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 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 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 (not medical devices);
• 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.

The scope of this submission is an addition of a manufacturer, slight update to dimensions and raw material for the cut guides related to the In2Bones QUANTUM® Patient Specific Instrumentation (PSI) Guides for Total Ankle Replacement (TAR) previously cleared in K211883.

AI/ML Overview

This document describes the In2Bones QUANTUM® Patient Specific Instrumentation (PSI) System, which is an orthopaedic instrument system used to assist in the positioning of instrumentation for Total Ankle Replacement (TAR) implantation.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device. This type of document typically focuses on demonstrating "substantial equivalence" to a previously cleared predicate device, rather than presenting a comprehensive clinical study with detailed performance metrics and acceptance criteria as one might find for a novel device or AI algorithm. Therefore, many of the requested data points (like specific performance metrics, sample sizes for test sets, expert qualifications for ground truth, and details about training sets) are not detailed in this type of submission. The focus here is on non-clinical performance and equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit from 510(k) submission)	Reported Device Performance and Evidence Used
Functional Equivalence/Performance of PSI Guides	Demonstrated through non-clinical performance data and validations. The primary goal is that the PSI guides and TAR Planning Software accurately facilitate the positioning for TAR according to the surgical plan. This is implicitly accepted if the device is found substantially equivalent to its predicate.
Biocompatibility (for materials in contact with patient)	"biocompatibility (ISO 10993)" were conducted. This implies the materials used for the PSI guides meet the biological safety requirements. Performance data were "included in the 510(k) submission."
Sterilization (for single-use PSI Guides)	"sterilization (ISO 17665)" were conducted. This indicates the PSI guides can be effectively sterilized for single use. Performance data were "included in the 510(k) submission."
Equipment Performance/Functionality (for associated reusable instruments)	"Validations equipment" were conducted. This suggests the reusable instruments associated with the PSI system function as intended. Performance data were "included in the 510(k) submission."
Substantial Equivalence to Predicate Device (K211883)	"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." The "primary difference is an additional manufacturer for the cut guides," and "slight update to dimensions and raw material."

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a non-clinical performance study and a comparison against a predicate device for the purpose of demonstrating substantial equivalence.

The 510(k) summary states: "Non-clinical performance data were included in the 510(k) submission. Validations equipment, biocompatibility (ISO 10993) and sterilization (ISO 17665) were conducted to demonstrate that the QUANTUM PSI system is substantial equivalence to the predicate device."
The conclusion explicitly states: "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."

This implies a series of engineering tests, material characterization, and process validations (biocompatibility and sterilization) were performed to ensure the device's safety and performance characteristics are consistent with its predicate and regulatory standards. However, specific performance metrics (e.g., accuracy of bone cuts, alignment deviation) are not provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify a sample size for a "test set" in the context of clinical performance or a specific AI/software validation. The studies mentioned are primarily non-clinical engineering tests (biocompatibility, sterilization, equipment validation).
Data Provenance: Not applicable in the context of clinical data for performance evaluation in this 510(k) summary. The "data" refers to engineering test results.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This information is not provided in the document. For a 510(k) of this nature, especially one focused on demonstrating equivalence and non-clinical performance, expert-established ground truth for a test set (as would be typical for an AI diagnostic device) is not usually a central component. The ground truth for the non-clinical tests would be defined by the specifications and standards (e.g., ISO for biocompatibility/sterilization).

4. Adjudication Method for the Test Set

This information is not provided as it is not relevant to the type of non-clinical testing described.

