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The Anatotemp Anatomic Dental Implant Healing Abutment is a pre-manufactured healing abutment intended for use with endosseous root-form dental implants to aid in prosthetic rehabilitation. The abutment is a temporary device that aids in creating an esthetic emergence through the gingiva during the healing period. The single use, sterilized device is used by dental professionals during the dental implant healing process and is removed prior to permanent prosthetic placement.

Anatotemp Anatomic Dental Implant Healing Abutments are compatible with the following implant systems:

The Anatotemp Anatomic Dental Implant Healing Abutment product line includes anatomically shaped temporary dental implant healing abutments that aid in creating an esthetic emergence through the gingiva during the healing period. Anatotemp Anatomic Dental Implant Healing Abutments are made of a polymethylmethacrylate biocompatible plastic and are held securely to an endosseous implant with a titanium abutment screw. Anatotemp Anatomic Dental Implant Healing Abutments are positioned well below the occlusal plane and are non-load bearing components that guide healing tissue.

Anatotemp Anatomic Dental Implant Healing Abutments are designed not to be in occlusion or sustain occlusal forces. Anatotemp Anatomic Dental Implant Healing Abutments come in six shapes that mimic original tooth shape at the gingival level and also exhibit a mild, biconcave shape interproximally that aids in creating an esthetic emergence through the gingiva during the healing period. Anatotemp Anatomic Dental Implant Healing Abutments exhibit anti-rotational connections that are compatible with many dental implant connections. Anatotemp Anatomic Dental Implant Healing Abutments are provided sterile, are single use, and are recommended for temporary placement of no longer than 180 days. Anatotemp Anatomic Dental Implant Healing Abutments are removed after dental implant healing (approximately 90-180 days) and replaced by the permanent abutment and crown.

The provided text describes a 510(k) premarket notification for the "Anatotemp Anatomic Dental Implant Healing Abutment." This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets acceptance criteria through a clinical study with a specific test set, ground truth, and expert adjudication as one would find for a novel AI/imaging device.

Therefore, many of the requested criteria cannot be directly extracted from this document, as the regulatory pathway for this device (a dental implant healing abutment) does not involve the same type of performance evaluation as, for instance, an AI-powered diagnostic imaging system.

This document primarily relies on non-clinical testing (biocompatibility, chemical characterization, packaging, sterilization, shelf-life, and reverse engineering analysis) and comparison to a predicate device to establish substantial equivalence. It explicitly states that "Formal clinical studies were not conducted to support the claim for substantial equivalence to the predicate device."

Here's an attempt to address your points based on the provided text, highlighting where information is not applicable or not present for this type of device submission:

Acceptance Criteria and Device Performance for the Anatotemp Anatomic Dental Implant Healing Abutment

Since this is a 510(k) submission for a physical medical device (dental implant healing abutment) demonstrating substantial equivalence to a predicate, the "acceptance criteria" and "device performance" are typically related to material properties, biocompatibility, sterility, and functional equivalence, rather than diagnostic accuracy metrics as would be seen for an AI system. The study described is a series of non-clinical tests and a comparison.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the standards and characteristics required for demonstrating substantial equivalence to the predicate device, as well as the successful completion of the non-clinical tests. Performance is reported as meeting these standards.

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

• Test Set Sample Size: For the non-clinical testing, specific sample sizes are not explicitly stated for each test (e.g., number of animals for biocompatibility, number of packages/devices for sterilization/packaging). The document mentions "sample of the OEM implants were measured" for reverse engineering. This is not a "test set" in the context of an AI study.
• Data Provenance: Not applicable for this type of submission. The data is generated from internal company testing and contract lab testing, not patient data from a specific country or collected retrospectively/prospectively in a clinical setting.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. This device does not use human "experts" to establish a ground truth for performance evaluation in the way an AI diagnostic imaging system would. The "ground truth" for the non-clinical tests is established by adherence to recognized international standards (ISO, ASTM, USP) and laboratory protocols.

4. Adjudication Method for the Test Set

• Not applicable. There is no "test set" in the context of human interpretation or diagnostic accuracy for this device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No. The document explicitly states: "Formal clinical studies were not conducted to support the claim for substantial equivalence to the predicate device..." An MRMC study is a type of clinical study, typically for diagnostic devices or AI assistance in interpretation.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this submission type is based on:
  • Regulatory Standards: Compliance with ISO, ASTM, and USP standards for biocompatibility, sterility, packaging, etc.
  • Engineering Specifications: Data derived from reverse engineering analysis of OEM implant systems to ensure compatibility.
  • Predicate Device Equivalence: The characteristics and performance of the legally marketed predicate device (Contour Healer).

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device. There is no "training set."

9. How the Ground Truth for the Training Set was Established

• Not applicable. There is no "training set."

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