Search Results

Blue Sky Bio CAD-CAM Abutments are intended to be used in conjunction with Blue Sky Bio endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations. All digitally designed abutments for use with Blue Sky Bio CAD-CAM Abutments are intended to be sent to a Blue Sky Bio validated milling center for manufacture.

The purpose of this submission is to obtain marketing clearance for Blue Sky Bio CAD-CAM Abutments, to be used with compatible components from the Blue Sky Bio Dental Implant System cleared in K051507. K060957, and K102034. The subject device includes Titanium Base Abutments, Cobalt Base Abutments, and Titanium Blank Abutments. For the Titanium Base Abutments and the Cobalt Base Abutments, the final finished device is intended to be used as a two-piece abutment composed of the base bottom-half (titanium base or cobalt base) bonded to a CAD-CAM zirconia top-half. Each abutment type provided in six (6) internal implant connections to the previously-cleared compatible Blue Sky Bio implants (BIO | MAX; BIO | Internal Hex; BIO | Conus 12; BIO | One Stage; and BIO | Trilobe). Titanium Base Abutments are designed for retention of a CAD-CAM fabricated zirconia superstructure and are provided in both straight and 15° angled base designs, and with engaging, non-engaging, and nonengaging conical implant connections. Cobalt Base Abutments are provided in both straight and 15° angled base designs, and with engaging and non-engaging implant connections. Cobalt Base Abutments (Straight) are designed to be a base for a final abutment fabricated by either of two methods. The first method is the same as for the Titanium Base Abutments: a CAD-CAM fabricated zirconia superstructure is bonded to the Cobalt Base Abutment (Straight) and the final two-piece abutment is used for the prosthetic restoration. For the second method, the Cobalt Base Abutments (Straight) can be cast to a straight abutment only, no angulation. The design of the final abutment can be by CAD-CAM, fabricated in wax, and fixed to the Cobalt Base Abutment, or the final design be done using traditional wax-up technique. The final one-piece abutment is fabricated using standard lost wax casting techniques. Cobalt Base Abutments (Angled 15°) are designed to be a base for a CAD-CAM fabricated zirconia superstructure bonded to the Cobalt Base Abutment (Angled 15°) and the final two-piece abutment is used for the prosthetic restoration. Cobalt Base Abutments (Angled 15°) are not to be cast to a final abutment. Titanium Blank Abutments are designed for fabrication of a customized all titanium alloy abutment by CAD-CAM processes. Titanium Blank Abutments have an engaging implant connection. The subject device abutments are made of titanium alloy conforming to ASTM F136 , or cobaltchromium alloy conforming to ASTM F1537. The titanium alloy subject device components are manufactured from identical materials, in the identical facilities using the identical manufacturing processes as used for Blue Sky Bio products cleared previously in K051507, K060957, and K102034. All zirconia superstructures (copings) for use with the subject devices Titanium Base Abutments and Cobalt Base Abutments will be made at a Blue Sky Bio validated milling center under FDA quality system regulations, and the material will conform to ISO 13356. All wax designs for casting to the subject device Cobalt Base Abutments also will be made at a Blue Sky Bio validated milling center. For the lost wax technique, final one piece abutment may be cast in cobalt-chromium alloy or nickel-chromium alloy.

The provided text is a 510(k) Summary for Blue Sky Bio CAD-CAM Abutments, which is a dental device. It focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than providing detailed acceptance criteria and study results for a novel AI/ML device.

Therefore, the document does not contain the information requested in points 1-9 regarding acceptance criteria and a study proving a device meets these criteria for an AI/ML product.

The text describes:

• Device: Blue Sky Bio CAD-CAM Abutments (dental implant components).
• Indications for Use: To be used with Blue Sky Bio endosseous dental implants to support single-unit or multi-unit prosthetic restorations. Digitally designed abutments are sent to a Blue Sky Bio validated milling center for manufacture.
• Performance Data (Non-clinical): Mentions sterilization validation (ISO 17665-1, ISO 17665-2), biocompatibility testing (ISO 10993-5, ISO 10993-12), and static and dynamic compression-bending testing (ISO 14801).
• Clinical Data: Explicitly states "No clinical data were included in this submission."
• Substantial Equivalence: Compares the subject device to various predicate and reference devices in terms of indications for use, design principles, materials, physical dimensions, packaging, and sterilization methods. The mechanical testing (ISO 14801) is mentioned as mitigating minor design differences.

