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510(k) Data Aggregation
(127 days)
Immediate Molar Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed loading, or with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.
Immediate Molar Dental Implants may also utilize immediate loading for these indications. Immediate Molar Dental Implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. The Immediate Molar Dental Implants may be placed immediately following an extraction or loss of natural teeth provided there is sufficient volume of alveolar bone to provide good primary stability. The Immediate Molar Dental Implants are intended for implantation in the maxillary or mandibular molar region where bone exists and the surgeon has determined that the placement of a narrower diameter implant would increase the probability of failure due to poor primary stability, or increased surgical procedures leading to complications.
The Immediate Molar Dental Implants are also indicated for compatibility with the following OEM abutment systems:
| Abutment System Name | Models | Platform Diameters |
|---|---|---|
| Abutments manufactured by | ||
| Terrats Medical SL | Titanium Abutments | 4.1, 5.0 and 5.7mm |
| Abutments manufactured by | ||
| Zfx GmbH | Titanium Abutments | 4.1, 5.0 and 5.7mm |
The Immediate Molar Implants are basic screw-type designs available in tapered body geometry. The devices are manufactured from Commercially Pure Titanium (ASTM F67) and feature a roughened apex and traditional OSSEOTITE® coronal surface. The device is packaged in a Titanium sleeve that is inserted into a polypropylene inner tray, covered with a Tyvek lid and heat-sealed. This assembly is then placed inside a larger polyethylene thermoformed outer tray, covered with a Tyvek lid and heat-sealed. The outer tray is packaged inside a box. The device is sold sterile. The shelf life of the Immediate Molar Implants is 5 years and they are intended for single use only. The device is sterilized using gamma irradiation method. The implants are available in various platform options and feature an internal hex connection for mating with associated Biomet 3i internal connection restorative components and also a TSV connection for mating with associated Zimmer Dental TSV connection restorative components. The implants are also compatible with titanium abutments manufactured by Terrats Medical SL and Zfx GmbH. The implants are offered in a variety of diameters and lengths to accommodate varying patient anatomy. The T3 PRO Immediate Molar Implants are offered in 8, 10 and 11.5mm implant lengths for each of the implant body diameter sizes of 7, 8 and 9mm. The TSX Immediate Molar Implants are offered in 6, 8, 10 and 11.5mm implant lengths for each of the implant body diameter sizes of 7 and 8mm. The TSX Immediate Molar Implants are offered in 8, 10 and 11.5mm lengths for implant body diameter size of 9mm.
The provided text is a 510(k) summary for a medical device (Immediate Molar Implants) and does not contain information about acceptance criteria or a study proving that an AI/software device meets acceptance criteria.
The document explicitly states: "No clinical data were included in this submission." and focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics, non-clinical testing (fatigue, MR compatibility, pull-out tests, surface area analysis, sterilization, biocompatibility, shelf life), and contractual agreements for compatible components.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving a device meets acceptance criteria using clinical or performance data, as this information is not present in the provided text. The document describes a dental implant, not an AI or software-based device that would typically have acceptance criteria presented in the manner requested.
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(163 days)
The TSX Implants are designed for use in the maxilla or mandible for immediate loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. Implants may be placed immediately following an extraction or loss of natural teeth provided there is sufficient volume of alveolar bone to minimally support the implant (minimum 1mm circumferential and 2mm apical) and provide good primary stability.
The 3.1mmD TSX Implants should be splinted to additional implants when used in the pre-molar region and should not be used in the molar region.
TSX Dental Implants are manufactured from biocompatible titanium alloy. TSX Dental Implants surface consists of a Contemporary Hybrid Surface Treatment (Dual Acid Etch + MTX™ Textured Surface). The implants are available in different platform diameters and feature an internal hex connection for mating with associated Zimmer Dental and Biomet 3i internal connection restorative components.
For specific product descriptions, please refer to individual product labels.
The provided text is a Premarket Notification (510(k)) for the Biomet 3i LLC TSX Implants. It focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical testing. It does not contain information about an AI/ML powered device, nor does it include data from a clinical study on device performance against acceptance criteria.
Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample size for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types.
The document explicitly states: "No clinical data were included in this submission." This means that the information needed to answer most of your detailed questions about device performance validation against specified criteria is not present in the provided text.
The closest relevant information is under "XI. Non-Clinical Testing," which describes mechanical testing (ISO 14801:2016), sterility validation, pyrogenicity testing, SEM/EDS imaging for surface assessment, and biocompatibility testing. These are non-clinical tests to show the device's physical and biological properties are equivalent to predicate devices, not performance against clinical acceptance criteria for an AI/ML algorithm.
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(126 days)
The T3 Pro Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed loading, or with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.
The T3 Pro Implants may also utilize immediate loading for these indications. The T3 Pro Implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.
