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Straumann® RidgeFit Implants Ø2.4 mm are for oral endosteal implantation in the upper and/or lower jaw of fully edentulous patients. The implants can be placed with immediate function when primary stability is achieved for all implants or with conventional loading if primary stability is not achieved for all implants. Straumann® RidgeFit Implants are intended for the stabilization of removable dentures.

• For mandibular restorations, at least 4 Straumann® RidgeFit Implants Ø2.4 mm should be placed.
• For maxillary restorations, at least 6 Straumann® RidgeFit Implants Ø2.4 mm should be placed.

The Straumann® RidgeFit Implants are tapered implants manufactured from Roxolid (TiZr) with a finished SLA surface. The implant neck is machined with an Optiloc® attachment portion resulting in a one-piece implant system acting as a retention feature for dentures, this feature is coated in a Titanium Nitride (TiN) coating. The Straumann® RidgeFit Implants have an external diameter of 2.4 mm and are available in implant lengths 10 mm, 12 mm and 14 mm with a gingival height of 2.8 mm and implant lengths 10 mm and 12 mm for gingival heights 3.8 mm and 4.8 mm. The Straumann® RidgeFit Implants are identical to the Straumann® Mini Implants cleared under K191895 apart from proposed labeling changes. Note for US Markets, Straumann has identified Straumann® Mini Implants as Straumann® RidgeFit Implants to distinguish it from other markets, this change has been documented through Memo to File. The purpose of this traditional 510(k) is to propose labeling changes to the cleared indications and the addition of contraindications to the existing devices cleared under K191895.

The provided text does not include information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically associated with algorithms or diagnostic tools. Instead, it is a 510(k) summary for a medical device (dental implants) and focuses on demonstrating substantial equivalence to a predicate device.

The "performance testing" described in the document primarily relates to:

• Sterilization Validation and Shelf Life: Ensuring the device remains sterile and functional over time.
• Biocompatibility Testing: Confirming the materials are safe for use in the human body.
• Electromagnetic Compatibility: Indicating the device is MR Conditional.
• Bench Testing: Mechanical testing (insertion torque, wear, dynamic fatigue) to ensure structural integrity and function, likely against material and mechanical standards.
• Clinical Performance (Reference): A literature review to support a change in "Indications for Use" regarding the number of implants for mandibular and maxillary restorations.

Therefore, many of the requested fields cannot be filled as they pertain to the evaluation of an algorithm's performance, which is not the subject of this document.

However, I can extract the information that is present and note where information is not applicable or not provided.

Here's the breakdown based on the provided text:

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

Study Details (where applicable for a medical device application):

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

• Sample Size for Bench Testing: Not explicitly stated in this summary. It refers back to K191895 for the detailed bench testing, and for the new gingival height, it mentions "a fatigue test" without specifying sample size.
• Data Provenance: Not applicable in the context of an algorithm's test set. For physical device testing, it's typically internal lab data or certified external lab data.

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)

• Not Applicable. This information pertains to the evaluation of an algorithm's ability to interpret data, which is not what this document describes.

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

• Not Applicable. This is for algorithm ground truth establishment.

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

• No. An MRMC study is not mentioned as this is a physical dental implant, not an AI/diagnostic tool. The clinical support cited for the labeling change is a systematic review of existing literature, not a new comparative effectiveness study on the device itself.

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 (expert consensus, pathology, outcomes data, etc)

• For Bench Testing: Ground truth is established through engineering standards, test methods, and comparison to predicate device performance.
• For Clinical Support of Indications for Use: The "ground truth" or supporting evidence for the revised Indications for Use (specifying implant numbers) comes from a systematic review of clinical literature (Lemos et al. 2017), which synthesizes existing outcomes data from various clinical studies on mini implants.

8. The sample size for the training set

• Not Applicable. This device is not an AI algorithm.

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

• Not Applicable. This device is not an AI algorithm.

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