(98 days)
The Monster Screw System™ is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair and fracture fixation, appropriate for the size of the device.
The Monster Screw System™ is comprised of bone screws and washers. The Monster Screw is a threaded bone screw offered in 2.0mm to 9.5mm diameters (in 0.5 mm increments) having overall lengths from 8mm (for smaller diameters) thru 200mm (for larger diameters). The screws are offered having a variety of features with respect to head, thread, tip, cannulation and material. Size-matched washers are also available in flat, dome and bowl configurations.
Here's an analysis of the provided text regarding the acceptance criteria and study for the "Monster Screw System™":
It is important to note that this submission (K124027) is for a medical device (bone fixation screws), not an AI/Software as a Medical Device (SaMD). Therefore, many of the typical AI/SaMD study parameters (like multi-reader multi-case studies, standalone performance, training sets, ground truth methodology for AI models, etc.) are not applicable in this context. The "acceptance criteria" and "study" refer to mechanical performance testing against established industry standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance (Worst Case Monster Screws) |
|---|---|
| Torsion (ASTM F543) | Passed (demonstrated substantial equivalence) |
| Insertion/Removal (ASTM F543) | Passed (demonstrated substantial equivalence) |
| Pullout (ASTM F543) | Passed (demonstrated substantial equivalence) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact number of screws or tests performed. It generically states "Mechanical testing of the worst case Monster Screws."
- Data Provenance: Not applicable in the context of mechanical testing of physical devices. The testing was performed on newly manufactured devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth for mechanical testing is established by compliance with a predetermined engineering standard (ASTM F543), not by expert human interpretation.
4. Adjudication Method for the Test Set
Not applicable for mechanical testing. Data is quantitative and compared directly to the specified standard.
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
No, an MRMC study was not done. This device is a bone fixation screw system, not an AI/SaMD.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study was not done. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for determining device performance was compliance with the specified mechanical testing standards: ASTM F543 (Standard Specification for Metallic Medical Bone Screws). This standard provides quantitative thresholds and methodologies for measuring torsion, insertion/removal force, and pullout strength.
8. The Sample Size for the Training Set
Not applicable. There is no concept of a "training set" for mechanical testing of physical devices.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set.
Summary of the Study Proving Acceptance Criteria:
The study conducted to demonstrate that the Monster Screw System™ meets the acceptance criteria was focused on mechanical performance testing.
- Study Design: Mechanical testing was performed on "worst case Monster Screws." The specific test methodologies were in accordance with ASTM F543.
- Tests Performed:
- Torsion testing
- Insertion/removal testing
- Pullout testing
- Acceptance Criteria: The device's performance was considered acceptable if its mechanical properties (torsion, insertion/removal, pullout) were "substantially equivalent" to predicate devices, as demonstrated by the results of the ASTM F543 tests. This implies that the measured values met or exceeded the performance of the predicate devices in these defined mechanical parameters, which themselves would have been shown to meet the ASTM F543 standard.
- Results: The mechanical test results, along with "theoretical comparisons," "demonstrated that the Monster Screw System™ mechanical performance is substantially equivalent to the predicate devices."
- Conclusion: Based on these mechanical tests, the sponsor concluded that the device possesses the same technological characteristics (including performance) as the predicate devices and is therefore substantially equivalent for its intended use.
§ 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.