(30 days)
The Medline UNITE® Jones Fracture Screws are indicated for use in bone reconstruction, osteotomies, arthrodesis, joint fusion and repair and fixation of mal-unions, acute fractures, avulsion fractures, and repetitive stress fractures for bones appropriate for the size of the device including the fifth metatarsal (Jones fracture). Screws are intended for single use only.
The Medline UNITE® Jones Fracture Screws are manufactured from titanium alloy. The screws are offered in various diameters ranging from 4.5mm up to 6.0mm and overall lengths ranging from 34mm up to 65mm with consistent thread lengths.
This document is a 510(k) premarket notification for the Medline UNITE Jones Fracture Screw System. This type of FDA submission is for medical devices and focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy through extensive clinical trials as typically seen for novel drugs or high-risk devices. Therefore, the information provided does not directly align with a study designed to meet specific acceptance criteria in the manner you described for an AI/CADe device.
Here's an analysis based on the provided text, addressing your questions to the extent possible, and highlighting where the information is not applicable due to the nature of a 510(k) submission for a bone fixation screw:
1. A table of acceptance criteria and the reported device performance
The document does not present acceptance criteria in terms of clinical performance metrics like sensitivity, specificity, accuracy, or reader agreement that would be typical for an AI/CADe device. Instead, the "acceptance criteria" for a 510(k) for a bone fixation screw relate to demonstrating substantial equivalence to a predicate device through mechanical testing and design comparisons.
Therefore, a table cannot be constructed as requested for an AI/CADe device. The reported "performance" is based on the results of non-clinical mechanical testing and engineering analysis to show that the new device is comparable to the predicate.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not applicable as there was no test set in the context of clinical data for an AI/CADe device. The testing involved mechanical testing of the screws, not patient data.
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)
This information is not applicable as there was no clinical test set requiring expert ground truth for an AI/CADe device. The review of the device's design and mechanical testing would be conducted by engineers and regulatory experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable as there was no clinical test set with human readers to adjudicate for an AI/CADe 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
This information is not applicable. An MRMC study is relevant for AI/CADe devices that assist human readers in image interpretation. This submission is for a physical medical device (bone fixation screws) and does not involve AI or image reading.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is a bone fixation screw, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable as there was no clinical ground truth established for patient data in the context of an AI/CADe device. The "ground truth" for this submission would be established by engineering standards and mechanical test results demonstrating the screw's physical properties are suitable for its intended use and comparable to the predicate.
8. The sample size for the training set
This information is not applicable as there was no training set for an AI model.
9. How the ground truth for the training set was established
This information is not applicable as there was no training set for an AI model.
Summary of what was done based on the provided text:
The submission for the Medline UNITE Jones Fracture Screw System (K201319) is a Special 510(k), indicating minor changes to an already cleared device. The "study" refers to non-clinical testing and engineering analysis to demonstrate substantial equivalence to a predicate device, not clinical efficacy or AI performance.
- Non-Clinical Testing: ASTM F543 testing was performed, including:
- Insertion torque testing
- Torsional strength testing
- Axial pullout strength testing
- Engineering Analysis: Used to compare screw mechanical performance, fixation performance, and usability.
- Comparison to Predicate (Medline Cannulated Screw - K130319):
- Intended Use: Identical.
- Indications for Use: Similar, with the new device having more specific indications consistent with other screws cleared under 21 CFR 888.3040, but still falling under fracture fixation.
- Materials: Identical (titanium alloy per ASTM F136).
- Geometry and Size: Similar. The new device's diameters (4.5mm, 5.5mm, 6.0mm) and lengths (34mm - 65mm) are within the range of the predicate (2.0mm to 7.5mm diameter, 10mm to 130mm length).
- Design Feature: Similar, but with a key difference: the Jones Fracture Screws are solid core and only self-drilling to reduce the risk of bi-cortical fixation in the 5th metatarsal, whereas the predicate is cannulated and self-drilling/self-tapping. Both feature a torx drive mechanism.
The conclusion is that the Medline UNITE® Jones Fracture Screws are substantially equivalent to the predicate device based on these non-clinical comparisons and testing. Clinical testing was not applicable for this submission.
§ 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.