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510(k) Data Aggregation
(366 days)
CORE1 Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.
CORE1 Implant System 3.3mm diameter implants may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.
CORE1 Fixture is a thread type implant made of CP Titanium Gr.4 according to ASTM F67 which will be placed in the alveolar bone to replace the function of missing tooth. This device has connection between the upper prosthesis and the internal hex. Fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic device or other components of a dental implant set with human body (mandibular or maxillary bone). Fixtures are provided after gamma sterilization as a set package including a cover screw or as a single fixture.
CORE1 Abutment intended for Single Unit restorations is a superstructure of a dental implant system and connecting elements between the dental implant and the crown. It is to made of Ti-6A1-4V ELI (ASTM F136), and intended to be placed on the fixture allows single prosthetic restorations to restore a patient's chewing function. Abutment Screw made of Ti-6AI-ELI (ASTM F136) is used to connect and fix the abutment to the fixture. The contained various abutments and accessories in the system are Solid Abutment, Cement Abutment, Angled Abutment, Milling Abutment, Temporary Abutment, Solid Protect Cap, Cover Screw, Healing Abutment, Healing Abutment (Scan). Angled Abutment can select 15° and 25° angles for prosthetics, and Milling Abutment is up to 20° for hand milling only.
CORE1 Abutment intended for Multi-Unit restorations is a superstructure of a dental implant system and connecting elements between the dental implant and the bridge. It is to made of Ti-6A1-4V ELI (ASTM F136), and intended to be placed on the fixture allows multi prosthetic restorations to restore a patient's chewing function. Universal Plastic Cylinder is a burn-out device only used in the lab for casting and is not part of the final restoration. Abutment Screw made of Ti-6A1-ELI (ASTM F136) is used to connect and fix the abutment to the fixture. The contained various abutments and accessories in the system are Universal Abutment, Universal Angled Abutment, Universal Ti Cylinder, Universal Temporary Cylinder, Universal Healing Cap. Universal Angled Abutment has angles of 17%30°.
The provided document is a 510(k) summary for the CORE1 Implant System, demonstrating its substantial equivalence to predicate devices. It focuses on physical and material characteristics and performance testing based on industry standards, rather than clinical study results involving human or expert evaluation for diagnostic accuracy.
Therefore, many of the requested details, such as those related to "acceptance criteria" for diagnostic accuracy, "sample size for the test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," and "training set details" are not applicable or extractable from this document as it pertains to a dental implant system, not an AI/diagnostic device.
However, I can extract information related to the device's performance through non-clinical testing.
Here's a breakdown of the relevant information provided:
1. A table of acceptance criteria and the reported device performance:
The document doesn't define specific numerical "acceptance criteria" in a table format for diagnostic performance, as it's a dental implant. Instead, it describes performance through non-clinical testing against established ISO standards and FDA guidance for dental implants. The "acceptance" is demonstrated by meeting the requirements of these standards.
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bacterial Endotoxin Test | According to USP and ANSI/AAMI ST72:2011. Testing limit of 20 EU/device for blood contacting and implanted device. | Confirmed that the endotoxin test reagent (PTS cartridge) and laboratory environment were suitable, meeting endotoxin standards and established criteria. Implies performance within the accepted limit. |
| Fatigue Testing | According to ISO 14801:2016 and FDA guidance document "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments". Objective: Confirm permanent restoration of the implant without failure. | Performed on the subject device and reference device K190837 to confirm covering permanent restoration of the implant without failure. The language "to confirm covering permanent restoration of the implant without failure" implies successful completion meeting the standard. |
| Surface Analysis | Not explicitly stated as a separate acceptance criterion but is part of material characterization. | SEM & EDS analysis showed surface roughness leading to a macroroughness and no other impurity on the surface of the final product. This indicates the desired surface characteristics were achieved. |
| Gamma Sterilization | According to ISO 11137-1:2006/Amd.1:2013, ISO 11137-2:2013, and ISO 11137-3:2006. Objective: Acceptable range of densities of other product in carrier and confirm process stability. | Evaluation showed an acceptable range of densities of other products in the carrier and confirmed process stability. Concluded that the packaging with gamma sterilization of the subject device is equivalent to predicate/reference devices, with a shelf life of 5 years. |
| End User Sterilization | According to ISO 17665-1:2006, ISO 17665-2:2009, and ANSI/AAMI ST79:2010/A4:2013. | Performed according to the stated standards. The implicit result is that it meets the requirements for end-user sterilization. |
| Biocompatibility Testing | According to ISO 10993-1:2018 and FDA Guidance Document "Use of International Standard ISO 10993-1...", and ISO 10993-5:2009. | Performed for each subject device. The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate devices, which includes assurance of biocompatibility. |
2. Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated as a number of devices. The testing is based on performing the required tests as per relevant ISO standards. For fatigue testing, it states it was performed on "subject device and reference device K190837," implying at least one of each for the test, but typically these tests involve multiple samples to establish robustness and statistical significance as required by the standards.
