(25 days)
The DePuy Synthes MAXFRAME™ Multi-Axial Correction System is indicated for external fixation of fractured long bones and bones of the foot, limb lengthening, and deformity correction in adult, children* (3-12), and adolescent* (12-21) patient populations. The DePuy Synthes MAXFRAME™ Multi- Axial Correction System utilizes software for assisting surgeons in treatment planning. *in which the growth plates have fused or will not be crossed.
The DePuy Synthes MAXFRAME™ Multi-Axial Correction System is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which the growth plates have fused or will not be crossed with hardware:
• fracture fixation (open and closed)
• pseudoarthrosis of long bones
• limb lengthening (epiphyseal or metaphyseal distraction)
• joint arthrodesis
• infected fractures or nonunions
• correction of bony or soft tissue deformities
• correction of segmental defects.
The DePuy Synthes MAXFRAME™ Multi Axial Correction System, is an external ring fixation system that consists of MAXFRAME Hardware (schanz screws, pins, struts, rings) and MAXFRAME Web Software, used in treatment of soft tissue and bone deformities.
The subject device MAXFRAME 3D II Software (Moderate Software Level of Concern) is a software re-write of the MAXFRAME Web Software to make it more efficient, simplify software upgrades for functionality and fixing of software anomalies or bugs. Additionally, based on surgeon feedbacks and voice of customer, new functionality has been added around how frames are identified on X-Rays/radiographic images and how the treatment of the deformity can be planned.
This document describes the MAXFRAME™ Multi-Axial Correction System (aka MAXFRAME) software, specifically the MAXFRAME 3D II Software. It is a software re-write of the existing MAXFRAME Web Software, cleared under K161417.
Here's an analysis of the provided text in relation to your request:
1. Table of acceptance criteria and the reported device performance:
The provided document (510(k) Summary) is a submission for substantial equivalence based on non-clinical performance testing. It does not contain specific acceptance criteria for performance metrics in a quantitative sense (e.g., accuracy, sensitivity, specificity). Instead, it generically states:
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Outputs meet input requirements | "The performance of the subject MAXFRAME 3D II Software has been evaluated by confirming that the outputs meet the input requirements..." |
| Conform to user needs and intended uses | "...and conform to the user needs and intended uses." |
| Same intended use, indications for use, and fundamental principles as predicate | "The subject device has the same intended use, indications for use, and fundamental principles as the predicate device." |
| Creates similar patient treatment plan | "...creates a similar patient treatment plan..." |
| Highly comparable functionality and usability to predicate | "...and has highly comparable functionality and usability to the predicate MAXFRAME Web Software." |
| Software verification and validation demonstrates substantial equivalence | "The results of non-clinical performance data in terms of software verification and validation demonstrate that the subject device is substantially equivalent to the predicate device." This implies the results of V&V testing met internal acceptance criteria for demonstrating that the new software performs as intended and is equivalent to the prior version. |
Important Note: This is a 510(k) summary for a software update to an existing device. The primary claim is substantial equivalence to the predicate device (MAXFRAME Web Software, K161417), meaning it performs similarly and raises no new questions of safety or effectiveness. As such, detailed quantitative performance metrics often associated with novel AI/ML devices or completely new technologies are typically not disclosed in this type of submission summary. The "acceptance criteria" here are focused on demonstrating that the new software maintains the safety and effectiveness profile of the predicate.
2. Sample size used for the test set and the data provenance:
The document explicitly states: "Non-clinical Performance Testing: The performance of the subject MAXFRAME 3D II Software has been evaluated by confirming that the outputs meet the input requirements and conform to the user needs and intended uses."
This indicates software verification and validation (V&V) activities were performed. However, the document does not specify a sample size for a "test set" in the context of clinical or image-based evaluation. Given it's a software re-write of an existing system, the testing likely involved functional testing, regression testing, and possibly performance testing against a set of representative cases or simulated scenarios to ensure calculations are correct and the user interface functions as expected.
