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The Healing Collar is used to assist in the forming of the soft tissue during healing before a final restoration is placed. The Healing Collar is for single use only.

The healing collar is designed to form the soft tissue during the healing period before a final restoration is placed. The device is threaded onto the implant immediately after implant placement in a one-stage protocol. In a two-stage protocol, the healing collar is placed on the implant following the bone healing period. The soft tissue is sutured around the healing collar and the device remains in the mouth until the soft tissue fully develops. Depending on the needs of the patient, various healing collar sizes are available to interface with the implant and also to properly form the soft tissue. Healing collars are offered with three distinct implant platform diameters to accommodate for the different implant platform sizes. They are also available in differing cuff heights and emergence profile diameters to assist in forming the soft tissue. Because of the various sizes available, certain features are being incorporated into the design to assist in identifying the healing collars visually: The bottom half of the healing collar will be colored according to 1.) the shade that defines its respective implant platform size. The top face will be etched with all size parameters related to the 2.) use of the healing collar: implant platform diameter, emergence profile diameter, cuff height.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

This document describes a 510(k) premarket notification for a device modification – specifically, the addition of an anodization process to an existing healing collar. Crucially, the document explicitly states that no non-clinical or clinical testing was performed to establish new acceptance criteria or prove device performance for this modification. Instead, the submission relies on the substantial equivalence to a predicate device.

Therefore, many of the requested sections regarding specific testing details will not be applicable based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable. No test set was used for this modification.
• Data Provenance: Not applicable. No new data from testing was generated for this submission. The basis for equivalence is the existing predicate device.

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

• Not applicable. No ground truth for a test set was established as no new testing was performed.

4. Adjudication Method for the Test Set

• Not applicable. No test set requiring adjudication was used.

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

• No. An MRMC comparative effectiveness study was not done, as no clinical or even new non-clinical testing was performed.

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

• Not applicable. This device is a physical healing collar, not software or an algorithm.

7. The Type of Ground Truth Used

• Not applicable for the modified device. The submission relies entirely on the ground truth established for the predicate device, which is implicitly safe and effective based on its prior 510(k) clearance (K953101).

8. The Sample Size for the Training Set

• Not applicable. This device is a physical healing collar, not a machine learning model.

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

• Not applicable. This device is a physical healing collar.

Summary of the Document's Approach:

The provided document details a 510(k) Special Notification for a device modification, specifically adding an anodization process for color-coding. The core argument for clearance is substantial equivalence to a previously cleared predicate device (Paragon Implant System, K953101).

The manufacturer explicitly states:

• "Non-clinical testing was not performed."
• "No clinical testing was performed."

The justification for not performing testing is that:

• The healing collars are not load-bearing components ("placed out of occlusion and experience minimal mechanical forces").
• The design and function, material, implant interface, and dimensions of the anodized healing collars are equivalent to the existing (predicate) healing collars.
• Therefore, the mechanical properties of the material are sufficient, loading conditions remain the same, and the anodization does not present a "new worst case."

In essence, the "study" proving the device meets acceptance criteria is the argument of substantial equivalence based on the predicate device's established safety and effectiveness, rather than new testing data. The "acceptance criteria" for the modified device are implicitly met because its fundamental design and function are identical to the predicate, with the anodization being a surface treatment for identification that does not alter mechanical properties or intended use in a way requiring new performance validation.

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