(102 days)
The Omni Foot Plating System is intended for use in internal fixation, reconstruction, or arthrodesis of the 1st Metatarsalphalangeal joint.
The Omni Foot Plating System is a bone fixation system consisting of unalloyed Titanium plates and Titanium Alloy (Ti-6AL-4V) locking and non-locking plate screws, which meet ASTM F67 and ASTM F136, and a set of instruments used for implant site preparation and delivery. The plates are available in various configurations, essentially differing by the lengths and number of holes. The plate screws are provided in diameters of 2.8mm and 3.5mm in lengths from 8mm to 50mm. The System offers 3.5mm cannulated screws in various lengths to be used as adjunctive fixation. The 3.5mm cannulated screw can also be used with a specialized locking screw ("Peg") which contains a locking feature at the distal end for compression/stabilization.
The provided document is a 510(k) premarket notification for the Omni Foot Plating System, which is a metallic bone fixation device. This type of device is classified as a Class II medical device. For such devices, clinical performance studies using patient data (like those involving AI-powered diagnostic tools) are typically not required, as substantial equivalence is often demonstrated through technological comparison, engineering analysis, and non-clinical bench testing.
Therefore, the requested information regarding acceptance criteria and studies proving the device meets those criteria, particularly aspects like sample size for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth for training data, is not applicable to this type of device submission.
The document explicitly states under "Clinical Testing": "No clinical testing was performed."
Instead, the acceptance criteria and proof of meeting them for the Omni Foot Plating System are based on:
- Technological Comparison: Demonstrating that the design, materials, and principle of operation are substantially equivalent to legally marketed predicate devices.
- Engineering Analysis: Detailed analysis of the device's design and function.
- Mechanical/Bench Testing: Physical tests conducted in a laboratory setting to verify performance specifications.
Here's a breakdown of the relevant information provided for the Omni Foot Plating System in relation to its acceptance criteria:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Demonstrated Equivalence through) | Reported Device Performance (Summary from 510(k)) |
|---|---|
| Design and Materials Similarity to Predicates | Omni Foot System, Bone Plates: Similar to predicate devices (K161864, K140397, K121349) regarding design and materials. Features a polyaxial locking feature identical to K161864. |
| Screw Design Similarity to Predicates | Omni Foot System, Bone Screws: Identical in design to Arix Foot System Screw (K161864). |
| Locking Peg Functionality Equivalence | Omni Foot System, Locking Peg: Acts like a locking screw and bone washer/nut for compression, similar to the crossing screw construct of IO FiX (K121349). Its 4.2mm diameter is equivalent to Paragon 28 ParaLock Plating System (K140397). |
| Mechanical Performance (Bench Testing) | Bench tests (pullout, torque, static bend testing) were conducted on the proposed 3.5mm screw and Peg device. The results indicate that the Omni Foot Plating System is equivalent to the predicate device in terms of these mechanical properties. |
| Material Compliance | Components meet ASTM F67 (unalloyed Titanium plates) and ASTM F136 (Titanium Alloy Ti-6AL-4V screws). |
| Intended Use Equivalence | The intended use for internal fixation, reconstruction, or arthrodesis of the 1st Metatarsalphalangeal joint is aligned with the presumed uses of the predicate devices for similar orthopedic applications. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. No human subjects test set or clinical data was used for this submission. The "test set" primarily refers to the physical samples of the device components used for bench testing. The document does not specify the exact number of samples tested for each bench test (e.g., how many screws were tested for pullout strength).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth, in the context of clinical studies with human data, is not relevant here. Device equivalence was established through engineering principles and mechanical testing, which would involve qualified engineers and technicians performing the tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods apply to the interpretation of clinical data by multiple experts. Not relevant for this type of device submission.
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:
- Not Applicable. The device is a physical implant, not an AI-powered diagnostic tool. MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. For this device, the "ground truth" for demonstrating safety and effectiveness is primarily established through adherence to engineering design specifications, material standards (ASTM), and the results of validated mechanical bench tests demonstrating properties (like pullout strength, torque, static bend) that are equivalent to or meet the requirements of predicate devices.
8. The sample size for the training set:
- Not Applicable. "Training set" refers to data used to train algorithms, which is not relevant for this physical device.
9. How the ground truth for the training set was established:
- Not Applicable. As per point 8, there is no training set in the context of this device submission.
In summary, the 510(k) submission for the Omni Foot Plating System relies on non-clinical data (engineering analysis and mechanical bench testing) to demonstrate substantial equivalence to predicate devices, rather than clinical studies with human data. Therefore, many of the questions related to clinical study design and data analysis are not applicable.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.