The OrthoGlide Lateral Knee Implant is intended for use in the osteoarthritic knee, where substantial amounts of cartilage have been lost as a result of the disease. The device is indicated for uncemented use in the treatment of moderate degeneration of the lateral compartment of the knee (grade II-IV chondromalacia) with no more than minimal degeneration (grade I-II chondromalacia, no loss of joint space) in the medial and patellofemoral compartments in patients with osteoarthritis.

Device Description

The OrthoGlide Lateral Knee Implant is placed in the lateral compartment of the knee between the tibial plateau and femoral condyle by means of minimally invasive surgery. The instruments are intended to aid in the surgical preparation of the implant site and implant placement. The OrthoGlide is made of a Cobalt-Chrome-Molybdenum Alloy. Device geometry and ligament tension combine to keep the implant in place. The implant covers the lateral tibial plateau. The device is designed to improve the alignment of the knee, returning the joint to a less valgus position. Realignment of the knee distributes the weight-bearing forces across the joint and helps restore the normal relationships of the articular surfaces and the surrounding capsular, ligamentous and muscular structures. The device is designed to help relieve pain by providing an articulating surface with a low coefficient of friction and high durability. Device geometry improves knee alignment and joint spacing. The device surface is smooth and when wet, is intended to mimic the lubricious surface previously provided by the articular cartilage.

AI/ML Overview

The advanced Bio-Surfaces, Inc. OrthoGlide® Lateral Knee Implant did not undergo clinical studies with acceptance criteria and measured performance in the traditional sense as this was a 510(k) premarket notification for a Class II medical device. The device was found substantially equivalent to predicate devices based on non-clinical testing.

Here's a breakdown of the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this was a 510(k) submission based on substantial equivalence to predicate devices, there isn't a direct "acceptance criteria" table with measured performance like in a clinical trial. Instead, the "acceptance criteria" revolved around demonstrating that the device performed similarly to the predicates and met established standards through bench and cadaver testing.

Acceptance Criteria Category	Reported Device Performance (Summary from provided text)
Physical Attributes & Durability (Bench Testing)	Demonstrated through tensile elongation, load deflection, cyclic fatigue resistance, material consistency and stability, and processing control.
Surgical Technique & Instrument Verification (Cadaver Testing)	Verified the surgical technique and instruments.
Physiological Effects (Cadaver Testing)	Verified desired physiological effects of stability and range of motion preservation.
Biocompatibility	Meets internationally recognized standards for biocompatibility (ISO 10993).
Sterility	Meets internationally recognized standards for sterility (EN550).
Material Specifications	Conforms to material specifications.
Substantial Equivalence to Predicate Devices	Substantially equivalent to FDA approved predicate devices (K003269, K033242, K053094) regarding indications for use, materials, technological characteristics, and surgical techniques, offering no additional risks or safety concerns.

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

Sample Size for Test Set:
- Bench Testing: Not specified in terms of number of samples, but implied to be sufficient to demonstrate the listed physical attributes and durability.
- Cadaver Testing: Not specified in terms of the number of cadavers used.
Data Provenance: The data is from non-clinical testing (bench and cadaver studies) conducted by Advanced Bio-Surfaces, Inc. The document does not specify the country of origin for the cadavers or the exact location of the bench testing facilities, but the manufacturer is based in Minnetonka, MN, USA. The studies are by nature prospective for the device's design verification and validation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This type of information is generally not applicable to non-clinical bench and cadaver testing for medical devices, particularly for a 510(k) submission not involving clinical data. The "ground truth" for bench testing would be defined by the specifications and standards (e.g., ISO, EN) the device is tested against. For cadaver testing, the "ground truth" would be the successful execution of the surgical technique and observation of desired physiological effects by medical professionals/surgeons involved in the cadaver labs.

The document does not mention the number or qualifications of experts involved in the cadaver evaluations.

4. Adjudication Method for the Test Set

Not applicable, as this was not a clinical study requiring adjudication of expert opinions on patient outcomes. The evaluation of bench and cadaver tests would be based on objective measurements and observations against pre-defined criteria.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not used to determine substantial equivalence." and "The OrthoGlide as well as the predicates are submitted without clinical information."
Effect Size: Not applicable, as no MRMC study was conducted.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The OrthoGlide® Lateral Knee Implant is a physical implant, not an AI algorithm. Therefore, "standalone" performance in the context of AI is not relevant. The performance of the implant itself is assessed through the bench and cadaver testing described.

7. Type of Ground Truth Used

Bench Testing: Engineering specifications, material standards (e.g., tensile strength, fatigue limits), and international voluntary standards (e.g., ISO 10993 for biocompatibility, EN550 for sterility).
Cadaver Testing: Direct observation and measurement of surgical technique execution, instrument fit, knee stability, and range of motion on cadaveric specimens, likely by surgical experts or engineers.

8. Sample Size for the Training Set

Not applicable. As a physical implant, there is no "training set" in the context of machine learning or AI. The design and manufacturing processes are refined through engineering development and testing.

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

Not applicable, as there is no training set for this type of medical device.

Summary

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Ko73233 (pg 1/3)

510(k) Summary

Advanced Bio-Surfaces, Inc.

