Search Results

BioHorizons implants are intended for use in the mandible or maxilla for use as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. The implants may be restored immediately (1) with a temporary prosthesis that is not in functional occlusion or (2) when splinted together for multiple tooth replacement or when stabilized with an overdenture supported by multiple implants.

BioHorizons Tapered Short Implants are intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. The implants may be restored using delayed loading, or with a terminal or intermediate abutment for fixed or removable bridgework, and for overdentures.

BioHorizons Tapered Internal 3.0, Tapered Tissue Level 3.0 Implants may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. The implants may be restored immediately (1) with a temporary prosthesis that is not in functional occlusion, (2) when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or (3) for denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.

Intra-Lock implants are intended for use in the mandible or maxilla for use as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. The implants may be restored immediately (1) with a temporary prosthesis that is not in functional occlusion or (2) when splinted together for multiple tooth replacement or when stabilized with an overdenture supported by multiple implants.

Intra-Lock 3.3mm diameter implants may be used as an artificial root structure for single tooth replacement of mandbular central and lateral incisors and maxillary lateral incisors. The implants may be restored immediately (1) with a temporary prosthesis that is not in functional occlusion, (2) when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or (3) for denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.

Mini Drive-Lock™ Dental Implants are intended for use as a self-tapping titanium screw for transitional or intra-bony long-term applications.

Mini Drive-Lock™ Dental Implants are indicated for long-term maxillary and mandibular tissue-supported denture stabilization. Multiple implants should be used and may be restored after a period of time or placed in immediate function.

MILO™ Dental Implants are indicated for long-term maxillary and mandibular tissue-supported denture stabilization. Multiple implants may be restored after a period of time or placed in immediate function. They are also indicated for the rehabilitation of single maxillary lateral incisors and mandibular lateral incisors. The implants may be restored after a period of time or placed in immediate function.

BioHorizons Prosthetics are abutments that include healing abutments for contouring tissue and final restorative abutments to support a prosthesis. The abutments may be used for a single or multiple unit restoration and are compatible for use with BioHorizons Internal and Tapered Internal implant systems and Zimmer® Dental Screw-Vent® and Tapered Screw-Vent® implants with 3.5mm, 4.5mm and 5.7mm internal hex-connection mating platform diameters.

BioHorizons Titanium Base Abutments and Laser-Lok Titanium Base Abutments are intended to be used as straight abutments.

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.

BioHorizons CAD/CAM Abutments are dental abutments placed onto a dental implant to provide support for dental prosthetic restorations. The abutments include: 1) Titanium abutment blanks with a pre-machined implant connection where the upper portion may be custom-milled in accordance with a patient-specific design using CAD/CAM techniques; and 2) Titanium bases with a pre-machined implant connection upon which a CAD/CAM designed superstructure may be fitted to complete a two-piece dental abutments include an abutment screw for fixation to the underlying implant. The abutments may be used for single-unit (single-tooth) or multiple-unit (bridges and bars) restorations and are compatible for use with BioHorizons Internal and Tapered Internal implant systems and Zimmer® Dental Screw-Vent® and Tapered Screw-Vent® implants with 3.5mm and 5.7mm internal hex-connection mating platform diameters. All digitally designed abutments and/or copings for use with BioHorizons CAD/CAM Abutments are intended to be sent to a BioHorizons-validated milling center for manufacture. BioHorizons abutments designed using CAD/CAM techniques must fulfill the BioHorizons allowable range of design parameters.

Intra-Lock Prosthetics are abutments that include healing abutments for contouring tissue and final restorative abutments to support a prosthesis. The abutments may be used for a single or multiple unit restoration and are compatible for use with Intra-Lock implants.

Intra-Lock Titanium Base Abutments and Laser-Lok Titanium Base Abutments are intended to be used as straight abutments.

Intra-Lock CAD/CAM Abutments are dental abutments placed onto a dental implant to provide support for dental prosthetic restorations. The abutments include: 1) Titanium abutment blanks with a pre-machined implant connection where the upper portion may be custom-milled in accordance with a patient-specific design using CAD/CAM techniques; and 2) Titanium bases with a pre-machined implant connection upon which a CAD/CAM designed superstructure may be fitted to complete a two-piece dental abutments include an abutment screw for fixation to the underlying implant. The abutments may be used for single-unit (single-tooth) or multiple-unit (bridges and bars) restorations and are compatible for use with Intra-lock implants. All digitally designed abutments and/or copings for use with Intra-Lock CAD/CAM Abutments are intended to be sent to a BioHorizons-validated milling center for manufacture. Intra-Lock abutments designed using CAD/CAM techniques must fulfill the BioHorizons allowable range of design parameters.

The MILO and Mini Drive Lock Implant System Prosthetics have been designed to restore partially or fully edentulous patients. The abutments have been designed to be used in either the mandible or maxilla and to support removable or fixed prosthesis.

Not Found

The provided text is a clearance letter and Indications for Use statement for BioHorizons dental implants and abutments regarding their MRI compatibility. It does not contain any information about an AI/ML device, its acceptance criteria, or performance studies. Therefore, I cannot extract the requested information.

The document pertains to the regulatory clearance of a medical device (dental implants) for use in an MRI environment, not an AI or machine learning product. It describes the physical characteristics and intended use of the implants in a traditional medical context.

