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Thommen SPI® VARIOmulti Angled Abutments are intended to be used in conjunction with SPI® System dental implants in the maxillary and/or mandibular arch to provide support for splinted crowns, bridges or overdentures.

SPI® VARIOmulti Angled Abutments are dental implant abutments for use with the SPI® Dental Implant System. They have an internal connection to the implant and are used for multi-unit, screw-retained, prefabricated restorations. VARIOmulti Angled Abutments are made of titanium and are available in diameters from 3.5 to 4.5 mm with an angle of 30° to the implant. The system includes dedicated prosthetic components including protective and temporary caps. SPI® VARIOmulti Angled Abutments are compatible with the Nobel Biocare Multi-unit Abutment System.

The provided text is for a 510(k) premarket notification for a dental implant abutment (SPI® VARIOmulti Angled Abutment). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable to this document. The focus here is on performance testing to show equivalence to a predicate device, not on a clinical trial with a defined acceptance threshold for performance metrics like sensitivity, specificity, etc.

Here's a breakdown of what can be extracted and what information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified. The document only states "Fatigue testing was performed." It doesn't mention the number of units tested.
• Data Provenance: Not specified. The testing was performed according to an international standard (ISO 14801), but the location of the testing facility or the origin of any "data" beyond the test results is not mentioned. It is not a clinical study, so concepts like "prospective" or "retrospective" are not relevant here.

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

Not applicable. This was a physical performance test for fatigue, not a study requiring expert clinical assessment or ground truth establishment in a diagnostic context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This was a physical performance test for fatigue, not a study requiring adjudication of expert opinions.

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 document describes a dental implant abutment, not an AI-powered diagnostic device. An MRMC study is not relevant here.

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

Not applicable. This is a medical device (dental abutment), not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. For the fatigue testing, the "ground truth" would be the engineering standard (ISO 14801) and the performance of the predicate device. There is no biological or outcome-based ground truth in this context.

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 AI.

9. How the ground truth for the training set was established

Not applicable. This device does not involve a "training set" or "ground truth" in the context of machine learning or AI.

Summary specific to this document:

The provided 510(k) summary focuses on demonstrating substantial equivalence of the new SPI® VARIOmulti Angled Abutment to previously cleared predicate devices (K090153 and K072856). The primary method used to support this claim, beyond shared materials and design, was fatigue testing according to ISO 14801. The acceptance criterion for this testing was that the device should have "sufficient resistance to fatigue and performed comparably to the predicate device." The study stated that this criterion was met. No other formal studies with clinical acceptance criteria, sample sizes, or ground truth establishment (as would be seen in diagnostic device submissions) are presented in this document.

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Thommen SPI® VARIOmulti Angled Abutments are intended to be used in conjunction with SP1® System dental implants in the maxillary and/or mandibular arch to provide support for splinted crowns, bridges or overdentures.

SPI® VARIOmulti Angled Abutments are dental implant abutments for use with the SP10 Dental Implant System. They have an internal connection to the implant and an external hex prosthetic attachment, and are used for multi-unit, screw-retained, prefabricated restorations. The system includes dedicated prosthetic components.

The provided text is a 510(k) summary for a dental implant abutment (SPI® VARIOmulti Angled Abutment). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting entirely new clinical data or performance studies against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, specific device performance, sample sizes, expert involvement, and ground truth establishment will not be present in this document.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device itself. The primary "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to a predicate device.
• Reported Device Performance: No specific quantitative performance data is provided. The document states that the device is "substantially equivalent in indications and design principles to predicate devices."

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

• Sample Size: Not applicable/not provided. This document doesn't describe a performance test set in the traditional sense with a specific sample size of units tested against acceptance criteria. The equivalence demonstration is likely based on design comparisons, materials testing, and adherence to relevant standards, not a clinical performance study with a "test set" of patients or devices.
• Data Provenance: Not applicable. No specific experimental data from a "test set" of patients or devices is referenced.

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

• Number of Experts: Not applicable/not provided. Ground truth establishment is not relevant in this 510(k) summary as it does not rely on a clinical "test set" requiring expert evaluation.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable/not provided. This is not a clinical study requiring adjudication of results.

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:

• MRMC Study: No. This device is a dental implant abutment, not an AI-assisted diagnostic tool.

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

• Standalone Study: No. This device is a physical medical device, not an algorithm.

7. The type of ground truth used:

• Type of Ground Truth: Not applicable. There is no specific "ground truth" referenced for performance testing in this document. Substantial equivalence in a 510(k) relies on comparison to a legally marketed predicate device's established safety and effectiveness.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable/not provided. This is not an AI/machine learning device, so there is no concept of a "training set."

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

• Ground Truth Establishment for Training Set: Not applicable.

Summary of the Study (Equivalence Demonstration):

The "study" described in this 510(k) summary is not a traditional clinical trial or performance study with acceptance criteria and specific performance metrics. Instead, it is a demonstration of substantial equivalence conducted as part of the FDA 510(k) premarket notification process.

• Methodology: Thommen Medical AG "demonstrated that... the SPI® VARIOmulti Angled Abutments are substantially equivalent in indications and design principles to predicate devices that have been determined by FDA to be substantially equivalent to preamendment devices." This involves comparing the new device's indications for use, technological characteristics (design, materials, intended function, attachment mechanism), and performance (often non-clinical testing like mechanical strength, fatigue, biocompatibility, but no specific data is included in this summary) to those of a legally marketed predicate device.
• Proof of Meeting Acceptance Criteria (Substantial Equivalence): The FDA's letter (K090153) explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially-equivalent... You may, therefore, market the device..." This letter serves as the FDA's "acceptance" that the device meets the regulatory requirements for market clearance based on substantial equivalence.

In essence, for a 510(k) submission, the "acceptance criteria" relate to regulatory compliance and the ability to demonstrate that the new device is as safe and effective as a legally marketed predicate device, rather than achieving specific quantitative performance thresholds from a de novo study.

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