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Dental implants OKTAGON® are surgically placed in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. The implants are intended to be used with OKTAGON® abutments and prosthetic parts. The implants are intended for delayed loading in a two-stage surgery or for immediate loading when good primary stability is achieved and with appropriate occlusal load.

The proposed implants represent a line extension of dental implants OKTAGON®, which have been previously cleared in the submissions K170287, K162073 and K143539. The proposed implants have a root-form design and are made of Titanium Grade 4 conforming to ASTM F67-13. The surface is microstructured in the endosteal section by blasting with high-grade corundum and acid-etching. Tissue Level Conical Implants have a conical shape, and the endosteal body of Bone Level Tapered Design Implants is cylindrical in the coronal region and conical in the apical region. The prosthetic connection is achieved with the help of an inner cone with an additional octagonal antirotation device. A sterile cover screw is enclosed with the implant so that an immediate occlusion of the internal thread is possible after successful insertion. OKTAGON® Implant System includes four variations of the prosthetic connection: Tissue Level Implants: Regular Platform (RP) and Wide Platform (WP) Bone Level Implants: Regular Connect (RC) and Narrow Connect (NC). The proposed Tissue Level Conical Implants will increase the range of lengths available for this implant variation. The proposed Bone Level Tapered Design implants will be offered in the same range of lengths as the predicate devices, but with an increased diameter. The proposed healing abutments increase the range of diameters available for Bone Level Narrow Connect implants. They are manufactured from Titanium Grade 4, and are intended to close the implant and shape the surrounding soft tissue during the healing phase. No occlusal loading is intended.

The provided text is a 510(k) premarket notification for the OKTAGON® Implant System, which is a dental implant device. As such, it does not contain information about the acceptance criteria or a study proving the device meets those criteria in the way a clinical study or AI algorithm validation would.

Instead, this document focuses on demonstrating substantial equivalence to previously cleared predicate devices. Substantial equivalence means the new device is as safe and effective as a legally marketed device that is not subject to premarket approval.

Therefore, I cannot fulfill your request to provide a table of acceptance criteria and reported device performance directly from this document, nor can I provide details about sample sizes for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, types of ground truth, or training set information. These concepts are typically associated with the rigorous validation of new technologies, particularly in the context of AI or novel medical devices requiring de novo clearance or PMA.

What the document does provide regarding "performance" and "acceptance criteria" (within the context of a 510(k) for dental implants):

The "performance testing" section (page 5) and the comparison table (pages 6-7) confirm that the device meets relevant standards and is comparable to previously cleared devices. The "acceptance criteria" here are implicitly tied to meeting these standards and demonstrating equivalence.

Here's a summary of the performance testing relevant to this 510(k) submission:

1. Acceptance Criteria and Reported Device Performance (as demonstrated by equivalence to predicate devices and adherence to standards):

• Performance: Referenced from predicate K143539, with a revalidation report in Section 14 of this submission. Proposed abutments determined not to present a new sterilization challenge; thus, no additional testing required. |
  | Sterile Barrier System: Packaging must maintain sterility. | - Validation Standard: ISO 11607.
• Performance: Referenced from predicate K143539. Packaging of subject device is the same as the reference device; thus, no additional testing required. |
  | Biocompatibility: Materials must be safe for patient contact. | - Assessment Standard: ISO 10993-1 (biological evaluation), ISO 10993-5 (cytotoxicity testing).
• Performance: Referenced from predicate K143539. Subject device uses the same materials and manufacturing methods, intended use, sterilization methods, and tissue contact as the reference device; thus, no additional testing required. |
  | Fatigue Strength: Device must withstand mechanical forces without failure. | - Testing Standard: ISO 14801 and FDA Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.
• Performance: Referenced from predicates K143539, K162073, and K170287. Based on the same design and comparative surface area analysis, the proposed implants were determined not to represent a new worst case; thus, no additional testing required. |
  | Material Composition: Device materials must conform to established standards. | - Material Standard: Titanium Grade 4 conforming to ASTM F67-13.
• Performance: The proposed implants are made of Titanium Grade 4 conforming to ASTM F67-13, identical to predicate devices. |
  | Design/Technological Characteristics: Device design must be equivalent to predicates. | - Performance: The proposed implants are described as a line extension of previously cleared OKTAGON® implants (K170287, K162073, K143539). They share root-form design, microstructured and acid-etched titanium surface, inner cone with octagonal anti-rotation device, and comparable dimensions (increased length for some Tissue Level, increased diameter for some Bone Level Tapered). Healing abutments offer increased diameter options but maintain the same base material and purpose. The manufacturer asserts the subject device and predicate devices have "identical intended use and technological characteristics, and are made of identical materials." The changes (expanded length/diameter options) are considered within the scope of previously cleared designs, not introducing new safety or performance issues. |

Regarding the other points you've asked for, based on the provided text:

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

   • No specific sample size for a "test set" (in the context of new device validation studies like clinical trials) is mentioned. The device relies on demonstrating equivalence through non-clinical testing (material, sterilization, fatigue) and comparison to predicate devices, rather than a new clinical test set.
   • Data Provenance: The referenced standards (ISO, ASTM, FDA guidance) are international and US-based. The previous predicate devices were submitted by Hager & Meisinger GmbH (Germany).

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. This document describes a 510(k) submission, which relies on engineering and material standards, and comparison to predicate devices, not on expert-established ground truth for a clinical test set in the way an AI algorithm might be validated.

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

   • Not applicable. This relates to clinical trial or AI validation protocols, which are not detailed in this 510(k) 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. MRMC studies are typically for evaluating the impact of an AI system on human diagnosticians. This device is a dental implant, not an AI diagnostic tool.

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

   • Not applicable. This device is a physical dental implant, not an algorithm.

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

   • The "ground truth" for this 510(k) approval is essentially:
     • Compliance with recognized international and national standards (e.g., ISO, ASTM).
     • Demonstration of identical technological characteristics and materials to previously cleared predicate devices.
     • Demonstration that the device does not raise new performance or safety issues.
     • This is established through documented non-clinical testing (as mentioned in point 1) and comparisons of specifications.

8. The sample size for the training set:

   • Not applicable. This device is not an AI algorithm that requires a training set.

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

   • Not applicable. As above, this is a physical medical device, not an AI algorithm.

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