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The Astra Tech Implants – Dental System are for single-stage or two-stage surgical procedures and cement or screw retained restorations. The Astra Tech Implants - Dental System are intended for immediate placement and function on single tooth and/or multiple tooth applications recognizing sufficient bone stability (type I or II bone) and appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be splinted with a bar.

The Astra Tech Dental Implants are root-formed threaded screws made from commercially pure titanium.

The provided text is a 510(k) summary for the Astra Tech Implants - Dental System, related to a labeling change for "immediate function." It focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving that the device meets those criteria.

Therefore, I cannot provide the requested information. The document appears to be a regulatory submission for a device modification (change in labeling/intended use for immediate function) rather than a report detailing a new performance study with acceptance criteria.

Missing Information from the Provided Text:

• Table of acceptance criteria and reported device performance: This document does not specify any performance-based acceptance criteria or report device performance against such criteria. The submission is for a labeling change allowing "immediate function," which implies clinical outcomes, but no such data is presented.
• Sample size used for the test set and data provenance: No test set is described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment activity is described.
• Adjudication method for the test set: No test set is described.
• Multi-reader multi-case (MRMC) comparative effectiveness study: No MRMC study is mentioned.
• Standalone (algorithm only without human-in-the-loop performance) study: No such study is mentioned.
• Type of ground truth used: No ground truth is described.
• Sample size for the training set: No training set is described.
• How the ground truth for the training set was established: No training set is described.

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For use in selected fully edentulous and partially edentulous arches

The additional fixture provided for by this 510(k) is added to the fixtures, abutments and other components necessary to meet various clinical situations in partially and totally edentulous patients. The implant is a root-form uncoated screw. It is cylindrical in shape. The coronal portion has a minute thread - microthread - and the apical part a magnified thread - Macrothread. It is made from commercially pure titanium. It has a defined surface texture achieved through titanium oxide grit blasting. The component is intended for use in selected fully edentulous and partially edentulous arches.

This 510(k) summary (K991053) describes an additional component, the MicroMacro fixture, for the Astra Tech Implants - Dental System. It is a premarket notification for a medical device and does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML algorithm.

The document pertains to the regulatory clearance of a physical dental implant component, made of commercially pure titanium, with a specific design (microthread and macrothread). The FDA's review determined substantial equivalence to legally marketed predicate devices, allowing its market entry.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or human reader effectiveness with AI. These concepts are relevant to the evaluation of AI/ML-driven medical devices, not to a physical dental implant as described in this 510(k) summary.

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For use in cement retained crown and bridge construction.

The following table describes the indication for use for each component listed as part of this 510(k) submission:

Cast-to Abutment, Cast-to Abutment ST and Abutment Screws- Gold - are ADDITIONAL COMPONENTS to the Astra Tech Dental Implant System.

The Cast-to abutments are manufactured in gold alloy and are used as a base for castto customized abutment post construction. Allowing for compensation of poorly aligned fixtures and for meeting esthetic demands for design and position of the crown margin.

The Abutment Screws are manufactured in gold alloy and are attachment elements for connection/fixation of abutments to fixtures.

The provided text, a 510(k) summary for the Astra Tech Implants - Dental System, does not contain information about acceptance criteria, device performance, or any studies conducted to prove the device meets such criteria.

The document is a premarket notification for additional components (Cast-to Abutments and Abutment Screws) to an existing dental implant system. It primarily focuses on:

• Identification of the device and submitter.
• Description of the device and its intended use: These are additional components for cement-retained crown and bridge constructions, allowing for customization and fixation of abutments to fixtures.
• Classification and predicate devices: It states the device is an Endosseous Implant and references previously approved similar devices.
• List of components: Details the specific product names, diameters, and part numbers.
• FDA correspondence: The letter from the FDA confirms review of the 510(k) notification and a determination of "substantial equivalence" to devices marketed prior to May 28, 1976. It also mentions device tracking requirements.
• Indications for Use: Specifically lists the indications for each component, which mostly relate to their function as a base for customized abutment construction or as attachment elements.

Therefore, I cannot provide the requested information regarding acceptance criteria and the study proving device performance because it is not present in the provided text.

This type of 510(k) submission generally relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive new performance studies to establish safety and effectiveness from scratch. The assumption is that if the new device is substantially equivalent in design, materials, and intended use to an already approved device, then its safety and effectiveness are also similar. Specific performance studies with detailed acceptance criteria might have been performed for the predicate device, or for the original implant system, but not necessarily for these "additional components" in this specific 510(k) submission.

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