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(235 days)
TDS PRECISION DENTAL BAR
TDS Precision Dental Bars are indicated for use with dental implants as a prosthetic framework to support and/or retain removable or fixed dental prostheses in the treatment of partially or totally edentulous jaws to restore chewing function. The abutment screws are intended to secure the bar to the endosseous implants.
TDS Precision Dental Bars are prosthetic frameworks and made of machined titanium, zirconia-titanium, and zirconia materials. They are connected with dental implants utilizing the TDS screw which is made of Ti-6A1-4V ELI (Extra Low Interstitial) alloy. TDS Precision Dental Bars are fabricated individually following instructions to each patient and serve to support and/or retain fixed dental prosthesis or removable dental prosthesis. They are compatible with dental implants manufactured by NobelBiocare, Camlog, BIOMET 3i, Zimmer, Lifecore, Astra, BioHorizons, Straumann, Dentsply Friadent, and Osstem.
Here's an analysis of the provided text regarding the acceptance criteria and study for the TDS Precision Dental Bar:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Strength: Device must have sufficient mechanical strength for its intended clinical application (e.g., support/retain dental prostheses). | "These testing results show that TDS Precision Dental Bar... have sufficient mechanical strength for their intended clinical application." |
| Material Compatibility: Adherence to material specifications (titanium, zirconia-titanium, zirconia). | Device is made of "machined titanium, zirconia-titanium, and zirconia materials." Abutment screws are "Ti-6A1-4V ELI (Extra Low Interstitial) alloy." |
| Implant System Compatibility: Physical and functional compatibility with various specified dental implant systems (e.g., NobelBiocare, Camlog, BIOMET 3i). | "Compatibility testing was conducted on the abutments and corresponding dental implants with designated screws, the dimensions, tolerances and rotation parameters were evaluated in determining appropriate fit." |
| (Extensive lists of compatible implant brands and models are provided in the document for each bar material type.) | |
| Fit (Dimensions, Tolerances, Rotation Parameters): Proper fit with corresponding dental implants. | "Compatibility testing was conducted on the abutments and corresponding dental implants with designated screws, the dimensions, tolerances and rotation parameters were evaluated in determining appropriate fit." |
| Safe for Use (Worst-Case Scenario): Strength under challenging conditions (e.g., angled abutment). | "Mechanical testing, according to ISO 14801 Dentistry - Fatigue test for endosseous dental implants, was conducted on a worst-case scenario with construction of an angle abutment to ensure that the strength of the abutment for TDS Precision Dental Bar is appropriate for its intended use." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the numerical sample size for the mechanical and compatibility testing. It refers to "a worst-case scenario" for fatigue testing.
- Data Provenance: The study was conducted by Pou Yu Biotechnology Co., Ltd. in Taiwan. The text does not specify if the data is retrospective or prospective, but given it's a pre-market notification for a new device, the testing would generally be prospective in nature, specifically for the purpose of demonstrating device performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document does not mention the use of experts to establish a "ground truth" in the traditional sense of medical image analysis or diagnostic studies. The evaluation is based on objective engineering and mechanical testing standards (ISO 14801) and physical assessments of fit. Therefore, this information is not applicable in this context.
4. Adjudication Method for the Test Set
- This is not applicable as the study involves mechanical and compatibility testing against defined engineering standards and physical measurements, not interpretation by human experts that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human interpretation is involved. The TDS Precision Dental Bar is a prosthetic device.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- Yes, the described testing is fundamentally a standalone evaluation of the device's physical and mechanical properties. There is no "human-in-the-loop" component as the device is a physical prosthetic, not a diagnostic algorithm. The tests (fatigue, compatibility) assess the device itself.
7. Type of Ground Truth Used
- The "ground truth" in this context is established by engineering standards and physical measurements.
- For mechanical strength: Compliance with performance requirements of ISO 14801 Dentistry - Fatigue test for endosseous dental implants.
- For compatibility and fit: Dimensional, tolerance, and rotation parameters with specified implant systems.
8. Sample Size for the Training Set
- This concept is not applicable here. The TDS Precision Dental Bar is a manufactured component whose performance is assessed through physical testing, not a "training set" for an algorithm or AI model.
9. How the Ground Truth for the Training Set Was Established
- Not applicable as there is no "training set" in the context of this device's evaluation.
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