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The ITI synOcta angled abutments for Wide Neck Implants are indicated for use in cases where the placement of an implant requires an angled reconstruction for an optimal result. The abutment can be used to restore crowns for single tooth replacements and bridges for multiple tooth restorations.

The ITI Dental Implant System is an integrated system of endosseous dental implants which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments, and surgical and prosthetic parts and instruments. The devices covered by this submission are angled abutments which are placed into the dental implant to provide support for a prosthetic reconstruction. The angled abutment is used for angulation correction in cases where the position of the dental implant requires an angled reconstruction for an optimal restoration.

The 15° synOcta angled abutment for the Wide Neck Implant is made from commercially pure Grade 4 titanium (F67). The basal portion of the abutment has an 8° conical taper with an inset octagonal design. The abutment is seated in the implant with a screw, which is mounted in the basal portion of the abutment. The abutment is used for cemented restorations.

This document is a 510(k) premarket notification for a medical device and does not contain information about acceptance criteria or a study proving the device meets them. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information, which typically comes from performance studies.

Here's why the document doesn't contain the requested information:

• Substantial Equivalence: The primary purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This is often done by comparing design, material, intended use, and performance characteristics, rather than conducting new clinical trials or extensive performance studies with predefined acceptance criteria.
• Focus on Design and Material: The document explicitly states that "The ITI synOcta angled abutments for the Wide Neck Implant are substantially equivalent in intended use, material, and design to the ITI synOcta angled abutments cleared under K994119." This indicates that the equivalence is based on these aspects, not necessarily on new performance data against specific acceptance criteria.
• No Performance Study Description: There is no section describing a study conducted to test the device's performance against specific metrics. The document details the device's description and intended use but not any testing methodology, results, or acceptance thresholds.

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The synOcta® angled abutments are indicated for use in cases where the placement of the implant requires an angled reconstruction for an aesthetic result. The abutment can be used to restore crowns for single tooth replacements and bridges for bound situations.

The angled abutment is not to be used in conjunction with the ITI 15° angled implant as the total degree of angulation is 30 degrees or above.

The subject device of this 510(k) is the ITI® synOcta® Angled Abutment which is placed into the dental implant to provide support for a prosthetic reconstruction. The angled abutment is used for angulation correction in cases where the angle of placement of the dental implant requires an angled reconstruction for an aesthetic result.

The synOcta® abutment is available in 15° and 20° angles and is made from commercially pure Grade 4 titanium (cold worked) which conforms to ASTM Standard Specification F67. The abutment is provided non-sterile in medical grade heat-sealed packaging.

The basal portion of the modified angled abutment has an 8° conical taper which fits into the coronal portion of the ITI implants. The abutment is held in place with a screw located in the basal portion of the abutment. This screw is composed of titanium alloy. The abutment is manufactured out of a single piece of titanium. The screw and suspension ring are mounted into the basal portion of the abutment. The coronal aspect of the abutment has an occlusal thread for the impression coping and a lateral screwdriver access hole.

The provided text is a 510(k) summary for the synOcta® Angled Abutment, which is a dental implant accessory. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a study. Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, and multi-reader comparative effectiveness studies is not present in this type of regulatory submission.

However, I can extract information related to the device description and the basis for its substantial equivalence.

Here's a breakdown of what can be inferred or explicitly stated from the provided document, and what is absent:

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

This information is not provided in the 510(k) summary. A 510(k) primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, not on presenting novel performance data against pre-defined acceptance criteria for a new clinical study. The device's performance is implicitly considered equivalent to the predicate devices.

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

Not applicable/Not provided. No specific "test set" for a performance study is mentioned. The submission relies on a comparison to predicate devices already on the market.

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

Not applicable/Not provided. This document does not describe a study involving expert-established ground truth for a test set.

4. Adjudication method for the test set

Not applicable/Not provided. No adjudication method is mentioned as there is no test set described for performance evaluation.

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/Not provided. This is a dental implant abutment, not an AI-powered diagnostic device. Therefore, no MRMC study or AI assistance is relevant here.

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

Not applicable/Not provided. This is a physical medical device, not an algorithm.

7. The type of ground truth used

Not applicable/Not provided. No ground truth for a performance study is mentioned. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable/Not provided. This is not an AI/ML device; therefore, there is no "training set."

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

Not applicable/Not provided. As there is no training set, this question is irrelevant.

Summary of Device and Equivalence Argument (derived from the provided text):

• Device Name: synOcta® Angled Abutment
• Intended Use: "The synOcta® angled abutment is indicated to be used in cases where the angle of placement of the implant requires an angled reconstruction for an aesthetic result. The abutment can be used to restore both crowns for single tooth replacements and bridges for bound situations."
• Description: Available in 15° and 20° angles, made from commercially pure Grade 4 titanium. It has an 8° conical taper, a titanium alloy screw, and features for impression coping and screwdriver access.
• Predicate Devices:
  • ITI® synOcta® Abutment (K990342)
  • ITI® Angled Abutment (K962647)
  • Calcitek Angled Abutment (K number unknown)
  • Nobel Biocare Angled Abutment (K905434)
  • Implant Innovations Angled Abutment (K number unknown)
• Basis for Substantial Equivalence: The ITI® synOcta® angled abutment is claimed to be "substantially equivalent in intended use, material and design" to the listed predicate devices. The FDA concurred with this finding, allowing the device to be marketed.

Note: The provided document is a 510(k) summary, which is a premarket notification for demonstrating substantial equivalence. It does not typically contain detailed clinical study data with acceptance criteria as would be found in a Premarket Approval (PMA) application or a clinical trial report for an AI/ML device.

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