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.

Device Description

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.

AI/ML Overview

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.

Summary

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Lifecore Biomedical, Inc. Abbreviated 510(k) Premarket Notification PrimaSolo™ One-Piece Implant System

K050506

510(K) SUMMARY AND CERTIFICATION [As required by 21 CFR 807.92(c)]

1. Submitter's Name and Contact Person

1. Submitter's Name and Contact Person
Lifecore Biomedical, Inc.	Rachel Kennedy
3515 Lyman Blvd	Regulatory Affairs Manager
Chaska, MN 55318	Ph: 952-368-6294; Fax: 952-368-4278

2. General Information

Trade Name	Lifecore PrimaSolo™ One-Piece ImplantSystem
Common Name	Endosseous dental implant system
Classification Name	Endosseous implant
Identification of Predicate Devices	Restore® Self-Tapping Dental Implant System, RD (Lifecore Biomedical, Inc.) (K924589) Restore® Self-Tapping Dental Implant System, WD (Lifecore Biomedical, Inc.) (K944068) Restore® Self-Tapping Dental Implant System, SD (Lifecore Biomedical, Inc.) (K951111) Altiva Immediate Function Dental Implant (Altiva Corporation) (K992512) Replace® One Piece Implant (Nobel Biocare USA, Inc.) (K023952) Nobel Direct (Nobel Biocare USA, Inc.) (K031345) Biohorizons the Maestro System™ 3.0mm Diameter Implant (Biohorizons Implant System, Inc.) (K032351)

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	Renova™ Internal Hex ImplantSystem (Lifecore Biomedical, Inc.)(K032774)
--	---------------------------------------------------------------------------------

3. Device Description

4. Intended Use

Lifecore Biomedical Dental Implant System 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.

5. Substantial Equivalence Comparison

The Lifecore Biomedical PrimaSolo One-Piece Implant System and the predicate devices Restore® Self-Tapping Implant System (K924589, K944068 and K951111), Renova™ Internal Hex Implant System (K032774), Replace® One Piece Implant (K023952), Nobel Direct (K031345), Biohorizons the Maestro System™ 3.0mm Diameter Implant (K032351), and the Altiva Immediate

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Lifecore Biomedical, Inc. Abbreviated 510(k) Premarket Notification PrimaSolo™ One-Piece Implant System

Function Dental Implant (K992512) the share a substantially equivalent intended use. The PrimaSolo and the predicate devices are similar in fundamental scientific technology in that they are all threaded, root form implants constructed of titanium with roughened surfaces. The subject and predicate devices are similar in size and materials. All systems offer an integral abutment feature for cement retained restorations as well as associated accessories and instruments. When compared with the predicate devices, no new questions of safety or effectiveness have been raised for the PrimaSolo One-Piece Implant System.

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Image /page/3/Picture/1 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

APR 1 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Lifecore Biomedical, Incorporated Ms. Rachel Kennedy Regulatory Affairs Manager Oral Restorative Division 3515 Lyman Boulevard Chaska, Minnesota 55318-3051

Re: K050506

K050500
Trade/Device Name: PrimaSolo™ One-Piece Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: February 25, 2005 Received: March 2, 2005

Dear Ms. Kennedy:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your because is = // he device is substantially equivalent (for the referenced above and have acterimined to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mershale collinered pror to they 20, 777, accordance with the provisions of Allendlichts, of to devroos that is is Act (Act) that do not require approval of a premarket the rederal Pood, Drug, und Ocember , therefore, market the device, subject to the general approval application (1111). controls provisions of the rich. "The genices, good manufacturing practice, requirements for sibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III II your device is classified (see ass roy into seontrols. Existing major regulations affectings (PMA), it may be subject to suer adantenal versions on the 21, Parts 800 to 898. In your device can oc found in the South one of Personal one
addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Kennedy

Please be advised that FDA's issuance of a substantial equivalence determination does not Flease oe auvisod that I Dri b issuaires on that your device complies with other requirements Incall that 1 271 has made a astes and regulations administered by other Federal agencies. of the Act of ally I ederal backed and equirements, including, but not limited to: registration 1 ou must comply with an 07); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Pat 067), labeling (21 CFR Part 820); and if requirents as set form in the quartly sion control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to ough finding of substantial equivalence of your device to a premarket notified.com - The x Breasults in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific advice for Jour at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Ifray obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chr L

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K050506

PrimaSolo™ One-Piece Implant System Device Name:

Indications for Use:

Indications for Use:
Lifecore Biomedical Dental Implants are intended for use in partially or
e in and Siomedical Dental Implant of single or multiple-unit Lifecore Biomedical Dental Infipiant Oyotan unipont of single or multiple-unit
fully edentulous mandibles and maxillae, in support of single or overdenture resto fully edentulous mandibles and intaxiliae, in support on one one one one one of the restorations,
restorations including; cement retained, screw retained, or overdenture res restorations including, centent retailled, coron
and terminal or intermediate abutment support for fixed bridgework.

Specific Intended Uses: The PrimaSolo One-Piece (3.5 – 5.0mm) Implant is a threaded
Specifical Uses: The Primated on tweet designed for single-stage surgical Specific Intended Uses: "The Printations one i for single-stage surgical
one-piece implant with an integrated abutment designed for single-stage surgical one-piece implant with an integrated abunche acception of einended for procedure and cemented restorations: Triniteens only prosthesis in single tooth
immediate placement and can be restored with a temporary prosthesis in single tooth immediate placemontations with good quality bone.

The PrimaSolo One-Piece (3.0mm) Implant is a threaded one-piece implant with an
the end is in The PrimaSolo One-Plece (3.0mm) intellent is a tirrordure and is indicated for integrated abutment designed in Single-Stage of the mandibular central and
use in the treatment of missing maxillary later and in order to restor use in the treatment of missing maxiliary facer their in order to restore
lateral incisors to support prosthetic devices, such as artificial teeth, incisors lateral incisors to support prosthent de news, business of the mail incisors
chewing function in partially edentulous patients adasont to one another chewing function in partially edenturous putionto. The management to one another.
must be splinted if using two or more 3.0mm implants adjacent to one another.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ken Mubej for HSR

K050506

Page 1 of _

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.