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510(k) Data Aggregation
(258 days)
Paltop Short Implants (Internal Hex and Conical Connections) are in surgical and restorative applications for placement in the bone of the upper or lower jaw as an artificial root structure for single tooth replacement or for fixed bridgework to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Paltop Short Implants are indicated to be used only with straight abutments and are for delayed loading only.
The purpose of this submission is for the marketing clearance for the Paltop Short Implants which comprises endosseous root-form dental implants, cover screw, and compatible abutments.
The Subject device abutments are compatible with prior cleared implant bodies, and abutments from prior clearances are compatible with new Subject device implant bodies. Subject device abutments are also compatible with previously cleared implant bodies in K112795. Subject device are compatible with straight abutments previously cleared in K112795, K131451, K220200, and K221381.
Endosseous dental implants are surgically implanted into a patient's mouth to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Endosseous dental implant abutments are secured to dental implants with a retaining screw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.
The Paltop Short Implant System includes endosseous screw type dental implant bodies, which can be used in twostage surgeries with associated compatible abutments. The Subject device abutments provide a range of cementretained and screw-retained prosthetic solutions for dental implant restoration. Paltop Short Implant System includes six compatible implant abutment designs: Healing Caps, Straight, Temporary, Snap-On Abutment System (SAS) Abutment, and Straight Ball Abutment.
The implant bodies, titanium abutments and cover screw are fabricated from a Titanium 4 Vanadium ELI titanium alloy (Grade 23) which conforms to ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium EU (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The Subject device implant bodies are surface treated with SLA (Sand-blasted, Large Grit, Acid Etched). The Snap On Abutment System(SAS) Abutments are supplied sterile with a PEEK cap.
All implants and prosthetic components are one-time use device components are provided sterile and sterilized by gamma irradiation except for the replacement cover screws which are provided nonsterile. Devices provided as non-sterile are sterilized by steam.
I am sorry, but the provided text does not contain the specific details about the acceptance criteria or a study proving the device meets those criteria. The document is an FDA 510(k) summary for Paltop Short Implants, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed acceptance criteria and study results for device performance in the way you've requested.
The text does mention "Comparative testing in the form of Pull-Out, surface area and BIC testing was performed to ensure that the performance of the subject device is appropriate for its intended use," but it does not provide the acceptance criteria for these tests, nor does it present the reported device performance values from these tests. It also states that "static and dynamic testing were not required" because the device is not significantly different from predicate devices.
Therefore, I cannot fulfill your request for the detailed table and study information as the necessary data is not present in the provided document.
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(90 days)
DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.
All digitally designed custom abutments for use with DESS Ti Base abutments or Pre-Milled Blank abutments are to be sent to a Terrats Medical validated milling center for manufacture.
The purpose of this submission is to add components to the DESS Dental Smart Solutions system, which includes dental implants, abutments, and prosthetic components cleared previously in various submissions. The previously cleared abutments and prosthetic components are compatible with a variety of original equipment manufacturer (OEM) dental implants as well as DESS Dental Smart Solutions dental implants.
This submission adds various abutments to the DESS and OEM implant lines as summarized on the following pages in Table 1 Summary of Subject Device Abutment Designs, and Table 2 Summary of Subject Device Abutment Sizes.
The subject device abutment designs include Cover Screws, Healing Abutments, Temporary Abutments, Ti Base Abutments, AURUM Base Abutments (Ti Base abutments with a screw channel design that allows easier instrument access to the abutment screw), CoCr Base Abutments, Pre-Milled Blank Abutments, Multi-Unit Abutments (straight and angled), DESSLoc Abutments (Locator-type abutments), and abutment screws.
This document is a 510(k) summary for the DESS Dental Smart Solutions, a line of endosseous dental implant abutments. It details the device's characteristics, intended use, and a comparison to predicate devices to establish substantial equivalence.
Based on the provided text, the device itself is a physical medical device (dental implant abutments and associated components), not a software or AI-driven system. Therefore, the questions related to AI acceptance criteria, training/test sets, expert adjudication, MRMC studies, and ground truth establishment for AI would not be directly applicable to this product as described.
The document focuses on establishing substantial equivalence to previously cleared predicate devices through:
- Identical Intended Use: The device is intended for "functional and esthetic rehabilitation of the edentulous mandible or maxilla" by providing support for prosthetic restorations, which is the same as the predicate devices.
- Similar Technological Characteristics: The device utilizes similar designs, materials (Ti-6Al-4V, Co-Cr-Mo alloy), manufacturing processes, and sterilization methods as its predicates.
- Performance Data: Non-clinical testing (mechanical testing per ISO 14801, MR environment assessment) and comparison to existing data from predicate devices are used to demonstrate safety and effectiveness.
Therefore, many of the requested elements for describing AI acceptance criteria and studies are not present or applicable in this document.
However, I can extract information relevant to the device's performance assessment and criteria for its type of submission.
Here's an attempt to answer the questions based solely on the provided text, acknowledging that the nature of the device (a physical implant component) means many AI-specific questions will be answered as "Not Applicable" (N/A):
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantifiable "acceptance criteria" in a table format with corresponding "reported device performance" metrics for this specific 510(k) submission. Instead, it relies on demonstrating substantial equivalence to existing predicate devices.
