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The X-BOLT® IM Hip Nailing System is intended for use in fracture fixation in adults with osteopenia or osteoporosis. The X-BOLT® IM Hip Nailing System is indicated for use in:

• · Intertrochanteric and subtrochanteric fractures
• Segmental fractures
• · Comminuted fractures
• · Pathological fractures
• Fractures with bone loss
• · Pseudoarthrosis, non-union, mal-union, and delayed union
• · Surgically created defects such as osteotomies

The X-BOLT® Dynamic Hip Plating System is intended for use in fracture fixation in the proximal femur in adults with osteopenia or osteoporosis. The X-BOLT® Dynamic Hip Plating System is indicated for use in:

• · Intracapsular and extracapsular fractures of the femoral neck
• · Trochanteric fractures of the proximal femur
• · Stable subtrochanteric fractures of the proximal femur

The X-BOLT® Hip Fracture Fixation System is a single use device intended for long-term (greater than 30 days) implantation into the femur or proximal femur. The system consists of two parts: the IM Hip Nailing System and the Dynamic Hip Plating System.

IM Hip Nailing System components:
A. X-BOLT®: An expanding hip bolt.
B. X-BOLT® IM Hip Nail: A metal nail used with the X-BOLT® for femur fracture fixation.
C. End-Cap: Prevents bone ingrowth into the proximal end of the nail.
D. Set Screw: Prevents X-BOLT® rotation while allowing dynamic movement.
E. X-BOLT® Distal Locking Screws: Bone fixation screws used with the IM Hip Nail for distal fixation.

Dynamic Hip Plating System components:
A. X-BOLT®: An expanding hip bolt.
B. X-BOLT® Dynamic Hip Plate: An angled metal plate used with the X-BOLT® for proximal femur fracture fixation.
C. X-BOLT® Cortical Screws: Bone fixation screws used with the Dynamic Hip Plate for proximal femur fracture fixation.

This document is a 510(k) premarket notification for the X-BOLT® Hip Fracture Fixation System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving specific acceptance criteria for AI/ML performance. Therefore, most of the requested information regarding AI/ML device testing, ground truth establishment, expert adjudication, and sample sizes for training/test sets is not available in this document.

The document describes a medical device, specifically orthopaedic implants for hip fracture fixation, not an AI/ML powered device. The "performance testing" detailed refers to biomechanical and material testing of the physical implant, not software or algorithmic performance.

However, based on the provided text, I can extract information related to the device and its testing as presented, which primarily supports its physical and material properties, rather than AI/ML performance.

Here's what can be gathered, addressing the questions to the extent possible, with many points being "Not Applicable" (N/A) or "Not Provided" due to the nature of the device and document:

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

The document does not present specific "acceptance criteria" in a quantitative table for device performance in the common sense of AI/ML evaluation (e.g., accuracy thresholds, sensitivity/specificity). Instead, performance is demonstrated through adherence to, and successful completion of, well-established ASTM and ISO standards for orthopedic implants. The "performance" reported is that the device "demonstrates that it performs comparably to predicate devices, thereby supporting its substantial equivalence."

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

• Test Set Sample Size: Not explicitly stated for each test. For biomechanical testing, often a defined number of samples (e.g., typically N=6 or more for each test condition) are required by the standards, but the exact numbers are not provided in this summary. Cadaver testing details are not quantified in terms of sample size.
• Data Provenance: Not specified. Standardized ASTM and ISO tests are laboratory-based. Cadaver testing would be conducted in a laboratory setting. No mention of geographical origin for data or if it's retrospective/prospective is relevant for this type of device.

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. Ground truth for mechanical and biocompatibility testing is established by adhering to widely accepted engineering and biological test standards (ASTM, ISO). These do not typically involve human expert consensus for "ground truth" in the way AI/ML models do.
• Qualifications of Experts: N/A. The "ground truth" is typically the physical and chemical properties of the materials and the mechanical performance defined by the test standards, measured by qualified laboratory personnel using calibrated equipment.

4. Adjudication method for the test set

• Adjudication Method: N/A. The testing described does not involve human interpretation or subjective assessment that would require an adjudication method. Results are quantitative measurements against defined standards.

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: N/A. This is a physical medical device (implant), not an AI/ML diagnostic or assistive tool. MRMC studies are specific to evaluating diagnostic imaging systems and reader performance.

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

• Standalone Performance: N/A. See above; this is not an algorithm or software device.

7. The type of ground truth used

• Type of Ground Truth: For the mechanical and biocompatibility testing, the "ground truth" is defined by the requirements and methodologies outlined in the referenced ISO and ASTM standards. For example, for mechanical tests, the ground truth is the measured force, displacement, or fatigue life against the specified limits. For biocompatibility, it's the biological response (or lack thereof) according to the ISO 10993 series.

8. The sample size for the training set

• Training Set Sample Size: N/A. This device is not an AI/ML product; therefore, there is no "training set."

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

• Ground Truth for Training Set: N/A. As there is no AI/ML component, there is no training set or associated ground truth establishment process.

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