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The Cannulated 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 Cannulated 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). 3) Highly comminuted fractures, which would not be appropriate for fixation with metallic screws. 4) Patients with suspected or known allergy to the implant material.

The device description of the Cannulated NuGen™ FX Screw biodegradable bone fixation screw is as follows.

• Composed of poly-L/D-lactide copolymer
• Lengths 14 70mm
• Diameters 3.5mm with cannulation for 1.2mm K-wire and 4.5 mm with cannulation for 1.6mm K-wire.
• Fully and partly threaded models

The only modifications that were made are:

• Amendment of screw models with cannulation
• Amendment of suitable instruments into instrumentation accordingly.

This submission is a 510(k) premarket notification for a medical device called the Cannulated NuGen™ FX Screw. As such, it focuses on demonstrating substantial equivalence to previously cleared devices rather than robust clinical studies with acceptance criteria and detailed performance reporting as would be seen in a PMA (Premarket Approval) application.

Therefore, many of the requested categories of information for a study and acceptance criteria are not applicable or available within this 510(k) submission. 510(k)s typically rely on design principles, material equivalence, and potentially limited bench testing rather than extensive clinical trials.

Here's the breakdown of what can be extracted and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not Applicable/Available: This document does not present formal acceptance criteria or detailed device performance metrics from a study in the way a clinical trial would. The basis of this 510(k) is substantial equivalence to predicate devices rather than meeting specific performance thresholds in a de novo study. The "performance" demonstrated here is the similarity to the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance:

• Not Applicable/Available: No test set in the sense of a clinical trial or large-scale performance evaluation is described. The submission focuses on product modifications and demonstrating equivalence to existing cleared devices. Data provenance is not relevant as no specific patient data is analyzed or referenced for a test set.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Applicable/Available: Ground truth is not established in this context. The submission relies on regulatory judgment of substantial equivalence based on device design, materials, and intended use, not expert consensus on diagnostic or prognostic outcomes.

4. Adjudication Method for the Test Set:

• Not Applicable/Available: No test set means no adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Not Applicable/Available: This type of study is for evaluating human performance, often in diagnostic imaging, with and without AI assistance. This device is an orthopedic implant, so an MRMC study is entirely irrelevant.

6. Standalone (Algorithm Only) Performance:

• Not Applicable/Available: This device is a physical implant, not an algorithm, so standalone performance is not applicable.

7. Type of Ground Truth Used:

• Not Applicable/Available: As mentioned, no ground truth is established as part of this submission. The "truth" in a 510(k) is whether the new device is substantially equivalent to existing, legally marketed predicate devices.

8. Sample Size for the Training Set:

• Not Applicable/Available: This device is not an AI/ML algorithm or a diagnostic tool that relies on a training set.

9. How the Ground Truth for the Training Set Was Established:

• Not Applicable/Available: As above, no training set.

Summary of Relevant Information from the K033447 Submission:

This 510(k) submission (K033447) by Linvatec Biomaterials Ltd. for the Cannulated NuGen™ FX Screw seeks to demonstrate substantial equivalence to several predicate devices, primarily existing NuGen™ FX Screw models (K012001, K023022) and other Bionx Implants Inc. Biofix® and SmartScrew™ products.

The core argument for equivalence is based on the following similarities to the cleared predicate NuGen FX Screw models:

• Same indicated use
• Same operating principle
• Same basic design of thread
• Same basic dimensions
• Manufactured by machining
• Packaged and sterilized using the same materials and processes
• Same shelf life

The only modifications introduced in this new device are:

• Amendment of screw models with cannulation
• Amendment of suitable instruments into instrumentation accordingly

The FDA's review letter (pages 2-3 of the provided text) confirms that they found the device substantially equivalent for the stated indications for use. This means FDA determined that the device is as safe and effective as a legally marketed device that does not require premarket approval (PMA).

In essence, the "acceptance criteria" here implicitly revolve around demonstrating that the new device, despite minor modifications (cannulation), does not raise new questions of safety or effectiveness when compared to its existing, predicate counterparts. The "study" is the submission's argument and evidence of this substantial equivalence based on design, materials (poly-L/D-lactide copolymer), and manufacturing processes.

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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..."

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