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The MOR™ implants are intended to be used for oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible to support single unit restorations. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures. These implants are intended for delayed loading. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. The MOR™ implants are only intended for use with straight abutments. The implant body is intended to be placed such no angle correction is necessary.

The PUR Implants are intended to be used for oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible to support single unit, and multiple unit retained restorations may consist of single crowns or bridges as well as complete or partial dentures. These implants are intended for delayed loading. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.

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

The MOR 3.0mm Implant System consists of 3.0mm endosseous dental implants. The MOR 3.0mm implant is a one-piece endosseous dental implant, manufactured of Titanium 6AL-4V ELI. The portion of the implant that is submerged in the bone is a treated roughened surface (blasted and etched) to facilitate osseointegration. The MOR 3.0mm implant is similar in design to the MOR 2.4mm implant previously cleared by FDA. The implant lengths are10mm, 13mm, 15mm, and 18mm. The implant has two prosthetic head design options - 0-ball identical to Sterngold MOR 2.4mm Implant (K153173), and a Tapered Abutment similar to the IMTEC MDI MII One Piece Implant 2.9mm (K081653). This implant has the same design threads as the MOR 2.4mm Implant. The MOR Implants will be provided "Sterile" using Gamma sterilization.

The PUR 3.2mm Implant System consists of 3.2mm threaded endosseous dental implants, as well as prosthetic components. The prosthetic components include a Straight Narrow Platform Slim Abutment with a 1.5mm and 3.0mm cuffs and a 0.050' Hex Prosthetic Screw. The purpose of the Slim Abutments is to provide surgical and prosthetic options for smaller spaces. They attach directly to the implant with the aid of the prosthetic screw and provide the transitional link between the head of the implant and the restorative components. These abutments are straight and not intended for angulation. The PUR Straight Slim Abutments are similar to FDA cleared PUR Straight Abutments Narrow and Regular Platforms 1.5mm and 3.0mm cuffs (K151928). The difference is the body of the proposed Straight Narrow Platform Slim Abutment is more tapered. The abutments and prosthetic screw are made of Titanium 6AL-4V ELI. The ancillary component is a 3.2mm cover screw, which is flush with the top surface of the implant to prevent tissue and bone from growing inside the implant. It is screwed onto the immediately after implant placement. It is made of Titanium 6AL-4V ELI. The PUR 3.2mm implant is an endosseous dental implant made of Titanium 6AL-4V ELI with a treated roughened surface (blasted and etched). The implant body is tapered with double-lead threads and10 start micro threads at the collar. The implant lengths are 8mm, 10mm, 12mm and 14 mm. This implant The PUR 3.2mm implant features the same prosthetic platform as the 3.5mm and 4.3mm implants already cleared by FDA (K151928). The purpose of the 3.2mm PUR implant is to provide surgical and prosthetic options for smaller spaces. The PUR 3.2mm Implants will be provided "Sterile" using Gamma sterilization.

This looks like a 510(k) summary for dental implants, which are hardware devices and do not utilize AI. As such, the requested information (acceptance criteria, study details, sample sizes, expert involvement, MRMC studies, standalone performance, ground truth, and training data) is not applicable to this document.

The document describes non-clinical performance testing for mechanical properties (torque) and sterilization/biocompatibility, which are standard for medical devices. The core of the submission is to demonstrate substantial equivalence to previously cleared predicate devices through direct comparison of material, design, and intended use.

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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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The SternSnap Angled Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The attachment screws into SFI Abutments which are screwed into endosseous implants.

The SternSnap Angled Attachment is compatible with Sterngold SFI Abutments.

The SternSnapAngled Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially edentulous patients to restore chewing function. An appropriate height Sterngold SFI Abutment is screwed into an endosseous implant. A SternSnap Angled Attachment is screwed into the SFI Abutment. The SternSnap Angled Attachment can be manually pivoted on the hemispherical occlusal of the SFI Abutment until alignment is achieved. A retaining cap is processed into the denture. The retention cap engages the outside of the modified ball shape and allows retention of the prosthesis to the denture.

The proposed device is intended for angulation of divergent implants.

The SternSnap Angled Attachment can be pivoted from a central, 0 degree, position up to and including 17 degrees. It can also be rotated through 360 degrees. Therefore, two SternSnap Attachments can align two implants that are up to and including 34° out of parallel. The SternSnap Angled Attachment is only to be used with Sterngold SFI Abutments.

