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The 3i Patient-Specific Dental Abutment and Overdenture Bars are intended for use as an accessory to an endosseous dental implant to support a prosthetic device in a partially or edentulous patient. It is intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prostheses can be screw or cement retained to the abutment.

The 3i Patient-Specific Dental Abutments and Overdenture Bars are designed to match individual patients.

This is a 510(k) premarket notification for a dental device, not an AI/ML medical device. As such, the document does not contain the information required to answer the questions regarding acceptance criteria and studies that prove the device meets them in the context of AI/ML performance.

The document primarily focuses on establishing substantial equivalence to predicate devices based on overall design and intended use, rather than presenting a performance study with acceptance criteria for an AI algorithm.

Therefore, most of the requested information (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types for AI) is not applicable or present in this submission.

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3i dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth, freestanding bridges and to retain overdentures.

In addition, when a minimum of 4 implants, ≥ 10 mm in length, are placed in the the mandible and splinted in the anterior region, immediate loading is indicated.

This 510(k) requests an expansion of the indications for use of all externally and internally hexed 3i dental implants to include immediate loading procedures in the mandible when using a minimum of four (4) splinted implants ≥ 10mm in length. Standard, commercially available 3i abutments and screws can be used with 3i dental implants in immediate loading procedures. Several new components will complement the standard line for the clinicians use as necessary in immediate occlusal loading.

The provided 510(k) summary for K030614 describes the acceptance criteria and supporting studies for the 3i Dental Implants, specifically for the expansion of indications to include immediate loading procedures in the mandible.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state numerical acceptance criteria in a clear, tabulated format for the clinical performance. Instead, it relies on substantiating "clinical success" and "osseointegration" based on existing literature and previous clearances.

2. Sample Size Used for the Test Set and the Data Provenance

The submission primarily relies on a literature review of previously published clinical studies, rather than a single, dedicated prospective clinical trial for this specific 510(k) submission. Therefore, "test set" sample sizes are derived from these referenced studies.

• Tarnow et al.: 107 implants (in 10 edentulous cases).
• Testori et al.: 12 Osseotite implants (in 1 patient).
• Defrancq et al.: 417 Osseotite implants in 68 mandibular procedures; 309 Osseotite implants in 34 maxilla procedures.
• Ibanez and Jalbout: 87 Osseotite implants in 11 patients.
• Data Provenance: The studies are published clinical literature. The country of origin is not explicitly stated for all, but given the names and journals, they are likely international, possibly with an emphasis on European and North American research. All are retrospective analyses of cases or small prospective case reports/series.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided. The summarized studies are clinical publications, and the ground truth (e.g., osseointegration, implant success/failure) would have been established by the clinicians/researchers involved in those individual studies based on standard dental and surgical assessment methods (clinical examination, radiographs, and for one study, histologic analysis). There is no mention of an independent panel of experts establishing a ground truth for a unified "test set" for this 510(k) specifically.

4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set

Not applicable in the context of this submission. Since the submission relies on published literature, there's no mention of a formal adjudication method for a specific test set. The outcomes in the referenced studies were assessed by the respective study authors.

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 submission is for dental implants, not an AI-powered diagnostic device. Therefore, no MRMC study or AI-related comparative effectiveness is presented.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a medical device (dental implant), not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the referenced clinical studies was primarily:

• Outcomes Data: Clinical success/failure, implant survival rates, absence of mobility, absence of periimplant radiolucency.
• Clinical Examination: Assessment of implant stability and health.
• Radiographic Examination: To check for periimplant radiolucency and bone levels.
• Histology/Pathology: Testori et al. specifically mention "histologic analysis after 4 months of occlusal loading" and "histomorphometric evaluation revealed 78%-85% bone-to-implant contact."

8. The Sample Size for the Training Set

Not applicable. This is a medical device, not a machine learning algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is a medical device, not a machine learning algorithm.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The submission leverages a combination of non-clinical (mechanical) testing and a literature review of clinical studies to demonstrate that the 3i Dental Implants, when used for immediate loading, are "substantially equivalent" to predicate devices and clinically successful.

Non-clinical Testing:

• Mechanical tests (Static Load Compression, Cyclic Fatigue) were performed on 3i implants and the new single-piece abutment. These tests simulated biting and chewing forces and passed established criteria, showing the components' physical integrity. Insertion torque for the new abutment also passed, exceeding recommended levels.

