(118 days)
The Arsenal Plating System is intended for use in trauma and reconstructive procedures of the small bones in the hand/ foot, ankle, and other bones appropriate for the device. The plates (implants), screws (implants), washers (implants), olive wires (instruments), and guide wires (instruments) are intended for single use only.
The Arsenal Plating System consists of plates of various shapes and sizes composed of implant grade titanium alloy intended for use in trauma and reconstructive procedures of the small bones in the hand/foot, ankle, and other bones appropriate for the size of the device. The system will incorporate multiple locking and non-locking screws of various lengths and diameters, washers, and the necessary instruments to facilitate the placement of these implants.
This document is a 510(k) Premarket Notification for the Arsenal Plating System. It focuses on demonstrating substantial equivalence to predicate devices based on non-clinical testing, rather than reporting on a study to meet acceptance criteria for a new device performance.
Therefore, the requested information about acceptance criteria and a study proving device performance in the context of an AI/medical imaging device is not applicable to this submission. This is a traditional medical device submission for orthopedic hardware.
Here's a breakdown of why and what information is available (or not available) based on the provided text:
Rationale for Not Meeting Request:
- Device Type: The Arsenal Plating System is an orthopedic hardware system (plates, screws, washers). It is not an AI/software device, imaging device, or diagnostic tool that would typically have acceptance criteria related to sensitivity, specificity, or reader performance.
- Submission Type: This is a 510(k) Premarket Notification. The primary goal of a 510(k) is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove absolute safety and effectiveness through extensive novel clinical trials against defined acceptance criteria (like an AI algorithm would).
- Clinical Studies: The document explicitly states: "No clinical studies were performed." This immediately indicates that there will be no data on human reader performance, ground truth establishment, or multi-reader multi-case studies.
- Non-Clinical Testing: The "studies" performed were mechanical bench tests (Single Cycle Bend Testing, Dynamic Bend Testing, Axial Pullout Strength Testing, Torsional Property Testing, Driving Torque Testing) designed to show equivalence in physical performance to the predicate devices, not diagnostic or AI performance.
Information based on the provided text (and why other requested sections are N/A):
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Table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail criteria in the context of a new performance claim. The "acceptance" is implicitly that the device performs equivalently to the predicate devices in the listed mechanical tests.
- Reported Device Performance:
Test Type Referencing Standard Performance Single Cycle Bend Testing ASTM F382 Results indicate the Arsenal Plating System is equivalent to predicate devices. (Specific quantitative results are not provided in this summary.) Dynamic Bend Testing ASTM F382 Results indicate the Arsenal Plating System is equivalent to predicate devices. (Specific quantitative results are not provided in this summary.) Axial Pullout Strength Testing ASTM F543 Results indicate the Arsenal Plating System is equivalent to predicate devices. (Specific quantitative results are not provided in this summary.) Torsional Property Testing ASTM F543 Results indicate the Arsenal Plating System is equivalent to predicate devices. (Specific quantitative results are not provided in this summary.) Driving Torque Testing ASTM F543 Results indicate the Arsenal Plating System is equivalent to predicate devices. (Specific quantitative results are not provided in this summary.)
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for the mechanical tests. Typically, these involve a small number of physical samples of the device components.
- Data Provenance: Not applicable. These are laboratory mechanical tests, not human data.
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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)
- N/A. This device does not have "ground truth" established by experts in the context of diagnostic performance. Mechanical tests are assessed against engineering standards.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Not relevant for mechanical testing.
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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. The document explicitly states: "No clinical studies were performed." This is not an AI or diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is not an algorithm or software device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- N/A. The "ground truth" for mechanical testing is adherence to established ASTM standards for material properties and mechanical performance.
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The sample size for the training set
- N/A. This device does not use a "training set" as it is not an AI/machine learning device.
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How the ground truth for the training set was established
- N/A. As above, no training set.
§ 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.