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The Nextra™ Ti Hammertoe Correction System is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.

The Nextremity Solutions Nextra™ Ti Hammertoe Correction (Nextra) System consists of proximal and distal components provided as a set with the necessary surgical site preparation and insertion instruments in a procedure pack. Nextra is fabricated from medical grade titanium alloy (6Al-4V) and the design allows the clinician to establish a natural angulation of the fused interdigital joint.

The provided text describes mechanical testing for the Nextra™ Ti Hammertoe Correction System. However, it does not include the specific acceptance criteria or detailed results of that testing. It simply states that "Mechanical testing was performed as described in relevant recognized standards, including testing for pull-out force, driving torque, torque to failure, static and dynamic flexion extension resistance."

Therefore, based on the provided input, I cannot answer most of your questions as the necessary information is not present.

Here's what I can provide based on the given text:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). This was mechanical testing, so "provenance" might refer to the lab conducting the tests.

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. This was mechanical testing, not a study requiring expert-established ground truth.

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

• Not applicable. This was mechanical testing.

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 was mechanical testing of a bone fixation device, not an AI-assisted diagnostic tool or an MRMC study.

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

• Not applicable. This was mechanical testing of a bone fixation device, not an algorithm.

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

• Not applicable in the conventional sense for mechanical testing. The "ground truth" would be the engineering specifications and recognized testing standards (e.g., ISO, ASTM) against which the device's mechanical properties are measured.

8. The sample size for the training set

• Not applicable. This was mechanical testing, not a machine learning study with a training set.

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

• Not applicable. This was mechanical testing, not a machine learning study.

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The Nextremity Solutions FlexFusion™ Fixation Implant is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.

The Nextremity Solutions 3.4mm FlexFusion™ Fixation implant system consists of a two-part 3.4mm diameter bone fixation implant. The proximal and distal components are provided as a set and as a procedure pack with the necessary surgical site preparation and insertion instruments. The Nextremity Solutions FlexFusion™ Fixation Implant is fabricated from medical grade stainless steel and the design allows the clinician to establish a natural angulation of the fused inter-digital joint.

The sponsor, Nextremity Solutions, LLC, did not provide acceptance criteria and a study to prove that the device meets the acceptance criteria. The 510(k) K110445 outlines that the device is substantially equivalent to the predicate device Arthrex Bio-Pin (Marketed as Arthrex Trim-It™ Spin Pin) [510(k) K050259]; Smooth or threaded bone fixation fasteners, StayFuse™ Fixation implant [510(k) Number K990804]; FlexFusion™ Fixation implant and NEWDEAL K Wire [501(k) K022599]; Memometal Intramedullary Arthrodesis Device [510(k) K070598]. This is based on the following:

• Intended Use: The device shares the same intended use.
• Basic Design: The device has a similar basic design.
• Material: The device is fabricated from medical grade stainless steel, similar to predicate devices.
• Size: The device is of comparable size (3.4mm diameter).
• Fundamental Technology: The device utilizes similar fundamental technology for bone fixation.

Performance Data:

Mechanical testing was performed for the Nextremity Solutions FlexFusion™ Fixation implant. This testing included:

• Pull-out force: To assess the force required to remove the implant from bone.
• Driving torque: To evaluate the torque needed to insert the implant.
• Torque to failure: To determine the maximum torque the implant can withstand before failure.
• Static and dynamic flexion extension resistance: To assess the implant's resistance to bending and movement under different conditions.

In addition to mechanical testing, results from cadaver test labs were also presented to support the performance of the device.

No information was provided regarding:

1. A table of acceptance criteria and the reported device performance.
2. Sample sizes used for any test set or data provenance.
3. The number of experts used to establish ground truth or their qualifications.
4. Adjudication methods.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
6. Standalone performance studies (i.e., algorithm only without human-in-the-loop performance).
7. The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
8. The sample size for any training set.
9. How ground truth for any training set was established.

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