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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.

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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.

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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.

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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.

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