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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 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.

I'm sorry, but this document does not contain the information requested to describe the acceptance criteria and study proving device performance for a medical device. The document is a 510(k) summary for a dental implant system, primarily focusing on its substantial equivalence to predicate devices. It lists predicate devices, describes the device, and states its intended use, but it does not provide details on specific acceptance criteria for a study demonstrating performance, nor does it detail a study with performance metrics, sample sizes, ground truth establishment, or expert involvement as requested.

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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 prosthetic phase and installation of the prospectives consideration for for the patient.

Endosseous implant system consists of implants, tools and abutments long the 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 prostheric attachments are fabricated to these abutments.

This document is a 510(k) summary for dental implant abutments. It does not contain information about acceptance criteria or a study proving that a device meets such criteria because it describes a device that is substantially equivalent to predicate devices already on the market, rather than a novel device requiring new performance studies.

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 eacilitate the prosthetic phase and installation of the prosthesis for the patient.

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.

The provided text describes a 510(k) summary for an endosseous implant system, focusing on its substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study demonstrating the device meets such criteria. The document is primarily a letter to the FDA seeking approval, outlining the device's description, intended use, and technological characteristics by comparing them to existing cleared devices.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving the device meets them based only on the provided text. The document is a regulatory submission, not a study report.

Ask a specific question about this device

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 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 a medical device submitted in 1996. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study data for a new device's performance.

Therefore, the requested information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not available in the provided text. This document is a regulatory submission for pre-market notification, not a clinical study report.

The 510(k) summary outlines:

• Predicate Devices: Lists previously cleared devices that the current device claims substantial equivalence to.
• Device Description: Briefly describes the endosseous implant system, including implants, tools, and particularly pre-machined angulated abutments (15 and 25 degrees) and wide-body abutments (4, 5, and 6 mm platform diameters).
• Intended Use: To facilitate the prosthetic phase and installation of prostheses.
• Technology Characteristic Summary: States that design, material, manufacturing process, sterilization, geometry, and materials are similar to predicate devices. It specifies the use of ASTM standard B-348-93 titanium grade 3, 4, and titanium alloy ELI-grade 5, and mentions GMP compliance.

Without a clinical study report or a different type of technical document, it's impossible to provide the requested details about acceptance criteria and device performance as these are not part of a standard 510(k) summary.

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