(309 days)
The I.B.S.™ osteosynthesis screws are intended for:
- The fixation of arthrodeses, osteotomies or fractures of long or short bones of the upper and lower limbs
- Osteosyntheses requiring a mono or bicortical compression
The size of the chosen screw should be adapted to the specific indications.
The I.B.S.TM osteosynthesis screws are cannulated screws, available in a compression and a neutralization 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 neutralization design is fully threaded and may be preferred when stabilization of the bone fragments without strong compression is required, as for example in some fractures in multiple fragments, or osteoporotic bone. Both designs 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 osteosynthesis screws are available in 2.5mm, 3.0mm, 3.5mm, 4.5mm, 6.0mm, 6.5mm, and 8.0mm diameters, in length ranging from 20mm to 160mm.
Material: The I.B.S.TM osteosynthesis screws are manufactured from titanium alloy Ti6A14Vas per ISO 5832-3 and ASTM F136. They do not have any coatings.
Single use: The I.B.S.TM osteosynthesis screws are designed for single use only.
Sterilization: The I.B.S.TM osteosynthesis screws are supplied sterile, using gamma irradiation.
Place of use: The I.B.S.TM osteosynthesis screws are indicated for use in a hospital, or outpatient surgery center where sterile fields may be created and maintained. They are prescription devices.
Here's an analysis of the provided 510(k) summary regarding the In2Bones I.B.S.™ osteosynthesis screws, focusing on acceptance criteria and supporting studies:
This submission is for a medical device (osteosynthesis screws), not an AI/ML powered device. Therefore, many of the typical acceptance criteria and study components related to AI devices (such as sample size for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable.
The approval for this device is based on substantial equivalence to existing predicate devices, meaning it has similar intended use, materials, dimensions, and designs, and does not raise new questions of safety or effectiveness. The study demonstrating this is primarily a comparative engineering and dimensional analysis rather than a clinical trial or AI performance study.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrated Equivalence) | Reported Device Performance (as demonstrated by comparison to predicates) |
|---|---|
| Intended Use: Fixation of arthrodeses, osteotomies or fractures of long or short bones of upper and lower limbs; osteosyntheses requiring mono or bicortical compression. | Identical. The I.B.S.™ osteosynthesis screws have the same indications for use as the predicate devices. This is stated as: "The I.B.S.™ osteosynthesis screws are intended for: - The fixation of arthrodeses, osteotomies or fractures of long or short bones of the upper and lower limbs - Osteosyntheses requiring a mono or bicortical compression." |
| Technological Characteristics: | Similar/Equivalent. The device's technological characteristics are deemed the same as the predicate devices. Specifically: |
- Cannulation: The I.B.S.™ screws and all predicates are cannulated.
- Material: The I.B.S.™ screws are made from Titanium alloy Ti6A14V (ISO 5832-3 and ASTM F136), similar to most predicates (except SBI® AutoFix which uses Stainless Steel 316L). No new materials are introduced.
- Compression Design: The I.B.S.™ Compression screw has a non-threaded part for compression, similar to all compression predicates.
- Neutralization Design: The I.B.S.™ Neutralization screw is fully threaded, similar to all neutralization predicates.
- Size Range: The I.B.S.™ screws (2.5mm to 8.0mm diameters, 20mm to 160mm lengths) are covered by the size ranges of the predicate devices. |
| Material/Biocompatibility: Titanium alloy Ti6A14V (ISO 5833-3, ASTM F136). | Compliant/Equivalent. Manufactured from titanium alloy Ti6A14Vas per ISO 5832-3 and ASTM F136, which are established medical device standards and consistent with predicate devices. |
| Sterilization Method: Gamma irradiation. | Compliant/Equivalent. Supplied sterile via gamma irradiation, a standard sterilization method for medical devices. |
| Safety and Effectiveness: Demonstrate no new questions of safety or efficacy. | Demonstrated by Substantial Equivalence. Based on the identical intended use and similar technological characteristics (materials, design features, size range), the device is deemed as safe and effective as the predicate devices. An "engineering / dimensional comparison to the predicates was performed to demonstrate substantial equivalence." |
2. Sample size used for the test set and the data provenance
- Not Applicable. This is a hardware medical device seeking substantial equivalence, not an AI/ML device requiring a test set of data. The "test" here refers to the comparison of the physical device to its predicates.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. No ground truth in the context of expert labeling or adjudication is required for this type of device submission. The "ground truth" for substantial equivalence is the established safety and efficacy of the predicate devices, which has been previously reviewed and cleared by the FDA based on their respective data.
4. Adjudication method for the test set
- Not Applicable. No test set or expert adjudication process as would be used for an AI/ML device.
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 not an AI-assisted diagnostic or therapeutic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" in this context is the regulatory clearance of the predicate devices by the FDA, which implicitly confirms their safety and effectiveness for their stated indications. The I.B.S.™ screws are compared against these already-cleared devices. No new clinical "ground truth" (e.g., pathology or outcome data specific to this device) was required for this 510(k) submission.
8. The sample size for the training set
- Not Applicable. This is a hardware medical device, not an AI/ML device. The "training" for such a device involves engineering design, material selection, and manufacturing processes, not data training.
9. How the ground truth for the training set was established
- Not Applicable. As above, no training set in the context of AI/ML. The design and manufacturing of the device would have followed established engineering principles and medical device standards (e.g., ISO, ASTM), and in-house testing to ensure it meets its specifications, but this is not referred to as a "training set" with "ground truth" in the AI sense.
§ 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.