To provide the requested information, a document describing an AI/ML device and its validation studies would be necessary.

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

BioHorizons Tapered IM Implants are intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. The implants may be restored immediately (1) with a temporary prosthesis that is not in functional occlusion or (2) when splinted together for multiple tooth replacement or when stabilized with an overdenture supported by multiple implants.

The BioHorizons Tapered IM Implants are machined titanium, screw-form endosseous dental implants supplied in 7.0mm and 8.0mm diameters. Both implants include a 5.7mm prosthetic platform. The implants are provided in 7.5mm, 9.0mm and 10.5mm lengths across both diameters. Implant material is titanium alloy as specified in ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surqical Implant Applications. The devices are further processed by roughening the threaded surface with Resorbable Blast Texture (RBT) media (hydroxylapatite) and by micro-machining grooves, known as Laser-Loke microchannels, on the implant collar. The product is packaged using materials known in the industry to be appropriate for medical device packaging and is provided with a minimum sterility assurance level of 10°, validated in compliance with ANSI/AAMI/ISO 11137-1 Sterilization of healthcare products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.

The provided document is a 510(k) Premarket Notification from the FDA for a dental implant device. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a performance study with acceptance criteria in the typical sense of a human-in-the-loop or standalone AI/software study.

Therefore, many of the requested points regarding acceptance criteria and performance study details (like sample size, number of experts, adjudication, MRMC, standalone performance, training data, etc.) are not applicable to this type of submission. This document describes a medical device (a dental implant), not a diagnostic AI or imaging device that would typically involve such performance metrics and studies.

However, I can extract the relevant information pertaining to the "acceptance criteria" and "study" as presented in the context of this 510(k) submission, which are focused on physical and mechanical properties of the implant and demonstrating its safety and effectiveness through substantial equivalence.

Here's a breakdown based on the provided document:

Relevance of the Document to the Request:

This document is a 510(k) Premarket Notification for a dental implant (a physical medical device). The primary objective of a 510(k) submission is to demonstrate that the new device is substantially equivalent (SE) to a legally marketed predicate device, meaning it is as safe and effective as the predicate. This is different from a clinical trial or performance study typically conducted for AI/software-as-a-medical-device (SaMD) where metrics like sensitivity, specificity, or reader accuracy are paramount.

Therefore, many of the questions asked in the prompt, which are highly relevant to SaMD performance studies, are not directly addressed or applicable in this document about a physical dental implant.

Acceptance Criteria and Study for BioHorizons Tapered IM Implants (based on provided text):

The "acceptance criteria" and "study" in this context refer to the engineering and quality control measures to demonstrate the new implant's mechanical integrity, material compatibility, and manufacturing consistency, primarily by comparing it to already cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set (for dimensional assessment): Not explicitly stated as a numerical sample size. It refers to "the worst-case subject Tapered IM implant device (smallest implant body diameter combined with the shortest implant length)." This implies a single representative sample was chosen for a comparative dimensional analysis, demonstrating a specific design characteristic rather than a statistical test on a batch.
• Test Set (for mechanical fatigue): Not explicitly stated for the subject device. For the predicate devices, which were used to establish equivalence, the test involved the "worst-case 3.8mm x 15mm Tapered Internal Plus implant assembled with a 3.0mm Angled Esthetic Abutment" and "the worst-case 3.8mm x 15mm Tapered Internal implant assembled with a 3.5mm Angled Custom Abutment." The phrase "three consecutive fatigue runouts" suggests at least three samples of the predicate devices were tested to 5 million cycles.
• Data Provenance: The data are from BioHorizons Implant Systems, Inc., a U.S.-based company. The studies referenced (dimensional assessment, retrospective mechanical testing, sterilization validation, endotoxin testing, material conformity) are internal or industry-standard tests; the document implies typical
  • Retrospective for the mechanical testing of the predicate devices (data was already available from previous 510(k)s).
  • Prospective/Current Quality Control for endotoxin testing, sterilization validation, and the dimensional assessment of the subject device.

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

• Not Applicable. This document pertains to the physical and mechanical properties of a dental implant, not a diagnostic task requiring expert human interpretation of data/images to establish ground truth for a test set. Ground truth for these tests is based on engineering measurements, physical endurance testing, chemical analysis, and microbiological validation, conforming to industry standards (e.g., ISO, ASTM, USP).

4. Adjudication Method for the Test Set:

• Not Applicable. As above, no human "adjudication" in the sense of reconciling clinical interpretations is required for physical and mechanical testing of a device. The results are from quantifiable measurements and standard methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

• Not Applicable. This is a 510(k) for a physical dental implant, not an AI/software device that would involve human readers or AI assistance.

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

• Not Applicable. This is not an algorithm or software device. The "standalone performance" here refers to the device's physical performance (e.g., strength, material properties) as demonstrated through engineering tests.

7. The Type of Ground Truth Used:

• The "ground truth" for the device's performance is established through:
  • Engineering Specifications and Measurements: For dimensional assessment (wall thickness).
  • Mechanical Testing Standards: For fatigue testing (meeting ISO 14801 standards and surviving specified cycles).
  • Material Standards and Chemical Analysis: For material composition (ASTM F136).
  • Sterilization Standards and Validation: For sterility (ANSI/AAMI/ISO 11137-1).
  • Microbiological Standards: For endotoxin levels (USP <161>).
  • Established Predicate Device Performance: The primary "ground truth" for substantial equivalence is the safety and effectiveness of the legally marketed predicate devices, which the new device is demonstrated to be similar to in design, materials, and function, with comparable or superior performance in key engineering metrics.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/ML device that requires a "training set" in the context of machine learning.

