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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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The Osteon Precision Milled Suprastructure is indicated for attachments in the treatment of partially orfully edentulous for the purpose of restoring chewing function. The Osteon Precision Milled Suprastructures are intended for attachment to a minimum of two (2) abutments.

The Osteon Milled Suprastructure is indicated for compatibility with the following abutment systems:

• · Nobel Biocare Multi Unit Abutment Plus, 4.8mm, max 30°
• · Nobel Biocare Xeal Abutments, 4.8mm, max 30°
• · Nobel Biocare Multi Unit Abutment, 4.8mm, max 30°
• MIS Multi-unit Abutments, 4.8mm
  • · C1 Conical Connection Implant System, max 30°
  • · V3 Conical Connection Implant System, max 30°
  • · Internal Hex Implant System, max 30°
  • · Conical Connection, max 30°
• Southern Compact Conical Abutments, 4.8mm
  • · MAX Implant System, 0°
  • · Provata Implant System, max 30°
  • · Deep Conical (DC) Implants, 0°
  • · Piccolo Implants, 0°
  • · External Hex Implants, max 30°
• · Astra Tech Implant System® Multi Base Abutment EV, 4.8mm, max 30°
• Keystone Multi Unit Abutment, 4.8mm, 0°
• · Neodent GM Mini Conical Abutment, 4.8mm, max 30°
• · Implant Direct GPS® Angled Abutment, 5.0mm, max 30°
• · Dentium SuperLine® Abutments, 4.5-5.5mm, max 30°
• · Zimmer Angled Tapered Abutments, 4.5mm, max 30°
• · Paltop Multi Unit Abutment, 5.0mm, max 17°

The Osteon Precision Milled Suprastructures (also referred as superstructures) are metallic dental restorative device that is intended for attaching by screw retention to dental abutments to aid in the treatment of partial and totally edentulous patients for the purpose of restoring their chewing function. These suprastructures attach to previously-cleared original equipment manufacturers (OEM) dental abutments using the (OEM) prosthetic screws. The abutmentborne subject devices are indicated for placement only on OEM implant/abutment constructs placed according to the labeling of the previously-cleared systems, and not to exceed the maximum angulation allowed for each OEM implant/abutment construct as identified in the Indications for Use Statement of the subject system.

The Osteon Precision Milled Suprastructure is designed for an individual patient from scans of the patient's impression. The suprastructure is manufactured in biocompatible Titanium alloy with the aid of Computer Aided Design (CAD) and Computer Aided Manufacturing (CAM) technology. All CAD/CAM fabrication is performed by Osteon Medical, within our premises.

Osteon Precision Milled Suprastructures facilitate the attachment of both removable and fixed dental prosthesis and hence categorized as type A and type B.

This document is a 510(k) summary for a dental device, the Osteon Precision Milled Suprastructure. It outlines the regulatory process and demonstrates substantial equivalence to predicate devices, rather than presenting a study that proves the device meets specific performance acceptance criteria. Therefore, most of the requested information about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not available in this document.

Here's why and what information can be extracted:

• This is a 510(k) submission: The primary goal of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove its performance against a set of novel acceptance criteria through a clinical trial.
• Focus on Substantial Equivalence: The document compares features like indications for use, materials, design, and manufacturing processes to existing devices.
• Non-Clinical Testing Mentioned: The document refers to non-clinical tests performed, but these are primarily for demonstrating compatibility, material safety, and sterility, not performance against specific clinical efficacy or accuracy metrics.

Information that can be extracted or inferred:

1. A table of acceptance criteria and the reported device performance:

This document does not present explicit "acceptance criteria" in the traditional sense of performance metrics for an AI/algorithm-driven device. Instead, it demonstrates similarity to predicate devices based on design specifications and material properties. The "performance" is implicitly deemed acceptable if it's shown to be substantially equivalent to the established predicate devices.

(Note: "Similar" indicates that the values or characteristics fall within or are comparable to those of the predicate/reference devices, with stated differences not impacting safety/efficacy from the manufacturer's perspective.)

2. Sample sizes used for the test set and the data provenance:

• Test Set Sample Size: Not applicable. This submission relies on "non-clinical tests" (dimensional analysis, biocompatibility, sterilization validation) and comparison to existing predicate marketing clearances. It does not describe a "test set" in the context of an AI/ML algorithm evaluation with human interpretation or image analysis. The "test" consists of demonstrating manufacturing conformance and material properties for the physical device.
• Data Provenance: The device is manufactured by Implant Solutions PTY LTD (trading as Osteon Medical) in Mulgrave, Victoria, 3170 Australia. The non-clinical tests (e.g., biocompatibility and sterilization validation) would have been performed there or at certified labs. These are bench tests, not clinical data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. There's no "ground truth" to establish in the context of an AI/ML algorithm or diagnostic accuracy study. The assessment is based on physical device characteristics and established standards.

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

• Not applicable. This is not a study requiring adjudication of expert interpretations.

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 physical dental device (suprastructure), not an AI algorithm.

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

• Not applicable. This is a physical dental device (suprastructure), not an AI algorithm.

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

• Not applicable. The "ground truth" for this medical device submission is compliance with engineering specifications, material standards (e.g., ASTM F136), and validated manufacturing processes, all demonstrated through non-clinical bench testing.

8. The sample size for the training set:

• Not applicable. This is a physical dental device. While it is manufactured using CAD/CAM technology, it does not involve an AI/ML model that requires a training set of data.

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

• Not applicable. See point 8.

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