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SuperLine® implants are indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. SuperLine® implants are indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Single tooth cases on 7 mm length implants are indicated for delayed loading.

The purpose of this submission is to add dental implants to the SuperLine components cleared in K160965. This submission includes two series of implants: SuperLine FXSxxxxB Series and SuperLine FXSxxxx Series.

The FXSxxxB Series has a machined collar height that ranges from 0.03 mm (on the 3.6 mm body diameter implant) to 0.6 mm (on the 5.0 mm body diameter implant). All FXSxxxxB Series implants have an endosseous length of 7 mm, and threaded lengths ranging from of 6.98 mm to 6.4 mm. Other than the endosseous length of 7 mm, the subject device FXSxxxB implants are identical in design and sizes to SuperLine implants cleared in K160965.

The FXSxxxx Series has machined collar 1.5 mm in height for all implant body diameter sizes. For body diameters 4.0 mm to 5.8 mm, the collar has a reverse taper. All FXSxxxx Series implants have an endosseous length of 7 mm, and a threaded length of 5.5 mm. The FXSxxxx series implant design has not been cleared previously by FDA for any body diameter or length.

All subject device implants are manufactured from the same unalloyed titanium conforming to ASTM F67 and have the same surface treatment (S.L.A., Al2O3 blasted and acid etched) as the dental implants cleared in K160965.

All subject device implants are compatible with previously-cleared abutments and prosthetic components from Dentium Co., Ltd., including those cleared in K192436, K141457, and K041368.

The provided document is a 510(k) summary for a medical device (SuperLine dental implants) and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document discusses substantial equivalence to predicate devices based on non-clinical data and design comparisons.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study demonstrating device performance against those criteria.

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SuperLine is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. SuperLine is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

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This document is a 510(k) clearance letter for a dental implant device called "SuperLine." It mostly contains regulatory information and does not describe any specific studies or performance criteria in the detail requested. The 510(k) process primarily confirms substantial equivalence to a predicate device, not necessarily extensive clinical performance testing with defined acceptance criteria in the manner of a new drug or novel medical device requiring broad clinical trials.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be stated based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

• This document does not contain a table of acceptance criteria or reported device performance metrics like sensitivity, specificity, AUC, or similar statistical measures. The 510(k) clearance process often relies on testing for substantial equivalence, which may involve bench testing and comparisons to a predicate device's design and materials, rather than detailed clinical performance metrics with defined acceptance criteria against a ground truth as would be seen in AI/CADe device submissions.

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

• Not specified. The document does not describe a clinical test set or its provenance.

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

• Not specified. The document does not describe a test set or ground truth establishment.

4. Adjudication method for the test set:

• Not specified. The document does not describe a test set or adjudication method.

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 device is an endosseous dental implant, not an AI or CADe system designed to assist human readers. Therefore, an MRMC study with AI assistance is not relevant to this product.

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

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

7. The type of ground truth used:

• Not specified. The document does not describe any ground truth. For a physical implant, "ground truth" related to its performance would typically involve measures of biocompatibility, mechanical strength, osseointegration, and clinical success over time, which are implied by substantial equivalence to a predicate device rather than explicitly detailed here.

8. The sample size for the training set:

• Not applicable/Not specified. This document is for a physical medical device, not an AI model requiring a training set.

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

• Not applicable/Not specified. This document is for a physical medical device, not an AI model.

In summary: The provided document is a regulatory clearance letter for an endosseous dental implant. It confirms the device's substantial equivalence to a legally marketed predicate device, enabling its market access. It does not contain the kind of detailed study design, acceptance criteria, or performance data typically associated with a new AI/CADe device or a clinical trial report. The information requested aligns more with performance evaluations of diagnostic software or AI-powered medical devices.

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