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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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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, K962106, is a 510(k) summary for a dental implant system. It primarily describes a modification to an existing device and compares it to its predicate device. This type of regulatory submission (510(k)) for a dental implant system, especially from 1996, typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a controlled clinical study with acceptance criteria and detailed device performance metrics in the way modern AI/software as a medical device (SaMD) clearances do.

Therefore, the requested information pertaining to acceptance criteria and a study proving the device meets them (especially items 1-7, and 9 for a test set) is largely not applicable in the context of this specific 510(k) document. Dental implants are physical devices, and their performance is usually assessed through bench testing, material characterization, and in some cases, limited clinical data focusing on osseointegration and success rates, often compared to historical data or the predicate device.

However, I can extract and infer information relevant to the nature of this submission. Here's a breakdown based on the provided text, highlighting where information is not available or relevant to a SaMD-style submission:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not contain explicit acceptance criteria or a "reported device performance" table in the typical sense for a clinical study comparing performance metrics. 510(k) submissions for physical devices like dental implants in this era focus on demonstrating substantial equivalence to a predicate device based on intended use, technological characteristics, and materials.

The "performance" implied here is that the modified device performs as well as or similarly to the predicate device, specifically regarding its ability to function as a dental implant. The key "performance" aspect mentioned is the addition of "self-tapping capabilities" to the apical portion, which is a design feature rather than a measurable clinical outcome in this context.

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

Not applicable in the context of this 510(k) summary. This document does not mention a "test set" for performance evaluation in the way a clinical study for software or diagnostics would. Instead, it describes a modification to an existing device. Any testing performed would likely have been bench testing or material characterization, for which "test sets" or "data provenance" as defined for clinical studies are not relevant.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. There is no "ground truth" establishment by experts mentioned for a test set in this 510(k) summary.

4. Adjudication Method:

Not applicable. No adjudication method is mentioned, as there is no test set or expert evaluation described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This is a physical dental implant, not an AI or software product. Therefore, an MRMC study is not relevant or mentioned.

6. Standalone (Algorithm Only) Performance:

Not applicable. This is a physical dental implant, not an algorithm.

7. Type of Ground Truth Used:

Not applicable. There is no "ground truth" mentioned or established in this 510(k) summary. The demonstration of safety and effectiveness for dental implants typically relies on biocompatibility, mechanical testing, and clinical history of similar devices.

8. Sample Size for the Training Set:

Not applicable. This relates to AI/machine learning. This 510(k) summary is for a physical dental implant and does not involve a training set.

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

Not applicable. As above, no training set or ground truth in this context.

Summary of Device and Regulatory Focus (based on the provided text):

• Device: Spline Dental Implant System (Class III dental implants).
• Modification: Addition of "self-tapping capabilities" to the apical portion of the implant body.
• Key Aspect of Submission: Demonstrating "substantial equivalence" to the predicate device (Calcitek's existing Spline Dental Implant System).
• Basis for Equivalence:
  • Identical intended use.
  • No significant change to prosthetic components.
  • No change to materials.
  • Overall design of implants and prosthetic components are identical to predicate devices (except for the self-tapping feature).
  • Implants are supplied sterile.

This 510(k) document is a classic example of a "traditional" 510(k) submission for a physical medical device seeking to demonstrate that a modified version is as safe and effective as a previously cleared device. It does not contain the types of clinical study data, performance metrics, or "acceptance criteria" formatted as you would find for a modern AI/SaMD product.

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