(29 days)
The Medline UNITE® Digital Fusion Screws are indicated for use in bone reconstruction, osteotomies, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the device including corrective procedures for hammertoe, mallet toe, and claw toe deformities. Screws are intended for single use only.
The Medline UNITE® Digital Fusion Screws are manufactured from titanium alloy. The screws are nonsterile and will be offered in a 2.3mm diameter with various thread lengths and overall screw lengths ranging from 20mm up to 55mm in 5mm increments. The screws feature low profile headed and headless screws. The screws are self-drilling and self-tapping.
This is a medical device 510(k) summary, not a study describing the performance of an AI/ML device. Therefore, the requested information about acceptance criteria and study details for an AI/ML device is largely not applicable.
Here's a breakdown based on the provided document:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. This document describes a traditional medical device (surgical screws), not an AI/ML device that requires performance metrics like sensitivity, specificity, or AUC based on a clinical study of its algorithmic output. The substantial equivalence is based on physical and material properties and intended use.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. There is no "test set" in the context of an AI/ML algorithm being evaluated. The testing described is non-clinical bench testing for mechanical properties.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. Ground truth, in the context of AI/ML, refers to expert-labeled data used for training and evaluating algorithms. This document does not involve such a process.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No adjudication method is referenced as there is no expert-based labeling of data.
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/ML device, so no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a surgical screw, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No ground truth is established in the context of AI/ML. The "truth" for this device is its physical and mechanical properties, assessed through engineering tests.
8. The sample size for the training set
- Not Applicable. No AI/ML algorithm is involved, therefore no training set.
9. How the ground truth for the training set was established
- Not Applicable. No AI/ML algorithm is involved, therefore no ground truth establishment for a training set.
Summary of Device and Evidence provided in the document:
The Medline UNITE® Digital Fusion Screw System is a traditional medical device (screws for bone fixation). Its clearance (K211944) is based on substantial equivalence to a previously cleared predicate device, Medline Cannulated Screws (K130319).
Acceptance Criteria (Implicit from Substantial Equivalence):
The acceptance criteria are implicitly that the device performs as safely and effectively as the predicate device such that it has the same indications for use and meets relevant mechanical performance standards.
| Feature / Criteria | Predicate Device (Medline Cannulated Screws, K130319) | Subject Device (Medline UNITE® Digital Fusion Screw System) | Comparison / Performance |
|---|---|---|---|
| Intended Use | Not explicitly detailed for predicate, but consistent with general bone fixation | Bone reconstruction, osteotomies, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the device including corrective procedures for hammertoe, mallet toe, and claw toe deformities. | Identical |
| Indications for Use | General bone fixation (implied by description) | Bone reconstruction, osteotomies, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the device including corrective procedures for hammertoe, mallet toe, and claw toe deformities. | Similar (more specific) |
| Material | Titanium alloy | Titanium alloy | Identical |
| Sizes (Diameter) | 2.0 to 7.5mm | 2.3mm | Within range |
| Sizes (Length) | 10 - 130mm | 20 - 55mm (in 5mm increments) | Within range |
| Non-Clinical Testing | Bench testing (implied for predicate clearance) | Analysis performed to demonstrate substantial equivalence to predicate. The subject device does not represent a new worst-case compared to the predicate. Demonstrated substantial equivalence in predicted shear failure force (axial pullout force) and torsional yield strength. | Pass |
| Clinical Testing | Not mentioned/applicable for predicate | Not applicable (No new clinical concerns raised by the modifications; substantial equivalence shown via non-clinical testing). | Not performed |
| Sterility | (Implicitly provided sterile for surgical use, or sterilized by user) | Nonsterile (Implying sterilization prior to use, which is common for this type of device and not a performance criterion for the device itself but rather a use instruction). | N/A |
| Screw Features | Not explicitly detailed for predicate | Low profile headed and headless screws. Self-drilling and self-tapping. | N/A |
| Regulatory Classification | Class II, Product Code HWC, Regulation Number 21 CFR 888.3040 for Smooth Or Threaded Metallic Bone Fixation Fastener | Class II, Product Code HWC, Regulation Number 21 CFR 888.3040 for Smooth Or Threaded Metallic Bone Fixation Fastener | Identical |
Study Proving Device Meets Acceptance Criteria:
The document states: "Summary of Non-Clinical Testing: The subject device, Medline UNITE® Digital Fusion Screws, do not represent a new worst-case when compared to the previously cleared Medline Cannulated Screws (K130319). However, analysis was conducted to further demonstrate substantial equivalence of the Medline UNITE® Digital Fusion Screws to the predicate. Medline Cannulated Screws. Based on this analysis, the subject device, Medline UNITE® Digital Fusion Screws, are substantially equivalent to the predicate, Medline Cannulated Screws, in predicted shear failure force (axial pullout force) and torsional yield strength."
- Study Type: Non-clinical bench testing and engineering analysis.
- Sample Size: Not specified for the bench tests, but typically involves a representative number of devices for mechanical testing.
- Ground Truth: Engineering standards and established mechanical properties for bone fixation devices.
- Training Set/Test Set (AI/ML context): Not applicable.
- Data Provenance: Not explicitly stated, but typically conducted in a laboratory setting.
- Experts/Adjudication (AI/ML context): Not applicable.
§ 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.