LAGWIRE SYSTEM by FXDEVICES | FDA 510(k) Summary

The Lagwire fixation system consists of two (2) main components, a wire and a cap. The Lagwire materials are Titanium 6Al-4V alloy, which meets the requirements of ASTM F-136. It is available as 4.5 mm diameter device and is obtainable in various length ranges. The Lagwire is provided sterile and intended for single use only.

AI/ML Overview

Here's an analysis of the provided text regarding the Lagwire System, focusing on the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary (K070393) for the Fx Devices Lagwire System focuses on demonstrating substantial equivalence to a predicate device, the Triage Medical BONE-LOK® MVP Cortical-Cancellous Compression Device (K042244). As such, explicit numeric acceptance criteria and detailed device performance metrics (e.g., specific tensile strength, compression force) are not provided in this summary.

Instead, the acceptance criteria are implicitly met by demonstrating "substantial equivalence" to the predicate in key areas, and the "performance" is reported as satisfying this equivalence.

Aspect of Equivalence/Performance	Acceptance Criteria (Implicit)	Reported Device Performance
Design	"Substantially equivalent to predicate"	"Substantially equivalent in design"
Material Composition	"Substantially equivalent to predicate materiais"	"Titanium 6Al-4V alloy, which meets the requirements of ASTM F-136. Substantially equivalent in materials"
Construction	"Substantially equivalent to predicate construction"	"Substantially equivalent in construction"
Intended Use	"Substantially equivalent to predicate intended use"	"Intended for use in the general management of fractures and reconstructive surgery. Substantially equivalent in intended use"
Performance (general)	"Comparable mechanical performance to predicate to ensure safety and efficacy"	"Bench testing was conducted to support equivalency. Does not raise any new safety and efficacy concerns when compared to these similar legally marketed devices."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document only mentions "Bench testing was conducted to support equivalency." It does not specify the sample size (e.g., number of devices tested) for this bench testing.
Data Provenance: The document does not specify the country of origin of the data. It is a pre-market notification to the FDA in the USA, so the testing was likely conducted in North America or by a laboratory that adheres to standards acceptable to the FDA. The testing conducted was retrospective in the sense that it's a pre-market submission, but the "bench testing" itself is a prospective experimental study on physical devices, not an analysis of existing patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to this type of submission. The ground truth for this device's performance is established through bench testing against engineering standards and comparison to a predicate device's known performance, rather than through expert human interpretation of data (like in imaging or diagnostic devices). There are no "experts" in the context of establishing ground truth for a test set as described for AI/diagnostic devices.

4. Adjudication Method for the Test Set

This information is not applicable. Since the evaluation is based on objective bench testing and comparison to engineering specifications or predicate device characteristics, there is no need for human adjudication of test results in the way it might be done for diagnostic assessments.

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

There was no MRMC comparative effectiveness study performed. This type of study is relevant for diagnostic or AI-assisted devices where human readers (e.g., radiologists) interpret images or data. The Lagwire System is a physical orthopedic fixation device, not a diagnostic tool or AI software.

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

There was no standalone (algorithm-only) performance study done. This concept is specific to AI or software algorithms. The Lagwire System is a physical medical device.

7. The Type of Ground Truth Used

The ground truth used for the Lagwire System is based on:

Engineering Standards: Specifically, ASTM F-136 for the Titanium 6Al-4V alloy. This implies that the material properties meet established industry standards for medical implants.
Predicate Device Performance: The primary "ground truth" for substantial equivalence is the established safety and effectiveness of the legally marketed predicate device (Triage Medical BONE-LOK® MVP Cortical-Cancellous Compression Device). The bench testing would have aimed to show that the Lagwire's mechanical performance is comparable to that of the predicate, thus inferring similar safety and efficacy.

8. The Sample Size for the Training Set

This information is not applicable. Training sets are used for machine learning models. The Lagwire System is a physical medical device, not a software or AI product.

9. How the Ground Truth for the Training Set was Established

This information is not applicable as there is no training set for this device.

Summary

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K070393
2/6/2007

510K Summary of Safety and Effectiveness Fx Devices Lagwire System

1. Sponsor Name FxDevices One South Ocean Blvd., Suite 324 Boca Raton, FL 33432
  MAY - 4 2007
1. Device Name Lagwire System Panel Orthopaedic Classification Name CFR Number
  Smooth or Threaded Metallic Bone Fixation Fastener Class II (per 21 CFR 888.3040) HWC
ന് Identification of Predicate or Legally Marketed Device The Lagwire is substantially equivalent to the Triage Medical BONE-LOK® MVP Cortical-Cancellous Compression Device cleared under K042244
1. Device Description

Product Code

ട്. Intended Use The Lagwire System is intended for use in the general management of fractures and reconstructive surgery.
റ. Comparison of Technological Characteristics The Lagwire was compared to the predicate with respect to in design, materials, construction, intended use, and performance.
7 Performance Testing Bench testing was conducted to support equivalency
1. Statement of Equivalency The Lagwire System is substantially equivalent in design, materials, construction and intended use as those of the predicate device and therefore does not raise any new safety and efficacy concerns when compared to these similar legally marketed devices.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FxDevices % Mr. Rich Lipschutz Operations Manager One South Ocean Boulevard Suite 324 Boca Raton, Florida 33432

MAY - 4 2007

Re: K070393

Trade/Device Name: Lagwire System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: February 6, 2007 Received: February 9, 2007

Dear Mr. Lipschutz:

We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the devices, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your devices are classified (see above) into either class II (Special Controls) or class III (PMA), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your devices in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your devices comply with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 – Mr. Rich Lipschutz

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your devices as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Chabaud Buens

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):	K070393
Device Name:	Lagwire System
Indications For Use:

The Lagwire is indicated for use in the general management of fractures and reconstructive surgery.

Prescription Use _ X _ _ _

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sarhare Buehum formykn
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

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510(k) Number 1620393

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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.