that the materials... met the established specifications." It doesn't define what those "established specifications" are, nor does it provide quantitative performance data for OSTEON II.
2. Sample size used for the test set and the data provenance:
- Not applicable/Not provided. This document does not describe a clinical study with a "test set" in the context of diagnostic device performance. The performance data presented are for laboratory-based biocompatibility and bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. This document does not pertain to an AI/diagnostic device that would require expert-established ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided.
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/Not provided. This device is a bone grafting material, not an AI-based diagnostic tool, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable/Not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not provided. For the biocompatibility and bench tests, the "ground truth" would be the established scientific methods and standards (e.g., ISO standards) that define what constitutes a passing result for cytotoxicity, pyrogenicity, material composition, etc.
8. The sample size for the training set:
- Not applicable/Not provided. There is no mention of a training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable/Not provided.
Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):
The document details two types of studies used to support the substantial equivalence of OSTEON II:
-
Biocompatibility Testing:
- Purpose: To evaluate the biological safety of the proposed device's materials.
- Methodology: Followed the Blue Book memorandum G95-1 and ISO10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing."
- Specific Tests Conducted: ISO Cytotoxicity, ISO Pyrogenicity, ISO Intracutaneous reactivity, ISO Ames, ISO Systemic toxicity, ISO Sensitization, ISO Implantation, ISO Micro-nucleus.
- Results: "The biocompatibility test results show that the materials used in the design and manufacture of the components of the proposed device are non-toxic and non-sensitizing to biological bone and tissues with its intended use." (No quantitative results or specific acceptance criteria are provided, only a statement of conformance).
-
Performance Bench Testing:
- Purpose: To confirm the physical and chemical characteristics of the OSTEON II device.
- Specific Tests Conducted: -Ca/P ratio, -Crystalline Phase Compositions, -Porosity, -Water Solubility Test, -Density, -Crystallinity Value.
- Results: "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the OSTEON II met the established specifications necessary for consistent performance according to its intended use." (Again, no quantitative results or specific acceptance criteria are provided, only a statement of conformance to "established specifications").
Conclusion from the document: Based on these tests, the manufacturer concludes that OSTEON II is substantially equivalent to the predicate device OSTEON. The FDA's letter concurs with this determination for the stated indications for use.
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