OrthoGlide® Lateral Knee Implant

JAN 28 2005

510(k) Notification

MANUFACTURER INFORMATION

Advanced Bio-Surfaces, Inc. Name & Address: 5909 Baker Road, Suite 550 Minnetonka, MN 55345 USA
Summary Prepared: November 12, 2007
Contact: Albert Schafer Manager, Q.A. / Regulatory Affairs 952-912-5400 phone 952-912-5410 fax

DEVICE INFORMATION

Trade Name: OrthoGlide® Lateral Knee Implant

Classification Name: 21CFR 888.3590 - Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis · ·· ·- ·- ··· ·············· ·· · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·

Product Code: HSH

. . . .-----------------------------------------------------------------------------------------------------------------------------------------------------------------------

Common / Usual Name: Hemi- knee prosthesis

Substantial equivalence: The ABS OrthoGlide Lateral Knee Implant is substantially

equivalent to FDA approved predicate devices with regard to indications for use,

materials, technological characteristics and surgical techniques. These predicate devices

Sulzer Orthopedics, Inc. Unicondylar Interpositional Spacer (K003269) are:

ITI, Knee Interpositional Mini-Repair system (KIMRS) (K033242)

Advanced Bio Surfaces, Inc. OrthoGlide Lateral 510(k) Premarket Notification

Confidential Section 5 Page 1 of 3

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ABS OrthoGlide® Medial Knee Implant (K053094)

Device Description: The OrthoGlide Lateral Knee Implant is placed in the lateral compartment of the knee between the tibial plateau and femoral condyle by means of minimally invasive surgery. The instruments are intended to aid in the surgical preparation of the implant site and implant placement. The OrthoGlide is made of a Cobalt-Chrome-Molybdenum Alloy. Device geometry and ligament tension combine to keep the implant in place. The implant covers the lateral tibial plateau. The device is designed to improve the alignment of the knee, returning the joint to a less valgus position. Realignment of the knee distributes the weight-bearing forces across the joint and helps restore the normal relationships of the articular surfaces and the surrounding capsular, ligamentous and muscular structures.

The device is designed to help relieve pain by providing an articulating surface with a low coefficient of friction and high durability. Device geometry improves knee alignment and joint spacing. The device surface is smooth and when wet, is intended to mimic the lubricious surface previously provided by the articular cartilage.

The OrthoGlide Lateral Knee Implant is intended for use in the Intended Use: osteoarthritic knee, where a substantial amount of cartilage has been lost as a result of the disease. The device is indicated for uncemented use in the treatment of moderate degeneration of the Lateral compartment of the knee (grade II-IV chondromalacia) with no more than minimal degeneration (grade I-II chondromalacia, no loss of joint space) in the medial and patellofemoral compartments in patients with osteoarthritis.

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Substantial Equivalence: The ABS OrthoGlide Lateral Knee Implant is substantially equivalent to FDA approved predicate devices with regard to indications for use, materials, technological characteristics and surgical techniques. OrthoGlide offers no additional risks to the patient and the materials and manufacturing methods add no new or additional safety concerns. The OrthoGlide as well as the predicates are submitted without clinical information. The substantially equivalent predicate devices are:

Sulzer Orthopedics, Inc. Unicondylar Interpositional Spacer (K003269)

ITI, Knee Interpositional Mini-Repair system (KIMRS) (K033242)

ABS OrthoGlide Medial Knee Implant (K053094)

Testing: The OrthoGlide Implant has been developed, verified and validated in compliance with a comprehensive design process. The corresponding Bench Testing has been accomplished according to a Master Test Plan for the device. The test plan shows the required test, the source of the requirement, the protocol and the report. If the method is from a standard, the voluntary standard is referenced. The bench testing has demonstrated the physical attributes and durability of the OrthoGlide by tensile elongation, load deflection, cyclic fatigue resistance, material consistency and stability and processing control.

Cadaver testing has verified the surgical technique and instruments. Cadaver evaluations have also verified the desired physiological effects of stability and range of motion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . preservation. .. ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------

The OrthoGlide also demonstrated that it meets internationally recognized standards for biocompatibility (ISO 10993), sterility (EN550), and conformance to material specifications. Clinical testing was not used to determine substantial equivalence.

Summary: Based on the evidence of substantial equivalence the OrthoGlide is considered to be safe and effective and will perform as well or better than the referenced predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird in flight, with three curved lines representing the wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol.

Public Health Service

JAN 28 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Advanced Bio-Surfaces, Inc. % Mr. Albert Schafer Manager, Q.A./Regulatory Affairs 5909 Baker Road, Suite 550 Minnetonka, MN 55345

Re: K073233 Trade/Device Name: OrthoGlide® Lateral Knee Implant Regulation Number: 21 CFR 888.3590 Regulation Name: Knee joint tibial (hemi-knee) metallic resurfacing uncemented prothesis Regulatory Class: II Product Code: HSH Dated: December 30, 2007 Received: January 29, 2008

Dear Mr. Schafer:

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.

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 (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.

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Page 2 - Mr. Albert Schafer

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Mark M. Mulheran

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Eyaluation Center for Devices and Radiological Health

Enclosure

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K0732333 (pg 1/ 门

Indications for Use

510(k) Number (if known):

Device Name: OrthoGlide® Lateral Knee Implant

Indications for Use:

Prescription Use _ Yes (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use No (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)

(Posted November 13, 2003)

Mark N. MilkenPage1 of1

Division Sign-Off Division of General, Restorative, and Neurological Devices

510(k) Number K073233

Regulation Number and Section

§ 888.3590 Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis.

(a)
Identification. A knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This prosthesis is made of alloys, such as cobalt-chromium-molybdenum, and is intended to resurface one tibial condyle. The generic type of device is limited to those prostheses intended for use without bone cement (§ 888.3027).(b)
Classification. Class II.