(112 days)
The Cadence Ankle PSI System is intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intraoperatively, and in guiding bone cutting. The Cadence Ankle PSI System is intended for use with Smith + Nephew's Cadence Total Ankle System and its cleared indications for use.
3D Systems' Cadence Ankle PSI System consists of patient specific outputs including surgical guides, anatomical models, and case reports. The Cadence Ankle PSI System guides are made from biocompatible nylon and surgical grade stainless steel and are designed to fit the contours of the patient's distal tibial and proximal talar anatomy. The surgical guides in combination with the Smith+Nephew Cadence Total Ankle System instruments, facilitate the positioning of Cadence Total Ankle Prostheses.
The manufacturer, 3D Systems, Inc., has introduced the Cadence Ankle PSI System, a device intended for patient-specific surgical planning and instrumentation to assist in total ankle replacement component positioning and bone cutting. This device is designed for use with Smith + Nephew's Cadence Total Ankle System.
The information provided by the FDA 510(k) summary for K241326 primarily focuses on non-clinical performance testing to demonstrate substantial equivalence to the predicate device, not on clinical performance with human readers or standalone AI performance. Therefore, many of the requested details regarding clinical study design (e.g., MRMC studies, human reader improvement, expert consensus for ground truth) are not applicable based on the provided document.
Here's an analysis of the acceptance criteria and the study conducted, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary mentions "all acceptance criteria for all performance tests" were met, but it does not explicitly list the quantitative acceptance criteria. It broadly states the types of tests conducted and their qualitative outcomes.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Non-clinical Performance Testing: Mechanical Integrity (post-processing) | Met all acceptance criteria. |
| Non-clinical Performance Testing: Debris Generation | Met all acceptance criteria. |
| Non-clinical Performance Testing: Intra- and Inter-Designer Variability analysis | Met all acceptance criteria. |
| Non-clinical Cadaveric Comparison Testing: Implant Alignment Accuracy (vs. reference device) | Shown to be similar to that of the standard instrumentation currently used for the Cadence Total Ankle System. |
| Non-clinical Cadaveric Comparison Testing: Guide Usability (vs. reference device) | Shown to be similar to that of the standard instrumentation currently used for the Cadence Total Ankle System. |
2. Sample Size Used for the Test Set and Data Provenance
The document indicates "Non-clinical cadaveric comparison testing", which implies a test set was used. However, the exact sample size (number of cadavers or anatomic specimens) is not specified.
The data provenance is cadaveric testing, which is a form of pre-clinical, laboratory-based testing, not human patient data (retrospective or prospective). The country of origin for the data is not specified, though 3D Systems, Inc. is based in the USA.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the studies described are non-clinical, cadaveric, and mechanical/design verification tests. There is no mention of experts establishing a "ground truth" in the context of diagnostic or clinical interpretation. Performance was assessed mechanically or by comparison to standard instrumentation.
4. Adjudication Method for the Test Set
This is not applicable as the studies are non-clinical and do not involve human diagnostic interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document describes non-clinical and cadaveric testing, not studies involving human readers or clinical cases.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device is a "patient specific surgical planning and instrumentation" system. While it likely involves algorithms for design and manufacturing, the studies described are for the physical outputs (surgical guides, anatomical models) and their performance (mechanical integrity, debris, accuracy in cadavers), rather than a standalone AI algorithm's diagnostic performance. Therefore, a standalone AI performance study in the typical sense of evaluating an algorithm’s output without human-in-the-loop was not explicitly described for this submission. The focus is on the device's accuracy in physical guidance.
7. The Type of Ground Truth Used
For the non-clinical tests (mechanical integrity, debris generation, intra-/inter-designer variability), the "ground truth" would be established by engineering specifications, quality control standards, and measurement protocols.
For the cadaveric comparison testing, the "ground truth" for "Implant Alignment Accuracy" and "Guide Usability" would be based on direct measurements against design specifications and comparison to the performance of established standard instrumentation (the reference device, K151459 Cadence Total Ankle Replacement System). This is a technical, rather than a clinical, ground truth.
8. The Sample Size for the Training Set
The document does not describe the use of a "training set" in the context of machine learning or AI algorithm development. The device is a patient-specific instrument system, and its design is CADD-based. If there's an underlying AI component that uses a training set, this information is not provided in the summary.
9. How the Ground Truth for the Training Set Was Established
As no training set is described for an AI algorithm, this information is not applicable based on the provided document. If there are proprietary algorithms involved in the patient-specific design, the "training" data (if any) and its ground truth would be part of the manufacturer's internal development process, not typically disclosed in this level of detail in a 510(k) summary focused on the final product's performance.
