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The First Choice® Partial Ulnar Head implant is intended for partial replacement of the distal ulna for rheumatoid, degenerative, or post-traumatic arthritis presenting with pain and weakness localized to the distal radioulnar joint and not improved by conservative treatment.

The First Choice Partial Ulnar Head implant is intended for press-fit use.

The First Choice Partial Ulnar Head implant is a onepiece hemi-arthroplasty device intended to replace the articulating surface of the distal ulnar head. It is constructed from cobalt chromium alloy and replaces the ulnar head while retaining the ulnar neck and styloid. The distal head is polished to a mirror finish for articulation within the distal radioulnar joint and the proximal stem has a roughened grit-blasted surface for uncemented press-fit fixation in the ulnar medullary canal. The First Choice Partial Ulnar Head implant is available in 12 sizes.

Here's an analysis of the provided text regarding the "First Choice Partial Ulnar Head Implant" and how it addresses the requested information about acceptance criteria and supporting studies:

This document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device rather than explicitly defining and meeting new acceptance criteria through a clinical study. Therefore, many of the requested categories related to independent clinical studies with specific performance metrics will not be directly applicable or present in this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

• Ulnar Head Biomechanics testing.
• DRUJ Stem Bend Strength testing.
  (Specific quantitative acceptance thresholds for these tests are not provided in this summary, but the implicit acceptance criterion is that the results fall within limits demonstrating equivalence to the predicate.) |
  | Clinical Performance: | Clinical Performance: |
  | Not necessary to support substantial equivalence. | Clinical performance data were not necessary to support substantial equivalence. |

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

• Sample Size for Test Set: Not applicable. No clinical test set. The non-clinical tests were conducted on prototypes of the new device and, by inference, compared to design specifications or performance characteristics of the predicate device. The document does not specify the number of units tested.
• Data Provenance: Not applicable. The testing described is non-clinical (biomechanical), likely conducted in a lab setting by the manufacturer, Ascension Orthopedics.

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

• Not applicable. There was no clinical test set requiring expert-established ground truth. The "ground truth" for the non-clinical tests would be the established engineering and biomechanical principles and potentially the performance data of the predicate device.

4. Adjudication Method for the Test Set

• Not applicable. There was no clinical test set requiring 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 orthopedic implant, not an AI or imaging-based diagnostic tool. Therefore, MRMC studies and AI-assisted reading are irrelevant.

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

• Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

• Non-Clinical: The implicit "ground truth" for the non-clinical performance data (Ulnar Head Biomechanics and DRUJ Stem Bend Strength) is the established engineering and biomechanical performance characteristics considered acceptable for the device's function, and, critically, the performance of the predicate device (Ascension® Modular Ulnar Head, K052137). The goal was to prove substantial equivalence, meaning the new device performs at least as well as the legally marketed predicate.
• Clinical: Not applicable, as clinical data was deemed unnecessary for this 510(k) submission.

8. The Sample Size for the Training Set

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

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

• Not applicable. As noted above, this is not an AI or machine learning device.

Explanation of the Study and Why it Meets "Acceptance Criteria"

The "study" in this context is the non-clinical performance testing conducted to demonstrate substantial equivalence to a predicate device, not an efficacy or safety study to meet specific, pre-defined acceptance criteria for a novel device.

• Device: First Choice Partial Ulnar Head Implant
• Purpose of the "Study" (Non-Clinical Testing): To demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device (Ascension® Modular Ulnar Head, K052137) in terms of intended use, technological characteristics, and performance (strength and function).
• Acceptance Criteria (Implicit): The primary acceptance criterion for this 510(k) submission is that the First Choice Partial Ulnar Head Implant's performance, as measured by the non-clinical tests, is comparable to, or as safe and effective as, the predicate device. This ensures the new device does not raise new questions of safety or effectiveness.
• Tests Performed:
  • Ulnar Head Biomechanics: Likely assessed mechanical properties related to joint articulation and stress distribution.
  • DRUJ Stem Bend Strength: Assessed the structural integrity and resistance to bending of the stem portion of the implant, which is fixed into the ulna.
• Outcome: The document states, "Performance data demonstrates that the subject device design is substantially equivalent to the predicate in terms of strength and function." This statement is the conclusion that the device has met the implicit acceptance criterion for substantial equivalence based on the non-clinical testing.
• Why Clinical Data Wasn't Needed: For many 510(k) submissions, if the new device is sufficiently similar to a predicate, and non-clinical data can bridge any differences, clinical data is not required by the FDA. This was the case here, as noted: "Clinical performance data were not necessary to support substantial equivalence."

In summary, for medical devices cleared through the 510(k) pathway, the "acceptance criteria" are usually tied to demonstrating substantial equivalence to an already legally marketed device, often through non-clinical testing, rather than through a new clinical trial establishing standalone efficacy and safety metrics.

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