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MOR Implants are self-tapping titanium threaded screws intended for long-term applications in the bone of the patient's upper or lower arch. The MOR implants may also be used for interradicular transitional applications.

These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full or partial edentulous cases, and employing minimally invasive surgical intervention.

The MOR Implant System is only intended for use with straight abutments. The MOR implant body is intended to be placed such that no angle correction is necessary.

The MOR is a self-tapping, small diameter, screw implant, manufactured from titanium alloy (6% Al, 4% V - ASTM F136). The portion of the implant that is submerged in the bone is grit blasted and acid etched. The implants are manufactured with two body diameters, 2.1 mm and 2.4 mm. They are packaged sterile in a double blister, which contains: the implant in a titanium tube. The MOR implant body is designed with an O-ball denture connection and a separate straight titanium alloy (6% AI, 4% V - ASTM F136) abutment which may be cemented over the O-ball for crown or bridge fixation.

The MOR Implant System is not intended for correction of implants placed at an angle. It is only intended for use with straight abutments. The MOR implant body is intended to be placed such that no angle correction is necessary.

The MOR Dental Implant will be available in a range of lengths and diameters.

Thread Major Diameter (mm): 2.1mm, 2.4mm
Overall Implant Length (mm): 10mm, 13mm, 15mm

Dimensional requirements for the finished abutment:
Angulation of final abutment: No angles
Minimum and Maximum Gingival Height: 1.0 - 3.0mm
Minimum abutment post height may be fabricated to: 4.0mm

This document is a 510(k) Premarket Notification for the MOR Implant System, a dental implant device. It primarily focuses on demonstrating "substantial equivalence" to predicate devices rather than providing detailed clinical study data or performance metrics for an AI/algorithm-based device.

Therefore, many of the requested elements for describing the acceptance criteria and the study that proves an AI/algorithm-based device meets these criteria cannot be found in this document. This document describes the testing for a physical medical device (dental implants).

However, I can extract the information that is present and explain why other information is missing.

Summary of Information from the Provided Document Regarding Device Acceptance and Performance:

This document is a 510(k) Premarket Notification for a physical medical device (dental implants). The core of a 510(k) submission is to demonstrate substantial equivalence to a predicate device, not necessarily to set new performance criteria or conduct extensive clinical trials that would be typical for novel AI/algorithm-based devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document states:

• "Performance testing demonstrated that the device performs appropriately for the proposed indications for use." ([Page 4] - under 'Performance Testing')
• "Based on our analysis, technological characteristics and performance testing, the MOR Implant System is substantially equivalent in intended use, material, design and performance to its predicates." ([Page 5] - under 'Conclusion')

However, it does not provide a table of quantitative acceptance criteria for a specific performance metric (like accuracy, sensitivity, or specificity, which would be relevant for an AI device) nor does it report specific numerical performance results. The "performance testing" mentioned is non-clinical and likely refers to mechanical, material, and biocompatibility testing to show the physical implant functions as intended and is safe, rather than a clinical outcome or diagnostic performance metric.

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

• Not Applicable/Not Provided for Clinical Performance Data: This document does not describe a "test set" in the context of an AI model's performance on clinical data (e.g., patient images or records). The "performance testing" mentioned refers to non-clinical bench testing of the physical implant.
• Data Provenance: Not applicable for an AI test set.

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

• Not Applicable: This process is for validating AI/algorithm performance. The document describes a physical dental implant, not an AI device.

4. Adjudication Method for the Test Set:

• Not Applicable: This is relevant for establishing ground truth in clinical data for AI validation.

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

• No: This study type is for evaluating human performance (e.g., radiologists) with and without AI assistance. This document describes a physical dental implant, not an AI system. Even if clinical data were mentioned, an MRMC study is not typically required for dental implant 510(k)s focused on substantial equivalence.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

• Not Applicable: This is exclusively for AI/algorithm performance. The device is a physical dental implant.

7. The Type of Ground Truth Used:

• For the device (dental implant): The "ground truth" for a physical device like this is primarily established through engineering specifications, material science standards (e.g., ASTM F136 for titanium alloy), and non-clinical performance testing (e.g., fatigue testing, sterilization validation, biocompatibility) to ensure it meets mechanical strength, material safety, and functional requirements. It's not "expert consensus" or "pathology" in the diagnostic sense.
• The document explicitly references: "Non clinical Testing was performed following 'Guidance for Industry and FDA Staff -Class 11 Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments.'" ([Page 4])

8. The Sample Size for the Training Set:

• Not Applicable: This concept applies to the development of AI models. The document is about a physical dental implant, not an AI or algorithm.

