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510(k) Data Aggregation
(138 days)
JUELLCure Soft is intended for use as a permanent soft relining for total and partial dentures
- . To relieve pressure from pressure points
- To dam the palatal vibrating line ●
- . In cases of flabby ridge and/or insufficient adhesion
- . To cushion sharp-edged alveolar processes
JuellCure Soft is a self-curing, silicone-based and permanently soft relining material for removable dentures.
The provided text describes the 510(k) summary for the JUELLCure Soft device, which is a soft impression material for dentures. The submission aims to demonstrate substantial equivalence to a predicate device, Ufi Gel SC.
Here's an analysis based on the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for JUELLCure Soft are based on demonstrating equivalence to the predicate device, Ufi Gel SC, across chemical composition and key physical properties.
| Test Item | Acceptance Criteria (Equivalent to Ufi Gel SC) | JUELLCure Soft Performance |
|---|---|---|
| Monomer Matrix (Base) | 70-80 % | 70-80 % |
| Rheologic Modifier (Base) | 15-30 % | 15-30 % |
| Catalyst (Base) | 0.1-0.5 % | 0.1-0.5 % |
| Colorant (Base) | <0.1 % | <0.1 % |
| Co-Monomer (Base) | 5-10 % | 5-10 % |
| Monomer Matrix (Glazing Base) | 80-90 % | 80-90 % |
| Rheologic Modifier (Glazing Base) | 10-20 % | 10-20 % |
| Catalyst (Glazing Base) | 0.1-0.5 % | 0.1-0.5 % |
| Monomer Matrix (Glazing Catalyst) | 60-70 % | 60-70 % |
| Rheologic Modifier (Glazing Catalyst) | 20-30 % | 20-30 % |
| Stabilizer (Glazing Catalyst) | 8-15 % | 8-15 % |
| Monomer Matrix (Entire mix, likely) | 70-85 % | 70-85 % |
| Rheologic Modifier (Entire mix, likely) | 15-20 % | 15-20 % |
| Stabilizer (Entire mix, likely) | 0.1-0.5 % | 0.1-0.5 % |
| Co-Monomer (Entire mix, likely) | 2-5% | 2-5% |
| Surface hardness (Shore hardness A) | 26.3 | 26.3 |
| Adhesion to dentures | 190 N | 190 N |
| Working time | 201 s | 201 s |
Study Proving Device Meets Acceptance Criteria:
The study described is a bench testing comparison of the JUELLCure Soft with the predicate device, Ufi Gel SC. The stated goal is to demonstrate "substantial equivalence" based on "indications, composition, and testing results."
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample sizes used for the bench tests (surface hardness, adhesion, working time). It only provides the resulting performance values. It does not mention any clinical test sets with patient data. The data provenance is implied to be from the manufacturer's internal testing. There is no information about country of origin or whether it's retrospective or prospective, as it's a materials science test.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This device is a material, and its performance is evaluated through physical and chemical testing, not by expert interpretation of patient data. Therefore, there is no "ground truth" established by experts in the context of diagnostic accuracy.
4. Adjudication Method for the Test Set
Not applicable. As described above, the evaluation is based on objective material property measurements, not subjective interpretation 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 material for dental use, not an AI-powered diagnostic device. Therefore, no MRMC study or AI assistance is relevant.
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 device.
7. The Type of Ground Truth Used
For the chemical composition, the ground truth is the chemical analysis of the material and its components. For the physical properties (surface hardness, adhesion, working time), the ground truth is the objectively measured value obtained through standardized testing methods, comparing it directly to the reported values of the predicate device.
8. The Sample Size for the Training Set
Not applicable. This is a medical device material, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
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(138 days)
JuellCure Hard is intended for use as a permanent hard relining for total and partial dentures. Hard permanent total or partial relining for restoring partial and complete dentures. Lengthening denture margins.
JuellCure hard is a cold-curing, hard relining material for permanently relining dentures.
The provided text describes the 510(k) summary for the JuellCure Hard, a hard impression material for relining dentures. The submission aims to demonstrate substantial equivalence to a predicate device, Ufi Gel Hard C (K030916).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Predicate Device K030916) | Reported Device Performance (JuellCure Hard) |
|---|---|---|
| Setting Time | 135-180 seconds | 135-180 seconds |
| Appearance | Paste is a colorless, homogenous liquid and the catalyst is a white homogenous paste. | Paste is a colorless, homogenous liquid and the catalyst is a white homogenous paste. |
| Composition of Catalyst | Matrix 40-60%, Filler 30-40%, Catalyst 2-4%, Modifier 6-7%, Stabilizer <0.1% | Matrix 40-60%, Filler 30-40%, Catalyst 2-4%, Modifier 6-7%, Stabilizer <0.1% |
| Composition of Paste | Monomer: HEDMA, UDMA, Bis-GMA 30-50%, Filler 40-60%, Colorant <0.1%, Modifier 5-6%, Stabilizer <0.1% | Monomer: HEDMA, UDMA, Bis-GMA 30-50%, Filler 40-60%, Colorant <0.1%, Modifier 5-6%, Stabilizer <0.1% |
| Flexural Strength | 78 Mpa | 78 Mpa |
| Translucency of 2mm specimens | 44% | 44% |
| Adhesion to denture material | Implied to be similar to predicate | Implied to be similar to predicate |
| Thermocycling | Implied to be similar to predicate | Implied to be similar to predicate |
| Color stability | Implied to be similar to predicate | Implied to be similar to predicate |
| Heat of polymerization | Implied to be similar to predicate | Implied to be similar to predicate |
Note: For "Adhesion to denture material," "Thermocycling," "Color stability," and "Heat of polymerization," the document states: "The values for these performance characteristics was found to be very similar to the predicate device." While specific numerical acceptance criteria are not explicitly given for these, the "very similar" statement implies the JuellCure Hard met an unstated acceptance threshold based on predicate performance.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for performance testing (e.g., for flexural strength, translucency, etc.) nor does it explicitly mention data provenance (e.g., country of origin, retrospective or prospective). The testing appears to be laboratory-based evaluation of material properties, not clinical data from patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The performance testing described relates to the physical and chemical properties of the material, which would be measured in a lab setting, not typically evaluated by clinical experts in the same way, for example, diagnostic imaging studies would be.
