(88 days)
The Lifecore PrimaConnex® CAD/CAM Abutment System is intended for use as an accessory to a Lifecore PrimaConnex endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prostheses in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. The copings are intended for use as a core structure for a prosthetic restoration in partially or fully edentulous mandibles and maxillae in the construction of single-unit cement retained restorations on Lifecore PrimaConnex CAD/CAM Abutments.
The PrimaConnex CAD/CAM Abutments and abutment-specific ceramic copings are placed onto the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations.
The abutments and copings are milled using computer-assisted technology that enables the creation of final abutments that are manufactured with specific geometry to meet individual anatomic variations in patient tooth and jaw structure.
This document describes a 510(k) premarket notification for the "Lifecore PrimaConnex® CAD/CAM Abutment System." This is a dental device, specifically an abutment and coping system for endosseous dental implants.
The information provided is primarily focused on establishing substantial equivalence to predicate devices, which is a regulatory pathway for medical devices in the US. It does not describe a study involving "acceptance criteria" in the sense of a diagnostic or AI-driven device's performance metrics (e.g., sensitivity, specificity, AUC). Instead, the "study" referred to is a physical performance test for a mechanical device.
Here's an analysis based on the provided text, addressing your questions to the extent possible for this type of device submission:
1. Table of Acceptance Criteria and Reported Device Performance
For this medical device (dental abutment system), the "acceptance criteria" are related to mechanical strength and fatigue resistance, rather than diagnostic accuracy. The study mentioned is "Static and Dynamic Fatigue Testing of Endosseous Dental Implant Systems."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Strength/Fatigue | Demonstrated to withstand static and dynamic fatigue testing as described in Attachment B. Specific quantitative results (e.g., force applied, number of cycles) are not provided in this summary documento. |
| Material Composition | Substantially equivalent to predicate devices (implied: meets established biocompatibility and material strength standards). |
| Intended Use | Same as predicate devices. |
| Fundamental Scientific Technology | Same as predicate devices. |
| Principles of Operation | Same as predicate devices. |
| Basic Design | Same as predicate devices. |
Note: The submission states that the device is "substantially equivalent" to predicate devices, meaning it meets the same functional and safety requirements, which includes performance under mechanical stress. The detailed results of the static and dynamic fatigue testing would be in "Attachment B," which is not provided.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample size for the static and dynamic fatigue testing. For physical testing of medical devices, sample sizes are typically much smaller than for clinical studies (e.g., a few units per test condition).
- Data Provenance: The testing was conducted by or for the manufacturer, Lifecore Biomedical, Inc. The country of origin of the data is implicitly the United States (Chaska, MN). The study is prospective in the sense that the tests were designed and executed to evaluate the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This question is not applicable to this type of device submission. The "ground truth" for a mechanical device is established by engineering standards and test methods (e.g., ISO, ASTM standards for dental implant systems) for static and dynamic fatigue, not by expert medical opinion on a diagnosis. The testing itself measures physical properties against these established engineering benchmarks.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods (like 2+1, 3+1 consensus) are used for resolving disagreements among human readers or experts in diagnostic studies. For mechanical testing, the "adjudication" is based on whether the device passes the predefined physical test criteria.
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 question is not applicable. This is a physical medical device (dental abutment), not an AI or diagnostic software device. Therefore, no MRMC study or AI-assistance comparison was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. This is not an algorithm or AI-driven device.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on engineering standards and established physical test methods for dental implant systems, specifically related to static and dynamic fatigue strength. These standards define the acceptable performance limits for such devices.
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" in the context of a physical medical device like a dental abutment. Training sets are relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set was Established
This question is not applicable. As there is no training set for this type of device.
Summary for K072241 (Lifecore PrimaConnex® CAD/CAM Abutment System):
This 510(k) submission successfully demonstrated substantial equivalence to predicate devices for a dental abutment system. The "study" referenced is focused on mechanical performance testing (static and dynamic fatigue) rather than clinical diagnostic accuracy or AI performance. The acceptance criteria and performance are based on engineering standards and physical test results, confirming the device's mechanical integrity and safety for its intended use, rather than a statistical evaluation of diagnostic accuracy.
§ 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.)