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The MAVEN™ Patient-Specific Instrumentation System is intended to be used as patient specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively and in guiding the marking of bone before cutting. The MAVEN™ Patient- Specific Instrumentation System is intended for use with the Paragon 28® APEX 3D™ Total Ankle Replacement System and its cleared indications for use, provided that anatomic landment and positioning of the implant are identifiable on patient imaging CT scans. The MAVEN™ Patient- Specific Instrumentation System is intended for single use only. The Paragon 28® TAR Patient- Specific Case Reports are intended for use with the Paragon 28® APEX 3D™ Total Ankle Replacement System and its cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging CT scans.

The Paragon 28® MAVEN™ Patient Specific Instrumentation (PSI) system is intended to assist a surgeon with pre-operative planning and transfer of the pre-operative plan to the surgery in total ankle replacement procedures. The system contains several physical and digital outputs including patient-specific anatomical models and guides (physical outputs); and a patient-specific case report (digital or documentation output).

The MAVEN™ PSI System is for use with the APEX 3D™ Total Ankle Replacement System.

This document describes a 510(k) premarket notification for the MAVEN™ Patient-Specific Instrumentation system. The notification seeks to demonstrate substantial equivalence to a previously cleared device, not to introduce a new device requiring extensive clinical trials to prove its performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, performance studies, sample sizes, expert ground truth, and MRMC studies is not applicable to this specific submission.

The core of this 510(k) is a Special 510(k), which signifies a modification to an already cleared device. The purpose is not to prove the device meets pre-defined performance metrics for a new claim, but rather to demonstrate that specific minor changes (material and supplier) to an existing device do not alter its safety or effectiveness.

Here's an analysis of the provided text in relation to your request:

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

• Not Applicable. This 510(k) is a Special 510(k) for a modification (material and supplier), not a submission for a novel device that requires establishing new performance acceptance criteria and then proving the device meets them through clinical or comprehensive performance studies for initial market clearance. The company conducted an internal "design and manufacturing process validation" to ensure the changes did not alter "the creation of a patient specific instrument," but no specific numerical performance metrics or acceptance criteria are reported in this summary for the altered device.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable in the context of a clinical test set. The document states: "The company conducted a design and manufacturing process validation, to demonstrate that the changes presented within this premarket submission, did not change the outputs, which is the creation of a patient specific instrument." This suggests internal engineering or manufacturing validation, not a patient-based test set from a clinical study. Therefore, no information on sample size, origin, or retrospective/prospective nature is provided for a "test set" in the sense of clinical performance evaluation.

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)

• Not Applicable. As no clinical "test set" for performance evaluation against a specific clinical claim is described, there's no mention of experts establishing ground truth for such a set.

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

• Not Applicable. No clinical 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. The MAVEN™ Patient-Specific Instrumentation system is described as assisting in positioning and guiding bone marking, it's not described as an AI-powered diagnostic or assistive tool for human readers (like radiologists interpreting images). An MRMC study would be irrelevant for this device's described function and the nature of this 510(k) submission.

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

• Not Applicable. The device is patient-specific instrumentation intended to assist surgeons (human-in-the-loop) in the operating room. It's not a standalone algorithm performing a task without human intervention for which performance would be evaluated in isolation.

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

• Not Applicable. No clinical ground truth is established or reported for this Special 510(k). The "ground truth" relevant to this submission would be internal engineering specifications or manufacturing quality controls, ensuring the changed materials/suppliers still result in instruments that meet original design parameters, but this is not detailed.

8. The sample size for the training set

• Not Applicable. The MAVEN™ System creates patient-specific instruments based on imaging (CT scans) of individual patients. It's not an AI model that undergoes a "training set" in the machine learning sense. The device is customized for each patient, not trained on a general dataset.

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

• Not Applicable. As there is no training set in the AI sense, there is no ground truth established for it. The "ground truth" for the device's function relies on the accuracy of the patient's CT scan and the accuracy of the surgical planning software to generate the instrument.

Summary specific to this document:

This 510(k) is a Special 510(k). Its purpose is to demonstrate that a minor modification (change in material grade of nylon and OTS design software) to an already cleared device (K202019) does not raise new questions of safety or effectiveness. The FDA's letter explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...".

