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510(k) Data Aggregation
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(110 days)
- Class I and II restorations in deciduous teeth
- Class I, and non-stress bearing Class II restorations in permanent teeth
- Stress bearing Class II restorations in permanent teeth, keeping ≥1 mm distance from the cusp tips
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(175 days)
- Class I, II, III, IV and V restorations
- Root surface restoration
- Core build-up
EQUIA LC ONE is a resin-modified glass ionomer dental restorative material which is intended to be used as a restorative filling material for direct restorations and or core buildups. The applicant device is provided as a powder/liquid formulation in a mixing capsule.
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(84 days)
Rodin Envision veneer cement (Light Cure):
- Permanent adhesive luting of glass-ceramic, lithium disilicate glass-ceramic and composite restorations (inlays, onlays and veneers)
- Only use Rodin Envision veneer cement Light Cure for restorations with a low thickness of <2mm that have sufficient translucency.
Rodin Luting Cement (Dual Cure):
- Adhesive luting of glass-ceramic, lithium disilicate glass-ceramic and composite restorations (inlays, onlays, partial crowns, crowns, bridges).
- Restorations made of opaque ceramics, e.g. oxide ceramics, can only be permanently cemented if an adhesive is additionally used that is separately light-cured.
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(59 days)
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(171 days)
Choice 2 DC is a dual-cured, resin luting/veneering cement. The indications for use are to cement:
- Indirect restorations (i.e. crowns, fixed prostheses (bridges), inlay, onlays
- Endodontic posts
- Cement-retained implant restorations/abutments (i.e. screws and crowns)
- Veneers
Choice 2 DC is a color stable dual-cured, resin luting/veneering cement that is specially formulated for the cementation of indirect restorations made from Glass Ceramic, Lithium Disilicate, Porcelain, Composite, Metal, or Zirconia.
The provided FDA 510(k) clearance letter for Choice 2 DC, a dental cement, does not contain information about a study proving the device meets acceptance criteria in the context of an AI/ML algorithm or similar diagnostic device. The document explicitly states:
"Clinical testing is Not Applicable."
Instead, the submission relies on non-clinical testing to demonstrate substantial equivalence to predicate and reference devices. The acceptance criteria for this device are based on performance metrics defined by ISO standards for dental cements, rather than diagnostic accuracy metrics.
Therefore, many of the requested elements for describing an acceptance criteria study related to AI/ML or diagnostic performance (e.g., sample size for test set, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this specific 510(k) clearance.
However, I can still extract details about the non-clinical testing and the "acceptance criteria" as implied by the standards chosen for comparison:
Non-Clinical Performance Study Details for Choice 2 DC Dental Cement
The provided FDA 510(k) summary for Choice 2 DC Dental Cement describes non-clinical testing performed to demonstrate substantial equivalence to predicate and reference devices.
1. Table of Acceptance Criteria and Reported Device Performance
For this dental cement, "acceptance criteria" are implied by adherence to established ISO standards and performance at least equal to predicate devices. The document does not provide specific numerical "reported device performance" values for each test, but states that the device met the requirements of the ISO standard and performed at least equal to predicate and reference devices.
| Performance Metric (Acceptance Criteria per ISO 4049:2019) | Reported Device Performance |
|---|---|
| Film thickness | Met requirements of ISO 4049:2019 and performed at least equal to predicate/reference devices. |
| Working time | Met requirements of ISO 4049:2019 and performed at least equal to predicate/reference devices. |
| Setting time | Met requirements of ISO 4049:2019 and performed at least equal to predicate/reference devices. |
| Flexural strength | Met requirements of ISO 4049:2019 and performed at least equal to predicate/reference devices. |
| Water sorption | Met requirements of ISO 4049:2019 and performed at least equal to predicate/reference devices. |
| Water solubility | Met requirements of ISO 4049:2019 and performed at least equal to predicate/reference devices. |
| Shade/color stability | Met requirements of ISO 4049:2019 and performed at least equal to predicate/reference devices. |
| Radiopacity | Met requirements of ISO 4049:2019 and performed at least equal to predicate/reference devices. |
| Shear bond strength (per ISO 29022:2013) | Performed at least equal to predicate/reference devices. (ISO 29022:2013 is a test standard, not necessarily defining a singular "requirement" like ISO 4049 for certain properties, but rather a methodology for comparison). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in the 510(k) summary. These details would typically be found in the full test reports referenced by the ISO standards.