The provided text is a 510(k) summary for the "SternSnap Angled Attachment." This document primarily focuses on establishing substantial equivalence to predicate devices for regulatory clearance, rather than presenting a detailed study proving the device meets specific acceptance criteria in the way a clinical trial or performance study might for a novel diagnostic algorithm.

Therefore, the requested information elements related to algorithms, ground truth, expert adjudication, multi-reader studies, and training sets are not applicable to this type of regulatory submission and device.

However, I can extract the relevant information regarding acceptance criteria and the non-clinical studies performed for this device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a number of devices tested. The non-clinical tests likely involved a representative sample of manufactured devices.
• Data Provenance: The studies were non-clinical bench tests performed by the manufacturer, Sterngold Dental, LLC, or referenced data from Cendres & Metaux, SA for predicate devices. There is no mention of country of origin for the data (beyond the companies' locations) or whether it was retrospective/prospective, as these are clinical study terms.

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

• Not Applicable. This is a mechanical device, and "ground truth" as typically defined for AI algorithms (e.g., expert consensus on medical images) does not apply. Performance was assessed through engineering and mechanical testing methodologies.

4. Adjudication Method for the Test Set

• Not Applicable. See point 3. Testing results were evaluated against engineering specifications and industry standards/guidance.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

• Not Applicable. This is a non-AI, non-diagnostic medical device. No human readers or AI assistance are involved in its primary function or evaluation.

6. Standalone (Algorithm Only) Performance Study

• Not Applicable. This is a mechanical device, not an algorithm.

7. Type of Ground Truth Used

• Not Applicable (in the AI/clinical sense). For this device, "ground truth" would be established through engineering specifications, material properties, and validated bench testing protocols (e.g., ASTM standards for cyclic loading, torque retention measurements, dimensional accuracy verification).

8. Sample Size for the Training Set

• Not Applicable. This is a mechanical device, not an AI algorithm requiring a training set.

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

• Not Applicable. See point 8.

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The Stern AC Dental 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 Stern AC Dental Implant System is intended for delayed loading. It is also indicated for immediate loading with good primary stability and appropriate occlusal loading.

The Stern AC Dental Implants are compatible with the Straumann Rn Synocta, Straumann SynOcta Meso Abutments, Straumann RC Temporary Abutments, Straumann RC Cementable abutments and Stern IC Solid Abutments.

The Stern AC Dental Implant System is only intended for use with straight abutments.

The proposed implant is a self-tapping, double thread screw implant, manufactured from pure grade 4 titanium. The implant is acid etched except for the neck, which is machined to a smooth finish. Stern AC Implants are manufactured with a flared neck, used for one-stage, transgingival implantation. The neck and body include an internal taper and octagon. The implants are manufactured with three body diameters, 3.3 mm, 4.0 mm, and 5.0 mm, all with the same prosthetic head.

The proposed implants are prosthetically compatible with the Straumann ITI implant system and the Stern IC Dental Implant System previously approved for market:

Straumann Rn Synocta - K073628 Straumann SynOcta Meso Abutments - K033243 Straumann RC Temporary Abutments - K093027 Straumann RC Cementable abutments - K072071 Stern IC Solid Abutments - K111798

They are packaged sterile in a double blister, which contains implant with an implant mount screw secured in a titanium tube. The Mount Body is screwed into the using the mount screw, which keeps it in place. This configuration is known as "Direct Delivery", which allows the surgeon to transport the implant from the package to the prepared implant site and save chairside time. The proposed Stern AC Dental Implant will be available in a range of lengths and diameters.

The provided document is a 510(k) Premarket Notification for the Stern AC Dental Implant System. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving the device meets specific acceptance criteria with quantifiable performance metrics. Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted from this document.

However, based on the information provided, here's what can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state numerical acceptance criteria or quantifiable performance metrics for the Stern AC Dental Implant System. Instead, the "performance" demonstrated is that the device is "substantially equivalent" to predicate devices and "performs appropriately for the proposed indications for use." The performance testing mentioned is primarily non-clinical, focusing on material and design characteristics.

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

• Test Set Sample Size: Not applicable in the context of this document. The submission is based on demonstrating substantial equivalence through comparison of design, materials, and non-clinical performance to existing cleared devices, not on a clinical "test set" of patients or a defined dataset with ground truth for algorithm evaluation.
• Data Provenance: The data provided primarily stems from the manufacturer's internal design specifications, material characterization, manufacturing process descriptions, and comparisons to predicate devices. It is entirely retrospective in the sense that it relies on existing knowledge and data for predicate devices and internal validation of the manufacturing processes and material properties of the new device. There is no mention of patient data, clinical trials, or external datasets.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

• Not applicable. There is no "test set" in the sense of a dataset requiring expert ground truth establishment for algorithm evaluation. The "ground truth" for this submission is FDA's existing clearances for predicate devices and established standards for dental implant materials and design.

