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The T2® Recon Nail System indications include fixation of subtrochanteric, interochanteric, ipsilateral neck/shaft, communited proximal femoral shaft fractures, femoral fixation required as a result of pathological disease, and temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur.

Device Description

The T2® Recon Nail System is a family of IM (Intramedullary) Nails for various types of femoral fractures. This Special 510(k) submission is intended to address modifications to the T20 Recon Nail System cleared under K032898. The anterior curve is being modified as part of a line extension of the T2® Recon Nail System. The T2 Recon Nail System currently contains 2000mm anterior to posterior radius of curvature.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called the "T2® RECON NAIL SYSTEM LINE EXTENSION," an intramedullary nail for femoral fractures. The submission is for a modification to an existing device, specifically changing the anterior-to-posterior radius of curvature of the nail.

It is crucial to understand that this document does not describe a study involving algorithms, AI, or human readers/experts in the way your prompt asks. This is a mechanical device, and the "study" described is an engineering analysis to demonstrate mechanical safety and anatomical fit. Therefore, many of the requested categories are not applicable to this type of device submission.

Here's an attempt to address your prompt based on the provided text, with clear indications of which categories are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (Implicit from text)	Reported Device Performance
Safety	The modified radius of curvature must not adversely affect the safety of the device.	An "engineering analysis" and "failure mode effect analysis (FMEA)" were performed, indicating that the modified radius does not affect safety.
Effectiveness	The modified radius of curvature must not adversely affect the effectiveness of the device.	An "engineering analysis" was performed, and "prior mechanical testing" which analyzed critical loading areas demonstrated that the proposed radius of curvature does not affect device performance. The device is "substantially equivalent" to predicate devices.
Anatomical Fit	The new radius of curvature must maintain appropriate anatomical fit for its intended use (femoral fractures).	"Potential risks analyzed include anatomical fit of the new radius of curvature." The FMEA and mechanical testing implicitly demonstrated acceptable anatomical fit to allow for intended performance.
Mechanical Strength	The mechanical strength of the T2® Recon Nail with the new radius of curvature must be maintained and suitable for its intended use.	"Potential risks analyzed include... mechanical strength of the T2® Recon Nail." "Prior mechanical testing which analyzed the critical loading areas of the device" demonstrated that the proposed radius of curvature does not affect device performance.
Substantial Equivalence	The modified device (1500mm radius of curvature) must be substantially equivalent to other legally marketed predicate devices in the United States, retaining the same indications for use as the original T2 Recon Nail System and for the predicate Gamma 3 Nail System.	The 1500mm radius of curvature nail design is stated to be "substantially equivalent to other devices currently marketed in the United States." The Gamma 3 Nail System (K034002) is cited as a predicate for the 1500mm radius of curvature.

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

Sample size for test set: Not applicable (N/A). This was an engineering analysis and mechanical testing, not a clinical study with human subjects or a dataset of images/medical records. The "test set" would be the physical devices or computational models used in the engineering analysis. The document does not specify a number of physical implants tested or simulations run.
Data provenance: N/A. No country of origin is specified. The analysis is based on engineering principles and mechanical testing. The document states it was a "Summary of Data" for an "engineering analysis."

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

Number of experts: N/A. No experts were used to establish "ground truth" in the context of clinical interpretation or diagnosis. The "ground truth" for mechanical performance is established by engineering principles and physical testing.
Qualifications of experts: N/A.

4. Adjudication method for the test set

Adjudication method: N/A. This concept is typically relevant for studies where human readers independently assess data and their agreement needs to be resolved. This was an engineering analysis.

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

MRMC study done: No. This is a modification to a mechanical implant, not an AI or diagnostic imaging device.
Effect size: N/A.

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

Standalone performance: No. This is a physical medical device, not a software algorithm.

7. The type of ground truth used

Type of ground truth: The "ground truth" implicitly used for this device's performance assessment is based on established engineering principles and validated mechanical testing standards for orthopedic implants, ensuring the device meets predefined material properties, strength, and fatigue resistance under simulated physiological loads. This is distinct from clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

Sample size for training set: N/A. There is no concept of a "training set" in the context of this device modification. The design is based on established biomechanical principles and previous designs.

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

How ground truth was established: N/A. (See point 8).

Summary of the "Study" from the Document:

The "study" conducted for this line extension was an engineering analysis combined with a Failure Mode Effect Analysis (FMEA) and prior mechanical testing. The purpose was to demonstrate that a change in the anterior-to-posterior radius of curvature from 2000mm to 1500mm does not negatively affect the safety and effectiveness of the T2® Recon Nail System. The analysis specifically investigated potential risks related to "anatomical fit" and "mechanical strength." The conclusion was that the proposed radius of curvature "does not affect device performance" and that the modified design is "substantially equivalent" to other marketed devices, including its predicate.

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