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

• Not Applicable: As above, this pertains to AI model development.

In summary, the provided document is a 510(k) submission for a physical medical device (dental implants). It demonstrates "substantial equivalence" to previously cleared predicate devices based on design, materials, manufacturing processes, and non-clinical performance testing. It does not contain any information related to AI/algorithm performance, clinical study test sets, ground truth establishment by experts, or MRMC studies, as those concepts are not relevant to the type of device and regulatory submission described.

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The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

Titamax WS implant is indicated for a delayed loading protocol.

The Facility implant is indicated for replacement of maxillary lateral incisors, mandibular incisors or retention of overdentures.

The Neodent Implant System implants included in this submission are threaded, self-tapping, root form, endosseous dental implants with a Morse taper abutment interface. They are designed to provide support for prosthetic teeth to restore chewing function. They are made of commercially pure titanium or titanium alloy, with a surface that is grit blasted and acid etched. In addition, multiple abutments made of titanium alloy are provided for each implant for both cement-retained and screw-retained prostheses. The CM Drive implant comes in three diameters (3.5, 4.3 and 5.0 mm), each in five lengths (8.0, 10.0, 11.5, 13.0, and 16.0 mm). The Titamax WS implant design comes in three diameters (4.0, 5.0, and 6.0 mm) with corresponding platform diameters. The 4.0 mm diameter Titamax WS implant comes in one length (6.0 mm). The 5.0 and 6.0 mm diameter Titamax WS implants come in two lengths (5.0 and 6.0 mm). The Facility implant design comes in one diameter (2.9 mm), and in five lengths (8, 10, 12, 14, and 16 mm). All abutments included in this submission are straight and have a Morse taper connection.

The provided 510(k) summary for the Neodent Implant System does not contain information related to acceptance criteria or a study proving device performance against such criteria.

The document is a premarket notification for a medical device (dental implants). It focuses on demonstrating substantial equivalence to predicate devices already on the market, rather than proving performance against specific acceptance criteria through a clinical study or benchmark performance testing with ground truth.

Therefore, many of the requested elements cannot be extracted from this document, as they are not present in a "substantial equivalence" submission for this type of device.

Here's an breakdown of what can be stated based on the provided text, and what cannot:

1. Table of acceptance criteria and the reported device performance

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 Test Set: Not applicable. No clinical or performance test data on a "test set" are presented.
• Data Provenance: Not applicable. The submission explicitly states: "Clinical data were not submitted in this premarket notification." The non-clinical data mentioned (engineering analysis, dimensional analysis, comparative surface area analysis) would not typically involve a "test set" in the sense of patient 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. As no clinical or performance test data are presented, there is no "ground truth" established by experts for a test set in this submission.

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

• Not applicable. No test set requiring adjudication is mentioned.

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 is a submission for a physical medical device (dental implants), not an AI diagnostic tool. No MRMC study was done, nor is AI assistance relevant to this device.

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

• Not applicable. This is not an algorithm or AI device.

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

• Not applicable. No performance data requiring ground truth ascertainment is presented. The submission relies on "substantial equivalence" based on design, materials, and non-clinical characteristics (engineering, dimensional analysis) comparing the new device to existing predicate devices.

8. The sample size for the training set

• Not applicable. As no machine learning or AI model is involved, there is no "training set."

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

• Not applicable. No machine learning or AI model is involved, so no training set or ground truth for it was established.

Summary based on the provided document:

The 510(k) summary for the Neodent Implant System explicitly states: "Clinical data were not submitted in this premarket notification." The submission focuses on demonstrating that the new components of the Neodent Implant System are "substantially equivalent" to predicate devices already cleared for market. This equivalence is based on:

• Identical intended use.
• Similar design, identical material, and identical surface to a previously cleared Neodent system (K101945).
• Similar indications, design, and dimensions to other predicate devices for the new Titamax WS and Facility implants.
• Non-clinical data including engineering analysis, dimensional analysis, and comparative surface area analysis.

The conclusion drawn is that "The device is safe and effective for its intended use and performs as well as or better than the predicate devices," based on the comparison of an existing cleared device characteristics rather than new performance data against specific acceptance criteria.

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