The underlying "acceptance criteria" for demonstrating substantial equivalence for this device type are primarily through:
- Mechanical Testing (ISO 14801): This is a critical performance standard for dental implants and abutments. The document states that mechanical testing was "conducted according to ISO 14801 to support the performance." The acceptance criteria would be successful completion of these tests, demonstrating the device's mechanical strength and fatigue resistance are comparable to or better than predicate devices. The reported performance is simply that the tests supported the performance.
- Material Conformance: Materials must conform to specific ASTM standards (e.g., ASTM F136 for Ti-6Al-4V, ASTM F1537 for Co-Cr-Mo). The reported performance is that the materials conform to these standards.
- Biocompatibility: While not detailed in this excerpt, the mention of "biocompatibility" in relation to predicates implies conformance to relevant biocompatibility standards (e.g., ISO 10993 series). The reported performance is that it is compatible.
- Sterilization Validation: Demonstrated sterility assurance level (SAL) of 10⁻⁶ via validated methods (moist heat or gamma irradiation). The reported performance is that validation was performed and met this SAL.
- Dimensional Compatibility: The abutments must fit the corresponding OEM implants correctly. The reported performance is that reverse engineering dimensional analysis confirmed compatibility.
Due to the nature of the document being a 510(k) summary focusing on substantial equivalence rather than a full study report, specific numerical performance results for the device tests are not provided in this text.
2. Sample sizes used for the test set and the data provenance
- Sample Size for Mechanical Testing: The document states "mechanical testing conducted according to ISO 14801." For such tests, ISO 14801 typically specifies minimum sample sizes (e.g., 10-11 samples for static strength, typically more for fatigue). The exact number of samples used for this specific submission is not explicitly stated, but it would have followed the standard's requirements.
- Data Provenance: The mechanical testing and material analyses are assumed to be "non-clinical data submitted or referenced" by the manufacturer, Terrats Medical SL, based in Barcelona, Spain. The "reverse engineering dimensional analysis" was done by Terrats Medical SL or through contractual agreement. This is prospective testing performed to support the 510(k). The document itself does not specify the country of origin for the underlying OEM implant data used for reverse engineering, although the OEM companies are listed (e.g., Astra Tech AB, BioHorizons).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. This is a physical device. Ground truth, in the context of AI, refers to validated labels for data used to train and test an algorithm. For a physical device, performance is evaluated through engineering and biocompatibility testing against defined standards. There are no "experts" establishing ground truth in the AI sense. Testing would be performed by qualified engineers and technicians.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. Adjudication methods are typically used in clinical studies involving interpretation (e.g., by radiologists) to resolve discrepancies. This document describes non-clinical performance testing of a physical device.
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 product is a dental implant abutment, not an AI software intended to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
N/A. For engineering tests of physical devices, the "ground truth" is typically derived from established engineering principles, international standards (e.g., ISO 14801 for mechanical properties, ASTM for materials), and the physical properties of the materials and designs themselves. There isn't "expert consensus" or "pathology" in the AI or clinical trials sense.
8. The sample size for the training set
N/A. This is a physical device; there's no "training set" in the machine learning sense. The device is manufactured based on established engineering designs and material specifications.
9. How the ground truth for the training set was established
N/A. No training set for AI. For device manufacturing, the "ground truth" for design and production parameters comes from established engineering best practices, prior successful device designs (predicate devices), and adherence to quality systems regulations (21 CFR Part 820).
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(90 days)
DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.
All digitally designed custom abutments for use with DESS Bases or Blanks are to be sent to a Terrats Medical validated milling center for manufacture.
The purpose of this submission is to add components to the DESS Dental Smart Solutions system, which includes abutments cleared previously in K170588, K173908, K191986, K203464, K212577, and K212628. This submission adds various abutments to eight (8) OEM implant lines from Keystone Dental, Inc., having three (3) implant-abutment connections (Internal TiLobe, Internal Conical). The subject device abutment designs include Multi Unit Abutments (straight and angled 17° and 30°), Ti Base abutments, and Premilled Blank Abutments. Abutments are provided with the appropriate abutment screw (if applicable) for attachment to the corresponding implant, and the appropriate prosthetic screw (if applicable) for attachment of a screw-retained prosthesis. All abutments and screws are provided non-sterile.
The provided text is a 510(k) Summary for a dental device (DESS Dental Smart Solutions abutments). It focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily through engineering specifications, material composition, and non-clinical performance data for mechanical integrity and biocompatibility.
Crucially, this document does not describe an AI/ML-driven device or study parameters related to AI/ML performance. Therefore, most of the requested information (related to AI acceptance criteria, training/test sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for AI) cannot be extracted from this text.
The document details the physical characteristics, intended use, and mechanical testing of dental abutments, which are physical components used in dental implants. There is no mention of algorithms, artificial intelligence, machine learning, or any form of image analysis or diagnostic support that would involve such technologies.
Therefore, I can only provide information related to the device itself and its non-clinical testing, not an AI/ML study.
Here's what can be extracted from the document:
1. A table of acceptance criteria and the reported device performance (for non-AI device):
The document discusses "performance data" in the context of non-clinical analyses, referencing compliance with various ISO standards and published literature. The acceptance criteria are implied by adherence to these standards and the demonstration of substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Sterilization validated according to ISO 17665-1 and 17665-2 | Referenced from predicate K212628 (meets standard) |
| Biocompatibility according to ISO 10993-5 and 10993-12 | Referenced from predicate K212628 (meets standard) |
| Metallic devices evaluated for MR environment safety | Analysis performed using scientific rationale and published literature (TO Woods, JG Delfino, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices," 2021); addressed displacement force and torque per FDA guidance. |
| Static compression and compression fatigue testing of worst-case constructs in conformance with ISO 14801 | Testing performed on worst-case constructs comprising subject device Multi Unit Angled Abutments and compatible OEM implants (meets standard). |
Regarding the AI-specific questions (2-9), the document provides no relevant information.