The "Performance Data" section of the 510(k) summary only states: "The company conducted a design and manufacturing process validation, to demonstrate that the changes presented within this premarket submission, did not change the outputs, which is the creation of a patient specific instrument. The validation successfully demonstrated the minor changes made to the subject device are substantially equivalent to the predicate." This refers to internal validation of manufacturing processes and design outputs, not a clinical study to meet acceptance criteria for a new device.

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The Paragon 28 MAVEN™ Patient-Specific Instrumentation is intended to be used as patient specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively and in guiding the marking of bone before cutting. The Paragon 28 MAVENTM Patient-Specific Instrumentation is intended for use with the Paragon 28 APEX 3D Total Ankle Replacement System and its cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging CT scans. The Paragon 28 MAVEN™ Patient-Specific Instrumentation is intended for single use only. The Paragon 28 TAR Patient-Specific Case Reports are intended for use with the Paragon 28 APEX 3D Total Ankle Replacement System and its cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging CT scans.

The Paragon 28 MAVENTM Patient-Specific Instrumentation is used in conjunction with the APEX 3D Total Ankle Replacement System instrumentation (K192994). The guides are created to fit the anatomy of the patient's distal tibia and proximal talus, and when used in combination with the APEX 3D instruments, facilitate positioning of the APEX 3D implants.

The provided text is a 510(k) Summary for the Paragon 28 MAVEN™ Patient-Specific Instrumentation. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on performance data. However, the document does not contain the detailed acceptance criteria or the specifics of the study that proves the device meets those criteria in the format requested.

Here's a breakdown of what is and is not available in the provided text:

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

• Not available. The document states that "The device performance was characterized via Guide Design Process Validation, Pre-operative vs Post-Operative Analysis of Implant Placement and Resection Location, and Software Validation." However, it does not provide specific acceptance criteria (e.g., maximum allowable deviation for implant placement) or the quantitative results of these performance characterizations.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not available. The document mentions "Pre-operative vs Post-Operative Analysis of Implant Placement and Resection Location" but does not specify the sample size of patients or images used for this analysis, nor does it describe the data provenance.

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)

• Not available. The document does not describe any expert-based ground truth establishment or the involvement of experts in the performance characterization studies.

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

• Not available. Since no explicit ground truth establishment process involving experts is described, there is no mention of an adjudication method.

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 available. The document describes a "Patient-Specific Instrumentation" (PSI) system, which is a physical guide to assist surgeons, not an AI-assisted diagnostic or interpretation tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device type.

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

• Not applicable/Not explicitly stated. The device is "Patient-Specific Instrumentation" intended to be used intraoperatively by surgeons. While there is a "Software Validation" mentioned, the performance characterization seems to be related to the accuracy of the physical guides and the resulting implant placement, rather than a standalone algorithm's diagnostic performance. The document itself focuses on the instrument's ability to facilitate positioning, inherently a human-in-the-loop process.

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

• Inferred, but not explicitly stated. For "Pre-operative vs Post-Operative Analysis of Implant Placement and Resection Location," the ground truth would likely be the intended implant placement/resection location based on the surgical plan (pre-operative) compared to the actual post-operative placement, possibly verified by post-operative imaging. However, the document does not explicitly define how this "ground truth" was established or measured.

8. The sample size for the training set

• Not applicable/Not available. As this device is a patient-specific surgical instrumentation system rather than a machine learning model that requires a training set, the concept of a training set sample size is not relevant in the context usually meant for AI/ML devices. The "Guide Design Process Validation" implies internal software validation, but not a training set for an AI model.

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

• Not applicable/Not available. See point 8.

In summary, the provided document offers a high-level overview of the device and its claimed equivalence but lacks the granular details of performance criteria and study results requested. It indicates that "Clinical data are not needed to support the safety and effectiveness of the subject device," suggesting that the performance data presented (Guide Design Process Validation, Pre-operative vs Post-Operative Analysis, Software Validation) were considered sufficient without specific clinical trials.

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