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

• Not Applicable. (See #8)

Ask a specific question about this device

BioHorizons CAD/CAM Bars are intended for use as superstructures of a multiple-unit endosseous dental implant system, attaching directly to implants or abutments, to support a prosthetic device in a partially or fully endentulous patient for the purpose of restoring chewing function. Implant-level bars are compatible with all BioHorizons Internal and Tapered Internal implant systems. Implant-level bars are compatible with Zimmer Dental Screw-Vent® and Tapered Screw Vent® implants with 3.5mm, 4.5mm internal hex connection mating platform diameters and are intended to be used with straight bar cylinders only. Abutment-level bars are compatible with BioHorizons Multi-unit Abutments.

All digitally designed BioHorizons CAD/CAM Bars are intended to be sent to a BioHorizons-validated milling center for manufacture.

The BioHorizons CAD/CAM Bars are computer aided designed (CAD), precision computer aided milled (CAM) superstructures manufactured for individual patients. The BioHorizons CAD/CAM Bars provide support for a fixed or removable prosthetic device. The BioHorizons CAD/CAM Bars will be provided in a fixed shape configuration (e.g. Dolder®, Hader, Round) or a free form shape configuration (e.g. Freeform/Milled, Hybrid, Montreal, Paris, Wrap Around), both configurations designed to fit the individual needs of the patient. The BioHorizons CAD/CAM Bars will be provided with either an implant-level or abutment-level connection interface. Implant-level CAD/CAM bars will include passive, non-indexing connection geometry with seating on the coronal (top) surface of the implant. Abutment-level CAD/CAM bars will include passive, non-indexing connection geometry with seating on the restorative platform of the abutment. The occlusal surface of the CAD/CAM bars may include connection geometry (e.g. female threads) to accept overdenture attachments. Bar material is titanium alloy as specified in ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.

The CAD/CAM Bars are provided non-sterile, and they are packaged using materials known in the industry to be appropriate for medical device packaging.

When used with BioHorizons Internal and Tapered Internal implant systems, the BioHorizons CAD/CAM bars allow for up to 40° divergence between bar cylinders, with no individual bar cylinder angulated greater than 20° from the vertical axis. Only straight bar cylinders are compatible with the Zimmer Dent® and Tapered Screw Vent® implants with 3.5mm. 4.5mm and 5.7mm internal hex connection mating platform diameters.

The provided text is a 510(k) Summary for a dental device, the BioHorizons CAD/CAM Bars. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a performance study in the way a clinical trial for an AI/CADe device would.

Therefore, many of the requested points, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable or not provided in this type of regulatory document for a physical dental implant component.

However, I can extract information related to what aspects were tested and what was considered sufficient to demonstrate acceptable performance for this device, which serves as the "acceptance criteria" for a physical device in this context.

Here's a breakdown of the available information:

(N/A = Not Applicable or Not Provided in the document)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in terms of number of devices tested for fatigue or dimensional analysis. The document refers to "a worst-case 3.0mm prosthetic platform, single-unit endosseous dental implant system test configuration" and "a representative subset of Zimmer® Screw-Vent® and Tapered Screw-Vent® implants". The exact number of units or datasets used in these "worst-case" or "representative" scenarios is not detailed.
• Data Provenance: N/A. This is bench testing data, not human patient data. The manufacturer is BioHorizons Implant Systems, Inc., based in Birmingham, Alabama, USA, so the testing was presumably conducted or overseen in the USA.

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)

• N/A. This is a physical dental implant component, not an AI/CADe device. The "ground truth" is based on engineering standards (ISO 14801, ASTM F136, BS EN ISO 17665-1:2006) and the device's functional performance against these standards and its intended use, rather than expert interpretation of images or data.

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

• N/A. This process does not involve human adjudication in the context of diagnostic interpretation. Performance is assessed against quantitative engineering and material standards.

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

• N/A. This is not an AI/CADe device.

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

• N/A. This is not an AI/CADe device. However, the performance testing described (fatigue, dimensional analysis, material compatibility) can be considered "standalone" in that it evaluates the device's intrinsic physical properties and functional compliance.

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

• For physical performance and material properties: Engineering Standards and Design Specifications.
  • Fatigue: Compliance with ISO 14801 and specific FDA Guidance Document.
  • Dimensionality: Comparison to existing, historically tested BioHorizons components and design specifications.
  • Material: Compliance with ASTM F136.
  • Sterilization: Compliance with BS EN ISO 17665-1:2006.
  • Biocompatibility: Historical testing on the same material shown to be non-cytotoxic, non-irritating, and negative for sensitization.

8. The sample size for the training set

• N/A. This is not an AI/CADe device that uses machine learning in the conventional sense requiring a training set based on data. The "training" here would refer to the engineering design and manufacturing processes development, which is not quantified by a "sample size" in this context.

