(27 days)
The DePuy Anatomic Locked Plating System Extra Long Plate Line Extension is intended for fixation of fractures, fusions, osteotomies and nonunions of the clavicle, humerus, radius, ulna, olecranon, metacarpal, metatarsal, malleolus, tibia, fibula, particularly in osteopenic bone.
The Anatomic Locked Plating System Extra Long Plate Line Extension offers various longer length anatomically contoured plates for use with non-locking, locking and variable angle screws. With conventional nonlocking plating, compression of the plate to the bone is a necessary mode of action. However, with locking plating technology, the plate does not need to contact bone or load against the periosteum for construct strength. The locking plate/screw construct provides stability even in osteopenic bone where screw purchase can be more difficult. These posterior lateral plates will be available in 210mm and 250mm lengths.
The provided document is a 510(k) summary for the DePuy Anatomic Locked Plating System Extra Long Plate Line Extension. It outlines the device's characteristics, its substantial equivalence to predicate devices, and its intended use.
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Predetermined Acceptance Criteria (specific criteria are not detailed in this summary, but are implied) | Performed equivalently to the predicate devices. This implies that the device successfully met all defined criteria for mechanical properties like load and bend strength, and functional performance in a biological model. |
| Achieve "Substantial Equivalence" to predicate devices (K082300 and K072423) | Confirmed through bench testing and validation in cadaveric models. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated. The document mentions "bench testing" and "validation in cadaveric models" but does not provide specific numbers for the plates tested or the number of cadavers used.
- Data Provenance: The testing was likely conducted in a controlled laboratory environment by the manufacturer (DePuy Orthopaedics, Inc. in Warsaw, IN). The data is prospective in the sense that it was generated specifically for this submission to demonstrate equivalence. The country of origin for the data is implicitly the USA given the address of the submitting company.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the document. For a medical device like a bone plate, "ground truth" typically refers to established biomechanical standards and measurements, and potentially expert evaluation of surgical construct stability in cadaveric models. The document doesn't detail who performed these evaluations or their qualifications.
4. Adjudication method for the test set
- This information is not provided. Given the nature of bench testing and cadaveric validation for a bone plate, it's less likely to involve a human adjudication process in the same way an imaging AI might. Instead, performance is measured against established engineering and biomechanical specifications.
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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic imaging devices where human interpretation is involved. This device is a mechanical implant (bone plate), and its effectiveness is determined through mechanical testing and biological modeling, not human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable to the device described. This device is a bone plate, not an algorithm or a system that operates with or without human-in-the-loop performance. Its performance is entirely "standalone" in the sense that its mechanical properties are inherent to the device itself.
7. The type of ground truth used
- The ground truth for this device's performance relies on established biomechanical engineering standards and specifications. This includes:
- Mechanical Load and Bend Testing: Measuring the plate's resistance to deformation and failure under various forces, simulating physiological loads.
- Cadaveric Model Validation: Assessing the plate's performance and stability when implanted in human cadaveric bone, simulating surgical application. This type of "ground truth" in this context is based on in vitro and ex vivo experimental data, comparing its performance directly to the legally marketed predicate devices.
8. The sample size for the training set
- This question is not applicable to the device described. There is no mention of "training set" as this is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
- This question is not applicable for the reasons stated above (no training set for a physical implantable device).
In summary, the substantial equivalence of the DePuy Anatomic Locked Plating System Extra Long Plate Line Extension was established through direct comparison to predicate devices using bench testing (load and bend testing) and cadaveric validation. The acceptance criteria, while not explicitly detailed in quantitative terms in this summary, were met by demonstrating equivalent performance to the predicate devices in these tests.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.