(316 days)
In2Bones PSI: In2Bones QUANTUM® Patient Specific Instrumentation (PSI) Guides for Total Ankle Replacement (TAR) is indicated as an orthopaedic instrument system to assist in the instrumentation positioning dedicated to In2Bones QUANTUM® Total Ankle Replacement implantation. In2Bones QUANTUM® PSI guides are compatible with QUANTUM® tibial tray, QUANTUM® tibial inlay, as well as standard and Flat- Cut QUANTUM® talar implants.
PSI Guides are intended for single use only. PSI Guides are manufactured in correlation with a pre-operative planning validated by the surgeon on the TAR Planning Software and assist in the positioning of the dedicated QUANTUM® instrumentation with which drillings or bone cuts will be performed. In2Bones QUANTUM® PSI guides are indicated for patient population fulfilling the QUANTUM® Total Ankle Replacement indications and for which X-rays and CT-scan images are available and compliant with imaging protocol provided by In2Bones.
TAR Planning software: The TAR Planning Software is a preoperative surgical planning software intended to be used with In2Bones QUANTUM® Patient Specific Instrumentation (PSI) Guides and QUANTUM® Total Ankle Replacement. TAR Planning Software allows the surgeon to use advanced display and positioning tools to guide the marking of bone before cutting and preview the total ankle replacement components intraoperatively, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient X-rays and imaging scans. X-rays and CT-scan are the accepted imaging modalities for these procedures.
The previously cleared single use QUANTUM® Patient Specific Instrumentation (PSI) system subject of this submission consists of:
• QUANTUM® patient specific instrumentation (PSI) and reusable instruments:
- QUANTUM® patient specific tibial and talar guides;
- QUANTUM® reusable instruments;
- QUANTUM® patient specific tibial and talar bone models
• ORTHO-PLANIFY Total Ankle Replacement (TAR) planning software (specific modification implemented in this submission).
The QUANTUM® PSI Guides are patient-specific devices adapted to the patient bones anatomy and the preoperative surgical plan validated by the surgeon. QUANTUM® PSI guides and bone models are designed using the dedicated ORTHO-PLANIFY TAR planning software.
The QUANTUM® system is to be used with the given QUANTUM® Total Ankle Prosthesis (K191380) and their cleared indication for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
The ORTHO-PLANIFY TAR planning software involved in this submission was previously cleared under K221432.
The scope of this submission is an addition of a manufacturer for the ORTHO-PLANIFY Total Ankle Replacement (TAR) planning software related to the In2Bones QUANTUM® Patient Specific Instrumentation (PSI) Guides for Total Ankle Replacement (TAR) previously cleared in K211883.
This FDA document, K231699, describes the QUANTUM® Patient Specific Instrumentation (PSI) System. However, it does not contain specific acceptance criteria or a detailed study proving the device meets those criteria in the format requested.
The document primarily focuses on:
- The FDA's determination of substantial equivalence for the device.
- The indications for use of the device and its associated planning software.
- A 510(k) summary, which outlines contacts, device description, predicates, and a high-level statement about performance data.
Key points from the document regarding performance:
- Performance Data: "Non-clinical performance data were included in the 510(k) submission. Functional cadaver testing and software validations (previously provided under K221432) were conducted to demonstrate that the QUANTUM® PSI system is substantial equivalence to the predicate device."
Based on the provided text, I can answer some of your questions, but not all, as the detailed study information is not present.
Here's an analysis of what can be inferred and what is missing:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states that "non-clinical performance data were included in the 510(k) submission," and mentions "functional cadaver testing and software validations." However, the actual acceptance criteria (e.g., specific thresholds for accuracy, precision) and the reported performance values from these tests are not detailed in this publicly available summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Partially available. The document mentions "functional cadaver testing." This implies the test set involved cadavers. The sample size (number of cadavers or cases) is not specified. The provenance (e.g., country of origin, retrospective/prospective) of the cadaver data or the software validation data is not provided.
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)
- Cannot be determined. The document does not mention the use of experts to establish ground truth for a test set, nor their number or qualifications. The "pre-operative planning validated by the surgeon" for the PSI guides suggests surgeon involvement in the clinical application, but not necessarily in an independent ground truth assessment for a test study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be determined. The document does not describe any adjudication methods used for a test set.
