(387 days)
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:
| Acceptance Criterion (Demonstrating Substantial Equivalence) | Reported Device Performance (DynaNail Ankle Nail) |
|---|---|
| Material Composition: Ti-6AL-4V Titanium | Made from Ti-6AL-4V Titanium |
| Device Body Design: Hollow body with flutes | Hollow body with flutes |
| Attachment Points: Distal and proximal screw attachment points | Distal and proximal screw attachment points |
| Diameter: 12 mm | Offered in a 12 mm diameter |
| Lengths: Comparable to predicate device | Offered in lengths comparable to predicate device |
| Functional Performance (ASTM F 1264-03): | |
| - Four-point bend testing (nail and screws) | Performed; results demonstrate substantial equivalence to predicate. |
| - Fatigue testing (fixation screws) | Performed; results demonstrate substantial equivalence to predicate. |
| - Nickel Release Testing | Performed; results demonstrate substantial equivalence. |
| - Corrosion Testing | Performed; results demonstrate substantial equivalence. |
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).
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.