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The I.B.S.® Snap-off screws are indicated for bone reconstruction, osteotomy and fracture fixation of bones appropriate for the size of the device. Examples include: Mono-cortical fixation of small bone fragments Weil osteotomy Osteotomies and fractures fixation in the foot and hand.

Device Description

The I.B.S.® Snap-off screw is a one-piece device made of Titanium Alloy intended to be used as a screw for bone reconstruction, osteotomy and fracture fixation of bones appropriate for the size of the device. The implant is a self-drilling and self-tapping snap-off screw. It is machined on the end of a drill shank which inserts into a driver. After insertion of the screw into the bone, the drill shank twists off and breaks cleanly from the screw head. The implant is supplied sterile and is available in various sizes diameters and lengths. The I.B.S.® Snap-off screws are manufactured from titanium alloy TA6V as per ISO 5832-3 and ASTM F136. They do not have any coating. The I.B.S.® Snap-off screws are designed for single use only. The I.B.S.® Snap-off screws are supplied sterile, using gamma irradiation.

AI/ML Overview

The provided document is a 510(k) summary for a medical device, the In2Bones I.B.S.® Snap-off screw. It details the device's characteristics and its comparison to predicate devices to establish substantial equivalence, which is the basis for FDA clearance for similar devices.

Here's an analysis based on the information provided:

A table of acceptance criteria and the reported device performance:

Acceptance Criteria (What was tested)	Reported Device Performance
Mechanical performance according to ASTM F543-07 (Torque to failure, insertion torque, axial pullout strength, and self-tapping performance of screws). This standard also covers requirements for materials, finish, marking, care and handling, and acceptable dimensions and tolerances.	The I.B.S.® Snap-off screw performed as expected for each test.
Engineering / dimensional comparison to predicate devices.	Performed to ascertain substantial equivalence.
Material: Made from Titanium Alloy TA6V (ISO 5832-3 and ASTM F136).	Manufactured from Titanium Alloy TA6V as per ISO 5832-3 and ASTM F136.
Design Features: Solid/non-cannulated, self-tapping, self-drilling, snap-off design.	Same as predicate devices.
Indications for Use: Bone reconstruction, osteotomy, and fracture fixation of bones appropriate for the size of the device. (Specifically: Mono-cortical fixation of small bone fragments, Weil osteotomy, Osteotomies and fractures fixation in the foot and hand).	Substantially equivalent to predicate devices.
Intended for surgical implantation longer than 30 days.	Same as predicate devices.
Equivalent size range (diameters and lengths).	Covered by the predicate devices.

Sample size used for the test set and the data provenance:
The document does not specify the sample size used for the mechanical testing or the engineering/dimensional comparison.
The provenance of the data is a "test lab" (stated under "Summary Performance Data"), but further details such as country of origin, retrospective or prospective nature of the data collection (if applicable) are not provided. Given these are mechanical and dimensional tests, they are inherently prospective during the device development and validation phase.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to this type of regulatory submission. The device is a bone fixation screw; its performance is assessed through objective mechanical testing and engineering comparisons, not through human interpretation of images or symptoms that would require expert consensus for ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable for the reasons stated above. Adjudication methods are typically used in clinical studies or studies involving expert review of ambiguous cases, which is not the nature of the testing described here.
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:
This information is not applicable. This submission is for a physical orthopedic implant, not an AI-powered diagnostic or assistive device. Therefore, no MRMC study or AI assistance evaluation was conducted.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable for the same reasons as #5.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the mechanical testing, the "ground truth" is defined by the standards set forth in ASTM F543-07 (e.g., minimum torque to failure, pullout strength, etc.) and by the specifications and dimensions of the predicate devices for comparison. It's objective, quantitative data derived from engineering principles and standardized tests, not biological outcomes or expert opinions.
The sample size for the training set:
This information is not applicable. There is no "training set" as this is not a machine learning or AI device.
How the ground truth for the training set was established:
This information is not applicable for the same reasons as #8.

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