- Data Provenance: The testing was non-clinical (laboratory testing of material properties). Therefore, concepts like country of origin or retrospective/prospective collection are not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not applicable. This was non-clinical material testing based on ISO standards, not a diagnostic study requiring expert consensus for ground truth.
4. Adjudication Method for the Test Set
- Not applicable. This was non-clinical material testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- Not applicable. This applies to diagnostic devices, not dental cements.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This applies to diagnostic algorithms, not dental cements.
7. The Type of Ground Truth Used
- The "ground truth" (or reference standard) was defined by the methodologies and reference materials/procedures specified in the international standards ISO 4049:2019 (Dentistry — Polymer-based restorative materials) and ISO 29022:2013 (Dentistry — Adhesion — Notched-edge shear bond strength test). This involves standardized laboratory measurements of material properties.
8. The Sample Size for the Training Set
- Not applicable, as this is not an AI/ML device or a clinical study requiring training data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set mentioned or implied.
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(114 days)
Final cementation of
- Metal inlays, onlays, crowns and bridges
- Resin inlays, onlays, crowns and bridges
- Ceramic inlays
- Zirconia crowns and bridges
- Metal, ceramic and fiber posts
EsCem RMGI is a radiopaque resin modified glass ionomer luting cement corresponding to ISO 9917-2, Class 3. This product facilitates the removal of excess cement through the tack-cure option, allowing for quick treatment. The contents consisting of base and catalyst are provided in a dual syringe and are used to cement indirect restoration by mixing the two types of paste.
This is a 510(k) premarket notification for a dental cement, EsCem RMGI. The provided document does not contain any information about an AI/ML powered device or a study involving human readers or AI assistance. It focuses solely on the substantial equivalence of the dental cement to a predicate device based on its physical and chemical properties and biocompatibility.
Therefore, I cannot provide an answer that includes:
- A table of acceptance criteria and reported device performance related to AI/ML.
- Sample sizes, data provenance, expert ground truth establishment, or adjudication methods for an AI/ML test set.
- Information about MRMC studies, effect sizes of AI assistance, or standalone AI performance.
- Details about ground truth for training sets or their establishment for AI/ML.
The document discusses the following performance criteria for the dental cement:
1. Acceptance Criteria and Reported Device Performance (for the dental cement, not an AI device):
The document states that the flexural strength and film thickness tests of EsCem RMGI were conducted in accordance with ISO 9917-2. It also mentions that the technical data sheet of the predicate device (RelyX™ Luting Plus Automix) was referenced for these mechanical properties.
The report's conclusion is: "The flexural strength and film thickness test results of the subject device and predicate device meet the ISO 9917-2 requirements, and the values of those performances are comparable to those of the predicate device."
Without the actual numerical values from the "technical data sheet" or the "test results" for EsCem RMGI, a specific table cannot be created. The document only confirms compliance with the ISO standard and comparability.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify sample sizes for the flexural strength and film thickness tests. It also does not mention data provenance in terms of country of origin or whether the studies were retrospective or prospective, beyond stating that biocompatibility testing was performed in accordance with ISO 10993-1.
3. Number of Experts and Qualifications for Ground Truth:
This information is not applicable as the clearance is for a dental cement, not an AI device requiring expert consensus for image interpretation or diagnosis.
