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Intended Use: The Incompass Total Ankle System is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.

Indications for Use: The Incompass Total Ankle is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. The Incompass Total Ankle is additionally indicated for patients with a failed previous ankle surgery.

Incompass™ Total Ankle System is a total ankle replacement system consisting of implants and instruments.

Incompass™ Total Ankle System will harmonize the Infinity™ and Inbone™ Total Ankle Systems into one comprehensive system consisting of modular stemmed and low-profile pegged tibial trays, tibial inserts, and talar domes. The harmonized system is facilitated by sharing the same tibial resection geometry between the pegged and the stemmed tibial tray designs.

The provided text is a 510(k) clearance letter for the Incompass Total Ankle System. It outlines the device's indications for use, its classification, and declares its substantial equivalence to predicate devices based on non-clinical evidence.

However, the clearance letter explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence."

This means that the information requested regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment (which are typical for studies proving a device meets acceptance criteria, especially for AI/ML-based devices or those requiring clinical trials) is not included in this document. The clearance was based on non-clinical performance bench testing to demonstrate substantial equivalence in wear, articular stability, lock detail, manufacturing processes, static strength, fatigue strength, fretting, corrosion, and MRI safety, rather than clinical efficacy studies.

Therefore, I cannot provide the requested information from this document. If this were a submission for a device that required clinical performance data to demonstrate safety and effectiveness (e.g., an AI/ML device), this section would typically contain summaries of those studies.

Based on the provided document, here's what can be inferred or explicitly stated regarding the acceptance criteria and study proving adherence to them:

The device in question is a Total Ankle System, a type of orthopedic implant, not an AI/ML-based device or one that underwent a clinical efficacy study for its 510(k) clearance.

The "study" that proves the device meets acceptance criteria, in this context, refers to non-clinical performance bench testing.

1. A table of acceptance criteria and the reported device performance:

Since no clinical efficacy study was conducted for this 510(k) clearance, there's no data to populate such a table detailing clinical performance metrics (like sensitivity, specificity, or human reader improvement).

The acceptance criteria for this device were related to substantial equivalence through bench testing. The document states:

2. Sample sized used for the test set and the data provenance:

• Sample Size: Not specified in the document, as it refers to engineering and materials testing (bench testing) rather than a dataset of patient cases. For bench testing, "samples" would refer to the number of devices or components tested.
• Data Provenance: Not applicable in the context of clinical patient data (e.g., country of origin, retrospective/prospective), as the evidence was non-clinical bench testing. The testing would have been conducted in a laboratory setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. Ground truth as typically defined for AI/ML or clinical studies (e.g., expert consensus on medical images) was not established. The "ground truth" for bench testing is determined by engineering standards, material science principles, and established testing methodologies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. This is relevant for studies involving human reviewers or AI output, not for materials and mechanical bench testing.

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. This type of study is specifically for AI/ML-assisted diagnostic devices. The Incompass Total Ankle System is a physical medical implant.

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

• No. This is relevant for AI/ML algorithms.

7. The type of ground truth used:

• The "ground truth" for this clearance was established through engineering standards, material specifications, and validated bench testing protocols comparing the device's physical and mechanical properties against those of legally marketed predicate devices. It is not based on expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:

• Not applicable. This device is not an AI/ML algorithm.

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The APEX 3D™ Total Ankle Replacement System is indicated as a total ankle replacement in primary surgery for patients with ankle joints damaged by severe rheumatoid, post traumatic, or degenerative arthritis. Revision surgery for these patients is also indicated for patients with sufficient bone stock present. In the United States, components are intended for cemented use only.

The APEX 3D Total Ankle Replacement System has been cleared under K192994. The purpose of this submission is to introduce a new diffusion bonded talar dome to the APEX 3D Total Ankle Replacement System. The APEX 3D Total Ankle Replacement System is a cemented, fixed-bearing device comprised of a tibial component, a talar component, and a UHMWPE component used for ankle joint replacement. Based on patient anatomy, a number of component sizes and design configurations can be selected for best fit.

