Search Results

Inclusive® Titanium Abutments are premanufactured prosthetic components connected to endosseous dental implants in edentulous or partially edentulous maxilla or mandible to provide support for cement-retained prosthetic restorations. All digitally designed abutments for use with Inclusive® Titanium Abutments for CAD/CAM are intended to be sent to a Prismatik Dentalcraft validated milling center for manufacture.

Compatible Implant System: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic®

Inclusive® Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. Inclusive® Titanium Abutments are designed and fabricated to be compatible with Neoss® ProActive® Narrow Implant System, Neoss® ProActive® Standard Implant System, MIS® SEVEN® Implant System, and Zimmer® Eztetic® Implant System. The products are made from titanium alloy Ti-6A1-4V ELI, which meets ASTM standard F136. They include Inclusive® Titanium Abutment Blanks intended to be used to fabricate one-piece, all-titanium, patient-specific abutments using CAD/CAM technology and Inclusive® Titanium Abutments 4.5mmH intended to be used for support of fabricated crowns/bridges or a zirconia coping to complete the two-piece abutment. Inclusive® Titanium Abutments are a two-piece abutment with a titanium base and a ceramic top-half which when cemented together (Shofu MonoCem K020481) constitutes the final finished abutment. Each patient-specific abutment is prescribed by a clinician and manufactured by an authorized milling center validated by Prismatik Dentalcraft Inc. Inclusive® Titanium Abutments are provided non-sterile and intended for single use and prescription use.

Inclusive® Multi-Unit Coping is manufactured from titanium alloy, Ti-6A1-4V ELI conforming to ASTM F136 and used in conjunction with the Neoss® ProActive® Standard and MIS® SEVEN® multi-unit abutment. Inclusive® Multi-Unit Coping is bonded with the dental restoration prior to being seated on the multi-unit abutment via a multi-unit prosthetic screw. The non-engaging configuration of the multi-unit coping does not have an internal connection feature and seats onto the flat mating surface of the multi-unit abutment. The multi-unit coping is used in combination with screw-retained multi-unit dental prosthetics, e.g. bridges and bars, which are used to reconstruct the function and aesthetics of lost teeth. The multi-unit coping is straight with no angle correction and provided non-sterile. The device is intended for singe use and prescription use.

This document is a 510(k) premarket notification for Inclusive® Titanium Abutments. It describes the device, its intended use, and provides a comparison to a predicate device to demonstrate substantial equivalence, rather than standalone performance criteria. Therefore, the information typically requested in your prompt regarding acceptance criteria and a study proving device meeting those criteria (especially for AI/software devices) is not directly applicable to this submission.

This is a submission for a physical medical device (dental abutments), and the "acceptance criteria" here refer to demonstrating substantial equivalence to a legally marketed predicate device, rather than the performance metrics of a diagnostic or AI algorithm.

However, I can extract the relevant information regarding the performance data and the aspects that were tested to demonstrate substantial equivalence, which serves a similar purpose in this context:

Summary of Performance Data (to demonstrate Substantial Equivalence):

Additional Information based on the provided text:

1. Sample size used for the test set and the data provenance:

   • Biocompatibility: The text does not specify a separate "test set" sample size for dedicated biocompatibility testing on this specific device, as it leverages existing data. It states, "additional biocompatibility testing was not conducted" due to identical materials, manufacturing, and facility as the predicate (K191222) and reference device (K160979). Cytotoxicity testing (ISO 10993-5) was referenced from K160979.
   • Mechanical Properties: The document states that static load and fatigue testing was performed "with the worst-case scenario." It does not specify the number of samples tested for this specific submission, but it would have been a sufficient number to meet the requirements of ISO 14801:2016. Data provenance is implied to be internal testing by Prismatik Dentalcraft, Inc.
   • Sterilization: No sample size is specified, as "additional sterilization was not conducted" for this submission due to identical materials, manufacturing, and parameters as predicate and reference devices. Validation was referenced from K083192 and K160979.
   • Packaging: "A packaging validation according to ASTM D4169-16 was conducted" but no specific sample size is mentioned.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a physical device submission relying on established engineering standards and material properties, not an AI or diagnostic device that requires expert-established ground truth for its performance assessment.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a physical device submission for dental abutments.

