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510(k) Data Aggregation
(216 days)
Point implant system is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple units restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.
Point implant system is a dental implant system consisting of fixtures, mount & mount screws, abutments (cemented, solid, angled, temporary, healing), abutment screws, and cover screws. The applied part is oral and the contact duration is C (>30 days). The patient population is dental prosthetic patients. The materials used include Unalloyed Titanium (ASTM F67), Alloyed Titanium (ASTM F136), and Polyoxymethylene (CAS No.: 30846-29-8).
The provided document is a 510(k) Summary for the Point implant system. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study proving a device meets specific acceptance criteria for performance metrics like accuracy, sensitivity, or specificity. Therefore, many of the requested categories about acceptance criteria, efficacy studies, and ground truth are not directly addressed in this type of submission.
However, I can extract information related to non-clinical testing and general acceptance of performance based on standards.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria / Standard | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Met criteria of ISO 10993 series for medical devices. |
| Fatigue (ISO 14801:2016) | Result is "strong enough to achieve their intended use." |
| Non-pyrogenic (USP Bacteria Endotoxins Test) | Meet established pyrogen limit. |
| Usability Evaluation (ISO 11607-1:2019 & FDA Guidance) | Aseptic presentation evaluated. |
| Packaging Integrity (Low and high magnification images) | Evaluation of broken tip and damage after removal from packaging and disconnection of fixture jig. |
| Quality System (QS) Plan | Method and frequency of acceptance activities ensure conformity with product specifications. |
| Gamma Sterilization (ISO 11137-1, -2) | Achieved a Sterility Assurance Level (SAL) of 10^-6. Demonstrated a shelf life of 5 years for fixture, 8 years for healing abutment. |
| Steam Sterilization (ANSI/AAMI ST79, ST8, ISO 17665-1, -2) | Achieved a Sterility Assurance Level (SAL) of 10^-6. Validated for abutments with the same material/process. |
| MRI Safety (FDA Guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment") | MRI review performed to evaluate metallic devices for magnetically induced displacement force and torque. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for any of the non-clinical tests.
- Data Provenance: Not specified. The manufacturer is PointNix Co., Ltd. from REPUBLIC OF KOREA.
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)
- This information is not applicable and not provided in a 510(k) summary for a dental implant system. The document focuses on physical, chemical, and biological performance testing against established standards, not on diagnostic accuracy requiring expert consensus as ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. The tests mentioned are non-clinical, objective tests against engineering and biological standards, not requiring human adjudication of results in the way a clinical imaging study might.
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. This is a dental implant system, not an AI-powered diagnostic device. No MRMC studies were mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a dental implant system, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For the non-clinical tests, the "ground truth" or reference for acceptance is primarily the criteria defined by international and national standards (e.g., ISO 10993, ISO 14801, ISO 11137, ANSI/AAMI, USP), as well as FDA guidance documents. These standards define methodologies and acceptable limits for properties like biocompatibility, fatigue strength, sterility, and packaging integrity.
8. The sample size for the training set
- Not applicable. This is a medical device (dental implant), not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. (See answer to #8).
Summary of Study Type:
The "studies" described are a series of non-clinical performance tests conducted to demonstrate that the physical, chemical, and biological properties of the Point implant system meet established international standards and FDA guidance for dental implants. These are largely laboratory-based tests comparing the device's performance against predefined thresholds and methodologies specified in the standards. No clinical studies (human trials) were included in this 510(k) submission.
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(297 days)
URIS OMNI System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.
URIS OMNI System fixtures are dental implants made of Unalloyed Titanium, grade 4 (ASTM F67) intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations. The surface is SLA (Sandblasted, Large grit and Acid etched) treated and is provided sterile. It consists of two implant lines, the OMNI and the OMNI Tapered, with corresponding cover screws, healing abutments and prosthetic abutments. The OMN Tapered implant has a tapered wall with a single thread design. The OMN is straight walled with smaller threading at the coronal end, and bigger threading at the apical end. Both implant lines have two platform sizes, Narrow (Ø 3.5 mm) and Regular (Ø 4.0 - Ø 6.5 mm). Both implant lines share the following diameters and lengths:
Ø 3.5 x 8.5, 10, 11.5, 13, 14.5mm (L) Ø 4.0 x 7. 8.5. 10. 11.5. 13. 14.5mm (L) Ø 4.5 x 7, 8.5, 10, 11.5, 13, 14.5mm (L) Ø 5.0 x 7, 8.5, 10, 11.5, 13, 14.5mm (L) Ø 5.5 x 7. 8.5. 10. 11.5. 13. 14.5mm (L) Ø 6.0 x 7, 8.5, 10mm (L) Ø 6.5 x 7, 8.5, 10mm (L).
