(51 days)
The INFILOOP® Fixed Loop UHMWPE Suture Titanium Button is indicated in surgical procedures for soft tissue fixation to the bone. It is used for fixation of tendons and ligaments during orthopaedic reconstruction procedures such as Knee ligament reconstruction which includes anterior cruciate ligament (ACL), posterior cruciate ligament (PCL), medial collateral ligament (MCL), and lateral collateral ligament (LCL).
The use of the INFILOOP® Fixed Loop UHMWPE Suture Titanium Button provides the orthopaedic surgeon a means of accurate fixation in ligament reconstructive surgery of soft tissue to bone fixation. The fixation device allows for arthroscopic ligament reconstruction approaches.
Here's a breakdown of the acceptance criteria and study information for the INFILOOP® Fixed Loop UHMWPE Suture Titanium Button, based on the provided FDA 510(k) summary.
Note: This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed de novo clinical study with specific acceptance criteria in the vein of a novel AI/software device. Therefore, the information provided will reflect the nature of a medical device clearance process for a predicate-based device, emphasizing non-clinical performance and material equivalence.
Acceptance Criteria and Device Performance
The acceptance criteria for this device are primarily demonstrated through non-clinical performance testing and material equivalence to predicate devices. The "performance data" acceptance criteria are implicitly tied to demonstrating comparable or superior mechanical properties and biocompatibility.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on Predicate Device Performance and Standards) | Reported Device Performance (INFILOOP® Fixed Loop UHMWPE Suture Titanium Button) |
|---|---|---|
| Mechanical Performance | Pull Out Strength: Comparable to predicate devices (Conmed Linvatec XO Button™, RIGIDLOOP™ Cortical Fixation System). | "Pull Out Testing" performed and results demonstrated suitability for intended use. (Exact values not provided in summary, but deemed acceptable by FDA). |
| Cyclic Loading: Comparable to predicate devices. | "Cyclical Loading" performed and results demonstrated suitability for intended use. (Exact values not provided in summary, but deemed acceptable by FDA). | |
| Biocompatibility | Non-toxic, non-irritating, non-sensitizing, and biologically inert when implanted. | Skin Sensitization, Intracutaneous reactivity, Material Mediated Pyrogenicity, Acute Systemic Toxicity, In-vitro cytotoxicity, Bone Implantation, Intramuscular Implantation, Bacterial Endotoxin USP tests performed. All results deemed acceptable. |
| Material Equivalence | Button and Loop materials (Titanium, UHMWPE) are the same as predicate devices. | Button: Titanium |
| Loop: UHMWPE | ||
| (Similar to predicate devices) | ||
| Suture Material Equivalence/Superiority | Acceptable mechanical properties for suture material (UHMWPE) for soft tissue fixation. | UHMWPE suture used. Literature study cited indicating "Pure UHMWPE suture had higher ultimate failure load than sutures composed of either polyester or polyester plus UHMWPE." This suggests superiority or at least equivalence to predicate suture materials. |
| Sterilization | Effective sterilization validated. | ETO (Ethylene Oxide) sterilization validated. (Similar to predicate devices) |
| Shelf Life | Validated shelf life. | 5 Years validated. (Similar to predicate devices) |
| Single Use | Device designed for single use. | Single Use. (Similar to predicate devices) |
| MRI Compatibility | No contraindications or adverse effects in MRI environment. | MRI Compatibility testing performed. Results deemed acceptable. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each individual non-clinical test (e.g., number of specimens for pull-out strength or cyclic loading, number of animals for biocompatibility studies).
The data provenance is from non-clinical laboratory testing conducted by the manufacturer, Healthium Medtech Limited, likely in India, as that is the submitter's location. The studies are retrospective in the sense that they are conducted on manufactured devices as part of the clearance process, but they are not clinical studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable in the context of this 510(k) submission. For non-clinical performance and biocompatibility testing of a medical device like this button and suture system, "ground truth" is established by adherence to recognized ASTM/ISO standards for mechanical testing and biocompatibility. There isn't an "expert" panel establishing a diagnostic ground truth as there would be for an AI/software device interpreting medical images.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication typically refers to the process of resolving discrepancies among expert interpretations in clinical studies, particularly for diagnostic devices. For mechanical and biocompatibility testing, results are quantitative and compared against predefined specifications from relevant standards or predicate device performance. Deviation from these specifications would lead to failure, not "adjudication."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, especially those involving human interpretation of medical images, to assess reader performance with and without AI assistance. The INFILOOP® Fixed Loop UHMWPE Suture Titanium Button is a surgical implant, not a diagnostic imaging device or an AI-assisted interpretation tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance evaluation in the context of a "human-in-the-loop" scenario is not applicable. This device is a physical surgical implant. The concept of "standalone" typically applies to AI algorithms that can perform a task without human intervention or interpretation (e.g., an AI that directly diagnoses an illness from an image).
7. The Type of Ground Truth Used
For this device, the "ground truth" is predominantly based on:
- Established industry standards: ASTM/ISO standards for mechanical testing (e.g., tensile strength, fatigue) and biocompatibility (ISO 10993 series).
- Performance of legally marketed predicate devices: The "Conmed Linvatec XO Button™" and "RIGIDLOOP™ Cortical Fixation System" set the precedent for acceptable performance and safety profiles.
- Material properties data: Scientific literature and material specifications for UHMWPE and Titanium.
8. The Sample Size for the Training Set
This is not applicable. "Training set" refers to data used to train machine learning models. This device is a physical implant; there is no AI model involved in its function that would require a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for this type of device.
§ 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.