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Implants:
The Astra Tech Dental Implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols:

• replacing single and multiple missing teeth in the mandible and maxilla, ●
• immediate placement in extraction sites and in situations with a partially or completely . healed alveolar ridge,
• especially indicated for use in soft bone applications where implants with other implant ● surface treatments may be less effective,
• immediate loading in all indications, except in single tooth situations on implants shorter . than 8 mm or in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate.

The intended use for OsseoSpeed™ Plus 3.0S is limited to replacement of maxillary lateral incisors and mandibular incisors.

Abutments:
Astra Tech Implant System Plus abutments are intended to be used in conjunction with Astra Tech Implant System Plus in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures.

Atlantis Abutments:
The Atlantis™ Abutment is intended for use with 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 prostheses, in the mandible or maxilla. The prosthesis can be cemented, screw retained or friction fit to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

The Atlantis™ Crown Abutment in Zirconia is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in partially or completely edentulous patients. The prosthesis is screw retained. The abutment screw is intended to secure the crown abutment to the endosseous implant.

The purpose of this submission is to expand the OsseoSpeed™ Plus Implant System to include all the components of the previously cleared OsseoSpeed System. The OsseoSpeed Plus Implant System, cleared September 26, 2011 under K111287, has the same design as the OsseoSpeed system, except for addition of an anti-rotation feature to the implant/abutment interface.

The OsseoSpeed Plus System includes implants with diameters ranging from Ø3.0 mm to Ø5.4 mm and lengths ranging from 6 mm to 17 mm. Radiographic guides are available for all implant sizes. Abutments sizes range from Ø3.0 mm to Ø5.4 mm in straight and angled designs ranging from 15° to 30°. Abutment designs include coverscrews, healing abutments, temporary abutments, cast-to abutments, ball abutments, straight and angled abutments.

This 510(k) Premarket Notification for the OsseoSpeed™ Plus Dental Implant System primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices. Therefore, the information provided does not detail specific acceptance criteria for a new clinical study and a study that proves the device meets those criteria, as one would typically find for a novel device.

The submission is for an expansion of an existing system (OsseoSpeed™ Plus) to include components from the previously cleared OsseoSpeed System (K111287). The core argument for substantial equivalence is based on the device having the "same intended use and design principles" and "same technological characteristics" as predicate devices, supported by non-clinical testing.

Here's an analysis of what is available in the document, acknowledging that typical clinical study acceptance criteria and results are not present:

1. Table of Acceptance Criteria and Reported Device Performance

As this submission relies on substantial equivalence and non-clinical testing, explicit acceptance criteria tied to a clinical performance study with defined metrics (e.g., success rates, complication rates) are not provided in the document.

The "acceptance criteria" here are implicitly linked to demonstrating that the OsseoSpeed™ Plus system is as safe and effective as the predicate devices. The non-clinical data presented aims to show that any differences in technological characteristics do not raise new issues of safety or efficacy.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable in the context of this 510(k) submission, as there is no specific clinical test set described from a prospective study. The evaluation relies on non-clinical engineering and bench testing data, and the historical performance of the predicate devices. The document does not specify sample sizes for the non-clinical tests, other than referencing the types of tests performed (e.g., ISO 14801).
• Data Provenance: The referenced predicate devices would have been previously marketed (interstate commerce prior to May 28, 1976, or reclassified devices). The non-clinical testing data would typically be generated in a lab setting by the manufacturer (Astra Tech AB, Sweden, or its testing partners).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• This question is not applicable for this submission. The ground truth, in the absence of a clinical study, is the established safety and efficacy of the predicate devices, supported by the non-clinical testing confirming that the new device variant performs similarly. Expert consensus on clinical outcomes for a novel test set is not described.

4. Adjudication Method for the Test Set

• Not applicable. There is no clinical test set requiring an adjudication method by experts for ground truth establishment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

• No. This type of study is not mentioned or implied in this 510(k) submission, as it focuses on dental implants, not image-based diagnostic aids or similar devices where MRMC studies are common.

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

• Not applicable. The OsseoSpeed™ Plus is a physical dental implant system, not a software algorithm or AI-driven device.

7. The type of ground truth used

• The "ground truth" for this 510(k) clearance is primarily:
  • The established safety and efficacy profile of the legally marketed predicate devices.
  • Bench test results and engineering analyses (e.g., mechanical strength, dimensional accuracy, surface characteristics) demonstrating that the subject device performs comparably to the predicates and meets relevant standards (like ISO 14801).
  • The regulatory precedent set by the predicate devices.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of a machine learning algorithm for this physical device. If referring to product development and testing, the sample size for non-clinical tests would be defined by engineering standards and internal validation protocols, but specific numbers are not provided in this summary.

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

• Not applicable. As there is no training set for an AI algorithm, this question doesn't apply. The "ground truth" for the overall submission is based on regulatory precedent and engineering validation against established standards and predicate devices.

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The Atlantis Abutment is intended for use with 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 cemented or screw retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

This device is compatible with the following manufacturers' implant systems:

The Atlantis Abutment in Zirconia for Astra Tech Osseospeed Implant is compatible with the Astra Tech Osseospeed Plus 3.6mm and 4.2mm 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 on small diameter implants are intended for the anterior region of the mouth only.

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 or screw retained restorations. The Atlantis™ Abutment in Zirconia for Astra Tech Osseospeed Plus Implant for the Astra Tech Osseospeed Plus 3.6mm and 4.2mm Implants is made of biocompatible material, yttria-stabilized tetragonal for the zirconia polycrystals (Y-TZP) ( meets ISO Standards 6972 & 13356). Zirconia may have variation in shade. The abutment screw is made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). The zirconia abutments are placed over the implant shoulder and are mounted into the implant with a titanium screw.

This is not an AI/ML device and therefore no AI/ML specific information can be extracted.

The document describes the Atlantis™ Abutment in Zirconia for Astra Tech Osseospeed Plus Implant.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document states that "Static and fatigue compression testing was conducted on 'worst case scenario' implant assemblies." However, it does not specify the exact sample size (number of assemblies tested) or the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable as the study described is a non-clinical, mechanical testing study, not a study evaluating human interpretation or diagnosis. Therefore, no experts were needed to establish ground truth in this context.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reason as point 3.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The study was non-clinical mechanical testing of an implant abutment.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This information is not applicable as the device is a physical medical device (dental abutment), not an algorithm or AI system.

7. The Type of Ground Truth Used:

The ground truth for the non-clinical testing was based on engineering standards and expected mechanical performance limits for dental implant systems, as detailed in ISO Standards 6972 & 13356 and ASTM Standard F-136. The "appropriate static and fatigue test loads" represent the ground truth for mechanical integrity.

8. The Sample Size for the Training Set:

This information is not applicable as the device is a physical medical device and does not involve AI/ML a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the same reason as point 8.

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