(125 days)
The Tornier ForeFoot STP Screw System is indicated for fixation of fractures, fusions, and osteotomies of bones of the hand and foot.
The submission is regarding the ForeFoot STP System. This system consists of screws of various diameters, lengths and thread configurations.
This document is a 510(k) premarket notification for the Tornier ForeFoot STP System, a medical device. It describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices. Based on the provided text, a "study" in the context of device performance refers to mechanical testing rather than a clinical study or a study involving AI/software analysis of data.
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a dedicated table format for this 510(k) submission. However, it mentions the types of tests performed and the conclusion that the device is substantially equivalent based on these tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalent strength in cross-sectional bending | Cross-sectional bending analysis performed; results support substantial equivalence to predicate devices. |
| Equivalent strength in mechanical axial pull-out | Mechanical axial pull-out testing performed; results support substantial equivalence to predicate devices. |
| Appropriate torsional strength | Mechanical testing was completed to ensure that the torsional strength is appropriate for the potential applications of the device. |
| Appropriate insertion torque | Mechanical testing was completed to ensure that the insertion torque is appropriate for the potential applications of the device. |
| Appropriate removal torque | Mechanical testing was completed to ensure that the removal torque is appropriate for the potential applications of the device. |
| Overall safety and effectiveness compared to predicate devices | Demonstrated to be as safe and effective as the predicate devices due to similarities in indications, design, and materials, supported by mechanical testing. |
2. Sample Size Used for the Test Set and the Data Provenance
This document describes mechanical testing of a physical medical device (screws), not a study analyzing data (like images or patient records). Therefore, the concept of a "test set" in the context of data provenance (country of origin, retrospective/prospective) and sample size for data analysis does not directly apply.
- The "sample size" would refer to the number of physical screws tested in the mechanical evaluations. This information is not provided in the document.
- "Data provenance" is not applicable as this concerns mechanical properties of the device itself, not clinical or image data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This is not applicable. The "ground truth" for mechanical testing of screws is defined by the physical properties of the materials and the engineering standards for such devices. It does not involve expert interpretation in the way clinical or imaging studies do.
4. Adjudication Method for the Test Set
This is not applicable. Mechanical testing results are objective measurements based on engineering principles and test protocols, not subjective interpretations requiring adjudication.
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 is not applicable. This submission is for a physical medical device (fixation screws), not an AI or software-based medical device. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This is not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for the mechanical testing of the ForeFoot STP System would be based on engineering standards and established material properties for bone fixation devices. The performance is compared against the known performance of the predicate devices, which also comply with these engineering standards. The focus is on demonstrating equivalent mechanical strength and characteristics.
8. The Sample Size for the Training Set
This is not applicable. This refers to a physical medical device, not an AI or software-based system that uses a "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable. This refers to a physical medical device, not an AI or software-based system.
§ 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.