The document does not specify the data provenance (e.g., country of origin, retrospective or prospective data) for any test cases used during V&V.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. As it is a software re-write and not a novel diagnostic AI algorithm, the "ground truth" for V&V would likely be based on:
- Expected outputs from calculations based on well-defined anatomical parameters or clinical scenarios.
- Comparison to results from the predicate software.
- Expert review of UI/UX and functionality rather than diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided. Given the nature of a software re-write, a formal adjudication process for diagnostic interpretations (like 2+1 review) is unlikely to be the primary method of evaluation. Software V&V typically uses internal testing protocols.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical Performance Data: Clinical data was not necessary for the determination of substantial equivalence." Therefore, there is no information about the effect size of human readers improving with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The document describes the device as providing "software for assisting surgeons in treatment planning." The "MAXFRAME 3D II Software" is a component of the "MAXFRAME™ Multi-Axial Correction System," which is an "external ring fixation system." This implies it's an assistive tool for a human-in-the-loop workflow (surgeons using the software for planning), not a standalone diagnostic algorithm designed to provide unassisted outputs.
While standalone software verification and validation was performed on the software alone to ensure its functionality and calculations are correct, this is distinct from proving clinical performance as a standalone diagnostic or assistive device in a clinical setting.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The specific type of ground truth used for the software's verification and validation is not explicitly stated. For a software re-write focused on treatment planning and calculation, the "ground truth" would likely be derived from:
- Engineering specifications and requirements: Ensuring the software correctly implements the intended algorithms and calculations.
- Comparison to predicate device's output: Confirming that the new software produces equivalent results to the previous, cleared version for identical inputs.
- Industry standards or clinically accepted formulas: For calculations related to limb lengthening, deformity correction, etc.
It's highly unlikely that expert consensus on diagnostic images, pathology, or outcomes data was used as the ground truth for this software re-write's V&V, given the nature of the device (treatment planning software for an external fixator).
8. The sample size for the training set:
This information is not applicable and not provided. The MAXFRAME 3D II Software is a software re-write of an existing system, and the description does not suggest it employs machine learning or artificial intelligence that would require a "training set" in the conventional sense. It is a deterministic rule-based or algorithmic software for planning.
9. How the ground truth for the training set was established:
This information is not applicable and not provided, as there is no indication of a machine learning component requiring a training set with established ground truth.
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May 25, 2021
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Synthes (USA) Products, LLC Suchitra Basu Associate Director, Regulatory Affairs 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K211313
Trade/Device Name: MAXFRAME™ Multi-Axial Correction System (aka MAXFRAME) 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: April 29, 2021 Received: April 30, 2021
Dear Suchitra Basu:
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/cdrh/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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ting Song, PhD Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211313
Device Name
MaxFrame™ Multi-Axial Correction System
Indications for Use (Describe)
The DePuy Synthes MaxFrame™ Multi-Axial Correction System is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which the growth plates have fused or will not be crossed with hardware:
- · fracture fixation (open and closed)
- · pseudoarthrosis of long bones
- · limb lengthening (epiphyseal or metaphyseal distraction)
- joint arthrodesis
- · infected fractures or nonunions
- · correction of bony or soft tissue deformities
- · correction of segmental defects
| Type of Use (Select one or both, as applicable) | |
|---|---|
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for DePuy Synthes Trauma. The logo consists of a circular design on the left, followed by the text "DePuy Synthes" in a bold, sans-serif font. Below "DePuy Synthes" is the word "TRAUMA" in a smaller, sans-serif font. Underneath the word "TRAUMA" is the text "COMPANIES OF Johnson & Johnson" in a smaller font.
