(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.
§ 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.