The provided document is an FDA 510(k) clearance letter for the APEX 3D Total Ankle Replacement System. This document does not describe AI/ML-driven medical devices or related acceptance criteria studies.

The 510(k) summary explains that the submission is to introduce a new diffusion-bonded talar dome to an already cleared total ankle replacement system. The performance testing described is focused on the physical and mechanical properties of the implant materials and manufacturing processes, such as:

• Porous Structure Characterization
• Diffusion Bonded Tensile Strength
• Diffusion Bonded Static Shear Strength
• Diffusion Bonded Fatigue Shear Strength
• Diffusion Bonded Abrasion Resistance
• Metallurgical Analysis
• Accelerated Corrosion Soak

The document explicitly states: "Clinical data are not needed to support the safety and effectiveness of the subject device."

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and studies for an AI/ML-driven device, as this document pertains to a mechanical orthopedic implant, not an AI/ML product.

To answer your request, I would need a different source document that details the performance study of an AI/ML-driven medical device.

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The Hintermann Series H2 Total Ankle (Hintermann Series H2) system is designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, replacing flexion and extension movement in the ankle joint, and allowing for movement at the replaced joint.

The Hintermann Series H2 is indicated as a total ankle replacement in primary of ankle joints damaged bv:

• Systemic arthritis of the ankle (e.g., rheumatoid arthritis, hemochromatosis)

• Primary arthritis (e.g., degenerative disease)

• Secondary arthritis (e.g., post-traumatic, avascular necrosis, provided enough of the talus is preserved to support the implant)

The Hintermann Series H2 is also indicated for patients with a failed previous ankle surgery and revision surgeries following failed total ankle replacement or non-union of the ankle arthrodesis, provided sufficient bone stock is present.

Note: In the United States, this device is intended for cemented use only.

The Hintermann Series H2 Total Ankle System is a total ankle prosthesis designed to replace the ankle joint. The Hintermann Series H2 Total Ankle System includes the following implantable components.

• H2 Tibial Component
• H2 Tibial Polyethylene (PE) Inlay
• Hintermann Series Talar Component

The tibial and talar components are coated with plasma spray titanium on the cement contacting surfaces. These components are used together to address the indications as outlined.

The provided text is a 510(k) summary for the Hintermann Series H2 Total Ankle System, a medical device. This document focuses on demonstrating the substantial equivalence of the new device to a legally marketed predicate device, rather than providing an acceptance criteria table and detailed study results typical of an AI/ML medical device submission.

As such, the information required to answer your specific questions about acceptance criteria and a study proving the device meets those criteria (especially in the context of AI/ML performance) is not present in the provided text.

The document describes non-clinical testing/performance data for the ankle system, which refers to mechanical and material tests to ensure the physical properties and safety of the implant, not the performance of an AI/ML algorithm.

Here's why the document doesn't contain the requested information:

• Device Type: The Hintermann Series H2 Total Ankle System is a physical orthopedic implant (an ankle joint prosthesis), not an AI/ML-driven diagnostic or therapeutic device.
• Regulatory Pathway: A 510(k) submission for a physical device like this primarily focuses on demonstrating substantial equivalence to a predicate device through engineering analysis, material characterization, and mechanical testing (e.g., wear, fatigue, range of motion). It does not involve AI/ML performance metrics, ground truth establishment, or human reader studies.

Therefore, for each of your points, the answer based solely on the provided text would be:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document lists mechanical tests (e.g., Range of Motion per ASTM F2665-09, Locking Mechanism Testing per ASTM F1814) that were performed, but it does not present a table of specific quantitative acceptance criteria or the numerical results of these tests. It simply states that testing was done to support substantial equivalence.
2. Sample sizes used for the test set and the data provenance: Not applicable in the context of AI/ML. For mechanical testing, sample sizes would refer to the number of prostheses tested, but this information is not detailed in the summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No human experts are establishing ground truth for an AI/ML algorithm in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a mechanical device would be established by standardized testing protocols (e.g., ASTM standards) measuring physical parameters, not by expert consensus on clinical cases.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided FDA 510(k) document is for a physical medical device (an ankle prosthesis) and not an AI/ML-driven device. As such, it does not contain the information related to acceptance criteria, test sets, ground truth, or human reader studies typically associated with AI/ML medical device performance evaluation.

