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.

Device Description

The 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.

The QUANTUM® PSI 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.
QUANTUM® PSI guides are single use instruments designed using the dedicated ORTHO-PLANIFY TAR planning software, in correlation with a pre-operative surgical plan validated by the surgeon. They fit the anatomy of the specific patient's distal tibia and proximal talus.

AI/ML Overview

The provided document is limited to a 510(k) summary for the QUANTUM® Patient Specific Instrumentation (PSI) System, which includes the ORTHO-PLANIFY Total Ankle Replacement (TAR) planning software. The document mentions that "software verification and validation, repeatability testing and cadaveric validations" were included in the non-clinical performance data. However, it does not provide specific details on the acceptance criteria, reported device performance metrics, study design, sample sizes, ground truth establishment, or expert involvement in a way that would allow for a comprehensive answer to all parts of your request.

Based on the available information, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance
The document states: "Tests results demonstrate that QUANTUM PSI system and its associated ORTHO-PLANIFY TAR planning software are safe and effective for their intended use." However, specific acceptance criteria and quantitative performance metrics (e.g., accuracy, precision) from the software validation, repeatability testing, or cadaveric validations are not detailed in this 510(k) summary.

2. Sample size used for the test set and the data provenance
This information is not provided in the document.

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.

4. Adjudication method for the test set
This information is not provided in the document.

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 is not mentioned in the document. The software is described as a "preoperative surgical planning software" and PSI guides, suggesting it assists surgeons, but a formal comparative effectiveness study with human readers is not detailed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document states "software verification and validation" was performed. This implies some level of standalone algorithm testing. However, specific details of this standalone performance, including metrics or methodology, are not provided. The device is intended to be used by a surgeon, indicating a human-in-the-loop setup for its clinical application.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document mentions "cadaveric validations." For these, the ground truth would likely be measurements taken directly from the cadaveric specimens after the application of the PSI guides and potentially after bone cuts, using highly precise measurement tools to compare against the planned surgical outcome. However, the specific methodology for establishing this ground truth is not detailed. For software verification, ground truth might involve simulated data with known correct outputs or comparison against established gold-standard algorithms/methods.

8. The sample size for the training set
This information is not provided in the document. The document refers to the system as "software" and "planning software," but does not explicitly state that it employs machine learning or requires a 'training set' in the traditional sense of AI/ML development. If it uses rule-based algorithms or traditional image processing, a "training set" might not be applicable in the same way.

9. How the ground truth for the training set was established
This information is not provided in the document, as the existence or nature of a training set is not detailed.

In summary, while the K211883 summary states that non-clinical performance data (including software verification and validation, repeatability testing, and cadaveric validations) were used to demonstrate safety and effectiveness, it lacks the specific details required to answer most of your questions regarding acceptance criteria, study design parameters, and ground truth establishment. This level of detail is typically found in the full submission, not in the publicly available 510(k) summary.

Summary

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August 11, 2021

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In2Bones SAS % Christine Scifert VP QA & RA In2Bones USA 6600 Poplar Ave, Suite 115 Memphis, Tennessee 38119

Re: K211883

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: June 16, 2021 Received: June 21, 2021

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 (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

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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 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 (OS) 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, Ph.D., R.A.C. 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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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K211883

Device Name

QUANTUM® Patient Specific Instrumentation (PSI) System

Indications for Use (Describe)

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 For QUANTUM® Patient Specific Instrumentation (PSI) System

Sponsoridentification	In2Bones SAS28 chemin du Petit Bois69130 Ecully – FrancePhone: +33.4.72.29.26.26Fax: +33.4.72.29.26.29
Establishmentregistrationnumber	3010470577
Date ofpreparation	August 11, 2021
Contact person	Christine SCIFERT, MS, MEMIn2BonesUSA6000 Poplar Avenue, suite 115Memphis, TN 38119Cell: 901-831-8053Email: cscifert@i2b-usa.com
ProprietaryName	QUANTUM® Patient Specific Instrumentation (PSI) System
Common name	PSI 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 QUANTUM® Patient Specific Instrumentation (PSI) systemsubject of this submission consists of:• QUANTUM® patient specific instrumentation (PSI) and reusableinstruments:- QUANTUM® patient specific tibial and talar guides;- QUANTUM® reusable instruments;- QUANTUM® patient specific tibial and talar bone models;• ORTHO-PLANIFY Total Ankle Replacement (TAR) planningsoftware.
	The QUANTUM® PSI system is to be used with the givenQUANTUM® Total Ankle Prosthesis (K191380) and their clearedindication for use, provided that anatomic landmarks necessary foralignment and positioning of the implant are identifiable on patientimaging scans.QUANTUM® PSI guides are single use instruments designed usingthe dedicated ORTHO-PLANIFY TAR planning software, incorrelation with a pre-operative surgical plan validated by thesurgeon. They fit the anatomy of the specific patient's distal tibia andproximal talus.
PredicateDevices	Primary predicate:PROPHECY INVISION Pre-operative NavigationSystem(K162795 & K170968), Wright Medical Technology Inc.Reference predicate:QUANTUM® Total Ankle Prosthesis (K191380), In2Bones SAS.
Indications foruse:	In2Bones PSI: In2Bones QUANTUM® Patient SpecificInstrumentation (PSI) Guides for Total Ankle Replacement (TAR)is indicated as an orthopaedic instrument system to assist in theinstrumentation 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-CutQUANTUM® talar implants.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 population fulfillingthe QUANTUM® Total Ankle Replacement indications and for which X-rays and CT-scan images are available and compliant with imagingprotocol provided by In2Bones.
	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 these procedures.
Technologicalcharacteristics:	The provided detailed comparison demonstrates the QUANTUM PSIsystem and its associated ORTHO-PLANIFY TAR planningsoftware is substantially equivalent in intended use, design, operatingprinciples, materials and performance characteristics to the predicatedevice cleared in K162795 and K170968. The differences intechnological characteristics do not raise new questions of safety andeffectiveness.
PerformanceData	Non-clinical performance data were included in the 510(k)submission demonstrating that QUANTUM PSI system and itsassociated ORTHO-PLANIFY TAR planning software has beenvalidated for its intended use and demonstrating substantialequivalence to the predicate device. Non-clinical testing includedsoftware verification and validation, repeatability testing andcadaveric validations. Tests results demonstrate that QUANTUM PSIsystem and its associated ORTHO-PLANIFY TAR planningsoftware are safe and effective for their intended use.
CONCLUSION	Based on the comparison of indications for use and technologicalcharacteristics and the results of the testing performed, theQUANTUM® PSI System is substantially equivalent to thepredicate device identified in the 510(k) submission.

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TAR Planning software: The TAR Planning Software is a preoperative surgical planning software intended to be used with In2Bones QUANTUM® Patient Specific Instrumentation (PSI)

Regulation Number and Section

§ 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.