(157 days)
This device is intended for use in selective trauma of the mid-face and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
The LeForte Neuro system bone screw is made of Titanium alloy (ASTM F136) and consists of common bone screw, self-drilling screw (auto screw & NS auto screw). The common bone screws are classified to 4 classes: Micro screw, Mini screw, Mini screw, Maxi screw. And the auto screws (self-drilling screws) are divided to 3 classes; Micro auto, Mini auto screws. Additionally, the NS auto screws are divided to 2 classes. This device is manufactured and intended for use in selective trauma of the mid-face and craniofacial skeleton; craniofacial surgery; reconstructive procedures; selective orthognathic surgery of the maxilla and chin.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the LeForte Neuro System Bone Screw.
Based on the provided 510(k) summary, this document is a premarket notification for a new medical device, the LeForte Neuro System Bone Screw. For 510(k) submissions, the primary method for demonstrating safety and effectiveness is to show substantial equivalence to a predicate device already legally marketed. This typically does not involve conducting a new clinical study with acceptance criteria in the same way one might for a PMA (Pre-Market Approval) submission. Instead, the focus is on comparing the new device to existing ones based on design, materials, intended use, and performance characteristics.
Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical trial with specific performance endpoints is not directly applicable here. The "study" done is a comparative analysis demonstrating substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for substantial equivalence, the "acceptance criteria" are not quantitative performance metrics in a clinical study but rather a demonstration that the new device is as safe and effective as the predicate devices. The performance is demonstrated by comparing its characteristics to those of the predicate devices.
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (LeForte Neuro System Bone Screw) |
|---|---|
| Intended Use (Same as predicate) | Intended for use in selective trauma of the mid-face and craniofacial skeleton; craniofacial surgery; reconstructive procedures; selective orthognathic surgery of the maxilla and chin. |
| Technological Characteristics (Similar to predicate) | Made of Titanium alloy (ASTM F136). Consists of common bone screws (Micro, Mini, Mini, Maxi) and self-drilling screws (Micro auto, Mini auto). Similar dimensions and characteristics to predicate. |
| Material (Same as predicate) | Titanium Alloy (ASTM F136) |
| Safety and Effectiveness (As safe and effective as predicate) | Potential adverse effects are identical to those of the predicate device. Manufactured using state-of-the-art technology, complying with MDD(93/42/EEC) and ISO 14630:1997. |
| Classification (Same as predicate) | Class II (21 CFR 872.4880) - Screw, Fixation, Intraosseous |
| Single Use (Same as predicate) | Single Use |
2. Sample Size Used for the Test Set and Data Provenance
For a 510(k) submission based on substantial equivalence, there isn't a "test set" of clinical data in the traditional sense with a specific sample size. The evidence is primarily based on:
- Engineering and Material Testing: While not explicitly detailed in the provided summary, such submissions typically include mechanical testing (e.g., tensile strength, fatigue testing, torque strength) of the device to ensure it meets relevant ASTM/ISO standards and performs comparably to or better than predicate devices. The "sample size" for these tests would refer to the number of devices tested, which isn't provided here.
- Comparison to Predicate Devices: The "data" provenance is the information available about the predicate devices (Synthes (USA) 1.3mm Craniofacial Screws - K021850 and Synthes (USA) Neuro Plate & Screw System - K042365), which are already FDA-cleared and on the market. This is retrospective information from existing devices. The country of origin for the predicate devices (Synthes (USA)) indicates the US; the new device is from Jeil Medical Corporation in South Korea.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This is not applicable to a 510(k) substantial equivalence submission. Ground truth (e.g., clinical outcomes, imaging interpretations) from experts is typically part of a clinical trial for novel devices where substantial equivalence cannot be established through non-clinical means.
4. Adjudication Method for the Test Set
Not applicable to a 510(k) substantial equivalence submission, as there is no clinical test set requiring adjudication in this context.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. These types of studies involve human readers evaluating cases, often with and without AI assistance, to measure diagnostic performance. This is typically relevant for diagnostic imaging devices, not for an intraosseous fixation screw.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a mechanical bone screw, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" in a 510(k) substantial equivalence submission is the established safety and effectiveness profile of the predicate devices. The new device's design, materials, and intended use are compared against these known, legally marketed predicates. This is implicitly based on:
- Regulatory clearance: The predicate devices have already been found safe and effective by the FDA.
- Material standards: Adherence to standards like ASTM F136 for titanium alloy.
- Performance standards: Implicit mechanical performance expectations for bone screws.
8. The Sample Size for the Training Set
Not applicable. There is no concept of a "training set" for this type of medical device submission. This term is relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this 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.