MedicineLodge, Inc. (MLI) Modular Staples are indicated for use in soft tissue graft fixations to the femur or tibia, or both, during cruciate ligament, tendon or other soft tissue graft (e.g. semitendinosus) repair procedures.

Device Description

The MLI Modular Staple is a three piece device consisting of a staple, a washer and a set screw that are designed to be used as an assembly unit. Each of the implant components are manufactured from Ti-6Al-4V ELI, per ASTM F-136 and are discussed in turn below.

AI/ML Overview

The MedicineLodge, Inc. (MLI) Modular Staple is a medical device, and the provided text is a 510(k) Premarket Notification summary. This document is a pre-market submission to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed device (predicate device) and does not require extensive device testing based on its substantial equivalence.

Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the traditional sense for a new AI/software medical device does not apply here. This document is essentially arguing that no new performance studies are necessary.

Here's an analysis based on the provided text, addressing your questions in the context of a 510(k) for a physical medical device relying on substantial equivalence:

1. A table of acceptance criteria and the reported device performance

This document does not present quantitative acceptance criteria or device performance data from a specific study designed to show the MLI Modular Staple meets those criteria. Instead, it argues for substantial equivalence to predicate devices based on design concepts, materials, manufacturing methods, and indications for use.

The closest to "reported device performance" are statements affirming that:

"MLI Modular Staples are manufactured from proven materials"
"equivalent in design to the selected predicate devices"
"the staple design is virtually identical to standard bone staple design (per ASTM F-564)"
"the set screw thread and hexagonal head drive design is in accordance with applicable ISO standards (ISO 5835, ISO 9268)"

The table (Table 1) provided in the document is a feature comparison to predicate devices, highlighting similarities and differences, rather than a performance comparison against specific acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

No test set or data provenance is mentioned because no new device performance testing was performed to support this 510(k) submission. The manufacturer explicitly states: "MedicineLodge, Inc. does not believe that device testing is necessary to demonstrate the substantial equivalence of the device."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable, as no new device performance testing or expert review of a test set was conducted for this 510(k). The ground truth for the claims of substantial equivalence relies on industry standards (ASTM, ISO) and the established safety and effectiveness of the predicate devices.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable, as no new device performance testing or adjudication of results was conducted for this 510(k).

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 is for a physical orthopedic staple, not an AI or software device. Therefore, MRMC studies are irrelevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/algorithm device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context is based on:

Established industry standards: ASTM F-136 (Ti-6Al-4V ELI material), ASTM F-564 (Bone Staples), ASTM F-116 (Hex driver), ISO 5835 and ISO 9268 (Bone Screws).
Prior regulatory approvals: The existence and prior approval of predicate devices (Richards Fixation Staples and Linvatec Concept Staple Fixation System) which the MLI Modular Staple claims substantial equivalence to.
General acceptance of materials and manufacturing methods: "proven implant materials and manufacturing methods."

8. The sample size for the training set

Not applicable, as this is not an AI/machine learning device. No training set was used.

9. How the ground truth for the training set was established

Not applicable, as this is not an AI/machine learning device. No training set was used.

Summary of the Document's Stance on "Device Testing":

The core of this 510(k) submission is the argument for substantial equivalence to existing legally marketed devices, thus circumventing the need for new clinical performance studies or extensive device testing at the time of submission. The manufacturer states:

"MedicineLodge, Inc. does not believe that device testing is necessary to demonstrate the substantial equivalence of the device."
They rely on "materials and vendor certifications, in-house standard operating procedures (SOP's), and applicable ASTM standards" during manufacturing.
They do plan for "future device testing according to appropriate ASTM standards to quantitatively compare the performance of the MLI Modular Staple device to other commercially available bone staples in simulated testing," but this is future and not part of the current justification for the 510(k) clearance.

