(82 days)
The MedicineLodge, Inc. (MLI) - Set Screw is used to secure graft fixations during cruciate ligament, tendon or other soft tissue reconstruction surgeries.
The MedicineLodge, Inc. (MLI) Set Screw is a threaded, cannulated bone screw used to attach bone-tendon-bone allografts or autografts to host bone.
To begin, the design is similar in design to currently marketed endosteal set screws. The spiral threads are designed to firmly grasp the bone and graft during screw insertions, and the tapered proximal nose allows the set screw to hold the bone end of the graft upon insertion of the set screw. MLI Set Screws are designed to be manually inserted using a standard cannulated 3.5mm (cannulation of 0.096") hex driver, per ASTM F-116-85.
The MLI Set Screw will be available in 9mm and 11mm outer diameters, each offered in lengths of 20mm, 25mm, 30mm, 35mm and 40mm. The table below lists the various set screw combinations along with corresponding part numbers.
All MLI Set Screws are manufactured from Ti-6Al-4V ELI material (ASTM F-136) and are anodized per AMS 2488C for a smoother and more uniform surface finish. The anodized layer additionally provides an inert coating which helps to prevent galling and corrosion by providing a passive surface.
As mentioned previously, the MLI Set Screw possesses a central cannulation to allow the use of guide wires for accurate placement of the screw in the host bone. In application, the use of guide wires reduces the chances of tunnel screw divergence. All MLI Set Screws are designed for use with a 0.093 inch diameter guide wire, which is also provided by MedicineLodge, Inc.
The provided text describes a 510(k) submission for the MLI - Set Screw, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving independent effectiveness through a traditional clinical study with defined acceptance criteria and statistical performance metrics typically seen in diagnostic or AI device submissions.
Therefore, many of the requested categories related to medical device performance metrics, such as sensitivity, specificity, MRMC studies, and ground truth establishment, are not applicable to this submission. The "acceptance criteria" here is primarily about demonstrating mechanical equivalence and performance comparable to the predicate device.
Here's an attempt to extract the relevant information based on the provided text, while acknowledging the limitations:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance | MLI Set Screw Performance (Compared to DePuy Cannulated Set Screw) |
|---|---|---|
| Mechanical Fixation Strength | No statistical significance (p ≤ 0.005) in fixation strength between the subject and predicate devices. | "no statistical significance (p ≤ .005) could be found between the set screws." |
Explanation: The "acceptance criteria" here is implicitly defined by the chosen statistical threshold for non-inferiority or equivalence in mechanical testing. The goal was to show that the MLI Set Screw's fixation strength was not statistically different from the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The text mentions "fresh frozen porcine knee specimens" and "the test results... were compared," implying multiple specimens were used, but the exact number for statistical analysis is not provided.
- Data Provenance:
- Country of origin: Not explicitly stated, but the testing was conducted by "MedicineLodge, Inc." (located in Logan, UT, USA).
- Retrospective or Prospective: Not explicitly stated, but the description of the testing procedure ("The fixation strength testing was conducted on fresh frozen porcine knee specimens") suggests a prospective, experimental study design on biological models.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. For a mechanical device like a set screw, "ground truth" typically refers to objective physical measurements rather than expert interpretations. The "truth" for this test was the measured fixation strength.
4. Adjudication Method for the Test Set
- Not Applicable. This concept is relevant for studies involving human interpretation or classification, not for direct mechanical testing.
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
- No. This is not an AI-assisted diagnostic device, and therefore, an MRMC study is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithmic or AI device.
7. The Type of Ground Truth Used
- Mechanical Fixation Strength Data. The "ground truth" for this study was the quantified "Fixation strength" measured in the pig model through tensile testing.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" as this is not a machine learning or AI device. The testing described is a direct mechanical comparison.
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.