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Removable Cuff Abutments are screw retained endosseous dental implant abutments and are intended to function as an anchor to which prosthetic devices may be attached using either dental oement or a lingual screw.

They are indicated for use on endosseous implants placed in the mandible or maxilla for support of fixed bridgework, removable bridgework or free standing single tooth replacements.

A Removable Cuff Abutment is a two piece titanium alloy abutment with a separate titanium alloy retaining screw. Each Removable Cuff Abutment is composed of one abutment core body and one removable cuff. Removable Cuff Abutments will be offered as fixed abutments and as pre-angled (15 and 25 degree) abutments for use with both cement and screw retained prosthetics. Abutments will be available in three different diameters at the abutment/implant interface: 3.25mm, 4.0mm and 5.0mm. Flare diameters of cuffs will range from 4.0 to 6.5mm and cuff heights will range from 0.5 mm. A new feature is the addition of a transverse (lingual) screw to some designs. This feature will permit attachment of screw retained prostheses in addition to cement retained prostheses. Removable Cuff Abutments will be packaged with or without the transverse (lingual) screw components.

The provided text is a 510(k) summary for a dental implant abutment and does not contain information about an AI device or a study involving acceptance criteria and device performance as typically understood for AI/ML medical devices. The document describes a "Removable Cuff Abutment" and its comparison to predicate devices, focusing on manufacturing, material, and design characteristics.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details as these are not discussed in the provided text.

The section titled "Performance Data" states: "Bench top testing demonstrated the equivalence of the Removable Cuff Abutment to the predicate devices." This is the only mention of performance or testing, and it refers to physical bench testing, not an AI model's performance.

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A Temporary Abutment is indicated for use for a maximum of six weeks as an abutment for cemented provisional prostheses. This abutment can be used for single tooth provisional restorations or splinted to other abutments for multi-unit provisional restorations. Single use.

The Spline Dental Implant System - Temporary Abutment will consist of a titanium alloy abutment cylinder with a separate titanium alloy retaining screw. A Temporary Abutment will attach.directly to the Spline implant with the retaining screw but does not engage the tines. It will be available in three different cuff diameters at the abutment/implant interface: 3.25mm, 4.0mm and 5.0mm. Abutments will also be available with straight wall or stepped cuffs with either a straight or a tapered retentive wall.

The provided text describes a 510(k) premarket notification for a medical device, specifically the "Spline Dental Implant System - Temporary Abutment." This type of submission aims to demonstrate substantial equivalence to a predicate device, rather than proving safety and effectiveness through extensive clinical trials as would be required for a novel device. Therefore, the information typically requested in your prompt regarding acceptance criteria and detailed study designs for AI/software-based devices is not present in this document.

However, I can extract the relevant information that is available about the "performance data" and comparison to a predicate device, interpreting the request in the context of this specific regulatory submission.

Explanation of Device and Regulatory Context:

The device is a "Temporary Prosthetic Component" for dental implants. It's designed to be used for a limited duration (maximum of six weeks) to support temporary restorations. The submission focuses on demonstrating that this "Temporary Abutment" is substantially equivalent to an already legally marketed "Spline Dental Implant System - Fixed Abutment" (the predicate device).

Substantial equivalence is demonstrated by showing that the new device has the same intended use and technological characteristics as the predicate, or if there are differences, that those differences do not raise new questions of safety and effectiveness.

Here's how I can address your prompt based on the provided text:

Acceptance Criteria and Device Performance for Spline Dental Implant System - Temporary Abutment (K982305)

Regulatory Context: This submission is a 510(k) premarket notification, which establishes "substantial equivalence" to a predicate device, not necessarily standalone safety and efficacy through clinical outcomes. Acceptance criteria here refer to the demonstration of identical or highly similar technological characteristics and equivalent performance in bench testing to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not specified. The submission mentions "bench top testing," which refers to laboratory-based mechanical or physical tests, not human subject data. The number of units tested is not provided.
• Data Provenance: Not specified, but generally, bench testing data for such submissions would be generated by the manufacturer (Sulzer Calcitek Inc.) in a controlled laboratory environment. It is not retrospective or prospective clinical data from patients.

