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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 PUR Implant System can be used in dental implant applications, for oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures. The PUR Implant is intended for delayed loading. It is also indicated for immediate loading with good primary stability and appropriate occlusal loading.

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

The PUR is a self-tapping, double thread screw implant with a micro groove section, manufactured from Wrought Titanium 6AL-4V ELI. The implant surface is grit-blasted and acid etched. The implants are manufactured with four body diameters 3.5 mm, 4.3 mm, and 6.0 mm. The 3.5 and 4.3 mm implants have a Narrow Platform (NP) prosthetic head. The 5.0 and 6.0 mm implants have a Regular Platform (RP) prosthetic head. The PUR implants are substantially equivalent to the Zimmer Tapered Screw-Vent® 3.5 mmD Platform and the 4.5 mmD Platform implant systems. They provide for non- rotational single and multiple tooth restorations in both the maxilla and mandible. They are packaged sterile in a double blister, which contains: the implant in a titanium tube. A special driver is available for the implants which simplifies implant insertion by eliminating the need for an implant mount.

This device uses straight abutments with no angles. Sterngold has SA Abutments) which are intended for multi-unit restorations. Sterngold also has UCLA abutments which are twopiece abutments composed of Wrought Titanium 6AL-4V ELI, conforming to ASTM F136-13 and Gold Alloy (64% gold, 22% palladium and 14.0% platinum). These UCLA abutments are intended for single and multiple unit use.

The PUR implant system is not intended to include any angled abutments or allow for any correction of angled implant placement.

The provided document is a 510(k) premarket notification for a dental implant system. This type of document is used to demonstrate that a new medical device is "substantially equivalent" to a legally marketed predicate device, meaning it is at least as safe and effective. The FDA's decision is based on comparing the new device's technological characteristics and intended use to those of the predicate.

Crucially, a 510(k) summary for a dental implant system typically does not include "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the way one might find for an AI/ML-driven diagnostic device. The concept of "acceptance criteria" for performance metrics like sensitivity, specificity, or AUC is not directly applicable here. Instead, the "acceptance criteria" for a 510(k) are related to demonstrating substantial equivalence through various tests (mechanical, biocompatibility, sterilization validation) and design comparisons.

Therefore, many of the requested points are not applicable to this type of regulatory submission. However, I will extract and describe the relevant information that is present.

Here's an analysis based on the provided text, addressing the points where possible and indicating when they are not applicable for this kind of device and submission:

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

As explained above, this submission does not present acceptance criteria and performance in terms of diagnostic metrics (e.g., sensitivity, specificity, or F1 score). Instead, the "performance" demonstrated for dental implants revolves around mechanical properties, biocompatibility, and sterilization effectiveness to show substantial equivalence to predicate devices.

The document states:

• Performance Testing: "Non clinical Testing was performed following "Guidance for Industry and FDA Staff -Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments." Performance testing demonstrated that the device performs appropriately for the proposed indications for use."
• Surface analysis: "SEM photographs confirm that all residue of blasting material had been removed from the treated implant surface, and the surface chemical analysis confirmed that no contaminants remained on the surface."
• Sterilization, shelf life, and biocompatibility: "PUR Implants have the same sterilization process and radiation dose, same shelf life and biocompatibility as previous cleared Sterngold devices, therefore sterility, shelf life and biocompatibility testing performed on previous cleared Sterngold devices is applicable to the PUR Implants."

Table of Comparison (extract of relevant parts from page 6, representing "performance" in the context of substantial equivalence):

The "acceptance criteria" here are that the subject device's characteristics and performance testing results are comparable to the predicates and meet the established guidance standards for dental implants, demonstrating that it is as safe and effective.

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

This information is not provided in the document. The testing described is "non-clinical testing," which typically refers to benchtop mechanical tests or material characterization rather than human subject trials. Therefore, concepts like "test set" in the context of patient data, data provenance, or retrospective/prospective studies are not applicable.

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 is not applicable. The device is a physical dental implant, not a diagnostic AI/ML device requiring expert-labeled medical images for ground truth.

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

This is not applicable. As above, there is no "test set" in the context of expert adjudication for diagnostic accuracy.

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. This is a physical medical device (dental implant), not an AI/ML software device.

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

This is not applicable. This is a physical medical device (dental implant), not an AI/ML software device.

