Search Results
Found 1 results
510(k) Data Aggregation
(90 days)
FP3D is a dual cure resin indicated for the 3D printed fabrication of flexible partial dentures in dental laboratories.
The FP3D is designed for additive manufacturing on Carbon 3D printers (wavelength = 385 nm). FP3D is intended to be used within a computer-aided design and manufacturing (CAD/CAM) digital dentistry system that includes a 3D scanner, design software, 3D printer, post-cure unit (wavelength = 385-405 nm), and post-cure oven for the fabrication of flexible partial dentures for partially edentulous patients.
Acceptance Criteria and Device Performance for FP3D
This document analyzes the provided FDA 510(k) Clearance Letter (K250489) for the FP3D device to detail its acceptance criteria and the studies that prove its compliance.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document details non-clinical performance testing against specific ISO and ASTM standards. The acceptance criteria are implicitly defined by these standards, and the "reported device performance" is the conclusion that the device "meets the requirements" or "was completed per" these standards. Specific numerical values for the performance are not provided in this summary.
| Acceptance Criteria (Standard Reference and Property) | Reported Device Performance (Summary) |
|---|---|
| Physical Properties | |
| ISO 20795-1:2013 - Colour stability | Testing completed per standard, indicating compliance. |
| ISO 20795-1:2013 - Ultimate Flexural Strength | Testing completed per standard, indicating compliance. |
| ISO 20795-1:2013 - Flexural Modulus | Testing completed per standard, indicating compliance. |
| ISO 20795-1:2013 - Water sorption | Testing completed per standard, indicating compliance. |
| ISO 20795-1:2013 - Water solubility | Testing completed per standard, indicating compliance. |
| ASTM D348 (tensile properties) | Additional performance testing completed per standard. |
| ASTM D790 (flexural modulus) | Additional performance testing completed per standard. |
| Biocompatibility | |
| ISO 10993 (biocompatibility for permanent device, mucosal membrane contact) | Confirmed biocompatible and meets requirements for a permanent (>30 days) device in contact with the mucosal membrane. |
Note: The FDA 510(k) summary typically summarizes the results rather than providing raw data or specific passing/failing values for each test. The statement "completed per" or "meets the requirements" implies that the device satisfied the acceptance criteria of the respective standards.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the sample sizes used for the physical and biocompatibility tests. It only states that "Nonclinical performance testing was conducted."
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the tests were conducted retrospectively or prospectively. Given the nature of these tests (material properties and biocompatibility), they are typically conducted prospectively in a laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable to the provided extract. The tests described (physical properties and biocompatibility) are objective, laboratory-based evaluations against established international standards (ISO, ASTM). They do not involve interpretation by human clinicians or the establishment of "ground truth" by experts in the same way clinical diagnostic studies do. The standards themselves define the "ground truth" for performance.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3. Laboratory tests against standards do not typically involve adjudication methods like 2+1 or 3+1, which are characteristic of expert review for clinical judgments.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical Testing: Not Applicable." The device is a material for fabricating dentures, not a diagnostic imaging or AI-assisted diagnostic tool that would typically involve a multi-reader study.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable. The FP3D is a material (resin) for 3D printing, not an algorithm or software device. Therefore, a standalone performance study for an algorithm is not relevant here.
7. Type of Ground Truth Used
The ground truth for the non-clinical performance tests was established by international standards and regulations:
- For physical properties: ISO 20795-1:2013 (Dentistry - Base polymers - Part 1: Denture base polymers), ASTM D348 (tensile properties), and ASTM D790 (flexural modulus).
- For biocompatibility: ISO 10993.
These standards define the acceptable range or criteria for the properties being tested.
8. Sample Size for the Training Set
This information is not applicable. The FP3D is a material (resin), not a machine learning model or algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
Ask a specific question about this device
Page 1 of 1