(80 days)
The Medline UNITE® MIS Foot Recon Screw System is indicated for the stabilization and fixation of bone reconstructions, osteotomies, joint fusions (arthrodeses), and fractures of short (tarsals) and long (metatarsals, phalanges, distal tibia and fibula) bones comprising the foot and ankle. Screws are intended for single use only.
The Medline UNITE® MIS Foot Recon Screw System includes screws manufactured from Titanium Alloy (Ti-6Al-4V ELI) per ASTM F136 or IOS 5832-3. The screws are offered in various diameters from 2.5mm up to 4.0mm and overall lengths ranging from 14mm up to 70mm. The screws are single use and provided non-sterile intended to be cleaned and steam sterilized prior to use. The system also includes non-sterile, single use instrumentation necessary to implant the screws, e.g. drill bits and countersinks. Validated cleaning and sterilization instructions are included in the instructions for use.
The provided text is a 510(k) Summary for the Medline UNITE® MIS Foot Recon Screw System, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It explicitly states that no clinical testing (human or animal) was performed.
Therefore, many of the requested details, such as those related to multi-reader multi-case studies, expert adjudication for ground truth, and the use of training and test sets in the context of an AI/ML algorithm, are not applicable to this document as it does not describe an AI/ML powered device or a clinical study for device performance.
However, I can extract the acceptance criteria and performance data for the physical device based on the non-clinical testing conducted.
Here's the information that can be extracted and responses for the "not applicable" sections:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from FDA's Bone Screw SPBP Guidance) | Reported Device Performance (Medline UNITE® MIS Foot Recon Screw System) |
|---|---|
| Torsional Yield Strength: 0.6 N-m for a 2.5mm nominal major diameter screw | Average torsional yield strength: 0.66 N-m for Ø2.5mm PT screws (MSCP2526) |
| Driving or removal torque less than 50% of the torsional yield strength | Driving and removal torque: 6.36% of the torsional yield strength |
| Predicted shear failure force (for Axial Pullout Strength) | Met FDA's Bone Screw Guidance acceptance criteria for predicted shear failure force (via engineering analysis) |
2. Sample size used for the test set and the data provenance
- Sample Size (Torsional Yield Strength): 6 samples (Ø2.5mm PT screws - MSCP2526)
- Data Provenance: Not specified, but given it's non-clinical lab testing of physical screws, it's likely internal lab data or from a testing facility. It is not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a physical device, and ground truth for its mechanical properties is established through standardized engineering testing (ASTM F543-23) rather than expert interpretation of medical images or clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See response for #3. Data is derived from objective physical testing, not subjective expert assessment.
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. No MRMC study was conducted as this is a physical medical device (bone screw), not an AI/ML diagnostic software. No human readers are involved in its primary function or assessment for regulatory clearance in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. No algorithm performance was assessed as this is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth for Physical Properties: Established by the specifications of ASTM F543-23 and the FDA's Bone Screw SPBP Guidance for mechanical performance. This is an objective, quantitative ground truth based on engineering standards.
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is a physical device being cleared through substantial equivalence based on non-clinical performance testing, not an AI/ML algorithm.
9. How the ground truth for the training set was established
- Not Applicable. See response for #8.
§ 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.