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The PANTA® Nail system is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. Examples include:

• Post-traumatic and degenerative arthritis involving both ankle and subtalar joints
• Rheumatoid arthritis
• Revision of failed ankle arthrodesis with subtalar involvement or with insufficient talar body
• Revision of failed total ankle arthroplasty with subtalar intrusion
• Talar deficiency conditions (requiring a tibiocalcaneal arthrodesis)
• Avascular necrosis of the talus
• Neuroarthropathy or neuropathic ankle deformity
• Severe deformity as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease
• Severe pilon fractures with trauma to the subtalar joint.

The modified Panta® Nail (dia. 10mm and XL) is ideally suited for tibiotalocalcaneal fusion indications. These Nails affords rigid, load sharing fixation that incorporates a simple nailmounted, in-line method of compression across the arthrodesis site.
The Panta® Nail (dia. 10mm and XL) affords even more torsional rigidity and better calcaneal purchase through its two transcalcaneal locking screws that are inserted from posterior to anterior, using a nail-mounted targeting device. Calcaneal screws eliminate significant rotation, preventing the calcaneus from "rocking" on the nail during weight-bearing. Some screws allow a sufficient stability for the fixation between calcaneus, talus and tibia.
The Panta® Nail (dia. 10mm and XL) is provided with sterile end caps which sit flush to the end of the nail and protect the internal threads from tissue ingrowth.

The provided text describes a 510(k) premarket notification for a medical device called the "Newdeal Panta® Nail (dia. 10mm) Newdeal Panta® Nail XL." This submission primarily focuses on establishing substantial equivalence to existing predicate devices based on mechanical testing, rather than clinical performance or AI algorithm effectiveness. Therefore, many of the requested categories related to AI performance, expert consensus, and human-in-the-loop studies are not applicable or cannot be extracted from this document.

Here's the information that can be extracted and a clear indication where information is not available:

{
  "1. A table of acceptance criteria and the reported device performance": {
    "Acceptance Criteria": [
      "Mechanical properties equivalent to the unmodified device Newdeal Ankle Nail, [K050882](https://510k.innolitics.com/search/K050882)."
    ],
    "Reported Device Performance": [
      "Mechanical tests have been carried out. Results have shown that the mechanical properties of the modified Panta® Nail (dia. 10mm and XL) is equivalent to the properties of the unmodified device Newdeal Ankle Nail, [K050882](https://510k.innolitics.com/search/K050882)."
    ]
  },
  "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "This information is not provided in the document. The study involved mechanical tests, not a clinical test set with patient data.",
  "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. The study involved mechanical testing, not expert consensus on medical images or patient outcomes.",
  "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "Not applicable. The study involved 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 is a medical device for surgical fixation, not an AI-powered diagnostic tool.",
  "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Not applicable. This is a medical device for surgical fixation, not an AI algorithm.",
  "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "The 'ground truth' for the mechanical testing was the established mechanical properties of the predicate device (Newdeal Ankle Nail, [K050882](https://510k.innolitics.com/search/K050882)).",
  "8. The sample size for the training set": "Not applicable. This document describes mechanical testing for a physical medical device, not an AI model requiring a training set.",
  "9. How the ground truth for the training set was established": "Not applicable. This document describes mechanical testing for a physical medical device, not an AI model requiring a training set."
}

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