4. 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 pertains to AI/software performance, not a physical dental implant component.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This pertains to AI/software performance.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • "Ground truth" in this context is based on established engineering standards (e.g., ISO 14801:2016 for dynamic loading, ISO 10993-1 for biocompatibility, ISO 17665-1/2 for sterilization, ASTM D4169-16 for packaging), material specifications (e.g., ASTM F136 for Ti-6Al-4V ELI), and dimensional analysis / reverse engineering for compatibility with OEM implant systems. Biocompatibility also referenced cytotoxicity testing (ISO 10993-5) from a previous submission.

7. The sample size for the training set: Not applicable. This is not an AI/machine learning device.

8. How the ground truth for the training set was established: Not applicable. This is not an AI/machine learning device.

Ask a specific question about this device

Neoss Individual Prosthetics are designed to be connected to Neoss Implants and intended for use as an aid in prosthetic rehabilitation. All digitally designed CAD/CAM customizations for the Neoss Individual Abutments are only intended to be sent to and manufactured by an FDA registered and Neoss approved milling facility. Digital designs for Individual Bars/Bridges are sent to Neoss.

Neoss Individual Prosthetics are endosseous dental implant abutments used to support single tooth restorations (Abutment) or multi-unit prosthetic restorations (Abutment, Bridge or Bar) on Neoss Implants on implant level or abutment level. Neoss Individual Prosthetics are generally produced with straight screw channels (SSC) to be used with Neo Abutment screws and Neo Screwdrivers. Neoss Individual Prosthetics also features the option to customize the angulation of the screw access channel. Compatible Neoss Implant System includes two implant/prosthetic interfaces, i.e. platforms, SP and NP. Neoss Implant System also includes one abutment/prosthetic interface. This platform is called Access with a platform diameter of 4.0 mm.

Neoss Individual Abutments are patient specific and are manufactured from Abutment Blanks. Blanks are hollow metal cylinders available in either Titanium (grade 4 ASTM F67 or Ti-6A1-4V alloy ASTM F136). The blank has a precision milled prefabricated Neoss® implant connection (NeoLoc®) for the SP and NP platforms. The top part of the blanks can be milled to a patient-specific shape. The design of the patient-specific shape of the abutment is performed by a licensed clinician or dental technician and then verified for compliance with the abutment design limits by Neoss or a Neoss approved milling facility. Following the verification of the design the CAD/CAM processing and production of the individual prosthetics is conducted by Neoss or a Neoss approved milling facility. The finished abutment is attached to a Neoss Implant with a screw and a screwdriver at a set torque that depends on the platform.

Neoss Individual Bridges are patient specific and are manufactured from bulk material in Titanium (Ti-6Al-4V alloy ASTM F136).The posts that attach to Neoss Implants, optionally with intermediate Neoss Access Abutments, have a pre-defined interface, SP, NP or Access, to assure compatibility. The design of the patient-specific shape of the bridges is performed by a licensed clinician or dental technician and then verified for compliance with the bridge design limits by Neoss. Following the approval of the design, CAD/CAM processing and production of the individual prosthetics is conducted by Neoss. The implant interface is manufactured to Neoss specification to facilitate compatibility with Neoss platforms SP, NP or Access. The finished bridge is attached to a Neoss Implant or Neoss Access abutment with a screw and a screwdriver at a set torque that depends on the platform.

Neoss Individual Bars are patient specific and are manufactured from bulk material in Titanium (Ti-6Al-4V alloy ASTM F136). The posts that attach to Neoss Implants, optionally with intermediate Neoss Access Abutments, have a pre-defined interface to assure compatibility. The bars are designed for use with full or partial removable dentures and can be made with pre-defined design features making them compatible with commercially available precision attachments. The design of the patient-specific shape of the bars is performed by a licensed clinician or dental technician and then verified for compliance with the bar design limits by Neoss. Following the approval of the design, CAD/CAM processing and production of the individual prosthetics is conducted by Neoss. The implant interface is manufactured to Neoss specification to facilitate compatibility with Neoss platforms SP, NP or Access. The finished bar is attached to a Neoss Implant or Neoss Access abutment with a screw and a screwdriver at a set torque that depends on the platform.

The provided text describes a 510(k) premarket notification for "Neoss Individual Prosthetics". This document focuses on demonstrating substantial equivalence to already legally marketed predicate devices, rather than presenting a study to prove novel acceptance criteria for a new device type.

Therefore, many of the requested details about acceptance criteria, device performance from a new study, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training data provenance are not applicable to this type of regulatory submission.

