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510(k) Data Aggregation
(89 days)
Implant Logistics, Inc.
Implant-One™ System Abutments are intended for use as an aid in prosthetic rehabilitation in the mandible or maxilla for support of single-unit or multi-unit restorations.
The Implant-One Ti-Base Abutment consists of the titanium base and a mesostructure component, making up a two-piece abutment, and will be attached to the implant using an abutment screw. The mesostructure for use with the Implant-One Ti-Base is intended only to be designed and manufactured according to digital dentistry workflow that integrates scan files from lab scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.
The subject devices comprise abutments designed for the 300, 400, and 500 Series of the Implant-One" system. All subject device abutments incorporate a Morse taper at the implant/abutment interface, have a hexagonal male end for alignment purposes and are screw retained. The series is grouped according to the implant/abutment interface size and each series is color coded for ease of identification. The subject devices are Titanium Base Abutments.
The Implant-One™ Titanium Base Abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation. The Implant-One" Titanium Base Abutments consist of two major components. Specifically, the titanium base and the mesostructured component make up a two-piece abutment. The system integrates multiple components of the digital dentistry workflow: scan files from scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling.
The standard Ti Base Abutments are offered in cuff heights of 0.5mm, 1.5mm and have a Ø4.0mm profile for the 300 series and a Ø4.5mm profile for the 400 & 500 series.
The following components are intended to be used for scanning, designing and manufacturing of ceramic mesostructures for the Implant-One™ Titanium Base Abutment:
- Lab scanner: Medit/Identica T500 3D Scanner (Medit Corp) ●
- CAD software (PNP): 3Shape Abutment Designer & Abutment Design (3Shape A/S -● K151455 & K200100) and exocad AbutmentCAD (exocad GmbH - K193352)
- Ceramic material: Katana™ Zirconia (Kuraray Noritake Dental, Inc. K143439) ●
- . Milling machine: Ceramill Motion 2 (Amann-Girrbach AG)
- Milling software: Ceramill Match 2 CAM Software (Amann Girrbach AG)
- Cement: RelyX™ Luting Plus Automix Cement (3M ESPE Dental Products K11185) ●
The provided document is a 510(k) Premarket Notification for a dental implant abutment system (Implant-One™ System). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting an AI/ML-based device performance study.
Therefore, the document does not contain the information requested regarding acceptance criteria and performance data for an AI/ML device, as it describes a traditional medical device submission.
Specifically, the following points from your request cannot be addressed based on the provided text:
- A table of acceptance criteria and the reported device performance: This document does not describe acceptance criteria for an AI/ML system or statistical performance metrics. Instead, it describes mechanical testing (ISO 14801) and sterilization validation (ISO 17665-1 and ISO 17665-2) for a physical medical device.
- Sample size used for the test set and the data provenance: There is no "test set" in the context of AI/ML evaluation. The performance data refers to mechanical and sterilization tests, not data for an algorithm.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment is irrelevant in this context, as there is no AI/ML algorithm being evaluated.
- Adjudication method: Not applicable due to the absence of an AI/ML performance study.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: The document explicitly states "No clinical data were used in support of this submission," meaning no MRMC study was performed.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML device.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable, as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.
The document primarily focuses on demonstrating that the Implant-One™ System is substantially equivalent to a legally marketed predicate device (NobelActive™ Universal Base Abutments) by comparing their indications for use, technological characteristics, materials, dimensions, and sterilization methods. It mentions "Software verification and validation testing was conducted to demonstrate that the restrictions prevent design of the mesostructure component outside of design limitations," which refers to CAD/CAM software used in the manufacturing process, not an AI/ML diagnostic or prognostic algorithm.
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(598 days)
Implant Logistics, Inc.
The Implant-One™ Multi-Unit Abutment is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for prosthetic rehabilitation of the mandible or maxilla with a multi-unit restoration.
The subject devices comprise abutments designed for the 300, 400, and 500 Series of the Implant-One™ system. All subject device abutments incorporate a Morse taper at the implant/abutment interface, have a hexagonal male end for alignment purposes and are screw retained. The series is grouped according to the implant/abutment interface size and each series is color coded for ease of identification. The subject devices are Angled Multi-Unit Abutments.
The Implant-One Multi-Unit Abutment is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation. The Implant-One Multi-Use Abutments are indicated for multiple-tooth restorations.
Angled Multi-Unit Abutments are available for the 300, 400, and 500 series and used for multiple implant restorations such as screw retained dentures. These abutments are offered in cuff heights of 2.5 mm and 3.5 mm for all series.
The provided text K212394 is a 510(k) premarket notification for an dental implant abutment. The document describes the device, its intended use, and claims substantial equivalence to predicate devices based on non-clinical performance data.
From the text, there is no information provided regarding acceptance criteria for a study proving device performance in a clinical setting, nor any details of a study involving human subjects or AI algorithms. The submission explicitly states: "No clinical data were used in support of this submission."
