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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 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.

AI/ML Overview

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.

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K Number

K230313

Device Name

QUANTUM Patient Specific Instrumentation (PSI) System

Manufacturer

In2Bones SAS

Date Cleared

2023-04-06

(59 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K211883

Intended Use

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.

Device Description

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.

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.

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K Number

K211883

Device Name

QUANTUM® Patient Specific Instrumentation (PSI) System

Manufacturer

In2Bones SAS

Date Cleared

2021-08-11

(51 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K191380,K162795,K170968

Intended Use

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.

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.

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