(25 days)
The OsteoMed ExtremiLOCK Foot Plating System is indicated for use in trauma, general surgery, and reconstructive procedures of the foot, ankle or other bones appropriate for the size of the device.
The OsteoMed ExtremiLOCK Foot Plating System implants are intended for single use only.
The 14 MTP Primary and Transfix plates are designed as part of the OsteoMed ExtremiLOCK Foot Plating System. The system consists of plates of various shapes and sizes featuring compression, locking, elongated or compression elongated holes, angulated locking, non-locking and cannulated screws, implantable K-Wires, washers, and appropriate instrumentation. Modifications to plates of the subject system include increasing the thickness of the plates, material changes, and addition of features.
The implants of the OsteoMed ExtremiLOCK Foot Plating System are made from Titanium (ASTM F-67) or Titanium alloy (ASTM F-136). Surgical instrumentation is provided to facilitate modification. insertion. and removal of implants. The instrumentation is made from various grades of stainless steel, anodized aluminum, and/medical grade polymer.
The provided text describes a Special 510(k) Summary for the OsteoMed 1st MTP Primary and Transfix plates, which are part of the OsteoMed ExtremiLOCK Foot Plating System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the context of AI/software performance.
Therefore, many of the requested sections (2-9) regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies are not applicable or cannot be extracted from this type of regulatory submission. This document is for a physical medical device (bone fixation plates) and not an AI/software device.
However, I can extract the acceptance criteria and the reported device performance as much as possible from the provided text, while noting the limitations.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Strength for Intended Use: Design features must meet required mechanical strength criteria. | The 1st MTP Primary and Transfix plates underwent "verification evaluation to ensure that the design features met the required mechanical strength criteria for their intended use." Performance equivalence was shown through "verification comparison to the predicate devices." |
| Biocompatibility: Materials must be biocompatible. | ExtremiLOCK implants are manufactured from Titanium (ASTM F-67) or Titanium alloy (ASTM F-136), which are "the same materials used in the manufacture of the predicate devices. These materials are biocompatible." |
| Substantial Equivalence: Similarities in intended use, material, function, performance, design, technology, operational principles, and sterilization to the predicate device (OsteoMed ExtremiLOCK Foot Plating System, K131445). | A "design, dimensional, and performance comparison was performed to establish substantial equivalence" to the predicate. The "basis of substantial equivalence for this device is based on similarities in intended use, material, function, performance, design, technology and operational principles to the OsteoMed ExtremiLOCK Foot Plating System (K131445)." Specifically for the 1st MTP plates, the basis is "similarities in design, technology, material, function, sterilization, and intended use." "Non-clinical evaluation demonstrate that the device is as safe and effective as the predicate devices." |
Explanation of the Study and its Context (based on the provided text):
The "study" described here is a premarket notification (510(k)) submission to the FDA for a physical medical device. The primary goal of this submission is to demonstrate substantial equivalence to an already legally marketed predicate device (OsteoMed ExtremiLOCK Foot Plating System, K131445) rather than to prove performance against specific clinical efficacy endpoints in a new clinical study.
The "study" involved:
- Verification Evaluation: This refers to in-house testing (likely mechanical and material testing) to ensure the modified plates (1st MTP Primary and Transfix plates) meet required mechanical strength criteria and material specifications.
- Comparison to Predicate Device: A detailed comparison of design, dimensions, materials, function, performance, technology, and operational principles between the new plates and the predicate.
Missing Information (Due to the nature of the document being a 510(k) for a physical device, not an AI/software study):
For the following points, the information is either not relevant to this type of submission or not provided in the document:
- Sample size used for the test set and the data provenance: Not applicable in the context of an AI/software test set. The "test set" here would refer to the physical samples of the plates that underwent mechanical and material testing, but specific sample sizes are not detailed in this summary.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's mechanical properties is established through engineering standards and testing, not expert consensus in the way an AI model's output would be.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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, as this is not an AI-assisted device for human readers.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical device and not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this device, the "ground truth" for its performance would be established through engineering specifications, material standards (e.g., ASTM F-67, ASTM F-136), and mechanical testing results against predetermined pass/fail criteria.
- The sample size for the training set: Not applicable, as this is not a machine learning/AI device.
- How the ground truth for the training set was established: Not applicable, as this is not a machine learning/AI device.
In summary, the document describes a regulatory filing for a physical medical device, focusing on demonstrating equivalence to an existing product through engineering and material comparisons rather than a clinical study or AI performance evaluation.
§ 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.