- Data provenance: Not specified in terms of country of origin or whether it was retrospective/prospective. As this is non-clinical bench testing, the data is generated in a laboratory setting. The manufacturer, Cybermed Inc., is from the Republic of Korea.
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. This device is a dental implant, not a diagnostic device requiring expert review for "ground truth" establishment of medical conditions. The "ground truth" for performance is based on established engineering and materials science standards for dental implants.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as this is non-clinical bench testing against established 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 dental implant, not an AI/diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a dental implant, not an AI/diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance is derived from compliance with international and national standards for medical device safety and performance, specifically for dental implants (e.g., ISO 14801 for fatigue, ISO 10993 for biocompatibility, ISO 11137 for sterilization, USP for endotoxins).
8. The sample size for the training set:
Not applicable. This document does not describe a machine learning or AI algorithm, so there is no "training set."
9. How the ground truth for the training set was established:
Not applicable, as there is no "training set."
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(113 days)
The BellaTek Encode Emergence Healing Abutments are intended for use as an accessory to endosseous dental implants during endosseous and gingival healing to prepare gingival tissue for acceptance of a final abutment and restoration.
The BellaTek Encode Emergence Healing Abutment is a two-piece healing abutment (abutment with a retaining screw) designed to facilitate gingival tissue healing before a final restoration is placed. It consists of an abutment and a retaining screw that are assembled and packaged together and provided sterile. Both components are machined from Titanium Alloy Ti-6Al-4V ELI (ASTM F136). They are available in pre-defined diameters, emergence profiles and heights to accommodate varying patient anatomies. The shelf life of the TSV BellaTek Encode Healing Abutment is 5 years from the date of manufacture and they are intended for single use only. The device is packaged in a blister tray with Tyvek Lid and sold sterile. The device is sterilized using the gamma irradiation method. The BellaTek Encode Emergence Healing Abutments are color anodized for aesthetic purposes.
This document is a 510(k) Premarket Notification from the FDA regarding the "BellaTek Encode Emergence Healing Abutments". It does not describe an AI/ML device, therefore the requested information regarding acceptance criteria and study details for AI/ML performance is not present.
The document focuses on demonstrating substantial equivalence to previously approved predicate devices, rather than an AI/ML device's performance.
Here's why the requested information cannot be extracted:
- No AI/ML Component: The device is a physical dental implant component (healing abutment), not a software algorithm or AI-powered system.
- Substantial Equivalence: The approval process here is based on showing that the new device is as safe and effective as a legally marketed predicate device, not on meeting specific performance metrics for an AI algorithm.
- Non-Clinical Testing: The "Non-Clinical Testing" section describes tests related to physical properties, biocompatibility, sterilization, and shelf-life, which are typical for physical medical devices. It does not mention any studies related to AI/ML performance metrics like accuracy, sensitivity, specificity, etc.
Therefore, since the input document describes a physical medical device and not an AI/ML device, it does not contain the information requested in the prompt about AI/ML acceptance criteria and study details.