4. Adjudication Method:
This information is not applicable as the clearance is for a dental cement, not an AI device requiring adjudication of expert readings.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This information is not applicable as the clearance is for a dental cement, not an AI device that assists human readers.
6. Standalone (Algorithm Only) Performance:
This information is not applicable as the clearance is for a dental cement, not an AI algorithm.
7. Type of Ground Truth Used:
For the dental cement's performance:
- Flexural Strength and Film Thickness: The "ground truth" or reference for performance is established by the ISO 9917-2 standard and comparison to the predicate device's technical data sheet. These are objective, measurable physical properties.
- Biocompatibility: Established by adherence to ISO 10993-1 and specific tests (in vitro cytotoxicity, skin sensitization, irritation testing).
8. Sample Size for the Training Set:
This information is not applicable as the clearance is for a dental cement, not an AI device with a training set.
9. How Ground Truth for the Training Set Was Established:
This information is not applicable as the clearance is for a dental cement, not an AI device with a training set.
In summary, the provided FDA 510(k) clearance letter pertains to a dental cement and does not describe an AI/ML-powered device. Therefore, most of the requested information regarding AI device acceptance criteria, study design, and ground truth establishment is not present in this document.
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(154 days)
- Definitive cementation of inlays, onlays, crowns and bridges, in ceramic or zirconia, composite or metal; 2-3 unit Maryland bridges and 3-unit inlay/onlay bridges (to be avoided for patients with bruxism or periodontitis).
- Definitive cementation of endocanal posts.
- Definitive cementation of ceramic, zirconia, composite or metal restorations on implant abutments and natural teeth.
- Definitive cementation of zirconium oxide superstructures for two-unit abutments
OverCEM is dual-curing, self-adhesive resin luting cement. The components consists of Paste A and B, which are filled in a one-body syringe. Both pastes are automixed with a mixing tip. The operating principle of the device is based on two reactions, one self-curing. OverCEM is designed to strongly and stably connect reconstruction materials and endocanal posts to patients' teeth or implants.
The provided text describes the 510(k) summary for the OverCEM SA dental cement devices. While it details performance bench tests conducted, it does not explicitly state specific acceptance criteria for each test or a direct "study" proving the device meets all acceptance criteria in the format of a clinical study report with individual acceptance criteria for each test and its outcome. Instead, it presents a comparison table showing the reported performance of the applicant device (OverCEM) against the predicate device (G-CEM ONE).
However, I can extract the reported device performance from Section 7 ("Performance Bench Tests") and Section 12 ("Comparison of Technology") for the applicant device and infer that these values are presumed to meet internal or regulatory acceptance criteria, as the device received a 510(k) clearance.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, specific acceptance criteria for each test (e.g., "flexural strength must be X MPa or greater") are not explicitly stated in the document. However, the reported performance values for the OverCEM device are provided, and they are implicitly deemed acceptable for 510(k) clearance by the FDA based on substantial equivalence to the predicate.
