(166 days)
No
The description focuses on calculations based on physician input and visualization, not on learning from data or complex pattern recognition typically associated with AI/ML. While it mentions "Software image recognition," this is likely basic image processing for fiducial marker identification, not advanced AI/ML image analysis. There is no mention of training or test sets for AI/ML models.
No
Explanation: This device is software that assists physicians in calculating strut lengths for an external fixation system, which is a therapeutic device. The software itself is not directly engaged in treatment but rather provides computational assistance to a physician for a therapeutic procedure.
No.
This device, the Deformity Analysis and Correction Software (DACS) and Instrumentation, is described as assisting the physician in calculating strut lengths to manipulate bone fragments for correction of deformities and fractures. It provides calculations and visualization to support a treatment plan, rather than diagnosing a condition.
No
The device description explicitly states that the "Deformity Analysis and Correction Software (DACS) and Instrumentation" includes "Instrumentation" which are "Radiopaque Fiducial Markers". This indicates a hardware component is part of the device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that this software and instrumentation are used in conjunction with an external fixation system applied to the patient's limb to assist in correcting bone deformities. The input is radiographic images of the patient with the fixator installed, not biological specimens.
- The purpose is to assist in surgical planning and execution. The software calculates strut lengths to manipulate bone fragments based on radiographic images and physician input. This is a tool for surgical correction, not for diagnosing a condition or monitoring a patient's health status through analysis of bodily fluids or tissues.
The device falls under the category of surgical planning software and instrumentation used in conjunction with an external fixation system.
N/A
Intended Use / Indications for Use
The Deformity Analysis and Correction Software (DACS) and Instrumentation are intended to be used as components of the Smith & Nephew Taylor Spatial Frame external fixation system that is indicated for the following: post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; open and closed fracture fixation; pseudoarthrosis of long bones; limb lengthening by epiphyseal distraction; correction of bony or soft tissue deformities; correction of bony or soft tissue defects; joint arthrodesis; infected fractures or nonunions.
Product codes (comma separated list FDA assigned to the subject device)
OSN, KTT
Device Description
The Deformity Analysis and Correction Software (DACS) and Device Description Instrumentation is an optional software component and is used to assist the physician in calculating the lengths of the struts connecting the rings to manipulate the bone fragments. The software receives inputs from the physician and allows the physician to visualize the moving bone position. The program computes the strut lengths necessary to implement any desired translation and/or rotation required by the surgeon. The instrumentation includes Radiopaque Fiducial Markers which are attached to the Smith & Nephew Taylor Spatial Frame external fixator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Orthogonal A/P, M/L radiograph after fixator installed on patient
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Performance and accuracy testing were performed to test the ability of the Deformity Analysis and Correction Software (DACS) and Instrumentation to produce correct results under different variations of bone deformities, anatomical orientations, and device combinations. This testing protocol was executed against a variety of CAD-generated image sets and a Smith & Nephew Taylor Spatial Frame x-ray image set. The known inputs for each image (device types and strut settings) was compared to the results calculated by the Deformity Analysis and Correction Software (DACS) and Instrumentation. Testing with these image pairs demonstrated that the Deformity Analysis and Correction Software (DACS) and Instrumentation is capable of successfully correcting the variety of deformities it may encounter in the clinical setting.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Functional testing of the Deformity Analysis and Correction Software (DACS) and Instrumentation was conducted and summarized in Exhibit 36 Verification and Validation Documentation - SWVR-AMD-0101 Software Verification Report. Performance and accuracy testing were performed to test the ability of the Deformity Analysis and Correction Software (DACS) and Instrumentation to produce correct results under different variations of bone deformities, anatomical orientations, and device combinations. This testing protocol was executed against a variety of CAD-generated image sets and a Smith & Nephew Taylor Spatial Frame x-ray image set. The known inputs for each image (device types and strut settings) was compared to the results calculated by the Deformity Analysis and Correction Software (DACS) and Instrumentation. Testing with these image pairs demonstrated that the Deformity Analysis and Correction Software (DACS) and Instrumentation is capable of successfully correcting the variety of deformities it may encounter in the clinical setting. From the evidence submitted in this 510(k), the Deformity Analysis and Correction Software (DACS) and Instrumentation demonstrates that the device is as safe, as effective, and performs as well as or better than the legally marketed device predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of a human figure. To the right of the symbol is a blue square containing the acronym "FDA" in white letters. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
August 13, 2018
Arrowhead Medical Device Technologies, LLC Thomas Twardzik VP - Marketing and Operations 328 Poplar View Lane East. Suite 2 Collierville, Tennessee 38017
Re: K180539
Trade/Device Name: Deformity Analysis and Correction Software (DACS) and Instrumentation Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: OSN, KTT Dated: July 5, 2018 Received: July 13, 2018
Dear Thomas Twardzik:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is 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 device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device 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 device complies 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); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jesse Muir -S 2018.08.13 18:43:19 -04'00' In lieu of. Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180539
Device Name
Deformity Analysis and Correction Software and Instrumentation
Indications for Use (Describe)
The Deformity Analysis and Correction Software (DACS) and Instrumentation are intended to be used as components of the Smith & Nephew Taylor Spatial Frame external fixation system that is indicated for the following: post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; open and closed fracture fixation; pseudoarthrosis of long bones; limb lengthening by epiphyseal distraction; correction of bony or soft tissue deformities; correction of bony or soft tissue defects; joint arthrodesis; infected fractures or nonunions.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Orthofix
OrthoHub
09/02/2014
09/28/2015
08/25/2014
510(k) Summary
| Sponsor: | Arrowhead Medical Device Technologies, LLC
328 Poplar View Lane East, Suite 2
Collierville, TN 38017 | | | |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|-------------------------------|----------------------------------------|
| Contact Person: | Thomas J. Twardzik
Vice President, Marketing and Operations
Office: (901) 853-4366
Fax: (206) 222-9173
Email: INFO@ArrowheadDevices.com | | | |
| Date of
Submission: | February 26, 2018 | | | |
| Proprietary Name: | Deformity Analysis and Correction Software (DACS) and
Instrumentation | | | |
| Common Name | Orthopaedic Software for Treatment and Instrumentation | | | |
| Regulatory Class | Class II | | | |
| Regulation | 21 CFR 888.3030 Single/multiple component metallic bone
fixation appliances and accessories | | | |
| Device Product
Code and Panel | OSN Software For Diagnosis/Treatment
KTT Appliance, Fixation, Nail/Blade/Plate Combination,
Multiple Component - Single/multiple component metallic
bone fixation appliances and accessories.
