(131 days)
The Orthofix external fixation screw (pin) with hydroxyapatite coating is indicated for use in the external fixation of bone.
The Orthofix Hydroxyapatite Coated Screws are manufactured from surgical grade stainless steel AISI 316L. The pins are available in a variety of diameters and lengths. The threaded end is gradually tapered, over approximately the last third of the pin's length. The threaded portion of the pin is coated with a very thin plasma sprayed coating of HA. The HA powder used in the plasma spray coating process conforms to ASTM F 1185. The mechanical properties of the coating conform to ASTM F 1501.
The provided 510(k) summary (K974186) describes the Orthofix® External Fixation Screw (Pin) With Hydroxyapatite Coating. This submission is for a modified version of an already cleared external fixation pin, with the modification being the addition of a thin plasma-sprayed coating of hydroxyapatite (HA). The purpose of the HA coating is to enhance fixation at the pin/bone interface.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state formal "acceptance criteria" in a quantitative sense as typically seen for AI/software devices. Instead, it argues for substantial equivalence to a predicate device based on demonstrating enhanced performance attributable to the HA coating. The performance metrics presented are comparative between HA-coated and uncoated pins.
| Acceptance Criteria (Implied) | Reported Device Performance (HA-Coated vs. Uncoated) |
|---|---|
| No significant difference in insertion torque. | No significant difference in insertion torques for standard uncoated and HA-coated Orthofix pins in both metaphyseal and diaphyseal bone. |
| Significantly greater extraction torque than uncoated pins. | Extraction torque is significantly greater for HA-coated Orthofix pins than for uncoated pins in both metaphyseal and diaphyseal bone. |
| Extraction torque significantly greater than insertion torque. | For HA-coated Orthofix pins, the extraction torque is significantly greater than the insertion torque in both metaphyseal and diaphyseal bone. |
| Reduced incidence of clinical loosening. | Significantly enhanced fixation and a reduced incidence of clinical loosening. |
| Osseointegration demonstrated. | Radiographic, histologic, SEM, and histomorphometric analyses demonstrate osseointegration with direct contact between the bone and the screw threads of the Orthofix HA-coated pins. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "randomized controlled clinical and animal studies" but does not specify the sample sizes for either the clinical or animal studies.
The provenance of the data is not explicitly stated (e.g., country of origin for clinical studies). It's implied to be prospective given the description of "randomized controlled clinical and animal studies."
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. The studies involved radiographic, histologic, SEM, and histomorphometric analyses, which would typically involve expert interpretation, but no details on the number or qualifications of these experts are given.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study is not applicable here as this is a medical device (external fixation screw) rather than an AI/software device intended for interpretation by multiple readers. The study focuses on the physical and biological performance of the device.
6. Standalone (Algorithm Only) Performance
This is not applicable as the device is a physical medical implant, not an algorithm or AI.
7. Type of Ground Truth Used
The ground truth was established through a combination of:
- Quantitative Mechanical Measurements: Insertion and extraction torque measurements.
- Imaging Data: Radiographic analyses.
- Histology: Histologic analysis (tissue samples).
- Microscopy: SEM (Scanning Electron Microscopy) and histomorphometric analyses (detailed microscopic examination and measurement of bone-implant interface).
- Clinical Outcomes: Reduced incidence of clinical loosening (though the specific metrics or details of this outcome are not elaborated).
8. Sample Size for the Training Set
This is not applicable as this is a physical medical device and does not involve AI or machine learning algorithms that would typically have a "training set." The HA coating is applied directly to the device.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated above. The "ground truth" for the device's performance was established via the described clinical and animal studies and mechanical/material characterization tests.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.