4. Adjudication Method for the Test Set:

• Not applicable. There is no "test set" requiring adjudication.

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 document describes a traditional medical device (dental implant) submission, not an AI/software as a medical device (SaMD) submission. Therefore, no MRMC study or AI-related effectiveness analysis was conducted or reported.

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

• Not applicable. This is not an AI/algorithm-based device.

7. The Type of Ground Truth Used:

• The "ground truth" in this context is established by:
  • Regulatory Precedent: The FDA's previous clearance of the predicate devices (Sterngold Acid Etch Dental Implant System (K023580) and Stern IC Dental Implant System (K111798)).
  • Industry Standards: Adherence to guidance documents like "Guidance for Industry and FDA Staff -Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments."
  • Material Science Principles: The properties of CP Titanium grade 4 and the known performance of specific surface treatments (blasted with aluminum oxide particles and acid etched).
  • Engineering Design Principles: The design features like self-tapping threads, flared neck, and internal connections are evaluated against known engineering principles for dental implants.
  • Laboratory Testing: SEM photographs for blasting residue removal and sterilization validation results.

8. The Sample Size for the Training Set:

• Not applicable. As this is not an AI/machine learning device, there is no "training set."

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

• Not applicable. There is no "training set" or ground truth for such a set.

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The Straight Stud Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The attachment screws into SFI Abutments which are screwed into endosseous implants.

The Straight Stud Attachment is compatible with all Sterngold SFI Abutments.

The Straight Stud Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The attachment screws into SFI Abutments which are screwed into endosseous implants.

The attachment consists of a modified ball, which screws into an SFI Abutment and a retaining female, which is processed into the denture. The retaining female engages the outside of the ball shape and allows retention of the prosthesis to the denture.

Sterngold SFI abutments are compatible with several implant systems that have been previously cleared under K130183 and K132814 - SFI Bar® Implant Abutments.

The Straight Stud Attachment is a straight attachment and is not intended for angulation of divergent implants. It has a 0.048" hex for tightening to the SFI abutment.

The provided text is a 510(k) summary for a medical device (Straight Stud Attachment) and does not describe acceptance criteria or a study proving that the device meets those criteria in the way typically expected for an AI/ML medical device. This document is for a mechanical dental device and the "performance data" refers to mechanical testing.

Therefore, many of the requested fields cannot be answered as they pertain to AI/ML device studies.

Here's an attempt to answer the questions based only on the provided text, recognizing its limitations:

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

The document mentions "specifications for a reliable connection" and "retention force testing was conducted to ensure level of retention was acceptable" and "dimensional verification against drawing." However, specific quantitative acceptance criteria and corresponding performance metrics are not provided in this summary.

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: The document states "fit checks of attachment to SFI abutment on several samples." This is vague and does not provide a specific sample size.
• Data provenance: Not specified. The testing is described as "Non-Clinical Performance Data," implying lab-based mechanical testing rather than human clinical 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 is not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" here would be the physical properties and performance characteristics of the mechanical device, verified through engineering tests.

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

Not applicable for this type of mechanical device testing.

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. This is a mechanical dental device, not an AI/ML diagnostic tool.

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

No. This is a mechanical dental device. The "standalone" performance would be its mechanical function, which was evaluated non-clinically.

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

The "ground truth" for this device's non-clinical performance data would be:

• Engineering specifications and drawings.
• Physical measurements (dimensions, forces, material properties).
• Functional requirements (e.g., ability to screw in, retention).

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI/ML algorithm that requires training data.

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

Not applicable, as there is no training set for a mechanical device. The design specifications and material properties are established through standard engineering practices and regulatory requirements.

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The ORA Implant Abutment System is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially edentulous patients to restore chewing function. The abutment screws directly into endosseous implants or they screw into SFI Abutments which are screwed into endosseous implants.

