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NeoConvert Solution: The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. The NeoConvert Solution may be used with single-stage or two-stage procedures, for temporary multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

Direct Screw to MUA: The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. The Direct Screw to MUA may be used with single-stage or two-stage procedures, for screw-retained multi-unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. All digitally designed personalized copings to be used with the Direct to Multi Unit Abutment Screw are intended to be sent to Straumann for manufacture at a validated milling center.

GM Attachment TiN 30°: The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. The GM Attachment TiN 30° may be used with single-stage or two-stage procedures, for multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

This premarket notification includes the following additions to the Neodent Implant System: NeoConvert Solution, Direct Screw to MUA, GM Attachment TiN 30°. The Neodent Multi-Unit Abutments proposed on this submission are similar to devices already cleared in previous submissions of Neodent Implant System, according to predicate devices described above. This submission intends to expand the portfolio of Neodent Abutments with these new solutions for multi-unit restorations, to provide more treatment options to customers. The NeoConvert Solution is a technique comprised by some abutments (not subject of this submission) used for converting removable temporary prosthesis into a screw-retained fixed temporary prosthesis. The Direct Screw to MUA is a prosthetic component designed to fix planned and digitally designed multi-unit milled restorations directly onto mini or micro abutments, eliminating the need for using the passive seating cylinder to restore chewing function. The GM Attachment TiN 30° is a prosthetic component used to stabilize implant-mucosa-supported removable full prosthesis (retained on the implant and supported on the mucosa), on implants installed in the maxilla or mandible. Although all these three new solutions are compatible with the same implants and components of Neodent Implant System and used for multiple unit rehabilitation, they are not used in conjunction with each other.

The provided text describes a 510(k) premarket notification for the "Neodent Implant System," focusing on the NeoConvert Solution, Direct Screw to MUA, and GM Attachment TiN 30°. This document details the device's technical characteristics, intended use, and its substantial equivalence to previously cleared predicate devices.

However, the provided text does not contain information about acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML medical device submission. The document is a traditional 510(k) submission for dental implants and abutments, which are physical medical devices, not AI/ML software. Therefore, the specific requirements for an AI/ML device study (such as sample sizes for test and training sets, expert qualifications for ground truth, MRMC studies, or standalone performance) are not applicable or present in this document.

The "Performance Testing" section (pages 15-16) describes bench testing (dynamic fatigue, torsion, SEM images), MRI compatibility testing, biocompatibility testing, sterilization validation, and shelf-life testing for the physical dental implant components. These are standard performance tests for this type of physical device, not AI/ML algorithm validation.

Therefore, I cannot provide a table of acceptance criteria and a study proving the device meets acceptance criteria as typically outlined for an AI/ML medical device, as this information is not present in the provided document. The document focuses on demonstrating substantial equivalence of a physical dental device to predicate devices through engineering and material testing.

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S.I.N. Dental Implant System Zygomatic implants are intended for placement in the maxillary arch to provide support for fixed or removable dental prostheses in patients with partially or fully edentulous maxillae. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System Zygomatic implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The purpose of this submission is to add components to the S.I.N. Dental Implant System. This submission includes zygomatic dental implants and mating abutments for screw-retained, multi-unit prostheses.

The subject device Zygomatic Plus Morse Taper implants have a body diameter of 4.0 mm that tapers to approximately 2.3 mm at the apex. The implants have a Morse taper ("CM") abutment interface connection, with an internal 16° cone taper. The abutment platform is 4.0 mm. All implants are threaded starting at the apex and extending approximately 17 mm in the coronal direction, with a major thread diameter of 4 mm; the thread tapers over the final 6 mm of the implant to the apex. The implants are provided with overall lengths of 30, 32.5. 35. 37.5. 40. 42.5.45. 47.5. 50. 52.5.57.5. and 60 mm. The surface of all subject device implants is acid-etched from the implant platform to the apex, followed by application of a hydroxyapatite coating (HA nano).

The subject device abutments are multi-unit, indexed abutments for use only with the subject device Zygomatic Plus Morse Taper implants for maxillary full-arch restorations. The subject device abutments have a prosthetic platform diameter of 4.8 mm, and gingival heights of 1.5, 2.0, and 2.5 mm. The prosthetic post is angled 52° or 60° to the long axis of the implant. These components are used with previously cleared abutment screws.

All subject device dental implants are manufactured from unalloyed titanium conforming to ASTM F67. All implants have an acid-etched HA100 surface treatment, identical to that cleared in K231127. All subject device abutments are manufactured from titanium alloy (Ti-6A1-4V) conforming to ASTM F136. All subject device implants and abutments are provided sterile to the end user.

The provided text is a 510(k) Summary for a dental implant system. It explicitly states that no clinical data were included in this submission to support substantial equivalence (see "No clinical data were included in this submission." on page 6 of 9).

Therefore, it is not possible to provide specific details about acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, or MRMC studies, as这些 types of studies were not conducted or reported in this 510(k) submission.

