(90 days)
The VersaNail™ is intended for use in tibiotalocalcaneal fusions and treatment of trauma to the hindfoot and distal tibia. Indications include: revision after failed ankle arthrodesis with subtalar involvement; absent talus (tibiocalcaneal arthrodesis); post traumatic or primary arthrosis involving both ankle and subtalar joints; rheumatoid hindfoot; avascular necrosis of the talus; previously infected arthrosis, second degree; failed total ankle arthroplasty. Indications also include non-union ankle arthrodesis; osteoarthritis; post-traumatic and degenerative arthritis; neuroarthropathy or neuropathic ankle deformity; neuromuscular disease with severe deformity and Charcot foot.
The VersaNail™ is a straight, cannulated intramedullary nail available in diameters of 10 and 12 mm and lengths of 15, 20, 25 and 30 cm. Holes in the nail allow for proximal and distal locking. The VersaNail™, the end cap and the screws are all manufactured from Ti-6AL-4V alloy.
The provided text is a 510(k) summary for the ACE® VersaNail™, an intramedullary fixation rod. It describes the device, its intended use, and claims substantial equivalence to previously cleared devices. However, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of performance metrics for an AI/ML medical device.
The 510(k) process for devices like the VersaNail™ (an intramedullary fixation rod) primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a performance study with detailed acceptance criteria as would be typical for an AI/ML diagnostic or assistive device. The "acceptance criteria" here are inherent in showing that the new device performs as safely and effectively as the predicate devices, which is typically done through design comparisons, material testing, and reference to existing clinical use of the predicate devices.
Therefore, many of the requested items (e.g., sample sizes for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set size) are not applicable or findable in this type of 510(k) submission for a physical orthopedic implant.
Here's a breakdown based on the information available and what is not applicable to this specific document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices in design, materials, manufacturing, and intended use. | The ACE® VersaNail™ is described as being substantially equivalent to the ACE® AIM® Titanium Supracondylar Nail, ACE® AIM® TTC Fusion Nail, Biomet Ankle Arthrodesis Nail, Smith and Nephew Intramedullary Nail, and Encore® UltiMax Ankle Fusion Rod based on:Similarities of designCommonly used materials (Ti-6AL-4V alloy)Identical sterilization processesEquivalent indications for use |
2. Sample size used for the test set and the data provenance
- Not Applicable. This 510(k) submission is for a physical orthopedic implant and does not involve a "test set" of clinical data to evaluate AI/ML performance. Substantial equivalence is primarily demonstrated through engineering design comparisons, material specifications, and comparison of intended uses with predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. As above, no "test set" or diagnostic ground truth establishment is described in this submission.
4. Adjudication method for the test set
- Not Applicable. No test set or adjudication process is 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. This is not an AI/ML device. No MRMC study or AI-assisted performance evaluation was conducted or is relevant to this type of device submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. The "ground truth" for this device revolves around its physical properties and biocompatibility matching established standards and predicate devices, not diagnostic accuracy against a specific medical condition.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device and does not involve a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML device.
Summary of the Study that Proves the Device Meets Acceptance Criteria (as per this 510(k) submission):
The "study" proving the device meets acceptance criteria in this context is the substantial equivalence comparison. The sponsor, DePuy ACE®, Inc., asserts that the ACE® VersaNail™ is substantially equivalent to several predicate intramedullary fixation rods based on:
- Design Similarities: The VersaNail™ is described as a "straight, cannulated intramedullary nail available in diameters of 10 and 12 mm and lengths of 15, 20, 25 and 30 cm," with "holes in the nail allow for proximal and distal locking." This design is compared to the designs of the predicate devices.
- Material Equivalence: All components (VersaNail™, end cap, screws) are manufactured from Ti-6AL-4V alloy, which is a commonly used material for such implants and presumably the material of the predicate devices.
- Identical Sterilization Processes: While not detailed, the submission states that identical sterilization processes are used, implying consistency with established safety protocols for the predicate devices.
- Equivalent Indications for Use: The VersaNail™'s intended uses for tibiotalocalcaneal fusions and treatment of trauma to the hindfoot and distal tibia, including specific indications like "revision after failed ankle arthrodesis," "absent talus," "post traumatic or primary arthrosis," "rheumatoid hindfoot," "avascular necrosis of the talus," "previously infected arthrosis," and "failed total ankle arthroplasty," as well as "non-union ankle arthrodesis," "osteoarthritis," "post-traumatic and degenerative arthritis," "neuroarthropathy or neuropathic ankle deformity," "neuromuscular disease with severe deformity and Charcot foot," are all covered by the indications cleared for the predicate devices (Biomet Ankle Arthrodesis Nail, Smith and Nephew Intramedullary Nail, and/or Encore® UltiMax Ankle Fusion Rod).
The FDA reviewed this submission (K023115) and determined on December 18, 2002, that the device is substantially equivalent to the legally marketed predicate devices, thereby allowing it to proceed to market. This determination by the FDA serves as the regulatory "proof" that the device meets its acceptance criteria for market authorization based on the substantial equivalence pathway.
§ 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.