(22 days)
The Synthes 3.5mm Low Profile Cortical Screws are intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneous, femur, and fibula in adults, and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by the screw fixation.
The 3.5mm Low Profile Cortical Screws are self-tapping, have either a stardrive or hexdrive recess, are manufactured from stainless steel and titanium and offered both sterile and non sterile. The self-tapping screws are available in lengths ranging from 10mm - 110mm and may be used independently or with any Synthes plate which accepts Synthes 3.5mm cortical screws. The low profile screw head is designed to minimize hardware prominence and the resultant potential for soft tissue irritation.
The Synthes 3.5mm Low Profile Cortical Screw is a bone fixation fastener. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria and results for the new device as an standalone product.
Therefore, the document does NOT contain information regarding:
- Acceptance criteria specified for the device's performance metrics.
- A formal study comparing the device's performance against defined acceptance criteria.
- Sample sizes for test sets, data provenance, number or qualifications of experts, or adjudication methods for ground truth.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Ground truth types or how ground truth for training or test sets was established.
Instead, the submission addresses substantial equivalence based on design, intended use, fundamental product technology, materials, and geometric cross-sectional analysis comparing it to predicate devices.
Summary of Information directly from the document:
The provided document describes the Synthes 3.5mm Low Profile Cortical Screw and asserts its substantial equivalence to predicate devices (specifically, Synthes 3.5mm Cortex Screws, K043185).
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The submission focuses on demonstrating substantial equivalence, not on acceptance criteria for novel performance metrics. The closest to "performance" mentioned is a "geometric cross sectional analysis" for comparison.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document. The submission does not describe a clinical performance study with a test set.
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 provided in the document. The submission does not describe a clinical performance study involving ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document.
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 and not provided. This device is a bone fixation screw, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable and not provided. 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 provided in the document. The document refers to "geometric cross sectional analysis" for comparison, which does not involve a "ground truth" as typically defined for diagnostic device performance.
8. The sample size for the training set:
This information is not applicable and not provided. This device is a bone fixation screw, not a machine learning model.
9. How the ground truth for the training set was established:
This information is not applicable and not provided.
Substantial Equivalence Claim and Supporting Information:
The document states:
"Information presented supports substantial equivalence of the Synthes 3.5mm Low Profile Cortical Screw to the predicate devices. The proposed low profile screw has similar indications for use, is similar in design, incorporates the same fundamental product technology and is composed of the same materials."
Additionally, to support this claim:
"To additionally support substantial equivalence, geometric cross sectional analysis was conducted to compare the subject device to the predicate device with results supporting substantial equivalence."
§ 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.