(174 days)
The Indications for Use of the I.T.S. GmbH - Distal Ulna Locking (DUL) and Ulna Osteotomy Locking (UOL) Plate Systems is to stabilize fractures/osteotomy in the long bone of the distal and mid-ulna of an adult patient.
The I.T.S. GmbH - Ulna Locking Plate (DUL & UOL) Systems are not intended for spinal use.
The I.T.S. Ulna Locking Plates are composed of the DUL (Distal Ulna Locking) & UOL (Ulna Osteotomy Locking) Systems which are fracture fixation plating systems for repairing bone factures located in the distal and mid-ulna bone in the human body. The DUL System consist of three(3) Standard plate lengths of 3, 4, & 6 hole and one(1) Small pre-contoured plate shape in a left/right configuration to fit the distal ulna. The UOL System consists of a single, 5 hole, straight plate for mid-ulna bone osteotomy procedures. Both plate systems are manufactured from Commercialy Pure (CP) Titanium material to allow for minor intra-operative forming/contouring by the surgeon. The plate design concept offers various type locking screw fixed-angle constructs using angular stability locking screws into the plate. Both locking and non-locking high strength 6-4 Alloyed Titanium screws in sizes of 2.4mm cortex locking, 2.7mm cortical non-locking, and 3.0mm cancellous/ cortical locking screws are offered. All screws are self-tapping for insertion into bone. 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. Ulna Locking 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. A full compliment of instrumentation is available for use with the system.
The provided text is a 510(k) summary for the I.T.S. GmbH Ulna Locking Plates (DUL/UOL) Systems. This type of regulatory submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through clinical studies.
Therefore, the prompt's request for detailed information about acceptance criteria and study design (like sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not applicable to this document.
Here's why and what information can be extracted:
- No acceptance criteria or device performance reported: The document explicitly states: "No nonclinical testing was used in the determination of substantial equivalence." This means the submission did not include new performance data from studies directly comparing the device against pre-defined acceptance criteria. Instead, it relied on the established safety and effectiveness of predicate devices.
- No study proving device meets acceptance criteria: Since no nonclinical testing was used and the determination was based on substantial equivalence, there isn't a study report proving the device meets specific performance acceptance criteria.
- Focus on Substantial Equivalence: The primary objective of this 510(k) is to demonstrate that the I.T.S. GmbH Ulna Locking Plate DUL & UOL Systems are substantially equivalent to established predicate devices already on the market regarding material, geometry design/markings, and indications for use.
Information that can be provided from the document:
1. Acceptance Criteria and Reported Device Performance:
There are no explicit acceptance criteria or reported device performance metrics in this 510(k) summary because the submission relies on demonstrating substantial equivalence to predicate devices rather than providing new performance data from the device itself.
2. Sample size used for the test set and the data provenance:
Not applicable. No test set or associated data provenance is mentioned as no nonclinical testing was used for the determination of substantial equivalence.
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, as no nonclinical testing was conducted.
4. Adjudication method for the test set:
Not applicable. No test set or adjudication method is described.
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 device is a bone plate system, not an AI-assisted diagnostic tool, and no MRMC study was performed or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a bone plate system, not an algorithm, and no standalone performance was assessed.
7. The type of ground truth used:
Not applicable. No ground truth definition is relevant or mentioned for this type of medical device submission. The "ground truth" here is the established safety and effectiveness of the predicate devices.
8. The sample size for the training set:
Not applicable. As a physical medical device (bone plate), there is no "training set" in the context of an algorithm or AI model development.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for this physical medical device.
Summary of what the document does state regarding equivalence:
The I.T.S. GmbH Ulna Locking Plate DUL & UOL Systems are considered substantially equivalent based on:
- Material: Composed of Commercial Purity (CP) Titanium material and high strength 6-4 Alloyed Titanium screws.
- Geometry Design/Markings: Similar to predicate systems.
- Indications for Use: To stabilize fractures/osteotomy in the long bone of the distal and mid-ulna of an adult patient.
Predicate Devices:
- Medartis AG - APTUS Ulna Plates (K103332)
- Zimmer - Periarticular Ulna Plate Systems (K082078)
- Acumed - Congruent System Acu-Loc 2 Plate (K120903 & K071715)
- TriMed - Ulnar Osteotomy Plate (K043263)
- Synthes - 2.7mm LCP Ulna Osteotomy System (K113364)
- OrthoPro - DC Ulnar Shortening System (K073228)
- I.T.S. GmbH - Straight Plate w/Angular Stability (K060156)
Conclusion:
This 510(k) summary does not contain the type of study data requested. Its purpose is to demonstrate substantial equivalence to existing devices through comparison of technological characteristics and indications for use, rather than presenting novel performance testing against specific acceptance criteria.
§ 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.