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

• N/A. As above, a training set with "ground truth" derived from expert consensus or pathology is not applicable for this physical medical device. The design and manufacturing processes are established based on established engineering principles, dental biomechanics, material science, and regulatory standards.

Ask a specific question about this device

BioHorizons Tapered Short Implants are intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. The implants may be restored using delayed loading, or with a terminal or intermediate abutment for fixed or removable bridgework, and for overdentures.

The BioHorizons Tapered Short Implants are machined titanium, screw-form endosseous dental implants supplied in 4.6mm and 5.8mm diameters. The 4.6mm diameter implant includes a 3.5mm prosthetic platform, while the 5.8mm diameter implant includes a 4.5mm prosthetic platform. The implants are provided in 6.0mm and 7.5mm lengths across both diameters. Implant material is titanium alloy as specified in ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Allov (UNS R56401) for Surgical Implant Applications. The devices are further processed by roughening the threaded surface with Resorbable Blast Texture (RBT) media (tricalcium phosphate) and by micro-machining grooves, known as Laser-Lok® microchannels, on the implant collar. The product is packaged using materials known in the industry to be appropriate for medical device packaging and is provided with a minimum sterility assurance level of 10°, validated in compliance with ANSI/AAMI/ISO 11137-1 Sterilization of healthcare products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.

The provided document is a 510(k) premarket notification for a medical device, specifically dental implants. It outlines the substantial equivalence of the BioHorizons Tapered Short Implants to legally marketed predicate devices. This type of submission focuses on demonstrating equivalence rather than proving safety and effectiveness through clinical trials in the same way a PMA (Premarket Approval) would.

Therefore, the study design elements typically found for AI/ML device evaluations (such as sample size for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance) are not applicable to this document as it pertains to a mechanical dental implant, not an AI/ML diagnostic or therapeutic device.

The study described here is primarily bench testing to demonstrate mechanical and material properties, and to verify sterilization and biocompatibility.

Here's the breakdown of the closest applicable information based on your request, understanding the context of a 510(k) for a physical medical device:

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

The document doesn't present a formal "acceptance criteria" table in the way one might for a diagnostic test with metrics like sensitivity/specificity. Instead, it describes performance based on industry standards and comparative testing against predicate devices.

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

• Mechanical Fatigue Testing (ISO 14801): "worst-case (smallest prosthetic platform/smallest implant body diameter combined with the shortest implant length) 4.6mm x 6.0mm Tapered Short Implant was performed". The exact N (number of implants tested) is not specified, but typically for such tests, a statistically relevant number (e.g., n=12 or similar based on ISO standards) would be used.
• Bacterial Endotoxin/Sterilization Validation/Shelf Life: "representative worst-case BioHorizons endosseous dental implant devices" / "representative worst-case BioHorizons dental implant devices". Exact N not specified. "all lots tested" for endotoxins.
• Surface Area/BIC/Axial Pullout: "shortest length worst-case subject implants across both offered implant diameters" compared to "shortest length worst-case primary predicate implants across equivalent implant diameters." Exact N not specified.
• Data Provenance: The studies were conducted internally by BioHorizons or by their A-level supplier. The document does not specify country of origin for the data, but implied to be in compliance with US regulatory requirements (FDA). These are prospective tests performed on manufactured devices.

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

• Not applicable. This pertains to a mechanical device, not imaging data requiring expert interpretation or ground truth establishment. The "ground truth" for these tests comes from physical measurements, chemical analyses, and adherence to validated international standards (ISO, ASTM, USP).

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

• Not applicable. This is relevant for human-interpreted data, not for direct physical measurements and compliance with engineering standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This is a study design for AI/ML diagnostic devices, not for mechanical implants.

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

• Not applicable. This refers to AI/ML algorithm performance.

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

• For this device, the "ground truth" is established by:
  • Validated laboratory measurements: e.g., bacterial endotoxin levels, gamma radiation dose verification, elemental analysis (EDX).
  • Adherence to national and international standards: ASTM (e.g., F136, F543), ISO (e.g., 14801, 11137-1), ANSI/AAMI, USP.
  • Comparative analysis against predicate devices: Demonstrating similar or superior performance on relevant mechanical and surface characteristics.
  • Published literature: For claims regarding Laser-Lok® microchannels (Nevins et al. study cited for connective tissue attachment claims).

8. The sample size for the training set:

• Not applicable. This applies to machine learning, not mechanical device testing.

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

• Not applicable. This applies to machine learning, not mechanical device testing.

In summary: The provided document is a 510(k) submission for a physical dental implant. The "acceptance criteria" and "study" are focused on demonstrating substantial equivalence through a series of bench tests and adherence to established material, manufacturing, and sterilization standards, rather than clinical trials or AI/ML performance evaluations.

Ask a specific question about this device

BioHorizons CAD/CAM Abutments are dental abutments placed onto a dental implant to provide support for dental prosthetic restorations. The abutments include: 1) Titanium abutment blanks with a pre-machined implant connection where the upper portion may be custom-milled in accordance with a patient-specific design using CAD/CAM techniques; and 2) Titanium bases with a pre-machined implant connection upon which a CAD/CAM designed superstructure may be fitted to complete a two-piece dental abutments include an abutment screw for fixation to the underlying implant. The abutments may be used for single-unit (single-tooth) or multiple-unit (bridges and bars) restorations and are compatible for use with BioHorizons Internal and Tapered Internal implant systems and Zimmer® Dental Screw-Vent® and Tapered Screw-Vent® implants with 3.5mm, 4.5mm and 5.7mm internal hex-connection mating platform diameters.