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(161 days)
Z5-TL implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. Z5-TL implants are suitable for patients with metal allergies and the chronic diseases resulting from them. Z5-TL implants are intended for delayed loading.
Z5-TL is a dental implant system that includes root-form, endosseous threaded dental implants indicated for tissue level placement. The dental implants are provided in two endosseous body diameters (4 mm and 5 mm) and each diameter is provided in three endosseous lengths (8 mm, 10 mm, and 12 mm). The corresponding platform diameters are: 4.8 mm platform diameter for 4 mm body diameter, and 6 mm platform diameter for 5 mm body diameter. The dental implants are manufactured from Y-TZP zirconia conforming to ISO 13356. The system also includes gingiva formers and a temporary abutment manufactured from polyetheretherketone (PEEK). Zirconia abutments for single-unit and multi-unit cemented restorations are provided in straight and 15° angled designs. For retention of overdentures, zirconia Locator-type abutments are provided in straight and 15° angled designs.
The subject device is compatible with the following components cleared in K190243: a healing cap manufactured from PEEK; Locator-type abutments manufactured from zirconia; and occlusal (abutment) screws manufactured from zirconia and from Ti-6Al-4V alloy conforming to ASTM F136.
The subject device implants are provided sterilized by plasma gas. All other subject device components are to be sterilized by the end user by moist heat (steam).
The provided text describes a 510(k) premarket notification for a dental implant system (Z5-TL) and does not contain information about the acceptance criteria and study design you've requested for typical AI/ML device evaluations. This document focuses on demonstrating substantial equivalence to already-marketed predicate devices, primarily through non-clinical data.
Therefore, I cannot populate the table or provide answers to most of your questions as the information is not present in the provided text.
Here is what can be extracted based on the document:
1. A table of acceptance criteria and the reported device performance
No specific acceptance criteria or tabulated performance data for an AI/ML device are provided in this document. The performance data discussed relates to the mechanical properties and sterilization of the dental implant itself.
2. Sample size used for the test set and the data provenance
Not applicable. This is not an AI/ML device relying on a test set of data. The "performance data" section refers to non-clinical testing of the dental implant's physical properties.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 MRMC study was mentioned or performed, as this is not an AI/ML diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For the non-clinical tests, the "ground truth" would be established by validated test methods and physical measurements according to specified ISO and ASTM standards.
8. The sample size for the training set
Not applicable.
9. How the ground truth for the training set was established
Not applicable.
Summary of relevant performance data (non-clinical, from the document):
The performance data submitted was non-clinical and aimed to demonstrate substantial equivalence of the Z5-TL dental implant device.
- Sterilization Validation: According to ISO 14937 and ISO 17665-1 (referenced from predicate K132881).
- Sterile Product Shelf Life Testing: According to ISO 11607-1, ISO 11607-2, ASTM F1886/F1886M, and ASTM D3078 (referenced from predicate K132881).
- Biocompatibility of PEEK material: According to ISO 10993-3, ISO 10993-12, ISO 10993-10, ISO 19003-11, ISO 10993-18, and USP Class VI testing according to USP 37-NF32 (referenced from predicate K190243).
- Static compression and compression fatigue testing: Of the zirconia implants and abutments according to ISO 14801.
- Assessment of abutment screw loosening and removal torque testing: According to ISO 18130, after insertion and dynamic testing (ISO 14801), including microscopic examination, and comparison to reference devices K063286 and K072642.
- Assessment of wear particles: Associated with the Ti-6A1-V alloy abutment screw used with zirconia implant bodies and abutments after dynamic testing (ISO 14801), including light microscopy and SEM/EDX, and comparison to all-titanium constructs of reference devices K063286 and K072642 (leveraged from K190243).
Conclusion on Performance: The document states that the non-clinical data demonstrated that the device has "sufficient strength for their intended use" and supports substantial equivalence to the predicate devices. No clinical data was included in the submission.
