Search Results

Medentika abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
Medentika abutments for the Dentsply Sirona Astra Tech OsseoSpeed EV 3.0mm and TX 3.0mm implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.
Medentika TiBase CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. Medentika TiBase is intended for use with the Straumann® CARES® System. All digitally designed copings and/or crowns are intended to be sent to Straumann for manufacture at a validated milling center.
Medentika abutments for the Nobel Biocare Nobel Active®* 3.0mm, Dentsply Sirona Astra Tech OsseoSpeed EV®* 3.0mm and TX®* 3.0mm implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.
Medentika PreFace CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
Medentika Preface is intended for use with the Straumann® CARES® System. All digitally designed abutments for use with Medentika CAD/CAM Abutments are intended to be manufactured at a Straumann® CARES® validated milling center. The final patient matched form is a MedentiCAD abutment.
Medentika abutments for the Dentsply Sirona Astra Tech OsseoSpeed EV 3.0mm implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.
Multi-unit abutments are indicated for use with dental implants as a support for multi-unit screw retained bridges and bars in the maxilla or mandible of a partially or fully edentulous patient.

The Medentika abutments include abutments, abutment screws, caps, and bases which are labelled under a specific Medentika series and are compatible with a specified dental implant system. The abutments include sinqle-unit abutments intended for use with dental implants as a support for single or multiple tooth protheses in the maxilla or mandible of a partially or fully edentulous patient. The abutments also include multi-unit abutments indicated for use with dental implants as a support for multi-unit screw retained bridges and bars in the maxilla or mandible of a partially or fully edentulous patient.
The purpose of this premarket notification is to add additional abutments. The subject abutments include abutments compatible with additional dental implant systems forming a new Medentika series (the OT series). The subject abutments also include abutments compatible with new implant diameters in existing Medentika series (E, EV, F, and S). Lastly, the subject abutments include new abutment designs compatible with existing implant diameters in existing Medentika series (R).

This looks like a 510(k) Summary for a medical device (dental abutments), which means the document is about proving "substantial equivalence" to a predicate device, not about proving clinical effectiveness or performance against pre-defined acceptance criteria in the way one might for a novel AI/software medical device.

Therefore, the information requested in your bullet points (e.g., acceptance criteria table, sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) is not applicable to this type of regulatory submission because the device is a mechanical one, not an AI/software device. The data presented here is focused on demonstrating physical and mechanical compatibility and equivalence to previously cleared devices.

Here's why each point is not applicable and what information is provided:

1. A table of acceptance criteria and the reported device performance: This document doesn't provide a typical "acceptance criteria" table as would be seen for an AI/software device measuring diagnostic performance (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating that the new abutments perform similarly to existing, cleared abutments through "dynamic fatigue testing" and "dimensional analysis and reverse engineering." The performance is implicitly "accepted" if these tests show equivalence to the predicate.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No "test set" in the context of diagnostic performance is mentioned. The "testing" refers to non-clinical, physical testing (fatigue, dimensional analysis). There is no patient data involved in this type of submission for a mechanical device.

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. Ground truth, in the AI/software sense, is not established for this device. The "truth" is based on engineered specifications and physical testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No human adjudication of diagnostic output is relevant here.

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 not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" is engineering specifications and physical measurements.

8. The sample size for the training set: Not applicable. There is no AI/machine learning component to "train."

9. How the ground truth for the training set was established: Not applicable for the same reason as above.

What the document does provide regarding device performance and testing:

• Type of Testing:

  • Dynamic fatigue testing according to FDA guidance and ISO 14801 (Dentistry - implants dynamic loading test for endosseous dental implants).
  • Dimensional analysis and reverse engineering of the implant-to-abutment connection platform.
  • Sterilization validation (steam and gamma irradiation) referenced from K191123, ISO 17665-1, ISO/TS 17665-2, ISO 11137-1, ISO 11137-2.
  • Sterile packaging validation referenced from K191123, ISO 11607-1, ISO 11607-2.
  • Biocompatibility evaluations referenced from K142167, K170838, K191123, K150203, K061804 in accordance with ISO 10993-1.
  • MR testing referenced from K180564 in accordance with ASTM F2052-15, ASTM F2213-06 (2011), ASTM F2182-11a, and ASTM F2119-13.