Summary

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OCT . I 1996

962705

Premarket Notification

510(k) Summary of Safety and Effectiveness Information

DATE OF SUMMARY PREPARATION

July 10, 1996

MANUFACTURER

MedicineLodge, Incorporated 152 South 600 West Logan, Utah 84321 Telephone: (801) 753-7675 .............................................................................................................................................................................. Fax: (801) 753-7698

MANUFACTURER CONTACT PERSON

Wade Fallin Executive Vice President MedicineLodge, Inc. 152 South 600 West Logan, Utah 84321

Telephone: (801) 753-7675 Fax: (801) 753-7698

PROPRIETARY NAME

MedicineLodge, Inc. (MLI) Modular Staple

COMMON NAMES

Orthopedic Bone Staple Orthopedic Washer

CLASSIFICATION NAME

Fixation Bone Staple

CLASSIFICATION REFERENCE

21 CFR § 888.3030

DEVICE PRODUCT CODE

87 JDR

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CLASSIFICATION PANEL

Orthopedic and Rehabilitation Devices

PROPOSED REGULATORY CLASS

In accordance with FDA classification of bone staples and orthopedic washers as Class II medical devices, this device is proposed for placement in Class II.

REASON FOR PREMARKET NOTIFICATION

The MLI Modular Staple is a new medical device proposed for placement in Class II.

SPECIAL CONTROLS

At this time, Food and Drug Administration generated Performance Standards applicable to MedicineLodge, Inc. Modular Staple are not in force. MedicineLodge, Inc. does not believe that device testing is necessary to demonstrate the substantial equivalence of the device. MedicineLodge, Inc. utilizes materials and vendor certifications, in-house standard operating procedures (SOP's), and applicable ASTM standards, as appropriate in the manufacture of the device.

DEVICE DESCRIPTION

SUBSTANTIAL EQUIVALENCE COMPARISON

Based on the design concept, indications for use, use of standard materials, and feature comparisons to selected predicate devices, MedicineLodge, Inc. believes that sufficient evidence exists to conclude that the MLI Modular Staple is substantially equivalent to existing legally marketed soft tissue bone staples.

Table 1 at the end of this section summarizes all relevant feature comparisons between the MLI Modular Staple and the selected predicate devices.

To begin, the general design concept, methods of sterilization, and device packaging for all MLI Modular Staple components are equivalent to those used for the selected predicate devices.

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MedicineLodge, Inc. also uses materials (Ti-6Al-4V per ASTM F-136) and manufacturing methods equivalent to those used for the production of the Linvatec, Inc. Concept Staple Fixation System. However, it should be mentioned that Richards Fixation Staples are instead manufactured from Cobalt-Chromium (per ASTM F-75) and the devices are cast rather than machined. MedicineLodge, Inc. believes that the use of proven implant materials and manufacturing methods relative to one of the selected predicate devices establishes the substantial equivalence of the device in this regard.

MLI Modular Staples are indicated for use in soft fissue graft fixations to the femur or tibia, or both, during cruciate ligament, tendon or other soft tissue graft (e.g. semitendinosus) repair procedures. The previously listed predicate device systems are similarly indicated for procedures involving soft tissue reconstruction. In fact, the Richards Fixation Staples have indications for use far broader in scope.

The MLI Modular Staple is designed to be used as an assembly unit. The use of screws and washers in soft tissue reconstruction is well established. The modular design of the MLI Modular Staple utilizes known screw and washer technology in combination with a standard bone staple design. The two legs of the staple serve to anchor the implant and soft tissue graft to the bone, while the washer and set screw act as an additional means of affixing the soft tissue graft to bone. In cases where the surgeon uses the stable assembly with the set screw alone, the assembled device is identical to a standard bone staple with an elongated spike extending from the center of the staple base.

The staples are designed in accordance with ASTM F-564: Standard Specification for Bone Staples and are thus similar in two-legged design to many currently marketed bone staple devices. The staples are provided in the sizes tabulated below:

MLI Staple Width	MLI Staple Length
13 mm	25.4 mm
16 mm
20 mm

For each of the three staple designs, a washer has been designed to uniquely fit the staple. Each washer is designed to be compatible with a single staple size and the device labeling will clearly indicate that the packaged washer is for use with only the specified size of staple. The MLI Modular Staple Washers are offered in the sizes indicated in the table below.

Washer Size	For Use With:
13 mm	13 mm Modular Staple
16 mm	16 mm Modular Staple
20 mm	20 mm Modular Staple

The washers possess spikes spaced equidistant from each other on the distal side of the washer to penetrate the soft tissue graft, thus anchoring the graft between the bone and the distal surface of the washer.

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The washers have a central hole smaller in diameter than the threaded portion of the set screw. This ensures that only the spike at the tip of the set screw passes through the central hole in the washer component. This provides a means for the set screw to apply a compressive force to the washer as the screw is threaded into the staple base. In this manner, the washer is more firmly pressed onto the soft tissue graft thus increasing the compression on the graft.