All digitally designed abutments and/or copings for use with BioHorizons CAD/CAM Abutments are intended to be sent to a BioHorizons-validated milling center for manufacture. BioHorizons abutments designed using CAD/CAM techniques must fulfill the BioHorizons allowable range of design parameters.

BioHorizons CAD/CAM Abutments are dental implant final restorative abutments supplied in platform diameters of 3.0mm, 3.5mm, 4.5mm and 5.7mm. The abutments are intended to provide support for dental prosthetic restorations. Each abutment includes an abutment screw for fixation to the underlying implant. Abutment material is titanium alloy as specified in ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.

Select abutments are further processed by applying patterns of micro-machined grooves or channels, known as Laser-Lok, to a specified region of the abutment margin. The abutments are provided non-sterile, and they are packaged using materials known in the industry to be appropriate for medical device packaging.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the BioHorizons CAD/CAM Abutments:

The document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory approval (510(k)). This means the "acceptance criteria" are largely based on showing the device performs comparably to existing, legally marketed devices, rather than establishing de novo performance targets. The "studies" are tests conducted to support this claim of equivalence.

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list numerical acceptance criteria in a typical pass/fail format with specific thresholds. Instead, the acceptance criteria are implicitly defined by the performance of the predicate devices and relevant industry standards. The reported device performance is demonstrated through various tests designed to show that the BioHorizons CAD/CAM Abutments perform in accordance with their intended use and are substantially equivalent to predicate devices.

Further Details on the Study:

Given the nature of this 510(k) submission for a dental abutment, it's highly unlikely that components like "test sets," "ground truth experts," "adjudication methods," or "MRMC comparative effectiveness studies" were part of the presented data. These concepts are more typically associated with diagnostic imaging AI/ML devices or clinical trials involving complex human interpretation.

Therefore, many of the requested items below will be marked as "Not Applicable" or "Not Provided" based on the document's content and the typical scope of device approval for implant components.

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

   • Sample Size (Test Set): Not explicitly stated for each test, but implied to be sufficient for compliance with the respective standards (e.g., ISO 14801 typically requires 12 samples per group for fatigue testing). The document mentions "worst-case 30° angled configurations" and "representative subset" for compatibility testing.
   • Data Provenance: Not specified, but generally assumed to be internal laboratory testing by the manufacturer or contracted labs. The document does not indicate data from human subjects or clinical sites.
   • Retrospective or Prospective: Not applicable as these are laboratory and validation tests, not clinical studies involving patient data.

2. 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 "ground truth" for mechanical and sterilization testing is defined by the physical properties measured against engineering standards (e.g., fracture strength, SAL level). For software validation, it's the correct implementation of defined design parameters. No human expert "ground truthing" in the sense of clinical interpretation is relevant here.

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

   • None. Adjudication methods are relevant for ambiguous human interpretations, which is not the case for material property or mechanical performance testing.

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 not a diagnostic device involving human readers or AI assistance.

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

   • Not Directly Applicable. While software validation for the CAD/CAM milling process was performed (an "algorithm only" component), this isn't a standalone diagnostic AI. Its "performance" is about correctly enforcing design parameters, not making a diagnosis or prediction. The core device is a physical product, not a software algorithm presented for standalone performance evaluation in a clinical context.

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

   • Engineering Standards / Defined Specifications:
     • For Dynamic Mechanical Fatigue: ISO 14801 standards and BioHorizons' internal performance specifications for expected strength and durability.
     • For Compatibility: Physical fit and function with the specified implant systems.
     • For Sterilization: AAMI/ANSVISO 17665-1:2006, specifically achieving a Sterility Assurance Level (SAL) of 10⁻⁶.
     • For Software: BioHorizons' allowable range of design parameters and criteria.

7. The sample size for the training set

   • Not Applicable. As a physical medical device submission, there is no "training set" in the context of machine learning algorithms. The design process for the abutments is based on engineering principles and existing product lines, not data training.

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

   • Not Applicable. (See above, no training set for this type of device submission).

Ask a specific question about this device

BioHorizons Tapered Internal Implants are intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. The implants may be restored immediately (1) with a temporary prosthesis that is not in functional occlusion or (2) when splinted together for multiple tooth replacement or when stabilized with an overdenture supported by multiple implants.

The BioHorizons Tapered Internal Implants are machined titanium, screw-form endosseous dental implants supplied in 3.4mm and 4.6mm diameters. The 3.4mm diameter implant includes lengths of 9mm, 10.5mm, 15mm and 18mm while the 3.8mm and 4.6mm diameter implants include an 18mm length option to complement currently cleared implant lengths within those implant body diameters. Implant material is titanium alloy as specified in ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.

The devices are further processed by roughening the threaded surface with Resorbable Blast Texture (RBT) media (tricalcium phosphate) and by micro-machining grooves, known as Laser• Lok® microchannels, to the implant collar of select models. The product is packaged using materials known in the industry to be appropriate for medical device packaging and is provided with a minimum sterility assurance level of 10-6, validated in compliance with ANSVAAMI/ISO 11137-1 Sterilization of healthcare products -- Radiation -- Part I: Requirements for development, validation and routine control of a sterilization process for medical devices.

