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The Phantom® Hindfoot TTC/TC Nail System is indicated for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Examples of specific indications include:

• Post-traumatic or degenerative arthritis
• Previously infected arthrosis
• Revision of failed ankle arthrodesis
• Revision of failed total ankle arthroplasty
• Talar deficiency conditions such as avascular necrosis of the talus (requiring tibiocalcaneal arthrodesis)
• Neuromuscular deformity or other neuromuscular disease with severe deformity or instability of the ankle
• Rheumatoid arthritis
• Osteoarthritis
• Nonunions or pseudarthrosis of hindfoot and distal tibia
• Trauma (severe or malunited tibial pilon fracture)
• Charcot foot (neuroarthropathy)
• Severe end-stage degenerative arthritis
• Instability and skeletal defects after tumor resection
• Pantalar arthrodesis
• Severe foot/ankle deformity

Phantom® Hindfoot TTC/TC Nail System is comprised of intramedullary nails, screws and accessory components. The subject Phantom® Hindfoot TTC Trauma Nails are offered in a variety of sizes and lengths to accommodate variations in patient anatomy. The Phantom® TTC/TC screws insert through the intramedullary nail to secure the construct. These are offered in varying lengths to accommodate the anatomical fixation required.

I am sorry, but the provided text is a 510(k) clearance letter for a medical device (Phantom® Hindfoot TTC/TC Nail System) and does not contain the specific information you are requesting about acceptance criteria, study details, expert qualifications, or ground truth establishment for a diagnostic or AI-based device.

This document is a regulatory approval notice that states the device is substantially equivalent to a previously cleared predicate device. It confirms the device's indications for use, its classification, and mentions that "engineering analysis is presented to provide evidence that the original testing and subsequent performance is not adversely affected by the modifications to the subject devices." However, it does not elaborate on:

1. A specific table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number or qualifications of experts used for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness study results or effect sizes.
6. Stand-alone algorithm performance (as this is not an AI/diagnostic device).
7. Type of ground truth used.
8. Training set sample size.
9. How ground truth for the training set was established.

The document discusses "performance testing" and "engineering analysis" to demonstrate substantial equivalence, but it does not detail these tests in the way you've outlined for a diagnostic or AI study. The "device" in question is a surgical implant system, not a diagnostic tool or an AI algorithm that would typically have the kind of performance metrics you are seeking.

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The Phantom® Hindfoot TTC/TC Nail system is intended for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Examples of specific indications include:

• · Post-traumatic or degenerative arthritis
• · Previously infected arthrosis
• Revision of failed ankle arthrodesis
• · Revision of failed total ankle arthroplasty
• · Talar deficiency conditions such as avascular necrosis of the talus (requiring tibiocalcaneal arthrodesis)
• · Neuromuscular deformity or other neuromuscular disease with severe deformity or instability of the ankle
• Rheumatoid arthritis
• · Osteoarthritis
• Nonunions or pseudarthrosis of hindfoot and distal tibia
• · Trauma (severe or malunited tibial pilon fracture)
• · Charcot foot (neuroarthropathy)
• · Severe end-stage degenerative arthritis
• Instability and skeletal defects after tumor resection
• · Pantalar arthrodesis
• · Severe foot/ankle deformity

The Paragon 28® Phantom® Hindfoot TTC/TC Nail System is comprised of intramedullary nails, screws and accessory components. The Phantom® nails are offered in a variety of sizes, lengths, and configurations to accommodate variations in patient anatomy. The Phantom® screws insert through the intramedullary nail to secure the construct. These are offered in varying lengths to accommodate the anatomical fixation required.

The provided text is a 510(k) summary for the Phantom® Hindfoot TTC/TC Nail System. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific performance criteria through a study with acceptance criteria.

Therefore, the input text does not contain the information requested in the prompt regarding acceptance criteria and a study that proves the device meets them. This type of submission (510(k)) typically relies on comparisons to existing devices, and often does not require new clinical or extensive non-clinical studies to establish new performance metrics.

Specifically, the document states:

• "Non-clinical testing was not necessary to support equivalence. Engineering analyses were provided to support equivalence."
• "Clinical testing was not necessary to support equivalence."

This clearly indicates that no studies were performed to establish and meet acceptance criteria for device performance. The submission relies on the device having the "same intended use and technological characteristics as the predicate devices" to claim substantial equivalence.

Ask a specific question about this device