(358 days)
The CoLS® Fixation System is designed for the fixation of tendons graft to the femur and tibia during orthopedic surgical procedures for Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) reconstructions.
The CoLS® Fixation System is composed of the following elements: The CoLS® tendon anchoring screw, implantable device, used for the fixation of the CoLS® tendon anchoring tape to the bone. The CoLS® tendon anchoring tape, it is a non absorbable surgical suture, used for the ACL and PCL reconstruction, to which the tendon graft is attached. This implantable tendon anchoring tape is used with accessories non implantable: tape support, passing wire and scalpel blade. The CoLS® Fixation System is provided sterile and it is intended to be implanted using the dedicated instrumentation supplied by the manufacturer.
Here's an analysis of the provided text regarding the CoLS® Fixation System, focusing on acceptance criteria and the study conducted.
It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. Therefore, the "study" described is a comparison of characteristics and performance rather than a full efficacy clinical trial.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Tensile Strength (measured on Fixation System) | "Tensile strength on the Fixation System" was compared to the predicate device. It was determined that "the Fixation System performances were substantially equivalent to the selected predicate device." |
| Biocompatibility (of final finished material) | "Biocompatibility of the final finished material" was compared to the predicate device. It was determined that "the Fixation System performances were substantially equivalent to the selected predicate device." |
| Material | Same material (titanium alloy and polyethylene terephtalate) as the predicate device. |
| Design | Same design as the predicate device. |
| Operating Principle | Same operating principle as the predicate device. |
| Sterilization Method | Same sterilization method (Gamma radiation) as the predicate device. |
| Indication for Use | Same indication for use (fixation of tendon grafts to femur and tibia for ACL/PCL reconstructions) as the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of a dedicated clinical or pre-clinical study with specific sample sizes for tensile strength or biocompatibility. Instead, the "tests were performed" to compare the new device to the predicate. This suggests laboratory testing rather than a patient-based test set.
- Sample Size: Not explicitly stated. The document refers to "tests were performed" but does not give the number of samples used for tensile strength or biocompatibility testing.
- Data Provenance: The tests were performed as part of a 510(k) submission from Fournitures Hospitalières Industrie, a French company. The nature of the tests (tensile strength, biocompatibility) implies laboratory testing, which is generally retrospective in the sense that the device has already been designed and manufactured when these comparative tests are conducted.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this 510(k) submission. The "ground truth" for demonstrating substantial equivalence here relies on direct comparative testing of physical characteristics (tensile strength, biocompatibility, material, design, etc.) against a legally marketed predicate device, rather than expert interpretation of data like images or patient outcomes.
4. Adjudication Method for the Test Set
This information is not applicable to this 510(k) submission. Adjudication methods (like 2+1, 3+1) are typically used in studies involving expert review of ambiguous cases or outcomes, such as in diagnostic imaging or clinical trials. The described "tests" are laboratory-based comparisons of physical and material properties.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study assesses how AI impacts human reader performance, usually in diagnostic scenarios. This 510(k) is for a physical medical device (fixation system) and does not involve AI or human interpretation of outputs.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone algorithm performance study was not done. This 510(k) is for a physical medical device and does not involve a diagnostic algorithm.
7. Type of Ground Truth Used
The "ground truth" for this substantial equivalence determination is established by:
- Comparative Laboratory Testing Data: Tensile strength and biocompatibility data from the novel device were compared directly to the predicate device.
- Direct Comparison of Device Characteristics: Material composition, design, operating principle, sterilization method, and indications for use were directly compared to the predicate device.
There is no "expert consensus," "pathology," or "outcomes data" in the typical sense used for diagnostic or treatment efficacy studies, as the core of this submission is device equivalence based on physical and functional characteristics.
8. Sample Size for the Training Set
This information is not applicable. This is a submission for a physical medical device, not an AI or machine learning model. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for an AI/ML model.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.