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The Para-Fix External Fixation System is intended to provide stabilization of open and/or unstable fractures and where tissue injury precludes the use of other fracture treatments such as IM rodding or casting.

The specific indications for the Para-Fix External Fixation System include:

· Bone fracture fixation
· Osteotomy
· Arthrodesis
· Correction of deformity
· Revision procedure where other treatments or devices have been unsuccessful
· Bone reconstruction procedures

The New Paradigm Biomedical (NPB) Para-Fix External Fixation System is intended for use in external fixation of various long bone fractures, including tibial, femoral, pelvic, and humeral fractures in adults. The Para-Fix system consists of implants, & instrumentation for external fixation. The system features implants (Schanz Screws) in various diameters (05 – 6mm) and lengths (120 – 300mm) to accommodate different anatomic sizes of patients. Schanz Screws are manufactured from medical grade stainless steel per ASTM F138. Para-Fix frame components include Clamps are available in Combination (pin to rod, rod to rod) or Multi-Pin clamps are manufactured from stainless steel. Ø11mm rods are available in lengths ranging from 65 – 500mm and are manufactured from carbon fiber. The Para-Fix system is provided non-sterile.

The provided text describes a 510(k) premarket notification for the "Para-Fix External Fixation System." This is a medical device for orthopedic use, specifically for stabilizing bone fractures and other orthopedic conditions.

The document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than describing a study to prove acceptance criteria for a new AI/software-based medical device. Therefore, much of the requested information regarding "acceptance criteria," "device performance," "sample sizes," "ground truth," "expert readers," and "MRMC studies" is not applicable or present in this specific 510(k) summary.

Here's how the provided information relates to the request:

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

• Acceptance Criteria: The primary acceptance criterion for a 510(k) submission like this is substantial equivalence to a predicate device. This is typically demonstrated through a comparison of technological characteristics, intended use, and performance data (often non-clinical in this case).
• Reported Device Performance: The performance is reported in terms of mechanical testing showing substantial equivalence to the predicate device.

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

• Sample Size for Test Set: Not explicitly stated as a number of patients or clinical cases. For mechanical testing, the "sample size" would refer to the number of devices or components tested. This information (e.g., number of replicates for each mechanical test) is not detailed in the summary but would be part of the full test reports.
• Data Provenance: The mechanical testing was performed by "Element Materials Technology (Fairfield, OH)" and "NexTek Innovations (Logan, UT)". This is laboratory-based testing, not human clinical or retrospective/prospective data collection from patients.

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

• This question is not applicable to this type of device (an external fixation system). "Ground truth" in the context of mechanical testing is established by the test standards (ASTM F1541-17) and the results obtained from the testing equipment, not by expert human interpretation like in diagnostic AI.

4. Adjudication method for the test set

• This question is not applicable. There is no human adjudication for mechanical test results; the results are quantitative measurements against defined standards.

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 question is not applicable. This device is a mechanical external fixation system, not an AI-assisted diagnostic tool. No human reader studies (MRMC) were conducted or are relevant.

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

• This question is not applicable. There is no algorithm or software for "standalone performance" in this context.

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

• The "ground truth" for demonstrating substantial equivalence for this device is based on pre-defined mechanical testing standards (ASTM F1541-17) and the measured performance of both the subject device and the predicate device under these standardized conditions.

8. The sample size for the training set

• This question is not applicable. This device does not involve machine learning or a "training set."

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

• This question is not applicable. As there is no training set for an AI algorithm, no ground truth was established for it.

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The Hoffmann 3 Modular External Fixation System components are external fixation frame components for use with the components of the Hoffmann II MRI and Hoffmann II Compact MRI External Fixation Systems, in conjunction with Apex Pins. It is intended to provide stabilization of open and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments such as IM rods, casts or other means of internal fixation.

The Hoffmann 3 Modular External Fixation System consists of Rods, Posts, Couplings, Clamps and Pins that can be combined to construct different frame configurations that are MR conditional. The components for the subject device where manufactured from a variety of materials including austentic steel, titanium, and a Vectran coating. This line extension is intended to add additional components for connecting rods and fixed posts, design and material modifications to the couplings, pin clamp, rods and posts. Although the Hoffmann II MRI External Fixation System will continue to be marketed, the Hoffmann 3 Modular External Fixation System will be available with additional components for connecting rods and include design and material modifications to the couplings, pin clamp, rods and posts.

{"1. A table of acceptance criteria and the reported device performance": "The document does not explicitly state numerical acceptance criteria in a table format. Instead, it describes a comparative evaluation against a predicate device. The "reported device performance" is stated as demonstrating "comparable mechanical properties to the predicate components" and that the system "could be safely used in Magnetic Resonance Imaging under predetermined conditions."\n\nAcceptance Criteria (Implied from testing and claim of substantial equivalence):\n* Mechanical Properties: Comparable to the Hoffmann II MRI System's mechanical properties.\n* Magnetic Resonance Environment Safety: Safe for use in MRI under predetermined conditions (Radio Frequency Heating, Force and Torque, Artifact).\n\nReported Device Performance:\n* Mechanical testing demonstrated comparable mechanical properties to the predicate components.\n* Testing in a Magnetic Resonance Environment established that the Hoffmann 3 Modular External Fixation System could be safely used in Magnetic Resonance Imaging under predetermined conditions. (Specific results like % difference or specific thresholds are not provided in this summary.)", "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 refers to "Non-Clinical Testing" and lists various mechanical and MRI environment tests. However, it does not specify the sample sizes used for these tests. There is no mention of human subject data, and thus no data provenance in terms of country of origin or retrospective/prospective studies are applicable for the type of testing described.", "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 section is not applicable. The study described is non-clinical performance testing of a medical device (external fixator system) and does not involve the establishment of ground truth by human experts in the context of diagnostic interpretation. The 'ground truth' for this type of device would relate to engineering standards and safety parameters established by regulatory bodies or industry best practices, not expert consensus on medical images or patient outcomes.", "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of data (e.g., medical images) by multiple experts to establish a consensus ground truth. The tests performed for this device were non-clinical mechanical and MRI compatibility tests.", "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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is an external fixation system, not a diagnostic imaging or AI-assisted device. The testing described focuses on the mechanical and MRI compatibility of the hardware components.", "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "This question is not applicable to the Hoffmann 3 Modular External Fixation System as it is a physical medical device, not an algorithm or AI system. There is no 'standalone' algorithm performance to report.", "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "For the non-clinical testing of this external fixation system, the 'ground truth' would be based on established engineering and material science principles, industry standards (e.g., for strength, bending, torsion, pull-out, rotation), and regulatory requirements for MRI compatibility (radio frequency heating, force and torque, artifact). It's not based on expert consensus, pathology, or outcomes data related to clinical diagnosis.", "8. The sample size for the training set": "This question is not applicable to the Hoffmann 3 Modular External Fixation System. This device is a physical medical hardware system, not a machine learning model or software that requires a 'training set.' The listed tests are non-clinical hardware performance tests.", "9. How the ground truth for the training set was established": "This question is not applicable, as there is no 'training set' for this physical medical device."}

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