(207 days)
CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS 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).
CARE Brand of DHS/DCS Plating System is used to provide fixation of fractures to the proximal femur shaft and generally indicated for use in trochanteric, intertrochanteric fractures.
The system is indicated for use in adult patients only. All implants are for single use only.
CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System consists of various shape and sizes of plates featuring compression and locking holes, full-threaded-cortical, locking self-tapping screws, compression and dynamic screws.
The plates and screws are fabricated from Stainless Steel and Titanium.
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, rear-foot, ankle, or other bones appropriate for the size of the device. The plate implants are in many models available: like, Reconstruction Plates, T- Plates, Anatomical Plates, Clavicle Hook Plates.
These all are mainly divided into
- DHS/DCS Plates.
- Large Fragment Plates
- Small Fragment Plates
- Mini Fragment Plates
The number of the holes varies from 2 to 22.
The Locking screw implants are in corresponding diameter ranges from 2.4mm, 2.7mm, 3.5mm, 5.0mm diameters with lengths varying as per the requirements and minimum length: 6 mm to maximum length 90mm.
The Non-locking screw implants are in 3.5mm and 4.5mm diameter and length range from 10mm to 74mm.
CARE Brand of DHS/DCS Plating System consist of DHS/DCS Plates, lag Screw, compression screw, and 4.5 Cortex screw (Standard and Self Tapping). The DHS plates are available with barrel length 25mm (short barrel) and 38mm (Standard barrel angels varies from 130° to 150°. The DHS/DCS Screw is available in total length from 50 to 120 mm. thread length 22mm. shaft diameter of 12.5. The thread of DHS/DCS Screw has a buttress type. The DHS/DCS Compression Screw can be used to achieve fracture compression. Its dimension is available with thread length 36mm and outer diameter 3.8 mm.
These devices are not indicated for use in spine.
These implants are supplied non-sterile, the products have to be sterilized prior to use.
This document is a 510(k) premarket notification for a medical device, the CARE BRAND Locking Bone Plate and Screws Osteosynthesis Plating System. The purpose of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it is as safe and effective as the predicate.
Here's an analysis of the acceptance criteria and study information based on the provided text:
Acceptance Criteria and Reported Device Performance
The document describes the device's performance in terms of conformance to specific ASTM standards. This is a common way to establish acceptance criteria for mechanical devices like bone plates and screws.
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Criteria | Acceptance Criteria (Implied by Standards) | Reported Device Performance |
|---|---|---|
| Material Standards: | ||
| ASTM F 136 (Titanium Alloy) | Conformance to standard specifications | Conforms |
| ASTM F 138 (Stainless Steel Bar/Wire) | Conformance to standard specifications | Conforms |
| ASTM F 139 (Stainless Steel Sheet/Strip) | Conformance to standard specifications | Conforms |
| Performance Standards (Bone Plates): | ||
| ASTM F 382 (Static Four Point Bend Test) | Conforms | Conforms |
| ASTM F 384 (Dynamic Four Point Bend Test) | Conforms | Conforms |
| Performance Standards (Bone Screws): | ||
| ASTM F 543 (Torsional Properties) | Conforms | Conforms |
| ASTM F 543 (Driving Torque) | Conforms | Conforms |
| ASTM F 543 (Pull-out Test) | Conforms | Conforms |
Explanation of "Conforms": For a 510(k), 'Conforms' indicates that the device met or exceeded the performance requirements specified in the referenced ASTM standards, demonstrating mechanical equivalence to the predicate devices which are also expected to meet these standards.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the non-clinical tests (e.g., how many plates were static bend tested, how many screws were pull-out tested). The provenance of the data is also not explicitly stated in terms of country of origin for the testing, nor whether it was retrospective or prospective. However, it mentions that "copies of the relevant test results were provided in the submission," implying that the testing was performed, likely by the manufacturer or a contracted lab, to generate this data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This type of information (number and qualifications of experts) is typically relevant for studies involving human interpretation or clinical data, such as image analysis for disease detection. For a mechanical device like bone plates and screws, "ground truth" is established by adherence to engineering specifications and performance standards through laboratory testing. Therefore, this section is not applicable in the traditional sense for this submission. The "experts" would be the engineers and technicians who conducted the specified ASTM tests, ensuring adherence to the methodology and interpretation of the results according to the standards.
4. Adjudication Method for the Test Set
As explained above, an adjudication method (like 2+1 or 3+1) is relevant for studies where subjective expert opinion is used to establish ground truth from clinical data. For this submission, which relies on objective mechanical performance testing against established standards, an adjudication method is not applicable. The results of the tests are binary (conforms/does not conform to the standard's requirements).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
An MRMC study is designed to evaluate the performance of human readers, often aided by AI, in tasks like medical image interpretation. This type of study is not applicable to the submission of a mechanical orthopedic device. The focus here is on the physical and mechanical properties of the implants themselves.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This refers to the performance of an AI algorithm without human involvement. Since the device is a physical bone plating and screwing system and not an AI algorithm, a standalone algorithm performance study is not applicable.
7. The Type of Ground Truth Used
For this device, the "ground truth" is based on accepted engineering standards and material specifications (ASTM standards). The device's performance is compared directly against the predefined requirements within these standards. This is a form of objective, empirical data.
8. The Sample Size for the Training Set
A "training set" typically refers to data used to train a machine learning algorithm. As this submission is for a physical medical device and not an AI/ML algorithm, the concept of a training set is not applicable. The device's design, materials, and manufacturing processes are developed based on established engineering principles and prior art, not an algorithmic training process.
9. How the Ground Truth for the Training Set was Established
Since the concept of a "training set" is not applicable, this point is also not applicable. The "ground truth" for the device's development (its design specifications and material choices) would be based on surgical requirements, biomechanical principles, and the performance characteristics of predicate devices, which are themselves validated through accepted engineering and clinical practice.
Summary of the Study:
The study presented in this 510(k) notification is a non-clinical bench testing study. It evaluates the physical and mechanical performance of the CARE BRAND Locking Bone Plate and Screws Osteosynthesis Plating System against recognized industry material and performance standards (ASTM F136, F138, F139 for materials, and F382, F384, F543 for performance). The purpose of this testing is to demonstrate that the device is mechanically equivalent to its predicate devices, thereby ensuring its safety and effectiveness for its intended use. Clinical studies were deemed "not necessary to demonstrate substantial equivalence" because the design, materials, and intended use are similar to already marketed 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.