(79 days)
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.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Design features similar to predicate devices (GingiHue Posts) | The PreFormance Post is "shaped similar to the currently marketed GingiHue Post." The PreFormance Posts are "identical in terms of size, biocompatibility, performance characteristics and basic design" to the proposed and currently marketed devices (GingiHue Posts). Key difference noted: PreFormance Post will be made of PEEK with a titanium insert. |
| Material composition meets biocompatibility and functional requirements | Made of PEEK with a titanium insert. (PEEK and titanium are common biomaterials in dentistry, implying biocompatibility and strength). The document states, "identical in terms of... biocompatibility." |
| Conforms to FDA's Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments | "Laboratory testing was conducted to determine device functionality and conformance to design input requirements, as well as FDA's Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments." |
| Risk Analysis conducted in accordance with ISO 14971 | "Risk Analysis was conducted in accordance with ISO 14971." |
| Functionality equivalent to predicate devices | "Laboratory testing was conducted to determine device functionality..." The PreFormance Posts are "equivalent to the GingiHue Conclusion Posts which provide similar functionality." |
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).
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)