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The Hex-Lock Temporary Abutment is designated for use on the internal hexagon implant interface for less than twenty-eight days usage which is placed in the edentulous mandibles or maxillae, for fixation of a final crown. The intended use of the Hex-Lock Temporary Abutment is identical to the intended use of the predicate device, the ProTect abutment from Friadent. The plastic temporary abutment is intended to be used to create an esthetic emergence through the gingiva between implant uncovering and final restoration with screw-retained or cemented restorations. Use of the plastic abutment is not to exceed twenty-eight (28) days. If time between placement of temporary abutment and final restoration needs to exceed twenty-eight (28) days then the use of a titanium abutment, which is indicated for longer-term use, is required.
The abutment can be used for either a single tooth or multiple tooth unit provisional restoration and can be modified in height to suit individual needs during the fabrication of the provisional prosthesis.
The plastic temporary abutment can be used to create esthetic, screw-retained or cemented provisional restorations at second stage uncovering. Once the restoration has been applied to the temporary abutment, it can be used to develop a more esthetic emergence profile. Temporary abutment is not to be used as a permanent abutment. Not to exceed 28-days of placement.

The Hex-Lock Temporary Abutment is available in 4.5mm, 5.5mm, and 6.5mm outer diameter lengths for the internal hexagon interface. The abutment/implant platform diameter is 3.5mm, 4.5mm, and 5.7mm for the internal hexagon interface. All the abutments exhibit the internal hexagon interface.
The Hex-Lock Temporary Abutment is a new abutment design that is being submitted to interact with an internal hexagon dental implant system. The abutment features an internal hex engaging plastic cylinder with retentive parallel walls and a flared cuff used for short term restorations less than twenty-eight (28) days. This abutment will attach directly to the implant with a retaining screw with a long shaft that protrudes from the top of the abutment to facilitate the fabrication of the provisional prosthesis. Both screws allow for length reduction for custom height restorations. The abutment will exhibit the internal hex engaging feature. The abutment/implant interface remains unchanged.

The provided text is a 510(k) summary for a dental device (Hex-Lock Temporary Abutment). It focuses on demonstrating substantial equivalence to a predicate device based on design, materials, and intended use. There is no information within the document about acceptance criteria or a study proving that the device meets such criteria in terms of performance metrics or clinical outcomes.

Therefore, I cannot provide the requested information. The document does not describe any such studies, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. This type of submission relies on demonstrating equivalence rather than fulfilling performance criteria through a specific study as would be seen for devices requiring clinical performance data.

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The intended use of the Sulzer Dental Ceramic System-HexLock is for anterior single unit restoration cases. This system is intended to improve esthetics in anterior cases by replacing the metal substructure within a restoration with a tooth color ceramic structure.

The Ceramic System-HexLock uses a titanium hex core (abutment) and a ceramic coping. The core is attached to the implant with a titanium retaining screw. The coping is cemented to the core for a final restoration. The core will be offered in two implant interface diameters, 3.5mm, and 4.5mm. The Ceramic System coping is available in six shapes: small incisor, 17º small incisor, large incisor, 17º large incisor, canine, and premolar.

The provided text is a 510(k) summary for the Sulzer Dental Ceramic System-HexLock. It primarily focuses on comparing the new device to predicate devices to establish substantial equivalence, rather than detailing a study with specific acceptance criteria and performance data in the typical sense of a clinical trial or algorithm validation.

However, based on the information provided, we can infer the "acceptance criteria" through the comparison analysis and the "study" demonstrating that the device meets these criteria is the comparison itself, which aims to show substantial equivalence.

Here's an attempt to structure the information according to your request, acknowledging the limitations of the provided text for a direct fit:

Acceptance Criteria and Device Performance

The core "acceptance criteria" here is that the Sulzer Dental Ceramic System-HexLock is substantially equivalent to existing, legally marketed predicate devices. The "reported device performance" is demonstrated by the comparison of its technological characteristics and intended use to these predicates.

Key Implicit Acceptance Criterion: Substantial Equivalence to predicate devices (HexLock Abutment (K953101) and FRIALIT®-2 CeraBase Abutment (K980630)).

Study Details:

It's important to clarify that this document is a 510(k) summary for regulatory clearance, not a research paper detailing a specific clinical study with granular data. The "study" here is implicitly the substantial equivalence comparison performed by the manufacturer and reviewed by the FDA.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable in the context of a traditional test set for performance parameters. The "test set" is the Sulzer Dental Ceramic System-HexLock itself, and its characteristics are compared against the established characteristics of the predicate devices.
   • Data Provenance: The data provenance is from the specifications and characteristics of the new device and the predicate devices (Sulzer Dental HexLock Abutment and FRIALIT®-2 CeraBase Abutment). The manufacturing site for the new device is listed as Carlsbad, CA (USA), and for one predicate as Meinnheim, Germany. This is a retrospective comparison based on existing device specifications.

