(159 days)
NEBULA BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, NEBULA BRAND of DHS Plating System are indicated for treating fractures of various bones including the clavicle, pelvis, scapula, long bone (humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, phalanges).
The system is indicated for use in adult patients only. All implants are for single use only.
The NEBULA BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, NEBULA BRAND of DHS Plating System is submitted as a bundled submission. Throughout the submission there is a mention of NEBULA BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, NEBULA BRAND of DHS Plating System that represents the range of products covered under this 510(k) submission. The NEBULA BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, NEBULA BRAND of DHS Plating System are subdivided into the following categories:
| S. No. | Category | Types |
|---|---|---|
| 01 | Mini, Small and Large | Volar Plates, T-Shaped, Angled Plates, |
| Reconstruction plates | ||
| 02 | Dynamic compression | Small, Narrow, Lengthening |
| 03 | Hip Plate | Dynamic Hip Screw Plates |
| 04 | Bone Screws | Locking and Non-Locking Version |
Generally, there are the following types of bone plates used with cortical (cortex), cancellous, and Locking Screws. These bone plates are generally designed on the basis of the bone contour and anatomy.
| S. No. | Type | Subtype |
|---|---|---|
| 01 | Mini, Small and Large | |
| Fragment | Volar Plates, T-Shaped, Angled Plates, | |
| Reconstruction plates | ||
| 02 | Dynamic compression | Small, Narrow, Lengthening Narrow, Broad Plates |
| 03 | Hip Plate | Dynamic Hip Screw Plates |
NEBULA BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, NEBULA BRAND of DHS Plating System consists of various shape and sizes of plates featuring compression and locking holes, full-threaded-cortical, locking selftapping screws, compression and dynamic screws.
The plates and screws are fabricated from Stainless Steel and Titanium. The implants are supplied non-sterile and should be steam-sterilized prior to use.
The system contains several models based on the size of the device and application site such as fixation/reconstruction of small fragment bones, forefoot, mid-foot, and the ankle. The plate implants are available in models such as Reconstruction Plates, T- Plates, , Anatomical Plates, and Clavicle Plates.
These all are mainly divided into the following:
- . Large Fragment Plates
- Small Fragment Plates
- Hip Plates (DHS Plate)
The thickness of the plates varies from 1.3mm to 6mm; and the nomber of the holes varies from 2 to 20. The Locking screw implants are in corresponding diameter ranges from 2.7mm, and 4.9 mm diameters with lengths varying as per the requirements and lengths of 10mm to 90 mm
The Non-locking cortical screw implants are in 3.5mm diameter and length range from 10mm to 80mm.
The Non-locking cancellous screws are in 6.5mm diameter and length range from 30mm to 120mm The Non-locking cannulated cancellous screws are in 4.0mm diameter and length range from 10mm to 72mm
The Lag Screw is of 12.5mm Diameter and length from 50mm to 120mm
This document is a 510(k) summary for the Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System and Nebula Brand of DHS Plating System. It focuses on demonstrating substantial equivalence to predicate devices, rather than proving the device meets acceptance criteria through a clinical study.
Therefore, the requested information about acceptance criteria, study design, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details cannot be extracted from this document, as it is not a clinical study report for device performance.
The non-clinical performance testing section briefly mentions:
- Non-Clinical Performance Testing: Performance was demonstrated through test parameters outlined in ASTM F-382 (Static and Dynamic Four Point Bend Testing) and ASTM F-384 (Static and Dynamic Four Point Bend Testing). Torsional and Axial pullout testing was conducted on the screws per ASTM F-543. These are standard test methods for mechanical properties of bone plates and screws. The document states that the performance is "similar" to predicate devices, implying that the results of these tests met a level comparable to the predicate devices, which is the basis for proving substantial equivalence.
Here's a breakdown of why many of your questions cannot be answered by this document:
- A table of acceptance criteria and the reported device performance: Not provided. The document focuses on demonstrating similarities to predicate devices based on design, materials, and non-clinical performance testing (mechanical properties). It doesn't present specific acceptance criteria in terms of clinical outcomes or diagnostic accuracy (which would be relevant for an AI/diagnostic device, not a bone fixation system).
- Sample sizes used for the test set and the data provenance: Not applicable. This document refers to mechanical testing of physical devices, not a test set of patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical data is not relevant to this type of device submission.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 not an AI/diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the context of clinical performance. The "ground truth" for this device's performance would be its mechanical properties meeting established standards (ASTM).
- The sample size for the training set: Not applicable. There is no "training set" for this type of device.
- How the ground truth for the training set was established: Not applicable.
In summary: This FDA 510(k) clearance letter and its associated summary are for a bone fixation system (plates and screws). The regulatory pathway for such devices typically relies on demonstrating substantial equivalence to existing legally marketed predicate devices through material characterization, mechanical testing, and sometimes benchtop or animal studies. It does not involve clinical studies with patient data, AI, or human reader performance, which are common for diagnostic or AI/ML-based medical 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.