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The SPI 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.

It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

SPI Dental Implant System is an internal hex implant system which comes in 3.3, 3.7, 4.2, 5.0, and 6.0 diameter. The implants come in lengths of 8, 10, 11.5, 13 and 16. Both straight and angled abutments are available.

The implant is a conical shape one with a grit blasted and acid etched surface. Standard abutments, standard narrow abutments, standard shoulder abutments, standard wide shoulder abutments, multiunit abutments, ball attachments, healing caps and standard 15° and 25° abutments are included in the system.

This is an FDA 510(k) summary for a medical device (SPI Dental Implant System), not a study report for an AI/ML powered device. As such, it does not contain the information requested in your prompt regarding acceptance criteria and a study that proves the device meets those criteria, specifically concerning AI/ML performance.

The document describes standard engineering and biocompatibility testing for a dental implant, confirming its substantial equivalence to a predicate device. It includes:

• Testing Summary:
  • Dynamic fatigue testing according to ISO 14801
  • Surface analysis (SEM and EDS)
  • Sterilization according to ISO 11137-1 and 11137-2 (implants), ISO 17665-1 and ISO 17665-2 (abutments)
  • Package integrity testing according to ASTM F1929-12
  • Accelerated aging according to ASTM F1980-07
  • Material compliance with ASTM F136
  • Biocompatibility (cytotoxicity) according to ISO 10993-5
  • Endotoxin testing according to USP 161

These tests are designed to demonstrate the physical, chemical, and biological safety and performance of the dental implant itself, not the performance of an AI/ML algorithm.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies because the provided document does not pertain to an AI/ML device.

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SPI® Dental Implant, ELEMENT is for one-stage or two-stage surgical procedures. SPI Dental Implant, ELEMENT is intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used in immediately loaded cases.

Contraindications for the use of SPI ELEMENT implant Ø 3.5 mm: These implants are not suitable for applications in areas where pronounced rotation and translation movements occur, causing the implant to be subjected to large bending movements.

• Restoration of posterior teeth in the upper and lower jaw .
• Single-tooth restoration of canines and central incisors in the upper jaw .
• Any application involving retentive anchors .

The design of the Thommen Medical AG SPI® Dental Implant System implants has been modified to include new sizes and corresponding abutments that will be marketed as the SPI® Dental Implant, ELEMENT. All features other than these implant sizes remain the same as the currently marketed SP1® ELEMENT implants. Other components of the SP10 Dental Implant System have not been modified, are suitable for use with the modified implants, and will be sold under the SPI Dental Implant System name.

I am sorry, but the provided text describes a 510(k) summary for a dental implant device (SPI® Dental Implant, ELEMENT) and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is primarily focused on demonstrating substantial equivalence to predicate devices for regulatory approval, rather than detailing performance studies with specific statistical metrics.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study details.
6. Standalone performance study details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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SPI® Dental Implant, INICELL® is for one-stage or two-stage surgical procedures. SPI Dental Implant, INICELL is intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used in immediately loaded cases.

Contraindications for the use of SPI ELEMENT INICELL implant Ø 3.5 mm and SPI CONTACT INICELL implant Ø 3.5 mm:

These implants are not suitable for applications in areas where pronounced rotation and translation movements occur, causing the implant to be subjected to large bending movements.

• Restoration of posterior teeth in the upper and lower jaw
• Single-tooth restoration of canines and central incisors in the upper jaw
• Any application involving retentive anchors

The design of the Thommen Medical AG endosseous dental implants has been modified to include a new surface treatment that will be marketed as the SP1® Dental Implant, INICELL® All features other than this surface treatment of the implants remain the same as the TST Surface implants. Other components of the SP1® Dental Implant System have not been modified, are suitable for use with the modified implants, and will be sold under the SPI Dental Implant System name.

The provided 510(k) summary for the Thommen Medical AG SPI® Dental Implant, INICELL® does not contain information related to acceptance criteria, device performance, or any studies proving the device meets specific acceptance criteria.

Instead, the document focuses on establishing substantial equivalence to previously marketed predicate devices based on similarities in intended use, operating principle, basic design, materials, packaging, and sterilization processes.

Therefore, I cannot provide the requested information in the format specified. The document primarily functions as a regulatory submission demonstrating equivalence, not as a report on a clinical or performance study with defined acceptance criteria and statistical outcomes.