Orthopedic | | | |
| Predicate Devices | Device | Manufacturer | 510(k)
No. | Clearance
Date |
| | Taylor Spatial Frame
(TSF) | Smith & Nephew | K110069
K093047
K970748 | 02/08/2011
09/27/2010
05/09/1997 |
TL-HEX Truelok
Hexapod System
OrthoHub External
Fixator Software
4
The Deformity Analysis and Correction Software (DACS) and Device Description Instrumentation is an optional software component and is used to assist the physician in calculating the lengths of the struts connecting the rings to manipulate the bone fragments. The software receives inputs from the physician and allows the physician to visualize the moving bone position. The program computes the strut lengths necessary to implement any desired translation and/or rotation required by the surgeon. The instrumentation includes Radiopaque Fiducial Markers which are attached to the Smith & Nephew Taylor Spatial Frame external fixator.
Intended Use The Deformity Analysis and Correction Software (DACS) and Instrumentation are intended to be used as component of the Smith & Nephew Taylor Spatial Frame (TSF) external fixation system that is indicated for the following: post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; open and closed fracture fixation; pseudo-arthrosis of long bones; limb lengthening by epiphyseal or metaphyseal distraction: correction of bony or soft tissue deformities; correction of bony or soft tissue defects; joint arthrodesis; infected fractures or nonunions.
5
The Deformity Analysis and Correction Software (DACS) and Technological Characteristics Instrumentation are substantially equivalent to predicate devices in terms of intended use, product technical characteristics and performance characteristics. Software documentation was conducted according to FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (Document issued on: May 11, 2005). The design characteristics of the subject system software do not raise any new types of questions of safety or effectiveness. Functional testing of the Deformity Analysis and Correction Software (DACS) and Instrumentation was conducted and summarized in Exhibit 36 Verification and Validation Documentation - SWVR-AMD-0101 Software Verification Report. Performance and accuracy testing were performed to test the ability of the Deformity Analysis and Correction Software (DACS) and Instrumentation to produce correct results under different variations of bone deformities, anatomical orientations, and device combinations. This testing protocol was executed against a variety of CAD-generated image sets and a Smith & Nephew Taylor Spatial Frame x-ray image set. The known inputs for each image (device types and strut settings) was compared to the results calculated by the Deformity Analysis and Correction Software (DACS) and Instrumentation. Testing with these image pairs demonstrated that the Deformity Analysis and Correction Software (DACS) and Instrumentation is capable of successfully correcting the variety of deformities it may encounter in the clinical setting. From the evidence submitted in this 510(k), the Deformity Analysis
and Correction Software (DACS) and Instrumentation demonstrates that the device is as safe, as effective, and performs as well as or better than the legally marketed device predicates.
6
A review of the device intended use, product technical Substantial Equivalence and characteristics and performance characteristics confirmed that the Conclusions Deformity Analysis and Correction Software and Instrumentation is substantially equivalent to the predicate device. While the Deformity Analysis and Correction Software and Instrumentation is not identical to the predicate device software, comparisons of the subject and predicate device software confirmed that any differences between the subject device and predicate software do not render the device NSE as there is not a new intended use; and any differences in technological characteristics do not raise different questions of safety and effectiveness than the predicate device. Therefore, it is concluded that the Deformity Analysis and Correction Software and Instrumentation is substantially equivalent to the Smith & Nephew Taylor Spatial Frame Software.
| Parameter | Deformity
Analysis and
Correction
Software and
Instrumentation | TSF System and
Software | TL-HEX Truelok
Hexapod System
and Software | OrthoHub
External
Fixator
Software |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Arrowhead
Medical Device
Technologies,
LLC | Smith & Nephew,
Inc.
