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510(k) Data Aggregation
(86 days)
The Arthrex Pilon Fusion Plates are intended to be internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, tibia, and calcaneous.
The Arthrex Low Profile Screws (3.5mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile, Small Fragment Plates, Distal Extremity Plates, Humeral Fracture Plates and Osteotomy Plates.
The Arthrex Pilon Fusion Plate System are a family of contoured plates and screws. The Arthrex Pilon Fusion Plates are manufactured from Titanium conforming to ASTM F136 and are available in a variety of configurations. The Arthrex Pilon Fusion Plates are intended to be used with solid locking and non-locking Low Profile Screws. The proposed plates are sold sterile or non-sterile and single use.
The proposed Arthrex Low Profile Screws are offered in a 3.5mm diameter, length range of 85 to 120 mm, in a solid and fully threaded design. The screws are manufactured from Titanium conforming to ASTM F136 and are sold sterile or non-sterile and single-use.
The provided FDA 510(k) clearance letter and summary for the Arthrex Pilon Fusion System do not contain information about a study proving that a device meets acceptance criteria related to artificial intelligence (AI) or software performance.
The document describes a medical device, which is a system of plates and screws for internal bone fixation. The performance data presented refers to mechanical testing of the plates and screws (e.g., insertion torque, failure torque, 4-point bend testing, pull-out testing) to demonstrate substantial equivalence to predicate devices. There is also mention of MR compatibility testing.
Therefore, I cannot extract the requested information about acceptance criteria and a study proving an AI/software device meets acceptance criteria from the provided text.
Based on the nature of the document (510(k) for orthopedic implants), it is highly unlikely to contain such information. This type of submission focuses on the physical and mechanical properties of the device, biocompatibility, and substantial equivalence to existing predicate devices, not AI or software performance.
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(75 days)
The Arthrex Mesh Plates are intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bone fragments of the hand/wrist, foot/ankle, osteopenic bone and patella fractures.
The Arthrex Mesh Plates are manufactured from either titanium alloy or stainless steel. The plates are 1.3 mm thick in a semi-contoured, mesh-like design. The plates are available in long and short versions ranging from 50 mm to 115 mm in length. The plates are designed for the surgeon to cut to a desired length as needed. The Arthrex Mesh Plates are intended to be used with existing FDA cleared Arthrex screws. The Arthrex Mesh Plates are sold sterile and non-sterile and are single use.
The document describes the acceptance criteria and supporting studies for the Arthrex Mesh Plates, a medical device, not an AI/ML product. Therefore, several points in your request related to AI/ML devices (e.g., sample size for the test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this submission.
Here's a breakdown of the available information regarding the acceptance criteria and studies for the Arthrex Mesh Plates:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test | Reported Device Performance |
|---|---|
| Mechanical Performance (Tensile & Cyclic Testing) | Demonstrates that the Arthrex Mesh Plates perform statistically equivalent to the predicate device cleared under K143702. The ultimate tensile strength, stiffness, and cyclic fatigue of the proposed device are substantially equivalent to that of the predicate device for the desired indications. |
| MRI Safety (Force, Torque, Image Artifacts, Heating) | Conducted in accordance with FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," ASTM F2052, ASTM F2119, ASTM F2182, and ASTM F2213. (Implies satisfactory performance for MR Conditional labeling). |
| Bacterial Endotoxins Test (BET) | Performed utilizing the Kinetic Chromogenic Method in accordance with ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14. Demonstrates that the Arthrex Mesh Plates meet pyrogen limit specifications. |
| Biocompatibility | Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity, Subchronic/Subacute Toxicity, Implantation, and Material Characterization testing conducted in accordance with ISO 10993-1:2018. (Implies satisfactory biocompatibility). |
| Sterilization & Shelf-Life | Assessment of physical product attributes (design, size, materials, manufacturing conditions, packaging) determined that the Arthrex Mesh Plates do not introduce additional risks or concerns regarding sterilization and shelf-life. (Implies acceptable sterilization and shelf-life). |
| Substantial Equivalence | The Arthrex Mesh Plates are substantially equivalent to the predicate devices K17057 and K143702. Basic design features, intended use, fundamental scientific technology, materials, sterility, packaging, and shelf-life are identical or have minor differences that do not raise different questions of safety or effectiveness. Supported by mechanical testing and technological comparison. |
2. Sample size used for the test set and the data provenance
- Not Applicable. This information is typically relevant for AI/ML device studies. This submission pertains to a physical medical device (bone fixation plates). The mechanical and other tests would have specific sample sizes as per relevant ASTM/ISO standards, but these details are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. Ground truth, in the context of expert review, is typically relevant for AI/ML devices where human expert judgment is used to label data. For a physical device, performance is evaluated against engineering specifications and regulatory standards.