• Conclusion: The tests demonstrated "implant to abutment compatibility" and "established substantial equivalency of the proposed device with predicate devices." This is the "proof" that the device meets the (implicit) acceptance of being substantially equivalent to existing, legally marketed devices.

In summary, this document is for a traditional mechanical medical device, and the regulatory pathway does not involve performance studies in the way you've outlined for AI/software-based devices.

Ask a specific question about this device

MIS dental implant systems are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate.

Narrow implants (Ø3.30mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another. The long MIS (18 & 20mm) implants can be used in a tilted manner. MIS short implants are to be used only with straight abutments. M4 short implants are indicated for delayed loading only.

The proposed MIS Angulated multi-unit abutments are endosseous dental implant abutments that are connected to MIS dental implants and used as an aid in prosthetic rehabilitation, for anchoring screw retained multiple-unit restorations.

MIS Angulated multi-unit abutments consist of a one-piece abutment and a prosthetic multi-unit screw, both made of Titanium complying with ASTM F136-13 (Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (USN R56401). The proposed abutments are available in 17° and 30° angulations and connected to the implant by a prosthetic multi-unit screw supplied with the proposed abutments. The proposed abutments are also supplied with a titanium gripping bar used to position the multi-unit abutment on the implant. The proposed abutments are supplied sterile to the user.

The proposed MIS cementing cap is a superstructure that has a standard connection design intended to be directly connected to all MIS straight and angulated multi-unit abutments with a prosthetic screw. The proposed cementing cap and prosthetic screw are made of Titanium complying with ASTM F136-13. Multi-unit cementing caps are delivered non-sterile, and are intended to be cleaned and steamsterilized by a professional user according to the instructions before use.

The provided text is a 510(k) Summary for a medical device (MIS Angulated multi-unit abutments). It outlines how the device demonstrates substantial equivalence to predicate devices, primarily through non-clinical performance data.

Here's a breakdown of the requested information based on the provided text:

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

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

• Sample Size (Test Set): The document does not specify the exact number of units tested for fatigue. It refers to "representative worst-case MIS Angulated multi-unit abutment-implant combinations." For sterilization and shelf life, it refers to "validation" and "study" without giving specific unit counts.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given that it's a 510(k) submission to the FDA, it is expected that the data would be generated in compliance with relevant international standards (like ISO 14801 for fatigue testing) and potentially reflect a global manufacturing and testing approach.

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 section is not applicable as the document describes non-clinical performance testing for a dental implant abutment, not a diagnostic device requiring expert interpretation for ground truth. The "ground truth" here is the physical performance and material properties meeting established engineering and biological standards.

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

This is not applicable. Adjudication methods are typically used in clinical studies involving human readers or interpretation, not for mechanical or sterilization testing of a physical device.

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. The device is a physical dental implant abutment, not an AI-powered diagnostic tool. No human reader or AI assistance is involved.

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

This is not applicable. The device is a physical dental implant abutment, not an algorithm.

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

For the non-clinical tests described:

• Fatigue Testing: The "ground truth" is established by the specified performance requirements of ISO 14801:2016 and FDA guidance (e.g., ability to withstand 5,000,000 cycles without failure at a specific load). This is a predetermined engineering performance standard.
• Sterilization: The "ground truth" is the achievement of a Sterility Assurance Level (SAL) of 10-6, which is an industry standard for sterility.
• Shelf Life: The "ground truth" is a 5-year shelf life, supported by real-time aging study data.
• Biocompatibility: The "ground truth" is the determination that the material and manufacturing process are safe for human contact based on established biocompatibility standards and equivalence to a previously cleared device.

8. The sample size for the training set

This is not applicable. The device is a physical product, not a machine learning model that requires a training set.

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

This is not applicable as there is no training set for this type of device.

Ask a specific question about this device

The BioHorizons Multi-unit Abutments for CONELOG® are intended to function in the mandble or maxilla to support single and multiple-unit temporary or definitive restorations on CONELOG dental implants.