Clinical Performance (Literature Review):
The submission relies on a review of existing clinical literature, specifically highlighting four studies:

• Tarnow et al. (1997): A case series involving various implant types (including 3i) for immediate loading in edentulous arches, reporting high osseointegration rates.
• Testori et al. (2001): A case report on Osseotite implants in the mandible, demonstrating clinical and histologic osseointegration during immediate loading, with good bone-to-implant contact.
• Defrancq et al. (2002): A report on successful immediate loading techniques using Osseotite implants in both maxilla and mandible, with very low implant loss rates (e.g., 0.48% in mandibular procedures).
• Ibanez, JC, Jalbout,ZN (2002): A two-year follow-up study on Osseotite implants for immediate loading, reporting 100% success with no implant mobility or periimplant radiolucency.

The submission argues that these studies, along with prior animal studies (K983347) and general current clinical practice, provide sufficient evidence of "substantial clinical success with early loading" for implants similar in design and materials to the 3i implants, thereby supporting the expanded indication for immediate loading. The overall argument for acceptance is based on the substantial equivalence of the 3i implants to other legally marketed devices indicated for immediate loading, supported by safety and performance data from both non-clinical testing and clinical literature review.

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The NSS-nonsubmerged implant system. These implants and prosthetic implant systems are to be used for the reconstruction of partial and totally edentulous implant patients. The implants are to be used in single or multiple units in the edentulous regions of the maxilla and mandible. The indications range from single tooth application, implant supported partial denture, implant supported bar/overdenture, implant retained overdenture, fixed-detachable implant prosthesis, and totally edentulous implant retained prosthetic designs. The diameter changes of the implant system are to correspond with the maximum available bone width in the treatment areas. Large diameter implants can be utilized to engage the greatest amount of bone volume. These implants can also be used in a submerged protocol if the tissue is thick and a short healing cover screw is utilized. The nonsubmerged protocol does not imply immediate loading, and the implants should integrate in a 3-8 month healing phase based on the bone density before prosthetic load is incorporated into the implant sites.

Endosseous implant system consists of implants, tools and prosthetic abutments. This submission includes premachine angulated abutments less than 30°, specifically included are 15 and 25° abutments. In addition, in the wide body series there are a series of one and two piece prosthetic abutments with 4, 5, and 6mm platform diameters. These diameters match with the platform diameters of the appropriate implant bodies included in this system. This system includes cylindrical and screw implants of a variety of lengths and geometrical shapes. These devices are similar in their intended use and follow the appropriate integration protocol phase and following prosthetic attachments.

The provided text is a 510(k) summary for a medical device (endosseous implant system), which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of submission generally does not include detailed studies with acceptance criteria and performance data as would be found in a clinical trial or performance study report for a novel device.

The document primarily focuses on demonstrating substantial equivalence to existing devices based on design, materials, manufacturing processes, gamma sterilization, geometry, and materials. There are no specific acceptance criteria or details of a study explicitly proving the device meets performance criteria in the way a diagnostic AI device or a novel therapeutic device would.

Therefore, many of the requested elements for the acceptance criteria and study section cannot be extracted directly from this 510(k) summary.

Here's what can be inferred or stated based on the provided text:

1. A table of acceptance criteria and the reported device performance

No explicit acceptance criteria or reported device performance metrics are provided in the document. The substantial equivalence is based on the device being "similar to the predicate devices currently on the market" in its characteristics and intended use.

2. Sample size used for the test set and the data provenance

No test set or data provenance is mentioned. This is a premarket notification for a device based on similarity to predicate devices, not a study reporting performance data on a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No test set or ground truth establishment process is described.

4. Adjudication method for the test set

Not applicable. No test set or adjudication method is described.

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 device, and no MRMC study content is present.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithmic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No ground truth is mentioned. The device's safety and effectiveness are established through substantial equivalence to predicate devices, implying that past clinical experience and regulatory approvals of similar devices form the basis.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device requiring a training set.

9. How the ground truth for the training set was established

Not applicable. No training set or ground truth establishment for a training set is described.

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The wide body abutments and pre-angled abutments are similar to those of other implant systems in their intended use which is to facilitate the prosthetic phase and installation of the prosthesis for for the patient.

Endosseous implant system consists of implants, tools and abutments. This submission includes pre-machined angulated abutments less than 30 degrees, specifically 15 and 25-degree abutments are included. In addition, in the wide-body abutment series, a series of one and two-piece prosthetic abutments are included in 4, 5 and 6 mm. platform diameters. These devices are similar in their use in that they are placed on top of the implant fixtures after the appropriate integration phase and prosthetic attachments are fabricated to these abutments.

