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510(k) Data Aggregation
(169 days)
BioHorizons Implant Systems Inc.
BioHorizons conical dental prosthetic components connected to the endosseous dental implants are intended for use as an aid in prosthetic rehabilitations of the maxillary or mandibular arch to provide support for prosthetic restorations.
All digitally designed abutments for use with Conical Ti Base abutments are to be sent to a BioHorizons validated milling center for manufacture or to be designed and manufactured according to digital dentistry workflow. The workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, milling machine and associated tooling and accessories.
The BioHorizons Conical Ti Base abutments are prosthetic components and are intended for the restoration of BioHorizons dental implants within the specific indications of each implant system. All Conical Ti Base abutments are two-piece titanium-base type abutments with a pre-manufactured titanium base component cemented to a zirconia superstructure to create the final finished dental abutment. All the titanium bases are manufactured from Ti-6Al-4V titanium alloy per ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications and are for single patient use. The prosthetics are provided non-sterile as indicated on the label. The subject devices are permanent or long-term, tissue/bone implant devices intended for more than 30 days of patient contact. BioHorizons dental prosthetics are invasive and / or surgically invasive devices placed in healed or compromised oral sites in direct contact with bone and soft tissue.
The Conical Ti-Base abutments are provided in engaging and non-engaging designs and are designed for single-unit or multi-unit restoration with a CAD/CAM zirconia superstructure attached to the abutment. The titanium base components are available for narrow and regular platforms and with gingival heights of 0.8 mm and 2.0 mm. The titanium base component post has been manufactured with matte finish creating a roughened surface to accommodate cementing. All patient-specific custom abutment fabrication for Conical Ti Base abutments are by prescription on the order of the clinician. All zirconia superstructures for use with the subject device Conical Ti Base abutments are made at a BioHorizons validated milling center under FDA quality system regulations, as cleared in K240187, or according to a digital dentistry workflow (subject of this submission described in the section below). As cleared in K240187, zirconia material, sagemax NexxZr® zirconia (K130991) is used to fabricate the patient-specific zirconia superstructure or direct crown. The cement for bonding of superstructures or crowns is a dual cure cement, 3M™ RelyX™ Unicem 2 Automix (K022476). These cleared materials are identical to the proposed digital dentistry workflow. The pre-manufactured titanium base component are not to be modified and are only intended to permit a customized zirconia restoration.
The design and fabrication of the zirconia superstructure will be conducted using a digital dentistry workflow requiring the use of the following equipment:
- Scanner: 3Shape Trios 5 intra-oral scanner.
- Design Software: 3Shape Abutment Designer Software, K151455.
- Zirconia Material: sagemax® NexxZr zirconia, K130991.
- CAM software: hyperDENT® Classic
- Milling machine: imes-icore® CORiTEC 150i Pro milling machine
- Cement: 3M™ RelyX™ Unicem 2 Automix Self-Adhesive Resin Cement, K022476.
The designed superstructure is attached to the titanium base component by the use of an FDA-cleared cement, 3M™ RelyX™Unicem 2 Automix Self-Adhesive Resin Cement, K022476. The resulting final prosthetic restoration is screwed to the dental implant. All subject abutments are single-use and provided non-sterile. Final restoration (which includes the corresponding screw) is intended to be sterilized at the dental clinic before it is placed in the patient. The final abutment is equivalent to the final abutment cleared in K240187.
The provided document is an FDA 510(k) clearance letter for the Conical Ti Base abutments.
*Crucially, this document does not contain information about acceptance criteria or a study proving that the device meets those criteria, nor does it provide details about any clinical studies, sample sizes, expert ground truth establishment, or AI effectiveness studies.
The letter focuses on establishing substantial equivalence to previously cleared predicate devices based on:
- Identical intended use: Both the subject device and the primary predicate (K240187) are "intended for use as an aid in prosthetic rehabilitations of the maxillary or mandibular arch to provide support for prosthetic restorations." The subject device adds the "digital dentistry workflow" aspect, which is equivalent to the secondary predicate (K231307).
- Similar or identical design and technological characteristics: This includes material composition (Ti-6Al-4V alloy for the titanium base, sagemax NexxZr zirconia for the superstructure), manufacturing methods, digital design software and hardware (for the zirconia superstructure), design limitations, usage, sterility, and biocompatibility.
The "Performance Data" section discusses:
- Reliance on predicate submission data for non-clinical aspects like mechanical testing, biological safety, steam sterilization, and magnetic resonance testing, as there were no changes since the previous clearance (K240187).
