(108 days)
NMUC Brand Small and Large Fragment Osteosynthesis System is intended for small and large bone fracture fixation, arthrodesis and osteotomy fixation. Examples include: fractures of the clavicle, scapula, humerus, olecranon, radius, ulna, distal femur, proximal tibia, tibial pilon, fibula, pelvis and acetabulum fractures; periprosthetic fractures; The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone. This system is not indicated for use in the spine.
NMUC Brand DHS/DCS plating system may be used for fixation of the fractures of proximal femur such as femoral neck, trochanteric or intertrochanteric zones. The system is indicated for use in adult patients only. All implants are for single use only
NMUC brand small fragment and large fragment Osteosynthesis plating system consists of plates and screws in a variety of designs and made from Ti-6AI-4V (Titanium) alloy or stainless steel. Plates are provided in a straight design also in various geometric configurations that are commonly used in trauma and reconstructive surgery. Plates are provided with screw holes to accommodate non-locking and locking screw designs. Screws are provided in, 3.5mm cortex self-tapping, 4.5 mm diameter cortex self-tapping and 2.7mm diameter self-tapping cortex locking, 3.5mm self-tapping cortex locking, 5.0mm cortex locking thread designs in various lengths.
DHS/DCS, systems are made from Ti-6AI-4V (Titanium) alloy or stainless steel and consists of DHS/DCS plates, lag screws, compression screws and 4.5mm diameter cortex screw selftapping. The plates are available with barrel length 25mm and 38 mm with angles variances between 130° to 150°. The DCS plate have angles of 95°.
The products are provided NON-STERILE only. Subsequent of being sold as NON-STERILE product, the intention is to achieve sterility by utilizing autoclaving method on parameters of SAL10-6 AAMI ST79 & ISO 17665-1.
The provided text is a 510(k) summary for the NMUC Brand Small And Large Fragment Osteosynthesis Plating System and NMUC Brand of DHS/DCS Plating System. This document asserts substantial equivalence to a predicate device and does not include data from a study demonstrating the device meets specific acceptance criteria based on performance testing. Instead, it relies on the predicate device's established performance.
Therefore, many of the requested sections about specific study data cannot be filled from the provided document.
Here's a breakdown of what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or report device performance data from a new study. Instead, it states that "Equivalence is concretely supported in its comparison as being the exact same device as noted in the substantial equivalence portion of this document and cleared under cited 510(k) clearance." and "Comparison between noted devices and predicates are exactly the same under all regards in its intended use, packaging, labeling, materials and design of the product."
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, as no performance study data is presented for this specific 510(k) submission. The equivalence is based on the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no performance study data is presented.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no performance study data is presented.
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 plating system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable, as no performance study data is presented.
8. The sample size for the training set
Not applicable, as no algorithm training is mentioned.
9. How the ground truth for the training set was established
Not applicable, as no algorithm training is mentioned.
Summary of available information:
The basis for the device's acceptance is substantial equivalence to an already legally marketed predicate device (K150561, Narang Medical Ltd, NET brand Small and large fragment Osteosynthesis family plating system and NET brand DHS/DCS family plating system).
The document explicitly states:
- "No performance testing was included in this submission."
- "All devices stated herein undergo the same manufacturing, testing and qualification methods as the predicate devices."
- "Equivalence is based on similarities in intended use, materials and design to the predicate devices demonstrating substantial equivalence to the predicate devices."
- "All critical features including: intended surgical use, safety and efficacy, and technical features of the devices remain unchanged as only the labeling of the devices shall now only correspond to Narang Medical USA corporation as the company to legally market these family of devices (under submission K163425)."
The document lists certain ASTM standards that the devices, by virtue of being equivalent to the predicate, are expected to meet through their manufacturing and qualification processes:
- ASTM F136 Standard specification for wrought titanium
- ASTM F138 Standard specification for wrought 18chromium-14nickel-2.5molybdenum stainless steel
- ASTM F139 Standard specification for wrought stainless steel sheet and strip for surgical implants
In essence, the "study that proves the device meets the acceptance criteria" is the original 510(k) submission and associated data for the predicate device (K150561), which established its safety and effectiveness. This current submission (K163425) argues that the NMUC Brand devices are identical in all critical aspects to the cleared NET brand predicate devices.
§ 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.