(127 days)
The Salto Talaris 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 Salto Talaris PSI System is intended for use with Smith + Nephew's Salto Talaris Total Ankle System and its cleared indications for use.
3D Systems' Salto Talaris Ankle PSI System consists of patient specific outputs including surgical guides, anatomical models, and case reports. The Salto Talaris 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 Salto Talaris Total Ankle System instruments, facilitate the positioning of Salto Talaris Total Ankle Prostheses.
The provided text is a 510(k) summary for the Salto Talaris Ankle PSI System. It describes the device, its intended use, and a summary of non-clinical testing. However, it does not contain the detailed information necessary to fully answer all aspects of your request, particularly regarding specific acceptance criteria, expert qualifications, adjudication methods, details of ground truth establishment, or specific sample sizes for training and testing sets in the context of an AI-based system.
The Salto Talaris Ankle PSI System is described as patient-specific surgical planning and instrumentation to assist in positioning total ankle replacement components and guiding bone cutting. This device primarily involves physical surgical guides and anatomical models derived from CT data, rather than a standalone AI algorithm for diagnosis or image analysis. Therefore, some of the requested information, such as an MRMC comparative effectiveness study with AI assistance or standalone algorithm performance, is not directly applicable to this type of device as typically described for AI/ML-based diagnostic software.
Here's a breakdown of the available information based on your request:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Integrity (post-processing) | Met all acceptance criteria. |
| Debris Generation | Met all acceptance criteria. |
| Inter-Designer Variability analysis | Met all acceptance criteria. |
| Implant Alignment Accuracy (cadaveric comparison) | Accuracy shown to be similar to standard instrumentation for the Salto Talaris Total Ankle System. |
| Guide Usability (cadaveric comparison) | Functionality shown to be similar to standard instrumentation for the Salto Talaris Total Ankle System. |
The document states that the Salto Talaris Ankle PSI System met all acceptance criteria for mechanical integrity, debris generation, and inter-designer variability analysis. For implant alignment accuracy and guide usability, cadaveric comparison testing showed similarity to standard instrumentation. The specific quantitative acceptance criteria values (e.g., specific thresholds for mechanical integrity or debris generation, or a numerical range for alignment accuracy) are not provided in this summary.
2. Sample size used for the test set and the data provenance
The document mentions "Non-clinical cadaveric comparison testing." However, it does not specify the sample size (number of cadavers or cases) used for this test set, nor does it provide information about the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide this information. Since the device involves surgical guides and bone cutting, "ground truth" in this context would likely relate to anatomical measurements or surgical outcomes, potentially assessed by orthopedic surgeons. However, no details on experts or their qualifications are given.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not specify any adjudication method.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC comparative effectiveness study of the type typically performed for AI/ML diagnostic software (where human readers evaluate cases with and without AI assistance) was not mentioned and is unlikely to be applicable based on the device description. This device provides physical guides for surgery, not AI-based image analysis for diagnosis. The non-clinical cadaveric testing compared the device to standard instrumentation, not to human readers using or not using AI.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device is described as "patient specific surgical planning and instrumentation to assist in the positioning... and in guiding bone cutting." This inherently implies a "human-in-the-loop" scenario (a surgeon using the guides). The "non-clinical cadaveric comparison testing" assessed the performance of the device in use, which is a form of standalone performance for the instrumentation itself but not in the context of an AI algorithm without human interaction for diagnosis or interpretation. The document does not describe a standalone algorithm performance test in the way it would be applied to AI/ML diagnostic software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the cadaveric comparison testing, the "ground truth" implicitly relates to implant alignment accuracy and guide usability, compared against the results achieved using standard (non-PSI) instrumentation. The summary doesn't explicitly state how this ground truth was definitively established (e.g., by highly accurate post-operative CT measurements validated by multiple experts), but it refers to comparison rather than an absolute ground truth method.
8. The sample size for the training set
The document describes the device as being "designed with CT-based methods to produce patient-specific instrumentation." This suggests a design process based on anatomical data, but there is no mention of a "training set" in the context of an AI/ML algorithm. The device is a custom-manufactured surgical guide, not a learned AI model.
9. How the ground truth for the training set was established
Since there's no mention of a "training set" for an AI/ML algorithm, this question is not applicable in the context of the provided document. The "design" information would likely come from anatomical studies, engineering specifications, and clinical experience with total ankle arthroplasty, rather than a formal "ground truth" establishment for an AI training set.
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August 30, 2024
3D Systems, Inc. Ashley Dawson Director, Regulatory Affairs 5381 South Alkire Circle Littleton, Colorado 80127
Re: K241148
Trade/Device Name: Salto Talaris 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.
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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" (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 QS 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 Rule"). 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-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-regulatory
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assistance/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,
Lixin Liu -S
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
Salto Talaris Ankle PSI System
Indications for Use (Describe)
The Salto Talaris 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 Salto Talaris PSI System is intended for use with Smith + Nephew's Salto Talaris 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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510(K) SUMMARY
1. INTRODUCTION
This document contains the 510(k) summary for the Salto Talaris 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: | Salto Talaris 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: K182878 Salto Talaris Total Ankle System, Produce Code HSN
6. DESCRIPTION OF THE DEVICE
3D Systems' Salto Talaris Ankle PSI System consists of patient specific outputs including surgical guides, anatomical models, and case reports. The Salto Talaris 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 Salto Talaris Total Ankle System instruments, facilitate the positioning of Salto Talaris Total Ankle Prostheses.
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7. INTENDED USE/INDICATIONS FOR USE
The Salto Talaris 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 Salto Talaris Ankle PSI System is intended for use with Smith + Nephew's Salto Talaris Total Ankle System and its cleared indications for use.
8. INDICATIONS FOR USE COMPARISON
The Salto Talaris 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 Salto Talaris 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. The Salto Talaris 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 Salto Talaris Total Ankle Prosthesis.
10. NON-CLINICAL AND/OR CLINICAL TESTS SUMMARY
Non-clinical performance testing on the Salto Talaris Ankle PSI System included Mechanical Integrity (post-processing), Debris Generation, and Inter-Designer Variability analysis. The Salto Talaris 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 used for the Salto Talaris Total Ankle System.
11. CONCLUSION
Based on a comparison of the intended use, indications for use, and technological characteristics, the Salto Talaris 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.