- New testing was conducted to support the CAD/CAM design and use within a digital dentistry workflow, demonstrating controls of this workflow and that the final abutment is equivalent to those produced by the validated milling center cleared in K240187. This involved assessing abutment angulation, diameter, height, wall thickness, tolerances, and part quality.
- Surface characterization (SEM and EDX) was done on the titanium base component to ensure no residual blast media.
- No clinical data were included in this submission.
Therefore, I cannot provide the requested information regarding acceptance criteria, specific study details, sample sizes, expert involvement, or AI effectiveness. The clearance is based on non-clinical data and substantial equivalence to existing devices.
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(158 days)
BioHorizons Implant Systems Inc.
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(133 days)
BioHorizons Implant Systems Inc.
BioHorizons Tapered Pro Conical dental 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 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 Conical dental implants are intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or fixed bridgework and dental retention. These dental implants must be restored using delayed loading, for single tooth replacement, or may be used with a terminal or intermediate abutment for fixed or removable bridgework or for overdentures. Tapered Short Conical implants should be used only when there is not enough space for a longer implant. If the ratio of crown length is unfavorable, the biomechanical risk factors have to be considered and appropriate measures have to be taken by the dental professional.
BioHorizons conical dental prosthetic components connected to the endosseous dental implants are intended for use as an aid in prosthetic rehabilitations of the maxillary or mandibular arch to provide support for prosthetic restorations.
All digitally designed abutments for use with Conical CAD/CAM Ti Blanks and Ti Bases are to be sent to a BioHorizons validated milling center for manufacture.
The purpose of this submission is to obtain marketing clearance for an endosseous dental implant and abutment system, Tapered Pro Conical Implant System, from BioHorizons Implant Systems Inc. The Tapered Pro Conical Implant System includes a range of ental implants and prosthetic components, BioHorizons Tapered Pro Conical implants feature a tapered screw-shaped design with a reverse buttress thread. Cutting flutes are incorporated into the thread to be self-tapping when placed into the prepared surgical site. The outer surface of the implant has been roughened with resorbable blast texturing (RBT) using a hydroxyapatite blast media. Internally, the implant features a deep conical prosthetic connection between implants and abutments with six anti-rotation cams at the base of the connection, intended to interface with the three cams of the prosthetic components. It is available with or without Laser-Lok treatment applied to the collar of the implant.
Tapered Pro Conical Implants are available in a range of implant diameters and lengths with two prosthetic platform (implant/abutment connection) sizes, as shown below. Internal surfaces of the Tapered Pro Conical Regular platform implants are anodized yellow to distinguish them from Narrow platform implants.
Abutments are available in multiple designs, including straight and angled abutments intended for single tooth and multi-unit restorations. The Conical Ti-Base abutments are a two-piece abutment composed of a pre-manufactured Ti Base component and a CAD/CAM patient-matched mesostructure (superstructure) composed of sagemax® NexxZr zirconia (K130991).
The provided text is a 510(k) premarket notification summary for a dental implant system. It does not describe a study to prove the device meets acceptance criteria related to an AI/ML-driven medical device, nor does it contain information on the performance data, sample sizes, expert ground truth establishment, or multi-reader multi-case studies typically associated with such devices.
The document focuses on demonstrating substantial equivalence to predicate dental implants and their components. The "PERFORMANCE DATA" section (page 7 of the PDF, starting on page 8 of the transcription) lists non-clinical data such as validation of sterilization, bacterial endotoxin testing, shelf-life testing, biocompatibility, MRI compatibility, and mechanical testing, which are standard for dental implants.
Therefore, I cannot fulfill the request as the provided text does not contain the necessary information about acceptance criteria and a study proving the device meets those criteria, specifically for an AI/ML medical device.
To be explicit, the document states:
- "No clinical data were included in this submission." (Page 7)
- The performance data discussed are entirely non-clinical and relate to the physical and material properties of the dental implants, not an AI or software component assessing images or providing diagnostic assistance.
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(308 days)
BioHorizons Implant Systems, Inc.
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.
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(132 days)
BioHorizons Implant Systems, Inc.