This document is a 510(k) summary for dental implant abutments, intended to demonstrate substantial equivalence to predicate devices already on the market. It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria.

The document discusses:

• Predicate Devices: Lists specific 510(k) numbers for previously cleared dental implant systems.
• Device Description: Describes the endosseous implant system, focusing on pre-machined angulated abutments (15 and 25-degree) and wide-body abutments (4, 5, and 6 mm platform diameters).
• Intended Use: To facilitate the prosthetic phase and installation of a prosthesis for the patient.
• Technology Characteristic Summary: States that design, material, manufacturing process, sterilization, geometry, and service are similar to predicate devices. Materials used are ASTM standard B-348-93 titanium grade 3, 4, and titanium alloy ELI-grade 5. It also mentions compliance with GMP guidelines.

Therefore, I cannot provide the requested information about acceptance criteria or a study demonstrating device performance because it is not present in the provided text. The document's purpose is to establish substantial equivalence for market clearance, not to detail performance studies against specific acceptance criteria.

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The wide body abutments and pre-angled abutments are similar to those of other implant systems in their intended use which is to facilitate the prosthetic phase and installation of the prosthesis for the patient.

system consists of Endosseous implant implants, tools and abutments. This submission includes pre-machined angulated abutments less than 30 degrees, specifically 15 and 25-degree abutments are included. In addition, in the wide-body abutment series, a series of one and two-piece prosthetic abutments are included in 4, 5 and 6 mm. platform diameters. These devices are similar in their use in that they are placed on top of the implant fixtures after the appropriate integration phase and prosthetic attachments are fabricated to these abutments.

This document is a 510(k) summary for a dental implant system. It describes the device, its intended use, and compares it to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) summary focuses on demonstrating substantial equivalence to existing predicate devices based on design, materials, manufacturing process, and intended use. It does not present performance data or clinical study results in the manner requested.

Therefore, I cannot provide the requested information.

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The wide body abutments and pre-angled abutments are similar to those of other implant systems in their intended use which is to facilitate the proBthetic phase and installation of the programs of the program and 824 U.S. Highway 1, Suite 370 1499 W. Palmetto Park Road Boca Raton 33486-3311 N. Palm Beach, Florida 33408 (407) 392-4747 (407) 627-5560 FAX (407) 392-8320 FAX (407) 627-4214 "Tomorrow's Technology Today"

Endosseous implant system consists of implants, tools and This submission includes pre-machined angulated abutments. abutments less than 30 degrees, specifically 15 and 25-degree abutments are included. In addition, in the wide-body abutment series, a series of one and two-piece prosthetic abutments are included in 4, 5 and 6 mm. platform diameters. These devices are similar in their use in that they are placed on top of the implant fixtures after the appropriate integration phase and prosthetic attachments are fabricated to these abutments.

This document is a 510(k) summary for an endosseous implant system, specifically focusing on wide body and pre-angled abutments. It primarily establishes substantial equivalence to predicate devices and does not describe a clinical study or performance testing against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and performance metrics cannot be found in this document.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance

• None stated: The document does not define specific quantitative acceptance criteria or report on device performance against such metrics. Its focus is on demonstrating substantial equivalence to predicate devices.

Study Details

As no specific study is described in this 510(k) summary, the following information is not available:

1. Sample size used for the test set and the data provenance: Not applicable.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
3. Adjudication method for the test set: Not applicable.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used: Not applicable.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

Information that is available in the document:

• Device Description:
  • Consists of implants, tools, and pre-machined angulated abutments (15 and 25-degree).
  • Includes wide-body abutments of one and two-piece prosthetic designs with 4, 5, and 6 mm platform diameters.
  • Placed on top of implant fixtures after integration.
• Intended Use:
  • Similar to other implant systems.
  • To facilitate the prosthetic phase and installation of prostheses.
• Technology Characteristic Summary:
  • Material, manufacturing process, gamma sterilization, design, geometry, and services are similar to predicate devices.
  • Materials: ASTM standard B-348-93 titanium grade 3, 4, and titanium alloy ELI-grade 5.
  • GMP guidelines are in place and have been inspected by the FDA Office of Compliance.
• Predicate Devices:
  • General: Dental Imaging Associates (K902433, K902434, K902435), Implant Innovations (K932123).
  • For Wide Body: Nobelpharma (K925766, K934826, K934495), Implant Innovations (K933969, K934126, K933462).

In summary, this document serves as a regulatory submission demonstrating substantial equivalence through comparison to existing devices, rather than presenting data from a clinical performance study with predefined acceptance criteria.

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