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The T2 Proximal Humeral Nail is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications according to AO classification include Type A-Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact calotte, or Humeral Fractures according to Neer-Classification.

This Special 510(k) submission is a line extension to the T2 Nailing System to add a new style of Proximal Humeral Nail. The nails are inserted using an opened or closed technique and can be statically or dynamically locked. The T2 Proximal Humeral Nail is intended for single use only.

The provided text describes a Special 510(k) submission for a line extension to the T2 Nailing System, adding a new style of Proximal Humeral Nail. The submission focuses on demonstrating substantial equivalence to a predicate device.

Here's an analysis of the requested information based on the provided text:

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

The submission does not specify quantitative acceptance criteria in terms of accuracy, sensitivity, specificity, or other performance metrics typically associated with AI/software devices. Instead, it relies on demonstrating comparable mechanical properties to a predicate device for a physical medical device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The text does not describe a test set or data provenance in the context of an AI/software device. The evaluation method mentioned is "FEA analysis and mechanical testing," which refers to engineering simulations and physical tests on the device itself, not data from patients or a clinical test set.

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 is not applicable to this submission. The "ground truth" here relates to the mechanical properties of the physical device, established through engineering standards and testing, not expert interpretation of medical images or clinical outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable to this submission as there is no human-interpreted 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

This is not applicable. This submission is for a physical orthopedic implant (an intramedullary nail), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study is not relevant.

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

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

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

The "ground truth" in this context refers to the established mechanical properties and material composition of the predicate device, which are used as a benchmark for comparison. This is based on engineering specifications and prior performance of approved devices.

8. The sample size for the training set

This is not applicable. There is no training set mentioned or implied for this physical device submission.

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

This is not applicable as there is no training set involved.

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

The study described is an engineering and materials-based assessment rather than a clinical or AI performance study.

• Study Type: Mechanical testing and Finite Element Analysis (FEA).
• Objective: To demonstrate that the new T2 Proximal Humeral Nail line extension has "comparable mechanical properties" to its predicate device and is made of "identical" material.
• Methodology:
  • Material Comparison: Stated that the material used for the new device is "identical" to that of the predicate.
  • Mechanical Property Comparison: Performed "FEA analysis and mechanical testing." While specific tests (e.g., bending, torsion, fatigue) are not detailed, these are standard methods for evaluating the structural integrity and performance of orthopedic implants.
• Results: The FEA analysis and mechanical testing "demonstrates the comparable mechanical properties of the subject T2 Nail System to the predicate device."
• Conclusion: The device meets the acceptance criteria by demonstrating substantial equivalence in material and mechanical performance to a legally marketed predicate device. This approach is typical for line extensions of physical medical devices where the changes are limited and do not alter the fundamental scientific technology or intended use.

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The T2 Proximal Humeral Nail is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications according to AO classification include Type A-Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact calotte, or Humeral Fractures according to Neer-Classification.

This 510(k) submission is a line extension to the T2 Nailing System to add new types of Proximal Humeral Nails. The nails are inserted using an opened or closed technique and can be statically or dynamically locked. The T2 Proximal Humeral Nails are intended for single use only.

The provided 510(k) summary (K042396) for the T2 Proximal Humeral Nail Line Extension is for a medical device (intramedullary nail) and not a diagnostic or AI-driven device. As such, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of diagnostic performance (e.g., sensitivity, specificity, AUC) is not applicable here.

Instead, for a medical device like an intramedullary nail, "acceptance criteria" would typically relate to mechanical performance (e.g., strength, fatigue resistance), biocompatibility, manufacturing quality, and substantial equivalence to a predicate device. The "study" proving these criteria would be mechanical testing, biocompatibility testing, and comparison to a predicate device.

Based on the provided document, here's an attempt to extract the relevant information, aligning it as much as possible with your requested categories, even though they are largely designed for diagnostic devices:

1. Table of Acceptance Criteria and Reported Device Performance

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

This is not applicable for a mechanical device submission. There is no "test set" in the context of patient data or readings for diagnostic accuracy. The "test set" would be physical nails subjected to mechanical testing. The document does not specify the number of nails tested in the FEA analysis. Data provenance relates to patient data, which is not relevant here.

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

Not applicable. "Ground truth" for a mechanical device is established through engineering specifications, material science, and mechanical testing standards. There are no "experts" establishing a "ground truth" in the diagnostic sense for this device.

4. Adjudication Method for the Test Set

Not applicable. There is no "adjudication method" as this is not a diagnostic interpretation task.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret images or data, and its goal is to assess the impact of AI assistance on reading performance. This device is a surgical implant.

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

Not applicable. This is not an algorithm. The "standalone" performance for a mechanical device would be its direct mechanical properties, which were assessed via FEA.

7. The Type of Ground Truth Used

For this device, the "ground truth" for mechanical properties would be:

• Engineering standards: e.g., ASTM standards for mechanical testing of orthopedic implants.
• Predicate device performance data: The mechanical performance of the legally marketed predicate device (to which the T2 Proximal Humeral Nail is claiming substantial equivalence) serves as the benchmark or "ground truth" for comparison.
• Material properties: Established properties of the implant materials.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a "training set" of data. The "training" for such a device is its design, manufacturing processes, and material selection based on established engineering principles.

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

Not applicable, as there is no training set in the AI/ML sense. The analogous "ground truth" for the development of such a device is based on long-standing biomechanical principles, clinical experience with similar devices, and engineering design specifications.

In summary, the 510(k) for the T2 Proximal Humeral Nail Line Extension relies on demonstrating "substantial equivalence" to a predicate device, primarily through comparable design concepts and mechanical properties (verified by FEA Analysis), rather than through diagnostic performance metrics.

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