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
| Acceptance Criteria (Not explicitly stated as such, but inferred from non-clinical tests for regulatory clearance) | Reported Device Performance (from "PERFORMANCE DATA" section) |
|---|---|
| Sterilization according to ANSVAAMI/ISO 11137-1 and ANSI/AAMI/ISO 11137-2. | "sterilization according to ANSVAAMI/ISO 11137-1 and ANSI/AAMI/ISO 11137-2, referenced from K172576, and K103691" (Implied compliance by reference to cleared predicates). |
| Biocompatibility according to ISO 10993-5 and ISO 10993-12. | "biocompatibility according to ISO 10993-5 and ISO 10993-12, referenced from K103691, K172576 and K193401" (Implied compliance by reference to cleared predicates). |
| Static compression and compression fatigue testing according to ISO 14801. | "Mechanical performance testing of the subject device was performed according to ISO 14801 Dentistry - Implants -Dynamic fatigue test for endosseous dental implants. The fatigue limit data demonstrated that constructs of the subject device abutments in combination with the previously-cleared compatible implants, and used according to the proposed labeling, have sufficient strength for their intended use." |
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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(70 days)
BioHorizons Implant Systems, Inc.
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:
| Acceptance Criteria Category | Specific Acceptance Criteria (as stated or inferred) | Reported Device Performance (Compliance) |
|---|---|---|
| Mechanical Strength (Design) | Tapered IM implant connection geometry, in relation to the implant external profile, shall have equal or greater (≥) wall thickness compared to the Tapered Internal Plus implant and the Tapered Internal implant (worst-case predicate devices). | Met: A comparative dimensional assessment was performed, and the Tapered IM implant design was found to be comparable or superior in wall thickness to the worst-case predicate devices. |
| Mechanical Strength (Fatigue) | Dynamic mechanical fatigue testing (ISO 14801) for worst-case predicate devices: implant-abutment assemblies survived three consecutive fatigue runouts for 5 million cycles. (This is a historical acceptance for the predicate, implicitly indicating the subject device must also be sufficiently robust due to comparable design). | Met (by reference to predicate): A retrospective review of mechanical testing for the predicate Tapered Internal Plus implant and Tapered Internal Implant showed successful fatigue testing (survived 3 consecutive fatigue runouts for 5 million cycles). The document states, "The aforementioned comparative dimensional assessment combined with the successful fatigue testing of the worst-case predicate device qualify the Tapered Internal IM implants for their intended use." |
| Sterilization Assurance Level | Minimum sterility assurance level of 10⁻⁶, validated in compliance with ANSI/AAMI/ISO 11137-1. | Met: "Sterilization validation was evaluated in accordance with ANSI/AAMI/ISO 11137-1. Validation parameters were established for this device and are substantially equivalent to those used in the primary predicate device cleared under K121787." (Implies compliance with 10⁻⁶ SAL). |
| Endotoxin Levels | Endotoxin levels do not exceed the acceptance limit of 20.0 EU per device per USP . | Met: "Testing consistently demonstrates that endotoxin levels do not exceed the acceptance limit of 20.0 EU per device per USP ." |
| Material Composition | Meet chemical requirements of ASTM F136 (Ti-6Al-4V ELI). | Met: "BioHorizons Tapered IM Implants meet the chemical requirements of ASTM F136." |
| Surface Treatment | Consistency and substantial equivalence of RBT (Resorbable Blast Texture) and Laser-Lok microchannels to existing cleared devices. | Met: "The surface and processing used in this device are substantially equivalent to those used in the reference predicate device cleared under K071638." and "The Laser-Lok feature is substantially equivalent to that cleared for the BioHorizons Tapered Internal Plus Implants." |
| Biocompatibility | Material (Ti-6Al-4V) commonly used in surgical implant applications, ensuring no special biocompatibility testing is required beyond what is established for this class of material. | Met (by reference to established material): "This grade of Titanium is commonly used in surgical implant applications thus no special biocompatibility testing was conducted for the proposed devices." The material is substantially equivalent to that used in K071638. |
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 ).
- 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)
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(165 days)
BioHorizons Implant Systems, Inc.