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The Thommen SPI® Dental Implant System, TST Surface, is intended to be surgically placed, either immediately or delayed, in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. SPI® Dental Implants can be loaded immediately if they are used for crowns, bridges or overdentures on at least four implants in the mandibular arch or six implants in the maxillary arch.

Contraindications for the use of SPI® CONTACT implant ø 3.5 mm and SPI® ELEMENT implant ø 3.5 mm:
These implants are not suitable for applications in areas where pronounced rotation and/or bending movements are expected to subject the implant to large bending movements.

• Restoration of posterior teeth in the upper or lower jaw -
• Single-tooth restoration of canines and central incisors in the upper jaw -
• Any application involving retentive anchors -

The Thommen SPI® Dental Implant System with TST Surface (the modified design) is a self tapping, root form, endosseous dental implant made of commercially pure grade titanium. The implant surface is smooth machined on the transgingival portion and treated with the TST implant surface process, in the area intended to contact bone. The modified TST Surface is available on all implants in the SPI® Dental Implant System. The system is constructed of materials that have a long clinical history of proven acceptance and performance.

This 510(k) summary describes a device modification to an existing dental implant system. The core of the submission focuses on demonstrating substantial equivalence to a predicate device, particularly concerning a new surface treatment (TST Surface). As such, a traditional "study" proving acceptance criteria with performance metrics, ground truth, and statistical analysis as one might find for an AI/ML diagnostic device is not applicable here.

Instead, the submission relies on the established safety and effectiveness of the predicate device and demonstrates that the modified device's characteristics (intended use, operating principle, basic design, materials, packaging, sterilization) are substantially equivalent.

Therefore, many of the requested categories (2-9) do not have direct answers in this document because they pertain to a different type of device evaluation.

However, I can extract the closest equivalent information for the acceptance criteria and implied "performance."

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" here are inferred from the requirements for demonstrating substantial equivalence for a device modification.

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

Not applicable. This is not a study assessing device performance on a clinical or imaging dataset. The "test" is the demonstration of substantial equivalence through comparison of device characteristics and compliance with standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth was established by experts in this context.

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

Not applicable. No adjudication of a test set occurred.

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/ML device, and no MRMC study was conducted.

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

Not applicable. This is not an AI/ML algorithm.

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

Not applicable. The "ground truth" for this submission is the established safety and effectiveness of the predicate device, against which the modified device's characteristics are compared for substantial equivalence.

8. The sample size for the training set

Not applicable. This device does not involve a training set.

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

Not applicable. This device does not involve a training set.

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

Thommen SP1® Dental Implant Abutments are endosseous dental implant abutments made of commercially pure grade titanium and intended for cemented restorations. They may be used for cemented single crowns or bridges.

This document is a 510(k) premarket notification for a medical device, specifically dental implant abutments. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study proving performance against acceptance criteria.

Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is not available in the provided text.

The document primarily provides administrative information, device classification, predicate device information, intended use, and a statement of equivalence to marketed products.

Here's a breakdown of why each requested point cannot be fulfilled based on the provided text:

• 1. A table of acceptance criteria and the reported device performance: This document does not establish new performance criteria or report performance data. It relies on the equivalence to devices that would have already met such criteria.
• 2. Sample sized used for the test set and the data provenance: No new performance study or test set is described.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment is not relevant in an equivalence submission of this type.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no new test set is described.
• 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: This is a physical medical device (dental abutment), not an AI-powered diagnostic or assistive tool. MRMC studies are completely irrelevant.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable as this is a physical medical device, not an algorithm.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
• 8. The sample size for the training set: Not applicable as this is not a machine learning/AI device.
• 9. How the ground truth for the training set was established: Not applicable.

Summary from the document:

This document is a 510(k) submission for Thommen SPI® Dental Implant Abutments. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices: the HA-Ti Dental Implant System (K901927) and SPI Easy Dental Implant Abutment (K023645).

The basis for equivalence is stated as:

• Same intended use
• Same operating principle
• Same basic design
• Same materials (commercially pure grade titanium)
• Same packaging materials and processes

The device is intended for use in conjunction with SPI System dental implants to support crowns, bridges, or overdentures in the maxillary and/or mandibular arch. No new performance studies or data are presented to establish acceptance criteria for the device itself; rather, its compliance is inferred through its similarity to already approved devices.

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