(253 days)
The I.B.S.TM 2.0 Osteosynthesis screws are intended for:
- The fixation of arthrodeses, osteotomies or fractures of the upper and lower limbs
- Osteosynthesis requiring mono or bicortical compression
The size of the chosen screw should be adapted to the specific indications.
The I.B.S.TM 2.0 Osteosynthesis screw is a line extension of the existing compression screw line cleared in K131920 I.B.S.TM Osteosynthesis screw.
The I.B.S.TM 2.0 Osteosynthesis screws are cannulated screws available in a compression design. The cannulation of the screws provides a helpful feature during surgery, as a wire is used to guide insertion of the screw. The compression design has a non-threaded shaft, allowing optimal compression between the two bone fragments, which may enhance bone osteosynthesis.
The I.B.S.TM 2.0 Osteosynthesis screws are self-drilling and self-tapping screws, which enables introduction of the screw without any preparation of the hole (using a drill and /or a tap) in most cases.
Sizes: The I.B.S.TM 2.0 Osteosynthesis screws are available in 2.0mm diameter, in length ranging from 10mm to 30mm.
Material: The I.B.S.TM 2.0 Osteosynthesis screws are manufactured from titanium alloy Ti6Al4V as per ISO 5832-3 and ASTM F136. They do not have any coatings.
Single use: The I.B.S.TM 2.0 Osteosynthesis screws are designed for single use only.
Sterilization: The I.B.S.TM 2.0 Osteosynthesis screws are supplied sterile, using gamma irradiation.
Place of use: The I.B.S.TM 2.0 Osteosynthesis screws are indicated for use in a hospital, or outpatient surgery center where sterile field may be created and maintained.
This document describes the I.B.S.™ 2.0 Osteosynthesis screw, a bone fixation fastener. The acceptance criteria and supporting studies are based on mechanical performance tests, demonstrating substantial equivalence to predicate devices rather than direct clinical outcomes or AI performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Test Name) | Reported Device Performance (I.B.S.™ 2.0) |
|---|---|
| Torsional Properties (Engineering/Dimensional Comparison) | Demonstrated substantial equivalence to the predicate device SBI AUTOFIX screw diameter 2.0 (K052567). The specific numerical values for torque resistance are not provided but are implied to be within acceptable ranges compared to the predicate. |
| Torque to Failure (ASTM F543-13) | Met all acceptance criteria and/or showed similar results as the predicate device Vilex Cannulated Bone Screw Double Thread (K014154). Specific numerical performance not provided. |
| Insertion Torque (ASTM F543-13) | Met all acceptance criteria and/or showed similar results as the predicate device Vilex Cannulated Bone Screw Double Thread (K014154). Specific numerical performance not provided. |
| Axial Pullout Strength (ASTM F543-13) | Met all acceptance criteria and/or showed similar results as the predicate device Vilex Cannulated Bone Screw Double Thread (K014154). Specific numerical performance not provided. |
| Self-Tapping Performance (ASTM F543-13) | Met all acceptance criteria and/or showed similar results as the predicate device Vilex Cannulated Bone Screw Double Thread (K014154). Specific numerical performance not provided. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the mechanical performance test set (e.g., number of screws tested for each mechanical property). The data provenance is from mechanical bench testing conducted by a test laboratory. The country of origin for the data is not specified, but the sponsor is In2Bones SAS, located in France. The study is a retrospective comparison against known predicate device performance and standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a mechanical bone fixation screw, and its performance is evaluated against engineering standards and comparison with predicate devices, not through expert-labeled data for an AI algorithm.
4. Adjudication Method for the Test Set
Not applicable. Performance is determined by mechanical testing results against predetermined criteria in ASTM F543-13 and comparison to predicate devices, not by expert adjudication of clinical outcomes or image interpretations.
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
Not applicable. This is a medical device for bone fixation, not an AI software/algorithm requiring an MRMC comparative effectiveness study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by engineering standards (ASTM F543-13) and direct mechanical comparison to legally marketed predicate devices. The objective is to demonstrate substantial equivalence in terms of mechanical properties.
8. The Sample Size for the Training Set
Not applicable. No training set is mentioned as this is a physical medical device, not an AI model.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is mentioned.
§ 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.