(77 days)
The DePuy ACE A.I.M.® Titanium Tibial Nail is indicated for internal fixation of tibial fractures including transverse fractures, oblique fractures, spiral fractures, comminuted fractures, fractures, fractures with bone loss, bone transport, open fractive osteotomies, pathologic fractures, pseudoarthrosis of the tibial shaft, nonunions, malunions, metaphyseal fractures and epiphyseal fractures.
The DePuy ACE A.I.M.® Titanium Tibial Nail is an intramedullary fixation of tibial fractures. The nail has a distal bend of 2º for the nails of 10mm, 11mm, 12mm diameters. The distal bend in the nails of 8mm and 9mm diameters is 5°. The DePuy ACE A.I.M.º Titanium Tibial Nail has diameters from 8.0mm to 13.0mm and lengths from 25.5cm. The proximal end of the 10mm, 11mm, 12mm , and 13mm nails is 13mm in diameter while the proximal end of the 8mm and 9mm nadiameter. The proximal end of the nail contains two 6mm cross locking screw holes which accept 5.5mm solid cortical bone screws and one 5mm long dynamization slot in the M-L plane. The distal end of the nail contains two 5.0mm holes in the M-L plane which accept 4.5mm solid cortical bone screws and one 5.0mm hole in the A-P plane positioned between the two transverse holes. The 8mm and 9mm nails are solid while the 10mm to 13mm nails are cannulated.
The DePuy ACE A.I.M. Titanium Tibial Nail is manufactured from Titanium 6A1-4V ELI (ASTM standard F-136).
The new DePuy ACE A.I.M.® Titanium Tibial Nail is the same basic design as the current DePuy ACE A.I.M. Titanium Tibial Nail, with the exceptions of adding a proximal dynamization slot in the M-L plane, which allows 5mm of length to dynamize across fracture site and that the two oblique proximal screw holes are moved more proximal to vield a longer working length for the nail. Also, there is an additional hole in the nail in the A-P plane. This is positioned between the current two distal transverse holes, allowing for oblique locking distally, which is more stable and allows the lagging of anterior fragments of the distal tibia. The additional holes and changes in placement are very similar to that of the Synthes Titanium Cannulated Tibial Nail and the Synthes Titanium Unreamed Tibial Nail.
The provided text describes a medical device, the DePuy ACE A.I.M.® Titanium Tibial Nail, which is an intramedullary rod for fixing tibial fractures. However, this document is a 510(k) summary and not a study report. Therefore, it does not explicitly define acceptance criteria or detail a study that proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, or reader improvement.
Instead, the document focuses on demonstrating substantial equivalence to existing legally marketed devices, which is the primary regulatory pathway for this type of device. The "study" mentioned is a biomechanical testing study to compare the new device's strength to a predicate device.
Here's an analysis of the provided information in relation to your request, with the understanding that the nature of the document limits the direct answers to your specific questions about "acceptance criteria" for a cognitive task or "AI performance":
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail metrics in the way one would define for a diagnostic or AI device (e.g., "sensitivity must be >X%", "AUC must be >Y%").
- Implied Acceptance Criteria (for substantial equivalence): The new device must be "at least as strong or stronger" than the predicate device in biomechanical tests.
- Reported Device Performance:
- "On all tests, the DePuy Tibial Nail was either at least as strong or stronger than the Synthes Tibial Nail."
| Acceptance Criterion (Implied for Substantial Equivalence via Biomechanical Testing) | Reported Device Performance (vs. Synthes Tibial Nail) |
|---|---|
| Mechanical strength | At least as strong or stronger |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document only mentions "Biomechanical testing was done." The number of different tests performed or the number of nails tested is not detailed.
- Data Provenance: Not specified. It's a biomechanical test, likely conducted in a lab environment rather than patient data.
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. This document describes a biomechanical test of physical strength, not a diagnostic or interpretive task that requires expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This relates to expert consensus for ground truth, which is not relevant for a biomechanical strength test.
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
- No. This is a biomechanical study, not a study involving human readers or AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. There is no algorithm or AI involved. The "device" is a physical implant. The "standalone performance" metaphorically refers to the intrinsic mechanical properties of the nail itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly stated in these terms. For biomechanical testing, the "ground truth" would be the objective measurement of mechanical properties (e.g., yield strength, ultimate tensile strength, fatigue life) compared against established engineering standards or the performance of a predicate device.
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of a biomechanical test for substantial equivalence.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set. The "ground truth" for biomechanical properties is derived from established material science and engineering principles and testing methodologies.
§ 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.