- 2. Sample sized used for the test set and the data provenance: Not an AI device.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not an AI device.
- 4. Adjudication method for the test set: Not an AI device.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not an AI device.
- 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not an AI device.
- 7. The type of ground truth used: Not an AI device (ground truth concepts apply to AI/diagnostic performance, not mechanical devices). For this device, "ground truth" would be the measured physical properties and clinical use case defined by dental/medical standards.
- 8. The sample size for the training set: Not an AI device.
- 9. How the ground truth for the training set was established: Not an AI device.
Summary of Device and its "Study":
The device is a set of dental implant abutments. The "study" described is a non-clinical bench testing and engineering analysis to demonstrate the physical and material characteristics of the abutments and their substantial equivalence to previously cleared devices. It involves:
- Material composition analysis: Ensuring materials meet ASTM standards (Ti-6Al-4V ELI).
- Biocompatibility testing: Referenced from previous 510(k) submissions.
- Sterilization validation: Referenced from previous 510(k) submissions.
- MR environment compatibility analysis: Based on scientific rationale and published literature.
- Mechanical testing: Static compression and compression fatigue testing performed in conformance with ISO 14801 on worst-case configurations of the Multi Unit Angled Abutments and compatible implants.
This document clearly states: "No clinical data were included in this submission." This reinforces that the review process for this particular device is based on technical specifications and non-clinical performance, not clinical trials or AI/ML performance evaluations.
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(89 days)
KDG Abutments are pre-manufactured prosthetic components for direct connection to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.
The KDG-Osteon Precision Milled Suprastructure is indicated for attachment to KDG Abutments in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function. The KDG-Osteon Precision Milled Suprastructure is intended for attachment to a minimum of two (2) abutments.
Endosseous dental implants are surgically implanted into a patient's mouth to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Endosseous dental implant are secured to dental implants with a retaining screw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Prosthetic devices used with the dental implant abutments in this submission may be screw-retained or cemented.
The purpose of this submission is the marketing clearance for KDG Abutments which comprises endosseous rootform dental abutments, abutment screws, and other associated components for single-unit, and overdenture restorations. The Subject device abutment components introduce 30° post correction angle multi-unit abutments compatible with the sponsor's previously cleared implants.
The Keystone family of abutments are compatible with the Keystone implants which have a hex-lobe internal connection. The Paltop family of abutments are compatible with the Paltop implants which have hex-wall internal connection.
The KDG-Osteon Precision Milled Suprastructure is an overdenture bar which is compatible with the Subject device abutments. The overdenture bar is dental restorative device that is intended for screw-retained attachment to dental abutments to aid in the treatment of partial and totally edentulous patients for the purpose of restoring their chewing function. The KDG-Osteon Precision Milled Suprastructure is fabricated by means of CAD/CAM technology and is used to facilitate the attachment of both fixed and removable prostheses.
The Osteon Precision Milled Suprastructure is designed for an individual patient from scans of the patient's impression. The suprastructure is manufactured in biocompatible Titanium alloy with the aid of Computer Aided Design (CAD) and Computer Aided Manufacturing (CAM) technology. All CAD/CAM fabrication is performed by Osteon Medical, within our premises. The abutment-born Suprastructure is only indicated for straight placement and is not to exceed the maximum angulation of the connected multi-unit abutments.
KDG-Osteon Precision Milled Suprastructures facilitate the attachment of both removable and fixed dental prosthesis and hence categorized as type B.
The Subject device abutments, abutment screws, and bar suprastructure are fabricated from Ti-6Al-4V ELI titanium alloy (Grade 23) which conforms to ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).
All Subject device components are one-time use device components are provided sterile and sterilized by gamma irradiation except for the Single-Unit and Multi-Unit copings, the KDG-Osteon Precision Milled Suprastructure and all replacement screws which are provided non-sterile. Devices provided as non-sterile are sterilized by steam.
The provided document is a 510(k) Premarket Notification from the FDA to Keystone Dental Inc. regarding their KDG Abutments. This document primarily focuses on establishing substantial equivalence to predicate devices based on indications for use and technological characteristics, supported by non-clinical performance data.
Crucially, this document does NOT contain information related to a study that proves the device meets specific acceptance criteria for AI/ML performance, nor does it describe a multi-reader multi-case (MRMC) comparative effectiveness study, standalone algorithm performance, or the establishment of ground truth for training or test sets in the context of an AI-powered device.
The acceptance criteria mentioned in the document refer to the performance of dental abutments in the context of mechanical testing (fatigue testing per ISO 14801:2016) and biocompatibility, not the performance of an AI/ML algorithm.
Therefore, I cannot provide the requested information for acceptance criteria and studies related to AI/ML performance based on the input text. The information in the document pertains to traditional medical device clearance.
