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The Paragon 28 Patient Specific Marking Guide is intended to be used as a surgical instrument to assist in preoperative planning and/or in guiding the marking of bone and/or in guiding surgical instruments in non-acute, non-joint replacing osteotomies for adult patients in the foot ankle. The Patient Specific Guide is not intended to directly guide the cutting of bone. The device is single use only.

The Paragon 28 Patient Specific Marking Guides are designed and additively manufactured based on an individual patient's CT scan(s). In surgery, these guides, templates, or anatomical models are used to assist a surgeon in guiding the marking of a bone and/or guiding a surgical instrument for placement (i.e., placing a k-wire). The guides are not used for cutting bone. All guides are patient specific and utilize a CT scanning protocol previously cleared in K180239 (Paragon 28 formerly Additive Orthopaedics). The anatomical landmarks necessary for the design and creation of the Patient Specific Marking Guides must be present and identifiable on computed tomography scan.

The Paragon 28 Patient Specific Marking Guides are additively manufactured from biocompatible nylon (PA 2200 - polyamide 12 white) and produced by laser sintering. The Patient Specific Marking Guides are optional for surgeons to help visualize and plan osteotomies in the foot and ankle and are for single use only.

The provided text is a 510(k) summary for the Paragon 28 Patient Specific Marking Guides. It describes the device, its intended use, and substantial equivalence to a predicate device, supported by various performance tests. However, it does not contain the specific details requested regarding acceptance criteria for device performance, a study proving those criteria were met, sample sizes for test or training sets, data provenance, number or qualifications of experts, adjudication methods, multi-reader multi-case studies, standalone performance, or how ground truth was established for training data.

Therefore, I cannot fulfill your request for that specific information based solely on the provided text.

The closest information provided related to performance is:

1. A table of acceptance criteria and the reported device performance
No explicit table of acceptance criteria or quantitative reported device performance is provided in the document. The general statement is that "a cadaver lab were conducted to prove the subject device performs in accordance with its intended use."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions a "Cadaver Study" but does not specify the sample size (number of cadavers or cases) or the provenance of the data.

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)
This information is not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.

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
This information is not provided. The device is a physical instrument, not an AI-assisted diagnostic tool, so an MRMC study in this context would be unlikely.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided. The device is a surgical guide, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the cadaver study, the "ground truth" would implicitly be the actual anatomical marking or instrument placement achieved by the surgeon using the guide, compared to the intended pre-operative plan. However, the specific method of establishing this ground truth (e.g., measurement, expert verification) is not described.

8. The sample size for the training set
This device is designed based on individual patient CT scans. There is no "training set" in the traditional machine learning sense, as it's a patient-specific physical device, not an algorithm being trained. Each guide is custom-made based on one patient's data.

9. How the ground truth for the training set was established
As there isn't a traditional training set, this question is not applicable. The design of each guide is based on the anatomical data from the specific patient's CT scan.

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The Additive Orthopaedics Patient Specific 3D Printed Locking Lattice Plate is indicated for alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot and ankle. It is a patient specific device.

The Additive Orthopaedics Patient Specific 3D Printed Locking Lattice Plate is indicated for alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot and ankle. This is a patient specific device which utilizes the CT scanning protocol previously cleared in K180239 by Additive Orthopaedics. These patient specific devices are manufactured within a size range of 30-80mm and are supplied non-sterile.

The subject device is manufactured from medical grade titanium alloy Ti6Al4V ELI and allows the surgeon to align and stabilize small bone osteotomies such as MPJ fusions, calcaneal osteotomies, Evans Osteotomies, opening wedge osteotomies and others. The plate is fixated using both locking and non-locking screws which were cleared in K 163593 (Additive Orthopaedics) and compatible with Additive Orthopaedics wedges (K153207 and K180239).

The provided text is a 510(k) summary for the Additive Orthopaedics Patient Specific 3D Locking Lattice Plates. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a predicate device. It does not contain information about a study proving the device meets acceptance criteria in the context of an AI/ML-based medical device performance evaluation.

Instead, this document focuses on demonstrating substantial equivalence based on:

• Device Description: The device is patient-specific plates made from Ti6Al4V ELI, indicated for alignment, stabilization, and fusion of small bones (foot and ankle).
• Comparison to Predicate Devices: The key argument is that the subject device, while patient-specific, has similar indications, geometry, materials, and manufacturing processes to its predicate devices (Additive Orthopaedics Locking Lattice Plates K170214, BIOPRO, INC. BioPro Foot Plating System K162674).
• Non-Clinical Evidence: It refers to mechanical testing (4-point bending, static torsion, static driving torque, removal torque, static axial pullout) performed on the predicate device (K170214) per ASTM standards. The rationale is that since the new device uses similar materials and manufacturing methods, and the differences are primarily patient-specific geometry based on a previously cleared CT scanning protocol (K180239), the prior testing on the predicate device is sufficient.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the type of device and submission described in the provided text.

The device is a physical implant, not an AI/ML diagnostic or therapeutic system which would typically involve the type of performance evaluation outlined in your request.

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