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Lifecore Biomedical Dental Implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.

Specific Intended Uses: The PrimaSolo One-Piece (3.5 – 5.0mm) Implant is a threaded one-piece implant with an integrated abutment designed for single-stage surgical procedure and cemented restorations. It is intended for immediate placement and can be restored with a temporary prosthesis in single tooth applications with good quality bone.

The PrimaSolo One-Piece (3.0mm) Implant is a threaded one-piece implant with an integrated abutment designed for Single-Stage procedure and is indicated for use in the treatment of missing maxillary lateral and mandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. The implants must be splinted if using two or more 3.0mm implants adjacent to one another.

The Lifecore PrimaSolo™ One-Piece Implant System is a one-piece implant incorporating both the implant and the abutment into one piece of machined titanium allov. It is designed for one-stage surgical procedures and utilizes cement-retained restorations. It is designed to be used for immediate placement and temporization on single and multiple-tooth restorations. The system also includes healing caps and surgical instrumentation: tissue punches, twist drills, surgical taps, parallel pins, try-ins, surgical depth probe, latch-type implant drivers, and ratchet adapters . Lifecore PrimaSolo One-Piece Implants are available with a Resorbable Blast Media (RBM) roughened surface.

This 510(k) premarket notification is for the Lifecore PrimaSolo™ One-Piece Implant System, a dental implant system. The document does not contain details about specific acceptance criteria, device performance results, or a clinical study in the way one would typically describe for AI/software-as-a-medical-device.

Instead, this document focuses on demonstrating substantial equivalence to previously marketed predicate devices, which is the primary pathway for 510(k) clearance for medical devices like this.

Based on the provided text, here's a breakdown of what can be extracted and what cannot:

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

This information is not present in the provided document. The 510(k) pathway for traditional medical devices like implants often relies on demonstrating that the new device has the same technological characteristics and intended use as predicate devices, or that any differences do not raise new questions of safety or effectiveness. This typically involves performance bench testing (e.g., mechanical strength, fatigue, biocompatibility) and sometimes animal or limited human studies, but the specific acceptance criteria and results of such tests are not detailed in this summary document.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not present. As this is not a study evaluating an AI/ML algorithm or a complex diagnostic device in the way implied by these questions, there is no "test set" in that context. The substantial equivalence argument relies on comparison to predicate devices, material testing, and design specifications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not present. "Ground truth" in the context of expert consensus is not applicable here as there is no diagnostic or interpretive task being performed by an algorithm.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not present.

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 information is not present. This is not an AI-assisted device, so an MRMC study related to human reader improvement is irrelevant.

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

This information is not present. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

This information is not present.

8. The sample size for the training set:

This information is not present. There is no "training set" as this is not an AI/ML device.

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

This information is not present.

Summary of what the document does provide regarding "acceptance criteria" and "study":

The "acceptance criteria" for this device, as per the 510(k) pathway, implicitly revolve around demonstrating substantial equivalence to predicate devices in terms of:

• Intended Use: The PrimaSolo™ One-Piece Implant System has a "substantially equivalent intended use" to its listed predicate devices (Section 5).
• Technological Characteristics: The device and predicates are "similar in fundamental scientific technology in that they are all threaded, root form implants constructed of titanium with roughened surfaces." They are "similar in size and materials" (Section 5).
• Safety and Effectiveness: "When compared with the predicate devices, no new questions of safety or effectiveness have been raised for the PrimaSolo One-Piece Implant System" (Section 5).

The "study" that proves the device meets these (implicit) acceptance criteria is the 510(k) premarket notification itself, which presents the comparison between the new device and the legally marketed predicate devices. The FDA's clearance letter (pages 3-5) confirms that they have "reviewed your Section 510(k) premarket notification of intent to market the device... and have determined the device is substantially equivalent...".

In essence, for this type of device and submission, the "proof" is the successful argument of substantial equivalence to existing devices that have already been deemed safe and effective for their intended use. This typically involves:

• Engineering analysis
• Materials testing
• Biocompatibility testing
• Mechanical property testing (e.g., fatigue, fracture resistance)

However, the specific data from such tests and the quantitative acceptance criteria for those tests are beyond the scope of this summary document.

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