The TSI and ERI Dental Implants are artificial root structures intended for permanent surgical implantation in the bone for the purpose of single or multiple tooth replacements (splinted or free standing), or for stabilization of a prosthetic system, such as artificial teeth in order to restore the patient's chewing function. The TSI and ERI can be placed in the anterior or posterior mandible/maxilla for immediate or delayed loading purposes. Immediate loading is only intended when good primary stability is achieved and appropriate occlusal loading.

Device Description

The TS1 & ERI implants are self-tapping, commercially pure. CP Titanium or Titanium Alloy threaded screws. with light grit blasting or roughened surface treatment. The TSI includes a 2mm collar and is available in 3.25, 4.0. 5.0mm diameters and each are available in 8. 10. 12. 14. and 16mm len gths. The ERI includes a 1 mm collar and is available in 3.25. 4.0. 5.0mm diameters and each are available in 8. 10. 12. 14. and 16mm lengths.

AI/ML Overview

The provided text (K090174) is a 510(k) summary for a dental implant called TSI & ERI. It outlines the device description, indications for use, and claims substantial equivalence to previously cleared predicate devices.

However, the provided document does not contain information about acceptance criteria or a study that proves the device meets those criteria, as typically seen for AI/ML-based devices or complex diagnostic tools.

Dental implants like TSI & ERI are cleared through the 510(k) pathway by demonstrating substantial equivalence to existing, legally marketed predicate devices. This means the new device has the same intended use, similar technological characteristics, and raises no new questions of safety and effectiveness. Clinical studies or performance data with acceptance criteria are generally not required if substantial equivalence can be demonstrated through non-clinical means (e.g., comparison of materials, design, manufacturing processes, and published literature on the predicate devices).

Therefore, I cannot provide the requested information because it is not present in the provided text.

Here's a breakdown of why each point cannot be addressed:

A table of acceptance criteria and the reported device performance: Not applicable for this type of 510(k) clearance. Performance is inferred through substantial equivalence to predicates.
Sample size used for the test set and the data provenance: No test set or associated data for performance evaluation is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method: Not applicable.
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: Not applicable, as this is a physical medical device, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

The 510(k) summary for TSI & ERI focuses on demonstrating that its materials, design, intended use, packaging, and sterilization processes are similar enough to existing cleared devices (Immediate Stabilizing Implant (ISI) K033392, OCO 5.0mm Taper Implant K023336, and MegaGen ExFeel K052369) such that it does not require new efficacy or safety studies.

Summary

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K090174

p 1 4 2009

510(k) Summary

Date: January 9th, 2009

Contact Person: David D. Dalise President Owner OCO Biomedical, Inc.

Trade Name: TSI & ERI Common Name: Dental Implant Classification Name: Dental Implant Endosseous, Root-Form

Substantial Equivalence to:

Immediate Stabilizing Implant (ISI) OCO 5.0mm Taper Implant MeggaGen ExFeel

K033392 (Cleared 12/11/03) K023336 (Cleared 10/9/02) K052369 (Cleared 1/10/06)

Description of Device:

Indications for Use:

Immediate loading is only intended when good primary stability is achieved and appropriate occlusal loading.

Substantial Equivalence:

OCO Biomedical. Inc. has submitted information to demonstrate that, for the purposes of FDA's regulation of medical devices. the TSI & ERI are substantially equivalent in indications and design principles to predicate devices previously cleared by the FDA: Immediate Stabilizing Implant (ISI) K033392 (Cleared 12/11/03), and OCO 5.0mm Taper Implant K023336 (Cleared 109/02). and MegaGen ExFeel K052369 (Cleared 1/10/06).

The TSI & ERI have the following similarities to the predicate devices: -has the same intended use

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-incorporates the same materials and design -is packaged and sterilized using the same materials and processes

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an abstract eagle-like symbol with three parallel lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol. The text is in all capital letters and is evenly spaced around the circle.

SFP 1 4 2009

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

Mr. Jack Bloom OCO Biomedical, Incorporated 8500 Washington Street NE. Suite A-1. Albuquerque, New Mexico 87113

Re: K090174

Trade/Device Name: TSI & ERI Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: August 27, 2009 Received: August 31, 2009

Dear Mr. Bloom:

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 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. Bloom

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 premarket notification" (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 Division of Small 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

for

Susan Runner, D.D.S., M.A. Acting 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: K090174

Device Name: TSI & ERI

Indications for use:

Immediate loading is only intended when good primary stability is achieved and appropriate occlusal loading.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH. Office of Device Evaluation (ODE)

Page 1 of 1

Susan Bonner

ivision Sign-Off) ***ision of Anesthesiology, General Hospital intection Control, Dental Devices

:10(k) Number: 20901374

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.