The purpose of this submission is to obtain marketing clearance for BioHorizons Multi-unit Abutments for CONELOG® implants. The submission includes a set of multi-unit abutment screws compatible with two (2) implant lines within the CONELOG® Implant System, manufactured by Altatec GmbH. This compatibility was established via a business agreement between BioHorizons Implant Systems, Inc. and Altatec GmbH. The corresponding compatible CONELOG implant platform diameters range from 3.3 mm to 4.3 mm. All sizes of the compatible CONELOG dental implants have the same tapered implant/abutment interface connection design as the subject device. The connection includes three (3) positioning cams on the abutment that engage complementary features on the implant to prevent rotation of the abutment relative to the implant.

The subject device Multi-unit Abutments for CONELOG are designed for attachment of single-unit and multi-unit screw-retained restorations. They are available in straight and angled designs, which are referred to as Multi-unit Straight Abutment for CONELOG and Multi-unit Angled Abutment for CONELOG, respectively. The straight and angled designs each are available in gingival heights of 2, 3, and 4 mm. All designs have a prosthetic diameter of 4.8 mm.

Multi-unit Angled Abutment for CONELOG designs have the coronal end inclined at either 17° or 30° to the implant axis for correction of angulation. The angled abutment includes an internal thread in the coronal portion of the abutment to accommodate a prosthetic screw for the screw-retained restoration. Each angled abutment is available in Type A or Type B orientations. Type A refers to an orientation in which one (1) of the three (3) positioning cams is aligned opposite the direction of abutment angulation. Type B refers to an orientation in which the cam alignment coincides with the direction of abutment angulation.

The subject device Multi-unit Abutments for CONELOG includes Class II abutment-level prosthetic components used for fabrication of provisional and final restorations. These prosthetic components include copings made of titanium alloy, gold alloy, or polyoxymethylene, a temporary cover cap made of titanium alloy, and prosthetic screws made of titanium alloy. The titanium alloy and gold copings and the prosthetic screws become part of the finished restoration.

All subject device abutments and abutment screws are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).

The provided text describes the regulatory clearance of a dental device and discusses its substantial equivalence to predicate devices, but it does not contain information about formal acceptance criteria or a study proving that the device meets specific performance criteria in a clinical or user-focused sense. The "performance data" section explicitly states "No clinical data were included in this submission."

The document details non-clinical data submitted for regulatory approval, which focuses on demonstrating safety and equivalence, not necessarily specific performance against clinical acceptance criteria.

Therefore, for most of your requested information, the answer based solely on the provided text is that the data is not present.

Here's a breakdown of what can and cannot be answered:

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

2. Sample sized 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 specified for any of the non-clinical tests. For mechanical testing (ISO 14801), while testing is mentioned, the number of samples tested is not provided in detail.
• Data Provenance: Not specified. The studies are non-clinical (laboratory testing) rather than clinical.

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. The described "performance data" refers to non-clinical (laboratory) testing, not studies requiring expert ground truth for clinical outcomes or diagnoses.

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

• Not Applicable. This pertains to clinical studies often involving human interpretation and consensus, which is not described here.

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. The document explicitly states: "No clinical data were included in this submission." This type of study is specifically clinical and often involves AI, which is not mentioned in the context of this device.

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

• Not Applicable. This device is a dental abutment, a physical medical device, not an algorithm or AI system.

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

• Not Applicable. The performance data discussed is for non-clinical, mechanical, and material testing. The "ground truth" for these types of tests would be the established scientific and engineering principles and the results from the standardized testing protocols themselves.

8. The sample size for the training set

• Not Applicable. This device is a physical medical device, not a machine learning model that requires a training set.

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

• Not Applicable. As per point 8, there is no training set for this type of device.

In summary: The provided text is a 510(k) summary for regulatory clearance, which focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing and comparison of characteristics. It does not provide information about clinical trials, user studies, or AI algorithm performance, which would typically involve the requested details on acceptance criteria, sample sizes, expert ground truth, and adjudication methods for clinical performance.