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(121 days)
The Paltop Conical Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Narrow diameter implants are intended for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the horizontal space is limited by the adjacent teeth and roots. The Paltop Conical Implant System is also indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The Paltop Conical Implant System which comprises endosseous root-form dental implants, mating abutment screws, and other associated components for single-unit, multi-unit, and overdenture restorations. Endosseous dental implants are surgically implanted into a patient's mouth to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Endosseous dental implant abutments are secured to dental implants with a retaining screw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Paltop Conical Implant System implants are one- and two-stage endosseous screw type dental implants with associated compatible abutments, screws, and other associated accessory components. The Paltop Conical Implant System prosthetic components include healing caps, and multi-unit abutments which are available in straight or angulated configurations. Prosthetic devices used with the dental implant abutments in this submission may be screw-retained or cemented. The implants, titanium abutment screws are fabricated from a Titanium-6 Aluminum 4 Vanadium ELI titanium alloy (Grade 23) which conforms to ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The Subject device implants are surface treated with SLA (Sand-blasted, Large Grit, Acid Etched). Immediate temporary abutments include a PEEK (Polyether ether Ketone) material sleeve, and the SAS abutment includes a PEEK healing cap/coping. All implants and prosthetic components are one-time use device components are provided sterile and sterilized by gamma irradiation except for Single-Unit and Multi-Unit copings, SAS Abutment components and all replacement screws which are provided non-sterile. Devices provided as non-sterile are sterilized by steam.
The provided text describes the 510(k) submission for the "Paltop Conical Implant System." This document is a regulatory filing demonstrating substantial equivalence to previously cleared devices, not a study performing clinical validation against acceptance criteria for a new AI/CADx device.
Therefore, most of the requested information (acceptance criteria for clinical performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, ground truth establishment, etc.) is not present in this document, as it pertains to a different type of device and regulatory submission.
The document focuses on non-clinical performance testing (fatigue testing, biocompatibility, endotoxin testing, sterilization validation, and MRI compatibility) to demonstrate the device's mechanical and material properties are equivalent to the predicate devices.
However, I can extract the information that is present and explicitly state what is missing based on the document's content:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative clinical performance acceptance criteria (e.g., sensitivity, specificity, AUC) because it's a dental implant, not a diagnostic AI device. Instead, it refers to non-clinical performance standards.
| Acceptance Criterion (Non-Clinical, General) | Reported Device Performance |
|---|---|
| Fatigue testing (per ISO 14801:2016) | Performed according to requirements. "demonstrate suitability for intended use." |
| Material Biocompatibility (per ISO 10993-1, 10993-5) | Leveraged from predicate devices. "support suitable biocompatibility." |
| Endotoxin testing (per USP and USP) | Performed. "conformance with testing requirements." |
| Sterilization validation | Leveraged from predicate devices. "demonstrate suitable sterilization of the Subject device sterile components." |
| MRI compatibility | Reviewed using scientific rationale and published literature. "addressed parameters per the FDA guidance." |
| Design and Dimensions (Equivalence to Predicates) | "Slight differences in design dimensions do not affect the intended use of the device and are mitigated or supported through non-clinical performance testing results." |
2. Sample sized used for the test set and the data provenance
- Test Set Sample Size: Not applicable. This document refers to non-clinical bench testing (e.g., mechanical fatigue, material properties), not a clinical trial with a test set of patient data.
- Data Provenance: Not applicable for a clinical test set. The non-clinical testing appears to be conducted by the manufacturer, Paltop Advanced Dental Solutions, Ltd.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No clinical ground truth was established as this was a 510(k) submission for a physical device, based on non-clinical testing and substantial equivalence to predicate devices.
4. Adjudication method for the test set
- Not applicable. No clinical test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No. This type of study is for evaluating medical imaging AI. This document is for a dental implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used
- Not applicable for clinical ground truth. The "ground truth" for this device's performance validation is based on engineering standards, material specifications, and regulatory guidelines (e.g., ISO 14801 for fatigue, ISO 10993 for biocompatibility).
8. The sample size for the training set
- Not applicable. There is no AI training set.
9. How the ground truth for the training set was established
- Not applicable. There is no AI training set.
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(191 days)
The Osteon Precision Milled Suprastructure is indicated for attachments in the treatment of partially orfully edentulous for the purpose of restoring chewing function. The Osteon Precision Milled Suprastructures are intended for attachment to a minimum of two (2) abutments.
The Osteon Milled Suprastructure is indicated for compatibility with the following abutment systems:
- · Nobel Biocare Multi Unit Abutment Plus, 4.8mm, max 30°
- · Nobel Biocare Xeal Abutments, 4.8mm, max 30°
- · Nobel Biocare Multi Unit Abutment, 4.8mm, max 30°
- MIS Multi-unit Abutments, 4.8mm
- · C1 Conical Connection Implant System, max 30°
- · V3 Conical Connection Implant System, max 30°
- · Internal Hex Implant System, max 30°
- · Conical Connection, max 30°
- Southern Compact Conical Abutments, 4.8mm
- · MAX Implant System, 0°
- · Provata Implant System, max 30°
- · Deep Conical (DC) Implants, 0°
- · Piccolo Implants, 0°
- · External Hex Implants, max 30°
- · Astra Tech Implant System® Multi Base Abutment EV, 4.8mm, max 30°
- Keystone Multi Unit Abutment, 4.8mm, 0°
- · Neodent GM Mini Conical Abutment, 4.8mm, max 30°
- · Implant Direct GPS® Angled Abutment, 5.0mm, max 30°
- · Dentium SuperLine® Abutments, 4.5-5.5mm, max 30°
- · Zimmer Angled Tapered Abutments, 4.5mm, max 30°
- · Paltop Multi Unit Abutment, 5.0mm, max 17°
The Osteon Precision Milled Suprastructures (also referred as superstructures) are metallic dental restorative device that is intended for attaching by screw retention to dental abutments to aid in the treatment of partial and totally edentulous patients for the purpose of restoring their chewing function. These suprastructures attach to previously-cleared original equipment manufacturers (OEM) dental abutments using the (OEM) prosthetic screws. The abutmentborne subject devices are indicated for placement only on OEM implant/abutment constructs placed according to the labeling of the previously-cleared systems, and not to exceed the maximum angulation allowed for each OEM implant/abutment construct as identified in the Indications for Use Statement of the subject system.
