(77 days)
The MEMOMETAL FIXOS Screws (S-Fix / C-Fix / P-Fix & W-FIX) are indicated for fixing and stabilizing the elective osteotomies of the mid-foot bones and the metatarsal and phalanges of the foot only.
MEMOMETAL FIXOS SCREWS are single-use bone fixation appliances intended to be permanently implanted. Screws are cannulated compressive screws made of titanium alloy (Ti - 6Al -4V ELI) and snap-off screws made of titanium alloy (alloy (Ti - 6Al -4V ELI)
The MEMOMETAL FIXOS Screws (S-Fix / C-Fix / P-Fix & W-FIX) are indicated for fixing and stabilizing the elective osteotomies of the mid-foot bones and the metatarsal and phalanges of the foot only.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conforms to ASTM F543-02 (Sections A1, A2, A3) | The MEMOMETAL FIXOS Screws conform to ASTM F543-02 Standard Specification and Test Methods for Metallic Bone screw (Section A1, A2 and A3). |
| Conforms to ISO 5832-3 | The MEMOMETAL FIXOS Screws conform to ISO 5832-3 Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy. |
| Substantially equivalent to predicate devices (K962233, K962236) in: | The MEMOMETAL FIXOS Screws are substantially equivalent to their predicate devices (LANDOS CANNULATED BONE SCREW and TWIST-OFF SCREW) in: |
| - Intended Use & Indications for Use | - Intended Use & Indications for Use (Same) |
| - Material | - Material (Same - titanium alloy (Ti - 6Al -4V ELI)) |
| - Design | - Design (Similar, minor differences do not raise new questions of safety and effectiveness) |
| - Function | - Function (Similar, minor differences do not raise new questions of safety and effectiveness) |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes performance testing against established industry standards (ASTM F543-02 and ISO 5832-3) and a claim of substantial equivalence to predicate devices.
- Sample Size for Test Set: The document does not specify the sample size for the mechanical performance tests conducted to meet ASTM and ISO standards. These standards typically define the minimum sample sizes for various tests.
- Data Provenance: Not explicitly stated as country of origin, but the company is based in France (MEMOMETAL TECHNOLOGIES, 35170 BRUZ - France). The testing would have been conducted to international standards. The document only mentions performance data without specifying if it was a retrospective or prospective study on human subjects; it appears to be laboratory-based engineering performance testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of information is not applicable to the provided 510(k) summary. The "ground truth" for this device is based on objective engineering and material science standards (ASTM and ISO) and comparison to predicate devices, not on expert clinical interpretation of data that typically requires human "ground truth" establishment.
4. Adjudication Method for the Test Set
Not applicable. As the performance data relies on objective engineering and material standards, there is no need for an adjudication method in the context of clinical interpretation, which is what "adjudication method" typically refers to.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The provided document does not mention any MRMC comparative effectiveness study. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data. The FIXOS Screws are implantable bone fixation devices, and their performance is assessed through mechanical testing and material conformance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical medical implant (bone screw), not a software algorithm. Therefore, the concept of "standalone algorithm performance" is not relevant.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- Objective Engineering Standards: Conformance to ASTM F543-02 (Standard Specification and Test Methods for Metallic Bone screw) and ISO 5832-3 (Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy). These standards define test methods and acceptance criteria for material properties and mechanical performance.
- Predicate Device Equivalence: The comparison of material, design, and function to previously legally marketed predicate devices (LANDOS CANNULATED BONE SCREW and TWIST-OFF SCREW) establishes the basis for demonstrating safety and effectiveness for a new device claiming substantial equivalence.
8. Sample Size for the Training Set
Not applicable. This device is a physical implant, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The manufacturing process and design are based on established engineering principles and materials.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As explained above, there is no "training set" for this device.
§ 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.