Ask a specific question about this device

Multi-unit abutments are indicated for use with dental implants as a support for multi-unit screw retained bridges and bars in the maxilla or mandible of a partially or fully edentulous patient.
Multi-unit Abutments are used for the restoration of the following dental implant systems:
Medentika series EV-Series, Implant system Dentsply® Implants - ASTRA TECH OsseoSpeed®, Implant diameter 3.6, 4.2, 4.8, Platform diameter 3.6, 4.2, 4.8
Medentika series F-Series, Implant system Nobel Biocare NobelActive - NobelReplace Conical, Implant diameter 3.5, 4.3, 5.0, Platform diameter NP 3.5, RP 4.3/5.0
Medentika series H-Series, Implant system Biomet 3i - Certain, Implant diameter 3.25, 4.0, Platform diameter 3.4, 4.1
Medentika series L-Series, Implant system Straumann - Bone Level, Implant diameter 3.3, 4.1, 4.8, Platform diameter 3.3, 4.1, 4.8
Medentika series N-Series, Implant system Straumann - Soft Tissue Level, Implant diameter 4.1, 4.8, Platform diameter 4.8, 6.5
Medentika series R-Series, Implant system Zimmer Dental Tapered Screw-vent, Implant diameter 3.3, 3.7, 4.1, 4.7, Platform diameter 3.5, 4.5

The proposed Multi-unit Abutments are dental abutments, which are intended to be screwed onto osseointegrated dental implants to provide support for prosthetic suprastructures on the gingival level. Multi-unit abutments can be used in combination with screw-retained multi-unit dental prosthetics, e.g. bridges and bars, which are used to reconstruct the function and aesthetics of lost teeth. Multi-unit abutments are very similar to the already FDA-cleared Straumann Screw-Retained Abutment System. Multi-unit abutments are available as straight abutments, which have an integrated thread and can be screwed directly into the implant, or as angled abutments, which can be screwed onto the implant with the corresponding abutment screw. All models of Multi-unit abutments have a universal interface for a variety of prefabricated prosthetic parts, e.g. Multi-unit caps, which become part of the superstructure and ensure a low-tension screw connection of the multi-unit prosthetics.
The Multi-Unit caps or base are used in conjunction with the Multi-Unit Abutment. The Multi-Unit Abutment is considered the bottom half of a two-piece abutment and the Multi-Unit Caps or Multi-Unit Titanium base are considered the top half of the two-piece abutment.
Multi-unit Abutments exist in two model types: straight multi-unit abutments without rotational indexing with various gingival heights and platform diameters and angled multi-unit abutments with rotary indexing with various ginqival heights and platform diameters.

The provided document is a 510(k) premarket notification for "Multi-unit Abutments." This document establishes substantial equivalence to predicate devices based on technological characteristics and performance testing. However, it does not describe a study that proves the device meets specific acceptance criteria related to AI/algorithm performance in a diagnostic or interpretive context.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" outlined in the request (e.g., MRMC study, ground truth, expert consensus, sample size, effect size) are typically attributes of studies supporting AI/ML-driven medical devices that output a diagnostic or interpretive result. The device described in this 510(k) is a physical dental implant component, not a software or AI device.

Therefore, I cannot extract the requested information regarding AI/algorithm performance. The provided text outlines:

• Device Description: Multi-unit abutments are dental components screwed onto implants to support prosthetic suprastructures (e.g., bridges, bars).
• Performance Testing: This refers to mechanical and biological testing (e.g., dynamic fatigue, static strength, biocompatibility, sterilization) to ensure the physical device's safety and effectiveness, not the performance of an AI algorithm.
• Substantial Equivalence: The primary goal of this 510(k) is to demonstrate that the new device is as safe and effective as previously cleared predicate devices through comparisons of indications for use, design, materials, and mechanical properties.

Specifically, here's why the requested information cannot be provided from the text:

1. Acceptance Criteria/Reported Device Performance (Table): The document provides a table of "Technological Characteristics" comparing the subject device to predicates, but these are design and material specifications, not performance metrics for an AI algorithm (e.g., sensitivity, specificity, AUC).
2. Sample Size and Data Provenance: Not applicable for an AI test set. The document discusses "test sets" in the context of mechanical fatigue and static strength tests (e.g., testing multiple abutment units), but not a dataset of images or patient cases for AI evaluation.
3. Number of Experts/Ground Truth Establishment/Qualifications: Not applicable. There's no AI component requiring expert review for ground truth.
4. Adjudication Method: Not applicable.
5. MRMC Comparative Effectiveness Study: Not applicable. This device is a physical component, not an AI assisting human readers.
6. Standalone Performance: Not applicable. There is no AI algorithm to evaluate in standalone mode.
7. Type of Ground Truth Used: Not applicable. Ground truth for an AI would involve labeled data (e.g., disease presence/absence from pathology), which is irrelevant for a dental abutment.
8. Sample Size for Training Set: Not applicable.
9. Ground Truth for Training Set: Not applicable.