The Osteon Precision Milled Suprastructure is designed for an individual patient from scans of the patient's impression. The suprastructure is manufactured in biocompatible Titanium alloy with the aid of Computer Aided Design (CAD) and Computer Aided Manufacturing (CAM) technology. All CAD/CAM fabrication is performed by Osteon Medical, within our premises.
Osteon Precision Milled Suprastructures facilitate the attachment of both removable and fixed dental prosthesis and hence categorized as type A and type B.
This document is a 510(k) summary for a dental device, the Osteon Precision Milled Suprastructure. It outlines the regulatory process and demonstrates substantial equivalence to predicate devices, rather than presenting a study that proves the device meets specific performance acceptance criteria. Therefore, most of the requested information about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not available in this document.
Here's why and what information can be extracted:
- This is a 510(k) submission: The primary goal of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove its performance against a set of novel acceptance criteria through a clinical trial.
- Focus on Substantial Equivalence: The document compares features like indications for use, materials, design, and manufacturing processes to existing devices.
- Non-Clinical Testing Mentioned: The document refers to non-clinical tests performed, but these are primarily for demonstrating compatibility, material safety, and sterility, not performance against specific clinical efficacy or accuracy metrics.
Information that can be extracted or inferred:
1. A table of acceptance criteria and the reported device performance:
This document does not present explicit "acceptance criteria" in the traditional sense of performance metrics for an AI/algorithm-driven device. Instead, it demonstrates similarity to predicate devices based on design specifications and material properties. The "performance" is implicitly deemed acceptable if it's shown to be substantially equivalent to the established predicate devices.
| Feature / Acceptance Criteria (Implied) | Reported Device Performance (Osteon Precision Milled Suprastructure) |
|---|---|
| Regulation Description | Endosseous dental implant abutment (Similar to Predicate) |
| Indications for Use | For attachment to dental abutments in the treatment of partially or fully edentulous jaws for restoring chewing function. Intended for attachment to a minimum of two (2) abutments and compatible with various listed OEM abutment systems. (Similar to Predicate) |
| Device Material | Titanium alloy Ti-6Al-4V (Same as Reference Device K173466) |
| Design/Technology | Single milling blocks (Similar to Predicate) |
| Fixation Method | CAD/CAM milling from single milling blanks (Similar to Predicate) |
| Design/Construction | Abutment-borne (Similar to Predicate) |
| Sterility | Supplied Nonsterile (Similar to Predicate) |
| Target Population | Adult patients (Similar to Predicate) |
| Prescription/OTC | Prescription only (Similar to Predicate) |
| Recommended Cleaning/Maintenance | Proper oral hygiene (Similar to Predicate) |
| Design Specifications (Type A - Removable Prosthesis) | |
| Total Cylinders | Min 2, Max 10 (Similar to Reference Device K173466) |
| Suprastructure Span Between Cylinders | Min 1mm, Max 30mm (Similar to Reference Device K173466) |
| Suprastructure Height | Min 3mm, Max 12mm (Allows wider than Reference Device K173466) |
| Suprastructure Width | Min 3.4mm, Max 12mm (Allows wider than Reference Device K173466) |
| Distal Cantilever Section | Min 0mm, Max 15mm (Similar to Reference Device K173466) |
| Cylinder Height | Min 0mm, Max 4.6mm (Lower max than Reference Device K173466) |
| Cylinder Diameter | Min 4.5mm, Max 8mm (Higher min than Reference Device K173466) |
| Design Specifications (Type B - Fixed Prosthesis) | |
| Total Cylinders | Min 2, Max 10 (Similar to Reference Device K173466) |
| Suprastructure Span Between Cylinders | Min 1mm, Max 30mm (Similar to Reference Device K173466) |
| Suprastructure Height | Min 3mm, Max 22mm (Allows wider than Reference Device K173466) |
| Suprastructure Width | Min 3.4mm, Max 12mm (Allows wider than Reference Device K173466) |
| Distal Cantilever Section | Min 0mm, Max 15mm (Similar to Reference Device K173466) |
(Note: "Similar" indicates that the values or characteristics fall within or are comparable to those of the predicate/reference devices, with stated differences not impacting safety/efficacy from the manufacturer's perspective.)
2. Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. This submission relies on "non-clinical tests" (dimensional analysis, biocompatibility, sterilization validation) and comparison to existing predicate marketing clearances. It does not describe a "test set" in the context of an AI/ML algorithm evaluation with human interpretation or image analysis. The "test" consists of demonstrating manufacturing conformance and material properties for the physical device.
- Data Provenance: The device is manufactured by Implant Solutions PTY LTD (trading as Osteon Medical) in Mulgrave, Victoria, 3170 Australia. The non-clinical tests (e.g., biocompatibility and sterilization validation) would have been performed there or at certified labs. These are bench tests, not clinical data sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There's no "ground truth" to establish in the context of an AI/ML algorithm or diagnostic accuracy study. The assessment is based on physical device characteristics and established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study requiring adjudication of expert interpretations.