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
| Acceptance Criteria / Performance Aspect | Reported Device Performance (BioHorizons CAD/CAM Bars) |
|---|---|
| 1. Dynamic Mechanical Fatigue Testing (Worst-Case Configuration) | |
| (in accordance with Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, May 12, 2004 and ISO 14801) | |
| Focus: Single bar cylinder subjected to occlusal loading without additional support. | Results demonstrate that the worst-case configuration performs in accordance with the subject device's intended use. (Implies it passed the specified fatigue requirements of the standards). |
| 2. Dimensional Analysis of Abutment-Level Bars | |
| Focus: Comparison to BioHorizons Multi-unit Titanium Coping at least material condition (LMC) in implant-abutment connection region. | Historical testing of the Multi-unit Titanium Coping combined with dimensional analysis demonstrated that the abutment-level CAD/CAM bar design is sufficient for its intended use. |
| 3. Compatibility Verification for Zimmer Dental Implants | |
| Focus: Mating platform geometry compatibility with specified Zimmer® Screw-Vent® and Tapered Screw-Vent® implants. | Testing on a representative subset of Zimmer® implants (TSV4B8, TSV4B10, TSVWH10, TSVWB10, TSVWB11, TSVWH11, TSVT6B10, TSV6H11, TSV6H13, TSV6H16) verifies compatibility of BioHorizons CAD/CAM Bars connection with all Zimmer® Screw-Vent® and Tapered Screw-Vent® items based on equivalent mating platform geometry. |
| 4. Sterilization Validation | |
| (in accordance with BS EN ISO 17665-1:2006) | Sterilization cycles were validated, demonstrating the device can be effectively sterilized by the end-user using specified steam sterilization cycles. |
| 5. Biocompatibility | |
| Focus: Material (ASTM F136 Ti-6Al-4V) safety. | BioHorizons CAD/CAM Bars meet the chemical requirements of ASTM F136. Historical biocompatibility testing on representative BioHorizons dental implant devices made of the same material showed the test articles were non-cytotoxic, non-irritating, and negative for dermal sensitization. Therefore, no new biocompatibility testing was required for the proposed devices. |
| 6. Manufacturing Process Workflow (CAD/CAM) | |
| Focus: Digital design, milling, and fit for final prosthesis. | Workflow described (digital capture, CAD software design, CAM data export, milling, laboratory processing, clinical delivery with verification of fit and securing with screws) ensures appropriate manufacturing and fit for intended use. |
| 7. Design Parameters (Geometric Compliance) | |
| Focus: Meeting minimum/maximum specifications for platform seating diameter, number of cylinders, bar span, height, angulation, diameter, and distal extension. | Implant Level Bars: |
- Platform Seating Diameter: 3.0mm - 5.7mm
- Total Cylinders: 2 - 10
- Bar Span Between Cylinders: 0mm - 30mm
- Bar Height incl. Cylinder: 2.5mm - 11mm
- Maximum Angulation Per Cylinder: 0° - 20°
- Cylinder Diameter: 3.0mm - 10.0mm
- Distal Extension: 0mm - 1.5x AP Spread
Abutment Level Bars:
- Platform Seating Diameter: 4.8mm - 7mm
- Total Cylinders: 2 - 10
- Bar Span Between Cylinders: 0mm - 30mm
- Bar Height incl. Cylinder: 2.5mm - 11mm
- Maximum Angulation Per Cylinder: 0° - 20°
- Cylinder Diameter: 3.0mm - 10.0mm
- Distal Extension: 0mm - 1.5x AP Spread
These parameters were used for "worst-case" design validation. |
| 8. Fundamental Equivalence to Predicate Device
Focus: Bar base material, bar-implant/bar-abutment connection, prosthetic platform sizes, mode of prosthetic retention. | The fundamental scientific technology is substantially equivalent. Similar features exist, including:
- Bar base material (Titanium alloy as specified in ASTM F136 for subject device; ASTM F136 or Grade 4 Titanium for predicate).
- Bar-implant/bar-abutment connection tailored to implant/abutment component(s).
- Prosthetic platform sizes.
- Mode of prosthetic retention (screw-retained).
Differences in bar shape, platform sizes, max implant span, etc., were mitigated by performance testing. |
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.
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(86 days)
BioHorizons Implant Systems, Inc.
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.
| Acceptance Criteria (Implied by Standards/Predicate Equivalence) | Reported Device Performance |
|---|---|
| Mechanical Fatigue Strength: Meet or exceed performance as per ISO 14801 and "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." (Equivalent to predicate devices) | The worst-case (4.6mm x 6.0mm) Tapered Short Implant, tested with angled prosthetic abutments, demonstrated results indicating substantial equivalence to predicate devices. (Exact load values not provided, but implies acceptance within standard limits). |
| Bacterial Endotoxin Levels (Sterility): Less than 20 EU/Device | EU/Device was less than 0.050 for all lots tested, which is below the established acceptance criterion of 20 EU/Device. |
| Sterilization Dose: Minimum 25 kGy gamma radiation substantiated and effectively sterilizes the product (minimum sterility assurance level of 10^-6) | A minimum gamma radiation sterilization dose of 25 kGy is substantiated, and products sterilized with this dose may be released based on dosimeter data without the need for sterility testing of each lot. Validated in compliance with ANSI/AAMI/ISO 11137-1. |
| Shelf Life: Maintain sterile seal and performance over time. | Shelf life established to be five years, provided the sterile seal is not breached, based on testing in accordance with applicable ASTM standards for evaluating seal strength. No degradation in performance expected over this period. |
| Biocompatibility: Non-cytotoxic, non-irritating, non-sensitizing. | Historical biocompatibility testing on representative BioHorizons dental implant devices (using the same ASTM F136 titanium alloy) concluded that test articles were non-cytotoxic, non-irritating, and negative for evidence of dermal sensitization. The device meets ASTM F136 chemical requirements. |
| Surface Treatment (RBT/Laser-Lok): Effective removal of residual HA particulates, no effect on underlying titanium biocompatibility. | Scanning Electron Microscopy (SEM) at 100X, 1000X, and 5000X demonstrated effective removal of all residual HA particulates. Energy Dispersive X-Ray (EDX) spectroscopy confirmed no effect on the biocompatibility of the underlying titanium alloy. |
| Surface Area/Bone-to-Implant Contact (BIC)/Axial Pullout Strength: Comparative analysis. | Subject device provides increased external surface area, increased bone-to-implant contact, and increased axial pullout strength compared to the primary predicate device. (This is a superiority finding, exceeding a simple equivalence "acceptance"). |
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.
