(85 days)
Pulpdent Tuff-Temp 2.0 is a dual-cure, glass-filled, resin composite used by the dental professional to make a temporary prosthesis, such as a crown or bridge, to be used until a permanent restoration can be fabricated.
Pulpdent Tuff-Temp 2.0 is a dual-cure, glass-filled, resin composite used by the dental professional to make a temporary prosthesis, such as a crown or bridge, to be used until a permanent restoration can be fabricated.
Dual-cure, glass-filled composite material in two parts. Blended dimethacrylate resins Chemical and Photo-initiators Barium glass and submicron silica fillers.
Below is a summary of the acceptance criteria and the study proving the device meets it, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Measurement) | Reported Device Performance |
|---|---|
| Flexural strength | 84.0 ± 4.0 MPa |
| Compressive strength | 205.0 ± 18.0 MPa |
| Deflection at break | 2.3 ± 0.3 mm |
| Heat rise | 5.4°C |
| Initial setting time (Self-cure) | 90 seconds |
| Initial setting time (Light cure) | 20 seconds |
| Final self-cure setting time | 5 minutes from beginning of mix |
Note: The document does not explicitly state numerical acceptance criteria (e.g., "must be greater than X MPa"). Instead, it presents the reported performance values as evidence that "Tuff-Temp 2.0 performs as intended" and supports substantial equivalence to predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the sample size used for the bench tests (flexural strength, compressive strength, etc.).
For biocompatibility, the text mentions "Pre-production clinical evaluations of Tuff-Temp 2.0 by dentists in the field and by dentist consultants were positive." However, no specific sample size (number of dentists or patients) is given. It also states, "Tuff-Temp 2.0 has been sold in Europe as a CE marked medical device for the past four months," implying real-world usage data.
The data provenance for the bench tests is not explicitly stated (e.g., country of origin), but it is implied to be from internal testing by Pulpdent Corporation. The clinical evaluation data appears to be from Europe (CE marked medical device) and general "field" evaluations. The study appears to be a prospective evaluation for Tuff-Temp 2.0 (pre-production clinical evaluations and 4 months of sales in Europe), while references to the original Tuff-Temp's performance ("ten years of problem-free use" and "two years on the market") are retrospective observations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The text mentions "Pre-production clinical evaluations of Tuff-Temp 2.0 by dentists in the field and by dentist consultants were positive." It does not specify the exact number of dentists or their specific qualifications (e.g., years of experience).
4. Adjudication Method for the Test Set
The document does not describe any formal adjudication method for the clinical evaluations. The statement "Pre-production clinical evaluations... were positive" suggests a general consensus or positive feedback rather than a structured adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not conducted. The provided information focuses on bench testing and general clinical feedback, not a comparative effectiveness study involving human readers with and without AI assistance. This device is a material, not an AI or imaging device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable as the device is a dental material (temporary crown and bridge resin), not an algorithm or AI system. The performance metrics are physical/material properties.
7. Type of Ground Truth Used
For the bench tests (flexural strength, compressive strength, etc.), the "ground truth" is derived from objective laboratory measurements based on established testing standards (though the specific standards are not cited).
For biocompatibility and clinical performance, the ground truth is based on dentist and patient feedback/observations during pre-production clinical evaluations and post-market use in Europe. It also relies on the "problem-free use" history of similar predicate devices and the original Tuff-Temp.
8. Sample Size for the Training Set
This is not applicable as the device is a material and not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as the device is a material and not an AI or machine learning model.
§ 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.