(123 days)
The MedicineLodge, Inc. (MLI) - Cross Pin is used to secure soft tissue graft fixations during cruciate ligament reconstruction surgeries.
The MedicineLodge, Inc. (MLI) Cross Pin is a partially threaded metal fixation fastener used to attach soft tissue allografts or autografts to host bone.
This document describes a medical device, the MLI - Cross Pin, and its comparison to a predicate device for the purpose of demonstrating substantial equivalence. The information provided is not from a study proving device meets acceptance criteria through clinical performance metrics, but rather a mechanical testing study aimed at demonstrating equivalence to a predicate device. Therefore, many of the requested fields cannot be directly populated as they relate to clinical efficacy and AI performance.
Here's an attempt to extract relevant information and note where the requested information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in terms of specific performance thresholds for clinical outcomes (e.g., accuracy, sensitivity, specificity). Instead, the criterion for the mechanical testing was "no significant differences (p > 0.05)" in load to failure when compared to the predicate device.
| Acceptance Criteria (Mechanical Testing) | Reported Device Performance |
|---|---|
| No significant difference (p > 0.05) in load to failure compared to predicate device (DePuy Cross Pin) in 3-point bending. | No significant differences (p > 0.05) found in comparing load to failure between the MLI Cross Pin and the DePuy Cross Pin in 3-point bending. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Mechanical Testing: Not explicitly stated. The document mentions "bending property studies on the subject and predicate device," implying multiple units were tested, but the exact number for each device type is not provided.
- Data Provenance: The tests were conducted by MedicineLodge, Inc. and are described as "non-in-vitro mode" which suggests lab-based mechanical testing, not human or animal data. The country of origin is MedicineLodge, Inc.'s location (Logan, UT, USA). The study is prospective in the sense that the tests were designed and executed to compare the devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This was a mechanical engineering test on physical devices, not a study requiring expert clinical interpretation or ground truth establishment in a medical context.
4. Adjudication Method for the Test Set
Not applicable. This was a mechanical engineering test, not a study requiring clinical adjudication. The comparison was based on statistical analysis (Students t-test) of physical properties.
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
Not applicable. This document describes a medical device (a fixation pin) and its mechanical properties. It does not involve AI or human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This document describes a medical device (a fixation pin) and its mechanical properties. It does not involve AI algorithms.
7. The Type of Ground Truth Used
The "ground truth" in this context is the measured mechanical load to failure performance of the predicate device (DePuy Cross Pin) which the new device (MLI Cross Pin) aimed to be equivalent to.
8. The Sample Size for the Training Set
Not applicable. Mechanical testing does not typically involve "training sets" in the same way machine learning models do.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
§ 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.