The "Performance Data" section (pages 6-7 of 9) refers to non-clinical data only:

• mechanical testing
• gamma irradiation sterilization
• bacterial endotoxin testing
• MR environment evaluation
• sterile barrier shelf life data
• biocompatibility data

These tests are typically conducted to assess the physical and biological characteristics of the device, not its clinical performance in patients as would be measured in an AI/MRMC study.

In summary, based on the provided document, no study was conducted to prove the device meets acceptance criteria related to AI/MRMC performance as outlined in your request. The submission relies on substantial equivalence to predicate devices, supported by non-clinical performance data.

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Indications for Use for Zygoma-S GM Implant:

Zygomatic implants are indicated for intraoral surgical procedures in the zygoma region in cases of severe maxilla bone resorption, to restore the patient's chewing function and aesthetics. Zygomatic Implants may be used in one or two-stage procedures, multiple unit restorations, and immediate loading when there is primary stability and adequate occlusal load.

Indications for Use for GM Mini Conical Abutment 52° and 45°:

Product indicated for surgical procedures in zygomatic bones, making possible the rehabilitation with screw-retained abutments over the implant, thus restoring the chewing function. It may be used in one- or two-stage procedures, multiple unit restorations, and immediate loading when there is primary stability and adequate occlusal load. Multiple rehabilitations may be splinted rigidly.

Indications for Use for Coping for Removable Prosthesis:

The product, when used with non-zygomatic implants, is intended to be surgically placed in the bone of the upper or lower jaw, to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single stage or two-stage procedures, for multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with approprate occlusal loading. Multiple tooth applications may be rigidly splinted. When used with zygomatic implants, the product is indicated for surgical procedure only in upper jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used in two-stage procedures (delayed loading protocol) and for multiple unit restorations. Multiple rehabilitations may be splinted rigidly.

The subject devices implants are single use devices, provided sterile by Gamma Radiation, made of commercially pure Titanium grade 4 (ASTM F67). The Zygomatic Implant is a long implant with a nominal diameter of 3.50 and 3.75mm, conical apex with rounded tip, 3 helical chambers, trapezoidal thread and GM prosthetic interface. The cervical portion in both models has Ø 4.3 mm. The length varies from 30 to 55 mm. Zygomatic Implants are intended to provide support for a fixed prosthesis in patients with severe atrophy in the maxillary region. They are extra-long to allow bone anchorage in the zygomatic bone. The subject implants consider the Zygoma Anatomy-Guided approach (ZAGA) for planning the surgical steps, being indicated for extrasinus and extra maxillary installation technique (ZAGA-4).

The subject abutments are single use devices, provided sterile by Ethylene Oxide, made of Titanium alloy (Tl6Al4V-ELI). They are intermediate prosthetic components angled at 52 and 45 degrees with gingiva heights 1.5 and 2.5 mm, to be installed on the implant, offering a structure to support the screw-retained multiple prosthesis. The abutments present GM prosthetic interface and are available in the anti-rotational form in the implant to abutment interface, and rotational form in the abutment to prosthesis interface, presenting different transmucosal heights.

The subject coping is single use device, provided sterile by Ethylene Oxide, made of titanium alloy (Ti6Al4V-ELI). It presents a NEO torque interface for torque application. The subject device has diameter 4.80 mm and total height 4.60 mm. They are indicated for removable prostheses with fitting over Mini Conical Abutment installed in the maxilla or mandible and can be used in partial removable prostheses or over dentures. They are compatible with all previously cleared GM Mini Conical abutments.

The provided document is a 510(k) premarket notification for a medical device (Neodent Implant System - GM Zygomatic Implant System). It focuses on demonstrating substantial equivalence to predicate devices through comparisons of indications for use, technological characteristics, and performance data, primarily bench testing, sterilization validation, shelf life validation, and biocompatibility.

Crucially, this document does not contain information about an AI/ML algorithm or a study validating its performance, nor does it detail acceptance criteria for software or AI/ML components. The product being cleared is a set of dental implants and abutments. Therefore, I cannot extract the acceptance criteria and study details for an AI-powered device as requested.

The document discusses performance data in the context of the physical dental implants and abutments, which includes:

• Performance Testing – Bench: Dynamic fatigue testing (ISO 14801), insertion tests, torsion tests, and microscopic analysis of the implant body.
• Surface treatment: Discussion of the NeoPoros surface.
• MR Compatibility testing: Assessment of safety in MRI environments.
• Sterilization validation: Conformance to ISO standards for Gamma Irradiation (implants) and Ethylene Oxide (abutments).
• Shelf Life validation: Based on packaging integrity and physical stability.
• Biocompatibility: Testing per ISO 10993 standards.
• Clinical data: A review of published literature on zygomatic implants, including survival rates and observed complications (not a specific clinical study conducted for this device clearance).

If you are looking for information regarding acceptance criteria and study data for an AI/ML medical device, this document does not provide it, as it pertains to a different type of medical device.

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