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Straumann® RidgeFit Implants ∅ 2.4 mm are indicated for oral endosteal implantation in the fully edentulous mandible and/or maxilla for the stabilization of removable dentures. The implants can be placed with immediate function when primary stability is achieved for all implants or with conventional loading if primary stability is not achieved on all implants.

• Mandibular restorations require at least 4 Straumann® RidgeFit Implants ∅ 2.4 mm.
• Maxillary restorations require at least 6 Straumann® RidgeFit Implants ∅ 2.4 mm.

The Straumann® RidgeFit Implants are tapered implants manufactured from Roxolid® (Titanium-Zirconium alloy, TiZ) with a finished SLA surface. The implant neck is machined with an Optiloc® attachment portion, which is coated in Titanium Nitride (TiN) coating, resulting in a one-piece implant system acting as a retention feature for dentures. The Straumann® RidgeFit Implants have an external diameter of 2.4 mm and are available in implant lengths 10 mm, 12 mm and 14 mm with a gingival height of 2.8 mm and implant lengths 10 mm and 12 mm for gingival heights 3.8 mm and 4.8 mm. The Straumann® RidgeFit Implants ∅ 2.4 mm are suitable for oral endosteal implantation in the upper and lower jaw of fully edentulous patients. Conventional loading is recommended if primary stability cannot be achieved immediately on all implants.

The provided FDA 510(k) clearance letter and summary for the Straumann® RidgeFit Implants contains information regarding the device's technical specifications and non-clinical testing. However, it does not include any information about acceptance criteria or a study that uses a test set with ground truth established by experts to prove the device meets these criteria.

The document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical engineering tests (fatigue, insertion torque, biocompatibility, sterilization, packaging stability, MRI compatibility). These are performance tests on the device itself, not evaluations based on human-in-the-loop or standalone AI performance using a study with a test set and expert-established ground truth.

Therefore, I cannot provide the requested information for the following points as they are not present in the given text:

• A table of acceptance criteria and the reported device performance: The document implicitly states that passing the non-clinical tests demonstrates "substantial equivalence," but does not define explicit acceptance criteria or performance metrics directly from a comparative study with a test set and ground truth.
• Sample sized used for the test set and the data provenance: No such test set or study is described within the provided text.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no such test set or expert ground truth establishment is described.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No MRMC study is mentioned. The clearance is for an endosseous dental implant, which is a physical device, not an AI software intended for interpretation or diagnostic assistance that would typically undergo such studies.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

What the document does provide regarding testing:

The device's performance is proven through a summary of non-clinical testing, which includes:

1. Dynamic fatigue testing: Conducted according to FDA guidance (Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments) and ISO 14801 ("Dentistry — Implants — Dynamic loading test for endosseous dental implants"). This testing demonstrated the subject devices are equivalent to primary predicate and reference devices.
2. Insertion torque and Torque-to-failure test: Conducted and demonstrated substantial equivalence to the primary predicate device.
3. Biocompatibility evaluation: Referenced K211052 and K191895 for evaluation in accordance with ISO-10993-1:2018 and FDA guidance.
4. Sterilization validation: Referenced K211052 and K191895 for validation in accordance with ISO 11137-1:2006 (VDmax25 method).
5. Packaging stability and shelf-life study: Referenced K211052 and K191895 for studies in accordance with ISO 11607-1:2019, ASTM F1886, ASTM F1929, and ASTM F88.
6. MRI simulations: Conducted to demonstrate that the devices are MR Conditional.

These tests are primarily physical and chemical performance assessments of the implant materials and design, aimed at establishing safety and effectiveness, and equivalence to existing cleared devices, not at evaluating an AI's diagnostic performance against human experts.

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The Simpler Mini Implants (ID SM3002-4) and the Simpler HA Mini Implants (ID SM5002-4) are intended to provide long term intra-bony applications. They are designed for immediate loading when there is good primary stability and an appropriate occlusal load. They may also be used for temporary support for partial and fully edentulous restoration in the mandible and maxilla. They may be used for full or partial edentulism and are used as an option to provide a minimally invasive surgical intervention.

