(56 days)
The intended use of the I.T.S. Extemity Fixation Systems is to draw two or more aligned bone fragments together to facilitate healing in an adult patient and is composed of the following catagories:
The I.T.S. FLS - Foot Locking Plates System is indicated for use in internal fixation, reconstruction or arthrodesis of small bones including the fore, mid and hind foot and ankle. Examples of these procedures may include but are not limited to replantation, lag screw techniques, joint fusions, corrective osteotomies, and treatment of fractures. Not for spinal use.
The I.T.S. HCS - Headless Compression Screw System for sizes of 3.5mm or smaller is indicated for use in fixation small bone fractures or for small bone reconstruction including; mono or bicortical osteotomies in the foot or hand; distal or proximal metatarsal or metacarpal osteotomies; weil osteotomy; fusion of the first metatarsalphalangeal joint and interphalageal joint; fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.); Akin type osteotomy; distal radius fractures (articular fragments), ulnar styloid fractures, radial head fractures, capitellum fractures, humeral head fractures, glenoid fractures, intercarpal distal and proximal fusions, malleolar fractures, patellar fractures, osteochondral fractures, talonavicular fusions, tibeo-talar fusions, and cuboid fusions.
And for sizes 4.3mm or larger is indicated for use for fractures, corrective osteotomies, pseudoarthrosis, degeneralive transformations of long bones in the hindfoot and large bone intra-articular fractures of the humerus, femur, and tibia. The size of the chosen compression screw should be adapted to the specific indication. Not for spinal use
The I.T.S. HOL – Hallyx Osteotomy Locking Plate System is indicated for use as an intramedullary self-locking plate for distal metatarsal osteotomies and for Hallux Valgus osteotomies up to a corrective angle of 25°. Not for spinal use.
The I.T.S. Twist-Off Screw System is indicated for use for small bone fixation of bone fractures or for bone reconstruction. Examples include small bone fragments, Weil-Osteotomy, Mono-Cortical fixation, Osteotomies and fractures fixation in the foot and hand. Not for spinal use.
The I.T.S. Extremity Fixation Systems consists of Predicate extremity trauma implant components commonly found with large companies with orthopedic markets in the United States. These 'extremity trauma implant devices' consist of the following categories:
- FLS - Foot Locking Plates System
- HCS - Headless Compression Screw System
- HOL- Hallux Osteotomy Locking Plate
- Twist-Off Screws
A brief and concise description of each system is enclosed as follows:
- FLS - Foot Locking Plates System: The I.T.S. FLS - Foot Locking Plates System is composed of various plate types(13) designed to address a wide variety of indications for fractures in the foot. The overall system is composed of a smaller bone series of locking plates (12 types) utilizing 2.4mm, 2.7mm and 3.0mm locking/non-locking screws and a larger bone calcaneus plate utilizing 3.5mm and 4.2mm locking/non-locking screws. The smaller bone system of twelve(12) plate designs consist of the following: (1) MTP Plate, (2) Curved Plate, (3) Straight Plate, (4) H-Shape Plate, (5) Square Plate, (6) I -- Shape Plate, (7) L-Shape Extended Plate, (8) L-Shape Extended, 1mm Step Plate, (9) L-Shape Extended 45º Plate, (10) T-Shape Plate, (11) T-Shape Extended Plate, and (12) TMT Plate. The larger bone system consists of a (13) Calcaneus Plate. All plate systems are manufactured from Commercially Pure (CP) Titanium material to ASTM F67 and allow for minor intra-operative forming/ contouring by the surgeon to fit the bone anatomy. All screws consist of 6-4 Alloyed Titanium material to ASTM F136. Small holes in the plate allow intermediate 'k-wire' bone fracture segment positioning for reducing and aligning the fracture bone segments while positioning the plate and introduction of multiple sizes of locking/non-locking screws as needed for stabilizing the fracture - when using x-ray fluroscopy. All I.T.S. Plates and Screws are processed with an anodize DOTIZE surface treatment. The low-profile and contoured plate design minimizes soft-tissue irritation for the patient.
