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The My3D® Personalized Pelvic Reconstruction system is indicated for use in patients requiring reconstruction of the pelvis and/or hip joint due to disease, deformity, trauma, or revision procedures where other treatments or revisions have failed. The device is a combination of single use guided osteotomy instruments, a pelvic implant, screws, and acetabular/ femoral components. The pelvic implant is intended for cementless application in individuals where bone quality or bony defect size cannot support a standard sized acetabular implant is intended to be fixed to the remaining pelvic anatomy using compatible bone screws to create a prosthetic acetabulum. The reconstructed prosthetic acetabulum is intended to be used with a compatible cemented acetabular cup, dual mobility head (POLARCUP Insert), and femoral components to restore hip function.

The My3D® Personalized Pelvic Reconstruction system is a patient specific combination of single use resection instruments, a pelvic implant, screws, acetabular, and femoral components. The system was developed to address conditions which require reconstruction of the acetabulum and hip joint.

This patient matched device is designed from inputs including imaging, diagnosis, and surgical approach. Together with the surgeon, these inputs are then translated via a design process to create patient specific implants and, if appropriate, instruments to reconstruct the patient's pelvis. If utilized, the patient specific instruments are used to resect the bone and allow for implantation of the patient matched pelvis. The joint is then reconstructed with a cemented acetabular cup, dual mobility head (POLARCUP Insert), and femoral components.

The implants and resection instruments are single use devices. Reusable instrumentation is provided non-sterile in surgical trays which are to be re-processed per validated instructions.

I am sorry, but the provided text content does not contain enough information to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as per your request. The document is an FDA 510(k) clearance letter and summary for the My3D® Personalized Pelvic Reconstruction device, which primarily addresses substantial equivalence to a predicate device.

Specifically, the document mentions "Performance Data" and lists several types of testing performed (biocompatibility, manufacturing residuals, sterilization validation, mechanical testing of porous structure, fatigue testing, screw performance, cadaveric evaluation of design process). However, it does not provide:

1. A table of acceptance criteria and reported device performance. It only lists the types of tests.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method.
5. Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or its effect size.
6. Whether a standalone performance study was done.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document explicitly states: "Clinical data were not deemed necessary for the subject device." This further indicates that no human-centric validation studies (like MRMC or studies requiring expert ground truth and adjudication) were conducted or included in this submission summary. The testing mentioned appears to be primarily engineering and material performance tests.

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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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The Vantage PSI System is intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intraoperatively, and in guiding bone cutting. The Vantage PSI System is intended for use with Exactech's Vantage Total Ankle System and its cleared indications for use.

3D System's Vantage PSI System is patient-specific guides created to fit the contours of the patient's distal tibial and proximal talar anatomy. The guides and models are designed and manufactured from patient imaging data (CT) and are made from biocompatible nylon. The surgical guides in combination with Exactech Vantage Total Ankle reusable instruments, facilitate the positioning of Vantage Total Ankle Implants. 3D System's Vantage PSI System produces a variety of patient specific outputs including surgical guides, anatomic models, and case reports for use with Exactech's Vantage Total Ankle System (K152217 and K183343).

Here's an analysis of the provided text regarding the acceptance criteria and study for the Vantage PSI System:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of acceptance criteria with numerical targets and the corresponding device performance tied to those targets. Instead, it describes general compliance with standards and successful meeting of "all test method acceptance criteria" or "pre-defined acceptance criteria."

However, we can infer some performance aspects from the Cadaver Study / Design Validation.

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size for Cadaver Study: The document states that the cadaver and design validation studies utilized three surgeon users and compared the subject device to standard instrumentation. The number of cadavers or individual surgical procedures performed is not explicitly stated.
• Data Provenance: Not specified, but given the nature of cadaver studies for device validation, it would be prospective data collection. The country of origin is not mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• The cadaver study involved three surgeon users.
• Their specific qualifications (e.g., years of experience, subspecialty) are not provided. They are simply referred to as "surgeon users."
• It's implied these surgeons contributed to evaluating the outcome, but the document doesn't explicitly state they established the "ground truth." The ground truth appears to be derived from objective measurements (2D and 3D analysis) comparing actual placement to pre-operative plans.

4. Adjudication Method for the Test Set

• The document does not specify an adjudication method for the cadaver study's results. It describes 2D and 3D analysis conducted but doesn't detail how discrepancies or interpretations between the three surgeon users, or between the measurements and the pre-operative plan, were resolved or adjudicated.

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 Vantage PSI System is a patient-specific surgical guide intended for use with total ankle replacement components and guiding bone cutting, not an AI-based diagnostic or interpretative system where human readers would interpret results with or without AI assistance.
• The cadaver study was a comparative performance study between the device and standard instrumentation, not an AI assistance study.

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

• The device itself (Vantage PSI System) is a physical surgical guide designed from imaging data via software, not a standalone algorithm that provides a diagnosis or output without human intervention. The "design and development process" involves software creating the guides based on patient imaging. The "performance testing" described primarily pertains to the physical aspects of the device and its manufacturing process, along with its accuracy in facilitating surgical procedures as a tool.
• The closest to "algorithm only" performance would be the accuracy of the software-generated patient-specific guides and models against the patient data, which is implicitly covered by the "Process Qualification" and the "Cadaver Study / Design Validation" where the physical output is compared to the pre-operative plan. However, it's not a standalone diagnostic algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• For the cadaver study, the ground truth appears to be based on objective measurements derived from post-operative imaging (CT scans for 3D analysis, fluoroscopic images for 2D analysis) compared against the pre-operative plan. This combines objective measurement with a pre-defined target.

8. The Sample Size for the Training Set

• The document does not provide information on a separate "training set" sample size. The Vantage PSI System involves designing patient-specific guides based on individual patient imaging (CT data), rather than a machine learning model that requires a discrete training dataset for algorithm development. The "design and development process" converts the CT data into a guide.

9. How the Ground Truth for the Training Set Was Established

• As there is no explicit mention of a "training set" in the context of a machine learning algorithm, the process of establishing ground truth for such a set is not applicable based on the provided text. The "ground truth" for the device's function is the patient's anatomy derived from imaging and the surgeon's pre-operative plan based on that anatomy.

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