(28 days)
The Small Bone Locking Plating System Line Extension is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis and craniomaxillofacial skeleton, particularly in osteopenic bone.
The Small Bone Locking Plating System Line Extension combines the attributes of a traditional compressive plating system with the enhanced benefits of locking screw and multidirectional locking screw technology.
The provided text appears to be a 510(k) summary for a medical device called the "DePuy Small Bone Locking Plating System Line Extension." It primarily focuses on demonstrating substantial equivalence to a predicate device through bench testing.
Based on the provided information, I can extract the following:
1. A table of acceptance criteria and the reported device performance:
The document states: "Equivalence was confirmed through bench testing." However, it does not provide specific acceptance criteria or detailed results of the bench testing. It only indicates that the testing confirmed equivalence to the predicate device (DePuy Small Bone Locking Plating System, K081546).
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. The summary only states that "Equivalence was confirmed through bench testing." | Not specified in the document. The summary only states that the bench testing confirmed equivalence to the predicate device (K081546). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not provide details about sample size, data provenance, or whether the study was retrospective or prospective. It only mentions "bench testing."
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):
This information is not applicable. This is a medical device for bone fixation, and the evaluation was based on "bench testing" (mechanical or physical testing), not an assessment requiring expert interpretation of medical images or patient data to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable, as the study was bench testing of a physical device, not an evaluation of a system requiring human interpretation or adjudication.
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 device is a bone plating system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable. This is a physical medical device (bone plating system), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the bench testing would be established by engineering specifications, material properties, and mechanical performance standards, compared against the predicate device. The document does not explicitly state what these specific ground truths were, beyond the general statement of "equivalence."
8. The sample size for the training set:
This information is not applicable. This is a physical medical device (bone plating system), not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable, as there is no training set for this type of device.
In summary, the provided document is a 510(k) summary for a bone plating system, which relies on a demonstration of substantial equivalence through bench testing. It does not contain the detailed information requested regarding acceptance criteria, specific performance metrics, sample sizes, expert involvement, or AI-related study design elements, as those are generally not relevant for this type of medical device submission.
§ 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.