(44 days)
The Newdeal Lisfranc Plates are intended for fractures, fusions, osteotomies and replantations of small bones at the tarsometarsal joints (Lisfranc joints).
The NEWDEAL® Lisfranc Plate consists of an osteosynthesis plate designed to bridge the tarsometatarsal joints (Lisfranc joints). It is available in different sizes, and is implanted using NEWDEAL® locking system fixation screws and washers. The NEWDEAL® locking system includes as many fixation screws as there are threaded lipped sockets on the plate and as many washers as implanted screws. The NEWDEAL® locking system creates a single implant/screw unit fixed into the bone. The osteosynthesis screws must be driven into the bone through the holes in the plate. The system is locked by means of washers drilled into the threaded lipped socket at the top of each hole, thus blocking each screw head.
This 510(k) summary describes a medical device, the Lisfranc Plate, and its mechanical testing for substantial equivalence to a predicate device. It is not a study of an AI/ML device, and therefore the requested information regarding AI/ML device performance, ground truth, and expert evaluation is not applicable.
Here's the relevant information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not explicitly state "acceptance criteria" in a quantitative manner as one might expect for an AI/ML device's diagnostic performance. Instead, the acceptance criterion for this medical device (Lisfranc Plate) is based on demonstrating substantial equivalence in mechanical properties to a predicate device.
| Acceptance Criterion Type | Acceptance Criterion Description | Reported Device Performance |
|---|---|---|
| Mechanical Properties | Mechanical properties of the modified Lisfranc Plates are similar to the predicate device (K060474). | "Results have shown that the mechanical properties of the modified LISFRANC PLATES are thus similar to the properties of the unmodified device, Lisfranc Plates, K060474." |
| Intended Use | Intended use remains unchanged from the predicate device. | "The modifications do not change the intended use or fundamental scientific technology of the device..." |
| Safety & Effectiveness | No new issues of safety or effectiveness are raised by the modifications. | "...and do not raise any new issues of safety or effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document states "Mechanical tests have been carried out," but does not provide details on the number of samples tested.
- Data Provenance: Not specified, but implied to be from laboratory mechanical testing of the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This is a mechanical device test, not a diagnostic or AI/ML evaluation requiring expert-established ground truth on patient data. The "ground truth" here is the physical performance of the device under specific mechanical testing conditions, compared to the predicate device.
4. Adjudication Method for the Test Set
- Not Applicable. This is a mechanical device test. The comparison is made against the known performance data of the predicate device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This is not an AI/ML or diagnostic device; it's a fixation plate. Therefore, an MRMC study is not relevant.
6. If a Standalone Performance Study Was Done
- Yes, implicitly. Mechanical tests were performed on the modified Lisfranc Plates in a "standalone" fashion (i.e., the device itself was tested). The performance was then compared to data from the predicate device, K060474.
7. The Type of Ground Truth Used
- Mechanical Test Data: The ground truth for comparison was the established mechanical performance characteristics of the predicate Lisfranc Plates (K060474) and the scientific principles of mechanical engineering.
8. The Sample Size for the Training Set
- Not Applicable. This is a mechanical device, not an AI/ML algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As above, no training set for an AI/ML algorithm was involved.
§ 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.