The MLI Modular Staple Set Screw is a small, spiked screw designed to be inserted into the threaded hole of the staple. The spike at the tip of the screw is designed to pass through the staple and washer to penetrate the soft tissue graft.

The screw is designed to be inserted using a standard 3.5 mm hex driver (per ASTM F-116). Both the threaded portion of the set screw and the hexagonal head drive connection conform to ISO 5835. Metal Bone Screws with Hexagonal Drive Connection. Spherical Under-Surface of Head. Assymetrical Thread Dimensions and ISO 9268. Metal Bone Screws with Conical Under Surface of Head, Symmetrical Thread Dimensions. In this respect, the set screw is equivalent in thread design and hexagonal head drive geometry to standard bone screws.

As described previously, the threaded portion of the screw is designed to thread into the central threaded hole of the staple component. As the screw is threaded into the staple, the spike is forced through the staple and washer and into the soft tissue graft. This mechanism potentially serves to more firmly secure the soft tissue graft between the implant and the host bone.

DEVICE TESTING

As described previously. MLI Modular Staples are manufactured from proven materials and are equivalent in design to the selected predicate devices. The staple design is virtually identical to standard bone staple design (per ASTM F-564) and the set screw thread and hexagonal head drive design is in accordance with applicable ISO standards (ISO 5835, ISO 9268). Also, the washers are designed to uniquely fit the staples and the device labeling clearly states that the packaged washer is only to be used with the indicated staple size.

For these reasons, MedicineLodge, Inc. does not believe that device testing is necessary to demonstrate the substantial equivalence of the device. MedicineLodge, Inc. does plan to perform future device testing according to appropriate ASTM standards to quantitatively compare the performance of the MLI Modular Staple device to other commercially available bone staples in simulated testing.

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TABLE 1

Feature comparisons between the MedicineLodge, Inc. Modular Staple and the selected predicate devices (differences are indicated in bold print).

	MLI Modular Staples	Richards Fixation Staples	Linvatec Concept Staple
			Fixation System
Indications	MedicineLodge, Inc. ModularStaples are indicated for use insoft tissue graft fixations to thefemur or tibia, or both, duringcruciate ligament, tendon orother soft tissue graft (e.g.semitendinosus) repairprocedures.	1.Tendon repairs, transfers ortransplants such as in the treatmentof paralytic conditions, tendonavulsions or ruptures, in which thetendon is fixed to bone using eithera table staple or two regular fixationstaples.2.Ligament repairs, reconstruction orreplacement in which the ligament isfixed to bone as in Number 1 above.3.Adjunctive internal fixation offractures, arthrodeses such as triplearthrodesis.4.The fixation of avulsed fragments tobone such as the greater humeral orfemoral tuberosity, the calcaneum,the tibial tubercle, or other suchinjuries.	The Linvatec Staple FixationSystem is used as a means ofattaching soft tissue to bone.
Materials	TI6AI4V ELI (per ASTM F-136)	Cobalt Chromium (per ASTM F-75)	Ti6Al4V ELI (per ASTM F-136)
ASTM F-664Conformance	Yes	Yes	Yes
Staple Plate Profile	Low	Low	Low
Staple Widths	13, 16, 20 mm	6.35, 7.9, 11.1, 14.3 mm	9.5, 13.5, 16.5 mm
Staple Lengths	25.4 mm	unknown	22-23 mm
Leg Geometry	Barbed	Barbed	Barbed
Optional Washer	Yes	No	No
Central Set Screw	Yes	No	No
Number ofComponents	Three	One	One
Method of Insertion	Staple Inserter	Staple Inserter	Staple Inserter
Option to exertfurther pressure onthe graft afterstaple insertion	Yes	No	No
Surface Texture	Satin Finish	Satin Finish	Satin Finish
Spikes on DistalSurface of Staple	Yes	Yes	Yes
Sterilization Status	Sterile & Non-sterile	Sterile & Non-sterile	Sterile & Non-sterile
Manufacturer	MedicineLodge, Inc.	Smith & Nephew Richards, Inc.	Linvatec, Inc.
510(k) Approved?	N/A	Presumed Premarket Amendment	Yes - K894929

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Regulation Number and Section

§ 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.