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The intended use of the I.T.S. IM Nail Systems is to stablilize and fix long bone fractures to facilitate healing in an adult patient and is composed of the following categories:

The I.T.S. CFN - Cannulated Femur Nail System is indicated for use in long bone femur fracture fixation which include:

Open and closed femur shaft fractures; Intertrochanteric, supracondylar and ipsilateral fractures; High subtrochanteric fractures; Combined inter and subrochanteric fractures; Pertrochanteric fractures; Pseudoarthrosis and correction osteotomy; Non-union, malunion and delayed union fractures; Pathological fractures, impending pathologic fractures, and tumor resections and; Fractures proximal to a total knee arthroplasty; The system is not for spinal use.

The I.T.S. CTN - Cannulated Tibia Nail System is indicated for use in long bone tibia fracture fixation which include:

Proximal, metaphyseal, epiphyseal and distal shaft fractures; Segmental, simple, compound and comminuted fractures; Transverse, oblique and spiral fractures; Surgically created defects using osteotomies,such as for leg length discrepencies or deformity; Pathologic fractures; Pseudoarthrosis, non-union, mal-union and delayed union of the tibia; Fractures involving osteopenic and osteoporotic bone; Open fractures of the tibia and; Reconstruction of the tibia after tumor resection and/or bone loss.

The system is not for spinal use.

The I.T.S. CHN - Cannulated Humeral Nail System is indicated for use in long bone humerus fracture fixation which include:

Dislocated, unstable 2, 3 and 4 part fractures of the proximal humerus; Valgusimpacted 4 part fractures of the proximal humerus; Proximal humeral fractures with diaphyseal extension into the shaft; Pseudoarthrosis, non-unions, mal-unions and malalignments of the proximal humerus and; Pathological and impending pathological fractures.

The system is not for spinal use.

The I.T.S. IM Nail Systems CFN-CTN-CHN consists of Predicate type intramedullary nail trauma implant components commonly found with large companies with orthopedic markets in the United States. These 'Intramedullary (IM) Nail trauma implant devices' consist of the following categories:

1. CFN - Cannulated Femur Nail System
2. CTN - Cannulated Tibia Nail System
3. CHN - Cannulated Humeral Nail System

A brief and concise description of each system is enclosed as follows:

1. CFN - Cannulated Femur Nail System: The I.T.S. CFN -Cannulated Femur Nail System is a curved/bowed Intramedullary(IM) Nail in a right and left configuration to fit the natural bow of the femur and is inserted proximally/antegrade over 3.5/3.0mm calibrated guide wires. The CFN - IM Nail is composed of various nail diameters in sizes of 9.0, 10.0, 11.0, 12.0 and 13.0mm and various lengths from 240mm to 480mm in 20mm increments. The CFN - IM Nail accepts a 6.5mm Cortical Screw in various lengths for cross-screw fixation in the larger diameter proximal region of the nail and a 4.7mm Triple-lead Cortical Screw in various lengths for crossscrew fixation in the distal portion of the nail. A dynamization slot is located in the distal portion of the nail and an End Cap (in +0, +5, +10, +15, +20, +25 & +30 lengths) is available for proximal closing of the nail. The nail proximal cross-screw insertion uses Insertion Guide instrumentation for location of the hole and screw insertion preparation throught the bone cortex and nail. The nail distal cross-screw insertion uses x-ray fluoroscopic imaging for nail distal hole/slot location.

All CFN - JM Nail, End Cap and Screw components are manufactured from Alloyed 6-4 Titanium material to ASTM F136 and are processed with an anodize DOTIZE surface treatment.

Associated instrumentation such as Insertion Guide accessories, guide pins, drill sleeves, drill guides, drills, screwdriver, depth gauge with removal instruments are available with the system. All CFN - IM Nails, End Caps and Screws are provided Non-Sterile.

