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The Tapered Screw-Vent®T Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.

The Tapered Screw-Vent® P Implants are designed for use in the maxilla or mandible for loading after a conventional healing period. Implants may be used to replace one or more missing teeth.

The Tapered Screw-Vent® T Implant is an endosseous dental implant. The implant is composed of titanium alloy. The implant section is designed for ease if implantation and with greater surface area for osseointegration. The implant section surface is treated to facilitate osseointegration. In addition, the implant section is tapered with triple-lead threads.

The Tapered Screw-Vent® P Implant is an endosseous dental implant. The implant is composed of titanium alloy and Cancellous-Structured Titanium (CSTi) coating. The implant section is designed for ease of implantation and with greater surface area for osseointegration. The CSTi coating is designed to allow for bone ingrowth. The implant section surface is treated to facilitate osseointegration. In addition, the implant section is tapered with triple-lead threads.

This medical device submission (K101880) is for dental implants and does not include any information about an AI-powered device or software. Therefore, the specific criteria requested for an AI device (like acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance) are not applicable to the provided document.

The document focuses on demonstrating substantial equivalence of the Tapered Screw-Vent® T Implant and Tapered Screw-Vent® P Implant to existing predicate devices based on material, design, manufacturing, and non-clinical testing.

Here's the relevant information that is present in the document:

1. Acceptance Criteria and Device Performance:

The document broadly states that "Functional laboratory testing performed in foreseeable operating conditions showed correct operation of the device per its intended use." However, it does not provide specific quantitative acceptance criteria or detailed device performance metrics in a table format as you would expect for an AI device. The general acceptance criteria are conformance to performance specifications and requirements outlined in the "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments."

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

Not applicable. No "test set" in the context of an AI device was used. The testing performed was "non-clinical bench testing" to assess functional operation.

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

Not applicable. No expert-established ground truth for a "test set" was involved.

4. Adjudication method for the test set:

Not applicable.

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. No clinical studies, let alone MRMC studies, were conducted.

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

Not applicable.

7. The type of ground truth used:

Not applicable in the context of an AI device. For this device, the "ground truth" for demonstrating safety and effectiveness relied on:

• Predicate Device Equivalence: The primary "ground truth" is that the new devices are substantially equivalent to legally marketed predicate devices with established safety and effectiveness.
• Bench Testing: Functional laboratory testing results served as evidence of device performance under foreseeable operating conditions.
• Regulatory Guidance: Conformance to the "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments" provided the framework for acceptable performance and safety.

8. The sample size for the training set:

Not applicable. No "training set" for an AI algorithm was used.

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

Not applicable.

In summary, this document is a 510(k) Pre-Market Notification for traditional dental implants, not an AI software/device. Therefore, the questions related to AI-specific evaluation criteria cannot be answered from the provided text.

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The Tapered Screw-Vent® T Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.

The Tapered Screw-Vent® T Implant is an endosseous dental implant. The implant is composed of titanium alloy. The implant section is designed for ease of implantation and with greater surface area for osseointegration. The implant section surface is treated to facilitate osseointegration. In addition, the implant section is tapered with triplelead threads.

This document is a 510(k) Pre-Market Notification for a dental implant, the Tapered Screw-Vent® T Implant. It establishes substantial equivalence to existing predicate devices. However, this document does not describe any study that proves the device meets specific performance acceptance criteria based on metrics like accuracy, sensitivity, or specificity.

Instead, the document focuses on:

• Device Description: Describing the Tapered Screw-Vent® T Implant's materials (titanium alloy), design features (tapered with triple-lead threads, treated surface for osseointegration), and size offerings.
• Indications for Use: Stating that the implants are for use in the maxilla or mandible, for immediate or conventional loading, and to replace one or more missing teeth.
• Predicate Device Comparison: Highlighting that the new device is "the same as the predicate Tapered Screw-Vent® Implant in the implant/abutment connection, implant body design, materials, and manufacturing." The only modifications mentioned are the addition of "MTX texture to the top of the implant and add small grooves on the implant collar similar to the predicate NobelReplace Tapered implant."
• Substantial Equivalence Determination: The FDA's letter explicitly states that they have "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."

Therefore, based on the provided text, I cannot provide the requested information regarding acceptance criteria and studies proving performance because:

1. No Acceptance Criteria or Reported Device Performance Table: The document does not define specific performance metrics (e.g., success rates, complication rates, osseointegration percentages) or acceptance criteria for those metrics. It assumes performance based on substantial equivalence to predicate devices.
2. No Performance Study Described: There is no mention of a study (clinical or otherwise) designed to measure the Tapered Screw-Vent® T Implant's performance against specific endpoints. The FDA's 510(k) clearance process for this type of device often relies on demonstrating substantial equivalence to already cleared devices rather than requiring new clinical performance studies unless the device raises new questions of safety or effectiveness.

In summary, the provided text does not contain the information required to populate the fields of your request. This 510(k) submission relies on substantial equivalence, not a de novo study demonstrating meeting specific performance criteria.

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