(372 days)
AUXEIN Brand of Bone plates and bone screws are provided non-sterile. AUXEIN Brand of bone plates and bone screws are intended 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).
AUXEIN Brand of DCS plate system is used to provide fixation of fractures to the proximal femur shaft and generally indicated for use in trochanteric, pertrochanteric fractures. The system is indicated for use in adult patients only. All implants are for single use only.
AUXEIN brand of Locking Plates and Locking screws have the same indications for use as mentioned above with additional feature of locking by way of combination threads in plates and corresponding Screws.
Auxein Brand of Bone Plates and Bone Screws, Auxein Brand of DCS Plate System, Auxein Brand of Locking Plates and Locking screws 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 modules 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
- . Mini Fragment Plates
- . Small Fragment Plates
- Large Fragment Plates .
- DCS Plates. ●
The thickness of the plates varies from 1.0mm to 6mm; and the number of the holes varies from 2 to 22.
The screw implants are in corresponding diameter ranges from 2.4mm, 2.7mm, 5.0mm diameters with lengths varying as per the requirements and minimum length: 6 mm to maximum length 90mm
These implants are sold non-sterile, the products have to be sterilized prior to use.
This is a 510(k) premarket notification for bone plates and bone screws, which typically relies on demonstrating substantial equivalence to a predicate device rather than conducting de novo clinical trials to prove safety and effectiveness.
Therefore, the study supporting this submission is primarily a non-clinical bench testing study comparing the performance of the applicant's device to established standards and predicate devices.
Here's the breakdown of the acceptance criteria and study information as derived from the provided document:
Acceptance Criteria and Reported Device Performance
Note: The document does not explicitly state numerical "acceptance criteria" for each test but rather indicates "Conforms" to referenced ASTM standards. The reported device performance is that it conforms to these standards.
| Acceptance Criteria (Referenced Standard) | Reported Device Performance |
|---|---|
| Material Standards: | |
| ASTM F 136 | Conforms |
| ASTM F 138 | Conforms |
| ASTM F 139 | Conforms |
| Performance Standards (Bone Plates): | |
| ASTM F 382 (Static Four Point Bend Test) | Conforms |
| ASTM F 384 (Dynamic Four Point Bend Test) | Conforms |
| Performance Standards (Bone Screws): | |
| ASTM F 543 (Torsional Properties) | Conforms |
| ASTM F 543 (Driving Torque) | Conforms |
| ASTM F 543 (Pull-out Test) | Conforms |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. For bench testing, sample sizes are typically determined by the testing standards (e.g., number of units tested for each standard). The document mentions "copies of the relevant test results were provided in the submission," implying multiple units were tested for each material and performance standard.
- Data Provenance: The testing was conducted by Auxein Medical to demonstrate compliance with ASTM standards. Since the submitter is based in India, the testing likely occurred in India or through a contracted lab. The document does not specify the country of origin for the data acquisition, but it is a prospective test conducted specifically for this 510(k) submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is a non-clinical bench testing study. The "ground truth" and "experts" in the context of clinical trials (e.g., radiologists) are not applicable here. The "ground truth" is established by the specified ASTM material and performance standards themselves. The experts involved would be engineers and quality control personnel responsible for conducting the tests and verifying compliance. Their qualifications would be in engineering, materials science, and quality assurance.
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Adjudication method for the test set:
- Not applicable in the sense of clinical adjudication. The results of the mechanical tests are compared directly against the quantitative requirements outlined in the ASTM standards. Compliance ("Conforms") is determined by whether the test results fall within the specified limits of the standards.
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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:
- No, an MRMC comparative effectiveness study was not done. This is a medical device for bone fixation, not an image analysis or AI-driven diagnostic device. Therefore, this type of study is not relevant to this submission.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical bone plate and screw system, not a software algorithm.
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The type of ground truth used:
- The "ground truth" for this submission is adherence to established industry material and performance standards (ASTM standards). The claim of substantial equivalence is based on demonstrating that the device meets these standards, which are recognized for orthopedic implants, and is comparable to predicate devices that also meet these standards.
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The sample size for the training set:
- This is a non-clinical bench testing study. The concept of a "training set" is not applicable, as there is no machine learning or AI model being developed or trained.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set. The "ground truth" for the overall submission is established by the well-defined, published ASTM standards for orthopedic implants.
§ 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.