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Straumann® Anatomic Healing Abutments are indicated to be placed in partially edentulous patients after implant placement. The healing components protect the inner configuration of the implant and form, maintain and stabilize the soft tissue during the healing process. Healing components have a maximum duration of usage of 180 days.

The Straumann Anatomic Healing Abutments XC (referred to as the AHAs) are intended for use with the Straumann Dental Implant System (SDIS). The healing components protect the inner configuration of the implant and form, maintain, and stabilize the soft tissue during the osseointegration phase of Straumann endosseous dental implants to be rehabilitated using the delayed loading technique. The AHA are to be used during the implant placement surgery or in the reopening surgery (second surgical phase) and are for temporary use up to 180 days. The AHAs are to be placed out of occlusion. The healing abutments do not support a prosthetic restoration.

The AHAs are composed of two united parts: a body that allows for customization and includes a through hole for fixation screw access, and a basal screw that cannot be altered. The Anatomic Healing Abutments are intended to be customized using only hand milling instruments manually controlled by dental professionals. To protect the consistent emergence profile for final abutment, a maximum 3mm height can be modified down to the occlusal surface. To preserve the scanning function of AHA, a 4.7mm circular area around the central axis of the screw channel cannot be modified. The body is milled from polyetheretherketone (PEEK Classix). The basal screws are existing basal screws manufactured from Titanium-Aluminum-Niobium (TAN) alloy previously cleared as part of the Straumann BLX system in K173961.

The AHA are designed for connection to BLC and BLX implants of the Straumann Dental Implant System (K173961, K181703, K191256, K210855, K212533, K230108, and K234049). The AHA are available in diameters of Ø3.8 mm, 4.5mm, 5.5mm, and 6.5mm. They are available in 4 shapes designed according to specific areas of the dentition including S, S1, M, and XL, however, they are not limited to use exclusively in these positions. The AHA are offered in regular base (RB) and wide base (WB) configurations consistent with the Straumann BLX and BLC prosthetic platform offerings.

The AHAs may also be used in intraoral scanning procedures of single-unit restorations to represent the position, axis, and orientation of the dental implant placed in the patient's jaw relative to the surrounding dentition. A scanbody feature extends from the occlusal surface of the AHA.

The provided text is a 510(k) summary for the Straumann Anatomic Healing Abutments XC (AHA). It describes the device, its intended use, and compares it to predicate devices. However, this document does not contain the detailed acceptance criteria or a study designed to prove the device meets specific performance criteria in the format typically used for AI/software-based medical devices.

Instead, this 510(k) summary focuses on demonstrating substantial equivalence to existing legally marketed devices through comparisons of technological characteristics, intended use, and various performance tests (sterilization, shelf life, biocompatibility, torque, and basic software verification) that confirm the new device functions as expected for a medical device of its class, rather than proving specific numerical performance metrics against defined acceptance criteria in a clinical setting.

Therefore, I cannot populate the requested table and answer many of the questions as the information is not present in the provided text.

Here is what can be extracted and inferred from the document:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit, quantifiable acceptance criteria with corresponding performance results are not provided in the document for the device itself (Straumann® Anatomic Healing Abutments XC). The document focuses on demonstrating substantial equivalence to predicate devices through various tests rather than meeting numerical performance thresholds for image analysis or diagnostic accuracy.

The performance tests mentioned are:

• Sterilization Validation and Shelf Life:
  • Acceptance Criteria (inferred): Sterility Assurance Level (SAL) of 10^-6 for gamma irradiation and successful steam sterilization validation. Packaging stability for a 5-year shelf life.
  • Reported Performance: Met SAL of 10^-6 using VDmax25 in accordance with ISO 11137-1:2006. Steam sterilization validation met all test method acceptance criteria. Packaging stability for the 5-year shelf life of predicate devices was adopted.
• Pyrogen Testing (LAL test):
  • Acceptance Criteria (inferred): Pyrogen limit specification of 20 endotoxin units (EU)/device.
  • Reported Performance: Met the specified limit.
• Biocompatibility Testing:
  • Acceptance Criteria (inferred): No cytotoxic reaction, no extractable substances above Analytical Evaluation Threshold (AET).
  • Reported Performance: No cytotoxic reaction detected. No extractable substances detected above AET.
• Performance Testing - Bench (Torque Testing):
  • Acceptance Criteria (inferred): Withstands repeated insertion and removal torques without damage.
  • Reported Performance: Performed, demonstrating the AHA withstands repeated insertion and removal torques without damage. (Specific numerical thresholds not provided).
• Software Testing (Scan Verification and Integration):
  • Acceptance Criteria (inferred): Can be scanned with an intraoral scanner and is suitable to work with CARES Visual software.
  • Reported Performance: Performed, demonstrating the subject AHAs can be scanned with an intraoral scanner and are suitable to work with CARES Visual software. (No specific metrics provided).

2. Sample size used for the test set and the data provenance

• The document describes engineering tests (sterilization validation, mechanical torque testing, biocompatibility, software verification) rather than a clinical study with a "test set" of patient data. Therefore, this information is not applicable in the context of this 510(k) for a physical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable as this is not a study involving expert-derived ground truth on a clinical dataset for AI/software performance.

4. Adjudication method for the test set

• Not applicable.

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 is a physical medical device (healing abutment), not an AI/software for diagnostic assistance.

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

• Not applicable.

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

• For the engineering tests:
  • Sterilization/Pyrogenicity: Laboratory test results against validated standards and specified limits.
  • Biocompatibility: Laboratory test results against ISO standards and AET.
  • Torque Testing: Mechanical testing results against functional requirements (withstanding torque without damage).
  • Software Testing: Functional verification (can be scanned, works with software).

8. The sample size for the training set

• Not applicable, as this is a physical device and not an AI/ML model that requires a "training set."

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

• Not applicable.

Summary of what the document implies about meeting criteria:

The document asserts that the Straumann® Anatomic Healing Abutments XC (AHA) meet the necessary performance criteria through a series of benchtop engineering tests and validations designed to demonstrate:

• Effective sterilization (gamma irradiation and steam sterilization).
• Pyrogenicity within acceptable limits.
• Biocompatibility of the materials.
• Mechanical integrity (torque resistance).
• Compatibility with intraoral scanning and associated software.

The primary "study" presented is a comparison to predicate devices to establish substantial equivalence based on similar technological characteristics and performance testing. The "acceptance criteria" are implicitly met by successful completion of these validation tests against established industry standards (e.g., ISO) and functional requirements, rather than through a clinical study with statistical performance metrics against a defined ground truth.

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