2. CTN - Cannulated Tibia Nail System: The I.T.S. CTN -Cannulated Tibia Nail System is a universal straight Intramedullary(IM) Naïl with a 50 proximal and distal bend configuration to fit the anatomy of the tibia and is inserted proximally/antegrade over 3.5/3.0mm calibrated guide wires. The CTN - IM Nail is composed of various nail diameters in sizes of 9.0, 10.0. 11.0. and 12.0mm and various lengths from 240mm to 420mm in 1 5mm increments. The CTN - IM Nail accepts only the 4.7mm Triple-lead Cortical Screw in various lengths for cross-screw fixation in both the proximal/distal portion of the nail. A dynamization slot is located in the proximal portion of the nail and an End Cap (in +0, +5, +10, +15, +20, +25, +30 lengths) is available for proximal closing of the nail. The nail proximal cross-screw insertion uses Insertion Guide instrumentation for location of the hole/slot and screw insertion preparation throught the bone cortex and nail. The nail distal cross-screw insertion uses x-ray fluoroscopic imaging for nail distal hole location.

All CTN - IM Nail, End Cap and Screw components are manufactured from Alloved 6-4 Titanium material to ASTM F136 and are processed with an anodize DOTIZE surface treatment.

Associated instrumentation such as Insertion Guide accessories, guide pins, drill sleeves, drill guides, drills, screwdriver, depth gauge and removal instruments are available with the system. All CTN - IM Nails, End Caps and Screws are provided Non-Sterile.

3. CHN - Cannulated Humeral Nail System: The I.T.S. CHN -Cannulated Humeral Nail System is a right and left Intramedullary (IM) straight Nail with a 4 proximal bend configuration to fit the anatomy of the humerus and is inserted proximally over 2.0/2.5mm calibrated guide wires. The CHN - IM Nail is composed of various nail diameters in sizes of 7.0. 8.0. and 9.0mm and various lengths from 140mm to 320mm in 10 and 20mm increments. The CHN - IM Nail accepts only a 3.5mm Double-lead Cortical Screw in various lengths for cross-screw fixation in both the proximal/distal portion of the nail. An End Cap (in +0, +5, +10, +15, +20, +25 & +30 lengths) is available for proximal closing of the nail. The nail proximal cross-screw insertion uses Insertion Guide instrumentation for location of the hole and screw insertion preparation throught the bone cortex and nail. The nail distal cross-screw insertion uses x-ray fluoroscopic imaging for nail distal hole location.

All CHN - IM Nail, End Cap and Screw components are manufactured from Alloyed 6-4 Titanium material to ASTM F136 and are processed with an anodize DOTIZE surface treatment.

Associated instrumentation such as Insertion Guide accessories, guide pin, drill sleeves, drill guides, drills, screwdriver, depth gauge and removal instruments are available with the system. All CHN -IM Nails, End Caps and Screws are provided Non-Sterile.

The provided text is a 510(k) summary for the I.T.S. IM Nail Systems CFN-CTN-CHN, which describes various intramedullary nails for stabilizing and fixing long bone fractures. This document focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a study to prove acceptance criteria based on device performance metrics like sensitivity, specificity, or accuracy.

Therefore, the following information cannot be fully extracted as it is not contained within the provided 510(k) summary:

• A table of acceptance criteria and the reported device performance: This document does not establish specific performance acceptance criteria or report a study comparing the device's performance against such criteria.
• Sample size used for the test set and the data provenance: No test set is described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described for a test set.
• Adjudication method for the test set: No adjudication method is described.
• 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 MRMC study is mentioned, nor is AI involved in this device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This pertains to algorithm performance and is not relevant to a physical medical device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as no ground truth is established for a performance study.
• The sample size for the training set: Not applicable as this is not an AI/algorithm-based device and does not involve training sets.
• How the ground truth for the training set was established: Not applicable.

The 510(k) summary explicitly states the method used for demonstrating the device meets acceptance criteria:

Equivalence and Study that Proves the Device Meets Acceptance Criteria:

The acceptance criterion for this device is "Substantial Equivalence" to legally marketed predicate devices. The study that proves the device meets this acceptance criterion is a comparison of technological characteristics to predicate devices.

