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The Newdeal Ankle Nail 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 ioints
• rheumatoid arthritis -
• revision of failed ankle arthrodesis with subtalar involvement or with insufficient talar body
• revision of failed total ankle arthroplasty with subtalar intrusion ー
• talar deficiency conditions (requiring a tibiocalcaneal arthrodesis) -
• avascular necrosis of the talus -
• Neuroarthropathy or neuropathic ankle deformity ー
• 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 Newdeal Ankle Nail is a straight, cannulated intramedullary nail available in diameters of 11mm, 12mm and 13mm, and lengths of 150mm and 180mm. It allows for proximal and distal locking, using locking cortical screws 5mm diameter, 20 to 110mm long by 5mm increment. The nail, the end cap and the locking screws are all made from Ti-6Al-4V ELI alloy.

Based on the provided text, the device in question is the Newdeal Ankle Nail, an intramedullary fixation rod. The document is a 510(k) Summary, which is a premarket notification demonstrating substantial equivalence to a legally marketed predicate device, rather than a clinical study establishing efficacy or safety against acceptance criteria in the same way a new drug or novel medical device might.

Therefore, the "acceptance criteria" and "device performance" in this context refer to demonstrating that the Newdeal Ankle Nail's technological characteristics and intended use are substantially equivalent to existing predicate devices, not that it meets specific numeric clinical performance metrics through new studies. The "study" mentioned is a "Summary of Studies" meant to support this substantial equivalence.

Here's the breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria for a 510(k) submission are based on demonstrating "substantial equivalence" to one or more legally marketed predicate devices. The "reported device performance" here describes how the new device matches the characteristics of those predicates. The document states, "The technological characteristics of the Newdeal Ankle Nail are the same as the predicate devices in terms of intended use and design."

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

• The document does not report on a test set in the traditional sense of a clinical or ex-vivo performance study with a specific sample size. The "Summary of Studies" section only states "Summary of Studies. Ankle Nail meets our acceptance criteria," without detailing any specific studies, their methodology, or data provenance. The assessment is based on comparing technological characteristics and intended use to predicate devices, not on a new performance study.

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. As noted above, there is no disclosed "test set" or independent clinical study requiring expert ground truth establishment for a novel device performance claim. The claims are based on substantial equivalence to existing devices.

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

• Not applicable. There is no disclosed "test set" or independent clinical study requiring adjudication.

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 medical implant (an ankle nail), not an AI-powered diagnostic tool, and therefore, an MRMC study comparing human reader performance with or without AI assistance is irrelevant to this submission.

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

• Not applicable. This device is a medical implant, not an algorithm, and does not operate as a standalone AI system.

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

• Not applicable. For a 510(k) submission focused on substantial equivalence for an implantable medical device, the "ground truth" is typically established by the regulatory history and accepted performance of the predicate devices already on the market, combined with engineering and biocompatibility testing (which are not detailed in this summary). There's no new "ground truth" established for clinical outcomes in this document for the Newdeal Ankle Nail itself.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device submission.

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

• Not applicable. This is not a machine learning or AI device submission.

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