(166 days)
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.
The Deformity Analysis and Correction Software (DACS) and 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.
The provided text is a 510(k) summary for the Deformity Analysis and Correction Software (DACS) and Instrumentation. It details the device, its intended use, and a comparison to predicate devices, but it does not contain a specific section outlining detailed acceptance criteria and a study that explicitly proves the device meets those criteria in a quantitative manner.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices through qualitative comparisons and general statements about performance and accuracy testing.
However, based on the information provided, we can infer some aspects and construct a table and description as requested, noting where specific details are absent.
Here's an analysis of the document to answer your questions:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" with quantitative performance metrics. It generally states that "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." It also states that testing "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."
Without explicit pass/fail criteria or quantitative results such as mean error, standard deviation, or accuracy ranges, it's impossible to create a strict "acceptance criteria" table from this document. However, based on the description of the testing, the implied acceptance criteria were that the software would "produce correct results" and "successfully correct deformities."
Here's a table based on the implied performance and accuracy from the document:
| Acceptance Criteria (Inferred) | Reported Device Performance (as stated in document) |
|---|---|
| Ability to produce correct results under different variations of bone deformities, anatomical orientations, and device combinations. | "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." |
| Capability of successfully correcting the variety of deformities encountered in clinical settings. | "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." |
| Functionality and safety in comparison to predicate devices. | "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." "…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." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document mentions that testing was "executed against a variety of CAD-generated image sets and a Smith & Nephew Taylor Spatial Frame x-ray image set." The exact number (sample size) of these image sets is not specified.
- Data Provenance:
- Source: "CAD-generated image sets" (simulated data) and "a Smith & Nephew Taylor Spatial Frame x-ray image set" (likely real patient data, but source country is not specified).
- Retrospective or Prospective: The use of "CAD-generated image sets" implies simulated, non-patient-specific, or laboratory data. The "Smith & Nephew Taylor Spatial Frame x-ray image set" could be retrospective, either from pre-existing clinical cases or data specifically acquired for testing, but the document does not clarify.
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)
The document does not specify the number or qualifications of experts used to establish ground truth for the test set. Given the use of "CAD-generated image sets" where "known inputs" were available, the ground truth for these would be inherent in the CAD model parameters rather than established by human experts. For the "Smith & Nephew Taylor Spatial Frame x-ray image set," it's unclear how ground truth was established or if experts were involved.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method for the test set. The validation approach appears to be a direct comparison of software-calculated results against "known inputs" for simulated data and (presumably) against accepted clinical measurements or calculations for real image data, rather than an expert consensus process.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this document. The DACS is described as software that "assists the physician in calculating the lengths of the struts" and allows "the physician to visualize the moving bone position." It computes strut lengths based on physician inputs. There is no mention of an AI component that would assist human readers in interpretation or diagnosis, nor any study comparing human performance with and without such assistance. The software is a calculation and visualization tool, not an AI-based diagnostic aid that would typically be evaluated in an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The performance testing mentioned ("Performance and accuracy testing were performed to test the ability of the Deformity Analysis and Correction Software (DACS) and Instrumentation to produce correct results...") appears to be a form of standalone testing where the software's output was compared to known or expected values. The document states: "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." This suggests testing the algorithm's direct output against a reference.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used appears to be:
- "Known inputs" from CAD-generated images: For simulated data, the ground truth is the inherent parameters or "true" values defined within the CAD models. This is a form of engineered or definitional ground truth.
- For the "Smith & Nephew Taylor Spatial Frame x-ray image set," the ground truth is presumably established clinical measurements or calculations associated with those images, although this is not explicitly detailed. It does not mention expert consensus, pathology, or outcomes data specifically.
8. The sample size for the training set
The document does not mention a training set or its sample size. This is a 510(k) summary for software that appears to be deterministic (performing calculations based on input parameters) rather than a machine learning/AI model that would typically require a training set. The phrase "Deformity Analysis and Correction Software (DACS)" itself suggests a rule-based or algorithmic system, not necessarily one that learns from data.
9. How the ground truth for the training set was established
As no training set is mentioned (see point 8), there is no information provided on how ground truth for a training set was established.
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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
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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
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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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Orthofix
OrthoHub
09/02/2014
09/28/2015
08/25/2014
510(k) Summary
| Sponsor: | Arrowhead Medical Device Technologies, LLC328 Poplar View Lane East, Suite 2Collierville, TN 38017 | |||
|---|---|---|---|---|
| Contact Person: | Thomas J. TwardzikVice President, Marketing and OperationsOffice: (901) 853-4366Fax: (206) 222-9173Email: INFO@ArrowheadDevices.com | |||
| Date ofSubmission: | February 26, 2018 | |||
| Proprietary Name: | Deformity Analysis and Correction Software (DACS) andInstrumentation | |||
| Common Name | Orthopaedic Software for Treatment and Instrumentation | |||
| Regulatory Class | Class II | |||
| Regulation | 21 CFR 888.3030 Single/multiple component metallic bonefixation appliances and accessories | |||
| Device ProductCode and Panel | OSN Software For Diagnosis/TreatmentKTT Appliance, Fixation, Nail/Blade/Plate Combination,Multiple Component - Single/multiple component metallicbone fixation appliances and accessories.Orthopedic | |||
| Predicate Devices | Device | Manufacturer | 510(k)No. | ClearanceDate |
| Taylor Spatial Frame(TSF) | Smith & Nephew | K110069K093047K970748 | 02/08/201109/27/201005/09/1997 |
TL-HEX Truelok
Hexapod System
OrthoHub External
Fixator Software
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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.