In summary, the provided document is a regulatory submission for a physical medical device (dental abutments), which successfully demonstrates substantial equivalence based on engineering and biocompatibility standards. It does not involve any artificial intelligence or machine learning component, and thus the acceptance criteria and study details relevant to AI performance are absent.

Ask a specific question about this device

Inclusive Multi-Unit Abutments are prosthetic components directly connected to endosseous dental implants and intended to provide support and retention for multi-unit screw-retained restorations. The 30-degree multi-unit abutments must be used within 45 degrees of parallelism for a splinted restoration. The 17-degree multi-unit abutments must be used within 32 degrees of parallelism for a splinted restoration.

The Multi-Unit Abutments with Angulations 17° and 30° are available in multiple cuff heights to provide angulation correction for off-angle implant placement. The abutments are in the following sizes: 3.5mm Platform - Angled 17° - 2mmH and 3mmH, 3.5mm Platform - Angled 30° - 3mmH, 4.5mm Platform - Angled 17° - 2mmH, 3mmH, and 5mmH, 4.5mm Platform - Angled 30° - 3mmH and 5mmH. The abutment is secured to the implant with an abutment retaining screw. The abutment and abutment retaining screw are fabricated from titanium alloy. The tapered abutments facilitate multi-unit, screw-retained restoration, and are available in titanium 6AI-4V and will provide an angulation up to 30°. The abutments are provided Sterile (Gamma) and are packaged in glass vials suspended by a carrier with a screw cap and is shrink wrapped. The glass vial is sealed inside a Chevron pouch that is compatible with radiation.

I am sorry, but the document you provided does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is primarily a 510(k) summary for a dental device (Multi-Unit Abutments) and focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Here's what the document does include:

• Device Identification: Multi-Unit Abutments with Angulations 17° and 30° for Inclusive Tapered Implant System.
• Predicate Device: Zimmer Dental Angled Tapered Abutment (K111853).
• Device Description: Details on abutment sizes, materials (titanium alloy), and intended use.
• Indications for Use: What the device is intended for (support and retention for multi-unit screw-retained restorations, with specific parallelism requirements for 30-degree and 17-degree abutments).
• Substantial Equivalence Claim: The device is substantially equivalent to the predicate in intended use, indications for use, material, design, and performance.
• Non-Clinical Testing:
  • It states that non-clinical test data was used to support safety and effectiveness.
  • Testing involved "analysis of platforms to identify worst-case test samples and their performance in accordance with the FDA guidance Class II Special controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments."
  • The conclusion of this testing was that "the device is safe and effective for its intended use and performed as well or better than the predicate device."

However, the document does NOT contain the specific details you requested, such as:

1. A table of acceptance criteria and reported device performance: While it mentions testing, it doesn't quantify "acceptance criteria" or provide specific performance metrics in a table format. It only states the device "performed as well or better than the predicate device."
2. Sample size used for the test set and data provenance: No information on how many abutments were tested or where the test data came from.
3. Number of experts used to establish ground truth and their qualifications: No mention of experts or ground truth establishment.
4. Adjudication method: Not applicable as no expert review process is described.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable, as this is a physical device, not an AI or imaging system.
6. Standalone performance study: The non-clinical testing implicitly serves as a standalone performance evaluation against a standard and the predicate, but it's not detailed.
7. Type of ground truth used: Not applicable in the context of this device's testing.
8. Sample size for the training set: Not applicable as this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable.

The non-clinical testing mentioned appears to be mechanical and material testing, common for implantable medical devices, rather than a clinical study or an AI algorithm validation study. The standard referenced, "FDA guidance Class II Special controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments," would outline the specific tests (e.g., fatigue strength, torque retention, biocompatibility) required for these types of devices, and presumably, the acceptance criteria would be defined within those standards. However, the summary provided here does not detail those specifics.