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

   • Not applicable as there is no "ground truth" expert consensus established for a test set in this 510(k) summary. The ground truth for the predicate devices' safety and effectiveness was established when they received their own regulatory clearances. For the new device, its specifications are provided by the manufacturer.

3. Adjudication method for the test set:

   • Not applicable. The process is a regulatory review by the FDA (specifically the Division of Dental, Infection Control and General Hospital Devices), comparing the new device's documentation to predicate devices. It is not an adjudication based on multiple expert opinions on a specific test set.

4. 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 device is a dental implant abutment and ceramic coping system, not an AI-powered diagnostic or assistive technology. Therefore, MRMC studies are irrelevant to this submission.

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

   • Not applicable. This is a physical medical device.

6. The type of ground truth used:

   • The "ground truth" in this context refers to the established safety, effectiveness, and regulatory clearance of the predicate devices based on their inherent characteristics, testing, and clinical track record. The new device's ground truth for approval is its "substantial equivalence" to these predicates. This involves comparing engineering specifications, materials, and intended use, likely supported by bench testing (though not detailed in the summary).

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that would require a training set.

8. How the ground truth for the training set was established:

   • Not applicable. No training set is involved.

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The Sulzer Dental Ceramic System - Spline is intended for use specifically for anterior and premolar, single-unit cement-retained restorations. This product should not be used in the molars and should not be splinted together for multiple unit cases. partials or bridgework.

The Ceramic System-Spline uses a titanium Spline core (abutment) and a ceramic coping. The core is attached to the implant with a titanium retaining screw. The coping is comented to the core for a final restoration. The core will be offered in three implant interface diameters, 3.25mm, 4.0mm, and 5.0mm. The Ceramic System coping is available in six shapes: small incisor, 17º small incisor, large incisor, 17º large incisor, canine, and premolar.

The provided document is a 510(k) summary for a dental implant abutment (Sulzer Dental Ceramic System - Spline) seeking substantial equivalence to existing predicate devices. It does not describe a study involving algorithms, AI, or performance metrics typically associated with device acceptance criteria in the context of AI/ML.

Instead, this document focuses on demonstrating that a new medical device (a physical dental implant component) is substantially equivalent to legally marketed predicate devices. The "acceptance criteria" here refer to the criteria for substantial equivalence under FDA regulations, which involve comparing the new device's intended use, technological characteristics, and safety/effectiveness concerns to those of existing devices.

Therefore, I cannot provide the requested information regarding AI/ML device performance, sample sizes for test sets, data provenance, expert ground truth, MRMC studies, standalone performance, or training set details because this submission is not about an AI/ML device.

The "acceptance criteria" in this context are established by the FDA's regulatory framework for 510(k) submissions, primarily evaluating substantial equivalence. The "study that proves the device meets the acceptance criteria" is the comparison analysis presented in the document, which argues for substantial equivalence based on a comparison to predicate devices, rather than a clinical trial or AI model validation study.

Here's a breakdown of what the document does provide, reframing the request to fit the content:

1. Table of Acceptance Criteria (for Substantial Equivalence) and Reported Device Performance (Characteristics):

The "study" demonstrating this device meets "acceptance criteria" is the comparison analysis itself, which asserts that differences do not raise new questions of safety or effectiveness.

The following points are not applicable to this document as it pertains to a physical device approval based on substantial equivalence, not an AI/ML model.

2. Sample size used for the test set and the data provenance: Not applicable. No "test set" in the context of AI/ML validation is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML-based test set is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the AI/ML sense. The "ground truth" for the substantial equivalence claim is the performance and characteristics of the legally marketed predicate devices.
8. The sample size for the training set: Not applicable. No AI model is being trained.
9. How the ground truth for the training set was established: Not applicable.

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The Spline Twist implants are intended for surgical implantation in edentulous or partially edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a freestanding single tooth replacement. The use of the 5.0mm implant is recommended when the quantity and density of bone would dictate the use of an implant larger than 4.0mm. In patients with an edentulous mandible, Spline Twist implants may be loaded immediately when at least four implants are placed between the mental foramina and rigidly splinted with a bar.

Spline Twist implants are screw type implants made from titanium alloy. They have the same surfaces as currently available Sulzer Dental implants. The implants are all provided sterile.