URIS Prosthetic System is made of titanium alloy (Ti-6Al-4V ELI) intended for use as an aid in prosthetic restoration. It consists of Cover screw, Healing abutment-direct type, D-basis abutmentcemented type, Angled abutment, Milling abutment, Temporary abutment screw. The surface of cover screw and healing abutment are anodized in yellow and green.
The provided text is a 510(k) Summary for the URIS OMNI System, a dental implant device. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical test data for mechanical properties and biocompatibility.
Crucially, this document explicitly states: "No clinical data were included in this submission."
Therefore, the information required to answer your request regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning human performance with or without AI, multi-reader multi-case studies, standalone algorithm performance, or ground truth derived from expert consensus, pathology, or outcomes data, cannot be found in this document.
The acceptance criteria mentioned in this 510(k) summary are for non-clinical tests to demonstrate the device's physical and biological properties.
Here's the relevant information that can be extracted, interpreting "acceptance criteria" in the context of this regulatory submission:
Acceptance Criteria and Device Performance (Non-Clinical)
The "acceptance criteria" for this submission are not expressed as performance metrics for an AI/CADe device, but rather as meeting established standards for dental implants and abutments. The "reported device performance" is a statement that the device met these criteria.
| Acceptance Criteria (Stated Purpose) | Reported Device Performance (Conclusion) |
|---|---|
| Biocompatibility: In accordance with ISO 10993 series (e.g., ISO 10993-5:2009 for cytotoxicity, -10:2010 for irritation/sensitization, -11:2006 for systemic toxicity, -3:2014 for genotoxicity, -6:2007 for implantation). | "Biocompatibility testing has been completed." and "The results of the non-clinical testing demonstrate that the results have met the criteria of the standards, and the subject device is substantially equivalent to the predicate device." (This implies all specified biocompatibility tests were performed and passed.) |
| Sterilization: In accordance with ISO 11137-1,-2,-3 and ISO 11737-1,-2 (for manufacturer sterilization) and ISO 17665-1,-2 (for end-user sterilization). | "Sterilization Testing according to ISO 11137-1,-2,-3 and ISO 11737-1,-2" and "End user sterilization Testing according to ISO 17665-1,-2" were performed. The conclusion states: "The results of the non-clinical testing demonstrate that the results have met the criteria of the standards..." (Indicating successful sterilization validation). |
| Shelf Life: In accordance with ISO 11607-1,-2 / ASTM F1980-07, ASTM F88, ASTM F1140, ASTM F1929, ASTM F2096, and sterility testing. | "Shelf Life Testing according to ISO 11607-1,-2 / ASTM F1980-07, ASTM F88, ASTM F1140, ASTM F1929, ASTM F2096 and sterility testing" were performed. The conclusion states: "The results of the non-clinical testing demonstrate that the results have met the criteria of the standards..." (Indicating successful shelf life validation, supporting the claimed 5-year shelf life for fixtures). |
| Fatigue Testing: In accordance with ISO 14801:2016 and FDA guidance "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" under worst-case scenario. | "Fatigue testing was conducted according to... ISO 14801:2016 Dentistry - Fatigue test for endosseous dental implants under the worst-case scenario." The conclusion states: "The results of the non-clinical testing demonstrate that the results have met the criteria of the standards..." (Indicating the device passed the specified fatigue tests for mechanical durability). |
| Product Characterization (SEM, EDS): Imaging and elemental analysis to characterize the material and surface. | "SEM (Scanning electron microscopy) images and EDS (Energy Dispersive X-ray Spectroscopy) analysis" were performed. While not explicitly stated as "passed," these are typically done for characterization to support the material and surface claims, which are deemed "substantially equivalent" to predicates. The overall conclusion supports this: "The results of the non-clinical testing demonstrate that the results have met the criteria of the standards, and the subject device is substantially equivalent to the predicate device." |
Since "No clinical data were included in this submission," the following requested information cannot be provided from this document:
- Sample sizes used for the test set and the data provenance: Not applicable, as no clinical test data is provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to device performance in a clinical context.
- The sample size for the training set: Not applicable (refers to AI/machine learning data, not present here).
- How the ground truth for the training set was established: Not applicable.
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