6 510(k) Summary
K211313
| Sponsor | Synthes | Address |
|---|---|---|
| Primary Contact | Suchitra Basu, PhD, RACAssociate Director, Regulatory AffairsDePuy Synthes | 1301 Goshen ParkwayWest Chester, PA USAT: 610-719-5448Email: sbasu23@its.jnj.com |
| Secondary Contact | Thomas SheaRegulatory Affairs ManagerDePuy Synthes | 1301 Goshen ParkwayWest Chester, PA USAT: 610-719-5679Email: tshea@its.jnj.com |
| Date Prepared | April 27, 2021 | |
| Proprietary Name | MAXFRAME™ Multi-Axial Correction System (aka MAXFRAME) | |
| Device Name | MAXFRAME™ Multi-Axial Correction System (aka MAXFRAME) | |
| Common Name | Software for Diagnosis/Treatment; Single/multiple component metallic bonefixation appliances | |
| Classification | Class IIProduct Code(s): OSN (Software for Diagnosis/Treatment),KTT (Appliance, fixation, nail/blade/plate combination, multiple components) | |
| PredicateDevice(s) | DePuy Synthes MAXFRAME™ Multi-Axial Correction System (K161417) | |
| ReferenceDevice(s) | None | |
| Reason forSubmission | To introduce MAXFRAME 3D II Software (software re-write of MaxFrame WebSoftware) compatible with existing MaxFrame Hardware cleared as a part of theMAXFRAME Multi Axial Correction System in K161417 | |
| DeviceDescription | The DePuy Synthes MAXFRAME™ Multi Axial Correction System, is anexternal ring fixation system that consists of MAXFRAME Hardware(schanz screws, pins, struts, rings) and MAXFRAME Web Software, usedin treatment of soft tissue and bone deformities.The subject device MAXFRAME 3D II Software (Moderate SoftwareLevel of Concern) is a software re-write of the MAXFRAME WebSoftware to make it more efficient, simplify software upgrades forfunctionality and fixing of software anomalies or bugs. Additionally, basedon surgeon feedbacks and voice of customer, new functionality has beenadded around how frames are identified on X-Rays/radiographic imagesand how the treatment of the deformity can be planned. | |
| Intended Use | The DePuy Synthes MAXFRAME™ Multi-Axial Correction System is intended | |
| Indications forUse | for external fixation of fractured long bones and bones of the foot, limblengthening, and deformity correction in adult, children* (3-12), and adolescent*(12-21) patient populations. The DePuy Synthes MAXFRAME™ Multi- AxialCorrection System utilizes software for assisting surgeons in treatment planning.*in which the growth plates have fused or will not be crossed. | |
| The DePuy Synthes MAXFRAME™ Multi-Axial Correction System is indicatedfor the following treatments in adults, and in both children (3-12) and adolescents(12-21) in which the growth plates have fused or will not be crossed with hardware:• fracture fixation (open and closed)• pseudoarthrosis of long bones• limb lengthening (epiphyseal or metaphyseal distraction)• joint arthrodesis• infected fractures or nonunions• correction of bony or soft tissue deformities• correction of segmental defects. | ||
| Comparison toPredicate | The DePuy Synthes MAXFRAME 3D II Software has the same indications foruse and design (fundamental software architecture) as the MAXFRAME WebSoftware. It utilizes the existing MAXFRAME hardware, creates a similar patienttreatment plan, and has highly comparable functionality and usability to thepredicate MAXFRAME Web Software. | |
| Non-clinicalPerformanceTesting | The performance of the subject MAXFRAME 3D II Software has been evaluatedby confirming that the outputs meet the input requirements and conform to theuser needs and intended uses. | |
| ClinicalPerformance Data | Clinical data was not necessary for the determination of substantial equivalence. | |
| SubstantialEquivalence | The subject device has the same intended use, indications for use, andfundamental principles as the predicate device. It has been adequately comparedto the predicate device to demonstrate substantial equivalence | |
| Conclusion | The results of non-clinical performance data in terms of software verification andvalidation demonstrate that the subject device is substantially equivalent to thepredicate device. |
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Image /page/4/Picture/0 description: The image shows the logo for DePuy Synthes Trauma, a company that is part of Johnson & Johnson. The logo consists of a geometric design on the left, followed by the company name in bold, blue letters. Below the company name is the word "TRAUMA" in smaller, black letters. At the bottom of the image, the words "COMPANIES OF Johnson & Johnson" are printed in a smaller font.
§ 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.