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
- Not applicable/Cannot be determined. The device is a "Patient Specific Instrumentation (PSI) System" and "TAR Planning Software" which assists in orthopedic surgery. It doesn't appear to be an AI-driven diagnostic or interpretative tool that would typically involve "human readers" in a traditional MRMC study comparing AI assistance. The software "allows the surgeon to use advanced display and positioning tools to guide the marking of bone before cutting and preview the total ankle replacement components intraoperatively." This is an assistive tool for surgical planning, not an AI for image interpretation. Therefore, a conventional MRMC study comparing human readers with/without AI assistance using diagnostic images is unlikely to have been performed or would be relevant in the typical sense.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Implied, but details are missing. The "software validations" mentioned likely included testing of the software's algorithms in a standalone capacity (e.g., accuracy of measurements, positioning calculations) without direct human interaction as part of the performance evaluation. However, the exact nature of these standalone tests and their results are not provided. The device is explicitly designed for a "surgeon... to use advanced display and positioning tools," indicating a human-in-the-loop system for its intended use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Implied to be anatomical/measurement-based. For surgical planning software and patient-specific instrumentation, ground truth would typically relate to anatomical accuracy (e.g., how closely the PSI guide matches the actual anatomy, or how accurately the software calculates bone cuts/implant positions relative to predefined anatomical landmarks). Given "functional cadaver testing," direct anatomical measurements on cadavers would form the basis of ground truth. Exact details are not specified.
8. The sample size for the training set
- Not applicable/Not provided. This document describes a medical device submission, not specifically a machine learning model's training set. While the software algorithms might have been developed using data, this document does not specify a "training set" in the context of an AI model.
9. How the ground truth for the training set was established
- Not applicable/Not provided. As with point 8, this information is not relevant to the content of this FDA document.
In summary, while the document confirms that performance data (functional cadaver testing and software validations) were submitted, it does not provide the specific details regarding acceptance criteria, reported performance values, sample sizes for test sets, expert involvement, or ground truth methodologies in a detailed manner.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern. To the right of the seal, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" below. The logo is simple and professional, reflecting the FDA's role in regulating food and drugs.
April 23, 2024
In2Bones SAS % Christine Scifert VP, QA & RA In2Bones USA 6600 Poplar Avenue, Suite 115 Memphis, Tennessee 38119
Re: K231699
Trade/Device Name: QUANTUM® Patient Specific Instrumentation (PSI) System Regulation Number: 21 CFR 888.3110 Regulation Name: Ankle Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: HSN, OYK Dated: March 20, 2024 Received: March 21, 2024
Dear Christine Scifert:
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.
{1}------------------------------------------------
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.
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).
Sincerely.
Peter G. Allen Digitally signed by Peter Date: 2024.04.23 01:36:03 နာ -04'00
For Lixin Liu, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices
{2}------------------------------------------------
OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known) K231699
Device Name
QUANTUM® Patient Specific Instrumentation (PSI) System
Indications for Use (Describe)
In2Bones PSI: In2Bones QUANTUM® Patient Specific Instrumentation (PSI) Guides for Total Ankle Replacement (TAR) is indicated as an orthopaedic instrument system to assist in the instrumentation positioning dedicated to In2Bones QUANTUM® Total Ankle Replacement implantation. In2Bones QUANTUM® PSI guides are compatible with QUANTUM® tibial tray, QUANTUM® tibial inlay, as well as standard and Flat- Cut QUANTUM® talar implants.
PSI Guides are intended for single use only. PSI Guides are manufactured in correlation with a pre-operative planning validated by the surgeon on the TAR Planning Software and assist in the positioning of the dedicated QUANTUM® instrumentation with which drillings or bone cuts will be performed. In2Bones QUANTUM® PSI guides are indicated for patient population fulfilling the QUANTUM® Total Ankle Replacement indications and for which X-rays and CT-scan images are available and compliant with imaging protocol provided by In2Bones.
TAR Planning software: The TAR Planning Software is a preoperative surgical planning software intended to be used with In2Bones QUANTUM® Patient Specific Instrumentation (PSI) Guides and QUANTUM® Total Ankle Replacement. TAR Planning Software allows the surgeon to use advanced display and positioning tools to guide the marking of bone before cutting and preview the total ankle replacement components intraoperatively, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient X-rays and imaging scans. X-rays and CT-scan are the accepted imaging modalities for these procedures.
| 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) |
|---|---|
| ------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
K231699 page 1 of 4
Image /page/4/Picture/1 description: The image shows the logo for IN2BONES. The logo is set on a gray oval shape. The text "IN2BONES" is in white, with the "2" in orange.
