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The SIGN Fin nail is indicated for internal fixation of stable fractures in the femur and humerus.

The SIGN Fin Nail system includes intramedullary nails, Interlocking Screws and Instruments. All components are manufactured from stainless steel. The SIGN Fin Nail is available with diameters of 7mm, 8mm, 9mm, 11mm, 11mm, and 12mm in the following lengths: 160mm, 190mm, 240mm and 280mm. Each nail is made from a solid type 316, ASTM F138, solid stainless steel bar with distal and proximal bends. Each nail has a hole and a slot at the proximal end to accept solid 4.5mm diameter cortical bone screws for fixation and uses rigid distal fins for rotational stability. The SIGN Fin Nail may be removed upon fracture healing.

This looks like a 510(k) summary for a medical device called the "SIGN Fin Nail." This type of document is for regulatory clearance and focuses on substantial equivalence to already approved devices, rather than a clinical study proving performance against acceptance criteria in the way a novel technology might.

Therefore, the requested information elements related to a human subject study or detailed performance criteria are largely not applicable in this document. The document primarily focuses on establishing that the SIGN Fin Nail is similar in design, materials, and intended use to existing, legally marketed devices.

Here's the breakdown based on the provided text:

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

• Not Applicable. This document does not present a table of specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) and corresponding reported performance from a clinical study. The clearance is based on substantial equivalence, implying that since predicate devices are safe and effective, and the new device is substantially equivalent, it too is safe and effective.

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 "test set" in the context of a clinical performance study. The evaluation is based on design, material, and indications for use comparison to predicate devices.

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. Ground truth in the context of a clinical study is not established or discussed in this document.

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

• Not Applicable. No adjudication method is mentioned as there's no clinical test set being adjudicated.

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 an intramedullary nail, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance is irrelevant.

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

• Not Applicable. This is a medical implant, not an algorithm, so standalone performance is not relevant.

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

• Not Applicable. Ground truth for clinical performance is not established or discussed. The "ground truth" for regulatory clearance is that predicate devices are legally marketed and considered safe and effective.

8. The sample size for the training set

• Not Applicable. No training set is mentioned as this device is not an AI/ML algorithm requiring one.

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

• Not Applicable. No training set, no ground truth establishment for it.

Summary based on the provided document:

The regulatory clearance for the SIGN Fin Nail is based on its substantial equivalence to already legally marketed predicate devices. The document explicitly states:

• Predicate Devices: SIGN IM Nail System, Howmedica Alta IM Rod System, Biomet Brooker Femoral nail, Encore True/Flex Upper Extremity Nail.
• Basis for Safety and Effectiveness: "The safety and effectiveness of the SIGN Fin Nail is also based on a long history of use of this type of device in the market place."
• Device Description: The document provides a detailed description of the device materials (stainless steel, type 316, ASTM F138), dimensions (diameters, lengths), design features (hole, slot, rigid distal fins), and mechanism of action (internal fixation, rotational stability). These details are implicitly compared to the known characteristics of the predicate devices to establish equivalence.
• Indications for Use: "The SIGN Fin nail is indicated for internal fixation of stable fractures in the femur and humerus." This indication is also compared to the predicate devices.

In essence, the "study" demonstrating the device meets "acceptance criteria" for a 510(k) is a comparison to predicate devices to show substantial equivalence. The acceptance criteria are implicitly that the new device does not raise new questions of safety or effectiveness compared to the similar, already-approved devices, given its design, materials, and intended use.

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