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The XLO Brand of Locking Distal Humerus Plating System is indicated for intra-articular fractures of the distal humerus, comminuted supracondylar fractures, osteotomies, and non-unions of the distal humerus.

The system is indicated for use in adult patients only. All implants are for single use only.

The XLO Brand of Locking Distal Humerus Plating System consists of various shape and sizes of plates featuring compression and locking or non-locking holes, full threaded-cortical, locking or non-locking & self-tapping screws. The XLO Brand of Locking Distal Humerus Plating System consists of the following implants:

• Distal Humerus Locking Plate 2.7/3.5, Dorsolateral, Left & Right
• Distal Humerus Locking Plate 2.7/3.5, Dorsolateral, With Lateral Support Left & Right
• 3.5mm cortical screw
• 2.7mm locking screw
• 3.5mm locking screw

The aforementioned plates are used with cortical screws & locking Screws.

These bone plates are generally designed on the basis of the bone contour and anatomy.

The plates and screws are fabricated from titanium-alloy (Ti-6Al-4V).

These implants are sold non-sterile, the products have to be sterilized prior to use.

The provided text is a 510(k) summary for the XLO Brand of Locking Distal Humerus Plating System. This document focuses on demonstrating substantial equivalence to predicate devices for a physical medical implant (bone plates and screws), not an AI/Software as a Medical Device (SaMD). Therefore, many of the requested categories about AI performance studies, such as sample sizes for test/training sets, number of experts for ground truth, adjudication methods, and MRMC studies, are not applicable to this submission.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document refers to performance criteria outlined in FDA guidance documents for orthopedic fracture fixation plates and metallic bone screws. The specific numerical acceptance criteria are not explicitly stated in the provided text, but the reported performance is that the device "conform[s] to the performance criteria outlined in [FDA guidance documents]."

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

This information is not explicitly provided. For mechanical testing of physical orthopedic implants, sample sizes are typically determined by specific ASTM standards (e.g., ASTM F382, ASTM F543) and validation protocols, rather than "test sets" in the AI/SaMD sense. The data provenance would be from laboratory mechanical testing.

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

Not applicable. This is a physical device, and its "performance" is evaluated through mechanical engineering tests against established standards, not through clinical interpretation or expert ground truth.

4. Adjudication method for the test set:

Not applicable. Mechanical tests have objective pass/fail criteria based on measured physical properties.

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. This is not an AI/SaMD device.

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

Not applicable. This is not an AI/SaMD device.

7. The type of ground truth used:

The "ground truth" for this device's performance is objective mechanical engineering data compared against established industry standards (ASTM F382, ASTM F543) and FDA guidance documents.

8. The sample size for the training set:

Not applicable. This is not an AI/SaMD device and does not involve a training set.

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

Not applicable. This is not an AI/SaMD device and does not involve a training set or its associated ground truth establishment.

Summary of Applicable Information from the Document:

• Device Type: Physical Metallic Bone Fixation Appliances and Accessories (Bone Plates and Screws).
• Study Type: Non-clinical (benchtop) mechanical testing and material standards compliance.
• Standards Used:
  • Material: ASTM F136 (Wrought Titanium-6Aluminium-4Vanadium ELI Alloy for surgical implant applications).
  • Performance: ASTM F382 (Static Four Point Bend Test for plates), ASTM F543 (Torsional Strength, Driving Torque, Removal Torque, Axial Pull-out Strength for screws).
• Performance Comparison: Test results were compared to performance criteria outlined in FDA guidance documents: "Orthopedic Fracture Fixation Plates – Performance Criteria for Safety and Performance Based Pathway" and "Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway."
• Conclusion: The device's test results conform to the specified performance criteria, and the material complies with the relevant standard, justifying its safety and effectiveness.
• Clinical Data: "Clinical data and conclusions were not needed for these devices to demonstrate substantial equivalence to the predicate devices."

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The Skeletal Dynamics Inc's Distal Humerus Plating System is indicated for intra-articular fractures of the distal humerus, comminuted supracondylar fractures, osteotomies, and non-unions of the distal humerus.

