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NobelZygoma 0° implants are endosseous dental implants intended to be surgically placed in the bone of the upper jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function. The NobelZygoma Implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Nobel Biocare's NobelZygoma 0° implants are threaded, root-form titanium dental implants intended to be integrated in the Zygomaticus bone to support prosthetic devices, such as artificial teeth, in order to restore chewing function. The NobelZygoma 0° implants typically pierces the oral mucosa in the premolar region and passes through the sinus along the lateral wall of the maxilla. Depending on the contour of the lateral maxillary wall, the mid-portion of the implant may also pass lateral wall. The NobelZygoma 0° implants are available in lengths between 30 and 50 mm and have a 4.5 mm external hex connection. They are made of commercially pure titanium and have the Nobel Biocare TiUnite surface treatment.

This document is a 510(k) Premarket Notification from the FDA regarding a dental implant, the NobelZygoma 0°. The key finding is that the submission is for a packaging modification of an already cleared device, not a new or modified device itself. Therefore, the questions related to AI/algorithm performance, training/test sets, ground truth establishment, expert consensus, and MRMC studies are not applicable to this document. The provided text does not describe an AI medical device or a study proving its performance against acceptance criteria in the way envisioned by the prompt.

However, I can extract information related to the "acceptance criteria" and "study" for the packaging modification as presented in this 510(k) summary.

Here's the analysis based on the provided text, focusing on the packaging modification:

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

For a packaging modification, the "acceptance criteria" relate to the ability of the new packaging to maintain sterility and device integrity over its shelf life. The "reported device performance" refers to the successful testing against these criteria.

2. Sample sized used for the test set and the data provenance

The document does not specify the exact sample sizes (e.g., number of packages) used for the non-clinical tests (package integrity, accelerated aging). It states that "NobelZygoma 0° implant represents a worst case and data from the predicate device was leveraged to demonstrate substantial equivalence."

• Sample Size: Not explicitly stated (e.g., how many packages were tested for integrity or aging).
• Data Provenance: The tests are non-clinical, likely conducted in a lab setting by the manufacturer (Nobel Biocare AB/USA LLC). The document doesn't specify country of origin for the test data itself, but the applicant is based in Sweden and the US. The "study" is a non-clinical verification/validation testing process, not a clinical study on patients.

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

This question is not applicable. The "ground truth" for packaging validation is established by adherence to recognized international and national standards (ISO 11607-1, ASTM F2096, ISO 11137-1.2, ISO 11737-1.2). There is no "expert blinding and consensus" process for establishing ground truth in this context; it's about meeting pre-defined physical and biological performance standards for packaging.

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical trials, especially for assessing image interpretations or outcomes where subjective judgment plays a role. Packaging performance is evaluated against objective, measurable standards.

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 document does not describe an AI device or a study involving human readers.

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

Not applicable. This document does not describe an AI algorithm or device.

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

For the packaging, the "ground truth" for performance is defined by the requirements of the standards cited:

• ISO 11607-1 (Packaging for terminally sterilized medical devices)
• ASTM F2096 (Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization)
• ANSI/AAMI/ISO 11137-1.2 (Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices)
• ISO 11737-1.2 (Sterilization of Medical Devices - Microbiological Methods - Part 1: Determination of a Population of Microorganisms on Products)
• ASTM F1980 (Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices)

The "ground truth" is therefore adherence to these internationally recognized and standard-based performance metrics for medical device packaging and sterilization.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device.

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NobelZygoma implants are endosseous dental implants intended to be surgically placed in the bone of the upper jaw arch to provide support for prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function. The NobelZygoma Implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Nobel Biocare's NobelZygoma 0° implants are threaded, root-form titanium dental implants intended to be integrated in the Zygomaticus bone to support prosthetic devices, such as artificial teeth, in order to restore chewing function. The NobelZygoma 0° implants typically pierces the oral mucosa in the premolar region and passes through the sinus along the lateral wall of the maxilla. Depending on the contour of the lateral maxillary wall, the mid-portion of the implant may also pass lateral to the lateral wall. The NobelZygoma 0° implants are available in lengths between 30 and 50 mm and have a 4.5 mm external hex connection. They are made of commercially pure titanium and have the Nobel Biocare TiUnite surface treatment.

Nobel Biocare's NobelZygoma 0° abutments are implant abutments intended to be used with the NobelZygoma 0° implant only. The NobelZygoma 0° abutments are used to accommodate the total angle of the implant – abutment joint. This is necessary since the subject implant has a flat platform rather than the 45° platform of the predicate device implants. The NobelZygoma 0° abutments are available in lengths between 6 and 10 mm and with angle of 45° or 60°. They contain the external hex connection and are made of a titanium alloy without any additional coating.

The Temporary Coping Multi-Unit and Temporary Coping Plastic Multi-unit are premanufactured dental abutment directly connected to the Multi-unit abutment. It is used as a temporary aid in prosthetic rehabilitation until the final restoration is attached. Maximum intraoral use is 180-days.

This document does not describe an AI/ML device and therefore does not contain the information requested regarding acceptance criteria and a study proving a device meets them for such a device.

The provided text is a 510(k) premarket notification for a medical device called "NobelZygoma 0°", which is an endosseous dental implant. The notification focuses on establishing substantial equivalence to a predicate device ("NobelZygoma 45°") through non-clinical performance data (bench testing) and material/design comparisons, not on evaluating the performance of an AI/ML algorithm.

Therefore, I cannot provide the requested information, such as:

1. A table of acceptance criteria and reported device performance (for an AI/ML device).
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study results.
6. Standalone (algorithm only) performance.
7. Type of ground truth used (for an AI/ML device).
8. Sample size for the training set.
9. How ground truth for the training set was established.

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