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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.
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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 | DeformityAnalysis andCorrectionSoftware andInstrumentation | TSF System andSoftware | TL-HEX TruelokHexapod Systemand Software | OrthoHubExternalFixatorSoftware |
|---|---|---|---|---|
| Manufacturer | ArrowheadMedical DeviceTechnologies,LLC | Smith & Nephew,Inc.OrthopaedicDivision | 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 | DeformityAnalysis andCorrectionSoftware andInstrumentation | TSF System andSoftware | TL-HEX TruelokHexapod Systemand Software | OrthoHubExternalFixatorSoftware |
| Intended Use | The Deformity Analysisand Correction Software( DACS ) and RadiopaqueFiducial Markers areintended to be used ascomponent of a spatialframe external fixationsystem that is indicatedfor the following: post-traumatic jointcontracture which hasresulted in loss of rangeof motion; fractures anddisease which generallymay result in jointcontractures or loss ofrange of motion andfractures requiringdistraction; open andclosed fracture fixation;pseudo-arthrosis of longbones; limb lengtheningby epiphyseal ormetaphyseal distraction;correction of bony orsoft tissue deformities;correction of bony orsoft tissue defects; jointarthrodesis; infectedfractures or nonunions. | The Smith & NephewSpatialframe.comsoftware is intended tobe used as a componentof multilateral externalfixation systems that areindicated for thefollowing: post-traumatic jointcontracture which hasresulted in loss of rangeof motion; fractures anddisease which generallymay result in jointcontractures or loss ofrange of motion andfractures requiringdistraction; open andclosed fracture fixation;pseudoarthrosis of longbones; limb lengtheningby epiphyseal ormetaphyseal distraction;correction of bony orsoft tissue deformities;correction of bony orsoft tissue defects: jointarthrodesis; infectedfractures or nonunions. | The TL-HEX Systemis intended for limblengthening bymetaphyseal orepiphyseal distractions,fixation of open andclosed fractures,treatment of nonunionor pseudoarthrosis oflong bones andcorrection of bony orsoft tissue defects ordeformities. Withinthis range, indicationsinclude:• Post-traumatic jointcontracture which hasresulted in loss ofrange of motion •Fractures and diseasewhich generally mayresult in jointcontractures or loss ofrange of motion andfractures requiringdistraction • Open andclosed fracture fixation• Pseudoarthrosis oflong bones • Limblengthening byepiphyseal ormetaphysealdistraction • Correctionof bony or soft tissuedeformities •Correction of bony orsoft tissue defects •Joint arthrodesis •Infected fractures ornon-unions | The OrthoHubExternal FixatorSoftware is usedwith Smith &Nephew TaylorSpatial Frame (TSF)rings and struts forthe treatment oftraumatic orreconstructive tibiadeformities. It isused to generate aprescription of strutadjustments toprovide to thepatient. |
| Substantial Equivalence Comparison Table | ||||
| Parameter | DeformityAnalysis andCorrectionSoftware andInstrumentation | TSF System andSoftware | TL-HEX TruelokHexapod Systemand Software | OrthoHubExternalFixatorSoftware |
| Software | ||||
| Use | Optional | Optional | Optional | Optional |
| Inputs | Surgeon inputs based onx-ray position | Surgeon inputs based onx-ray position | Surgeon inputs based onx-ray position | Surgeon inputs based onx-ray position |
| Visualization | Visualize the movingbone | Visualize the movingbone | Visualize the movingbone | Visualize the movingbone |
| Image forInput | Orthogonal A/P, M/Lradiograph after fixatorinstalled on patient | Orthogonal A/P, M/Lradiograph after fixatorinstalled on patient | Orthogonal A/P, M/Lradiograph after fixatorinstalled on patient | Orthogonal A/P,M/L radiograph afterfixator installed onpatient |
| Data to Input | DeformityMeasurementsMount ParametersFrame ComponentsStrut Settings | DeformityMeasurementsMount ParametersFrame ComponentsStrut Settings | DeformityMeasurementsMount ParametersFrame ComponentsStrut Settings | DeformityMeasurementsMount ParametersFrame ComponentsStrut Settings |
| Means ofMeasure andInput | Software imagerecognition andhardware identification.Graphical input.Single item of manualentry. | Manual measurement ofradiograph.Manual entry. | Manual measurementof radiograph.Manual entry.Limited graphicalinput | Manualmeasurement ofradiograph.Limited graphicalinput.Manual entry. |
| Output | Patient prescription withdetails for frameadjustment. | Patient prescription withdetails for frameadjustment. | Patient prescriptionwith details for frameadjustment. | Patient prescriptionwith details forframe adjustment. |
Substantial Equivalence Comparison Table
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Substantial Equivalence Comparison Table
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Substantial Equivalence Comparison Table
c:\users\tomt\dropbox (amdt)\dacs\510(k)\aa response draft a\003_exhibit 2 510(k) summary 180620a.docx
§ 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.