(95 days)
The Orthoglide Medial 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 medial compartment of the knee (grade II-IV chondromalacia) with no more than minimal degencration (grade I-II chondromalacia, no loss of joint space) in the lateral and patellofemoral compartments in patients with ostcoarthritis.
The Orthoglide Medial Knee Implant is placed in the medial 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 tibial plateau. The device is designed to improve the alignment of the knee, returning the joint to a more 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.
This 510(k) submission for the Orthoglide® Medial Knee Implant does not contain a study demonstrating that the device meets specific acceptance criteria in the manner typically seen for AI/ML-based medical devices or diagnostics. Instead, it demonstrates substantial equivalence to predicate devices through a combination of engineering bench testing and non-clinical evaluations.
The document states: "The Orthoglide as well as the predicates are submitted without clinical information." This explicitly indicates that no clinical studies, which would typically involve human subjects and outcome measures to establish specific acceptance criteria and performance against them, were conducted for this submission.
Therefore, many of the requested elements for AI/ML device studies are not applicable in this context. I will address the parts that are relevant based on the provided text.
Description of Acceptance Criteria and Study for Orthoglide® Medial Knee Implant
The Orthoglide® Medial Knee Implant's acceptance criteria are framed around demonstrating substantial equivalence to legally marketed predicate devices, rather than achieving specific performance metrics in a clinical study. The "study" in this context refers to a series of bench tests and cadaver evaluations designed to ensure the device's physical attributes, durability, material consistency, and surgical compatibility, mirroring what would be expected of the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission based on non-clinical data, the acceptance criteria are not in the form of diagnostic performance metrics (e.g., sensitivity, specificity). Instead, they relate to engineering and material properties, and the "reported performance" is that the device meets these criteria.
| Acceptance Criteria Category | Specific Criteria (Implicit or Explicit in Document) | Reported Device Performance (Summary) |
|---|---|---|
| Mechanical/Physical | Tensile elongation | Demonstrated adherence to specifications |
| Load deflection | Demonstrated adherence to specifications | |
| Cyclic fatigue resistance | Demonstrated adherence to specifications | |
| Material consistency and stability | Demonstrated adherence to specifications | |
| Processing control | Demonstrated adherence to specifications | |
| Biocompatibility | Conformance to ISO 10993 | Meets ISO 10993 standards |
| Sterility | Conformance to EN550 | Meets EN550 standards |
| Material Specifications | Conformance to material specifications | Meets material specifications (Cobalt-Chrome-Molybdenum Alloy) |
| Surgical Technique | Verification of surgical technique (cadaver) | Verified surgical technique, instruments |
| Physiological Effects (Cadaver) | Stability, angular correction, range of motion preservation | Verified desired physiological effects |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. The "test set" here refers to the samples used in bench testing and cadaver evaluations, not a clinical patient cohort. The document does not specify the number of individual components or cadavers used for these tests.
- Data Provenance: The tests were conducted internally by Advanced Bio-Surfaces, Inc. as part of their design verification and validation process. The origin of the raw materials (Cobalt-Chrome-Molybdenum Alloy) would typically be from suppliers, but specific "country of origin" for the test data itself is not stated beyond the manufacturer's location in Minnetonka, MN, USA. All data appears to be prospective in the sense that it was generated specifically for this device's development and submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This concept is not applicable in the context of this 510(k) submission. "Ground truth" for an AI/ML device typically involves expert interpretation of medical images or clinical data. Here, the "truth" is established by adherence to engineering standards, material specifications, and observed physical behaviors in controlled lab and cadaveric settings. There's no mention of a panel of experts establishing ground truth for diagnostic or prognostic interpretations.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving discrepancies in expert interpretations to establish ground truth in clinical/diagnostic studies (typically AI/ML). The "truth" in this submission relies on objective measurements from bench testing and observations during cadaveric procedures, not on expert consensus that requires adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. Such studies are relevant for evaluating the impact of an AI algorithm on human reader performance, which is not pertinent to this implant device's submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
Yes, in a sense. The "standalone" performance here refers to the inherent physical and mechanical properties of the device itself, as evaluated through bench testing and cadaver studies. This is the primary mechanism used to demonstrate substantial equivalence, rather than a clinical study with human patients. The device's performance (e.g., fatigue resistance, biocompatibility) was assessed independently of human interaction beyond the necessary execution of the tests themselves.