The provided document is a 510(k) premarket notification for a medical device called "BioHorizons Tapered Internal Implants." It aims to demonstrate substantial equivalence to previously cleared predicate devices, rather than establishing de novo acceptance criteria and performance through a clinical study.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth are not applicable to this type of submission. The document primarily focuses on technical characteristics and mechanical testing to justify equivalence.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not directly applicable as this is a substantial equivalence claim, not a de novo clearance with specific acceptance criteria from a clinical trial. The "acceptance criteria" here relate to demonstrating equivalence in design, materials, and mechanical performance to predicate devices. The performance reported is that the device "performs as well as the referenced predicate device."

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

• Sample Size: Not specified for a "test set" in the context of a clinical study. The testing refers to "Mechanical testing of the 3.0mm implant-abutment connection... in conjunction with angled prosthetic abutments representative of the worst-case scenario." This implies an engineering test, not a clinical trial with human subjects. Thus, the "sample size" would refer to the number of devices mechanically tested, which is not detailed but is typically a small number for such engineering tests.
• Data Provenance: The 'data' generated is from mechanical testing conducted according to ISO 14801 and FDA guidance documents. This is laboratory-based engineering data, not clinical data from countries of origin.

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

Not applicable. This submission relies on engineering and material standards (ASTM, ISO) and comparison to predicate devices, not on expert consensus for ground truth on clinical images or diagnoses.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical test set requiring adjudication in this 510(k) submission.

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 device is a dental implant, not an AI-powered diagnostic tool. No MRMC study was performed.

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

Not applicable. This device is a dental implant, not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this 510(k) is based on:

• Established engineering standards (e.g., ISO 14801 for fatigue testing, ASTM F136 for material).
• Performance of legally marketed predicate devices (K071638 and K093321), which have already demonstrated safety and effectiveness through their own clearance/approval processes.
• Physical and chemical properties of the materials and design features.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the machine learning/AI sense.

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

Not applicable. As above, no training set for an AI algorithm is involved.

In summary: The provided document is an FDA 510(k) clearance letter and summary for a dental implant, not a study evaluating acceptance criteria for a diagnostic device or AI software. The "study" referenced is mechanical testing to demonstrate substantial equivalence to existing devices.

Ask a specific question about this device

BioHorizons Tapered Internal Plus Implants are intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. The implants may be restored immediately (1) with a temporary prosthesis that is not in functional occlusion or (2) when splinted together for multiple tooth replacement or when stabilized with an overdenture supported by multiple implants.

BioHorizons Tapered Internal Plus Implants are machined titanium, screw-form endosseous dental implants supplied in 3.8mm, 4.6mm and 5.8mm diameters across lengths of 7.5mm (except 3.8mm diameter), 9mm, 12mm and 15mm. Implant material is titanium alloy as specified in ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Allov (UNS R56401) for Surgical Implant Applications.

The devices are further processed by roughening the threaded surface with Resorbable Blast Texture (RBT) media (tricalcium phosphate) and by micro-machining grooves, known as Laser-Lok® microchannels, to the implant collar. The product is packaged using materials known in the industry to be appropriate for medical device packaging and is provided with a minimum sterility assurance level of 10°, validated in compliance with ANSI/AAMI/ISO 11137-1 Sterilization of healthcare products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.

The provided text describes a 510(k) summary for the BioHorizons Tapered Internal Plus Implants. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove acceptance criteria for a new, independent device performance.

Therefore, many of the requested categories related to clinical study design, AI performance, expert review, and ground truth are not applicable to this type of regulatory submission. The document relies on mechanical testing to show equivalence, not clinical effectiveness studies as might be found for more complex medical devices, especially those involving AI/ML.

Here's a breakdown of the information that can be extracted or inferred from the provided text, and where the requested information is not applicable:

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 for each test (fatigue or insertion torque). Mechanical testing typically uses a small, statistically relevant number of samples for each size/configuration.
• Data Provenance: The document implies the testing was performed internally by BioHorizons or a contracted lab, as it refers to "the subject devices" and "this submission." No specific country of origin is mentioned beyond the manufacturer's location (Birmingham, AL, USA). The data is generated as part of a regulatory submission, which is prospective in the sense of demonstrating performance for a new product, but not a prospective clinical trial.

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

• Not Applicable. This is a mechanical engineering study, not a clinical study involving human assessment or interpretation where experts would establish ground truth for a test set in the conventional sense (e.g., radiologists for imagery). The "ground truth" here is the physical performance of the device against established engineering standards (ISO 14801).

4. Adjudication Method for the Test Set

• Not Applicable. See point 3. This is not a study where human adjudication of results/diagnoses would be relevant.

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

• No. This is not a study involving human readers or comparative effectiveness in a clinical setting. It's a mechanical testing report for hardware.

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

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

7. The Type of Ground Truth Used

• Physical Performance Against Standards: The ground truth for this submission is the objective measurement of mechanical properties (fatigue strength, insertion torque) as compared to:
  • The performance of the predicate device.
  • Established industry standards like ISO 14801.
  • Guidance documents such as the "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 is not an AI/ML device that requires a training set.