The Skeletal Dynamics Inc's Distal Humerus Plating System consists of five titanium bone plates in different shapes (medial direct, lateral direct, lateral capitellar, and supracondylar), in multiple lengths, and in left and right configurations to address distal humerus fractures. The plates are made of medical grade titanium allov. The system also includes 2.7mm, 3.5mm and 4.5mm locking and compression titanium alloy screws and 3.0mm polyaxial Cobalt Chrome locking screws which are provided in various lengths. The System is being modified to include additional lengths of existing screw options and new 3.5mm and 4.5mm locking and compression Titanium Alloy Screws. Additionally, minor modifications have been made to the plates to accept the new screws above mentioned. Also included in the system is specialized instrumentation. The System is provided nonsterile for sterilization in the user facility.

The Distal Humerus Plating System is comprised of:

• · Titanium alloy plates, screws, and fasteners
• · CoCr Cannulated Polyaxial Locking Screws (PLS)
• · Stainless steel K-wires (for provisional fixation; not for implantation)
• · System specific instrumentation

This document describes a medical device, the "Distal Humerus Plating System," which is a metallic bone fixation appliance. The FDA clearance is based on substantial equivalence to a predicate device, not on extensive clinical outcome studies typically associated with AI/software devices.

Therefore, many of the requested points, particularly those related to AI algorithm performance (acceptance criteria, ground truth, expert consensus, MRMC studies, etc.), are not applicable to this type of device clearance. The clearance is based on engineering analysis and mechanical testing, ensuring the device's physical properties are safe and effective.

Here's an analysis of the provided text in relation to your questions, highlighting what is present and what is absent:

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

• Acceptance Criteria (for this type of device): The primary acceptance criterion for this type of medical device cleared through the 510(k) pathway is substantial equivalence to a predicate device. This means demonstrating that the new device is as safe and effective as a legally marketed device and does not raise new questions of safety or effectiveness. For metallic bone fixation, this typically involves material compatibility, mechanical strength, and design similarities.
• Reported Device Performance: The document states:
  • "Engineering analysis and mechanical testing demonstrated that the Skeletal Dynamics Inc's Distal Humerus Plating System is equivalent to predicate devices currently marketed."
  • "Static testing, which established equivalency included ASTM-F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws."
  • "The subject device is as safe and effective as the legally marketed predicate device."

Table of Acceptance Criteria and Performance (as applicable to this device type):

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

• Not Applicable. This is a hardware device cleared through a 510(k) pathway, not an AI/software device requiring a test set of medical images or patient data in the sense of an algorithm. The "testing" refers to mechanical and engineering tests, not data sets.

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

• Not Applicable. See point 2. Ground truth in the context of AI relates to expert labels on data. For this device, "ground truth" relates to engineering standards and validated test methods.

4. Adjudication method for the test set

• Not Applicable. See point 2.

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. This is a physical implantable device, not an AI-assisted diagnostic tool. MRMC studies are used for evaluating the impact of AI on human interpretation of medical images.

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

• Not Applicable. This is not an algorithm.

7. The type of ground truth used

• Ground Truth (for this device type): Engineering specifications, validated mechanical testing standards (e.g., ASTM-F543-17), and material properties are the "ground truth" against which the device's performance is measured for substantial equivalence. There isn't "expert consensus" or "pathology" in the sense of clinical image interpretation for this specific clearance.

8. The sample size for the training set

• Not Applicable. This is a hardware device, not an AI algorithm requiring a training set.

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

• Not Applicable. See point 8.

In summary: The provided FDA clearance document for the "Distal Humerus Plating System" pertains to a physical medical device. The regulatory pathway (510(k)) relies on demonstrating substantial equivalence to a predicate device, primarily through engineering analysis and mechanical testing. The questions you posed are highly relevant to AI/machine learning medical devices, but not to this specific hardware device clearance.

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The Skeletal Dynamics Distal Humerus Plating System is indicated for intra-articular fractures of the distal humerus, comminuted supracondylar fractures, osteotomies, and non-unions of the distal humerus.

