Search Results

The PreFormance Abutment Posts and Temporary Cylinders are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support single and multiple unit prostheses in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non occlusal loading of single and multiple unit provisional restorations. The prostheses can be screw or cement retained to the abutment.

The PreFormance™ Abutment Posts and Temporary Cylinders will be made of the same material (PEEK) as the predicate PreFormance™ Posts and Temporary Cylinders. The posts will be available in both straight and 15° pre-angled configurations while the cylinders will be straight. The cylinders will have either a hexed or non-hexed connection. The hexed connection is for single unit prostheses while the non-hexed is for multi use. The posts and cylinders will connect to 3i's externally connected implants.

This 510(k) summary (K061969) is for a dental device, specifically "PreFormance™ Abutment Posts and Temporary Cylinders." It is a submission seeking clearance for a modified version of an already marketed device, primarily concerning the connection to the implant.

It's important to note that this document does not describe a study proving the device meets acceptance criteria. Instead, it's a 510(k) summary which details the device, its intended use, and argues for its substantial equivalence to existing predicate devices.

Therefore, many of the requested details about acceptance criteria, specific study designs, sample sizes, and expert adjudication are not present in this type of regulatory document. The FDA clearance for this device hinges on its similarity to already approved devices, not on a new, comprehensive performance study with acceptance criteria as typically understood for new major medical devices.

Here's an analysis based on the provided text, highlighting what is and isn't available:

Acceptance Criteria and Device Performance (Not directly available in this document)

This document does not specify quantitative acceptance criteria or report device performance against such criteria. The submission aims to demonstrate substantial equivalence to previously cleared devices based on similar materials, technological characteristics, and intended use, rather than presenting a de novo performance study with defined acceptance metrics.

1. Table of Acceptance Criteria and the Reported Device Performance

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

• Not applicable/Not provided. This 510(k) summary does not describe a performance study with a test set. The argument for substantial equivalence is based on design, materials, and intended use comparison.

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

• Not applicable/Not provided. No specific performance test set or ground truth establishment by experts is described in this regulatory submission.

4. Adjudication method for the test set

• Not applicable/Not provided. No adjudication method for a test set is described.

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/Not provided. This device is a physical dental implant accessory, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant here.

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

• Not applicable/Not provided. This is a physical medical device, not an algorithm.

7. The type of ground truth used

• Not applicable/Not provided. No performance study with a defined ground truth is presented in this document. The "ground truth" for regulatory clearance is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

• Not applicable/Not provided. This device is not an AI/ML algorithm that requires a training set.

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

• Not applicable/Not provided. As above, no training set or ground truth establishment for a training set is relevant for this device.

Summary of what the K061969 document does provide:

• Device Description: PreFormance™ Abutment Posts and Temporary Cylinders made of PEEK, available in straight and 15° pre-angled configurations (posts), and straight with hexed or non-hexed connections (cylinders). They connect to 3i's externally connected implants.
• Intended Use: Accessory to endosseous dental implants to support single and multiple unit prostheses in partially or fully edentulous patients, for up to 180 days during healing, for non-occlusal loading of provisional restorations.
• Technological Characteristics: Similar to predicate devices, with the sole modification being the connection to the implant (external hexed design for the modified device vs. internal connection for the predicate).
• Predicates: PreFormance™ Posts (K053170) and PreFormance™ Temporary Cylinders (K060291).
• Conclusion for Clearance: The device is "substantially equivalent" to the legally marketed predicate devices, based on similar materials, indications for use, and technological characteristics (with the noted connection modification). This "substantial equivalence" is the basis for its regulatory clearance, meaning it is deemed as safe and effective as the existing devices without requiring new extensive clinical trials to prove efficacy from scratch.

Ask a specific question about this device

The PreFormance Abutment Posts and Temporary Cylinders are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support single and multiple unit prostheses in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non occlusal loading of single and multiple unit provisional restorations. The prostheses can be screw or cement retained to the abutment.

The PreFormance Post will be shaped similar to the currently marketed GingiHue Post. However, the PreFormance Post will be made of PEEK with a titanium insert. The posts will be available in straight and 15° pre-angled configurations. The collar height on the PreFormance Post will be 4mm and 6mm and the post height will be 7mm.

This 510(k) Premarket Notification for the PreFormance™ Post from Implant Innovations, Inc. is for a dental abutment, which is a mechanical device. The information provided in the 510(k) summary focuses on demonstrating substantial equivalence to predicate devices through design characteristics and performance testing in a laboratory setting, rather than clinical study data involving human or AI performance.

Therefore, many of the typical elements of an acceptance criteria and study description related to AI or diagnostic device performance, such as sample size for test sets, expert ground truth, adjudication methods, MRMC studies, and standalone performance, are not applicable here.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format for performance metrics like sensitivity, specificity, or accuracy, as it pertains to a mechanical device. Instead, the acceptance criteria are implicit in demonstrating substantial equivalence to existing predicate devices (GingiHue Abutments and GingiHue Pre-Angled Abutments) and conformance to relevant standards.

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

This is not applicable. The "Performance Testing" described is laboratory testing of the mechanical device, not a study involving patient data or clinical samples. There is no mention of a "test set" in the context of diagnostic performance or AI evaluation.

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

This is not applicable. Ground truth as typically understood for diagnostic or AI studies (e.g., expert consensus on medical images) is not relevant for this type of mechanical device submission. The "ground truth" here is the engineering specifications, material properties, and functional performance measured against established standards.

4. Adjudication method for the test set

This is not applicable, as there is no "test set" in the context of human or AI assessment requiring adjudication.

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

This is not applicable. The device is a dental abutment, not an AI software or a diagnostic tool that involves human readers.

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

This is not applicable. The device is a physical dental abutment, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is based on:

• Engineering specifications and design input requirements: The device is rigorously designed to meet specific dimensions, material properties, and functional characteristics.
• Performance standards: Conformance to relevant national and international standards applicable to dental implants and abutments (e.g., FDA Class II Special Controls Guidance Document, ISO 14971 for risk management).
• Predicate device characteristics: The GingiHue Posts serve as a benchmark for "similar functionality" and "identical...performance characteristics."

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not an AI or machine learning device. The design, manufacturing, and testing processes for mechanical devices do not involve a training set in this context.

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

This is not applicable. (See #8).

Ask a specific question about this device