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(469 days)
Implacil Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit and/or multi-unit restorations. When a one-stage surgical is applied, the Implacil Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Implacil Implant System is composed of three implant lines that are divided according to the implant-toabutment interface: External Hex (HE), Internal Hex (HI) and Morse Taper AR Due Cone (CM AR). HE and HI lines are composed of tissue-level implants while CM AR line of bone-level implants. Each implant line is composed of implants and related prosthetic components available in multiple designs (temporary, screwed, cementable, angled, straight, UCLA, ball).
HE implant line implants are available in two root-forms designs: conical (tapered) and cylindrical. Conical implants are available in three diameters and platforms (3.5, 4.0 and 5.0 mm) and five lengths (7.0, 9.0, 11.0, 13.0 and 15.0 mm). Cylindrical implants are provided in four diameters (3.3, 3.75, 4.0 and 4.75 mm), three platforms (3.5, 4.0 and 5.0 mm) and five lengths (8.0, 10.0, 11.5, 13.0 and 15.0 mm). HE cylindrical implants of diameters 3.75 and 4.0 share the same platform of 4.0 mm.
HI implant line implants are available in two root-forms designs: conical (tapered) and cylindrical. Conical implants are available in three diameters and platforms (3.5, 4.0 and 5.0 mm). For diameters 3.5 and 4.0 are available in the lengths 8.0, 9.0, 11.0, 13.0 and 15.0 mm, and for diameters 5.0 are available in the lengths 7.0, 9.0, 11.0, 13.0 and 15.0 mm. Cylindrical implants are provided in four diameters (3.3, 3.75, 4.3 and 4.75 mm) and three platforms (3.5, 4.0 and 5.0 mm). For diameter 3.3 are available in the lengths 8.0, 9.0, 11.0, 13.0 and 15.0 mm, and for diameters 3.75 and 4.3 are available in the lengths 7.0, 9.0, 11.0, 13.0 and 15.0 mm. HI cylindrical implants of diameters 3.75 and 4.3 share the same platform of 4.0 mm.
CM AR implant line implants are available in conical root-form design only, in four diameters (3.5, 4.0, 4.5 and 5.0 mm) and five lengths (7.0, 9.0, 11.0, 13.0 and 15.0 mm).
lmplacil implants are made of commercially pure titanium (ASTM F67). Implacil prosthetic components are made of commercially pure titanium (ASTM F67) or titanium alloy (ASTM F136). Implant System screws (abutment screw, UCLA screws and coping screws) are made of titanium alloy (ASTM F136).
The subject device abutments components mate exclusively with the subject implants of the same line (HJ, HE, CM AR).
The provided document is a 510(k) Summary for a dental implant system. It outlines the device description, intended use, and a comparison to predicate and reference devices to demonstrate substantial equivalence. Crucially, this document does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of AI/ML-based medical devices.
The "Performance Data" section explicitly states: "No clinical data were included in this submission." Instead, it lists non-clinical data for physical and material properties of the dental implants, such as sterilization validation, shelf life testing, biocompatibility, and mechanical performance (fatigue and torsional loading).
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, ground truth establishment, or MRMC comparative effectiveness studies, as these types of studies are not described in this 510(k) submission for a traditional medical device (dental implants), which are not a software device or AI/ML-based device.
If you are looking for information on acceptance criteria and study data for AI/ML-based medical devices, you would need to consult a different type of FDA submission, specifically for software as a medical device (SaMD) or AI-enabled medical devices, where such performance data would be critical for demonstrating safety and effectiveness.
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(331 days)
Z5-BL implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. Z5-BL implants are suitable for patients with metal allergies and the chronic diseases resulting from them. Z5-BL implants are intended for delayed loading.