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August 30, 2024
3D Systems, Inc. Ashley Dawson Director, Regulatory Affairs 5381 South Alkire Circle Littleton, Colorado 80127
Re: K241326
Trade/Device Name: Cadence Ankle PSI System Regulation Number: 21 CFR 888.3110 Regulation Name: Ankle joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: OYK Dated: July 31, 2024 Received: July 31, 2024
Dear Ashley Dawson:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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Sincerely,
Image /page/2/Picture/3 description: The image shows the name "Lixin Liu-S" in a simple, sans-serif font. The text is black against a white background. The letters are evenly spaced and the text is left-aligned.
Lixin Liu, Ph.D. 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
Submission Number (if known)
Device Name
Cadence Ankle PSI System
Indications for Use (Describe)
The Cadence Ankle PSI System is intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intraoperatively, and in guiding bone cutting. The Cadence Ankle PSI System is intended for use with Smith + Nephew's Cadence Total Ankle System and its cleared indications for use.
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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Image /page/4/Picture/0 description: The image shows the 3D Systems logo and the text "K241326 (Page 1 of 2)". The 3D Systems logo is a stylized cube with the letters "3D" inside. The text "K241326 (Page 1 of 2)" is likely a document number and page number. The logo and text are arranged horizontally.
510(K) SUMMARY
1. INTRODUCTION
This document contains the 510(k) summary for the Cadence Ankle PSI System. The content of this summary is based on the requirements of 21 CFR 807.92.
2. SUBMITTER
| Name: | 3D Systems, Inc. |
|---|---|
| Address: | 5381 South Alkire CircleLittleton, CO 80127, USAPhone: (720) 643-1001Fax: (720) 643-1009 |
| Official Contact: | Dr. Ashley DawsonDirector of Regulatory Affairs |
| Date Prepared: | August 30, 2024 |
| 3. DEVICE | |
| Trade Name: | Cadence Ankle PSI System |
| Common Name: | Ankle Arthroplasty Implantation System |
| Classification Name: | Ankle joint metal/polymer semi-constrained cemented prosthesis |
| Classification: | Class II, 21 CFR 888.3110 |
| Product Code: | OYK |
| 4. PREDICATE DEVICE | |
| Predicate Device: | K193432 Vantage® PSI System, Product Code OYK |
5. REFERENCE DEVICE
Reference Device: K151459 Cadence Total Ankle Replacement System, Produce Code HSN
6. DESCRIPTION OF THE DEVICE
3D Systems' Cadence Ankle PSI System consists of patient specific outputs including surgical guides, anatomical models, and case reports. The Cadence Ankle PSI System guides are made from biocompatible nylon and surgical grade stainless steel and are designed to fit the contours of the patient's distal tibial and proximal talar anatomy. The surgical guides in combination with the Smith+Nephew Cadence Total Ankle System instruments, facilitate the positioning of Cadence Total Ankle Prostheses.
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7. INTENDED USE/INDICATIONS FOR USE
The Cadence Ankle PSI System is intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intraoperatively, and in guiding bone cutting. The Cadence Ankle PSI System is intended for use with Smith + Nephew's Cadence Total Ankle System and its cleared indications for use.
8. INDICATIONS FOR USE COMPARISON
The Cadence Ankle PSI System has the same Indications for Use as the predicate device with the only change being the orthopedic implant that the Patient-Specific Instrumentation is guiding.
9. TECHNOLOGICAL COMPARISON
The principles of operation and technological characteristics are substantially equivalent between the subject Cadence Ankle PSI System and the predicate Vantage PSI System (K193432). Both the predicate and the subject devices are designed with CT-based methods to produce patient-specific instrumentation. Cadence Ankle PSI System guides are manufactured using SLS technology with DuraForm® ProX PA (polyamide) material and surgical stainless steel components. Both the subject and predicate devices guide the placement of pins and resections of tibial and talar anatomies for total ankle arthroplasties. The difference between the subject device and the predicate device is that the subject device is designed to guide the accurate placement of the Smith+Nephew Cadence Total Ankle Prosthesis.
10. NON-CLINICAL AND/OR CLINICAL TESTS SUMMARY
Non-clinical performance testing on the Cadence Ankle PSI System included Mechanical Integrity (post-processing), Debris Generation, and Intra- and Inter-Designer Variability analysis. The Cadence Ankle PSI System met all acceptance criteria for all performance tests.
Non-clinical cadaveric comparison testing was performed to compare Implant Alignment Accuracy and Guide Usability between the subject device and reference device. Accuracy and functionality were shown to be similar to that of the standard instrumentation currently used for the Cadence Total Ankle System.
11. CONCLUSION
Based on a comparison of the intended use, indications for use, and technological characteristics, the Cadence Ankle PSI System is substantially equivalent to the identified predicate device. Additionally, the non-clinical testing supports that the system performs in accordance with its intended use and is as safe, as effective, and performs as well as the predicate device.
§ 888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no linkage across-the-joint. This generic type of device includes prostheses that have a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.