(194 days)
The Z-Medical SnapOff screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- Fixation of small bone fragments
- Weil osteotomy
- Mono-cortical fixation
- Osteotomies and fractures fixation in the foot and hand
The Z-Medical double thread compression screws are indicated for fixation of bone fractures or bone reconstruction. Examples included:
- Fixation of bone fragments or small bone fractures
- Fracture management in the foot and hand
- Arthrodesis in hand, foot or ankle surgery
- Mono or Bi-cortical osteotomies in the foot and hand
The Z-Medical's guide wires are intended to perform as fixation and stabilization unit of bone fractures or as guidance at insertion of implants into the skeletal system.
The Z-Medical Staples are indicated for fixation of bone fractures, bone reconstruction, ligament, soft tissue and tendon. Examples included:
- Fixation of bone fragments or small bones fractures
- Fracture management in the foot and hand
Z-Snap Off Screw: Main application is forefoot surgery. Intended to connect bones or bone fragments. Material: ASTM F136 (Ti-6AI-4V ELI), Length: 11 mm to 14 mm, Diameter: 2 mm.
Z-Double Thread Compression Screw: Mainly used in forefoot surgery. Most common use is in the "Scart"-osteotomy. Cannulated to work with a guide wire and drilled in manually. Material: ASTM F136 (Ti-6Al-4V ELI), Length: 10 mm to 36 mm, Diameter: 3 and 4 mm.
Z-Guide Wire: Used in all fields of surgery. Main applications are: determine the correct position for e.g. screws or drills, or fixation of bones, fragments. Usually put in by machine. Also used to drill holes, e.g. to apply staples. Material: ASTM F 138 (1.4441), Length: 80 mm to 380 mm, Diameter: 0.7 mm to 6.35 mm, End Styles: Trocar, Type: Smooth.
Z-Staple: Implants for fixing bones or fragments. Use the SnapOff-technology. The distal end can be used as drilling gauge as well as grip to put in the staple. After reaching the final position, the grip can be snapped off by moving sideways. Material: ASTM F136 (Ti-6Al-4V ELI), Size: 8 mm to 25 mm, Method of insertion: Staple inserter and SnapOff technique.
The acceptance criteria and study details for the Z-Medical GmbH & Co. KG bone fixation devices (Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-Staple) are described below.
1. Table of Acceptance Criteria and Reported Device Performance
| Device | Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Z-Snap Off Screw | Torque test | Conforming to respective requirements (implied equivalence to predicate) | Results "conforming to the respective requirements" |
| Break-off test | Conforming to respective requirements (implied equivalence to predicate) | Results "conforming to the respective requirements" | |
| Sideways stability test | Conforming to respective requirements (implied equivalence to predicate) | Results "conforming to the respective requirements" | |
| Maximum torque test | Conforming to respective requirements (implied equivalence to predicate) | Results "conforming to the respective requirements" | |
| Z-Double Thread Compression Screw | Screw-in test | Conforming to respective requirements (implied equivalence to predicate) | Results "conforming to the respective requirements" |
| Screw compression test | Conforming to respective requirements (implied equivalence to predicate) | Results "conforming to the respective requirements" | |
| Maximum torque test | Conforming to respective requirements (implied equivalence to predicate) | Results "conforming to the respective requirements" | |
| Z-Staple | ASTM F564-10 test | Conforming to ASTM F564-10 and respective requirements (implied equivalence to predicate) | Results "conforming to the respective requirements" |
| Break-off test | Conforming to respective requirements (implied equivalence to predicate) | Results "conforming to the respective requirements" | |
| Z-Guide Wire | Not explicitly listed, but implied mechanical testing for equivalence | Conforming to respective requirements (implied equivalence to predicate) | Results "conforming to the respective requirements" |
Note: The document provided is a 510(k) summary for medical devices where the primary goal is to demonstrate substantial equivalence to legally marketed predicate devices. As such, the acceptance criteria are generally framed in terms of meeting relevant standards (e.g., ASTM) and showing performance comparable to the predicate devices, rather than specific numerical thresholds presented in this summary. The "reported device performance" is a general statement indicating compliance.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each test. The studies mentioned appear to be mechanical/bench tests, not clinical studies involving human patients. Therefore, information regarding "country of origin of the data" and "retrospective or prospective" is not applicable in the context of clinical data. The tests are laboratory-based.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The tests performed are mechanical/bench tests to assess the physical properties and performance of the devices. They do not involve expert interpretation or human ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable, as the tests are mechanical/bench tests and do not require adjudication of human assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document describes bench testing for device characteristics, not studies on human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The devices are physical implants (screws, wires, staples), not algorithms or AI-driven systems.
7. The Type of Ground Truth Used
The "ground truth" for the performance claims is based on engineering standards and mechanical testing results. The devices were tested against established industry standards (such as ASTM F564-10 for Z-Staple, and implied similar standards for other components) and internal specifications designed to demonstrate equivalence to the predicate devices.
8. The Sample Size for the Training Set
Not applicable. The devices are physical implants, not AI/machine learning models that require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for these conventional medical devices.
§ 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.