The T3 Pro Implants are basic screw-type designs available in tapered body geometry. The devices are manufactured from Commercially Pure Titanium (ASTM F67) and feature a roughened apex and traditional OSSEOTITE® coronal surface. The device is packaged in a Titanium sleeve that is inserted into a polypropylene inner tray, covered with a Tyvek lid and heat-sealed. This assembly is then placed inside a larger polyethylene thermoformed outer tray, covered with a Tyvek lid and heat-sealed. The outer tray is packaged inside a box. The device is sold sterile. The shelf life of the T3 Pro Implants is 5 years and they are intended for single use only. The device is sterilized using gamma irradiation method. The implants are available in various platform options and feature an internal hex connection for mating with associated Biomet 3i internal connection restorative components. The implants are offered in a variety of diameters and lengths to accommodate varying patient anatomy.
The provided document is a 510(k) summary for a medical device (T3 Pro Implants) and does not contain information regarding software or AI performance.
Therefore, I cannot provide an answer addressing the acceptance criteria and study proving device performance for AI/software, as the document does not pertain to such a device.
The document discusses the substantial equivalence of the T3 Pro Implants to predicate devices based on non-clinical testing rather than AI/software performance evaluations.
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(255 days)
DenTack PYRAMIDION Dental Implants and Prostheses are intended for surgical placement in the maxilla and/or in the mandible to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous jaws utilizing conventional, delayed or immediate loading when good primary stability is achieved and with appropriate occlusal loading. Implants in 5-6mm length are indicated for delayed loading only.
DenTack has developed a range of expandable dental implants made of titanium (the most common material for dental implants) to serve the need of patients that require partial or complete tooth restoration.
The implant is placed so its end is in the trabecular (spongy) bone like any other implant. Once in place, the apical portion of the implant is expanded to achieve increased contact surface area with the surrounding bone.
The system also includes various accessories that are attached to the implant. The PYRAMIDION has an external hex connection with 0.7mm height and 2.7mm hex with a distinct projection externally to the implant body. The connection between the prosthetic part to the upper platform of the implant interacts with a recessed plain of 15-degrees into the upper platform of the implant body while it is projected from the prosthetic part.
All DenTack's implants are made of biocompatible Titanium. Prostheses and Surgical components are made of same Titanium alloy, stainless-steel and polymers.
DenTack's PYRAMIDION Implants with are the subject of this submission are available in outer diameter (OD) of 4.1 mm and in length of 5 and 6 mm.
DenTack's Prostheses and dimension ranges are identified as follows:
Metal Housing: 3.3 mm Height
Plastic Cup: 2.7 mm Height
Straight Multi-Unit Sleeve: 11 mm Height
Straight Multi-Unit Screw: 2.3 mm Diameter
Angled Abutments 15° And 22.5°: Length: 7 mm – 9 mm
Angled Abutments 15° Large: Total Length: 9 mm – 12 mm
Ball Attachments: 2, 3 and 4 mm Height
Direct Screw Platform
Straight Abutments 2, 3, 8.5 mm Length
Straight Multi-Unit Abutments 2, 3 and 4 mm Length
Angled Multi Unit Abutments 17° and 1.5 and 3 mm Length
Healing Caps 3, 4, 5 and 6 mm
Cover Screw
The Direct Screw Platform is to be used with a burn-out plastic sleeve for ensuring a minimum post height of 4 mm (with no angular correction).
Like the QUAD implants cleared under K152188, the subject PYRAMIDION implants expansion is performed using a reusable Expansion Tool and Ratchet Torque).
The provided text is a 510(k) summary for the DenTack PYRAMIDION Dental Implants and Prostheses. It describes the device, its intended use, and comparative testing performed to demonstrate substantial equivalence to predicate devices. However, this document does not describe a study involving an AI/Machine Learning device or its acceptance criteria and performance metrics.
The document primarily focuses on mechanical, physical, and biocompatibility testing of dental implants and prostheses, comparing them to legally marketed predicate devices. It covers aspects like:
- Fatigue testing (ISO 14801): To assess durability.
- Surface analysis (SEM): To characterize the implant surface.
- Implant removal after expansion: To evaluate interaction with artificial bone.
- Minimal rotation torque after placement and expansion: To assess stability.
- Partially expanded implant reciprocating effect test: To evaluate effects of rotation.
- Biocompatibility (ISO 10993): To ensure biological safety.
- Sterilization validation (Gamma and Steam): To ensure sterility.
- Cleaning validation: For reusable tools.
- Shelf life validation: To confirm sterility maintenance over time.
- Comparative pull-out test (ASTM F543): To assess mechanical strength.
- Comparative bone to implant contact surface area analysis: To compare integration potential.
- Implant surface area analysis: For physical characteristics comparison.
Therefore, I cannot provide the requested information regarding AI/ML device acceptance criteria and performance, as the document does not contain any details about an AI/ML component or study.
The questions posed (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone algorithm performance) are highly specific to AI/Machine Learning model validation in a medical context, which is not described in this 510(k) summary for dental implants.
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(86 days)
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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