Ask a specific question about this device

The Multi-Unit Abutments for Straumann and Astra Tech Implant Systems are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.

Nobel Biocare's Multi-Unit Abutments for Straumann and AstraTech Implant Systems are endosseous dental implant abutments. The Nobel Biocare Multi-Unit Abutments for Straumann and AstraTech Implant Systems attach directly to endosseous dental implants and provides a platform for restoration.

Nobel Biocare's Multi-Unit Abutments for Straumann and AstraTech Implant Systems are made entirely of titanium/vanadium alloy.

This document is a 510(k) Summary of Safety and Effectiveness for Nobel Biocare's Multi-Unit Abutments for Straumann and AstraTech Implant Systems. This device is an endosseous dental implant abutment. The submission demonstrates substantial equivalence to previously cleared devices.

Here's the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a numerical sample size for the test set. It mentions "worst-case test samples" were identified and tested. The data provenance is within a laboratory setting, as it refers to "fatigue testing" of the physical devices. No country of origin for the data is explicitly stated beyond Nobel Biocare USA LLC's address in California. The study is prospective in the sense that the testing was performed on the new device to demonstrate its equivalence.

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

Not applicable. This is a submission for a physical medical device (dental implant abutment) that undergoes mechanical and material testing, not a diagnostic or AI-driven device requiring expert-established ground truth. The "ground truth" for this type of device is compliance with specific mechanical and material standards as outlined in FDA guidance documents.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is mechanical testing of a physical device against established standards, not a diagnostic or AI study requiring adjudication of interpretations.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-reader Multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of medical images, often with AI assistance. This submission is for a physical dental implant abutment.

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

The "ground truth" for this device's safety and effectiveness is established by physical standards and performance requirements for endosseous dental implant abutments, as outlined in the "FDA guidance Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." This involves demonstrating mechanical properties (like fatigue strength) are equivalent to legally marketed predicate devices.

8. The Sample Size for the Training Set

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

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

Not applicable.

Summary of the Study:

The study conducted was a fatigue testing of "worst-case test samples" of the Multi-Unit Abutments for Straumann and AstraTech Implant Systems. The objective was to demonstrate that these abutments meet the safety and effectiveness requirements by being substantially equivalent to legally marketed predicate devices (listed in the "Legally Marketed Device(s)" section of the document). The criteria for "substantial equivalence" were based on the FDA's Class II Special Controls Guidance Document for Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, which sets out performance standards, particularly related to fatigue life. The testing results indicated that the new device met these criteria, thereby proving its substantial equivalence to the predicates.

Ask a specific question about this device

Nobel Biocare's Multi-Unit Abutment is a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation. Nobel Biocare's Multi-Unit Abutments fit the following endosseous implants:

• AstraTech 3.5, 4.0, 4.5, 5.0 mm
• Camlog 3.3, 3.8, 4.3, 5.0, 6.0 mm
• Ankylos 3.5, 4.5, 5.5, 7.0 mm

Nobel Biocare's Multi-Unit Abutment is an artificial tooth abutment designed to fit and function on the below endosseous implants:

• AstraTech 3.5, 4.0, 4.5, 5.0 mm -
• -Camlog 3.3, 3.8, 4.3, 5.0, 6.0 mm
• . Ankylos 3.5, 4.5, 5.5, 7.0 mm
  The Multi-Unit Abutment is a prosthetic device that fits only the endosseous implants specified. The device has been developed for long-term, permanent use.
  Nobel Biocare's Multi-Unit Abutment is similar in design, intended use, and operation to the abultnents cleared in predicate devices.

The provided text is a 510(k) Summary for a dental abutment device. It outlines the device description, indications for use, and a letter from the FDA confirming substantial equivalence. However, it does not include information about acceptance criteria, detailed study results, sample sizes for test or training sets, expert qualifications, ground truth establishment, or any comparative effectiveness studies (MRMC) or standalone performance studies.

Therefore, I cannot provide the requested information from the given input. The document focuses on regulatory approval based on equivalence to predicate devices, rather than detailed performance study results with acceptance criteria.

Ask a specific question about this device