| Performance Test | Reported OverCEM Device Performance (Applicant) | Predicate Device Performance (G-CEM ONE) | Notes |
|---|---|---|---|
| Diametral tensile strength | Not explicitly listed, but implied as part of "Performance Bench Tests" | Not explicitly listed | |
| Film thickness | 23.10 µm | 5 µm | The applicant device has a higher film thickness than the predicate. This difference was presumably deemed acceptable by the FDA for substantial equivalence. |
| Compression strength | Not explicitly listed, but implied as part of "Performance Bench Tests" | Not explicitly listed | |
| Working time | 90 seconds (at 23°C/73.4°F) / 01:30 (at 35°C/95°F) | 165 seconds | The applicant device has a shorter working time at 23°C compared to the predicate, and even shorter at 35°C. |
| Setting time | 240 seconds (declared in IFU, 200.40 test result) (at 23°C/73.4°F) / 04:00 (at 35°C/95°F) | 240 seconds | The applicant device's declared setting time is the same as the predicate's, with test results indicating slightly faster setting. |
| Flexural strength | 102.25 MPa | 150 MPa | The applicant device has a lower flexural strength than the predicate. This difference was presumably deemed acceptable by the FDA for substantial equivalence, possibly due to other compensating factors or falling within an acceptable range for the intended use. |
| Water sorption | 0.45 µm/mm³ | 0.0000025 µm/mm³ | The units for water sorption differ significantly between the applicant and predicate, making direct comparison difficult without clarification of units or magnitude. The applicant's value is much larger. |
| Solubility | 0.883 µm/mm³ | 0.0000016 µm/mm³ | Similar to water sorption, units or magnitude differences make direct comparison challenging. The applicant's value is much larger. |
| Color stability | Excellent overall behaviour in colour stability tests | Excellent colour stability | Both devices report excellent color stability. |
| Radio-Opacity | The OverCEM devices are radio-opaque. | No information on the radio-opacity of the device (for predicate) | The applicant device features radio-opacity, a characteristic for which information on the predicate is not provided in this document. |
| Adhesive bond strength (Dentin) | 12.95 ± 2.22 MPa | 9.24 ± 2.06 MPa | The applicant device shows higher adhesive bond strength to dentin. |
| Adhesive bond strength (Enamel) | 29.62 ± 7.75 MPa | 26.45 ± 7.72 MPa | The applicant device shows higher adhesive bond strength to enamel. |
| Adhesive bond strength (Zirconia) | 44.21 ± 6.53 MPa | 32.45 ± 3.09 MPa | The applicant device shows significantly higher adhesive bond strength to zirconia. |
| Adhesive bond strength (Glass Ceramic) | 31.40 ± 5.68 MPa | 19.55 ± 5.06 MPa | The applicant device shows significantly higher adhesive bond strength to glass ceramic. |
| Adhesive bond strength (Composite) | 31.27 ± 3.51 MPa | 22.85 ± 4.77 MPa | The applicant device shows higher adhesive bond strength to composite. |
| Adhesive bond strength (Metal) | 34.84 ± 4.97 MPa | 29.34 ± 4.71 MPa | The applicant device shows higher adhesive bond strength to metal. |
| Biocompatibility | Acceptable based on ISO 10993-1, 10993-5, 10993-10 tests | Not explicitly detailed, but implied as legally marketed | In vitro cytotoxicity, skin sensitization, and intracutaneous reactivity tests were performed and found acceptable for OverCEM. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each individual test. The document mentions "The device has been tested according to ISO 4049:2009... ISO 13116:2015... ISO 7491:2000... and ISO 29022:2013." These ISO standards typically specify minimum sample sizes for their respective tests, but the document does not report the specific number of samples used in these tests for OverCEM.
- Data Provenance: The document states, "Data for adhesion strength were obtained from a test performed by Overfibers S.r.l according to ISO 29022:2013." This indicates that at least the adhesion strength data is prospective and conducted by the manufacturer (Overfibers S.r.l.) based in Italy for the applicant device. The provenance for other bench tests is not explicitly stated beyond "The device has been tested according to..."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the document describes physical and chemical performance bench tests of a dental cement, not a diagnostic device or software requiring expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not applicable as the document describes physical and chemical performance bench tests, not a diagnostic device or software requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical testing has been performed on this device."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a dental cement, not a software algorithm. The performance tests are for the physical and chemical properties of the material itself.
7. The Type of Ground Truth Used
For the physical and chemical property tests, the "ground truth" is established by adherence to international standards (e.g., ISO standards) for dental materials testing. The outcomes of these standardized tests (e.g., MPa for flexural strength, µm for film thickness) are the "ground truth" for the device's performance attributes. For biocompatibility, the ground truth is compliance with ISO 10993 series for biological evaluation of medical devices.
8. The Sample Size for the Training Set
Not applicable. This device is a dental cement, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is a dental cement, not an AI/ML algorithm that requires a training set and established ground truth.
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