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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.

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