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The Prophecy® Surgical Planning System is intended to be used as patient-specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively, in guiding the marking of bone before cutting, and in the pre-surgical planning of the ankle and surrounding anatomy to support the total ankle implant. The Prophecy® Surgical Planning Guides and Reports are intended for use with the Inbone®. Infinity® and Invision® Total Ankle Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (e.g. CT scans and X-rays). The Prophecy® Surgical Planning guides are intended for single use only.

The Prophecy® Surgical Planning System is composed of three components:

• Prophecy® patient-specific guides
• Prophecy® 3D Planner
• Prophecy® Preoperative report

The Prophecy® Surgical Planning System is compatible with the Inbone®, Infinity®, and Invision® Total Ankle Systems.

The provided text describes a 510(k) premarket notification for the Prophecy® Surgical Planning System. The submission focuses on modifications to the Prophecy® 3D Planner software. The information available details non-clinical testing performed to demonstrate substantial equivalence, but it does not provide specific acceptance criteria or an explicit study proving performance against those criteria in a format you requested for a device that involves performance against defined metrics (e.g., accuracy, sensitivity, specificity).

Here's a breakdown of the available information based on your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states, "All test results met the acceptance criteria, demonstrating the subject device performs as intended and is substantially equivalent to the predicate device." However, the text does not explicitly list the specific acceptance criteria or the reported device performance metrics in a quantitative manner.

2. Sample size used for the test set and the data provenance

The document mentions "Software verification testing," "Software validation," "Usability test," and "Cybersecurity testing." These are general descriptions of testing types. No specific sample sizes for test sets or data provenance (e.g., country of origin, retrospective/prospective) are provided in the given text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document states, "Clinical testing was not necessary for the determination of substantial equivalence." This implies that the validation did not rely on expert-established ground truth in a clinical context for performance metrics as you typically find for AI diagnostic devices. For the usability testing, the number and qualifications of intended users (surgeons or engineers) involved in establishing ground truth are not specified.

4. Adjudication method for the test set

Since specific acceptance criteria involving expert-reviewed ground truth are not detailed, no adjudication method is mentioned or implied in the provided text.

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

The document explicitly states, "Clinical testing was not necessary for the determination of substantial equivalence." Therefore, no MRMC comparative effectiveness study was performed or is referenced.

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

The Prophecy® Surgical Planning System is described as a tool that "assists in the positioning of total ankle replacement components intraoperatively, in guiding the marking of bone before cutting, and in the pre-surgical planning," and involves "user interface software intended to be used by orthopedic surgeons" and "trained employees/engineers." This suggests a human-in-the-loop process. While software verification and validation would test the algorithm's performance, the context implies it's not a standalone diagnostic AI, but rather a planning and guidance tool. The text does not explicitly detail a standalone algorithm-only performance study in the manner of a diagnostic AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Given that clinical testing was not performed for substantial equivalence, the "ground truth" for the software's performance would likely be based on engineering specifications, design requirements, and possibly simulated or phantom data for accuracy of measurements and guide design. For usability, it would relate to user feedback and completion of tasks as per the system's design. The document mentions "software verification testing to ensure all design outputs meet all specified requirements" and "software validation to ensure software specifications conform to user needs and intended uses," which aligns with this interpretation.

8. The sample size for the training set

The document refers to a "Prophecy® 3D Planner" software update. It does not mention any machine learning or AI model training. Therefore, a training set size is not applicable or provided in this context.

9. How the ground truth for the training set was established

As there's no mention of a traditional machine learning training set, this question is not applicable. The "ground truth" for the software's development (not training) would have been established through engineering design processes and requirements.

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The Kinos Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. The Kinos Total Ankle System is additionally indicated for patients with failed previous ankle surgery. The Kinos Total Ankle System is intended for cement use only.