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

• This concept is not applicable here. "Ground truth" from experts is relevant for diagnostic devices (e.g., radiologists interpreting images). For a mechanical device like a dental abutment, "ground truth" is established through engineering specifications, material properties, and mechanical performance standards via bench testing, not expert consensus on clinical findings.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving discrepancies in expert interpretations (e.g., imaging studies). For bench testing, results are typically objective measurements against predefined engineering standards.

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/software device, and no MRMC study or human reader performance assessment was conducted or required for this type of medical 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, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for demonstrating substantial equivalence for this device would be the engineering specifications, material properties, and established mechanical performance characteristics of the predicate device. The Temporary Abutment's performance in bench testing was compared against these established characteristics to show it performs equivalently.

8. The Sample Size for the Training Set

• Not applicable. This is not a machine learning/AI device, so there is no training set in the conventional sense.

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

• Not applicable. There is no training set.

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Sulzer Calcitek 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 free standing 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.

Spline XI implants are available both with and without HA-coating. They are available in 3.75mm or 5.0mm diameters and are available in five lengths: 8, 10, 13, 15 and 18mm. A total of four surface styles are available: HA-coated, HAcoated/textured, HA-coated/machined and textured/machined. The implants are supplied sterile.

The provided document is a 510(k) summary for the Sulzer Calcitek Spline Dental Implant System - Spline XI. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel study to prove the device meets specific acceptance criteria in the way a new medical algorithm's performance would be assessed.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable to this type of submission.

Instead, the document's primary purpose is to compare the new device (Spline XI) to an existing, legally marketed predicate device (Sulzer Calcitek's existing Spline Dental Implant System) based on technological characteristics and intended use. The acceptance criteria are implicitly met if the device can demonstrate substantial equivalence to the predicate.

Here's an analysis of the provided information within the context of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the traditional sense for a 510(k) summary focused on substantial equivalence. The "acceptance criteria" are demonstrating that the new device shares fundamental technological characteristics and intended use with the predicate device, and that any differences do not raise new questions of safety and effectiveness.

The document provides a comparison table (Section 4) of features:

The reported "performance" is that the overall design of the Spline XI implants are identical to the predicate implants in these key characteristics, with a single modification: "There has been a modification to the apical portion of the implant body to provide the implant with self-tapping capabilities." The submission implicitly argues that this modification does not alter the fundamental safety or effectiveness.

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

Not applicable. This is not a performance study on a test set of data. The "test set" in a sense is the predicate device itself, against which the new device is compared. The data provenance is the design and manufacturing specifications of both the Spline XI and the predicate Spline Dental Implant System.

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

Not applicable for this type of submission. The "ground truth" for substantial equivalence is based on regulatory standards and the established safety and effectiveness profile of the predicate device. The information provided in the Class III Summary (Sections 3 and 4) cites scientific literature and FDA guidance regarding potential complications associated with dental implants generally, which serves as a background for evaluating the safety of the device type.

4. Adjudication Method for the Test Set

Not applicable. There is no adjudication of a test set in the context of this 510(k) submission.

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 device is a dental implant, not an AI-assisted diagnostic or therapeutic tool for which an MRMC study would be relevant.

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

The "ground truth" for this 510(k) submission is derived from:

• Regulatory definitions and established predicates: The FDA's classification of dental implants and the legal marketing status of the predicate device.
• Scientific and clinical literature: The Class III Summary (Sections 3 and 4) provides a detailed list of reported adverse safety and effectiveness information for endosseous dental implants, along with possible causes and citations to peer-reviewed journals and FDA documents (e.g., Federal Register). This serves as a comprehensive understanding of potential risks associated with this device type.
• Company documents and customer feedback: Mentioned in the Class III Certification as sources for understanding safety and effectiveness information, including specific issues like dental bur fracture, mal-positioned implants, and psychological rejection of implants (Section 4).

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or complex algorithm development.

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

Not applicable for the reasons stated above.

In summary, the provided document is a regulatory submission for a physical medical device, not a study evaluating an AI algorithm. The "acceptance criteria" and "study" described are fundamentally different, focusing on demonstrating equivalence to an existing device through a comparison of design, materials, and intended use, rather than a performance evaluation against a defined ground truth using statistical metrics.

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The Variable Parallel Pin is intended to provide a visual reference for evaluating parallelism, prosthetic fit and implant spacing between implants and natural teeth during implant placement surgery.
The Variable Parallel Pin is indicated for use in evaluating parallelism and fit of the many implant maning and fit of prosthetics with up to 25 degrees and to gadge implaire opensy lants and adjacent natural teeth.

