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Prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations.

The subject devices represent a line extension of the Straumann Dental Implant System (SDIS). The subject devices are an assembly of a noble metal alloy (Ceramicor®) Abutment Base and a polymer (POM) Modeling Aid. The Modeling Aid is attached to the abutment base by means of a friction fit. The subject devices employ the same Modeling Aid (catalog no. 049.217) as the identified predicate devices. The subject devices use the same Basal Screw for fixing the finished restoration to the implant (catalog no. 049.128) as the identified predicate devices. The subject devices interface with Straumann Tissue Level (TL) implants having the Regular Neck (RN) or Wide Neck (WN) implant-to-abutment interface. The subject devices do not engage the anti-rotation features within the TL implants. The non-engaging design makes these devices suitable for the fabrication of bar and bridge superstructures by the dental laboratory using either casting or soldering techniques.

This document is a 510(k) Premarket Notification for a dental abutment, specifically the "Straumann® synOcta Gold Abutments for Bridge." The purpose of this notification is to demonstrate that the new device is substantially equivalent to existing predicate devices already on the market, rather than proving a new medical claim or performance characteristic that would require extensive clinical trials. Therefore, the information provided focuses on the device's design, material, and mechanical performance compared to a predicate, not on complex acceptance criteria for a diagnostic algorithm or a clinical outcome.

Here's an analysis of the provided text in the context of the requested information, understanding that this is for a physical medical device (dental abutment) and not an AI/diagnostic tool:

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

The document does not present a formal table of "acceptance criteria" in the way one would for a diagnostic device (e.g., sensitivity, specificity, accuracy thresholds). Instead, it relies on demonstrating substantial equivalence to a predicate device through conformity to existing standards and showing comparable mechanical performance.

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

The document mentions "Dynamic fatigue test data" in support of the submission. However, it does not specify:

• The sample size for these tests.
• The specific data provenance (country of origin, retrospective or prospective).
• Details about a "test set" in the context of diagnostic performance. The testing here is mechanical (fatigue).

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)

This question is not applicable to this submission. The device is a physical dental abutment, and its "performance" is evaluated through mechanical bench testing and material characterization, not by expert interpretation or ground truth establishment in a clinical imaging or diagnostic context.

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

This question is not applicable. There is no "adjudication" in the sense of reconciling expert opinions for a diagnostic outcome. Mechanical tests are typically performed according to standardized protocols.

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

This question is not applicable. MRMC studies are used for diagnostic devices involving human readers and AI. This submission is for a physical dental abutment.

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

This question is not applicable. This is not an algorithm or AI device.

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

For this device, "ground truth" is established through:

• Mechanical standards: Adherence to international standards like ISO 14801 for dynamic fatigue testing.
• Material specifications: Conforming to material standards like ISO 22674 for metallic dental materials.
• Biocompatibility and Sterilization: Relying on the established safety of the materials and manufacturing methods used in the predicate devices.

8. The sample size for the training set

This question is not applicable. There is no "training set" as this is not an AI/machine learning device. The design, materials, and manufacturing processes are developed through engineering and materials science, not by training an algorithm on data.

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

This question is not applicable for the reasons stated above.

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The Klockner Essential implant system is especially designed for surgical insertion into the bone using additional material to replace the root of the teeth, acting as the support for the dental implants formed by implant accessories.

The Essential Solid implants are fitted with an internal octagonal conical connection combined with an external octagonal connection measuring 1.2 mm in height.

The Essential Cone implants are fitted with an internal octagonal conical connection.

The Essential ECK implants are fitted with a larger internal octagonal conical connection than that of the Essential Cone implants.

Immediate loading is appropriate for the Essential Cone and Essential Cone and Essential ECK implants when good primary stability is achieved with appropriate occlusal loading. Abutments can be used in single tooth replacements and multiple tooth restorations.

8mm Implants are not indicated for use as unitary implants and for immediate load.

The Klockner Essential implant system consists of a group of implants, implant accessories and additional material to restore the mastication system. The different EC, ES and ECK models are available in three different diameters: 3.5mm, 4.0mm and the range of lengths varies between 8mm and 16mm. They are internally connected.

This document (K080224) is a 510(k) premarket notification for the Klockner Essential Dental Implants System. It aims to demonstrate substantial equivalence to previously cleared devices. Based on the provided text, the submission focuses on asserting equivalence based on intended use, composition, endosseous surface treatment, and design principles, rather than presenting a study with acceptance criteria and performance data in the way a diagnostic AI device would.

Therefore, a table of acceptance criteria and device performance, as well as details about sample sizes, expert adjudication, MRMC studies, standalone performance, training data, and ground truth for a study proving the device meets acceptance criteria, cannot be extracted from this document. These types of studies are typically not required or presented for dental implant submissions that demonstrate substantial equivalence through comparison to predicate devices, especially concerning their physical and material properties.

The relevant sections of the document are primarily focused on:

• Device Identification: Name, manufacturer, contact.
• Device Description: Physical characteristics (diameters, lengths, connection types) of the Klockner Essential implant system (EC, ES, ECK models).
• Intended Use: Surgical insertion into bone to replace tooth roots, acting as support for dental implants, with specific indications for different diameters and bone types, and considerations for immediate loading.
• Predicate Devices: Listing of previously cleared Klockner dental implants and other manufacturers' implants used for comparison.
• Basis for Substantial Equivalence: Stating that "the intended use, the composition and the endosseous surface treatment are identical to the Klockner predicate devices. The design principles are the same as the Klockner predicate devices."

In summary, this document does not contain the information requested in your prompt regarding acceptance criteria and a study demonstrating performance against those criteria because it's a 510(k) submission based on substantial equivalence to predicate devices, not a performance study of a novel diagnostic or AI-based device.

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