The document primarily provides a comparison of characteristics between the subject device and its predicates to argue for substantial equivalence.

Here's an analysis based on the provided text, indicating where information is present and where it is not applicable for this type of submission:

1. Table of acceptance criteria and the reported device performance

This document does not define new "acceptance criteria" for novel performance. Instead, it compares the characteristics of the subject device (Neoss Individual Prosthetics) to several predicate devices. The "performance" is implicitly demonstrated through conformance to established standards and the side-by-side comparison with predicate devices.

Acceptance Criteria (Implied by Predicate Comparison) and Reported Device Performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. This is a 510(k) submission showing substantial equivalence, not a clinical trial or performance study requiring a test set of patient data with a specific sample size. The "testing data" refers to non-clinical performance and material characterization.
• The "Performance Testing" section mentions "engineering analysis and dimensional analysis" and "static and dynamic compression-bending testing according to ISO 14801." These are laboratory-based, non-clinical tests typically performed on a sample of manufactured devices (e.g., a batch or specific configurations), not on a "test set" of patient data. Specific sample sizes for these engineering tests are not provided in this summary.
• Data Provenance: The document does not specify the country of origin for the non-clinical testing data, nor whether it's retrospective or prospective. It's implied to be internal testing by Neoss Ltd, based in the UK.

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)

• Not Applicable. As there is no "test set" for diagnostic performance or interpretation of patient data, there are no experts establishing ground truth in this context. The "ground truth" for the device's technical specifications is based on engineering principles and international standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. No human interpretation of a "test set" is involved in this type of 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 dental prosthetic (abutments, bridges, bars), not an AI diagnostic or assistive tool. Therefore, MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This device is a physical dental prosthetic, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" for this device's performance is adherence to established international standards (ISO 10993-1, ISO 14801, ISO 17665-1) and comparison of technical specifications, materials, and intended use with previously cleared predicate devices. It's essentially engineering specifications and established regulatory benchmarks.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not a machine learning algorithm. There is no "training set" in the context of an AI model.
• However, the design and manufacturing process involves digital CAD/CAM customizations. While not a "training set" in the AI sense, the designs are verified for compliance against design limits by Neoss or an approved milling facility. The accumulated knowledge and design rules used for this verification could be considered analogous to a "training" data in a very broad sense, but it's not a formal dataset for training an AI.

9. How the ground truth for the training set was established

• Not Applicable. As there is no training set for an AI model, this question does not apply.
• For the CAD/CAM design process, the "ground truth" for the designs would be engineering specifications, anatomical considerations, and clinical requirements, validated by qualified personnel within Neoss or approved facilities.

Ask a specific question about this device

Membrane Tacks and Membrane Screws are intended for fastening membranes during bone regenerative treatment. These membrane fastening means are in direct body contact, intended for temporary use only. Membrane fastening means are submerged and clinically implanted more than 30 days with an expected duration of three to nine months or until bone regeneration is complete taking into account which membrane and bone grafting materials are being used.

Membrane Tacks and Membrane Screws are regenerative membrane fastening devices available in 3mm length. The Membrane Tack is used in conjunction with a Tack Positioning Instrument, while the Membrane Screw is applied with the Neoss Implant Inserter. Regenerative membranes are designed to prevent ingrowth of gingival soft tissue into bony defects, in order to facilitate the bone formation during the repair process of the defect. Membrane Tacks and Screws are made of titanium while related instruments are made in stainless steel. The Membrane fastening devices are single-use only while the instruments are for multiple use.

I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves a device meets the acceptance criteria in the context of AI or machine learning models.

The document is a 510(k) premarket notification for "Membrane Screws and Membrane Tacks," which are physical medical devices used in bone regenerative treatment. The content focuses on demonstrating substantial equivalence to predicate devices based on material composition, dimensions, intended use, and general performance characteristics (sterilization, shelf life, biocompatibility, instrument cleaning, and insertion/removal forces).

Therefore, I cannot provide the requested information, which includes details about:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample size and data provenance for test sets.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• MRMC studies and effect sizes.
• Standalone algorithm performance.
• Type of ground truth used (pathology, outcomes data, etc.).
• Training set sample size and ground truth establishment.

The document explicitly states that "Clinical data is not required to establish substantial equivalence in this submission," further indicating a lack of clinical study data relevant to AI/ML performance evaluation.

Ask a specific question about this device