The Variable Parallel Pin consists of two pivoting pegs that lock in orientations from straight (0) to 25°. The Variable Parallel Pin has cuff width geometry's that match the flare diameters of prosthetic abutments.

This 510(k) submission (K973521) for the "Variable Parallel Pin" does not contain the detailed information required to describe acceptance criteria and a study proving device performance in the manner requested.

The document is a 510(k) summary and the FDA's clearance letter. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study with specific acceptance criteria.

Here's what can be inferred from the provided text, and what information is missing:

Information that CANNOT be Extracted from the Provided Text:

• A table of acceptance criteria and the reported device performance: This document does not present any specific acceptance criteria (e.g., accuracy percentages, precision metrics) or the results of a performance study against such criteria.
• Sample size used for the test set and the data provenance: No information on a test set, its size, or origin is provided.
• Number of experts used to establish the ground truth for the test set and their qualifications: No ground truth establishment is described for a test set.
• Adjudication method for the test set: Not applicable as no test set is described.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance: This device is a mechanical surgical tool, not an AI or imaging device. Therefore, an MRMC study is not relevant.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an algorithm-based device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is described for a performance study.
• The sample size for the training set: Not applicable as this is not a machine learning or AI device.
• How the ground truth for the training set was established: Not applicable.

What the Document DOES State (and why it doesn't fit the requested format directly):

The submission demonstrates substantial equivalence by comparing the "Variable Parallel Pin" to predicate devices (Sulzer Calcitek's Parallel Pins and Nobelpharma BRANEMARK SYSTEM® Abutment Selection Kit).

Key Statements Regarding Performance/Equivalence (though not formal "acceptance criteria"):

• Intended Use: "The Variable Parallel Pin is intended to provide a visual reference for evaluating parallelism, prosthetic fit and implant spacing between implants and natural teeth during implant placement surgery." (This describes the purpose but not quantifiable performance metrics.)
• Technological Characteristics: "The technological characteristics between the Variable Parallel Pin and the predicate devices are identical. The addition of a hinging mechanism combines the function of fixed angle pins into a single pin." (This implies that its function is equivalent to the combined function of existing devices.)
• Comparison Analysis: "The overall design of the Variable Parallel Pin is similar or identical to the predicate devices. The Variable Parallel Pin is substantially equivalent to the predicate devices in design, manufacturing, materials and intended use."

Conclusion:

This 510(k) summary does not contain the type of detailed performance study data, acceptance criteria, and ground truth establishment methodology typically found for devices like AI algorithms or diagnostic tools. Its clearance is based on demonstrating substantial equivalence in design, materials, and intended use to existing predicate devices, rather than meeting specific quantifiable performance metrics through a dedicated clinical or technical performance study. The FDA's letter explicitly states, "We have determined the device is substantially equivalent...".

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For use when screw retention of a single or splinted prosthesis is desired, e.g., single crown, bars and bridges. Implants must be within 30° of parallelism to each other for a splinted prosthesis.

The Spline Engaging Shouldered Abutment System provides an antirotational option for single or multiple tooth prosthetic restorations. The components of this system are supplied non-sterile, for use by licensed dentists.

This document is a 510(k) summary for a medical device (dental implant abutment system). It is a regulatory submission for pre-market notification to the FDA, demonstrating substantial equivalence to a predicate device. This type of document does not contain the kind of study information requested in your prompt. Medical device 510(k) submissions primarily focus on comparing a new device to an already legally marketed one concerning technological characteristics, materials, and intended use. They are generally not accompanied by extensive clinical studies demonstrating performance against acceptance criteria in the way described in your request. Such studies are more typical for Premarket Approval (PMA) applications, which involve higher-risk devices or novel technologies.

Therefore, I cannot extract the following information from the provided text:

• Table of acceptance criteria and reported device performance: This document does not establish or report performance against specific acceptance criteria.
• Sample sized used for the test set and the data provenance: No test set is described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method: Not applicable.
• 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: This device is a mechanical dental implant component, not an AI-assisted diagnostic or therapeutic tool.
• If a standalone performance study was done: Not applicable in the sense of an algorithm's standalone performance.
• The type of ground truth used: Not applicable.
• The sample size for the training set: This device is a mechanical component, not an AI system that requires a training set.
• How the ground truth for the training set was established: Not applicable.