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

• Not Applicable. See point 8.

Ask a specific question about this device

BioHorizons Laser-Lok Abutments for Nobel Biocare™ are intended for use with dental implants as a support for single or multiple unit prostheses in the maxilla or mandible of partially or fully edentulous patients. The abutments are compatible for use with Nobel Biocare™ NobelReplace™ Straight Groovy™, NobelReplace™ Tapered Groovy™, NobelSpeedy™ Replace™, Replace™ Select Tapered and Replace™ Select Straight implants with 3.5mm (NP), 4.3mm (RP) and 5.0mm (WP) platform diameter internal trichannel connections. The abutment screw is intended to secure the abutment to the endosseous implant.

BioHorizons Laser-Lok Titanium Base Abutments for Nobel are intended to be used as straight abutments.

BioHorizons Laser-Lok Abutments for Nobel Biocare™ are a series of machined titanium endosseous dental implant healing abutments and final restorative abutments supplied in platform diameters of 3.5mm, 4.3mm and 5.0mm which are compatible with the internal trichannel connection of Nobel Biocare™ endosseous dental implants. The series includes Simple Solutions Abutments, Custom Titanium Abutments and Titanium Base Abutments. Abutment material is titanium alloy as specified in ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).

The devices are further processed by applying patterns of micro-machined grooves or channels, known as Laser-Lok, to a specified portion of the abutment margin. The product is packaged using materials known in the industry to be appropriate for medical device packaging. Devices labeled 'STERILE' are provided with a minimum sterility assurance level of 10°, validated in compliance with ANSI/AAMI/ISO 11137-1 Sterilization of healthcare products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.

This document is a 510(k) Premarket Notification for BioHorizons Laser-Lok Abutments for Nobel Biocare™. It focuses on establishing substantial equivalence to existing predicate devices, rather than defining specific acceptance criteria for a new type of performance claim or conducting a human-in-the-loop study.

Therefore, many of the requested sections about acceptance criteria, study types, sample sizes, and ground truth establishment, which are typical for studies evaluating diagnostic accuracy or AI performance, are not applicable in this context. This submission primarily relies on design and material equivalence, and existing scientific literature regarding its key feature (Laser-Lok technology).

However, I can extract information related to the device's characteristics and the study mentioned to support its substantial equivalence.

Description of Device and Study Context

The BioHorizons Laser-Lok Abutments for Nobel Biocare™ are machined titanium dental implant abutments designed to be compatible with Nobel Biocare™ endosseous dental implants. Their distinguishing feature is the "Laser-Lok" surface, which consists of micro-machined grooves applied to a specified portion of the abutment margin. This surface is claimed to promote a functional connective tissue attachment, inhibit epithelial cell downgrowth, and enable crestal bone attachment.

The submission aims to demonstrate "substantial equivalence" to predicate devices, meaning it is as safe and effective as legally marketed devices.

1. Table of acceptance criteria and the reported device performance

This section is Not Applicable in the traditional sense of performance metrics for a diagnostic or AI device. The acceptance criteria for this 510(k) submission are based on demonstrating substantial equivalence to predicate devices in terms of design, materials, intended use, and general safety/effectiveness.

Instead of specific performance metrics, the "acceptance criteria" are implied by the demonstration that:

• The device's design, materials (titanium alloy, Laser-Lok surface feature), and manufacturing processes are comparable to legally marketed predicate devices.
• The intended use is consistent with predicate devices.
• The compatibility with specified Nobel Biocare™ implants is verified.
• The Laser-Lok technology, as demonstrated by the canine study and previous research, shows beneficial biological responses comparable to or better than traditional machined surfaces.

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

• Test Set (Canine Study): The study consisted of four cohorts. "Each group received nine implants with abutments placed at the time of surgery."
  • Sample Size: 4 groups * 9 implants/group = 36 implants total. The number of animals is not explicitly stated, but typically multiple implants would be placed in each animal.
  • Data Provenance: Prospective animal study (canine model). No country of origin specified, but likely where BioHorizons Implant Systems, Inc. is based (USA).

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

• This information is Not Applicable as the canine study involved biological outcomes (healing patterns, tissue attachment) assessed directly by researchers/histologists, not by experts interpreting diagnostic images for a ground truth panel. The study relies on direct measurement and observation of histological and biological responses in an animal model.

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

• This information is Not Applicable. The canine study results would typically be based on objective measurements (e.g., histological analysis, bone-to-implant contact ratios, epithelial downgrowth measurements) rather than subjective adjudication of interpretations. The study summary does not detail the specific methods of outcome assessment or any 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

• This is Not Applicable. This submission is for a dental implant abutment, not an AI-assisted diagnostic device. No human reader or AI comparative effectiveness study was performed.

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, not a standalone algorithm.

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

• For the canine study mentioned, the "ground truth" was established through direct histological and biological assessment of the peri-implant tissues in the animal model. This would involve microscopic examination and potentially quantitative measurements of tissue integration, bone and soft tissue healing patterns, and epithelial attachment/downgrowth. This falls under outcomes data / pathology derived from an animal model.

8. The sample size for the training set

• This is Not Applicable. This device is a physical product, not an AI/machine learning model, so there is no training set in that context. The "training" data for the Laser-Lok technology itself would encompass previous research and development that led to its design, including prior studies referenced (like Nevins et al.).

