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The intended use/indications for use of the predicate devices identified remain the same as previously cleared in their respective 510(k)s. The respective 510(k)s for the devices can be referenced in the predicate device section above.

The purpose of this submission is the addition of MR Conditional information to the labeling for the predicate devices. The addition of MR labeling to the subject devices does not impact indications, materials, design features or dimensions, packaging or sterilization.

This is a 510(k) summary for a submission that adds MR Conditional information to the labeling of several existing medical devices. The submission does not introduce new devices or changes to the fundamental design, materials, or indications for use of the listed devices. Therefore, the "acceptance criteria" and "device performance" in this context relate to the MR compatibility of the devices according to established standards.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated in the provided text. For MR compatibility testing, the "sample size" typically refers to the number of device models/configurations tested. It's implied that "the devices" (referring to the listed product lines and their components) were tested.
• Data Provenance: The nature of this testing (MR compatibility) suggests it was conducted in a controlled environment as a prospective evaluation of the devices. The country of origin of the data is not specified but would likely have been where the testing laboratory is located, presumably in a country with recognized testing standards (e.g., USA or Europe).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This type of submission (MR compatibility of implants) does not typically involve human expert "ground truth" derived from clinical images. The "ground truth" here is objective measurements against engineering standards for MR safety and compatibility. The "experts" would be the engineers and physicists conducting the tests and interpreting the results according to ASTM standards and FDA guidance. Their qualifications would be expertise in MR safety testing and relevant engineering fields.

4. Adjudication Method for the Test Set

• Not applicable. This is not a study requiring adjudication of human-interpreted data. The results are based on objective physical measurements and adherence to specified test protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This submission is for device labeling updates based on physical properties (MR compatibility), not for evaluating the clinical effectiveness of a diagnostic or therapeutic algorithm with human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No, a standalone algorithm performance study was not done. This submission is about the physical properties of medical implants in an MRI environment, not about an AI algorithm.

7. The Type of Ground Truth Used

• The "ground truth" used is defined by internationally recognized engineering standards for MR compatibility: ASTM F2052 (displacement force), ASTM F2213 (torque), ASTM F2182 (RF-induced heating), and ASTM F2119 (image artifact). The FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" also serves as a framework for the "ground truth" criteria.

8. The Sample Size for the Training Set

• Not applicable. This submission is about MR compatibility testing of existing devices, not about developing or training an AI algorithm. Therefore, there is no "training set."

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

• Not applicable, as there is no training set.

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The QWIX Positioning Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:

• Mono or Bi-cortical osteotomies in the foot or hand (including Hallux Valgus treatment)
• Fractures management in the foot or hand -
• Fixation of bone fragments in long bones or small bones fractures -
• Arthrodesis in hand, foot or ankle surgery -

The size of the chosen screw should be adapted to the specific indication.

The QWIX® Positioning Screw is a cannulated fully threaded screw. It also has a self-tapping screw tip. It is provided in diameters 5.5 mm and 7.5 mm and in length from 30 mm to 80 mm for the 5.5 mm and from 40 mm to 120 mm for the 7.5 m. The QWIX® Positioning Screw is made from Titanium alloy (Ti-6Al-4V ELI).

The provided text describes a 510(k) premarket notification for the QWIX® Positioning Screw. This document focuses on demonstrating substantial equivalence to an existing predicate device rather than establishing new performance criteria through efficacy studies with acceptance criteria.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert involvement, and ground truth establishment cannot be fully provided from the given text.

Here's an analysis of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criterion	Reported Device Performance
   Mechanical Properties	"Mechanical tests have been carried out. Results have shown that the mechanical properties of the QWIX® Positioning Screw staples have similar to properties of predicate devices, such as Newdeal ICOS screws (K011821) and Synthes 7.3 screw (K962011)."
   Substantial Equivalence	"The new QWIX® Positioning Screws are substantially equivalent to the commercially marketed device, Stabilization Screw, K050346."

   Note: The document states "similar to properties" and "substantially equivalent" rather than specific quantitative acceptance criteria or numerical performance metrics. The 510(k) process is about demonstrating equivalence, not necessarily meeting a predefined performance target in the same way a de novo or PMA would require.

2. Sample size used for the test set and the data provenance:

   • No specific sample size for a "test set" (in the context of clinical or algorithmic performance evaluation) is mentioned.
   • The study referenced is "Mechanical tests," which typically involves material and component testing, not human or patient data. Therefore, data provenance relevant to clinical outcomes is not applicable here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. Ground truth in a clinical or diagnostic sense is not established for this type of submission. The comparison is mechanical properties against existing devices.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. There is no "test set" requiring expert adjudication in this context.

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 device is a bone fixation screw, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" or reference for the mechanical tests would be the established mechanical properties of the predicate devices (Newdeal ICOS screws (K011821) and Synthes 7.3 screw (K962011)) and relevant material standards. This is not "expert consensus, pathology, or outcomes data" in a clinical sense.

8. The sample size for the training set:

   • Not applicable. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established:

   • Not applicable.

Summary of what the document does provide:

• Device: QWIX® Positioning Screw, a cannulated fully threaded screw for bone fixation.
• Indicated Use: Fixation of bone fractures or bone reconstruction in the foot or hand, including osteotomies, Hallux Valgus treatment, fracture management, fixation of bone fragments, and arthrodesis.
• Basis for Approval: Substantial equivalence to predicate device Stabilization Screw, K050346.
• Supporting Evidence for Equivalence: Mechanical tests showing "similar" mechanical properties to other predicate devices (Newdeal ICOS screws K011821 and Synthes 7.3 screw K962011). The submission also asserts same intended use, materials, basic design, instructions for use, and manufacturing process as previously cleared devices.

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