The document states:

• Device Trade Name: Spline Engaging Shouldered Abutment System
• Intended Use: For use when screw retention of a single or splinted prosthesis is desired, e.g., single crown, bars and bridges. Implants must be within 30° of parallelism to each other for a splinted prosthesis.
• Technological Characteristics: A modification to the shouldered abutment and associated components. Both the implant/abutment and abutment/coping interface engage the spline tines, providing anti-rotation. No change to the materials of this device.
• Comparison Analysis: The overall design of the prosthetic components are similar or identical to the predicate devices.
• Predicate Device: Sulzer Calcitek's existing Spline Dental Implant System.

This submission is purely about regulatory clearance based on substantial equivalence, not performance studies as outlined in your prompt.

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Calcitek 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 free standing 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.

These Class III dental implants are supplied sterile, ready for placement by a licensed dontist.

The provided text is a 510(k) summary for Calcitek HA-Coated Endosseous Dental Implants from 1997. It describes the device and its intended use, and states that it is substantially equivalent to a predicate device. However, this document does not contain the information requested regarding acceptance criteria and a study proving device performance against those criteria.

Specifically, the document focuses on:

• Company and contact information.
• Classification and trade names.
• Intended Use statement.
• Description of the device.
• Technological characteristics (noting no change in design, and same materials except for an enhanced HA coating composition).
• Comparison Analysis emphasizing the identical overall design to predicate devices and the change in HA coating composition.
• FDA correspondence affirming substantial equivalence.

Therefore, I cannot provide a table of acceptance criteria, reported device performance, sample sizes, ground truth establishment, or details about comparative effectiveness studies, as this information is not present in the provided text. The document's purpose is to establish substantial equivalence for regulatory approval, not to present a detailed clinical or performance study report.

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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 free standing single tooth replacement.

These Class III dental implants are supplied sterile, ready for placement by a licensed dentist. There has been no significant change to the prosthetic components.

This document is a 510(k) summary for a dental implant system (ThreadLoc Dental Implant System). It serves to demonstrate substantial equivalence to a predicate device. The information provided is not relevant for characterizing device performance based on acceptance criteria from a clinical or diagnostic study for an AI-powered device.

Here's why and what information is missing based on your request:

• Device Type: This is a physical medical device (dental implant), not an AI-powered diagnostic or assistive technology. The acceptance criteria and performance metrics you're asking about (e.g., sensitivity, specificity, AUC, human reader improvement with AI) are specific to AI/software as a medical device (SaMD) used for analysis, diagnosis, or prediction.
• Study Type: A 510(k) summary primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, often through technological characteristics and intended use, rather than presenting clinical trial data that establishes performance against specific acceptance criteria in the way an AI/SaMD device would.
• Data Provided: The document details changes to the physical implant (self-tapping capabilities, surface textures) and states the intended use is identical to the predicate. It does not contain any performance metrics for diagnostic accuracy, classification, or human reader improvement.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, performance metrics, sample sizes, ground truth, or MRMC studies because the provided document does not contain this type of information for an AI/SaMD.

To answer your request for an AI-powered device, the input document would need to describe a study evaluating the diagnostic or assistive performance of an AI algorithm, including details like:

• Clinical study design and outcomes.
• Performance metrics (e.g., sensitivity, specificity, accuracy, F1-score, AUC).
• Pre-defined acceptance criteria for these metrics.
• Details about the test dataset (size, provenance, ground truth establishment, adjudication).
• Information on training data and methods.
• Results from standalone performance (if applicable) or human-in-the-loop studies (e.g., MRMC studies).

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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 free standing single tooth replacement.

These Class III dental implants are supplied sterile, ready for placement by a licensed dentist. There has been no significant change to the prosthetic components.

This 510(k) summary does not describe an AI/ML medical device, but rather a dental implant system (Spline X Endosseous Dental Implant System). Therefore, the specific information requested in your prompt (e.g., acceptance criteria for device performance studies, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) is largely not applicable or not provided in the context of this traditional medical device submission.

The document primarily focuses on establishing substantial equivalence to a predicate device (Calcitek's existing Spline Dental Implant System) by demonstrating similar intended use, description, and technological characteristics (design and materials). The "comparison analysis" section reinforces this by highlighting similarities in design, prostheses, and coating material.

Without further information from a different document describing an AI/ML device, I cannot fulfill the request as specified.

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