Search Results

The Zimmer Dental Tapered Screw-Vent®T Implant, HA Coated and Zimmer Dental Tapered Screw-Vent® M Implant, HA Coated are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional or delayed 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 Zimmer Dental Tapered Screw-Vent® T Implant, HA Coated and Zimmer Dental Tapered Screw-Vent® M Implant, HA Coated are a self-tapping, screw type endosseous dental implant designed for bone level placement and can be used in a single or two stage protocol. The implant is composed of titanium alloy with hydroxylapatite (HA) coating, and has a tapered body with an external triple lead thread design. Identical to predicate #1, the new device has the same implant to abutment internal hex friction-fit connection. The new device will have coronal microgrooves that extend to the collar within 0.64mm of the top of the implant identical to predicate #2.

The new implant will be offered in two surface finish configurations at the coronal end: full MTX texturing to the top of the implant and partial MTX texturing to 0.5mm from the top of the implant leaving a machined collar. Both coronal configurations are identical to the currently marketed predicate #2 device (K101977, K111889).

The Zimmer Dental Tapered Screw-Vent® T Implant, HA Coated and Zimmer Dental Tapered Screw-Vent® M Implant, HA Coated family is composed of tapered implants with a choice of diameters and lengths. Both implant configurations, machined and fully textured collar, will be available in diameters of 3.7mm, 4.1mm, 4.7mm, and 6.0mm and in five lengths: 8, 10, 11.5, 13, and 16mm. The implant/abutment interface platform diameter will be offered in sizes of 3.5mm, 4.5mm, or 5.7mm depending on the outside implant thread diameter. The drilling sequences and drills that will be utilized to place the new device are pre-existing sequences and drills that are listed in the previous 510(k) K011028.

The provided document describes a pre-market notification (510(k)) for dental implants. It does not contain information about acceptance criteria or a study that proves a device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity, as would be typical for AI/Software as a Medical Device (SaMD).

Instead, this K133339 submission focuses on demonstrating substantial equivalence of a new dental implant (Zimmer Dental Tapered Screw-Vent® T Implant, HA Coated and Zimmer Dental Tapered Screw-Vent® M Implant, HA Coated) to existing predicate devices already on the market.

Therefore, many of the requested criteria in your prompt are not applicable to this type of medical device submission.

Here's an analysis based on the information available:

1. A table of acceptance criteria and the reported device performance

The document does not specify performance-based acceptance criteria (e.g., accuracy, sensitivity, etc.) because it is for a physical dental implant, not AI/SaMD. The "acceptance criteria" here are related to demonstrating substantial equivalence in terms of design, materials, indications for use, and mechanical performance compared to predicate devices.

The non-clinical testing sections hint at the performance criteria:

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

For the non-clinical mechanical testing (fatigue and compression), the document does not specify the sample size used. It only states that "Non-clinical test data was used to support the decision of substantial equivalence." Details like the number of implants tested or the specific test conditions (e.g., cycles for fatigue) are not provided in this summary.

Data provenance (e.g., country of origin, retrospective/prospective) is not applicable or provided for this type of mechanical device testing.

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

This is not applicable. The "ground truth" for mechanical testing of implants involves engineering specifications and performance standards, not expert clinical interpretation.

4. Adjudication method for the test set

Not applicable for mechanical testing.

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 a physical dental implant, not an AI/SaMD. 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 a physical dental implant, not an algorithm.

7. The type of ground truth used

For the mechanical tests (fatigue and compression), the "ground truth" would be established by specified engineering standards and regulatory guidance documents (e.g., FDA guidance Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments). For MRI safety, it relates to the FDA Guidance: Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment.

8. The sample size for the training set

Not applicable. There is no training set as this is not an AI/SaMD.

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

Not applicable. There is no training set as this is not an AI/SaMD.

In summary:

This 510(k) submission primarily relies on demonstrating substantial equivalence to already legally marketed devices through:

• Design comparison: Showing the new device has the same fundamental technology, materials, and intended use as predicate devices. The key differences (coronal microgrooves, surface finish configurations) were shown to be identical to different aspects of existing predicate devices.
• Non-clinical testing: Mechanical tests (fatigue and compression) and MRI compatibility were performed to ensure the new device meets established performance standards and is safe. The document states these tests "demonstrated improvements over the predicate device" in mechanical strength, suggesting the new design's modifications did not negatively impact performance and might have enhanced it.
• No clinical testing: The submission explicitly states, "No clinical testing was performed. Non-clinical testing was used to support the decision of substantial equivalence." This is common for devices demonstrating substantial equivalence where the risks are well understood and adequately addressed by non-clinical means.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device