Z5-BL is a dental implant system that includes root-form, endosseous threaded dental implants indicated for bone level placement. The dental implants are provided in body diameters of 4 mm and 5 mm, and each diameter is provided in 8, 10, and 12 mm lengths. The dental implants are manufactured from Y - TZP zirconia conforming to ISO 13356. The system also includes a healing cap, gingiva formers, and a temporary abutment manufactured from polyetheretherketone (PEEK). Zircoma abutments for single-unit and multi-unit cemented restorations are provided in straight and 15° angled designs. For retention of overdentures, Zirconia Locator-type abutments are provided in straight and 15° angled designs. Occlusal (abutment) screws are provided in Ti-6Al-4V alloy conforming to ASTM F136 and in zirconia.
The subject device implants and Healing Cap are provided sterilized by plasma gas. All other components are to be sterilized by the end-user by moist heat (steam).
The provided text is a 510(k) summary for the Z5-BL dental implant. It focuses on demonstrating substantial equivalence to predicate devices based on indications for use, technological characteristics, and performance data. However, it does not contain information about acceptance criteria and studies proving the device meets those criteria in the context of AI/ML performance metrics (e.g., accuracy, sensitivity, specificity, or MRMC studies).
The document explicitly states: "No clinical data were included in this submission." This means there is no performance data related to human-in-the-loop studies, standalone AI performance, or any studies that would involve establishing ground truth from expert consensus or pathology for evaluating AI model performance.
Therefore, I cannot provide the requested information for acceptance criteria and a study proving the device meets those criteria from the provided text, as it describes a traditional medical device submission for dental implants, not an AI/ML-driven device.
To answer your specific questions in the context of an AI/ML device, I would need a different type of document that describes performance data related to an AI/ML algorithm.
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(196 days)
BoneTrust® Dental Implants are medical devices intended to be surgically placed in the bone of the maxillary and/or mandibular arches to provide support for prosthetic restorations (crowns, bridges or overdenture) in edentulous or partially edentulous patients to restore a patients' chewing function.
BoneTrust® implants can also be used for immediate loading when sufficient primary stability is achieved and with appropriate occlusal loading.
BoneTrust® Short Dental Implants with length 6.5 mm are intended for delayed loading only
BoneTrust® Abutments and Prosthetic parts are intended for use with Bone Trust Dental Implants in the maxillary and/or mandibular arches to provide support for crowns, bridges or overdentulous or partially edentulous patients.
The BoneTrust® Implant System includes various sizes of threaded root-form dental implants and abutments intended to support prosthetic restorations in edentulous or partially edentulous patients.
The BoneTrust® Implants are bone level, root form implants constructed of commercially pure titanium (Grade 4) per ISO 5832-2, with a sand-blasted, acid-etched surface treatment. BoneTrust® Implants are screw- shaped dental implants with a Hexagon or conical torx internal connection.
BoneTrust® Dental Abutments are intended for cement-retained and screw-retained restorations. A cylindrical internal hexagon or conical torx allows connection to the BoneTrust® implant. BoneTrust® Dental Abutments are available in different designs
This document is a 510(k) summary for the BoneTrust® Implant System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a standalone study for novel performance metrics. Therefore, many of the requested sections about acceptance criteria, sample sizes, ground truth establishment, expert adjudication, and MRMC studies are not applicable.
However, I can extract the information provided regarding non-clinical testing used to support substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for a novel AI device. Instead, it relies on demonstrating "substantial equivalence" through non-clinical testing to legally marketed predicate devices. The "reported device performance" is essentially that the device performed comparably to predicate devices in the described tests.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Biocompatibility in accordance with ISO 10993 series | Tests (including cytotoxicity per ISO 10993-5) support substantial equivalence to legally marketed predicate devices. |
| Fatigue strength of the implant-abutment interface | Tested for representative samples in accordance with ISO 14801. Results support substantial equivalence to legally marketed predicate devices. |
| Sterilization validation (for non-sterile devices) | Validation conducted per ISO 17665-1 and ISO 17665-2 for pre-vacuum steam sterilization (wrapped cycle), demonstrating a sterility assurance level (SAL) of 10^-6. |
| Sterilization validation (for sterile devices) | Validation conducted per ISO 11137-1 and 11137-2 for Beta-radiation sterilization. Shelf life testing per ISO 11607-1 and ASTM F1980 (accelerated and real-time aging). LAL testing per USP 85 and FDA Guidance. |
| Implant Surface Analysis | Investigation using EDX, SEM, and BSE. Results support substantial equivalence to legally marketed predicate devices. |
| Performance of BoneTrust® Short Implants | Comparative surface area analysis, comparative bone-to-implant contact study (using animal histology), and comparative pull-out strength test. Results support substantial equivalence to legally marketed predicate devices. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not provide specific sample sizes for the test sets in the non-clinical studies. It mentions "representative samples" for fatigue testing. Data provenance is not specified beyond being non-clinical testing performed to support substantial equivalence to legally marketed predicate devices.
