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510(k) Data Aggregation
(199 days)
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- Temporary inlay and onlay treatments of the cavity.
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- Sealing of openings for implant screws.
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- Relining material for temporary crowns and bridges.
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- Covering of the gingival margin.
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- Fixing of resin matrix during filling placement.
DiaTemp Flow is a temporary fililng material that sets with curing light. In case that the cavity is not permanently restored, DiaTemp Flow can be used as a temporary restoration until the next appointment. DiaTemp Flow has four models and packaged with the syringe, disposable tip, protective cap.
The provided text is a 510(k) summary for a medical device called "DiaTemp Flow," a temporary crown and bridge resin. It does not describe an AI/ML powered device, therefore, the request cannot be fully satisfied as it asks for information pertaining to AI/ML powered devices.
However, I can extract the information that is present and relevant to the "acceptance criteria and the study that proves the device meets the acceptance criteria" for the DiaTemp Flow device.
Acceptance Criteria and Device Performance (Non-AI Device)
The DiaTemp Flow device is a temporary filling material and its performance is evaluated against material properties and biocompatibility standards, rather than diagnostic accuracy or sensitivity/specificity metrics typically associated with AI assistance. The acceptance criteria are implicit in the conformance to the specified ISO standards and the comparison with the predicate device.
Here's a table based on the provided document:
| Acceptance Criteria (Implied by Standards & Predicate) | Reported Device Performance (DiaTemp Flow) |
|---|---|
| Conformance to ISO 4049:2009 (Dentistry Polymer-based restorative materials) | Demonstrated conformance |
| Conformance to ISO 7405:2009 (Dentistry Evaluation of biocompatibility) | Demonstrated conformance |
| Conformance to ISO 10993-1:2009 (Biocompatibility Risk Management) | Demonstrated conformance |
| Conformance to other ISO 10993 series (Biocompatibility Tests) | Demonstrated conformance |
| Similar Indications for Use as Predicate Device (K153493) | Indications for Use are "Equivalent" (Minor differences in coverage of "block-out material for retentive areas") |
| Similar Description as Predicate Device | Description is "Equivalent" |
| Similar Packaging and Contents as Predicate Device | Packaging and Contents are "Equivalent" |
| Similar Main Composition as Predicate Device | Main ingredients are "similar" (Slightly different in specific components like 2-hydroxyethyl methacrylate and Urethane Methacrylate, but biocompatibility and performance confirmed) |
| Similar Sensitivity to ambient light as Predicate Device | "homogeneous" (Equivalent) |
| Similar Depth of cure as Predicate Device | "More than 1.5mm" (Equivalent to predicate's light-cure specifications for various depths and times) |
| Similar Period of Use as Predicate Device | "Prolonged exposure(B)" (Equivalent) |
| Biocompatibility as Predicate Device | "Biocompatible" (Equivalent) |
| Use (Prescription/Hospital) as Predicate Device | "Prescription/Hospital" (Equivalent) |
Regarding AI/ML Specific Questions (Not Applicable to this Device):
The provided document specifically states:
"No clinical data was collected or provided to support substantial equivalence between the subject and predicate device."
"This device has demonstrated conformance with non-clinical performance requirements through evaluation and testing in accordance with the following harmonized standards:" (followed by a list of ISO standards).
Therefore, the following information is not applicable or available in the provided document for "DiaTemp Flow" as it is a material-based device, not an AI/ML software device:
- Sample size used for the test set and the data provenance: Not applicable. Performance demonstrated through non-clinical testing against standards.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for material properties is based on standard scientific measurements, not expert consensus on medical images/data.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a material device, not an AI-assisted diagnostic tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No. This is a material device.
- The type of ground truth used: For material properties, it's based on scientific measurements and adherence to ISO standards. For biocompatibility, it's based on in-vitro and in-vivo tests as per ISO 10993 series.
- The sample size for the training set: Not applicable. There is no training set for this type of device.
- How the ground truth for the training set was established: Not applicable.
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(188 days)
All types of temporary fillings, temporary protection in inlay and onlay technique.
DiaTemp is a temporary filling material that sets with curing light. In case the cavity is not permanently restored, Diatemp can be used as a temporary restoration until the next appointment. DiaTemp has four models and packaged with syringe and protective cap.
The provided document is a 510(k) premarket notification for a medical device called "DiaTemp," which is a temporary crown and bridge resin. The document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report with acceptance criteria and performance metrics typically seen in AI/ML device submissions.