4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set
The concept of an "adjudication method" (like 2+1 or 3+1 consensus) is primarily relevant for studies involving subjective human interpretation, such as medical image reading. For laboratory-based performance testing of a material, this method is not applicable and therefore not mentioned in the submission.
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
An MRMC study is relevant for evaluating the impact of AI on human reader performance in tasks like diagnostic interpretation. This submission is for a dental material (hard impression material), not an AI-powered diagnostic device. Therefore, an MRMC study was not conducted and is not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not an AI-powered device. Therefore, a standalone (algorithm-only) performance evaluation was not done and is not applicable.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance testing mentioned (e.g., flexural strength, setting time, translucency) would be established through standardized material testing methods and measurements. For instance, flexural strength would be measured using an appropriate mechanical testing machine, and setting time would be determined according to an established dental materials standard. The comparison is made against the reported performance of the predicate device.
8. The Sample Size for the Training Set
This question is relevant for machine learning or AI-based devices. The JuellCure Hard is a material, not an AI device, so there is no training set in this context.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, this question is not applicable.
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(154 days)
The OSI O-ball Abutment implant is a self-tapping titanium threaded screw indicated for long term intra-bony fixation of upper and lower dentures in edentulous cases. These devices will permit immediate splinting and ability and short-term fixation of failing crown and bridge installations, for full or partial edentulism. They can be used in the anterior regions of the maxillary and mandibular arches and are indicated for immediate loading when there is good primary stability and appropriate occlusal load.
The JUELL OSI O-Ball Abutment Dental Implant is available with a gingival collar in four diameters: 3.0mm, 3.5mm, 4.0mm and 4.5mm. The JUELL OSI O-Ball Abutment Dental Implant is available in thread lengths ranging from 10mm to 18mm. The implant is manufactured from ASTM F136 Ti6Al4V. The threaded surface is blasted with particulate media to increase the surface area.
The provided FDA 510(k) summary for the Juell OSI O-ball Abutment Dental Implant focuses on establishing Substantial Equivalence to legally marketed predicate devices, rather than performing a rigorous study to prove the device meets specific acceptance criteria with quantifiable metrics.
Therefore, many of the requested sections (e.g., sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies) are not applicable or cannot be extracted from this document as these types of studies are not typically required for 510(k) clearances focused on substantial equivalence through material and design comparison and existing test standards.
Here's a breakdown of the information that can be extracted, and where the requested information is not applicable:
Acceptance Criteria and Device Performance for Juell OSI O-ball Abutment Dental Implant (K110348)1
The primary "acceptance criterion" for this 510(k) clearance is Substantial Equivalence to existing predicate devices, particularly regarding materials, design, indications for use, and successful fatigue testing.
The study presented is a comparison to predicate devices and demonstration of compliance with an industry standard for mechanical performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (Juell OSI O-ball) |
|---|---|
| Material Equivalence (to Predicate) | Manufactured from ASTM F136 Ti6Al4V. |
| Design Equivalence (to Predicate) | O-ball implant head shape. Available in 3.0mm, 3.5mm, 4.0mm, 4.5mm diameters; 10mm-18mm thread lengths. "Designs are similar." |
| Indications for Use Equivalence (to Predicate) | "Indications for use is similar to those of the predicate devices." (See detailed description in the document). |
| Fatigue Performance (Modified ISO 14801) | "Tested to modified ISO 14801 successfully." |
| Surface Treatment Equivalence | "Blasted and clean" (compared to "Sandblasted and acid etched" and "Blasted and etched" for predicates). |
| Sterilization | Delivered sterile. |
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated for fatigue testing. Fatigue testing according to ISO 14801 typically involves multiple samples (e.g., 10-20 per condition) to establish a statistically significant endurance limit, but the exact number is not provided in this summary.
- Data Provenance: The fatigue testing was conducted by or for Juell Dental. The country of origin of the data is not specified, but the company is based in Ardmore, OK, USA. The testing is prospective for the device being submitted.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This type of submission relies on engineering standards (ISO 14801) and comparison to predicate devices, not on expert-established ground truth for a test set in the clinical or diagnostic sense.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical or diagnostic "test set" requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC study is not relevant for this type of device (dental implant) and submission, which focuses on mechanical performance and substantial equivalence.
6. Standalone Performance Study (Algorithm Only)
Not applicable. This device is a physical medical device (dental implant), not a software algorithm.
7. Type of Ground Truth Used
The "ground truth" for the fatigue test was established by the ISO 14801 standard, which defines how dental implants should be subjected to cyclic loading to assess their durability. The outcome is whether the device successfully met the standard's criteria (i.e., did not fracture within a specified number of cycles at a given load).
8. Sample Size for the Training Set
Not applicable. There is no "training set" in the context of this device. The device design and materials are based on established engineering principles and comparison to existing, already "trained" (i.e., clinically proven) predicate devices.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there's no training set, there's no ground truth establishment for it.
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