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the provided document does not contain this information.
Specifically, the following points of your request cannot be addressed from the given text:
- A table of acceptance criteria and the reported device performance: No such clinical performance study or its acceptance criteria are mentioned. The "performance data" section refers to mechanical testing (ISO 14801), sterilization (ISO 17665), biocompatibility (leveraged from K173701), and MRI review (scientific evidence/published literature). These are non-clinical and do not involve "reported device performance" in a clinical sense.
- Sample sizes used for the test set and the data provenance: Not applicable as no clinical test set is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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, as there is no mention of AI assistance or human reader studies.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as the device is a physical dental abutment, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for the reasons mentioned above. For the non-clinical tests, the "ground truth" would be the standard test methods (e.g., ISO standards), but this is not clinical ground truth.
- The sample size for the training set: Not applicable as this is not an AI/ML clinical study.
- How the ground truth for the training set was established: Not applicable.
The submission focuses on demonstrating substantial equivalence based on non-clinical performance data (mechanical, sterilization, biocompatibility, MRI safety) and comparison of indications for use and technological characteristics with predicate devices.
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(360 days)
Implant Logistics, Inc.
The Implant-One™ System is indicated for surgical placement in partially or completely edentulous upper or lower jaws to provide a means for prosthetic attachment to restore a patient's chewing function. The Implant-One™ system is indicated for immediate loading only when primary stability is achieved and with the appropriate occlusal loading.
Endosseous implants are self-tapping and threaded, and offered having root-form or wide thread forms. Root-form implant diameters range from 3.25mm to 5.5mm having lengths from 8mm to 14mm. Wide thread implant diameters are available in 4.1 and 4.5mm (8mm to 14mm lengths), 5.5mm (8mm to 12mm lengths) and 6.5mm (8mm to 10mm lengths). Cover screws and healing caps provide protection to the threads of the abutment connection during endosseous and gingival healing. Cover screws are pre- packaged with each implant. Healing caps are provided as an alternative to the cover screw and are packaged separately. The Implant-One™ dental implants and cover screws are provided sterile. Not all abutments can be used for single-unit restorations. The conical, angled conical, ball, locator and glueless abutments are intended only for multi-unit loaded restorations. The ball, locator and glueless abutments are to be used in fully removable dentures. The conical and angled conical abutments are to be used in screw retained dentures and with the titanium sleeve for screw retention. The final design parameters for the custom blank abutment are as follows: maximum total height, 12.5mm; minimum/maximum gingival height, 0.5mm/6mm; minimum post height, 4mm; maximum angulation, 30°; minimum wall thickness, 0.78 (at 1.5mm above the proximal end); minimum diameter, 3.75 mm for the 300 Series, 4.25 mm for the 300 Series and 4.75 mm for the 500 Series.
The provided text is a 510(k) summary for the Implant-One™ System, a dental implant device. It demonstrates the device's substantial equivalence to existing legally marketed predicate devices through non-clinical performance data.
However, the document does not describe a study involving an algorithm, AI assistance, human readers, or any form of "acceptance criteria" related to diagnostic performance or accuracy as one would expect for an AI/ML medical device.
Instead, the "acceptance criteria" and "study" described in this document pertain to engineering and biocompatibility performance of a physical medical device (dental implants and abutments), not a software or AI-driven system.
Therefore, for each of the requested points, the answer is that the information is not applicable (N/A) in the context of this document, as it describes a physical dental implant system and not an AI/ML device that would have such performance criteria.
Here's how to address each point based on the provided text:
Acceptance Criteria and Device Performance (Based on Device Type - Dental Implants)
Since this is for a physical dental implant system, the "acceptance criteria" are related to mechanical integrity, biocompatibility, sterilization, and packaging/shelf-life, rather than diagnostic accuracy. The "device performance" indicates that the device met these criteria by demonstrating substantial equivalence to predicates.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Demonstrated Equivalence To) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | ISO 14801 (for worst-case construct performance) | "Non-clinical mechanical testing of the worst case Implant-One™ System construct was performed according to ISO 14801 and demonstrated that the Implant-One™ system performs as well as or better than the predicate devices." |
| Biocompatibility | ISO 10993-5 | "Biocompatibility testing was performed according to ISO 10993-5 and demonstrated substantial equivalence." |
| Sterilization | ISO 11137 and ISO 17665 | "Sterilization validations were performed according to ISO 11137 and 17665 and demonstrated substantial equivalence." |
| Packaging & Shelf-life | ASTM D4169 (including ASTM F1886, ASTM F88, and ASTM F1929) | "Packaging and shelf-life validations were performed according to ASTM D4169 including ASTM F1886, ASTM F88 and ASTM F1929 and demonstrated substantial equivalence." |
| Endotoxin Limit |
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