(23 days)
The NuGen™ FX Screw is generally intended for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses or condylar grafts within the condylar aspects of the upper extremity, ankle and foot, in the presence of appropriate brace and/or immobilization. Specifically, it is intended for phalangeal fusion and fracture, metacarpal fusion and fracture, carpal fusion and fracture, wrist arthrodesis, Distal radius fractures, olecranon fractures, radial head fractures, humeral condylar fractures, cancellous fractures and osteotomies of the malleolus, ankle fractures, metatarsal osteotomies and correction of hallux valgus.
The NuGen™ FX Screw is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except those in the hand and foot) and proximal femoral fractures, 2) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection and where patient co-operation cannot be guaranteed (e.g. alcoholism).
NuGen™ FX Screw is composed of poly-L,D-lactide copolymer. It is supplied partly threaded with 3.5mm in diameter, lengths 14-40mm and 4.5mm in diameter, lengths 24 - 70mm.
The provided text describes a 510(k) submission for a medical device called the NuGen™ FX Screw. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria through novel studies.
Therefore, many of the requested details about acceptance criteria, study performance, sample sizes, expert involvement, and ground truth establishment are not applicable or extractable from this type of FDA submission. The purpose of a 510(k) is to show that a new device is as safe and effective as a legally marketed predicate device, not necessarily to independently prove its effectiveness with new clinical trials.
Here's an assessment based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
Not applicable. This document does not present specific quantitative acceptance criteria or a study designed to measure the NuGen™ FX Screw's performance against such criteria. The "performance" being demonstrated is its substantial equivalence to predicate devices, implying similar safety and effectiveness.
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. There is no mention of a distinct "test set" in the context of device performance testing in this document. The substantial equivalence argument relies on comparing the new device's characteristics (design, materials, intended use, operating principle, packaging, sterilization, shelf life) to those of predicate devices, which would have undergone their own testing previously.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. No ground truth establishment for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No test set adjudication is described.
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. This is a medical implant device, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI-related effectiveness 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 implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. The document discusses substantial equivalence based on the device's characteristics and intended use being similar to existing predicate devices.
8. The sample size for the training set:
Not applicable. No "training set" in the context of algorithm development or performance testing is mentioned.
9. How the ground truth for the training set was established:
Not applicable. No "training set" or ground truth establishment for it is mentioned.
Summary of Device Acceptance and "Study" (Demonstration of Substantial Equivalence):
The "acceptance criteria" for the NuGen™ FX Screw, as presented in this 510(k) submission, are effectively the conditions for demonstrating substantial equivalence to predicate devices. The "study" that proves the device meets these criteria is the comparison and argument presented in the submission itself.
Acceptance Criteria for Substantial Equivalence (implied from the document):
- Same indicated use: The NuGen™ FX Screw must have the same intended use as the predicate device(s).
- Same operating principle: The fundamental way the device achieves its intended action must be the same.
- Same basic design of thread: The screw thread design should be consistent.
- Same basic dimensions: The general size ranges should be comparable.
- Packaged and sterilized using the same materials and processes: Consistency in these aspects ensures similar safety profiles.
- Same shelf life: The stability and integrity over time should be equivalent.
- No new issues of safety or effectiveness: Any differences from the predicate devices must not raise new questions about the device's safety or how well it works.
- Similar materials: The raw materials used should be the same as or previously accepted for similar devices.
Reported Device Performance (as demonstrated for substantial equivalence):
The document asserts that the NuGen™ FX Screw meets these implicit criteria by stating:
- "NuGen™ FX Screw has the following similarities to the cleared SmartScrew (K003077):
- has the same indicated use
- uses the same operating principle
- incorporates the same basic design of thread
- utilizes the same basic dimensions
- is packaged and sterilized using the same materials and processes
- has the same shelf life"
- "This raw material and design of head of screw are already introduced with fully threaded screw model (K012001)."
- "In summary, the NuGen™ FX Screw described in this notification is, in our opinion, substantially equivalent to the predicate devices. Furthermore, the minor technological differences between the NuGen™ FX Screw and the predicate devices do not raise any new issues of safety or effectiveness."
The FDA's decision letter (K023022) confirms their agreement with this assessment: "We have reviewed your Section 510(k) premarket notification... and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."
§ 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.