The subject Kinos Total Ankle System consists of implant and instrument components designed to preserve motion in patients with ankle arthritis or previously failed ankle surgery. The device is a fixed bearing and semi-constrained implant construct, intended for replacement of the articulating surfaces of the ankle that have been affected by a disease state or injury. The subject device provides limited mobility to a patient by restoring alignment of the articulating surfaces, reducing pain, and providing flexion- extension movement within the ankle joint. The tibial and talar implants are intended to be used with bone cement. The subject Kinos Total Ankle System consists of three implant components - a tibial implant affixed to the tibia, a bearing implant assembled to the tibial implant and a talar implant affixed to the talus. The tibial implant and bearing implant, assembled intraoperatively, function together and articulate with the talar implant to create a fixed bearing prosthesis, replacing the articulating surface of the tibiotalar joint. The subject line extension includes tibial segments which are assembled intraoperatively to the tibial base plate to enhance tibial fixation height in the tibia.

This document is a 510(k) Summary for the Kinos Total Ankle System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, particularly not in the context of an AI/ML-driven device.

The Kinos Total Ankle System is a physical medical device (an ankle prosthesis), and the submission is for an expansion of indications for use. The performance testing section specifically states: "No performance testing was performed to establish substantial equivalence of the subject device to the predicates." Instead, a "dimensional analysis comparison of device components and a surgical technique comparison" was conducted.

Therefore, I cannot provide the requested information, as the provided text relates to a traditional medical device and its regulatory submission, not a study validating an AI/ML device's performance against specific acceptance criteria.

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The r3 Tibial Implants of the Kinos Total Ankle System are indicated for revision total ankle arthroplasty. The Kinos Total Ankle System is intended for cement use only.

The subject line extension to the Kinos Total Ankle System are implant and instrument components designed to preserve motion in patients with ankle arthritis or previously failed ankle surgery. The device is a fixed bearing and semi-constrained implant construct, intended for replacement of the articulating surfaces of the ankle that have been affected by a disease state or injury. The subject device provides limited mobility to a patient by restoring alignment of the articulating surfaces, reducing pain, and providing flexion-extension movement within the ankle joint. The tibial and talar implants are intended to be used with bone cement. The subject Kinos Total Ankle System consists of three implant components - a tibial implant affixed to the tibia, a bearing implant assembled to the tibial implant and a talar implant affixed to the talus. The tibial implant and bearing implant, assembled intraoperatively, function together and articulate with the talar implant to create a fixed bearing prosthesis, replacing the articulating surface of the tibiotalar joint. The extension includes tibial segments which are assembled intraoperatively to the tibial base plate to enhance tibial fixation height in the tibia.

The provided document is an FDA 510(k) clearance letter for the Kinos Total Ankle System. This document focuses on the substantial equivalence of a new device (a line extension) to a previously cleared predicate device, rather than the performance of an AI/ML device.

Therefore, the information required to answer the prompt (acceptance criteria, study details for AI/ML device performance, sample sizes, expert involvement, ground truth, etc.) is not present in this document.

The document details the device's classification, indications for use, and a summary of performance testing primarily related to mechanical properties of the implant (e.g., fatigue testing, bone stability, assembly tests, porous surface characterization). This is typical for a medical device clearance that is a physical implant, not a software or AI/ML diagnostic tool.

In summary, this document does not contain the information requested in your prompt regarding AI/ML device acceptance criteria and performance study details.

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The APEX 3D Total Ankle Replacement System is indicated as a total ankle replacement in primary surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. Revision surgery for these patients is also indicated for patients with sufficient bone stock present. In the United States, components are intended for cemented use only.

The APEX 3D Total Ankle Replacement System is a cemented, fixed-bearing device comprised of a tibial component, a talar component, and a UHMWPE component used for ankle joint replacement. Based on patient anatomy, a number of component sizes and design configurations can be selected for best fit.

The provided document is a 510(k) summary for a medical device (APEX 3D Total Ankle Replacement System), which focuses on demonstrating substantial equivalence to a predicate device. It addresses the device's indications for use, description, and the performance testing conducted to assure substantial equivalence.

However, the document does NOT contain information related to software or AI device performance, acceptance criteria, or ground truth establishment relevant to the questions asked about AI/software validation.