The ORA Implant Abutment is a precision machined ball shaped abutment that connects a compatible dental implant system with a removable partial or complete overdenture. The implant abutment is screwed into the dental implant. Connection to and retention of a denture is provided by a rubber o-ring, which may or may not be held within a metal housing. There are two color o-rings, a red processing o-ring and a white final o-ring. The retaining ring (metal housing) comes with the red o-ring (which is a firm rubber) inside. The retaining ring (metal housing) with the red o-ring is pushed over the wide part of the ball until seated. The stiffness of the red o-ring holds the housing in position. Any exposed areas of the abutment are blocked out so that only the metal housing is exposed. The retaining ring (metal housing) is then processed into the denture. After the material has cured, the denture is removed. The red o-ring is pulled out of the metal housing and the white o-ring is inserted into its place. The white o-ring is more flexible making insertion and removal easier. The bottom portion of the abutment (cuff area to end of threads) is an exact replica of the SFI Implant Abutments previously cleared by K130183 and K132814. ORA Implant Abutments are available in sixteen different platforms and each platform is compatible with one or more implant types.

Here's a breakdown of the acceptance criteria and the study information for the ORA Implant Abutment System, based on the provided text:

ORA Implant Abutment System

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) summary does not explicitly state quantitative performance acceptance criteria (e.g., specific thresholds for force, displacement, or reliability percentages). Instead, the acceptance criterion for the ORA Implant Abutment System is substantial equivalence to its predicate devices in terms of design, materials, intended use, operating principles, and manufacturing.

The reported device performance is that it meets this criterion through application and functional testing.

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

The document mentions "non-clinical test data" and "application and functional testing" to evaluate performance characteristics.

• Sample Size for Test Set: Not explicitly stated as a number of devices tested. The testing involved "tolerance analysis of platforms to identify worst case test samples." This suggests a selection of representative samples based on design variations, rather than a large statistical sample size of identical units.
• Data Provenance: The document does not specify the country of origin of the data. The testing appears to be internal (conducted by or for Sterngold Dental, LLC) and is retrospective in the sense that it's comparing a new device to existing predicate devices' performance characteristics, rather than collecting new clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This section is not applicable as the study described is non-clinical performance testing for substantial equivalence, not a study involving human expert interpretation for ground truth.

4. Adjudication Method for the Test Set

This section is not applicable as the described study is non-clinical performance testing, not a study requiring expert adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not necessary." The comparison is for substantial equivalence to predicate devices based on technical characteristics and non-clinical performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the ORA Implant Abutment System is a physical medical device (implant abutment), not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission is demonstration of equivalent performance characteristics to legally marketed predicate devices through non-clinical testing. The predicate devices themselves represent established safe and effective designs in the market.

8. The Sample Size for the Training Set

This section is not applicable as the ORA Implant Abutment System is a physical device and no machine learning algorithm was described that would require a "training set."

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

This section is not applicable for the same reasons as point 8.

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The SFI-Bar® Implant Abutments are indicated to be used with dental implants as a prosthetic framework to support and /or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The abutment screws are intended to secure the bar to the endosseous implants.

The SFI Bar® Implant Abutments provide the connection between compatible dental implant systems for the fixation of removable overdentures. The SFI Bar® Implant Abutments consist of an abutment, which is attached to a stress free bar for the fixation of removable overdentures. The implant abutment is screwed into the dental abutment.

The implant abutments fit Straumann Bone Level RP, Straumann Bone Level NP, Ankylos, Nobel 5mm Trilobe, Nobel Conical RP, Nobel Conical NP, Astra 4.5/5.0, Astra 3.5/4.0, Zimmer TSV 5.7mm.

There are nine (9) different platforms and each platform is compatible with one or more implant types. The platforms of the abutments are [BD], [BE], [AE], [AN], [AY], [AY], [AJ], [AK], [BF]. Table 1 indicates which implants are compatible with these platforms. The difference between each platform is the internal connection with the specific implant.

The devices are supplied non-sterile, therefore there is no shelf life.

The provided document is a 510(k) Premarket Notification for the SFI Bar® Implant Abutments. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the safety and effectiveness of a novel device through extensive clinical trials with specific acceptance criteria and detailed performance metrics.

Therefore, many of the requested categories for device performance, ground truth, and comprehensive study details are not applicable or available in this type of regulatory submission. The document primarily describes non-clinical testing to support the claim of equivalence.

Here's a breakdown based on the available information:

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: Not explicitly stated as numerical counts of products tested. The document mentions "tolerance analysis of platforms -to-identify-worst-case-test-samples" which implies selected samples were tested, but the exact number isn't provided.
• Data Provenance: Not specified. Given it's a US-based company submitting to the FDA, it's highly probable the testing was conducted in the US, but this is not explicitly stated. The testing is described as non-clinical, likely laboratory-based.
• Retrospective or Prospective: Not applicable, as this refers to clinical studies, and only non-clinical testing was performed.

