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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 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 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.

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.

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