Therefore, many of the requested elements for describing "the acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable to this type of submission. This document pertains to a physical material, not an AI/ML diagnostic or prognostic algorithm.
Here's a breakdown based on the information available in the document:
1. Table of acceptance criteria and the reported device performance:
Since this is a physical material cleared through substantial equivalence, the "acceptance criteria" are typically defined by harmonized standards (e.g., ISO standards) and comparison to a predicate device. Performance is assessed through non-clinical testing rather than complex statistical metrics for diagnostic accuracy.
| Acceptance Criterion (Implicit) | Reported Device Performance (DiaTemp) | Basis for Equivalence |
|---|---|---|
| Indications for Use: Temporary fillings, temporary protection in inlay and onlay technique (Equivalent to predicate). | All types of temporary fillings, temporary protection in inlay and onlay technique. | Equivalent to predicate (EVADYNE TEMPORARY CROWN AND BRIDGE RESIN) which is indicated for temporary restoration of crowns, bridges, or similar dental prostheses. |
| Description: Temporary filling material that sets with curing light, removable in one piece (Equivalent to predicate). | Temporary filling material that sets with curing light. Can be used as a temporary restoration until the next appointment. | Equivalent to predicate (EVADYNE) which is a light-cured temporary restoration material that can be removed in one piece. |
| Composition: Main ingredients are similar to predicate. | -Ethyl 4-(N,N-dimethylamino) benzoate | |
| -Silica amorphous,fumed | ||
| -Urethane acrylate | ||
| -BHT | ||
| -Camphorquinone | Main ingredients are similar to predicate (EVADYNE: Ethyl-4-dimethylamino benzoate, Fluoroaluminosilicate glass, Polyester urethane dimethacrylat). Bio-compatibility and performance tests demonstrate substantial equivalence despite slight compositional differences. | |
| Performance Standard Conformance: ISO 4049:2009 (Dentistry Polymer-based restorative materials) | Conforms to ISO 4049:2009 | Equivalent to predicate. |
| Physical and Mechanical Properties: | ||
| - Sensitivity to ambient light: Homogeneous | Homogeneous | Equivalent to predicate. |
| - Depth of cure: > 1.5mm (Predicate: 2.5mm) | More than 1.5mm (average: 2.9 mm) | Comparable to predicate (2.5 mm). |
| - Curing Time: 20-30 seconds (Predicate: 20 seconds) | 20 ~ 30 seconds | Comparable to predicate (20 seconds). |
| - Water sorption and solubility: (Implicit from ISO 4049) | Evaluated per ISO 4049 | Not explicitly detailed, but conformity to ISO 4049 ensures these properties meet the standard. |
| - Shade & Colour stability: (Implicit from ISO 4049) | Evaluated per ISO 4049 | Not explicitly detailed, but conformity to ISO 4049 ensures these properties meet the standard. |
| Period of Use: Prolonged exposure (exceed 24 hours but not 30 days) | Prolonged exposure (exceed 24 hours but not 30 days) | Equivalent to predicate. |
| Biocompatibility: Biocompatible, conforming to ISO 7405 and ISO 10993 standards. | Biocompatible (per ISO 7405, ISO 10993-1, -2, -3, -5, -6, -10, -11, -12) | Equivalent to predicate. Tests include genotoxicity, carcinogenicity, reproductive toxicity, cytotoxicity, local effects after implantation, irritation, skin sensitization, and systemic toxicity. |
| Use: Prescription/Hospital | Prescription/Hospital | Equivalent to predicate. |
Regarding the specific questions that largely pertain to AI/ML studies:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. This submission does not involve a "test set" in the context of an AI/ML algorithm. Performance was assessed through laboratory non-clinical testing of the material itself according to harmonized standards.
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):
- Not applicable. Ground truth for an AI/ML algorithm is not relevant here. The "ground truth" for a material device like DiaTemp is established by the validated methods of the ISO standards themselves.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No adjudication method for a test set of data is described as this is not an AI/ML device.
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. There was no MRMC study as this is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. There is no algorithm discussed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For material properties: The "ground truth" is defined by the validated measurement methods and specified criteria within the harmonized ISO standards themselves (e.g., ISO 4049 for polymer-based restorative materials, ISO 7405 and ISO 10993 series for biocompatibility). These standards dictate how to objectively measure characteristics like depth of cure, water sorption, cytotoxicity, etc.
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable. There is no "training set" or associated ground truth for an AI/ML algorithm described in this document.
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