(169 days)
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:
- CFN - Cannulated Femur Nail System
- CTN - Cannulated Tibia Nail System
- CHN - Cannulated Humeral Nail System
A brief and concise description of each system is enclosed as follows:
- 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.
- 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.
- 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:
| Acceptance Criteria (Demonstration for Substantial Equivalence) | Device "Performance" (Comparison to Predicate Devices) |
|---|---|
| Similar in Material | Manufactured from Alloyed 6-4 Titanium material to ASTM F136; anodize DOTIZE surface treatment (same as predicates, implied) |
| Similar in Geometry Design/Markings | Design features (cannulated, curved/straight, specific diameters/lengths, screw types, dynamization slot, end caps) are comparable to predicate devices. |
| Similar in Indications for Use | Indications for use for femur, tibia, and humerus fracture fixation are comparable to predicate devices. |
| No nonclinical testing required | Stated explicitly: "No nonclinical testing was used in the determination of substantial equivalence." |
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.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.