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The Atlantis Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

The Atlantis Abutment for Astra Implant is compatible with Astra's OsseoSpeed™ 3.5(S) mm, 4.0(S) mm Internal Hex Implants.

Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.

The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations.

The Atlantis™ Abutments for Astra Implant and abutment screws are made from Titanium grade Ti-6A1-4V ELI (Meets ASTM Standard F-136). The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutments are compatible with Astra's 3.5 S mm, 4.0 S mm OsseoSpeed™ Implants.

The provided text is a 510(k) summary for a dental device, the Atlantis™ Abutment for Astra Implant. It primarily focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a performance study with detailed acceptance criteria and a comprehensive study report.

Therefore, many of the requested sections regarding performance criteria, study design, and ground truth establishment cannot be found in this document. The purpose of a 510(k) is often to show that a new device is as safe and effective as a legally marketed one, which can be done through comparison of materials, intended use, and design, without necessarily requiring a new, extensive clinical performance study if the differences are minor.

Here's an analysis of the information that is available in the provided text, and where the requested information is missing:

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

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a study. The "basis for substantial equivalence" is the primary "acceptance criterion" in this context.
• Reported Device Performance: No specific performance metrics (e.g., success rates, longevity, strength) are reported for the device in a formal study within this document. The document states that the device is "substantially equivalent in intended use, material, design and performance" to predicate devices.

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 document does not describe a performance study with a test set. It's a regulatory submission focused on substantial equivalence.

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. No test set or ground truth establishment by experts is described in this document.

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

• Not Applicable. This document does not describe a performance study requiring adjudication.

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 abutment, not an AI-powered diagnostic tool. MRMC studies are not relevant here.

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

• Not Applicable. This device is a physical dental component, not an algorithm.

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

• Not Applicable. No explicit performance study requiring ground truth is described. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

• Not Applicable. This document does not describe the development of an algorithm requiring a training set.

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

• Not Applicable. No training set or ground truth establishment for a training set is described.

Summary from the Document:

The K070833 submission for the Atlantis™ Abutment for Astra Implant establishes its substantial equivalence to existing, legally marketed predicate devices rather than providing a new, independent performance study against specific acceptance criteria. The claim of equivalence is based on the device's intended use, material (Titanium grade Ti-6Al-4V ELI), design, and performance being similar to:

• Atlantis Abutment for 3i MicroMini (K062069)
• Atlantis Abutment for Astra Fixture (K053384)
• Astra Tech MicroThread™ OsseoSpeed™ (K024111)
• Astra Tech Implants-Dental System Fixture MicroMacro (No 510(k) number provided in table, but referenced)

This type of 510(k) filing relies on the FDA's prior determination of safety and effectiveness for the predicate devices.

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