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The Surcam 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. The Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. The C Type 3.3mm diameter implants are indicated for use with only straight abutments.

Temporary cylinders must be used in a splinted restoration only and are not for single crown restorations.

The Surcam Dental Implant System consists of endosseous dental implants in conical and internal hex connections along with abutments, cover screws, healing caps and abutment systems for each connection type. Conical devices come in two platforms, NP and RP. Implants and abutments are made from ASTM F136 Ti6AL4V ELI. Multi-unit abutments are for multi-unit restorations only.

The provided text does not contain information about acceptance criteria or a study proving that an AI-powered device meets such criteria. The document is a 510(k) premarket notification for a medical device called the "Surcam Dental Implant System," which is a traditional dental implant system, not an AI device.

The document discusses:

• Device Name: Surcam Dental Implant System
• Indications for Use: Surgical and restorative applications for placement in the bone of the upper or lower jaw to support prosthetic devices (artificial teeth) to restore chewing function. It also indicates immediate loading when good primary stability is achieved.
• Device Description: Consists of endosseous dental implants (conical and internal hex connections), abutments, cover screws, healing caps, and abutment systems. Made from ASTM F136 Ti6AL4V ELI.
• Testing Summary: Dynamic fatigue testing (ISO 14801), surface cleanliness analysis, sterilization (ISO 11137-1 and 11137-2 for implants; ISO 17665-1 and -2 for abutments), material compliance (ASTM F136), endotoxin testing (USP 161), shelf life and package integrity testing (ASTM F1980, ASTM F1929, ASTM 2338, ASTM D3078, ISO 11607-1) for a shelf life of 5 years.
• MR Environment Condition: Non-clinical worst-case MRI review performed based on scientific rationale and published literature.
• Predicate and Reference Devices: Comparison with other legally marketed dental implant systems to establish substantial equivalence.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI device meets them, as the subject of this document is a conventional dental implant system.

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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.

(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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The implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols:

• Replacing missing teeth in single or multiple unit applications in the mandible or maxilla.
• Immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge.
• Especially indicated for use in soft bone applications with other implant surface treatments may be less effective.
• Immediate and early loading for all indications, except in single tooth situations on implant shorter than 8 mm or in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate.

The proposed PrimeTaper EV Dental Implants are endosseous dental implants, which are manufactured from commercially pure titanium (Grade 4). The implant surface is blasted, and acid etched. The dental implants are intended to be surgically placed in the bone of the mandible and maxilla to replace missing teeth in order to restore chewing function. The proposed PrimeTaper EV Dental Implants have a root form shape with a self-tapping thread design. The coronal portion of the implant has a minute threading (MicroThread™). The residual implant body has macro threads. The proposed implants are available in the diameters 3.6, 4.8, 5.4 mm and in the lengths 6.5, 8, 9, 11, 13, 15, 17 mm. The proposed PrimeTaper EV Dental Implants incorporate a conical implant - abutment connection interface with indexing option (EV Connection), which is identical to the internal connection of the predicate OsseoSpeed Plus (K120414) implants. The PrimeTaper EV Dental Implants are intended to be used in combination with prosthetic components with the conical EV connection (cover screws, healing abutments, cement-retained abutments and screw-retained abutments), which were previously cleared for use with the OsseoSpeed Plus Dental Implant System (K120414, K163350, K183079 and K111287). Dental implant abutments are intended to be used in the upper or lower jaw used for supporting tooth replacements to restore chewing function. No new Abutments are being proposed as part of this submission. The PrimeTaper EV Dental Implants are provided sterile by electron-beam irradiation.

I am sorry, but the provided text does not contain information about acceptance criteria and a study proving a device meets these criteria in the context you specified (AI/ML device performance).

The text is a 510(k) summary for a PrimeTaper EV Dental Implant, which is a physical medical device (an endosseous dental implant). The document details the device description, indications for use, comparison to predicate devices, and non-clinical as well as clinical performance data to demonstrate substantial equivalence to previously cleared devices.

Therefore, I cannot extract the following information that you requested:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• MRMC comparative effectiveness study details.
• Standalone (algorithm only) performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

These specific points are relevant to AI/ML-enabled devices and their evaluation, not to the traditional medical device (dental implant) described in the provided document.

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