Therefore, I cannot extract the requested information from the provided text. The document explicitly states:

• "Clinical data are not needed to support the safety and effectiveness of the subject device." This indicates that there was no clinical study, including any involving AI or human readers, performed for this submission.
• The tests listed are all non-clinical performance tests on the physical components of the ankle replacement system (e.g., fatigue, material characterization, micromotion, magnetic resonance compatibility). None of these involve software or AI performance metrics.

To answer your request, if this were an AI/software device submission, the acceptance criteria and study details would typically involve metrics like sensitivity, specificity, AUC, human reader performance studies (MRMC), ground truth assessment by experts, sample sizes for training and testing, and adjudication methods. None of this information is present in the provided document.

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The restor3d Kinos Axiom Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. The restor3d Kinos Total Ankle System is additionally indicated for patients with failed previous ankle surgery. The restor3d Kinos Axiom Total Ankle System is intended for cement use only.

The subject restor3d Kinos Axiom Total Ankle System is an implant and instrument system designed to preserve motion in patients with ankle arthritis or previously failed ankle surgery. The device is a fixed bearing and semi-constrained implant construct, intended for replacement of the articulating surfaces of the ankle that have been affected by a disease state or injury. The device provides limited mobility to a patient by restoring alignment of the articulating surfaces, reducing pain, and providing flexion-extension movement within the ankle joint. The device is intended to be used with bone cement. The subject restor3d Kinos Axiom Total Ankle System consists of three implant components - a tibial implant affixed to the tibia, a bearing implant assembled to the tibial implant and a talar implant affixed to the talus. The tibial implant and bearing implant, assembled intraoperatively, function together and articulate with the talar implant to create a fixed bearing prosthesis, replacing the articulating surface of the tibiotalar joint.

The additively manufactured r3 talar dome and Vitamin E, cross-linked ultra-high molecular weight polyethylene (UHMWPE) r3 bearing component, subject of this 510(k), are compatible with:

• All Kinos Axiom Total Ankle System Tibial Tray Components and associated . instrumentation cleared via K192778
• All Kinos Axiom Total Ankle System X-Stem Tibial Components and associated . instrumentation cleared via K232595

This document is a 510(k) Summary for the restor3d Kinos Axiom Total Ankle System, which is a medical device. It does not describe an AI/ML-based device or a study involving human readers and AI assistance. The performance testing mentioned (ASTM F2665, engineering analyses) pertains to the mechanical and physical properties of the ankle implant, not to the performance of a software algorithm.

Therefore, most of the requested information (e.g., acceptance criteria for AI performance, sample size for test set/training set, ground truth establishment for AI, expert consensus, MRMC studies) is not applicable to this document.

The document discusses:

• Device Name: restor3d Kinos Axiom Total Ankle System
• Regulation Number: 21 CFR 888.3110 (Ankle Joint Metal/Polymer Semi-Constrained Cemented Prosthesis)
• Regulatory Class: Class II
• Product Code: HSN
• Indications for Use: Patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis, or failed previous ankle surgery. Intended for cement use only.
• Predicate Devices: Primarily INFINITY Total Ankle System (K123954) and SALTO TALARIS Total Ankle Prosthesis (K182878).
• Device Description: An implant and instrument system designed to preserve motion in patients with ankle arthritis or previously failed ankle surgery. It's a fixed bearing and semi-constrained implant construct, consisting of a tibial implant, a bearing implant (Vitamin E, cross-linked UHMWPE), and a talar implant (additively manufactured r3 talar dome).
• Performance Testing:
  • Contact Area Testing per ASTM F2665
  • Constraint Testing per ASTM F2665
  • Range of Motion Testing per ASTM F2665
  • Locking Mechanism Fatigue Strength Analysis per ASTM F2665
  • Implant Strength Engineering Analysis per ASTM F2665
  • Wear Engineering Analysis per ASTM F2665
• Conclusion: The device is substantially equivalent to predicate devices, and changes (additively manufactured talar component, Vitamin E cross-linked UHMWPE bearing component, design/size changes) do not raise new safety or effectiveness concerns.

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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 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.

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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