Without information specific to an AI/ML device, I cannot fulfill the request to describe acceptance criteria and a study proving an AI/ML device meets them, nor can I populate the table or provide details on sample size, data provenance, expert involvement, adjudication, MRMC studies, standalone performance, ground truth, or training set details.

Ask a specific question about this device

Implant:
The ELEMENT PF 3.0 is suitable for use in one-stage or two-stage surgical techniques for restoring chewing function. The ELEMENT PF 3.0 is suitable for immediate implantation in case of replacement of several teeth; prerequisites are good primary stability and appropriate occlusal loading. The ELEMENT PF 3.0 must only be used for replacement of the lateral incisors of the upper jaw and lateral incisors of the lower jaw.

VARIOunite PF 3.0:
Thommen Medical VARIOunite abutments PF 3.0 are only used in conjunction with the ELEMENT PF 3.0 and are for fabrication of provisional and final crowns in the anterior maxilla and mandible (upper lateral incisors, lower anterior teeth).
Digitally designed abutments for use with Thommen VARIOunite are intended to be sent to a Thommen validated milling center for manufacture.

VARIOunite:
Thommen Medical VARIOunite abutments are intended to be used in conjunction with Thommen System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges and overdentures.
Digitally designed abutments for use with Thommen VARIOunite are intended to be sent to a Thommen validated milling center for manufacture.

ELEMENT Ø 3.0 is a self-tapping, root form, endosseous dental implant made of commercially pure titanium. It is provided in two surfaces (TST and INICELL) and five lengths (8.0, 9.5, 11.0, 12.5, and 14 mm). Subject device components available for the ELEMENT Ø 3.0 implant are the healing cap, gingiva former and VARIOunite abutments. VARIOunite abutments can be used for temporary restorations, permanent restorations, or CAD/CAM zirconia superstructures. The indications for previously cleared VARIQunite abutments have been expanded to include angulation of the CAD/CAM zirconia superstructures.

This document describes a 510(k) premarket notification for the Thommen Implant System, specifically focusing on the ELEMENT PF 3.0 dental implant and VARIOunite abutments.

Here's an analysis of the acceptance criteria and the study used to demonstrate equivalence, based on the provided text:

No specific acceptance criteria in terms of performance metrics (e.g., success rates, survival rates, specific mechanical thresholds for clinical outcomes) are explicitly stated in this document for the device. The submission focuses on demonstrating substantial equivalence to predicate devices. This means the device is considered safe and effective because it is as safe and effective as a legally marketed device (predicate device).

The "study" or rather, the evidence provided, primarily consists of non-clinical testing data and comparisons to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

As stated above, no explicit quantitative acceptance criteria or corresponding clinical performance metrics are provided in the document. The general "acceptance criteria" for a 510(k) submission are that the new device is "substantially equivalent" to predicate devices in terms of intended use, technological characteristics, and materials, and that any differences do not raise new questions of safety or effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not applicable in the context of clinical trials. For non-clinical testing (mechanical, sterilization, etc.), specific sample sizes are not detailed in this summary. These tests typically involve a pre-defined number of units/samples for each test type according to the relevant standard.
• Data Provenance: The data is non-clinical, originating from laboratory testing conducted to international (ISO, ASTM) and FDA guidance standards. The manufacturer is Thommen Medical AG, Switzerland. The data is not derived from human subjects or patient populations.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

• This is not applicable as the submission did not include clinical data or studies requiring expert review of patient cases to establish ground truth.

4. Adjudication Method for the Test Set

• This is not applicable as the submission did not include clinical data requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No clinical data were included in this submission." This type of study is typically used for diagnostic or imaging devices, not for dental implants which rely on mechanical and biological performance demonstrated through non-clinical testing and clinical experience with similar devices.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

• This is not applicable. The device is a physical dental implant system, not a software algorithm.