The HA coated Simpler Mini Implants (K 083886) are identical to the Simpler Mini Implants (K073645) except for the addition of the HA coating to the threaded area of the implants. Natural dentition is composed of a subgingival root and a supragingival crown. For both coated and uncoated mini implant designs tend to minic this structure and transitional implants are no exception. The implant base and the abutment are all in one piece. They are 2.5mm in diameter with a choice of 10, 13 or 15 mm in length for both the Simpler HA mini implants.

For partial and complete edentulism, a retaining a rubber ring acts like a socket to receive the ball on the top of the implant. A soft liner is placed into the patient's denture to adapt around the ball portion of the implant to provide retention to the denture. When seated, the denture rests on the gum tissue.

Based on the provided text, the document is a 510(k) summary for the Simpler Mini Implant and Simpler HA Mini Implant, indicating no specific acceptance criteria or a study proving that the device meets such criteria.

The primary purpose of this 510(k) submission is to demonstrate substantial equivalence to already legally marketed devices, not to prove specific performance metrics against pre-defined acceptance criteria through a dedicated study.

However, I can extract information related to the device and its intended use, as well as the regulatory decision based on substantial equivalence.

Here's an analysis of the provided text in relation to your request, with "N/A" where the information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document does not define specific performance metrics or acceptance criteria that the device had to meet (e.g., success rates, torque values, bone-to-implant contact percentages, etc.) nor does it present data from a study directly measuring these against such criteria. The 510(k) process for this device focused on demonstrating substantial equivalence to predicate devices, implying similar performance and safety through comparison rather than independent proof against novel performance standards.

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

• Sample Size: N/A (No specific test set or clinical study data presented)
• Data Provenance: N/A (No specific clinical study data presented. The submission relies on comparison to predicate devices and general knowledge of dental implants, not on a new study's data.)

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

• N/A (No specific test set or ground truth establishment process is described.)

4. Adjudication Method for the Test Set

• N/A (No specific test set or adjudication method described.)

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

• Was it done? No. The document does not mention any MRMC comparative effectiveness study, or any clinical study of human readers with or without AI assistance. This device is a physical dental implant, not an AI-assisted diagnostic tool.
• Effect size of human readers with AI vs. without AI assistance: N/A (Not applicable to a physical dental implant.)

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done

• N/A (Not applicable. This device is a physical dental implant, not an algorithm.)

7. The Type of Ground Truth Used

• N/A (No specific ground truth (expert consensus, pathology, outcomes data) is mentioned as being established for the purpose of validating this device in a study.)

8. The Sample Size for the Training Set

• N/A (No "training set" is mentioned as this is not an AI/algorithm device.)

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

• N/A (Not applicable, as there is no training set for this type of device.)

Summary of what the document does provide:

• Device Description: The Simpler HA Mini Implants (K 083886) are identical to the Simpler Mini Implants (K073645) except for the addition of an HA coating. They are 2.5mm in diameter with lengths of 10, 13, or 15 mm. They are designed for retention of dentures in partial and complete edentulism.
• Indications for Use: Long-term intra-bony applications, immediate loading (with good primary stability and appropriate occlusal load), and temporary support for partial and fully edentulous restorations in the mandible and maxilla. They are presented as a minimally invasive surgical intervention option.
• Predicate Devices: K073645 (Simpler Mini Implants), K974856 (Simpler Threaded Implants), K031106 (Imtec Sendax MDI and MDI Plus), Mini Drive-Lock TM Dental Implants ITI Dental Implants K894593 K894595, IMTEC Sendax MDIs K031106, Nobel Biocare Branemark Implants.
• Regulatory Decision: The FDA determined the device to be substantially equivalent to legally marketed predicate devices, allowing its market entry under general controls (Class II, product code DZE). The basis for this decision is primarily the similarity in design, materials, and intended use to existing devices, and the addition of HA coating is considered equivalent to the non-HA coated version already cleared. The letter corrects an earlier substantial equivalence letter, indicating a review process.

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