(280 days)
The Tigon Medical FIRE System is intended to provide the orthopedic surgeon with a means of bone-to-bone fixation and to assist in the management of reconstructive surgeries.
- Bone Loss Deficiencies/Deformities
- · Latariet
- Free bone block
- Internal bone fixation for bone fractures, fusions, non-unions, and osteotomies in the foot, ankle, hand, and wrist.
The Tigon Medical Fractures, Instability, and Reconstruction (FIRE) System includes reconstruction devices that are designed to provide a means of bone-to-bone fixation and to assist in the management of reconstructive surgeries. The system includes instruments that allow for the placement of the reconstruction device and screws. The reconstruction devices and screws are available in various sizes.
This is a 510(k) premarket notification for a medical device called the Tigon Medical Fractures, Instability, and Reconstruction (FIRE) System. This device is a metallic bone fixation fastener (screws and reconstruction devices) used for bone-to-bone fixation and reconstructive surgeries.
Here's the breakdown of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from FDA guidance documents) | Reported Device Performance (from mechanical testing) |
|---|---|
| Torsional strength | Met the acceptance criteria for the proposed indications, as demonstrated by mechanical test data. |
| Torque | Met the acceptance criteria for the proposed indications, as demonstrated by mechanical test data. |
| Pullout strength | Met the acceptance criteria for the proposed indications, as demonstrated by mechanical test data. |
2. Sample Size Used for the Test Set and Data Provenance
- The document does not specify the sample size used for the mechanical testing (test set).
- The document does not specify the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "mechanical testing was performed."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This information is not applicable to this type of submission. The "ground truth" for a mechanical fixation device is typically established through adherence to standardized mechanical testing methods and published performance criteria, not expert consensus on clinical cases.
4. Adjudication Method for the Test Set
- This information is not applicable as the evaluation is based on mechanical testing, not interpretation of clinical data by multiple experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is more relevant for diagnostic AI devices where human readers interpret medical images. The FIRE system is a physical implant, and performance is assessed through mechanical properties.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done
- This is not applicable as the FIRE system is a medical device (screws and reconstruction devices), not an algorithm or AI system. Its performance is inherent in its physical properties and design, not in a computational algorithm.
7. Type of Ground Truth Used
- The "ground truth" for validating the device's performance is based on established mechanical testing standards (ASTM F543 and ASTM F382) and FDA guidance documents ("Orthopedic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway" and "Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway"). These standards define acceptable physical properties for such devices.
8. Sample Size for the Training Set
- This information is not applicable. The FIRE system is a physical medical device, not a machine learning model, so there is no "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable as there is no training set for a physical medical device.
§ 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.