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For use in selected fully edentulous and partially edentulous arches

The additional components provided for by this 510(k) added to the fixtures, abutments and other components necessary to meet various clinical situations in partially and totally edentulous patients. All implants are root-form uncoated screws and are made from commercially pure titanium. The indications and uses for these additional components are not different from similar components of the predicate device. The application also provides for the use of the Single Tooth Implant System in multiple construction clinical situations.

This submission (K990304) is for additional components (abutments and fixtures) for an existing dental implant system, not a device that would typically have performance criteria measured by a clinical study with specific metrics like sensitivity, specificity, or accuracy. The FDA's review for this type of device focuses primarily on substantial equivalence to a predicate device, material safety, and mechanical integrity rather than diagnostic accuracy or clinical outcomes in the same way an AI/ML device would.

Therefore, the requested information regarding acceptance criteria, study details, expert review, MRMC studies, standalone performance, and ground truth for training and test sets is not applicable to this 510(k) submission.

This submission is a traditional 510(k) for an updated version of a previously approved device (K931767), comprising a list of components made of a known material (commercially pure titanium). The "acceptance criteria" in this context would revolve around demonstrating that the new components meet the same performance standards (e.g., mechanical strength, biocompatibility) as the predicate device and do not introduce new safety or effectiveness concerns. These kinds of evaluations are typically done through bench testing (e.g., fatigue testing, force retention, material characterization) rather than efficacy studies involving patient data and diagnostic performance metrics.

The documentation provided indicates that the "indications and uses for these additional components are not different from similar components of the predicate device." This suggests the primary "study" supporting the submission would be a demonstration of equivalence to the predicate, likely through design comparisons and perhaps limited bench testing for mechanical properties if the design significantly changed from the predicate.

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For use in selected fully edentulous and partially edentulous arches.

The following table describes the indication for use for each component listed as part of this 510(k) submission:

| Component | Part
Number | Indication for Use |
|-------------------------------|----------------|-------------------------------------------------------------------------------|
| Profile UniAbutment 4.5 | 22852 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile UniAbutment 5.5 ultra | 22855 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile UniAbutment 5.5 | 22856 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile UniAbutment 7.0 | 22860 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile BiAbutment 4.5 | 22782 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile BiAbutment 5.5 ultra | 22785 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile BiAbutment 5.5 | 22786 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile BiAbutment 7.0 | 22790 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile BiAbutment ST 4.5 | 22870 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile BiAbutment ST 5.5 | 22872 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile BiAbutment ST 7.0 | 22874 | Prepable component that is placed in fixture for cemented bridge construction |
| Abutment Screw ST, short | 22554 | Screw that is used to attach the Profile BiAbutment ST to the fixture |

The Prepable Abutment System is comprised of a selection of components for prosthetic and laboratory procedures for single-tooth and multiple tooth constructions. The additional components provided for by this 510(k) are added to the fixtures, abutments and other components necessary to meet various clinical situations in partially and totally edentulous patients. All implants are made from commercially pure titanium. The indications and uses for these additional components are not different from similar components of the predicate device.

This 510(k) summary (K974738) is for "Astra Tech Implants - Dental System Prepable Abutment System - ADDITIONAL COMPONENTS." This device appears to be an update or expansion of an existing dental implant system, specifically adding new abutment components.

The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) notification and the FDA's response letter indicating substantial equivalence to predicate devices. This type of submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than on new clinical performance studies with acceptance criteria, which are typically required for Novel devices or PMA submissions.

Therefore, I cannot fulfill the request to provide information about acceptance criteria and a study that proves the device meets those criteria because that information is not present in the provided text.

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For use in selected fully edentulous and partially edentulous arches.

The following table describes the indication for use for each component listed as part of this 510(k) submission:

| Component | Part
Number | Indication for Use |
|-----------------------------|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Replica 3.5 | 22398 | Prosthetic component which can be embedded into a stone
cast model which replicates the interior shape and exterior
chamber and diameter of a fixture |
| Replica 4.0 | 22399 | Prosthetic component which can be embedded into a stone
cast model which replicates the interior shape and exterior
chamber and diameter of a fixture |
| Replica ST 4.5 | 22509 | Prosthetic component which can be embedded into a stone
cast model which replicates the interior shape and exterior
chamber and diameter of a fixture |
| Fixture Transfer - Short | 22841 | Single unit reseating type impression coping for accurate
transfer of fixture location and angulation |
| Fixture Transfer - Long | 22842 | Single unit reseating type impression coping for accurate
transfer of fixture location and angulation |
| Fixture Transfer ST - Short | 22847 | Two piece pick-up type impression coping for accurate
transfer of fixture location and angulation |
| Fixture Transfer ST - Long | 22848 | Two piece pick-up type impression coping for accurate
transfer of fixture location and angulation |
| Fixture Transfer PU - Short | 22867 | Multi-piece pick-up type impression coping for accurate
transfer of fixture location and angulation |
| Fixture Transfer PU - Long | 22868 | Multi-piece pick-up type impression coping for accurate
transfer of fixture location and angulation |