4. Adjudication method for the test set
- Not Applicable. Adjudication methods are typically used in clinical studies or for setting ground truth in AI/ML performance evaluation based on expert consensus.
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. MRMC studies are specific to AI/ML devices that assist human readers (e.g., radiologists interpreting images). This device is a surgical implant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This refers to AI/ML algorithm performance without human intervention, which is not relevant for a physical implantable device.
7. The type of ground truth used
- The "ground truth" for this device's performance is established by engineering standards, regulatory guidelines (e.g., FDA guidance for MR safety, ISO 10993 for biocompatibility), and direct mechanical testing against predicate device performance. It's not based on expert consensus, pathology, or outcomes data in the way an AI/ML diagnostic device might be. The goal is to demonstrate equivalence to a legally marketed predicate device.
8. The sample size for the training set
- Not Applicable. "Training set" is a concept specific to AI/ML model development.
9. How the ground truth for the training set was established
- Not Applicable. This is specific to AI/ML model development.
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(239 days)
The Arthrex FibuLock Nail is intended for use in the fixation of fibula fractures and osteotomies.
The Arthrex FibuLock Nail is used in the Fibula Repair System cleared under K160069. It is a stainless steel implant used with stainless steel bone screws for the fixation of fibula fractures and osteotomies. The Arthrex FibuLock Nail can be used with existing FDA cleared Arthrex Low Profile Cortical Screws (K141478, K143139 and K143614), Arthrex TightRope Syndesmosis Devices (K043248) and instrumentation required for the fixation of fibula fractures and osteotomies.
The provided text describes the Arthrex FibuLock Nail, its predicate device, and the basis for its 510(k) clearance. However, it does not contain information related to acceptance criteria, human reader studies (MRMC), standalone algorithm performance, or ground truth establishment for a study proving device performance in the context of AI/ML.
The "Performance Data" section briefly mentions "Worst-Case Cross-Section Comparison" and "Axial pullout and torsion comparison testing," which are mechanical performance tests typical for orthopedic implants, not studies involving AI or human readers for diagnostic tasks.
Therefore, many of the requested details, particularly those pertaining to AI/ML device evaluation, cannot be extracted from this document.
Here's a breakdown of what can be extracted and what cannot:
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | (Not explicitly stated as "acceptance criteria" but implied outcomes of comparison testing) | Worst-Case Cross-Section Comparison conducted to assess the risk of decreased bending strength (no specific numerical data provided). Axial pullout and torsion comparison testing performed on the 2.7 mm distal screws (no specific numerical data provided). |
| Substantial Equivalence | Device is substantially equivalent to the predicate device in terms of basic design features and intended uses. Differences are minor and do not raise questions of safety or effectiveness. | The Arthrex FibuLock Nail's design features and intended uses are the same as the predicate. Minor differences noted do not raise safety/effectiveness concerns. |
2. Sample size used for the test set and data provenance:
- Test Set Sample Size: Not applicable. This document describes mechanical testing for an orthopedic implant, not a study with a "test set" of patient data for diagnostic or predictive purposes.
- Data Provenance: Not applicable. The "data" refers to mechanical test results, not patient data from a specific country or collected retrospectively/prospectively.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
- Not applicable. Ground truth as typically defined for AI/ML studies (e.g., expert diagnosis, pathology) is not relevant for the mechanical testing described.
4. Adjudication method for the test set:
- Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:
- No. This document does not mention any MRMC studies or human reader performance.
6. If a standalone (algorithm only) performance study was done:
- No. This document describes a physical medical device (an intramedullary nail), not an algorithm or AI system.
7. The type of ground truth used:
- Not applicable. The relevant "ground truth" for this device would be its mechanical properties meeting engineering specifications, which is assessed through direct mechanical testing, not expert consensus or histopathology.
8. The sample size for the training set:
- Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable, as this is not an AI/ML device.
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