(108 days)
The Stryker Fixos Screw System is a single use device intended for the fixation, correction or stabilization of small and long bones in adult and adolescent patients. Indications include:
Ø4.0mm Headless Screw:
- · Fractures of the tarsals and metatarsals
- · Fractures of the olecranon, distal humerus
- Fractures of the radius and ulna
- · Patella fractures
- · Distal tibia and pilon fractures
- Fractures of the fibula, medial malleolus, os calcis
- · Tarso-metatarsal and metatarsophalangeal arthrodesis
- · Metatarsal and phalangeal osteotomies
- · Osteochondritis dissecans
- · Fractures of the pelvic ring
- · Small cancellous fragments of the small and long bones
05.0mm Headless Screw:
- · Medial and lateral malleolar and pilon fractures
- · Proximal and distal humerus fractures
- · Fractures of the olecranon process
- · Tibial plateau fractures
- Os calcis, talar and patellar fractures
- Fractures of the pelvis and acetabulum
- · Arthrodesis of the tarsals
07.0mm Headless Screw:
- · Tibial plateau fractures
- · Ankle arthrodesis
- · Calcaneus osteotomies
The Fixos Screw System is an internal fixation device that consists of various types of screws to treat a number of different types of fractures in small and long bones. The subject components will be available sterile and non-sterile.
This submission is for the Fixos Screw System, a bone fixation device, and does not involve AI or algorithms that would require a study with acceptance criteria as typically defined for AI/ML devices. Therefore, a table of acceptance criteria and reported device performance related to AI/ML is not applicable. Similarly, most of the requested points are not relevant to this type of medical device submission.
Here's an analysis based on the provided text, highlighting why most points are not pertinent:
1. Table of Acceptance Criteria and Reported Device Performance (AI/ML specific): Not Applicable
This product is a traditional medical device (bone screws), not an AI/ML diagnostic or therapeutic device. Acceptance criteria for such devices typically relate to engineering specifications, material properties, and mechanical performance, not AI-driven metrics like sensitivity, specificity, or F1-score. The document states "Testing demonstrated that Fixos Screw System is substantially equivalent to the predicate device currently cleared for marketing." This implies that the performance met the expected standards for a bone screw, which would be based on mechanical tests, not AI-specific metrics.
2. Sample Size for the Test Set and Data Provenance (AI/ML specific): Not Applicable
No "test set" in the context of AI/ML models was used. The non-clinical testing involved mechanical tests on the device components themselves.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications (AI/ML specific): Not Applicable
Ground truth established by experts is a concept relevant to AI model training and evaluation, particularly for image analysis or diagnostic tasks. This device is a physical implant, not a diagnostic tool requiring expert ground truth for its performance assessment.
4. Adjudication Method (AI/ML specific): Not Applicable
Adjudication methods (e.g., 2+1, 3+1) are used to resolve discrepancies in expert labeling or diagnoses, which is a process specific to establishing ground truth for AI model development and validation. This is not relevant to the mechanical testing of a bone screw.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study (AI/ML specific): No
The document explicitly states "Clinical testing was not required for this submission." MRMC studies are typically used to evaluate the impact of AI on human reader performance in diagnostic tasks. Since this is a physical device and no clinical testing was performed, an MRMC study was not conducted.
6. Standalone (Algorithm Only) Performance (AI/ML specific): Not Applicable
This is a physical device, not an algorithm. Therefore, "standalone algorithm performance" is not relevant.
7. Type of Ground Truth Used (AI/ML specific): Not Applicable
Ground truth (expert consensus, pathology, outcomes data) is used to validate AI systems. For a bone screw, the "ground truth" for its performance would be its mechanical integrity and biocompatibility, assessed through laboratory testing and material science, not through these types of data.
8. Sample Size for the Training Set (AI/ML specific): Not Applicable
There is no "training set" for an AI model as this is a physical device.
9. How the Ground Truth for the Training Set Was Established (AI/ML specific): Not Applicable
Again, this product is a physical device, not an AI model, so there is no training set or ground truth in that context.
Summary Relevant to the Provided Document:
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Acceptance Criteria: For the Fixos Screw System, acceptance criteria were based on non-clinical laboratory testing demonstrating substantial equivalence to predicate devices in terms of mechanical performance. These tests included:
- Insertion Torque Testing
- Shear-off Testing
- Pull-out Testing
The success criteria for these tests would typically be that the new device's performance falls within a predefined range that is equivalent to or better than the predicate devices, ensuring its mechanical integrity and strength for its intended use. The document confirms that "Testing demonstrated that Fixos Screw System is substantially equivalent to the predicate device currently cleared for marketing."
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Study Proving Acceptance: The study involved non-clinical laboratory testing of the Fixos Screw System components. The study's conclusion was that the device is "substantially equivalent to the predicate device identified in this premarket notification." The specific details of the exact values or thresholds for "substantial equivalence" are not provided in this summary but would be part of the full 510(k) submission.
In essence, the Fixos Screw System is a traditional medical device, and its evaluation for market clearance followed the standard path for such devices by demonstrating substantial equivalence through non-clinical mechanical testing when compared to already cleared predicate devices. AI/ML-specific validation criteria and studies are not applicable here.
§ 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.