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

• This is Not Applicable for the same reason as point 8. The underlying scientific principles of the Laser-Lok surface feature were established through prior research (e.g., the Nevins et al. study cited), which would have used similar direct biological and histological assessment methods.

Ask a specific question about this device

BioHorizons Abutments for Zimmer® are abutments that include healing abutments for contouring tissue and final restorative abutments to support a prosthesis. The contouring tissue and final rootena.vo and restoration and are compatible for abuthents may be assurfor a Single of the nal implant systems and Zimmer use with Blondons internal and Tapered Screw-Vent® implants with 3.5mm and 5.7mm internal hex-connection mating platform diameters.

BioHorizons Titanium Base Abutments and Laser-Lok Titanium Base Abutments are intended to be used to be used as straight abutments.

BioHorizons Abutments for Zimmer are comprised of endosseous dental implant healing abutments and final restorative abutments supplied in platform diameters of 3.5mm, 4.5mm and 5.7mm. Abutment materials are titanium alloy as specified in ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401), zirconia ceramic as specified in ISO 13356 Implants for surgery - Ceramic materials based on yttriastabilized tetragonal zirconia (Y-TZP), Gold Alloy 6019 and PEEK as specified in ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications (temporary abutments only).

Select abutments are further processed by applying patterns of micro-machined grooves or channels, known as Laser-Lok, to a specified portion of the abutment margin. Abutments provided sterile are packaged using materials known in the industry to be appropriate for medical device packaging and are provided with a minimum sterility assurance level of 108, validated in compliance with ANSI/AAMI/ISO 11137-1 Sterilization of healthcare products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices and ANSI/AAMI/ISO 11137-2 Sterilization of healthcare products -- Radiation -- Part 2: Establishing the sterilization dose.

The provided document is a 510(k) Summary for the BioHorizons Abutments for Zimmer, which are dental implant abutments. This document does not describe an AI/ML device, nor does it conduct a study comparing the device's performance against acceptance criteria in the format typically used for medical devices that involve diagnostic or predictive capabilities. It primarily focuses on demonstrating substantial equivalence to predicate devices through material properties, design, and biocompatibility, as well as specific functional testing related to mechanical performance and tissue integration.

Therefore, many of the requested elements (like acceptance criteria for diagnostic performance, sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone algorithm performance, and training set details) are not applicable and are not present in this type of submission.

However, I can extract the information that is present and relevant to the "acceptance criteria" and "study" as understood within the context of dental implant abutment regulatory submissions.

Here's a breakdown of the requested information based on the provided text, with clarifications where the concepts don't directly apply:

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

The document does not provide a formal table of acceptance criteria with corresponding performance metrics in the way one might see for a diagnostic AI device. Instead, the "acceptance criteria" for this type of device are implicitly met by demonstrating substantial equivalence to predicate devices through:

• Material properties: Matching specified ASTM and ISO standards.
• Design and intended use: Similar to existing cleared devices.
• Mechanical performance: Meeting standards like ISO 14801.
• Biocompatibility/tissue integration: Demonstrated through a canine study for the Laser-Lok feature.
• Sterilization: Validated to ANSI/AAMI/ISO 11137-1/2 standards.

The "reported device performance" is largely qualitative or indicates compliance with these standards.

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

• Sample Size for Compatibility Testing: A "representative subset" of Zimmer® Screw-Vent® and Tapered Screw-Vent® implants was used, listing specific item numbers. The exact number of abutments tested is not specified but implies multiple units for each implant type.
• Sample Size for Biological Study (Canine Model): The study consisted of four cohorts, with "Each group received nine implants with abutments placed at the time of surgery." This totals 36 implants/abutments (9 implants x 4 groups).
• Data Provenance: The canine study was a prospective study. The country of origin is not explicitly stated in this summary.
• Sample Size for Mechanical Testing: Not specified, but mechanical testing typically involves multiple samples to assess load to failure and fatigue.

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 ground truth in this context is established through objective material and mechanical testing standards (e.g., ISO 14801), and histological analysis in the canine study. It does not involve expert consensus on image interpretation or diagnostic outcomes in a way that requires a specific number of qualified human experts for ground truth establishment. The biological study would have been evaluated by veterinary pathologists or histologists.

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

Not Applicable. As this is not an AI/ML diagnostic device, there is no "test set" in the sense of data needing adjudication for ground truth. Results from mechanical tests and histological analyses are objective measurements.

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 not an AI-assisted device. Therefore, no MRMC study was conducted, and this question is not applicable.

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

No. This is a physical medical device (dental abutment), not an algorithm or AI. Standalone algorithm performance is not applicable.

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

• For Mechanical Testing: Compliance with ISO 14801 and FDA's "Class II Special Controls Guidance Document..." serves as the objective "ground truth" standard.
• For Biological Study (Laser-Lok): Pathology/histology data from the canine model, examining "peri-implant hard and soft tissue healing," "fibroblastic activity," and "epithelial cell downgrowth." The conclusions of Nevins et al. (a cited external reference) also contribute to the understanding of the mechanism.

8. The sample size for the training set

Not Applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

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

Not Applicable. As there is no AI/ML algorithm or training set, this question is not applicable.

Ask a specific question about this device