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 physical dental device (suprastructure), not an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical dental device (suprastructure), not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. The "ground truth" for this medical device submission is compliance with engineering specifications, material standards (e.g., ASTM F136), and validated manufacturing processes, all demonstrated through non-clinical bench testing.
8. The sample size for the training set:
- Not applicable. This is a physical dental device. While it is manufactured using CAD/CAM technology, it does not involve an AI/ML model that requires a training set of data.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
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(315 days)
The Paltop Narrow Implant is indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the horizontal space is limited by the adjacent teeth and roots, to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Paltop Narrow Implant is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
This submission expands the Predicate Narrow Implant device to include 3.0 mm diameter implants, additional implant thread configurations and additional prosthetic components to the previously cleared Paltop Narrow Implant (K130462).
Endosseous dental implants are surgically implanted into a patient's mouth to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Endosseous dental implant abutments are secured to dental implants with a retaining screw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.
Paltop Narrow Implant are one- and two-stage endosseous screw type dental implants with associated abutments. The implants, titanium abutment screws are fabricated from a Titanium-6 Aluminum 4 Vanadium ELI titanium alloy which conforms to ASTM F136. The Paltop Narrow Implants are surface treated with SLA (Sand-blasted, Large Grit, Acid Etched).
The implants are available in three thread/body configurations: Advanced, Advanced+, and Dynamic. The Advanced, Advanced+ and Dynamic implants have micro threads at the neck. All implants have a parallel coronal and mid-section area with an apical taper. The families have slight differences in thread profile and either a passive or active apex. The 3.0 mm diameter implants are prosthetically compatible with the previously cleared Paltop Narrow Implant (K130462) prosthetic devices.
This submission introduces Single-Unit Abutments for the Paltop Narrow Implant device. The submission replaces the original straight Multi-Unit Abutments from the K130462 submission and includes additional gingival heights. The submission also introduces an angulated Multi-Unit titanium abutment, all compatible with the Paltop Narrow Implant device. The submission expands the compatible prosthetic components to include new temporary titanium abutments and healing caps compatible with Single-Unit and Multi-Unit titanium implant abutments.
The Subject device implants may be used with the Predicate device abutments previously cleared under K130462, based on non-clinical performance bench testing provided in this submission.
The Subject device abutments may be used with the Predicate device implants previously cleared under K130462, based on non-clinical performance bench testing provided in this submission. The only exception is the implant cover screw (P/N 80-70100) which is specific to the 3.0 mm diameter implants in this submission.
The Subject device Multi-Unit Abutment components such as copings/interfaces, temporary abutments, cylinders, and screws may be used with the Predicate device Multi-Unit Abutments previously cleared under K130462 based on non-clinical performance bench testing provided in this submission.
All implants and prosthetic components are one-time use devices. All Subject devices in this submission are provided sterile and sterilized by gamma irradiation except for Single-Unit and Multi-Unit copings and all replacement screws which are provided non-sterile. Devices provided as non-sterilized by steam.
Here's a breakdown of the acceptance criteria and the study information for the Paltop Narrow Implant, based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a table format for specific performance metrics like fatigue life or bone-to-implant contact percentages. Instead, it refers to industry standards and general outcomes. The reported device performance is presented narratively.
| Performance Characteristic | Acceptance Criteria (implied/standards referenced) | Reported Device Performance |
|---|---|---|
| Fatigue Strength | Conformance to ISO 14801:2016 for dynamic loading | Successfully tested to ISO 14801:2016. Worst-case scenario chosen. |
| Biocompatibility | Suitable biocompatibility | Demonstrated suitable biocompatibility based on review of published literature, internal routine monitoring data, and post-market surveillance data. |
| Osseointegration | Successful osseointegration, industry-accepted bone level changes | 92% of implants showed bone level improvement or maintenance; bone level decreases less than 1mm; 100% met criteria for successful osseointegration. |
| Implant Survival Rate | Failure rates below industry levels | Post-market surveillance indicated failure rates below industry levels. |
| Residual Aluminum Particles | No negative impact on osseointegration and implant survival | Evaluation supported previous findings that residual aluminum particles (if present) from specific surface treatment do not negatively impact osseointegration and implant survival. |
| Endotoxin Levels | Conformance to USP | Confirmatory endotoxin testing performed according to USP acceptance criteria. |
| Sterilization (Sterile Components) | Suitable sterilization | Demonstrated suitable sterilization based on predicate/reference device validations. |
| Sterilization (Non-Sterile Components) | Suitable sterilization (cleaning validation, ISO 17665-1) | Cleaning validation and sterilization per ISO 17665-1 performed for non-sterile components and components requiring subsequent sterilization. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a test set sample size for each specific non-clinical test in terms of a number of devices. It refers to general testing.
- For the bone changes evaluation (part of biocompatibility/osseointegration): "A total of 174 surfaces were graded (87 implants)."
- Data provenance: The bone changes evaluation references "published literature" on patients, suggesting retrospective (or possibly prospective clinical studies mentioned in the literature). "Internal routine monitoring data" and "post-market surveillance data" are mentioned, indicating real-world data collection, likely retrospective for surveillance and ongoing for monitoring. The manufacturer is Paltop Advanced Dental Solutions, Ltd, Hashita 5, Industrial Park, Caesarea 3088900, Israel.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document doesn't specify the number or qualifications of experts used to establish "ground truth" for the test set. For the bone level evaluation, it states "Mesial and distal surfaces were examined and graded." It is implied that these evaluations were done by qualified clinical professionals as part of the published literature or internal monitoring, but no specific details are provided.