The Skeletal Dynamics Distal Humerus Plating System consists of five titanium bone plates in different shapes (medial direct, lateral direct, lateral capitellar, and supracondylar), in multiple lengths, and in left and right configurations to address distal humerus fractures. The plates are made of medical grade titanium alloy. Locking and compression screws in 2.7mm, 3.5mm and 4.5mm and 3.0mm polyaxial locking screws are provided in various lengths. Also included in the system is specialized instrumentation. The System is provided non-sterilization in the user facility.

The Distal Humerus Plating System is comprised of:

• . Titanium alloy plates, screws and fasteners
• CoCr Cannulated Polyaxial Locking Screws (PLS) .
• Stainless steel K-wires (for provisional fixation: not for implantation) ●
• System specific instrumentation ●

The provided text is a 510(k) summary for a medical device called the "Distal Humerus Plating System," which is a metallic bone fixation appliance. It describes the device, its indications for use, and how its substantial equivalence to predicate devices was demonstrated through mechanical testing.

However, the request asks for information related to "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/Software as a Medical Device (SaMD). The provided document does not describe an AI/SaMD device; instead, it describes a hardware device (bone plates and screws) and the performance testing (mechanical testing, specifically ASTM standards) done to demonstrate its equivalence to predicate devices.

Therefore, I cannot fulfill all aspects of your request because the document does not contain information about:

• A table of acceptance criteria and reported device performance related to AI metrics (e.g., sensitivity, specificity, AUC).
• Sample sizes for test sets in the context of AI (e.g., number of images).
• Data provenance for AI test sets.
• Number of experts and their qualifications for establishing ground truth for AI.
• Adjudication methods for AI test sets.
• MRMC studies for AI and human-in-the-loop performance.
• Standalone performance for an AI algorithm.
• Types of ground truth for AI (e.g., pathology, outcomes data).
• Sample size for AI training sets.
• How ground truth for AI training sets was established.

The document focuses on the mechanical and material equivalence of a physical implantable device.

Here's what can be extracted and inferred from the provided text, reinterpreted as much as possible for your request, but with the explicit understanding that it's not an AI/SaMD context:

Device Description:
The Skeletal Dynamics Distal Humerus Plating System is a physical medical device consisting of titanium bone plates, locking and compression screws, and specialized instrumentation, designed for fixing fractures of the distal humerus.

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

Since this is a physical device, the "acceptance criteria" and "performance" are based on mechanical equivalency to predicate devices.

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

• Test Set Sample Size: Not explicitly stated as "sample size" in the context of a discrete number of tests on identical units, but indicated to be sufficient to demonstrate equivalency according to ASTM standards. ASTM standards define the number of samples typically required for such tests.
• Data Provenance: The "study" is an engineering analysis and mechanical testing performed to demonstrate equivalency. The data provenance would be laboratory testing conducted by the manufacturer or a third-party lab. No information on country of origin of "data" in a clinical/retrospective sense, as this is pre-market mechanical testing.

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

• Not applicable in the context of mechanical testing. The "ground truth" for mechanical testing is established by the specified parameters and methodologies within the ASTM standards themselves, interpreted and executed by qualified engineers and technicians. This is not about human labelers/readers.

4. Adjudication method for the test set:

• Not applicable. This is mechanical testing against defined engineering standards, not human expert adjudication.

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. This device is a physical implant, not an AI or imaging device that would involve human readers.

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

• Not applicable. No algorithm is involved.

7. The type of ground truth used:

• The "ground truth" for the performance testing of this physical device is the mechanical and material specifications and performance parameters outlined in the referenced ASTM standards (ASTM F382 for plates and ASTM F543 for screws) and the performance characteristics of the legally marketed predicate devices.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a "training set."

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

• Not applicable.

In summary, the provided document details the regulatory clearance of a physical orthopedic implant based on demonstrating mechanical equivalence to existing products, not an AI/SaMD product. Therefore, most of your specific questions related to AI/SaMD testing and ground truth cannot be answered from this text.

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