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)

• Number of Experts & Qualifications: Not applicable. Non-clinical testing for equivalence does not typically involve expert consensus to establish a "ground truth" in the way clinical studies do. The "ground truth" for material specifications and performance would be established by engineering standards and internal company specifications.

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

• Adjudication Method: Not applicable. This concept is relevant to clinical studies involving human interpretation or subjective assessments. Performance testing of abutments involves objective measurements against engineering specifications.

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

• MRMC Comparative Effectiveness Study: No, this type of study was not done. The device is a dental implant abutment, not an AI-powered diagnostic tool.
• Effect Size: Not applicable.

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

• Standalone Performance: Not applicable. The device is a mechanical component (dental abutment), not an algorithm.

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

• Type of Ground Truth: For the non-clinical testing, the "ground truth" would be engineering specifications, material standards (like ASTM F136), and validated test methodologies to assess physical properties and fit. There is no biological "ground truth" in the context of this 510(k) submission.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. The device is a manufactured medical device, not an AI/ML model that requires a training set.

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

• Ground Truth for Training Set Establishment: Not applicable.

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The SFI-Bar® Implant Abutments are indicated to be used with dental implants as a prosthetic framework to support and /or retain removable or fixed dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The abutment screws are intended to secure the bar to the endosseous implants.

The SFI Bar® Implant Abutments provide the connection between compatible dental implant systems for the fixation of removable overdentures. The SFI Bar® Implant Abutments consist of an abutment, which is attached to a stress free bar for the fixation of removable overdentures. The implant abutment is screwed into the dental abutment. The implant abutments fit Nobel Biocare Brånemark System®. Nobel Biocare (Steri-Oss®), Keystone (Lifecore), 3i Implant Inovations®, Sterngold-ImplaMed®, Interpore IMZ™, Osstem, Zimmer (Paragon, Centerpulse), OIC, IMTEC Corporation®, MIS Implants, Minimatic/Stryker, Bud, Straumann, Biolok International, INNOVA, Implant Direct, Zimmer (Calcitek® Centerpulse), BioHorizons®. See table 1 for platform compatibility.

There are seven (7) different platforms and each platform is compatible with one or more implant types. The platforms of the abutments are [A], [B], [C], [S], [X], [X], [Z]. Table 1 specifies which dental implants are compatible with these platforms. The difference between each platform is the internal connection with the specific implant. The devices are supplied non-sterile, therefore there is no shelf life.

The provided text describes the SFI Bar® Implant Abutments, a medical device for dental use. It outlines the device's characteristics and its equivalence to predicate devices, supported by non-clinical performance data.

Here's an analysis of the acceptance criteria and study information, based only on the provided text, and noting what information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size: Not specified. The text only mentions "Test samples torqued above 50 Ncm".
• Data provenance: The studies were non-clinical tests conducted by the manufacturer, Sterngold Dental, LLC. The country of origin is not explicitly stated. It is a retrospective analysis of the device's performance against established standards and predicate devices.

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

• Number of experts: Not applicable for this type of testing. The 'ground truth' for mechanical performance tests like torque is typically defined by engineering specifications and industry standards rather than expert consensus on subjective evaluations.
• Qualifications: Not applicable.

4. Adjudication method for the test set:

• Not applicable. Mechanical tests for medical devices are typically assessed against pre-defined quantitative thresholds and standards, not through adjudication by experts.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. An MRMC study is relevant for diagnostic imaging or similar devices where human readers interpret results. This device is a dental implant abutment, and its performance is evaluated through mechanical testing.

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

• Yes, in essence. The testing described ("Torque tests, application and functional testing") is a standalone assessment of the physical device's performance characteristics. This is a mechanical device, not an algorithm, so the "standalone" concept translates to evaluating the device itself without human intervention affecting its inherent mechanical properties.

7. The type of ground truth used:

• Engineering specifications and regulatory guidance. The ground truth for this device's performance, particularly torque, is based on "implant manufacturer's recommended torque value" and likely general engineering standards for mechanical strength and durability. The evaluation also refers to "FDA guidance 'Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments.'"

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML algorithm that requires a training set. The "training" here would refer to the design and manufacturing processes, which are guided by established engineering principles and past experience with similar devices (the predicate devices).

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

• Not applicable. As noted above, this is not an AI/ML algorithm. The "ground truth" for the design and manufacturing of such a device is rooted in engineering principles, material science, and regulatory standards for dental implants and abutments. The text states, "The implant abutments were designed and developed, and manufactured according to manufacturer's specifications and controlled procedures," and they conform to "ASTM F136, Wrought Titanium 6 Aluminum-4 Vanadium ELI Alloy."

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