4. Adjudication Method
No adjudication method is mentioned for any of the evaluations (e.g., bone level grading, or evaluation of non-clinical tests). The document implies acceptance based on test results meeting standards or being comparable to predicate devices.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. This device is an endosseous dental implant, not an AI diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not applicable.
6. Standalone Performance Study
The primary studies detailed are "non-clinical bench performance testing." This refers to laboratory testing of the device itself (fatigue, pull-out, etc.) and biological evaluations based on literature review and historical data, which are "standalone" in the sense that they assess the device's physical and biological properties. There is no human element being assessed.
7. Type of Ground Truth Used
The ground truth used several types:
- Industry Standards: For fatigue testing (ISO 14801:2016), endotoxin testing (USP ), and sterilization (ISO 17665-1).
- Clinical Outcomes Data: For osseointegration and implant survival (from published literature and post-market surveillance). This includes "bone level improvement or maintenance" and "failure rates below industry levels."
- Analytical Data: SEM/EDS data for residual particles.
- Comparison to Predicate/Reference Devices: Demonstrating similarity in design and performance to already cleared devices.
8. Sample Size for the Training Set
The document does not mention a "training set" or "training data" in the context of an algorithm or AI. This is a medical device (dental implant) that undergoes physical and biological performance testing, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an algorithm described in this document.
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(90 days)
The XL Dental Implant System is 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. This XL implant system provides support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.
This submission includes threaded root-form dental implants with large diameter for use in the molar region. The implants are provided in diameters of 7, 8 and 9mm and lengths of 7, 9 and 11mm. This submission also includes mating components: Cover screws; Healing Abutments in varying diameters and cuff heights; Titanium Cylinder abutments for temporary restorations; Titanium Abutments in varying diameters and cuff heights for permanent restorations; and the abutment screw.
The XL implants are manufactured from titanium alloy conforming to ASTM F136. The implants have a is grit blasted, acid etched (SLA) surface. The Cover Screw, Abutments and Abutment Screw are manufactured from titanium alloy conforming to ASTM F136.
The provided text is a 510(k) Premarket Notification from the FDA for the Keystone Dental XL Dental Implant System. It discusses the device's administrative information, indications for use, device description, performance data, and a comparison to legally marketed predicate devices to demonstrate substantial equivalence.
However, it does not contain the specific information requested regarding acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/ML medical device.
The document details non-clinical performance data for physical characteristics of the dental implant (sterilization validation, biocompatibility, bacterial endotoxin testing, modified surface analysis), and relies on established standards (ISO, ASTM, FDA guidances) and substantial equivalence to predicate medical devices for these aspects. There is no mention of an "algorithm" or "AI assistance" in this document.
Therefore, I cannot extract the requested information as it is not present in the provided text. The device being reviewed is a physical implant, not an AI/ML-based diagnostic or therapeutic tool.
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(189 days)
The SPI Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.
It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
SPI Dental Implant System is an internal hex implant system which comes in 3.3, 3.7, 4.2, 5.0, and 6.0 diameter. The implants come in lengths of 8, 10, 11.5, 13 and 16. Both straight and angled abutments are available.
The implant is a conical shape one with a grit blasted and acid etched surface. Standard abutments, standard narrow abutments, standard shoulder abutments, standard wide shoulder abutments, multiunit abutments, ball attachments, healing caps and standard 15° and 25° abutments are included in the system.
This is an FDA 510(k) summary for a medical device (SPI Dental Implant System), not a study report for an AI/ML powered device. As such, it does not contain the information requested in your prompt regarding acceptance criteria and a study that proves the device meets those criteria, specifically concerning AI/ML performance.
The document describes standard engineering and biocompatibility testing for a dental implant, confirming its substantial equivalence to a predicate device. It includes:
- Testing Summary:
- Dynamic fatigue testing according to ISO 14801
- Surface analysis (SEM and EDS)
- Sterilization according to ISO 11137-1 and 11137-2 (implants), ISO 17665-1 and ISO 17665-2 (abutments)
- Package integrity testing according to ASTM F1929-12
- Accelerated aging according to ASTM F1980-07
- Material compliance with ASTM F136
- Biocompatibility (cytotoxicity) according to ISO 10993-5
- Endotoxin testing according to USP 161
These tests are designed to demonstrate the physical, chemical, and biological safety and performance of the dental implant itself, not the performance of an AI/ML algorithm.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies because the provided document does not pertain to an AI/ML device.
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(137 days)
NOVA® Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. NOVA® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
NOVA® Dental Implants System consists of internal hex dental implants. cover screws and healing caps; abutments system and superstructures; impression copy system & surgical instruments.
Internal hex implants:-
PSI implants are provided in diameters: 3.3, 3.75, 4.2, 5 & 6 with lengths 8, 10, 11.5, 13, & 16 mm. (16 mm is not provided for 6 mm diameter).
PCI implants are provided in diameters: 3.3, 3.75, 4.2, 5 & 6 with lengths 8, 10, 11.5, 13, & 16 mm. (16 mm is not provided for 6 mm diameter).
NOVA Dental Abutments internal hex system provides:
Healing Caps:
HC Series - Narrow (3.75 mm) - Platform height 2,3,4,5,6,7
HC Series - Standard (4.7 mm) - Platform height 2.3.4.5.6.7
HCW Series - Wide (6.00 mm) - Platform height 3,4,5,6
PMI Series - Premium (3.75, 4.7, 6.0 mm) - Platform height 2,3,4,5,6,7
Straight Abutments (Long, straight, narrow, anatomic, curve):
ST Series: Length 8.5, 9.5, 11.5, 12.5 mm.