7. The Type of Ground Truth Used

• For the non-clinical tests, the "ground truth" is defined by the specifications and acceptable limits set by recognized international standards (ISO, ASTM) and FDA guidance documents for each specific test (e.g., sterilization effectiveness, material strength, biocompatibility, packaging integrity).

8. The Sample Size for the Training Set

• This is not applicable. There is no software algorithm or AI model being trained for this device.

9. How the Ground Truth for the Training Set Was Established

• This is not applicable as there is no software algorithm or AI model being trained for this device.

Ask a specific question about this device

The CreoDent Solidex® Customized Abutment and Screw is intended for use with an endosseous implant to support a prosthetic device in patents who are partially or completely edentulous. The device can be used for single or multiple restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant.

The Solidex® Customized Abutment and Screw is Ti-6A1-4V Eli titanium alloy meets ASTM F-136 standard and is designed to be screw retained for use with endosseous dental implants to provide support for a prosthetic restoration. These abutments are indicated for cement or screw retained restorations. The design of subject device is customized to the requirements of each patient as may be specified by the prescribing dentist. Customization is limited by the minimum dimensions for wall thickness, diameter, post height, collar height and angulation.

The CreoDent Solidex® Customized Abutment is a dental device intended to support prosthetic devices with endosseous implants in partially or completely edentulous patients. The study aimed to demonstrate substantial equivalence to previously cleared predicate devices through non-clinical testing.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The information provided does not explicitly state numerical "acceptance criteria" for performance metrics in a pass/fail format typical of many medical device studies. Instead, substantial equivalence is established by demonstrating that the device has the same intended use, fundamental scientific technology, and comparable technological characteristics and performance to predicate devices, with any differences being "mitigated" or demonstrated to be safe and effective.

The provided document details comparisons between the CreoDent Solidex® Customized Abutment and several predicate devices across various technological characteristics. The "reported device performance" is primarily qualitative, asserting mechanical strength and compatibility, and is supported by specific non-clinical tests.

2. Sample Size Used for the Test Set and Data Provenance

The provided document describes non-clinical testing rather than a clinical study with a "test set" of patient data.

• Sample Size for Non-clinical Testing: The document does not specify the exact number of physical samples (e.g., abutments, screws, implants) used for static/fatigue testing or reverse engineering dimensional analysis. It refers to "worst-case scenario" testing for the abutment connection platform.
• Data Provenance: The data is from non-clinical bench testing rather than human patient data. Therefore, there is no country of origin or retrospective/prospective classification in the typical sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This device's clearance is based on non-clinical testing and demonstration of substantial equivalence, not a clinical study requiring expert-established ground truth from patient data. The "ground truth" here is the adherence to mechanical performance standards and dimensional compatibility, verified by engineering and material science evaluations.

4. Adjudication Method for the Test Set

Not applicable, as there is no test set in the context of clinical images or data requiring adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or AI-assisted interpretation, which is not the nature of this dental abutment device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical dental device (abutment) and not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by:

• Mechanical Standards: Adherence to established international standards for dental implants and abutments (e.g., ISO 14801:2007E for dynamic fatigue).
• Material Specifications: Compliance with material standards (ASTM F-136 for Ti-6Al-4V Eli titanium alloy).
• Dimensional Compatibility: Verification through reverse engineering dimensional analysis against original equipment manufacturer (OEM) compatible implant bodies, abutments, and fixation screws.
• Sterilization Standards: Compliance with ISO 17665-1.

8. The Sample Size for the Training Set

Not applicable. This is a physical dental device; there is no "training set" in the machine learning sense. The design and manufacturing processes are likely informed by extensive engineering knowledge and design principles accumulated over time for similar devices.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI/algorithm. For a physical device, the "ground truth" for design and manufacturing is established through engineering principles, material science, and adherence to accepted industry standards and regulatory requirements.

Ask a specific question about this device