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MIS dental implant systems are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate.

Narrow implants (Ø3.30mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another. The long MIS (18 & 20mm) implants can be used in a tilted manner. MIS short implants are to be used only with straight abutments. M4 short implants are indicated for delayed loading only.

The proposed MIS Angulated multi-unit abutments are endosseous dental implant abutments that are connected to MIS dental implants and used as an aid in prosthetic rehabilitation, for anchoring screw retained multiple-unit restorations.

MIS Angulated multi-unit abutments consist of a one-piece abutment and a prosthetic multi-unit screw, both made of Titanium complying with ASTM F136-13 (Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (USN R56401). The proposed abutments are available in 17° and 30° angulations and connected to the implant by a prosthetic multi-unit screw supplied with the proposed abutments. The proposed abutments are also supplied with a titanium gripping bar used to position the multi-unit abutment on the implant. The proposed abutments are supplied sterile to the user.

The proposed MIS cementing cap is a superstructure that has a standard connection design intended to be directly connected to all MIS straight and angulated multi-unit abutments with a prosthetic screw. The proposed cementing cap and prosthetic screw are made of Titanium complying with ASTM F136-13. Multi-unit cementing caps are delivered non-sterile, and are intended to be cleaned and steamsterilized by a professional user according to the instructions before use.

The provided text is a 510(k) Summary for a medical device (MIS Angulated multi-unit abutments). It outlines how the device demonstrates substantial equivalence to predicate devices, primarily through non-clinical performance data.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size (Test Set): The document does not specify the exact number of units tested for fatigue. It refers to "representative worst-case MIS Angulated multi-unit abutment-implant combinations." For sterilization and shelf life, it refers to "validation" and "study" without giving specific unit counts.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given that it's a 510(k) submission to the FDA, it is expected that the data would be generated in compliance with relevant international standards (like ISO 14801 for fatigue testing) and potentially reflect a global manufacturing and testing approach.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable as the document describes non-clinical performance testing for a dental implant abutment, not a diagnostic device requiring expert interpretation for ground truth. The "ground truth" here is the physical performance and material properties meeting established engineering and biological standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods are typically used in clinical studies involving human readers or interpretation, not for mechanical or sterilization testing of a physical device.

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

This is not applicable. The device is a physical dental implant abutment, not an AI-powered diagnostic tool. No human reader or AI assistance is involved.

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

This is not applicable. The device is a physical dental implant abutment, not an algorithm.

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

For the non-clinical tests described:

• Fatigue Testing: The "ground truth" is established by the specified performance requirements of ISO 14801:2016 and FDA guidance (e.g., ability to withstand 5,000,000 cycles without failure at a specific load). This is a predetermined engineering performance standard.
• Sterilization: The "ground truth" is the achievement of a Sterility Assurance Level (SAL) of 10-6, which is an industry standard for sterility.
• Shelf Life: The "ground truth" is a 5-year shelf life, supported by real-time aging study data.
• Biocompatibility: The "ground truth" is the determination that the material and manufacturing process are safe for human contact based on established biocompatibility standards and equivalence to a previously cleared device.

8. The sample size for the training set

This is not applicable. The device is a physical product, not a machine learning model that requires a training set.

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

This is not applicable as there is no training set for this type of device.

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