(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.
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.