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. This is a 510(k) submission for a physical medical device (dental implants and abutments), not an AI/software device requiring ground truth establishment by human experts for diagnostic or similar tasks. The "ground truth" for the non-clinical tests would be the measurement results from the tests themselves (e.g., cytotoxicity levels, fatigue limits, physical characteristics).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as this is for a physical device and involves objective non-clinical tests rather than subjective human interpretation needing adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted diagnostic or interpretation device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical studies performed, the "ground truth" would be objective measurements obtained through standardized testing methods, such as:
- Biocompatibility: Laboratory results (e.g., cell viability in cytotoxicity tests).
- Fatigue testing: Load cycles to failure or endurance limit under specified conditions, as per ISO 14801.
- Sterilization: Sterility Assurance Level (SAL), microbial ingress testing, package integrity.
- Implant Surface Analysis: Microscopic imagery (SEM, BSE) and elemental composition data (EDX).
- Short Implants Performance: Quantitative measurements from comparative surface area analysis, histological examination for bone-to-implant contact (animal study), and force measurements for pull-out strength tests.
8. The sample size for the training set
Not applicable. There is no training set mentioned for this physical device.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this physical device.
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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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(176 days)
DenTack QUAD 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 delayed loading or immediate loading when good primary stability is achieved and with appropriate occlusal loading.
DenTack has developed a range of expandable dental implants made of Titanium to serve the need of patients that require partial or complete tooth restoration. The implant is placed so its apical 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 attach to the implant. All DenTack's implant bodies are made of a combination of Titanium alloy according to ASTM F136 and c.p. titanium according to ASTM F67. Abutments are made of same Titanium alloy while denture components are made of stainless-steel and polymers.
DenTack's QUAD Implants are available in outer diameter (OD) of: 3.75 and 4.1 mm. The implants' length dimensions are from 7 to 11 mm.
DenTack's Prostheses are identified as follows:
Metal housing
Plastic cup
Straight Multi-unit Sleeve
Straight Multi-unit Screw
Angled abutments 15° and 25°
Angled abutments 15° Large
Ball Attachments (1, 2 & 3 mm)
Direct screw platform
Straight abutments
Screw retained abutments
Straight Multi-unit abutments
Healing caps
Cover Screw
The QUAD expansion is performed using a reusable Expansion Tool and Ratchet Torque.