STA Series: With Shoulder profile height 1, Length 9 mm; profile height 2, Length 10; profile height 3, Length 11; profile height 4 Length 12.
STN: Narrow length 11 mm.
SLM Series: Anatomic Straight Abutment: profile height 1,2,3 length 9,10,11 mm.
SCM Series: Anatomic Straight Abutment: profile height 1.2.3 length 9.10.11 mm.
Angulated Abutments (standard, anatomic, curve):
Standard Angulated Abutment Length 7,9,11 Angulations 15°, 25°.
Anatomic Angulated Abutments Platform height 1,2,3,4 Angulations 15°, 25°.
Anatomic Angulated Curve Platform height 1,2,3, Angulations 15°, 25° .
Ball Attachments Platform height 1.2.3.4.5.6 and related components covers and caps.
Material:
NOVA® Dental Implants System and Dental Abutments System is made of Titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136.
The provided document is a 510(k) premarket notification for the NOVA® Dental Implants System. It aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than establishing new acceptance criteria or proving performance through a clinical study.
Therefore, many of the requested details about acceptance criteria and a study proving the device meets those criteria are not available in this document. This submission focuses on demonstrating that the new device is as safe and effective as existing, predicate devices by comparing their characteristics and performance through non-clinical testing.
Here's what can be extracted and inferred from the document:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission, formal "acceptance criteria" for a new, standalone clinical study are not explicitly stated for individual performance metrics in the way you might find in an efficacy trial. Instead, the "acceptance" is based on the new device's performance being comparable to or meeting standards similar to the predicate devices, as demonstrated through various tests.
| Characteristic | Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (NOVA® Dental Implants System) |
|---|---|---|
| Biocompatibility | Conform to ISO 7405:2008 (Dentistry Evaluation of biocompatibility of medical devices used in dentistry) and demonstrate no evidence of causing cell lysis or toxicity, equivalent to predicate devices. | Test results demonstrated no evidence of causing cell lysis or toxicity and thus present equivalent performance as its predicate devices. |
| Dynamic Fatigue Strength | Comply with ISO 14801:2007 (Dentistry-Implants-Dynamic fatigue test for endosseous dental implants), demonstrating equivalent fatigue load strength to predicate devices. | Fatigue - Static & Cycling tests conducted comply with ISO 14801:2007. The results demonstrate that the subject devices are substantially equivalent to the predicate devices. |
| Sterilization | Achieve a Sterility Assurance Level (SAL) of 10-6 and meet all testing requirements. | Test results demonstrated that the SAL of 10-6 was achieved and all testing requirements were met. |
| Material Composition | Conform to ASTM F136 (Titanium alloy Ti-6Al-4V ELI) and be identical to predicate devices. | Made of Titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136. Shares the same raw material as its predicate devices (GR-5 Titanium Ti-6Al-4V ELI). |
| Primary Stability for Immediate Loading | (Implied to be achieved and maintained upon implantation, comparable to predicate devices stated for immediate loading with good primary stability and appropriate occlusal loading). | Indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading, similar to predicate devices. (No specific numerical data on primary stability is provided as this is a non-clinical submission). |
| Intended Use / Indication for Use | Equivalent to the predicate devices: surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices (artificial teeth) to restore chewing function. Also, for immediate loading when good primary stability is achieved and with appropriate occlusal loading. | Identical to the predicate devices. |
| Technological Characteristics (Design) | Similar to predicate devices: threaded, root form endosseous implants. Internal hex dental implants, cover screws, healing caps, abutments, superstructures, impression copy system, surgical instruments. Dimensions (diameters and lengths) comparable to predicate devices. Surface treatments (sand blast with acid etched, anodized) comparable to predicate devices. | Described as internal hex dental implants with various diameters (3.3, 3.75, 4.2, 5, 6 mm) and lengths (8, 10, 11.5, 13, 16 mm). Includes PCI (straight contour) and PSI (tapered contour) implants. Surface treatment includes sand blast with acid etched and anodized. Shares similarity with predicate devices in design and technological characteristics. |
| Risk Management | Conducted in accordance with ISO 14971:2007. | Risk management process was carried out with accordance to ISO 14971:2007. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This submission relies on engineering bench tests and comparisons to predicate devices, not patient-based test sets.
- Data Provenance: The document does not specify the country of origin for the data used in the biocompatibility, sterilization, or mechanical tests, nor does it refer to retrospective or prospective patient data. This is a non-clinical submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" in the context of expert consensus or pathology data is used for clinical studies diagnosing a condition. This document is for a dental implant system being cleared via substantial equivalence, which primarily involves engineering, material, and biocompatibility testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically for clinical performance evaluations, especially for diagnostic devices.
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 premarket notification for a physical medical device (dental implants), 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 physical dental implant and abutment system, not an algorithm or software. No standalone algorithm performance was studied.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The compliance of the device with established international standards (ISO 7405, ISO 5832-3, ISO 14801, ISO 14971), and the direct comparison of its design, materials, and intended use against already cleared predicate devices, serves as the basis for "truth" in this regulatory context of substantial equivalence. This is primarily engineering and material science compliance with standards, and logical deduction for equivalence to predicate devices.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth established for one.
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