(238 days)
Advanced Intramedullary Nail System is intended to be implanted into the medullary canal of limbs for alignment. stabilization, fixation of fractures caused by trauma or diseases.
Indications:
- Ulna Nail: Indicated for the fixation of fractures and osteotomies of the ulna.
2.Fibular Nail: Indicated for fixation of fractures and osteotomies of the fibula.
- Ankle Fusion Nail: Indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot: tibiocalcaneal arthrodesis; combined arthrodesis of the ankle and subtalar joints; avascular necrosis of the ankle and subtalar joints; failed total ankle replacement with subtalar intrusion;failed ankle arthrodesis with insufficient talar body; rheumatoid arthritis; severe deformity secondary to untreated talipes equinovarus or neuromuscular disease; and severe pilon fractures with trauma to the subtalar joints.
The method of intramedullary nail fixation is symmetrical central splint fixation; central fixati on is theoretically superior to cortical external fixation, which can reduce the moment arm, re duce the incidence of varus and valgus angulation and internal fixation failure. Intramedullary nail fixation of fractures is stress-distributed fixation rather than stress-shielded fixation, whi ch is beneficial to the plasticity of callus. Advanced Intramedullary Nail System are made of Ti-6Al-4V ELI following ASTM F136. Advanced Intramedullary Nail System is provided as non-sterile. The implants are intended for single-use only, while the instruments are reusable.
This document is a 510(k) Pre-market Notification for a medical device called "Advanced Intramedullary Nail System." It is a submission to the FDA seeking clearance to market the device based on its substantial equivalence to previously cleared predicate devices.
Based on the provided text, there is no study conducted to prove the device meets specific acceptance criteria in the context of an AI/algorithm-based medical device performance study.
The document describes a medical implant device, not an AI or software algorithm. The "Advanced Intramedullary Nail System" is a physical device used for fixation of fractures. The information provided is typical for a 510(k) submission for a physical medical device, focusing on material equivalence, design features, biocompatibility, and mechanical testing.
Therefore, many of the questions asked cannot be answered because they pertain to performance studies of AI/algorithmic devices, which are not relevant to this submission.
Let's break down why and what information is available:
1. A table of acceptance criteria and the reported device performance:
- Not applicable in the context of an AI/algorithmic device. The document discusses the device's physical properties and its equivalence to predicate devices.
- The "acceptance criteria" here would be related to the mechanical performance standards (e.g., specific loads the nails can withstand, or how well the screws perform under torsion), which are tested against ASTM standards (F543-17 and F1264-16). However, specific numerical acceptance criteria and reported performance values are not explicitly stated in a table format in this summary. The summary only lists the types of tests performed.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not applicable in the context of an AI/algorithmic device. For mechanical testing, the "sample size" would refer to the number of physical nails and screws tested. This information is not provided in the summary.
- There's no data provenance in the sense of patient data because this is a physical device, not an AI output.
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. There is no "ground truth" in the diagnostic or clinical sense for this physical device as it's not an AI evaluating patient data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There is no clinical "test set" requiring adjudication for a physical device like an intramedullary nail.
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 study design is relevant for AI image analysis or diagnostic support systems, not for a physical orthopedic implant.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
- Not applicable. This refers to AI algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The "ground truth" for this device's safety and effectiveness relies on its mechanical properties (meeting ASTM standards) and biocompatibility with human tissue, demonstrating equivalence to already cleared devices.
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable.
Summary of relevant information from the document related to "acceptance criteria" (understood as compliance with standards) and "study" (understood as non-clinical testing):
Acceptance Criteria (Implicit via Standards Compliance):
- Biocompatibility: The device should be biocompatible according to the FDA Guidance "Use of International Standard ISO 10993-1." Specific pass/fail criteria are not detailed in this summary but are inherent in the standard.
- Mechanical Performance: The device materials and mechanical properties should meet the requirements of:
- ASTM F543-17 (Standard Specification and Test Methods for Metallic Medical Bone Screws) for the locking screws.
- ASTM F1264-16 (Standard Specification and Test Methods for Intramedullary Fixation Devices) for the intramedullary nail.
- Specific acceptance values (e.g., minimum torque, maximum deflection) are not listed in this summary but would have been presented in the full 510(k) submission.
The Study that Proves the Device Meets the Acceptance Criteria:
The document refers to "Non-Clinical Performance Data" as the study justifying the device's safety and effectiveness and its substantial equivalence.
- Biocompatibility Testing: Conducted in accordance with FDA Guidance and ISO 10993-1. (No further details on methods or results are provided in this summary).
- Mechanical Testing: Performed on the Advanced Intramedullary Nail System.
- Locking Screw Tests: Torsion Test, Insertion/Removal Test, Self-tapping Test, Pullout Test, Bending Test. (These tests implicitly compare the device's performance to the predicate device and relevant ASTM standards).
- Intramedullary Nail Tests: Four-Point Bend Test, Static Torsion Test. (These tests implicitly compare the device's performance to the predicate device and relevant ASTM standards).
Conclusion: The supplied document is a 510(k) summary for a physical medical implant. It does not contain information about acceptance criteria or studies related to AI/algorithmic performance. The "studies" conducted are non-clinical (biocompatibility and mechanical testing) to demonstrate substantial equivalence to predicate devices by meeting recognized industry standards.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.