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(211 days)
BIOHORIZONS IMPLANT SYSTEMS, INC.
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.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Fatigue Strength (per ISO 14801 & FDA Guidance) | "Results of the testing demonstrate that the fully milled, worst-case 30° angled configurations of both the 3.0mm and 3.5mm prosthetic platform abutments and the titanium bases with bonded zirconia superstructure perform in accordance with their intended use." (Implies meeting or exceeding the performance established by the standard and predicate devices for similar angled abutments). |
| Implant Compatibility | "Compatibility testing was performed on a representative subset of Zimmer® Screw-Vent® and Tapered Screw-Vent® implants... This testing verifies compatibility of BioHorizons Abutments for Zimmer® with all Zimmer® Screw-Vent® and Tapered Screw-Vent® items based on equivalent mating platform geometry." (Implies successful and reliable fit/function with listed implant systems). |
| Sterilization Efficacy (for non-sterile devices requiring sterilization by user) | "Steam sterilization validation testing was performed new in accordance with AAMI/ANSVISO 17665-1:2006... Test results demonstrate a sterility assurance level (SAL) of 10⁻⁶." (Implies achievement of the industry-standard sterility level after a validated sterilization process). |
| Software Validation (for CAD/CAM design parameters) | "Software intended use validation testing of the software systems utilized in the manufacture of the CAD/CAM abutments was performed to ensure that the program design limitations prevent the user from milling abutments that do not fulfill the BioHorizons design criteria." (Implies the software correctly enforces design constraints to ensure proper abutment manufacturing). |
| Substantial Equivalence (Overall Safety & Effectiveness) | "The data presented in this submission demonstrates that the proposed devices are substantially equivalent with respect to performance and intended use. The proposed devices perform as well as the legally marketed predicate devices. Furthermore, the proposed devices do not pose any new or increased risks as compared to the legally marketed predicate devices." (This is the overarching conclusion of the submission, supported by all the aforementioned tests and comparisons). |
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
- Engineering Standards / Defined Specifications:
-
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.
-
How the ground truth for the training set was established
- Not Applicable. (See above, no training set for this type of device submission).
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(79 days)
BIOHORIZONS IMPLANT SYSTEMS, INC.
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."
| Feature/Performance Aspect | Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| Mechanical Strength (Implant-Abutment Connection) | Must meet or exceed the performance of predicate devices as tested by ISO 14801. | "The results of the fatigue load testing demonstrate that the subject devices are substantially equivalent to the predicate devices." |
| Material Composition | Must be ASTM F136 compliant (Ti-6Al-4V ELI Alloy). | "Implant material is titanium alloy as specified in ASTM F136..." |
| Surface Treatment | Must be RBT and/or Laser-Lok microchannels, proven effective in predicate devices. | "Roughening the threaded surface with Resorbable Blast Texture (RBT) media... and by micro-machining grooves, known as Laser-Lok® microchannels..." |
| Sterility Assurance Level | Minimum 10-6 SAL, validated per ANSVAAMI/ISO 11137-1. | "Provided with a minimum sterility assurance level of 10-6, validated in compliance with ANSVAAMI/ISO 11137-1..." |
| Intended Use | Must align with the intended use of predicate devices. | The intended use for the subject device is virtually identical to that of the BioHorizons Tapered Internal Implant System (K071638). |
| Overall Equivalence | Must be substantially equivalent in design, materials, intended use, and performance to predicate devices. | "The data presented in this submission demonstrates that the new devices are substantially equivalent with respect to performance, safety and effectiveness for their intended use and perform 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.
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