(74 days)
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.
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 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.
§ 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.