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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.

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.

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

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.

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