510(k) SUMMARY For QUANTUM® Patient Specific Instrumentation (PSI) System December 15, 2023
| Sponsoridentification | In2Bones SASStephan Epinette28 chemin du Petit Bois69130 Ecully – FrancePhone: +33.4.72.29.26.26Fax: +33.4.72.29.26.29 |
|---|---|
| Establishmentregistrationnumber | 3010470577 |
| Date ofpreparation | December15, 2023 |
| Contact person | Christine ScifertIn2BonesUSA6000 Poplar Avenue, Suite 115Memphis, TN 38119Cell: 901-831-8053Email: cscifert@i2b-usa.com |
| ProprietaryName | QUANTUM® Patient Specific Instrumentation (PSI) System |
| Common name | Ankle Arthroplasty Implantation System |
| Deviceclassificationregulation | 21 CFR 888.3110Class II |
| Device ProductCode and Panel | OrthopedicHSN: Prosthesis, Ankle, Semi-Constrained, Cemented,Metal/PolymerOYK: Ankle Arthroplasty Implantation System |
| DeviceDescription | The previously cleared single use QUANTUM® Patient SpecificInstrumentation (PSI) system subject of this submission consists of:• QUANTUM® patient specific instrumentation (PSI) and reusable instruments:- QUANTUM® patient specific tibial and talar guides;- QUANTUM® reusable instruments;- QUANTUM® patient specific tibial and talar bone models• ORTHO-PLANIFY Total Ankle Replacement (TAR) planning software (specific modification implemented in this submission). |
| The QUANTUM® PSI Guides are patient-specific devices adapted to the patient bones anatomy and the preoperative surgical plan validated by the surgeon. QUANTUM® PSI guides and bone models are designed using the dedicated ORTHO-PLANIFY TAR planning software. | |
| The QUANTUM® system is to be used with the given QUANTUM® Total Ankle Prosthesis (K191380) and their cleared indication for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. | |
| The ORTHO-PLANIFY TAR planning software involved in this submission was previously cleared under K221432. | |
| The scope of this submission is an addition of a manufacturer for the ORTHO-PLANIFY Total Ankle Replacement (TAR) planning software related to the In2Bones QUANTUM® Patient Specific Instrumentation (PSI) Guides for Total Ankle Replacement (TAR) previously cleared in K211883. | |
| PredicateDevices | Primary predicate:QUANTUM® Patient Specific Instrumentation (PSI) System (K211883), In2Bones SAS |
| Reference devices:QUANTUM® Patient Specific Instrumentation (PSI) System (K230313), In2Bones SAS | |
| QUANTUM® Total Ankle Prosthesis (K191380), In2Bones SAS | |
| 3D-Side Customize software (K221432) | |
| Indications foruse | In2Bones PSI: In2Bones QUANTUM® Patient SpecificInstrumentation (PSI) Guides for Total Ankle Replacement (TAR) isindicated as an orthopaedic instrument system to assist in theinstrumentation positioning dedicated to In2Bones QUANTUM®Total Ankle Replacement implantation. In2Bones QUANTUM® PSIguides are compatible with QUANTUM® tibial tray, QUANTUM®tibial inlay, as well as standard and Flat-Cut QUANTUM® talarimplants. |
| PSI Guides are intended for single use only. PSI Guides aremanufactured in correlation with a pre-operative planning validatedby the surgeon on the TAR Planning Software and assist in thepositioning of the dedicated QUANTUM® instrumentation withwhich drillings or bone cuts will be performed. In2BonesQUANTUM® PSI guides are indicated for patient populationfulfilling the QUANTUM® Total Ankle Replacement indications andfor which X-rays and CT-scan images are available and compliantwith imaging protocol provided by In2Bones. | |
| TAR Planning software: The TAR Planning Software is apreoperative surgical planning software intended to be used withIn2Bones QUANTUM® Patient Specific Instrumentation (PSI)Guides and QUANTUM® Total Ankle Replacement. TAR PlanningSoftware allows the surgeon to use advanced display and positioningtools to guide the marking of bone before cutting and preview thetotal ankle replacement components intraoperatively, provided thatanatomic landmarks necessary for alignment and positioning of theimplant are identifiable on patient X-rays and imaging scans. X-raysand CT-scan are the accepted imaging modalities for theseprocedures. | |
| Note: The Indications for Use of the QUANTUM® Patient SpecificInstrumentation (PSI) Guides and the TAR Planning Software remainunchanged compared to the primary predicate (K211883) includingthe QUANTUM® Patient Specific Instrumentation (PSI) and TARPlanning Software provided in the original submission. | |
| Technologicalcharacteristics | The provided detailed comparison demonstrates the subject cutguides for the QUANTUM® PSI system are substantially equivalentin intended use, design, operating principles, materials andperformance characteristics to the predicate device cleared inK211883. The primary difference is an addition of a manufacturer forthe ORTHO-PLANIFY Total Ankle Replacement (TAR) planningsoftware related to the In2Bones QUANTUM® Patient SpecificInstrumentation (PSI) Guides for Total Ankle Replacement (TAR). |
| PerformanceData | Non-clinical performance data were included in the 510(k) submission. Functional cadaver testing and software validations(previously provided under K221432) were conducted to demonstrate that the QUANTUM® PSI system is substantial equivalence to the predicate device. |
| CONCLUSION | Based on the comparison of indications for use and technological characteristics and the results of the testing performed, the QUANTUM® PSI System is substantially equivalent to the predicate device identified in the 510(k) submission. |
{5}------------------------------------------------
{6}------------------------------------------------
{7}------------------------------------------------
§ 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.