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510(k) Data Aggregation
(126 days)
Inversa Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading. Inversa Implants are intended for immediate function when good primary stability with appropriate occlusal loading is achieved.
Inversa implants are fully threaded, tapered, root-form dental implants with a design feature known as body shift, where the body design of the implant has a narrow, straight coronal portion with an increased maximum diameter midway down the length of the implant tapering toward the apex. The body of the implant includes two thread types (square and V-shaped) that transition in the middle of the implant body. Inversa implants have a platform that is inclined 12° to the long axis of the implants are made of unalloyed titanium and provided in two connection types (External Hex and Deep Conical).
External Hex Inversa implants are provided in three sizes: coronal diameter 3.5 mm with maximum apical diameter 4.5 mm; coronal diameter 3.5 mm with maximum apical diameter 5.0 mm; and coronal diameter 4.2 mm with maximum apical diameter 5.0 mm. Each size of the External Hex Inversa implant is provided in four lengths (11.5, 13, 15, and 18 mm).
Deep Conical Inversa implants are provided in three sizes: coronal diameter 3.6 mm with maximum apical diameter 4.5 mm; coronal diameter 3.6 mm with maximum apical diameter 5.0 mm; and coronal diameter 4.0 mm with maximum apical diameter 5.0 mm. Each size of the Deep Conical Inversa implant is provided in four lengths (11.5, 13, 15, and 18 mm).
Inversa implants are made from unalloyed titanium conforming to ASTM F67.
This document is a 510(k) summary for the "Inversa Implants" dental implant system, submitted to the FDA. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study proving a device meets specific performance acceptance criteria for a new AI/software device.
Therefore, many of the requested elements (e.g., acceptance criteria for device performance, sample sizes for test sets, expert involvement, MRMC study results, training set details) are not applicable or not found in this type of regulatory submission for a physical medical device like a dental implant.
The "Performance Data" section of this document refers to non-clinical tests for physical characteristics and safety, not for performance of a software/AI device.
Here's an attempt to extract relevant information and explain why other information is absent:
1. A table of acceptance criteria and the reported device performance
This document does not present a table of acceptance criteria and reported device performance in the way one would for a software or AI device. Instead, it focuses on demonstrating substantial equivalence to existing predicate devices based on technological characteristics and intended use.
The "Performance Data" section mentions the following non-clinical tests performed or referenced:
| Test/Characteristic | Acceptance Criteria (Implicit) | Reported Performance (Implicit) |
|---|---|---|
| Sterilization Validation (according to ISO 11137-1 and ISO 11137-2) | Meets ISO standards (referenced from K163634 and K163060) | Deemed acceptable by reference to predicate data. |
| Biocompatibility Evaluation (according to ISO 10993-1) | Meets ISO standards (referenced from K163634 and K163060) | Deemed acceptable by reference to predicate data. |
| Bacterial Endotoxin Testing (in accordance with USP 40-NF 35) | Meets USP standards | Deemed acceptable. Specific results not in this summary. |
| Sterile Barrier Shelf Life | Meets requirements (referenced from K163634) | Deemed acceptable by reference to predicate data. |
| Dynamic Compression-Bending (to ISO 14801) | Implied to meet ISO 14801 standards, comparable to predicates. | Results not explicitly detailed in summary. |
| Insertion Torque Testing | Implied to be acceptable, comparable to predicates. | Results not explicitly detailed in summary. |
No clinical data were included in this submission. This means no human study was performed to "prove the device meets acceptance criteria" in a clinical setting.
2. Sample sizes used for the test set and the data provenance
- Sample Size for Test Set: Not applicable for this type of submission. The "test set" for a physical device like this refers to the samples of the device used for non-clinical bench testing (e.g., for mechanical strength, sterilization). The specific number of units tested for each non-clinical test (e.g., how many implants were tested for dynamic compression-bending) is not provided in this summary.
- Data Provenance: Not applicable. The data is primarily derived from bench testing (non-clinical) of prototype/production units and references to previously cleared predicate devices (K163634, K163060, K030463, K053478, K070841, K093562). The manufacturer is Southern Implants (Pty) Ltd., based in Irene, Gauteng, South Africa.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a submission for a diagnostic AI/software device that requires ground truth established by medical experts. The "ground truth" for a dental implant's performance would be engineering specifications and physical test results, not expert consensus on images.
4. Adjudication method for the test set
Not applicable. This is not a study requiring adjudication of expert readings/assessments.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
No. This type of study is typically done for diagnostic imaging devices/software to evaluate human reader performance with and without AI assistance. This submission is for a physical dental implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or software device.