The provided text is a 510(k) summary for the Sulzer Dental Inc. Spline Twist dental implant. This document is a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices. It does not contain information about acceptance criteria or a study proving device performance in the way typically associated with AI/ML medical devices.

The document focuses on comparing the Spline Twist implant's characteristics (intended use, indications, design, material, dimensions, surface, packaging, and sterilization) to existing predicate dental implants (Branemark System and ITI Implants) to establish substantial equivalence.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth details, or training set size) as this information is not present in the provided text. The document is about a physical dental implant, not an AI/ML device, and thus the structure of evaluation is very different.

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The ScrewVent and Tapered ScrewVent implants are intended for surgical implantation in edentulous or partially edentulous mandibles or maxillae for attachment of complete In countilious of partially or intermediary abutment for fixed or removable bridgework, or as a freestanding single tooth replacement.

In patients with an edentulous mandible, ScrewVent and Tapered ScrewVent implants may be loaded immediately when at least four implants are placed between the mental foramina and rigidly splinted with a bar.

ScrewVent and Tapered ScrewVent implants are screw type implants made from titanium alloy. They have the same surfaces as currently available Sulzer Dental implants. The implants are all provided sterile.

This document is a 510(k) Pre-market Notification for a dental implant system. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and results for the new device. Therefore, much of the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in terms of algorithmic performance metrics (like sensitivity, specificity, etc.) is not applicable or available in this submission.

Here's a breakdown based on the provided text, addressing what can be inferred or explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not outline specific performance acceptance criteria for the ScrewVent® and Tapered ScrewVent® implants in the way one would for an AI/ML device (e.g., sensitivity, specificity, F1-score). Instead, the "acceptance criteria" for a 510(k) submission like this are met by demonstrating substantial equivalence to predicate devices.

The "performance" is implicitly demonstrated through the comparison of technological characteristics and intended use, asserting that the new device performs similarly to or no worse than the predicate devices for their stated intended uses.

Note: The "acceptance criteria" here are not numerical thresholds for performance metrics but rather a demonstration of similarity in design and function to legally marketed devices, ensuring safety and effectiveness are maintained.

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

This document does not describe a clinical "test set" in the context of an AI/ML device. It is a 510(k) submission for a physical medical device (dental implants). Therefore, concepts like "sample size used for the test set" and "data provenance" (country of origin, retrospective/prospective) are not directly applicable.

The "comparison" is based on the technical specifications and intended uses of previously cleared predicate devices.

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

This information is not applicable to a 510(k) submission for a dental implant. There is no "ground truth" establishment by experts in the context of a dataset for algorithmic evaluation. The safety and effectiveness are established through material compatibility, mechanical testing (which is not detailed here but implied by substantial equivalence), and historical clinical use of similar devices.

4. Adjudication Method for the Test Set

Not applicable. There is no test set adjudication for a physical dental implant in this type of submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC study is relevant for evaluating the impact of an AI algorithm on human reader performance. This document concerns a physical dental implant and therefore an MRMC study was not conducted or is not relevant to this submission.

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

No. This is not an AI/ML device.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically applied to AI performance evaluation (e.g., pathology, outcomes data for diagnostic accuracy) is not directly applicable here.

For a physical device like a dental implant, the "ground truth" for its safety and effectiveness is established through:

• Established clinical practice and long-term outcomes of very similar predicate devices.
• Material properties and biocompatibility testing (implied, not detailed).
• Mechanical performance such as strength, fatigue, and interface stability (implied, not detailed).
• Adherence to recognized standards (implied).

The document states, "There have been no modifications to the ScrewVent and Tapered ScrewVent implants. There has been no change to the implant materials or to the implant/abutment interface." This statement and the comparison table are the primary "evidence" presented for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device and therefore does not have a "training set."

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

Not applicable.

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Sulzer Dental Implant Systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a freestanding single tooth replacement. The use of the 5.0mm implant is recommended when the quantity and density of bone would dictate the use of an implant larger than 4.0mm. The 3.15mm implant is recommended for use in the maxillary laterals for replacement of teeth in narrow interproximal areas and narrow ridges.

Spline Twist implants are available with a roughened surface or a selectively Spince Twise Internally in a 3.15mm diameter and lengths of 10, 11.5, 13, 15, and 18mm. All implants have a Spline anti-rotational feature and are fabricated from titanium alloy. The implants are all provided sterile.

The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. This document is a 510(k) summary for a dental implant, which focuses on demonstrating substantial equivalence to predicate devices rather than providing performance study results against specific acceptance criteria.

Therefore, I cannot fulfill your request with the given input.

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Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device