(64 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 sterile, single use titanium Intramedullary Fixation Rod for use in tibiotalocalcaneal fusions. The DynaNail is available in 10, 11, and 12mm diameters and lengths of 180mm, 220mm, 260mm, and 300mm. The DynaNail is implanted with a deployment frame and fixation screws. The fixation screws are single use 5mm titanium headed and headless screws. The screws are available in lengths that range from 20 to 110mm. 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 fashion as existing nails.
The provided text describes a 510(k) summary for the DynaNail™ Ankle Arthrodesis Nail, seeking clearance based on substantial equivalence to predicate devices. It focuses on the device's design, materials, and functional aspects for tibio-talo-calcaneal fusions.
However, the document does not contain the detailed clinical study information requested regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies. The provided text primarily addresses regulatory submission details and claims substantial equivalence through functional performance analysis to predicate devices, not a standalone clinical trial with specific acceptance criteria and performance metrics for the new device.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be extracted. The document states that "Functional performance analysis of the predicate and proposed DynaNail™ and VersaNail™ were conducted per IM.v4 and ASTM F 1264-03" and "Analysis substantiates the statement that the proposed device performs equivalently to the predicate devices." This implies that the acceptance criteria were met by demonstrating equivalence to predicate devices based on these standards, but the specific numerical acceptance criteria and the reported performance metrics (e.g., strength, durability, wear, etc.) are not detailed in this summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be extracted. The document mentions "functional performance analysis," which typically involves laboratory testing (mechanical, materials, etc.) rather than a clinical human test set. No information on human subjects, data provenance, or study design (retrospective/prospective) is provided.
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 / Cannot be extracted. This relates to clinical studies and expert review for ground truth, which is not described in this technical performance analysis for substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Cannot be extracted. This relates to clinical studies and expert review for ground truth, which is not described.
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 / Cannot be extracted. This device is an intramedullary fixation rod, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Cannot be extracted. This device is a physical medical implant. The "functional performance analysis" would be considered a standalone evaluation of its mechanical properties, but it's not an "algorithm only" performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be explicitly stated for clinical outcomes. For the "functional performance analysis," the "ground truth" would likely be engineering specifications and established performance characteristics of the predicate devices or relevant ASTM standards, but the document doesn't explicitly label it as "ground truth."
8. The sample size for the training set
- Not applicable / Cannot be extracted. This relates to machine learning/AI models. The "functional performance analysis" would use test samples (e.g., multiple nails tested), but these are not a "training set" in the AI sense.
9. How the ground truth for the training set was established
- Not applicable / Cannot be extracted.
Summary based on available information:
The document describes the DynaNail™ Ankle Arthrodesis Nail, an intramedullary fixation rod intended for tibio-talo-calcaneal fusions. Its 510(k) clearance is based on substantial equivalence to existing predicate devices (DynaNail™ Ankle Nail, K101934, and DePuy Ace VersaNail™ Intramedullary Fixation Rod, K023115).
The primary evidence provided for substantial equivalence is functional performance analysis.
- Study Description: Functional performance analysis was conducted per IM.v4 and ASTM F 1264-03. This analysis aimed to substantiate that the proposed device performs equivalently to the predicate devices.
- Ground Truth: For this type of device and review, the "ground truth" for performance would be the established performance profiles and physical/mechanical specifications outlined by the referenced ASTM standards (F 1264-03 for intramedullary fixation devices) and the performance of the legally marketed predicate devices. The document implies that the device's performance aligned with these established benchmarks.
- Sample Size: Not explicitly stated. For mechanical or materials testing, "sample size" would refer to the number of devices or test specimens used in the laboratory evaluation, which is not detailed here.
No clinical studies involving human subjects, expert review, or AI performance are described in this 510(k) summary. The focus is entirely on demonstrating technological equivalence through laboratory-based functional testing.
§ 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.