The document states:

• "The I.T.S. IM Nail Systems CFN-CTN-CHN are Substantially Equivalent(SE) to the various predicate IM Nail, End Cap and Screw Systems as listed." (Page 3)
• "No nonclinical testing was used in the determination of substantial equivalence." (Page 3)
• "The I.T.S. IM Nail Systems CEN-CTN-CHN are Similar in Material, Geometry Design/Markings, and Indications to predicate system(s) currently sold in the U.S. market." (Page 3)

This means the "study" for this 510(k) submission was a documentary comparison, not a clinical trial or performance study typical for AI/software devices. The device meets "acceptance criteria" by demonstrating that its materials, design, and intended uses are sufficiently similar to devices already approved by the FDA, thereby inferring the same safety and effectiveness.

Key information explicitly found in the document related to acceptance criteria and the "study":

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

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

• Not applicable. No test set was used for a performance study. The evaluation was based on a comparison of device specifications and indications for use against predicate devices.

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

• Not applicable. No ground truth was established by experts for a test set. The review was primarily regulatory, comparing the new device's characteristics to existing predicate devices.

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

• Not applicable. No test set requiring adjudication was used.

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 MRMC study was done. This device is a physical intramedullary nail system and does not involve AI or human readers for diagnostic interpretation.

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

• Not applicable. This device is a physical intramedullary nail system and does not involve algorithms.

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

• Not applicable. For a substantial equivalence claim for a physical device like an intramedullary nail, the "ground truth" implicitly refers to the established safety and effectiveness of the predicate devices based on their prior approval and post-market experience.

8. The sample size for the training set:

• Not applicable. This is not an AI/algorithm-based device.

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

• Not applicable. This is not an AI/algorithm-based device.

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Indications for the Piccolo Composite Humeral Nail and Proximal Humerus Nail include simple humeral fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathological fractures; reconstruction, following tumor resection and grafting. The Piccolo Composite Humeral and Proximal Humerus Nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the humerus.

The Piccolo Composite Nailing System includes humeral and proximal humerus nails. interlocking screws and a set of instruments.

The Piccolo Composite Nail is a cylindrical solid rod, made of carbon fiber reinforced polymer. The humeral nail diameter ranges from 7 mm to 8.5 mm, with lengths in the range of 180 mm to 280 mm. The dimensions of the proximal humerus nail are 8 mm diameter (11 mm at proximal end), and length of 150 mm. The nails provide for holes at proximal and distal sections, designed for the insertion of self-tapping, titanium-allovmade, interlocking screws. The nails have a closed, pointed distal end, and their proximal end incorporates a thread enabling connection of insertion/extraction instrumentation.

The provided text is a 510(k) summary for the Piccolo Composite Nailing System. It focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical properties and intended use, rather than a clinical study evaluating diagnostic performance, as might be done for AI/ML-driven devices. Therefore, much of the requested information regarding acceptance criteria, study design for diagnostic performance, ground truth establishment, and expert involvement is not present in this document.

Here's an attempt to answer the questions based only on the provided text, indicating when information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The term "acceptance criteria" in this context refers to the criteria for demonstrating substantial equivalence based on mechanical testing and intended use. The document states: "Biomechanical evaluation demonstrates comparable mechanical properties to the predicate device."

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

Not applicable. This is a mechanical device, and the "test set" would refer to the samples used in biomechanical testing. The document states "Biomechanical evaluation demonstrates comparable mechanical properties," but does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective).

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 typically refer to clinical outcomes or definitive diagnoses for performance studies of AI/ML devices. For a mechanical device, the "ground truth" for biomechanical evaluation would be the physical properties and performance measured against engineering standards or predicate devices. No external experts for "ground truth" establishment are mentioned.

4. Adjudication method for the test set

Not applicable. No clinical test set or adjudication method is described. The evaluation is based on biomechanical 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

Not applicable. This is a medical device, not an AI/ML diagnostic software. No MRMC study was performed or needed.

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

Not applicable. This is a mechanical medical device, not an algorithm.

7. The type of ground truth used

For the biomechanical evaluation, the "ground truth" would be established by standardized mechanical testing protocols and comparison against the known mechanical properties of the predicate devices. The specific type of ground truth (e.g., specific load-bearing capacity, fatigue strength) is not detailed, but it falls under "biomechanical properties."

8. The sample size for the training set

Not applicable. This is a physical device, and the concept of a "training set" is not relevant in the context of this 510(k) submission.

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

Not applicable. As above, a "training set" and its "ground truth" are not relevant to this device's evaluation as described.

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