Here's an analysis of the acceptance criteria and supporting studies for the DenTack QUAD Dental Implants and Prostheses based on the provided document:
Acceptance Criteria and Device Performance for DenTack QUAD Dental Implants and Prostheses
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | ||
| Fatigue Test (ISO 14801:2007) | Device performs at least as good as or better than the predicate device. | "The QUAD met the acceptance criteria and performed at least as good as or better than the predicate device." Tested on worst-case configuration (25° abutment with narrowest implant OD). |
| Evaluation of Minimal Rotation Torque after Placement and Expansion | Test results to be similar to and thus equivalent to the predicate device. | "The tests results found to be very similar and thus equivalent. The QUAD met the acceptance criteria and performed at least as good as or better than the predicate device." |
| Partially expanded QUAD Implant Reciprocating Effect Test | No additional damage to surrounding bone or implant from counterclockwise/clockwise rotation; performs similarly to reference device. | "The study demonstrated that both the surrounding bone and the implant were not negatively affected by counterclockwise/clockwise rotation and that the QUAD performed similarly to the reference device." |
| Material & Surface Characteristics | ||
| Surface Analysis (SEM) | - | Implant surface tested using SEM. (No specific acceptance criteria or performance metric beyond "tested" is stated). |
| Biocompatibility (ISO 10993-1, -5, -12) | No incompatibility potential or adverse biological effect. | "The chemical and biological tests have not revealed any incompatibility potential or any adverse effect." |
| Sterilization & Packaging | ||
| Gamma Sterilization Validation (ISO 11137-2, AAMI TIR 33 / ISO TS 13004) | Successful sterilization according to standards. | "Sterilization was conducted with successful results, using Gamma Irradiation according to VDmax method..." |
| Steam Sterilization Validation (ISO 17665-1:2006, ANSI AAMI ST79:2010, ANSI AAMI ST77:2013) | Validation results support SAL 10⁻⁶; IFU in-line with validation. | "The validation results supported SAL 10-6. IFU (instructions for use) are in-line with the validation results." |
| Shelf Life Validation (ISO 11607-1) | Sterility maintained for the device shelf life. | "This validation confirmed that the sterility of DenTack's sterile products will be remained for the device shelf life." |
| Functional/Clinical Equivalence | ||
| QUAD Removal after Expansion | The expandable design does not cause additional damage to the surrounding tissue. | "The evaluation post implant removal showed that both implants performed equally in terms of interaction with the bone." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample sizes for most of the individual tests. It generally refers to testing being conducted "for Dentistry - Implants - Dynamic fatigue test for endosseous dental implants" and "in comparison to predicate device" or "legally marketed device."
- Fatigue Test (ISO 14801:2007): "Worst case configuration was selected." (Implies a specific combination of implant and abutment was tested, but no number of samples is given).
- QUAD Removal after Expansion: "artificial bone was used and a reference legally marketed device for comparison." (No number of samples or explicit provenance beyond "artificial bone").
- Evaluation of Minimal Rotation Torque: "artificial bone." (No number of samples).
- Partially expanded QUAD Implant Reciprocating Effect Test: "a legally marketed device with similar instructions for use." (No number of samples).
- Biocompatibility (ISO 10993-1, -5, -12): "final and sterilized products." (No number of samples).
- Sterilization and Shelf Life Validations: Not specified, but generally follow specific standards.
The data provenance is largely implied to be laboratory-based testing using in vitro models (e.g., artificial bone) and comparisons to existing devices, rather than in vivo or human data. There is no information regarding country of origin for the data other than the company being based in Israel. The studies are by nature prospective as they are specifically conducted to support the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
No direct mention of experts or their qualifications establishing "ground truth" for the test set is provided. The studies described are primarily engineering and laboratory performance tests against industry standards (e.g., ISO, AAMI) or in comparison to predicate devices, rather than clinical studies requiring expert consensus on outcomes.
4. Adjudication Method for the Test Set
Not applicable. The tests are primarily physical, chemical, and mechanical evaluations against defined standards and comparative performance with predicate devices, not subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study was done. The document describes laboratory and engineering tests, not clinical studies involving human readers or cases.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
Not applicable. This is a physical medical device (dental implants and prostheses), not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the various studies is typically defined by:
- Industry Standards: Compliance with international standards (e.g., ISO 14801, ISO 10993 series, ISO 11137-2, ISO 17665-1, ISO 11607-1).
- Comparative Performance: The performance of legally marketed predicate devices or reference devices, establishing a benchmark for substantial equivalence.
- Defined Benchmarks/Thresholds: For tests like sterilization success (SAL 10⁻⁶) or fatigue limits implied by ISO standards.
- Qualitative Assessment: Such as "no additional damage" or "no incompatibility potential" demonstrated in material science or biological tests.
8. The Sample Size for the Training Set
Not applicable. There is no training set mentioned, as this is for a physical medical device clearance, not an AI/ML algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
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