7. The type of ground truth used
For the non-clinical performance data, the "ground truth" would be the physical and chemical properties of the materials and the mechanical performance consistent with engineering standards (e.g., ISO 14801 for dynamic compression-bending). For the regulatory submission, the primary "ground truth" is the demonstration of substantial equivalence to existing, legally marketed predicate devices based on design, materials, and intended use.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of an AI/machine learning model for this physical medical device submission.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/machine learning model.
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(190 days)
Blue Sky Bio Zygomatic Implant System is indicated for surgical installation in the zygoma region, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function. Blue Sky Bio zygomatic implants are recommended for the posterior (pre-molar/molar) region, one implant on each side, with at least two standard dental implants in the anterior region to support a fixed restoration. Blue Sky Bio zygomatic implants may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
Blue Sky Bio Zygomatic Implant System submission includes threaded root-form dental implants and mating abutments designed for placement into the zygomatic bone. The zygomatic implants are provided with an internal hexagon connection and a tapered internal hexagon interface for connection to the subject abutments. The internal hexagon connection implants are provided with a body diameter of 4.7 mm and platform diameters of 3.5 mm and 4.5 mm. The tapered internal hexagon connection implants are provided with a body diameter of 4.3 mm and a narrow platform (NP) connection, and with a body diameter of 5.0 mm with a regular platform (RP) connection. All implants are provided in multiple overall threaded lengths ranging from 35 mm to 55 mm. This submission includes mating abutments with platform diameters of 3.5, 4.3, and 4.5 mm. and each abutment diameter is provided with 17° and 30° of angulation. All subject device abutments are for support of screw-retained overdenture prosthetic restorations. The abutment screws compatible with the subject device abutments were cleared in K060957 and K102034. The subject device zygomatic implants are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The previously cleared abutment screws also are made of material conforming to ASTM F136.
This is a 510(k) premarket notification for a dental implant system, which primarily relies on demonstrating substantial equivalence to already legally marketed predicate devices rather than proving a device meets specific performance acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable in this context.
The document mainly focuses on comparing the new device's characteristics to those of predicate devices and showing that any differences do not raise new questions of safety or effectiveness.
Here's a breakdown of the information that is available or applicable from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a substantial equivalence submission, formal "acceptance criteria" in the sense of predefined thresholds for clinical performance against a disease are not provided. Instead, the device demonstrates performance through engineering analysis, dimensional analysis, and dynamic compression-bending testing to show it is comparable to predicate devices.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Referenced from predicate devices K102034 and K060957, implying the new device materials are biocompatible. |
| Dimensional Analysis | Compared to predicate devices. The subject device implants are in the same overall length range as the primary predicate K141777 (35 mm to 52.5 mm), and the 55 mm length is supported by reference predicate K093562. Smaller body diameter (4.3 mm) is supported by reference predicate K093562 (4.05 mm) and dynamic compression-bending testing. Abutment platform diameters (3.5, 4.3, 4.5 mm) and angulations (17°, 30°) are presented. |
| Dynamic Compression-Bending Testing (Fatigue Performance) | According to ISO 14801 (Dentistry - Implants - Dynamic fatigue test for endosseous dental implants). Demonstrated fatigue performance substantially equivalent to that of the primary predicate K141777, especially for worst-case constructs (smallest diameter implant - Taper Hex 4.3 mm body diameter - and largest angulation - 30°). This implies meeting or exceeding the predicate's fatigue resistance as tested per the standard. |
| Material Composition | Ti-6Al-4V conforming to ASTM F136, same as previously cleared components in K102034 and K060957. |
| Surface Finish | Grit blasted and acid etched for endosseous surface, same as predicate implants in K102034 and K060957. |
| Sterilization & Packaging | Similar materials and processes as described in K102034 and K060957 (implants sterilized, abutments provided non-sterile for sterilization by user). |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated in terms of a "number of cases" or "number of patients" as this was a non-clinical submission. For the dynamic compression-bending testing per ISO 14801, the standard typically specifies the number of samples required for fatigue testing, but the exact number used in this specific test is not provided in the summary.
- Data Provenance: Non-clinical (lab-based engineering and material testing). Not applicable in terms of country of origin or retrospective/prospective for clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth in a clinical sense (e.g., disease presence/absence determined by expert radiologists) is not relevant for this type of non-clinical device submission.
4. Adjudication method for the test set:
Not applicable. No expert adjudication process as this was a non-clinical submission.
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 device is a physical dental implant system, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance metrics are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used:
- For Biocompatibility: Material specifications (ASTM F136) and prior clearance of similar materials in predicate devices (K102034 and K060957).
- For Dimensional Analysis: Engineering drawings and measurements, compared against predicate device specifications.
- For Dynamic Compression-Bending Testing: The performance requirements of the ISO 14801 standard and the comparative performance of the primary predicate device (K141777).
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. No training set was used.
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