(110 days)
Mini and Micro Fragments Reconstruction System – NEOFIX is intended for small bone fracture fixation, arthrodesis, reconstruction, and osteotomy fixation. Examples include small bones of the hand, wrist, foot and ankle. The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone.
Mini and Micro Fragments Reconstruction System – NEOFIX consists of plates and screws in a variety of designs and sizes. Straight plates are provided in various lengths and may be contoured to adapt to patient specific anatomy. Straight plates are available with screw holes to accommodate non-locking and locking screw designs. Plates also are provided in various geometric configurations that are commonly used in trauma and reconstructive surgery. The plates range in thickness from 0.7 mm to 2.7 mm, and are manufactured from commercially pure titanium conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications or Ti-6Al-4V ELI alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.
Self-tapping cortical screws are provided in locking and non-locking designs. The locking screws are provided with a thread diameter of 2.4 mm with a hexalobular instrument interface (Star Head) and a tapered thread tip to facilitate insertion. Locking smooth pins also are provided with a diameter of 2.4 mm in various lengths. The smooth pins are used with the Distal Radius Volar Plates. Non-locking cortical self-tapping screws are provided with thread diameters of 1.5, 2.0, 2.3, 2.4 and 2.7 mm, and in various lengths from 5 mm to 32 mm. The non-locking screws with thread diameters of 1.5, 2.0 and 2.3 mm have a cruciform instrument interface; the nonlocking screws with diameters of 2.4 and 2.7 mm have a hexalobular instrument interface. All screws are manufactured from Ti-6AI-4V ELI alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.
The document is a 510(k) premarket notification from the FDA for a medical device called "Mini and Micro Fragments Reconstruction System-Neofix." It primarily establishes substantial equivalence to previously marketed predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria with performance metrics.
Therefore, many of the requested sections regarding acceptance criteria, sample sizes, expert involvement, and ground truth cannot be fully extracted directly from this document. The document focuses on demonstrating that the new device is as safe and effective as existing legally marketed devices.
Here's an attempt to answer the questions based on the provided text, highlighting what is ascertainable and what is not:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present acceptance criteria in a table format with corresponding numerical device performance results. Instead, it asserts substantial equivalence based on similarity to predicate devices in terms of intended use, technological characteristics, materials, design principles, and packaging/sterilization methods.
It mentions:
- "Performance data provided to demonstrate substantial equivalence included detailed dimensional analysis of the subject and predicate device designs, engineering analysis, and mechanical testing of the subject designs."
Without the actual dimensional analysis or mechanical testing results, specific performance metrics cannot be reported in a table. The "acceptance criteria" here would implicitly be that the new device's performance in these analyses is comparable or non-inferior to the predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document mentions "detailed dimensional analysis" and "mechanical testing," which would involve samples, but the specific sample sizes are not disclosed. Data provenance (country of origin, retrospective/prospective) is also not specified for these tests.
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)
This information is not provided in the document. The types of tests (dimensional analysis, engineering analysis, mechanical testing) typically rely on engineering standards and measurements, not necessarily expert clinical review to establish "ground truth" in the same way an AI diagnostic device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. Adjudication methods are typically relevant for studies involving human interpretation or clinical outcomes, which are not directly detailed here for the mechanical performance tests.
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
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices involving human readers, which this device (a metallic bone fixation system) is not.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is a physical medical implant, not an algorithm, so this type of study is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "detailed dimensional analysis," "engineering analysis," and "mechanical testing," the "ground truth" would be established by:
- Engineering standards and specifications: For dimensions, materials, and mechanical properties.
- Physical measurements and test results: Obtained from the mechanical testing, compared against established benchmarks or predicate device performance.
This is not "expert consensus" or "pathology" in the clinical sense, but rather adherence to engineering and material science principles.
8. The sample size for the training set
This information is not applicable as the device is a physical implant and not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable as the device is a physical implant and not an AI algorithm requiring a 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.