(27 days)
The StealthFix Intraosseous Fixation System is indicated for fixation of bone fractures, fusions, or for bone reconstructions, including:
- · Arthrodesis in hand or foot surgery
- · Mono or bi-cortical osteotomies in the foot or hand
- · Fracture management in the foot or hand
- · Distal or proximal metatarsal or metacarpal osteotomies
- · Fixation of osteotomies for Hallux Valgus treatment such as scarf, chevron, etc.
The StealthFix Intraosseous Fixation System is an orthopedic intraosseous staple system consisting of staple and screw implants. The staples consist of two legs or posts connected by a bridge. The staples are available in post diameters of 2.5mm(mini), and 4.5mm(standard). The 2.5mm staples are provided with a bridge span of 10mm and range in post length from 8mm to 12mm. The 3.5mm staples are provided with a bridge span of 15mm and range in post length from 14mm to 20mm. The 4.5mm staples are available in bridge spans of 15mm and range in post length from 14mm to 32mm. The system provides crossing screws for optional fixation with the standard staple implants. Standard staples are designed with a screw slot to accept a crossing screw. The screws are available partially and fully threaded and are 3.5mm in diameter with lengths ranging from 16mm to 38mm in 2mm increments. The partially threaded screws are headed. The fully threaded and headless. The system provides accessory instruments designed for preparation of the and insertion of implants into bone, including implant specific inserters and targeting arms. The implants of the system are available packaged both sterile for single use. The instruments are provided non-sterile, reusable or single be cleaned and sterilized by the end user prior to use. The system also provides some instruments sterile packaged, individually and in sets. Sterile instruments are for single use only.
This document describes the 510(k) summary for the StealthFix Intraosseous Fixation System. It outlines the device, its intended use, and its substantial equivalence to a predicate device.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are based on demonstrating substantial equivalence to a legally marketed predicate device (K220181). This typically means showing that the new device is as safe and effective as the predicate and does not raise new questions of safety or effectiveness.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Material Equivalence | Subject device screw implants and instruments have no change in materials compared to the predicate device. All screw implants are manufactured from Ti-6Al-4V alloy conforming to ASTM F136. Instruments are manufactured using Stainless Steel in conformance with ASTM F899. |
| Design Equivalence | Subject device staple implants are identical in design to the predicate device. |
| Intended Use/Indications for Use Equivalence | The subject device has the same intended use and Indications for Use as the predicate cleared under K220181. |
| Operating Principles Equivalence | The subject device uses the same operating principles as the predicate device. |
| Biocompatibility/Safety (Endotoxin) | Endotoxin testing was performed (LAL method, AAMI ST72, USP 161, USP 85) and results met the Endotoxin limit of ≤20 EU per device. |
| Mechanical Strength (Screws) | An engineering analysis was performed to compare the subject and predicate screws to demonstrate that the new screws do not create a new worst-case for screw mechanical strength (cross-sectional area) or screw fixation (thread substrate interface area). |
| Functionality/Usability | Device usability was evaluated through cadaveric testing. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a separate "test set" in the context of clinical or performance data for a diagnostic device. The evaluation primarily relied on engineering analysis, materials comparison, and cadaveric testing.
- Data Provenance:
- Engineering Analysis: Based on design comparisons and calculations.
- Cadaveric Testing: Implied to be prospective testing carried out for usability evaluation.
- Endotoxin Testing: Laboratory testing on device samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable in the context of this 510(k) summary, as it does not involve a diagnostic algorithm requiring expert-established ground truth on a test set. The assessment is based on physical and engineering properties, and direct comparison to a predicate device.
- Qualifications of Experts: Not specified or relevant for this type of submission.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The evaluation is not based on interpreting results from a test set that requires expert adjudication.
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
- MRMC Study: Not applicable. This is a medical device (intraosseous fixation system), not a diagnostic artificial intelligence (AI) device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This is a medical device (intraosseous fixation system), not a diagnostic artificial intelligence (AI) device.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- Type of Ground Truth: The "ground truth" in this context is established through:
- Material Specifications: Conformance to ASTM standards for Ti-6Al-4V alloy and Stainless Steel.
- Design Documentation: Verification of identical staple designs and comparison of screw designs to the predicate device.
- Engineering Principles: Analysis demonstrating mechanical equivalence or non-inferiority of new screw designs.
- Performance Standards: Meeting endotoxin limits.
- Functional Assessment: Cadaveric testing for usability.
- Predicate Device Performance: The safety and effectiveness of the predicate device (K220181) serves as the benchmark.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable. This device does not involve 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.