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StayFuse GT-IP is indicated as a fusion or fracture fixation device for the IP joint of the great toe.

StayFuse GT-IP has identical design features as the original StayFuse™, as such, GT-IP is a scalar version indicated for the IP joint of the great toe.

This submission describes a medical device, the StayFuse GT-IP, which is a scalar version of an existing device (StayFuse K990804) designed for the IP joint of the great toe. The 510(k) summary highlights that the new device has identical design features to the original, differing only in physical size. Therefore, the provided documents do not contain information related to a clinical study or performance data of the GT-IP requiring acceptance criteria.

The core of this 510(k) submission is a claim of substantial equivalence to a previously cleared device (StayFuse K990804). Substantial equivalence means that the new device has the same intended use as the predicate device, and the same technological characteristics, or, if it has different technological characteristics, that the different characteristics do not raise different questions of safety and effectiveness.

Because the StayFuse GT-IP is described as having "identical design features as the original StayFuse™," and the only difference is "physical size" for use in a specific joint, a clinical study demonstrating performance against acceptance criteria for the new device is typically not required. The FDA's substantial equivalence determination for this device is based on the comparison to the predicate device, not on new clinical performance data for the GT-IP itself.

Therefore, the following information cannot be extracted from the provided text as it pertains to a performance study that was not conducted for this specific 510(k) submission:

• A table of acceptance criteria and the reported device performance
• Sample sizes used for the test set and data provenance
• Number of experts used to establish ground truth
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study and effect size
• Standalone (algorithm only) performance study
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

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The StayFuse is a screw device designed for small bone fusion and fractures. It is indicated for fractures, and inter-digital fusion of the fingers, toes and small bones.

The StayFuse is a device consisting of two components. The male half possesses a protruding connection feature and the female half an internal connection feature. The bone-mating portion has a cancellous type thread with a self-drilling and tapping tip. Distal to the screw tip is an external hex that is engaged with a hex driver. The hex driver is dual purpose: one end shaped for pre-drilling the bone and the other end features an internal hex for inserting the implant. The hex driver is designed to interface with a chuck of a standard cannulated drill. The implant will be offered in a number of diameters, lengths and hex drives to accommodate the variability in bone sizes.

The provided text is a 510(k) summary for a medical device called StayFuse and a letter from the FDA regarding its clearance. It does not contain information about specific acceptance criteria or a study with detailed performance data, sample sizes, expert qualifications, or ground truth establishment.

Instead, the document states: "The Pioneer StayFuse Implant was predicated on the use of K-Wires." This indicates that the device was deemed substantially equivalent to existing K-Wires based on its intended use and design, rather than being cleared through a study specifically demonstrating performance against detailed acceptance criteria in a clinical setting.

Therefore, most of the requested information cannot be extracted from this document as it describes a different type of regulatory submission.

However, I can provide what is available:

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

• Acceptance Criteria: Not explicitly stated in the provided text. The clearance is based on substantial equivalence to predicate devices (K-Wires).
• Reported Device Performance: Not explicitly reported in terms of quantitative metrics against acceptance criteria. The device is described as an "Intramedullary Bone Screw" for "small bone fusion and fractures," indicating its functional purpose.

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

• Not applicable/Not provided. The 510(k) summary does not describe a performance study with a test set.

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/Not provided.

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

• Not applicable/Not provided.

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 surgical implant, not an AI-assisted diagnostic tool, and no MRMC study is mentioned.

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 concensus, pathology, outcomes data, etc)

• Not applicable/Not provided.

8. The sample size for the training set

• Not applicable/Not provided.

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

• Not applicable/Not provided.

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