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

For a physical device like a dental implant, "ground truth" refers to its physical, mechanical, and biological properties meeting established standards and performance expectations. The document indicates:

• "Non clinical Testing was performed following 'Guidance for Industry and FDA Staff -Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments.'" This guidance document essentially defines the "ground truth" or standard for performance.
• "Surface analysis was conducted on the final device. SEM photographs confirm that all residue of blasting material had been removed from the treated implant surface, and the surface chemical analysis confirmed that no contaminants remained on the surface." This refers to chemical and microscopy analysis.
• The reliance on "sterility, shelf life and biocompatibility testing performed on previous cleared Sterngold devices" based on the subject device having the "same sterilization process and radiation dose, same shelf life and biocompatibility." This means previous testing results and established biological safety are the "ground truth."

8. The sample size for the training set

This is not applicable. This is a physical medical device (dental implant), not an AI/ML software device that relies on a "training set."

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

This is not applicable. As above, there is no "training set" for device performance in this context.

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The TRU Implant System can be used in dental implant applications for oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures. The TRU Implant System is intended for delayed loading. It is also indicated for immediate loading with good primary stability and appropriate occlusal loading.

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

The TRU is a self-tapping, double thread screw implant with a micro groove section, manufactured from pure grade 4 titanium. The implant surface is acid etched. The implants are manufactured with four body diameters 3.5 mm, 4.3 mm, 5.0 mm, and 6.0 mm. The 3.5 mm implants have a Narrow Platform (NP) prosthetic head. The 4.3 mm, 5.0 mm, and the 6.0 mm implants have a Regular Platform (RP) prosthetic head. They provide for non-rotational single and multiple tooth restorations in both the maxilla and mandible. They are packaged sterile in a double blister, which contains the implant in a titanium tube. A special driver is available for the implants which simplant insertion by eliminating the need for an implant mount.

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

The prosthetic components for the TRU implant System include Healing abutments, Straight Abutments and UCLA Abutments.

This report summarizes the acceptance criteria and study information for the TRU Dental Implant System based on the provided FDA 510(k) summary (K150968).

Acceptance Criteria and Device Performance

The document does not explicitly present a table of quantitative acceptance criteria or specific device performance metrics in numerical form. Instead, the substantial equivalence determination relies on comparison of technological characteristics and confirmation of appropriate performance through non-clinical testing.

The "Performance Testing" section states: "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.' Performance testing demonstrated that the device performs appropriately for the proposed indications for use."

Therefore, the acceptance criteria implicitly derived are that the device's technological characteristics and performance meet or are substantially equivalent to the predicate devices and the relevant FDA guidance document for root-form endosseous dental implants.

Table of Implicit Acceptance Criteria and Reported Device "Performance" (via Equivalence)

Study Details

The provided document describes a non-clinical study to demonstrate substantial equivalence, rather than a clinical trial with patient outcomes.

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

   • The document describes non-clinical testing, which typically does not involve human subjects or a "test set" in the sense of patient data.
   • The "test set" implicitly refers to the specific configurations and types of implants and abutments manufactured for performance testing, as detailed in the product description (e.g., various diameters and lengths).
   • Data Provenance: Not applicable in the context of human data. The testing refers to laboratory-based, non-clinical evaluations.

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

   • Not applicable. This was a non-clinical, laboratory-based study for demonstrating device performance and equivalence against established standards and predicate devices. No human 'ground truth' experts were involved in evaluating test outcomes in the way they would be for diagnostic accuracy studies. The "ground truth" here is compliance with engineering and material standards and performance comparable to established predicate devices.

3. Adjudication method for the test set:

   • Not applicable. As a non-clinical performance study, there's no "adjudication" in the sense of reconciling disagreements among human readers or evaluators. The results would be objectively measured physical properties and performance characteristics.

4. 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. This is a medical device for implantation, not an AI/diagnostic software. No MRMC study was performed.

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

   • No. This is a medical device, not an algorithm or AI. The performance testing is inherent to the physical device.

6. The type of ground truth used:

   • The "ground truth" for this substantial equivalence determination is conformance to recognized standards, engineering specifications, and established safe and effective performance of the predicate devices.
   • This includes:
     • Compliance with 21 CFR 872.3640 (Endosseous Dental Implant regulation)
     • Adherence to "Guidance for Industry and FDA Staff -Class 11 Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments."
     • Demonstrated equivalence of technological characteristics (material, design, dimensions, surface treatment, intended use, etc.) to the identified predicate devices (Nobel Active Internal Connection Implant (K071370) and Sterngold Acid Etch Dental Implant System (K023580)).

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set.

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

   • Not applicable. No training set was used.

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