Associated instrumentation such as disposable drills, mills & wires/guide wires, and ancillary instrumentation is available. All plates and screws are provided Non-Sterile.
HCS - Headless Compression Screw System: The I.T.S. 2. HCS - Headless Compression Screw System consists of six(6) sizes of compression screws (in sizes 2.0, 2.5, 3.0, 3.5, 4.3 and large/long bone 7.5mm) for small bone extremity and reconstruction fixation/arthrodesis procedures. All screws consist of a 6-4 Alloyed Titanium material to ASTM F136. All I.T.S. Compression Screws are processed with an anodize DOTIZE surface-treatment.
Associated instrumentation such as disposable wires/guide wires, cannulated spiral drills, countersink drills, and ancillary instrumentation is available. All screws are provided Non-Sterile.
- HOL - Hallux Osteotomy Locking Plate: The I.T.S. HOL -Hallux Osteotomy Locking Plate consists of a Nail Plate in three(3) sizes with Screws in various lengths for Halux and distal metatarsal foot/toe bone deformities. The Nail Plate is manufactured from CP Titanium to ASTM F67 and the Screws from 6-4 Alloyed Titanium to ASTM F136. All I.T.S. Nail Plate and Screws are processed with an anodize DOTIZE surface treatment.
Associated instrumentation such as guide wire, disposable drill, template, insertion/removal and ancillary instrumentation is available. All Plates and Screws are provided Non-Sterile.
- Twist-Off Screws: The I.T.S. Twist-Off Screws consist of a 2.0mm and 2.7mm twist-off shank screws in various lengths. All Turn-Off Screws are manufactured from 6-4 Alloyed Titanium to ASTM F136 and are utilized in metatarsal/phalangeal small bone fixation/osteotomy procedures. All I.T.S. Twist-Off Screws are processed with an anodize DOTIZE surface treatment. All Screws are provided Non-Sterile.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the I.T.S. Extremity Fixation Systems, structured according to your requested information.
It's important to note that this document is a 510(k) Summary for a medical device, which typically emphasizes substantial equivalence to predicate devices rather than novel performance studies demonstrating specific acceptance criteria.
Acceptance Criteria and Study Details for I.T.S. Extremity Fixation Systems
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| Not explicitly stated in terms of quantitative metrics. The primary criterion for 510(k) clearance is Substantial Equivalence to legally marketed predicate devices. | The I.T.S. Extremity Fixation Systems are deemed Substantially Equivalent to various predicate bone plate and screw systems. They are described as "Similar in Material, Geometry Design/Markings, and Indications" to predicate systems. |
| Functionality implied through intended use: "to draw two or more aligned bone fragments together to facilitate healing in an adult patient." | Deemed "safe and effective for use in plate and screw fracture fixation of small bones in the foot and hand extremities and screw compression fractures in long/large bones." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not report any specific test set sample size or data provenance (e.g., country of origin, retrospective/prospective) for performance testing.
The clearance is based on a comparison to predicate devices: "No nonclinical testing was used in the determination of substantial equivalence." This implies that the device's performance was not evaluated through a new, independent test set but rather by demonstrating similarity to existing, approved devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Not applicable. No independent test set with expert-established ground truth was reported for performance evaluation.
4. Adjudication Method for the Test Set
Not applicable. No independent test set requiring adjudication was reported.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "No nonclinical testing was used in the determination of substantial equivalence." Therefore, no MRMC study or assessment of human reader improvement with AI assistance (as this is not an AI device) was conducted or reported.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a mechanical fixation system, not an algorithm or AI-driven diagnostic tool. Therefore, a standalone algorithm performance study is irrelevant to this submission.
7. Type of Ground Truth Used
Not applicable in the context of device performance data. The "ground truth" for this 510(k) submission is the existence and established performance of the predicate devices to which the I.T.S. Extremity Fixation Systems are compared. The substantial equivalence argument relies on the well-understood clinical use and safety profile of these existing devices.
8. Sample Size for the Training Set
Not applicable. As this is a mechanical medical device, there is no "training set" in the context of machine learning or algorithms. The design and manufacturing are based on established engineering principles and material science.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.