Alike the Locator implant, the O-ring Prosthetic Attachment and the Nobel Ball Attachment systems, the LRT Attachment System provides a mean for attaching a removable prosthetic device to an endosseous implant body with the use of a mechanical based retention, hence eliminating permanent structures that prevent easy access to implant abutments.

The LRT Attachment System requires the use of two ball abutments to receive the The presence of additional implant abutments, although not attachment. mandatory, contributes to the support and stability of the prosthesis. These abutments are cone shaped and mate with a reciprocal cover in the denture base.

All predicate devices are snap-on devices. The retentive female part is embedded in the denture part and snaps on another part (e.g. a ball abutment). The retentive action relies on the expansion and constriction of the metal female counterpart. The LRT Attachment System provides for an innovative solution by featuring a lock-release retention system activated by digital pressure. This mechanical lock/release action offers ease of manipulation. One of the key elements of the LRT Attachemt System is the easily identified "buttons" of the lock/release mechanism which allow an assistant to manipulate the denture for the severely impaired person.

AI/ML Overview

The provided document is a 510(k) summary for the LRT Attachment System, which is an accessory to endosseous dental implants. It outlines the device description, indications for use, and a brief description of testing performed. However, it does not contain specific acceptance criteria, detailed study results with performance metrics, sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC study details, standalone algorithm performance, or training set information.

Based on the provided text, here's what can be inferred and what information is missing:

1. Table of acceptance criteria and reported device performance:

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the document. The document generally states that the device was "found substantially equivalent to the cited predicates."	In-vivo testing: Eased handling of the lock/release mechanism. Clinical testing (over 18 years): Found substantially equivalent to cited predicates (Locator implant anchor K994257, Ball Attachment system K955372, O-ring Prosthetic Attachment K001638). In-vitro biocompatibility testing: Cytotoxicity screening assays (USP 87) successfully performed.

Without explicit acceptance criteria in the document, it's impossible to create a quantitative table. The reported "performance" focuses on affirming substantial equivalence and successful biocompatibility rather than specific metrics against predefined thresholds.

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

Sample Size for Test Set: Not specified. The document mentions "over 18 years of clinical testing" but does not give a specific number of patients or cases in these tests.
Data Provenance:
- Country of Origin: Not specified for the clinical testing. The submitter is from Montréal, Québec, CANADA, but the location of the clinical tests is not mentioned.
- Retrospective or Prospective: Not specified. The "over 18 years of clinical testing" suggests a long-term, possibly prospective, study or a collection of clinical observations over time, but this is not explicitly stated.

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 provided in the document. The document refers to "clinical testing" but does not detail how "ground truth" or outcomes were assessed, nor who assessed them.

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

This information is not provided in the document.

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:

No MRMC study was performed or described. The device is a mechanical attachment system for dental prosthetics, not an AI-assisted diagnostic or interpretative tool for human readers. Therefore, this question is not applicable to the device described.

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

Not applicable. The device is a physical, mechanical system for dental prosthetics, not a software algorithm.

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

The term "ground truth" as typically used in AI/diagnostic studies is not directly applicable here. The "clinical testing" would have assessed patient outcomes, device retention, ease of use, stability, and absence of adverse events. The document states "the device was found substantially equivalent to the cited predicates" in these clinical tests and that "Cytotoxicity in-vitro screening assays... were successfully performed." These imply comparison against established benchmarks or standards rather than an "expert-established ground truth" for diagnostic accuracy.

8. The sample size for the training set:

Not applicable / not provided. As a mechanical device, there is no "training set" in the context of machine learning. The "over 18 years of clinical testing" might be considered a form of iterative development and refinement, but it does not constitute a "training set" in the computational sense.

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

Not applicable. See point 8.

Summary

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K112333

JAN 3 0 2012

510(k) Summary

1.	Name/Address of Submitter:	Innovation TAP inc.1441, rue du CollègeSuite 4Montréal, QuébecH4L 2L8 CANADA
2.	Contact Person:	Emmanuel Montini, Ph.D., Adm.ACo-President, BCF Certification inc.Phone: (514) 927-4635Fax: (514) 397-8515Email: emontini@bcf.ca
3.	Date Summary Prepared:	July 15th, 2011
4.	Classification:	21 CFR 872.3630
5.	Common Name:	Accessory to endosseous dental implanabutment
5.	Device Name:	LRT Attachment System
6.	Product Code:	NHA

5. Predicate Devices:

LRTSystem	Attachment	Locator implant anchor K994257Ball Attachment system K955372O-ring Prosthetic Attachment K001638
---------------	------------	----------------------------------------------------------------------------------------------------------

Device Description: 6.

All predicate devices are snap-on devices. The retentive female part is embedded in the denture part and snaps on another part (e.g. a ball abutment). The retentive

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action relies on the expansion and constriction of the metal female counterpart. The LRT Attachment System provides for an innovative solution by featuring a lock-release retention system activated by digital pressure. This mechanical lock/release action offers ease of manipulation. One of the key elements of the LRT Attachemt System is the easily identified "buttons" of the lock/release mechanism which allow an assistant to manipulate the denture for the severely impaired person.

7. Indication for Use:

The LRT Attachment System is indicated for providing a mean of attaching a removable prosthetic device to an endosseous implant body.

Brief Description of Clinical and Non-clinical Testing: The activation of the 8. mechanism to provide the lock/release function was tested in vivo to insure the ease of handling. Over 18 years of clinical testing were performed to fine tune the device and its integration to dental prostheses. In these clinical tests, the LRT Attachment System was found substantially equivalent to the cited predicates. Furthermore, Cytotoxicity in-vitro screening assays in accordance with USP 87 were successfully performed to assess the biocompatibility of the material.

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Image /page/2/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Louis-Paul Marin Consultant BCF Certification Incorporation 1100 Rene-Levesque Boulevard, West 25th Floor Montreal CANADA H4L 2L8

Re: K112333

Trade/Device Name: LRT Attachment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: January 19, 2012 Received: January 23, 2012

Dear Mr. Marin:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

JAN 3 0 2012

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Page 2 - Mr. Marin

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to Compilation ification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the 1 samall Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

es fer Anthony Diktson

Anthony D. Watson, B.S., M.S., M.B.A. 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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KII 2333

Indication for Use

510(k) Number (if known):

Device Name: LRT ATTACHMENT SYSTEM

Indication for Use: The LRT Attachment System is indicated for providing a mean of attaching a removable prosthetic device to an endosseous implant body.

Concurrence of CDRH Office of Device Evaluation

Prescription Use (per 21CFR 801.109)

: ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・

2291689.1

Over-the-counter Use

Susan Gunner

510(k) Number:

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

1-1

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.)