Orthopaedic
Division | Orthofix | OrthoHub |
| 510(k)
Number(s) | K180539 | K110069,
K093047,
K970748 | K141078,
K152171 | K140550 |
| Regulation | CFR 888.3030 | CFR 888.3030 | CFR 888.3030 | CFR 888.3030 |
| Product Codes | KTT, OSN | KTT, OSN | KTT, OSN | OSN |
| Parameter | Deformity
Analysis and
Correction
Software and
Instrumentation | TSF System and
Software | TL-HEX Truelok
Hexapod System
and Software | OrthoHub
External
Fixator
Software |
| Intended Use | The Deformity Analysis
and Correction Software
( DACS ) and Radiopaque
Fiducial Markers are
intended to be used as
component of a spatial
frame external fixation
system that is indicated
for the following: post-
traumatic joint
contracture which has
resulted in loss of range
of motion; fractures and
disease which generally
may result in joint
contractures or loss of
range of motion and
fractures requiring
distraction; open and
closed fracture fixation;
pseudo-arthrosis of long
bones; limb lengthening
by epiphyseal or
metaphyseal distraction;
correction of bony or
soft tissue deformities;
correction of bony or
soft tissue defects; joint
arthrodesis; infected
fractures or nonunions. | The Smith & Nephew
Spatialframe.com
software is intended to
be used as a component
of multilateral external
fixation systems that are
indicated for the
following: post-
traumatic joint
contracture which has
resulted in loss of range
of motion; fractures and
disease which generally
may result in joint
contractures or loss of
range of motion and
fractures requiring
distraction; open and
closed fracture fixation;
pseudoarthrosis of long
bones; limb lengthening
by epiphyseal or
metaphyseal distraction;
correction of bony or
soft tissue deformities;
correction of bony or
soft tissue defects: joint
arthrodesis; infected
fractures or nonunions. | The TL-HEX System
is intended for limb
lengthening by
metaphyseal or
epiphyseal distractions,
fixation of open and
closed fractures,
treatment of nonunion
or pseudoarthrosis of
long bones and
correction of bony or
soft tissue defects or
deformities. Within
this range, indications
include:
• Post-
traumatic joint
contracture which has
resulted in loss of
range of motion •
Fractures and disease
which generally may
result in joint
contractures or loss of
range of motion and
fractures requiring
distraction • Open and
closed fracture fixation
• Pseudoarthrosis of
long bones • Limb
lengthening by
epiphyseal or
metaphyseal
distraction • Correction
of bony or soft tissue
deformities •
Correction of bony or
soft tissue defects •
Joint arthrodesis •
Infected fractures or
non-unions | The OrthoHub
External Fixator
Software is used
with Smith &
Nephew Taylor
Spatial Frame (TSF)
rings and struts for
the treatment of
traumatic or
reconstructive tibia
deformities. It is
used to generate a
prescription of strut
adjustments to
provide to the
patient. |
| Substantial Equivalence Comparison Table | | | | |
| Parameter | Deformity
Analysis and
Correction
Software and
Instrumentation | TSF System and
Software | TL-HEX Truelok
Hexapod System
and Software | OrthoHub
External
Fixator
Software |
| Software | | | | |
| Use | Optional | Optional | Optional | Optional |
| Inputs | Surgeon inputs based on
x-ray position | Surgeon inputs based on
x-ray position | Surgeon inputs based on
x-ray position | Surgeon inputs based on
x-ray position |
| Visualization | Visualize the moving
bone | Visualize the moving
bone | Visualize the moving
bone | Visualize the moving
bone |
| Image for
Input | Orthogonal A/P, M/L
radiograph after fixator
installed on patient | Orthogonal A/P, M/L
radiograph after fixator
installed on patient | Orthogonal A/P, M/L
radiograph after fixator
installed on patient | Orthogonal A/P,
M/L radiograph after
fixator installed on
patient |
| Data to Input | Deformity
Measurements
Mount Parameters
Frame Components
Strut Settings | Deformity
Measurements
Mount Parameters
Frame Components
Strut Settings | Deformity
Measurements
Mount Parameters
Frame Components
Strut Settings | Deformity
Measurements
Mount Parameters
Frame Components
Strut Settings |
| Means of
Measure and
Input | Software image
recognition and
hardware identification.
Graphical input.
Single item of manual
entry. | Manual measurement of
radiograph.
Manual entry. | Manual measurement
of radiograph.
Manual entry.
Limited graphical
input | Manual
measurement of
radiograph.
Limited graphical
input.
Manual entry. |
| Output | Patient prescription with
details for frame
adjustment. | Patient prescription with
details for frame
adjustment. | Patient prescription
with details for frame
adjustment. | Patient prescription
with details for
frame adjustment. |
Substantial Equivalence Comparison Table
7
Substantial Equivalence Comparison Table
8
Substantial Equivalence Comparison Table
c:\users\tomt\dropbox (amdt)\dacs\510(k)\aa response draft a\003_exhibit 2 510(k) summary 180620a.docx