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The System is indicated for fixation of fractures and non-unions of the ulna, particularly in osteopenic bone.

The Ulna Plating System is comprised of two new low profile plates anatomically contoured for the ulna, existing screws and both system specific and general instrumentation. The plates, locking screws and non-locking screws are manufactured from titanium alloy Ti6Al4V ELI per ASTM F136. All the plates are Type II anodized. The plates incorporate both locking and nonlocking holes that allow the surgeon to stabilize the fracture by the use of compression plating techniques and then obtain neutralization of the construct with the locking screws. The locking screws construct can protect the compression screws while providing relative stability across extensive comminution of in osteopenic bone. The plate material and the inclusion of both locking and non-locking holes are design features also included in the predicate device cleared in K083843. The plates are designed to accept existing 2.7mm locking screws, 2.7mm non-locking screws, and 2.7mm multidirectional screws. The non-locking and locking screws are manufactured from Titanium Alloy per ASTM F-136 and are color anodized. The multidirectional screws are manufactured from Cobalt Chromium Alloy per ASTM 1537. The predicate also includes Cobalt Chromium (ASTM F1537) multidirectional screws. The Ulna Plating System will offer the surgeon several system specific instruments as well as various general instruments to facilitate the installation of the implants.

This document is a 510(k) premarket notification for a medical device called the "Ulna Plating System." It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices.

Here's an analysis of the acceptance criteria and study information provided, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states: "No clinical tests are provided for basis of substantial equivalence." This means there was no test set in the context of clinical data. The performance was assessed through non-clinical (mechanical and engineering) tests.

• Test Set Sample Size: Not applicable for clinical data. For non-clinical tests, specific sample sizes (e.g., number of plates, screws, test specimens) are not detailed in this summary.
• Data Provenance: Not applicable for clinical data. For non-clinical testing, the data would have originated from laboratory testing conducted by the manufacturer or a contracted lab. The document does not specify the country of origin for this testing.

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

Not applicable. As no clinical tests were performed, there was no clinical "ground truth" to be established by experts.

4. Adjudication Method 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. This device is a bone fixation system, not an AI-powered diagnostic tool. Therefore, an MRMC study related to readers and AI assistance would not be relevant.

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

Not applicable. This device is a physical implant, not an algorithm or AI.

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

For the non-clinical performance data, the "ground truth" was established by engineering standards and specifications (e.g., ASTM F382 for mechanical properties, and internal criteria for galvanic corrosion). The comparison was primarily against the performance of legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is not an AI/ML device requiring such. The design of the device would have been informed by engineering principles, predicate device designs, and potentially cadaver studies or biomechanical modeling, but not a "training set" in the context of AI.

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

Not applicable. No training set in the context of AI/ML.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria was a non-clinical performance evaluation. This included:

• Construct testing per ASTM F382: This standard specifies requirements for metallic bone plates and tests their mechanical integrity. The results demonstrated substantial equivalence to predicate devices.
• 4-point bend testing per ASTM F382: This is another mechanical test under the ASTM F382 standard, specifically assessing the bending strength and stiffness of the plates. Results also indicated substantial equivalence to predicate devices.
• Galvanic Corrosion engineering evaluation: This evaluated the potential for corrosion when different metals are in contact, a crucial safety aspect for implants. The evaluation found that the device met acceptance criteria.

The conclusion drawn from these non-clinical tests was that the Ulna Plating System is substantially equivalent to legally marketed predicate devices (specifically K083843 - Locking Anatomic and Composite Plate System, and K112345 - Distal Volar Radius Plating System) in terms of its intended use, indications for use, materials, design features, and sterilization method. No clinical tests were performed, nor were they deemed necessary by the FDA for this 510(k) submission based on the non-clinical data and comparison to predicates.

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The system is intended for fixation of fractures, malunions and osteotomies involving the distal radius.

The Modified Distal Radius Plating System consists of Titanium alloy Extra Narrow and Extra Long family of plates utilizing non-locking, locking and variable angle screws manufactured from Titanium alloy and CoCr for bone fixation and the management of fractures and reconstructive surgeries.

The provided text describes a 510(k) submission for a Modified Distal Radius Plating System and focuses on demonstrating substantial equivalence to predicate devices, rather than a study demonstrating the device meets specific acceptance criteria based on performance metrics such as sensitivity, specificity, or reader improvement.

Therefore, many of the requested elements for describing an AI/CAD-based study are not applicable to this document. The document primarily outlines pre-clinical mechanical testing to ensure the new device is comparable to existing ones.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "pre-clinical data including axial load construct testing, 4-point bending testing, evaluation of galvanic corrosion potential and multidirectional screw capability" demonstrated substantial equivalence. Specific quantitative acceptance criteria (e.g., minimum load bearing, maximum corrosion rate) and the exact quantitative results are not provided in this summary.

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

• Sample Size: Not applicable. The "test set" here refers to the physical devices undergoing mechanical and material testing, not a dataset of medical images or patient records. The number of physical implants/constructs tested is not specified in the provided summary.
• Data Provenance: Not applicable in the context of clinical/imaging data. The data provenance relates to laboratory testing of device components.

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

• Not applicable. Ground truth in this context would be defined by engineering specifications and physical measurements, not expert consensus on medical images.

4. Adjudication method for the test set

• Not applicable. This concept is relevant for expert review of clinical data, not for material and mechanical testing.

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. This document pertains to a medical device's physical and material properties, not an AI/CAD system for image interpretation.

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

• Not applicable. This is not an AI algorithm.

7. The type of ground truth used

• The "ground truth" for this device's performance would be derived from engineering specifications, material science standards, and mechanical testing protocols. For example, the load at which a construct fails in axial loading would be the measurable "truth" compared against a specified acceptance load.

8. The sample size for the training set

• Not applicable. This product is a physical implant, not an AI model requiring a training set.

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

• Not applicable. No training set for an AI model.

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