The MedicineLodge, Inc. (MLI) - Set Screw is used to secure graft fixations during cruciate ligament, tendon or other soft tissue reconstruction surgeries.

Device Description

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.

AI/ML Overview

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.

Summary

510 (K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION K961905

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13.1 Date of Summary Preparation

May 10, 1996

13.2 Manufacturers Contact Person

Wade Fallin
Vice President of Research and Development/General Manager
152 South 600 West
Logan, UT 84321
Telephone: 801-753-7675
Fax: 801-753-7698

13.3 Proprietary Device Name

MLI - Set Screw

13.4 Common Name

Endosteal Set Screw

13.5 Classification Name

Smooth or Threaded Metallic Bone Fixation Fastener

13.6 Classification Reference

21CFR 888.3040

13.7 Device Product Code

87 HWC

13.8 Regulatory Class

Class II

13.9 Special Controls

At this time, the Food and Drug Administration generated performance standards applicable to the MLI - Set Screw are not in force.

13.10 Materials

The following material is used in the manufacturing of the MLI - Set Screw.
Ti-6Al-4V ELI per ASTM F-136.

13.11 Indications for Use

The MedicineLodge, Inc. (MLI) - Set Screw is used to secure graft fixations during cruciate ligament, tendon or other soft tissue reconstruction surgeries.

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13.12 Device Description

The MedicineLodge, Inc. (MLI) Set Screw is a threaded, cannulated bone screw used to attach bone-tendon-bone allografts or autografts to host bone.

TABLE
MLI - Set Screw Sizes

PART # STERILE	PART # NON-STERILE	MLI - DIAMETER	LENGTH	DESCRIPTION
730920	740920	9mm	20mm	9mm x 20mm Set Screw
730925	740920	9mm	25mm	9mm x 25mm Set Screw
730930	740930	9mm	30mm	9mm x 30mm Set Screw
730935	740935	9mm	35mm	9mm x 35mm Set Screw
730940	740940	9mm	40mm	9mm x 40mm Set Screw
731120	741120	11mm	20mm	11mm x 20mm Set Screw
731125	741125	11mm	25mm	11mm x 25mm Set Screw

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PART # STERILE	PART # NON-STERILE	MLI - DIAMETER	LENGTH	DESCRIPTION
731130	741130	11mm	30mm	11mm x 30mm Set Screw
731135	741135	11mm	35mm	11mm x 35mm Set Screw
731140	741140	11mm	40mm	11mm x 40mm Set Screw

13.13 Substantially Equivalent Predicate Devices

TABLE
Predicate Device Identification

No.	MANUFACTURE'S NAME	DEVICE NAME	510(K) APPROVED
1	DePuy, Inc. Warsaw, IN	DePuy Cannulated Set Screw	Yes
2	Arthrotek, Inc. Ontario, CA	Arthrotek Set Screw	Yes

13.14 Substantial Equivalence Comparison

The following table displays the similarities and differences of the new device to the legally marketed devices to which equivalency is claimed.

TABLE
Direct Comparison to Already Marketed Products

NO	FEATURE	MLI Set Screw	DEPUY Set Screw
1.	Diameters	9mm and 11mm	9mm
2.	Lengths	20mm, 25mm, 30mm, 35mm and 40mm	20mm, 25mm, 30mm 35mm and 40mm
3.	Materials	Ti-6Al-4V ELI (ASTM - F136)	Ti-6Al-4V ELI (ASTM - F136)
4.	Intended Use	Cruciate Ligament Reconstruction Surgery	Cruciate Ligament Reconstruction Surgery
5.	Cannulated Wire Sizing	0.093" diameter	0.093" diameter
6.	Hex Driver Sizing	3.5mm Hex	4.0mm Hex
7.	Thread Crest	Soft	Soft

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NO	FEATURE	MLI Set Screw	DEPUY Set Screw
8.	Taper of inner diameter at proximal end of screw	Yes	Yes
9.	Surface finish	Ti Anodized Coating	High Polish
10.	Self tapping feature	No	No
11.	Flare at distal end of screw	9° Flare	None
12.	Packaging	Sterile and Non-Sterile	Sterile and Non-Sterile

As stated above, MedicineLodge, Inc. believes that the MLI Set Screw is substantially equivalent to the predicate devices indicated in the above table. To demonstrate the substantial equivalence of the MLI Set Screw, it is compared to the DePuy Set Screw.

With regard to the device design, the MLI Set Screw is designed with standard thread geometry. Both the MLI and DePuy sets screws are cannulated to allow use of a 0.093 inch diameter guide wire. Further, both set screws are available in 20mm, 25mm, 30mm, 35mm and 40mm lengths, with the MLI Set Screw available in 9mm and 11mm diameters.

To further elaborate on the design similarities, the proximal use of the MLI - Set Screws tapers at an angle of 45° similar to the DePuy Set Screw.

One of the two minor design differences between the MLI Set Screw and the DePuy Set Screw is the size of the Hex Driver (3.5mm for the MLI Set Screw versus 4.0mm for the DePuy Set Screw). MedicineLodge believes that this design difference does not represent a significant difference in design between the MLI Set Screw and the DePuy Set Screw. The second design difference is the presence of a 9° flare of the internal diameter of the MLI Set Screw at it's distal end which again does not represent a significant difference in functionality of the set screw itself.

To conclude, based on the design concept, indented use, use of standard materials, feature comparisons to selected predicate devices, and device testing, MedicineLodge, Inc. believes that sufficient evidence exists to conclude that the MLI Set Screw is substantially equivalent to existing legally marketed threaded metallic bone fixation fasteners.

13.15 Differences from Predicate Device

MedicineLodge, Inc. would like to claim that the MLI - Set Screw is substantially equivalent to the predicate devices and we find that there are no significant design differences between the subject and predicate device.

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Minor modifications such as a 3.5mm hex driver used with the MLI - Set Screw and a 4.0mm hex driver used with the DePuy Cannulated Set Screw do not contribute to the functionality of the implant/device and cannot be considered a significant design change. The 9° flare of the internal diameter of the MLI Set Screw can also be considered a non-functional design difference.

13.16 Performance Testing (Subject and Predicate Devices)

MedicineLodge, Inc. has conducted extensive mechanical testing on the subject and predicate devices to prove substantial equivalence. The following mechanical tests were performed.

a. Fixation strength of the DePuy Cannulated Set Screw in static bone patellar tendon tensile testing in the pig model.

b. Fixation strength of the MedicineLodge, Inc. Set Screw in static bone patellar tendon tensile testing in the pig model.

MedicineLodge, Inc. considers the DePuy Cannulated Set Screw as a suitable predicate device and would like to compare it's Set Screw to the same. The DePuy Set Screw was selected as a predicate due to it's similarity in design. Therefore, for all device testing, a similarly sized 9mm DePuy Set Screw was used for comparison.

The fixation strength testing was conducted on fresh frozen porcine knee specimens. The procedure of surgically placing the set screw and the bone-tendon-bone graft was adapted to mimic the human ACL reconstruction technique. The test results of the DePuy Set Screw and the MLI Set Screws were compared and no statistical significance (p ≤ .005) could be found between the set screws.

13.17 Conclusion

Based on the design concept, use of standard material, feature comparisons to selected predicate devices, the device and predicate device testing, MedicineLodge, Inc. believes that sufficient evidence exists to conclude that the MLI - Set Screw is substantially equivalent to existing legally marketed endosteal cruciate fixation devices.

Regulation Number and Section

§ 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.