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The DynaNail™ Ankle Nail is intended for tibio-talo-calcaneal fusions:

• Post-traumatic and degenerative arthritis.
• Post-traumatic or primary arthrosis involving both ankle and subtalar joints.
• Revision after failed ankle arthrodesis with subtalar involvement.
• Failed total ankle arthroplasty.
• Non-union ankle arthrodesis.
• Rheumatoid hindfoot.
• Absent Talus (requiring tibiocalcaneal arthrodesis).
• Avascular necrosis of the talus.
• Neuroarthropathy or neuropathic ankle deformity.
• Neuromuscular disease and severe deformity.
• Osteoarthritis.
• Charcot Foot.
• Previously infected arthrosis, second degree.

The proposed DynaNail™ is a sterile, single use titanium Intramedullary Fixation Rod for use in tibiotalocalcaneal fusions. The DynaNail is implanted with a proprietary deployment frame and various lengths of fixation screws. Similar to existing IMFR's, the DynaNail™ provides rigid fixation across the arthrodesis site, and also provides a method of in-line compression through the nail. The nail incorporates a method of compression that is applied during implantation in the same manner as existing nails. The construction of the DynaNail™ body is equivalent to that of the VersaNail™ device. Both devices are made from Ti-6AL-4V Titanium, have a hollow body with flutes and distal and proximal screw attachment points. The DynaNail™ is offered in a 12 mm diameter, as is the VersaNail™. The DynaNail™ is offered in lengths comparable to those of the VersaNail™. The DynaNail™ device has an external frame that aligns the IMFR with the tibia and calcaneous and compresses the fusion site before insertion of the distal fixation screws. The DynaNail™ fusion site compression is a function of the compression applied by the external frame and the DynaNail™ Nitinol element.

Here's an analysis of the provided text regarding the MedShape Solutions DynaNail Ankle Nail, focusing on the acceptance criteria and study information:

The provided text is a 510(k) summary for the DynaNail Ankle Nail, which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission relies on comparing the new device's characteristics and performance to a predicate device, rather than proving efficacy and safety through extensive clinical trials as an FDA PMA submission would.

Therefore, the "acceptance criteria" and "study" described are primarily focused on demonstrating substantial equivalence to the predicate device, not necessarily on meeting independent performance benchmarks in a clinical setting in the way an imaging AI algorithm might.

Here's the breakdown based on your request, filling in "N/A" where the information is not provided or applicable to this type of device submission:

Acceptance Criteria and Device Performance Study for DynaNail Ankle Nail (K101934)

The primary acceptance criterion for the DynaNail Ankle Nail, as demonstrated in this 510(k) submission, is substantial equivalence to its predicate device, the DePuy Ace VersaNail™ Intramedullary Fixation Rod (K023115), in terms of design, function, intended use, and functional performance.

The study performed was a functional performance comparison with the predicate device, conducted per ASTM F 1264-03, "Standard Specification and Test Methods for Intramedullary Fixation Devices."

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: The document does not specify the exact number of DynaNail and VersaNail™ devices or components tested for the functional performance studies (four-point bend, fatigue, nickel release, corrosion). Typically, these types of tests involve a statistically significant sample size based on engineering standards and regulatory guidance for device testing, but the specific number is not disclosed in this summary.
• Data Provenance: The data is based on prospective laboratory testing conducted by MedShape Solutions, Inc. on their DynaNail device and the predicate device. The country of origin of the data is implied to be within the USA, where MedShape Solutions is located.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

• N/A. This type of device submission does not involve clinical testing with "ground truth" established by medical experts for a "test set" in the way an AI diagnostic device would. The "ground truth" for mechanical testing is defined by the ASTM standard's methodology and acceptance limits, and the comparison to the predicate device's performance.

4. Adjudication Method for the Test Set:

• N/A. Adjudication methods like 2+1 or 3+1 are relevant for clinical studies involving human interpretation or pathology, not for mechanical device testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

• No. An MRMC study is not applicable to an intramedullary fixation rod. This type of study is typically used for diagnostic imaging devices to assess human reader performance with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:

• N/A. The DynaNail Ankle Nail is a physical implantable medical device, not an algorithm, so "standalone performance" in this context is not applicable. The functional performance tests described are essentially "standalone" device performance evaluations in a laboratory setting.

7. The Type of Ground Truth Used:

• For the functional performance testing, the "ground truth" or reference for evaluating performance was defined by:
  • ASTM F 1264-03 Standard Specification and Test Methods: This standard outlines the methodology and expected performance characteristics for intramedullary fixation devices.
  • Performance of the Predicate Device (DePuy Ace VersaNail™): The DynaNail was tested against the predicate, with the acceptance being that its performance is "substantially equivalent" to (i.e., not worse than) the predicate under the defined test conditions.

8. The Sample Size for the Training Set:

• N/A. The concept of a "training set" is not applicable here as this is a physical medical device, not a machine learning model.

9. How the Ground Truth for the Training Set Was Established:

• N/A. (See point 8).

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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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