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, an MRMC comparative effectiveness study was not done. The device (QUANTUM® PSI System and TAR Planning Software) is a surgical planning and instrumentation system, not an AI diagnostic tool primarily aimed at improving human reader interpretation of medical images. While the software utilizes "advanced display and positioning tools," its primary role is to create a pre-operative plan for physical guides used in surgery. The clinical efficacy is linked to the overall TAR procedure and the use of the PSI guides, rather than human "reading" performance improvement with AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a form of "standalone" evaluation of the planning software's capability is implied by "validations equipment" and the general assessment of the software's functional specifications. The TAR Planning Software, in a sense, operates "stand-alone" to generate the surgical plan based on imaging data before a surgeon validates it and the PSI guides are manufactured. The accuracy of this plan and the resultant PSI guides would have been verified through engineering tests and comparison to specifications, which is a form of standalone performance evaluation for the software component's capabilities. However, specific metrics for such a standalone performance are not enumerated in this summary.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests (biocompatibility, sterilization, equipment validation), the ground truth is based on established regulatory standards and engineering specifications (e.g., ISO standards, internal performance requirements for mechanical properties and fit).
For the TAR Planning Software, the "ground truth" for its output (the surgical plan and resultant PSI guide design) would be its ability to accurately reflect the desired surgical alignment and fit the patient's anatomy based on the input imaging data and surgeon validation. This is assessed indirectly through the overall substantial equivalence claim and the intended function of guiding the procedure.

8. The Sample Size for the Training Set

This information is not applicable/not provided for this device. The TAR Planning Software described is not a machine learning or AI algorithm that typically relies on a "training set" in the conventional sense of deep learning or supervised learning. It uses "advanced display and positioning tools" to facilitate surgical planning, which suggests it might be based on CAD/CAM principles and anatomical modeling rather than a data-driven learning model requiring a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no indication of a "training set" in the context of machine learning for this device.

Summary

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April 6, 2023

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

Re: K230313

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 Codes: HSN, OYK Dated: February 3, 2023 Received: February 6, 2023

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,

Image /page/1/Figure/5 description: The image shows the name "Peter G. Allen" in large, bold font, followed by "-S" on the next line. To the right of the name, there is text that reads "Digitally signed by Peter G. Allen -S Date: 2023.04.06 16:21:25 -04'00'". The text indicates that the document was digitally signed by Peter G. Allen on April 6, 2023, at 4:21:25 PM.

For:

[Vacant] 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)

K230313

Device Name

QUANTUM® Patient Specific Instrumentation (PSI) System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
XPrescription 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 February 3, 2023

Sponsor identification	In2Bones SASSabina Ahaddad28 chemin du Petit Bois69130 Ecully – FrancePhone: +33.4.72.29.26.26Fax: +33.4.72.29.26.29
Establishment registration number	3010470577
Date of preparation	January 9, 2023
Contact person	Christine ScifertIn2BonesUSA6000 Poplar Avenue, Suite 115Memphis, TN 38119Cell: 901-831-8053Email: cscifert@i2b-usa.com
Proprietary Name	QUANTUM® Patient Specific Instrumentation (PSI) System
Common name	Ankle Arthroplasty Implantation System
Device classification regulation	21 CFR 888.3110Class II
Device Product Code 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 reusableinstruments:- QUANTUM® patient specific tibial and talar guides;- QUANTUM® reusable instruments;- QUANTUM® patient specific tibial and talar bone models(not medical devices);• 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.
	The scope of this submission is an addition of a manufacturer, slightupdate to dimensions and raw material for the cut guides related tothe In2Bones QUANTUM® Patient Specific Instrumentation (PSI)Guides for Total Ankle Replacement (TAR) previously cleared inK211883.
PredicateDevices	Primary predicate:QUANTUM® Patient Specific Instrumentation (PSI) System(K211883), In2Bones SAS
	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.
CONCLUSION	Based on the comparison of indications for use and technologicalcharacteristics and the results of the testing performed, theOUANTUM® PSI System is substantially equivalent to thepredicate device identified in the 510(k) submission.
PerformanceData	Non-clinical performance data were included in the 510(k)Validationssubmission.equipment,biocompatibility (ISO 10993) and sterilization (ISO 17665) wereconducted to demonstrate that the QUANTUM PSI system issubstantial equivalence to the predicate device.
Technologicalcharacteristics:	The provided detailed comparison demonstrates the subject cutguides for the QUANTUM PSI system are substantially equivalent inintended use, design, operating principles, materials and performancecharacteristics to the predicate device cleared in K211883. Theprimary difference is an additional manufacturer for the cut guides.
	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.
	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 indicationsand for which X-rays and CT-scan images are available andcompliant with imaging protocol provided by In2Bones.

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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.