(91 days)
TriMed RipCord devices are intended for use to supplement repair or reconstruction during healing of ligament injuries or deficiencies of the extremities.
The TriMed RipCord device is indicated to be used as an adjunct in combination with compatible TriMed fixation implants to provide fixation during the healing process in syndesmotic trauma, such as fixation of syndesmosis disruptions in connection with Weber B and C ankle fractures.
The TriMed RipCord Screw is a single-use, sterile, non-absorbable implantable device designed to aid in the treatment of syndesmotic injuries of the lower extremities. The device consists of a far button, an ultra-high molecular weight polyethylene (UHMWPE) suture, and a cannulated screw.
The provided document K251134 is an FDA 510(k) Clearance Letter for a medical device called "RipCord." This document focuses on demonstrating substantial equivalence to existing legally marketed devices, primarily through non-clinical testing. It does not contain information related to software, imaging, or AI-assisted diagnostic tools. Therefore, many of the requested elements, such as those pertaining to AI model performance, human reader studies, and AI-specific ground truth establishment, are not applicable to this documentation.
However, I can extract the information relevant to the device's acceptance criteria and the study that proves it meets them, based on the provided text, while acknowledging the limitations for an AI-centric request.
Acceptance Criteria and Study Proving Device Meets Criteria
The device in question, the TriMed RipCord Screw, is a mechanical implant for bone fixation. The study proving its performance is based on non-clinical bench testing, demonstrating mechanical properties, rather than clinical efficacy or diagnostic accuracy.
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the acceptance criteria were established to demonstrate performance equivalence to the predicate device cleared under K220650. However, the specific numerical acceptance criteria values are not detailed in this public FDA clearance letter. Similarly, the exact numerical reported performance values are not provided; only a qualitative statement that the device "successfully met the established acceptance criteria" is present.
Here's a generalized table based on the information provided:
| Acceptance Criterion Type | Description (as inferred from document) | Reported Device Performance (as stated in document) |
|---|---|---|
| Static Loading Strength | Device's ability to withstand a constant load without failure. | "Successfully met the established acceptance criteria, demonstrating performance equivalence to the predicate device cleared under K220650." |
| Cyclic Endurance | Device's ability to withstand repeated loads without failure (fatigue). | "Successfully met the established acceptance criteria, demonstrating performance equivalence to the predicate device cleared under K220650." |
| Torsional Strength (for TriMed Cannulated Hex 3.2mm screws) | Device's resistance to twisting forces. | "Test samples met the acceptance criteria." |
| Driving Torque (for TriMed Cannulated Hex 3.2mm screws) | The torque required to drive the screw into bone. | "Test samples met the acceptance criteria." |
| Axial Pullout Strength (for TriMed Cannulated Hex 3.2mm screws) | Device's resistance to being pulled out along its axis. | "Test samples met the acceptance criteria." |
Note: The document explicitly states: "Clinical studies were not conducted for the subject devices." This means the "acceptance criteria" and "device performance" relate solely to the mechanical properties as demonstrated through bench testing, not clinical outcomes or diagnostic accuracy.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The specific sample sizes for the non-clinical tests (static loading, cyclic endurance, torsional strength, driving torque, axial pullout) are not specified in the provided document. The document simply states "TriMed RipCord Screw devices were subjected to static loading and cyclic endurance testing" and "TriMed Cannulated Hex 3.2mm screws were subjected to torsional strength, driving torque and axial pullout tests."
- Data Provenance: The data provenance for this in-vitro, non-clinical bench testing does not involve patient data or geographical origin in the context of clinical studies. It is based on laboratory testing performed by the manufacturer (TriMed, Inc.). The testing is by its nature prospective in the sense that the tests were designed and executed to evaluate the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable as the document describes a mechanical device cleared based on non-clinical bench testing. There is no "ground truth" derived from expert interpretation of medical images or patient data. The "ground truth" for these tests would be the measured physical properties of the materials and device, compared against pre-defined engineering and performance specifications.
4. Adjudication Method for the Test Set
This question is not applicable as the document describes non-clinical mechanical testing, not a study involving human interpretation or adjudication of medical data. The results of mechanical tests are objective measurements, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This question is not applicable. The device is a bone fixation implant, not an AI-assisted diagnostic tool. No MRMC study was conducted, as confirmed by the statement "Clinical studies were not conducted for the subject devices."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a bone fixation implant, not an algorithm or software.
7. The Type of Ground Truth Used
The "ground truth" for this medical device's performance is based on engineering specifications and mechanical property measurements. The device's performance was compared to that of a predicate device (K220650) to demonstrate "performance equivalence." This is an in-vitro, physical/mechanical ground truth, not a clinical, pathological, or outcomes-based ground truth.
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" as the device is a mechanical implant, not an AI model or software algorithm that undergoes machine learning training.
9. How the Ground Truth for the Training Set was Established
This question is not applicable for the reasons stated in point 8.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.