Search Results

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.

Ask a specific question about this device

ITI One Part octa implants are intended for surgical placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients.

ITI one-part octa implants are for use in edentulous jaws in conjunction with barborne superstructure on 4 implants. If ITI one-part implants are splinted with a bar, they can be loaded immediately.

ITI one-part implants can also be used for indications requiring endosseous implants for functional rehabilitation in regions where an ITI two part implant and an Octa abutment would normally be used.

The All-in-O re implants are screw type dental implants made from CP titanium. Grade 4. They are available in various insertion lengths. The implants have the same rough surface as cleared ITI endosseous implants. The transmucosal part has a smooth machined surface to allow for the attachment of epithelial tissue.

The provided document is a 510(k) summary for a dental implant system (ITI Dental Implant System®) seeking substantial equivalence to existing devices. It does not contain information on the acceptance criteria, study details, or performance of an AI/ML powered device. The document is primarily focused on the device description, intended use, and a comparison to predicate devices, which are all traditional medical devices and not AI-based.

Therefore, I cannot extract the requested information from the given text as it pertains to AI/ML device performance.

Ask a specific question about this device

The device is intended for surgical placement in maxillary and/ or mandibular arch to support crowns, bridges, overdentures in edentulous or partially edentulous patients. As with the predicate devices, the subject device is indicated for use in areas with available bone, including posterior regions with sufficient transverse bone and limited vertical bone height.

The ITI Wide Diameter Implant is a one-stage root-form design made of commercially pure titanium Grade 4 conforming to ASTM Standard Specification F67. It differs from the previously cleared 11 4.1 mm Solid Screw Implant (K894595, K920769) only in the diameter. The portion of the implant intended to be implanted into bone has an anchorage surface of a titanium plasma-sprayed coating 20 - 30 um thick. The neck of the implant, intended to remain above the crest of the bone upon implantation, is a smooth machined surface to allow for the attachment of epithelial tissue. It is 2.8 mm in height and tapers to 4.8 mm in diameter at the coronal end to permit all standard 171 The abutment mates with a tapered internal cone of the abutments to be used. implant; at its apex is a threaded region into which the matching thread of the The implant shoulder, which forms a mating surface for abutment is screwed. prosthetic components, is machined with a 45° chamter to maximize prosthesis The diameter at the coronal end, the internal taper, and thread for stability. attachment of the abutment and the 45° chamfer are identical to those of the 177 4.1 mm Solid Screw Implant.

For the junction between the primary part (the implant) and the secondary part (the abutment), a cone-screw construction is used, which helps ensure an accurate marginal tit within the implant, reducing risk of loosening or rotation of the abutment. All ITI abutments have a tapered cone-to-screw base which screws into the coronal portion of the implant and creates a mechanically locking triction fit (similar to Morse taper, a principle that has been used in machine shops for many years).

The external shape of the ITI Wide Diameter Implant consists of a solid body of 4.95 mm diameter with an external spiral screw having a major diameter of 5.6 mm. The principal teature of the thread form is the fact that the compressive (flank) songce of the thread is oriented at 75° to the implant axis, directing compressive forces into gre bone, rather than parallel to the implant axis. The thread pitch and thread form are identical to those of the ITI 4.1 mm Solid Screw Implant. The most apical 2 mm of the implant and the first 1.5 mm below the crest of the bone have no threads. The apex has a near-hemispherical shape. The implant is manufactured in sink depths (the depth intended to be implanted into bone, excluding the 2.8 mm neck) of 8 and 10 mm.

Accessories: The surgical technique intended for the implant includes initial use of the same IT 2.2 mm and 2.8 mm pilot drills as are used for other ITI solid screw implants, followed by The use of the standard ITI 3.5 mm twist drills of 4.2 mm and 5.0 mm and 5.0 mm diameter, included in this submission, are then used, followed by a thread tap. All IT twist drills and thread taps are made from martensitic stainless steel (DIN 1.4] 12, equivalent to AISI 440B) and include grooves to show the correct placement depth for each implant length. The depth gauge provided for use with the ITI Wide Diameter is made from austenitic stainless steel (DIN 1.4305, equivalent to AISI 303).

The provided document is a 510(k) Summary for the ITI Wide Diameter Implant. While it details the device's characteristics and compares it to predicate devices, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device.

The study described is a nonclinical test comparing the strength of the ITI Wide Diameter Implant to a predicate device. This is a performance test for a medical device (an implant), not a study for an AI/ML device.

Therefore, I cannot provide the requested information for an AI/ML device based on this document.

However, I can extract information about the nonclinical test described:

1. Table of Acceptance Criteria and Reported Device Performance (Nonclinical Study)

Explanation of Implied Acceptance Criteria: The stated objective of the nonclinical test was to demonstrate the substantial equivalence of the new device by showing it performs at least as well as, and in this case, better than, a predicate device specifically in terms of strength and bending. The acceptance criteria are implicitly defined as "exceeding" or being "substantially stronger than" the predicate device's performance.

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

• Sample Size: Not explicitly stated. The text says "Implants were imbedded..." and "Force vs. deflection curves were recorded for each test." It does not specify the number of implants or tests performed.
• Data Provenance: Not specified, but given it's a nonclinical test performed by the applicant (Straumann USA), it's likely internal lab testing.

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 strength test, not an AI/ML study requiring expert ground truth for image interpretation or diagnosis.

4. Adjudication method for the test set:

• Not applicable. This was a physical strength test.

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 was a physical strength test, not an AI/ML study.

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

• Not applicable. This was a physical strength test, not an AI/ML study.

7. The type of ground truth used:

• Ground Truth: Physical measurement of failure loads and observation of failure modes during mechanical testing.

8. The sample size for the training set:

• Not applicable. This was a nonclinical performance test, not an AI/ML study involving training data.

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

• Not applicable. This was a nonclinical performance test, not an AI/ML study involving training data.

Ask a specific question about this device