The Stage-1® Temporary/Healing Cap is placed after surgery to protect the Cement on Crown (COC) Abutment until the soft tissue has healed. It can be used alone or as the base for a temporary crown. The healing cap is intended for temporary use only up to 30 days.

Device Description

The Stage-1 ** Temporary/Healing Cap is a cap which is placed over the COC Abutment for protection during soft tissue healing. The Stage-1® Temporary/Healing Cap also offers a base for placement of a temporary crown. The temporary crown can be bonded directly to the Stage-1® Temporary/Healing Cap.

AI/ML Overview

This submission focuses on "Substantial Equivalence Comparison" for the Stage-1® Temporary/Healing Cap. Instead of providing acceptance criteria and a study demonstrating performance against these criteria, the document asserts substantial equivalence to predicate devices based on shared characteristics. Therefore, the requested information on acceptance criteria and a detailed study proving device performance as typically understood for AI/software-based devices is not applicable to this 510(k) submission.

Specifically, the submission from Lifecore Biomedical, Inc. for the Stage-1® Temporary/Healing Cap (K053643) relies on comparing the new device to existing predicate devices to establish substantial equivalence. It does not present a study with performance metrics against acceptance criteria in the manner one would expect for a diagnostic or AI-driven medical device.

Here's an explanation based on the provided text, addressing why the requested information cannot be fully provided:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable. The submission does not define specific performance acceptance criteria (e.g., accuracy, sensitivity, specificity) for a clinical study comparing the device against a benchmark. Instead, it argues substantial equivalence. The "performance" is implicitly tied to the predicate devices being legally marketed and safe/effective for their intended use.

2. Sample Size for the Test Set and Data Provenance:

Not applicable. No test set, as would be used in a performance study, is described. The submission is a regulatory comparison.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. Ground truth establishment is not relevant to this type of substantial equivalence comparison.

4. Adjudication Method for the Test Set:

Not applicable. No test set or expert adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. No such study is mentioned or implied. This device is a physical healing cap, not a diagnostic or AI-assisted interpretation tool where reader improvement would be measured.

6. Standalone Performance Study (Algorithm Only):

Not applicable. There is no algorithm or software component for which standalone performance would be assessed. The device is a physical medical implant accessory.

7. Type of Ground Truth Used:

Not applicable. Ground truth, in the context of diagnostic performance, is not established for this device.

8. Sample Size for the Training Set:

Not applicable. There is no machine learning component requiring a training set.

9. How Ground Truth for the Training Set Was Established:

Not applicable. No training set or ground truth for it exists in this submission.

Summary of Substantial Equivalence Comparison (as provided in the document):

The submission argues substantial equivalence based on the following:

Feature	Stage-1® Temporary/Healing Cap (New Device)	Predicate Stage-1® COC Abutment Healing Cap (K991114, K994205, K003226)	Predicate PrimaConnex™ Quick-Abutment Temporary/Healing Cap (K051614)
Intended Use	Placed after surgery to protect COC Abutment until soft tissue has healed; can be used alone or as base for temporary crown; temporary use up to 30 days.	Same	Same
Basic Healing Cap Design	Same	Same	Same
Biocompatible Materials	Implied to be the same as predicates (specifically stated for PrimaConnex™ comparison)	Not explicitly stated in comparison, but inherent to existing device	Same (explicitly stated)
Shelf Life	Same	Same	Same
Packaging & Sterilization	Same materials and processes	Same materials and processes	Same materials and processes

The FDA's letter (K053643) confirms that they "reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices." This determination is based on the comparative information provided by the applicant, rather than a performancetesting study with specific acceptance criteria.

Summary

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Lifecore Biomedical, Inc. Special 510(k) Premarket Notification Stage-1® Healing/Temporary Cap

JAN 2 3 2006

K053643

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

1. Submitter's Name and Contact Person

Lifecore Biomedical, Inc.3515 Lyman BlvdChaska, MN 55318	Brian SmekalRegulatory Affairs SpecialistPh: 952-368-6306; Fax: 952-368-4278
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2. General Information

Trade Name	Stage-1® Temporary/Healing Cap
Common Name	Healing Abutment Cap, Temporary Cap
Classification Name	Endosseous Implant Abutment
Identification of Predicate Devices	Stage-1® Cement-On Crown(COC) Abutment Healing Cap(K991114, K994205 andK003226) PrimaConnex™ Quick-AbutmentTemporary/Healing Cap(K051614)

3. Device Description

4. Intended Use

The Stage-1 * Temporary/Healing Cap is placed after surgery to protect the Cement on Crown (COC) Abutment until the soft tissue has healed. It can be used alonc or as the base for a temporary crown. The healing cap is intended for temporary use only up to 30 days.

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K053643

Lifecore Biomedical, Inc. Special 510(k) Premarket Notification Stage-1® Healing/Temporary Cap

5. Substantial Equivalence Comparison

Summary of how the new Stage-1® Temporary/Healing Cap is substantially equivalent to the Stage-1® COC Abutment Healing Cap:

Have the same intended use. .
Incorporate the same basic healing cap design, .
Have the same shelf life, and .
Are packaged and sterilized using the same materials and processes. .

Summary of how the new Stage-1® Temporary/Healing Cap is substantially equivalent to the PrimaConnex™ Quick-Abutment TemporaryHealing('); }); }); }); } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } }

Have the same intended use. .
Incorporate the same basic healing cap design, .
Incorporate the same biocompatible materials, .
. Have the same shelf life.
And are packaged and sterilized using the same matcrials and processes. t

In summary, the Stage-1* Temporary/Healing Cap described in this submission is, in our opinion, substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest the head and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged in a circular fashion around the bird symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 3 2006

Lifecore Biomedical, Incorporated Mr. Brian Smekal Regulatory Affairs Specialist Oral Restorative Division 3515 Lyman Boulevard Chaska, Minnesota 55318-3051

Re: K053643

Trade/Device Name: Stage-1® Temporary/Healing Cap-Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: NHA Dated: December 29, 2005 Received: December 30, 2005

Dear Mr. Smekal:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Smekal

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation 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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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), please contact the Office of Compliance 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 Division 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,

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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Lifecore Biomedical, Inc. Special 510(k) Premarket Notification Stage-1® Temporary/Healing Cap

K053643

Indications for Use Statement

510(k) Number (if known):

Device Name: Stage-1® Temporary/Healing Cap

Indications for Use:

Prescription Use X AND/OR (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)

Suse, Rünne

Mary General Hosp
Control, Dental Devices

Page 1 of 1

Regulation Number and Section

§ 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.)