The additional components provided for by this 510(k) are restorative components which will allow impression taking from the fixture level and fabrication of a stone cast with the fixture replicated in the correct position necessary to meet various clinical situations in partially and totally edentulous patients. The components are made of stainless steel. The indications and uses for these additional components are not different from similar components of the predicate device.

This 510(k) submission pertains to additional prosthetic and laboratory components for the Astra Tech Implants - Dental System, specifically fixture transfers and fixture replicas. The submission states that "The indications and uses for these additional components are not different from similar components of the predicate device." This is a key point, as it indicates that the device is being cleared based on substantial equivalence to a predicate device, rather than requiring extensive clinical trials to prove new performance criteria.

Therefore, the "acceptance criteria" for this submission are primarily focused on demonstrating that the new components perform identically or equivalently to the predicate devices and existing components of the Astra Tech Implants - Dental System. The study supporting this claim would be a verification study, likely laboratory-based, demonstrating dimensional accuracy, fit, and function.

However, the provided document does not contain a detailed study report with specific acceptance criteria and device performance results in the way one would expect for a more complex medical device requiring clinical efficacy or safety trials. The 510(k) summary focuses on the description of the device and its intended use, along with the predicate devices. This is typical for submissions relying heavily on substantial equivalence for simpler component additions.

Based on the provided information, I can deduce the following:

1. Table of Acceptance Criteria and Reported Device Performance:

Since a detailed study report is not provided, the "acceptance criteria" are implied by the nature of the device (prosthetic components for dental implants) and the substantial equivalence claim. The reported device performance is implicitly assumed to be equivalent to the predicate device as the basis for 510(k) clearance.

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

• Sample Size: Not explicitly stated. For a device like this, the "test set" would likely involve a small number of manufactured components tested for dimensional accuracy, fit, and potentially mechanical integrity in a laboratory setting. It would not be a "test set" in the sense of clinical patient data.
• Data Provenance: Not explicitly stated. Given the nature of a 510(k) for components, the tests would be performed by the manufacturer, Astra Tech Inc., likely in a laboratory setting at their facility (Lexington, MA). The data would be prospective to the clearance application.

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

• Number of Experts: Not explicitly stated. For a device relying on substantial equivalence and laboratory testing, "ground truth" would be established by engineering specifications, validated measurement techniques, and potentially conformity to ISO or ASTM standards. This would typically involve product designers, mechanical engineers, and quality control personnel.
• Qualifications: Likely engineers and quality assurance specialists with expertise in dental implant mechanics and manufacturing tolerances.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable in the context of this 510(k) and the type of device. Adjudication methods like "2+1" or "3+1" are relevant for clinical studies where human readers are making subjective assessments that need to be reconciled. For mechanical components, performance is typically measured against objective engineering specifications.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where different readers interpret cases. These dental implant components do not involve human interpretation of medical images or data in a diagnostic context.

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

• Standalone Performance: Not applicable. This device is a physical prosthetic component, not an algorithm or AI system.

7. The Type of Ground Truth Used:

• Ground Truth: Engineering specifications and established manufacturing tolerances for dental implant components. The "ground truth" for demonstrating substantial equivalence is the validated performance and design of the predicate device. This would include dimensional accuracy, material properties, and functional compatibility within the dental implant system.

8. The Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. This device is a physical product, not a machine learning algorithm that requires a "training set." The design and manufacturing processes are established through engineering principles, prior knowledge of dental implant systems, and experience with predicate devices.

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

• Ground Truth for Training Set: Not applicable, as there is no training set in the context of an algorithm. The design principles and manufacturing specifications were established through engineering design processes, adherence to relevant standards (e.g., ISO for medical devices, dental materials), and the proven performance history of the predicate device (Astra Tech Implants - Dental System, Steri-Oss Dental Implants). These would have been validated through mechanical testing, material analysis, and potentially in vitro simulations.

In summary, the 510(k) for these additional Astra Tech Dental Implant components is based on substantial equivalence to existing, legally marketed predicate devices. The "study" proving this would have been a set of internal engineering verification and validation tests demonstrating that the new components meet the same functional and dimensional requirements as the known predicate devices, thereby ensuring they perform as intended and are safe and effective for their indicated use. The document provided does not detail these specific tests, which is common for 510(k) summaries of such component additions.

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