7. The Type of Ground Truth Used
The "ground truth" for this submission consists of:
- Engineering Standards and Specifications: Adherence to established and voluntary standards (e.g., ISO 10993 for biocompatibility, EN550 for sterility) and the manufacturer's own design specifications for mechanical properties, materials, and processing.
- Observed Physical Properties: Measurements from tensile strength tests, load deflection, and cyclic fatigue, compared against predetermined engineering requirements.
- Cadaveric Observations: Direct observation and measurement during cadaver testing to verify surgical technique, instrument function, and physiological effects like stability, angular correction, and range of motion preservation.
8. The Sample Size for the Training Set
Not applicable. This device is a mechanical implant, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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Image /page/0/Picture/0 description: The image shows a logo with the text "LABS" in large, bold, sans-serif font. A trademark symbol is located to the right and slightly above the "S". Below "LABS", smaller text reads "APPLIED BIO SURFACES, INC." The text is black against a white background.
510(k) Summary
Advanced Bio-Surfaces, Inc.
Orthoglide® Medial Knee Implant
510(k) Notification K053094
MANUFACTURER INFORMATION
-
Advanced Bio-Surfaces, Inc. Name & 5909 Baker Road Address: Minnetonka, MN 55345 USA
Summary Prepared: November 2, 2005 -
Contact: Philip B. Jarvi Director, Q.A. / Regulatory Affairs 952-912-5400 phone 952-912-5410 fax
DEVICE INFORMATION
Trade Name: Orthoglide® Medial Knee Implant
Classification Name: 21CFR 888.3590 - Knec joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis
Product Code: HSH
Common / Usual Name: Hemi- knee prosthesis
Substantial equivalence: The ABS Orthoglide® Medial 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
- are: Sulzer Orthopedics, Inc. Unicondylar Interpositional Spacer (K003269)
ITI, Knee Interpositional Mini-Repair system (KIMRS) (K033242)
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Device Description: The Orthoglide Medial Knee Implant is placed in the medial 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 tibial plateau. The device is designed to improve the alignment of the knee, returning the joint to a more 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.
- Intended Use: The Orthoglide Medial Knee Implant is intended for use in the 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 medial 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 lateral and patellofemoral compartments in patients with osteoarthritis.
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Substantial Equivalence: The ABS Orthoglide Medial Knee Implant is substantially equivalcnt 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)
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, angular correction 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 safe and effective and will perform as well or better than the referenced predicate devices.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Public Health Service
2006 FEB 6
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Philip B. Jarvi Director, Q.A./Regulatory Affairs Advanced Bio-Surfaces, Inc. 5909 Baker Road Minnetonka, Minnesota 55345
Re: K053094
Trade/Device Name: Orthoglide Medial Knee Implant Regulation Number: 21 CFR 888.3590 Regulation Name: Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis Regulatory Class: II Product Code: HSH Dated: January 19, 2006 Received: January 20, 2006
Dear Mr. Jarvi:
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
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Page 2 – Mr. Philip B. Jarvi
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IT rail 0077, incomig (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation on begin marketing your device as described in your Section 510(k) I mo loter witification. The FDA finding of substantial equivalence of your device to a legally premated notification - 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 11 you desire of Compliance at (240) 276-0120. 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,
Mark H Millikan
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K053094
Device Name: Orthoglide® Medial Knee Implant
Indications for Use:
The Orthoglide Medial 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 medial compartment of the knee (grade II-IV chondromalacia) with no more than minimal degencration (grade I-II chondromalacia, no loss of joint space) in the lateral and patellofemoral compartments in patients with ostcoarthritis.
Prescription Use Yes (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N Mulkerso
Sign-Off) Divisio: Cone Restorative Division and Neu nical bevi Page 1 of 1 S10(k) Number
(Posted November 13, 2003)
§ 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.