(148 days)
This device is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedures.
The LeForte Neuro System Bone Plate & Screw is made of pure Titanium (ASTM F67) and Titanium Alloy (ASTM F136). It is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedures.
The provided document is a 510(k) summary for a medical device (LeForte Neuro System Bone Plate & Screw) seeking substantial equivalence to existing predicate devices. It does not describe a study to prove acceptance criteria in the way one would for a novel device demonstrating safety and effectiveness.
Instead, the submission focuses on demonstrating that the new device has the same characteristics, material, design, and intended use as already cleared predicate devices. Therefore, many of the requested categories (like sample size, ground truth, expert opinions, MRMC studies, standalone performance) are not applicable or not detailed in this type of submission.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not present a table of quantitative acceptance criteria for device performance in terms of clinical outcomes or specific measurements. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices. The "reported device performance" is essentially that its characteristics (material, dimensions, shape, sterilization, use, packaging) are either identical or acceptably similar to the predicate devices.
| Parameter | Acceptance Criteria (Implied - Substantial Equivalence to Predicates) | Reported Device Performance (LeForte Neuro System Bone Plate & Screw) |
|---|---|---|
| K# | Substantially equivalent to K091679, K103778, K091686 | Modified (new K# K112812) |
| Indications for Use | Must be identical to or a subset of predicate indications. | "This device is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedures." (Identical to predicate) |
| Shape | Must be acceptably similar, with potential additions. | The same models as predicate, "with the addition of Triangular shapes". |
| Dimensional | Acceptably similar to predicate dimensions. | Plate thickness 0.3 |
| Material | Identical to predicate materials. | Plate - Titanium ASTM F67 Grade1, 2, 3; Screw - Titanium Alloy ASTM F136 (Identical to predicate) |
| Surface | Identical to predicate. | Plate: Anodizing; Screw: N/A (Predicate not specified in table, but assumed to be equivalent) |
| Sterilization | Identical to predicate. | Non sterile (Predicate not specified in table, but assumed to be equivalent) |
| Single Use | Identical to predicate. | Yes (Predicate not specified in table, but assumed to be equivalent) |
| Packaging | Identical to predicate. | Vial, PA+PE film sealing (Predicate not specified in table, but assumed to be equivalent) |
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable. This submission is for substantial equivalence to existing devices, not a de novo clearance requiring clinical studies with test sets in the typical sense. There is no specific clinical "test set" described. The focus is on comparing the device's physical and functional characteristics to legally marketed predicates.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Not Applicable. As there's no clinical test set in this context, there's no need for experts to establish ground truth on patient data. The "ground truth" here is the established safety and effectiveness of the predicate devices.
4. Adjudication Method for the Test Set:
- Not Applicable. No clinical test set.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done:
- No. MRMC studies are used for diagnostic devices to assess reader performance. This device is a surgical implant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done:
- Not Applicable. This device is a physical surgical implant, not an algorithm or AI.
7. The Type of Ground Truth Used:
- The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices (Jeil Medical Corporation LeForte Neuro System Bone Plate / K091679, K103778, and LeForte Neuro System Bone Screw / K091686) as determined by their prior FDA clearances. The applicant's goal is to demonstrate that their new device is fundamentally the same and therefore equally safe and effective.
8. The Sample Size for the Training Set:
- Not Applicable. There is no "training set" in the context of this 510(k) submission for a physical medical device.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As there's no training set, there's no associated ground truth establishment process.
§ 882.5320 Preformed alterable cranioplasty plate.
(a)
Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).