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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).

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.

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The Distal Volar Radius Anatomical Plate System is intended for the fixation of fractures and osteotomies involving the distal radius.

The proposed Multidirectional Threaded Peg is manufactured from Cobalt Chromium (CoCr) and is available in 2.5 mm diameter and in a variety of lengths, ranging from 10 – 30 mm in 2 mm increments to accommodate varying patient anatomies and fracture morphologies.

This submission describes a medical device, the Multidirectional Threaded Peg, which is a component of a bone fixation system. The FDA 510(k) summary provided indicates that this is a substantially equivalent device filing, meaning the device's performance is compared to an already legally marketed predicate device. Therefore, a comprehensive "study that proves the device meets the acceptance criteria" in the sense of a standalone clinical trial with acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy for an AI system) is generally not applicable for this type of submission.

Instead, the "acceptance criteria" and "study" for this type of device revolve around demonstrating substantial equivalence to the predicate device through pre-clinical testing, primarily mechanical testing, to ensure that the new device performs at least as well as the predicate for its intended use.

Here's the breakdown of the information requested, tailored to this device type and the provided documents:

1. Table of Acceptance Criteria and the Reported Device Performance:

Regarding the other requested points (2-9), these are mostly relevant for diagnostic AI/software devices or clinical studies with human subjects, not for demonstrating substantial equivalence for a new mechanical implant component via pre-clinical testing as seen in this 510(k) summary.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for an implantable medical device undergoing pre-clinical mechanical testing for substantial equivalence. The "test set" would refer to physical prototypes or engineering samples.
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. Ground truth for mechanical testing is established by engineering standards, test methods, and quantitative measurements, not expert human assessment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for pre-clinical mechanical testing.
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 device or a diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical implant component, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For mechanical testing, the "ground truth" is defined by the objective physical properties and performance measured against established ASTM standards and benchmarked against the predicate device's known performance.
8. The sample size for the training set: Not applicable. There is no "training set" in the context of mechanical pre-clinical testing for substantial equivalence.
9. How the ground truth for the training set was established: Not applicable.

In summary, for this particular medical device (Multidirectional Threaded Peg), the "study" demonstrating its meeting of "acceptance criteria" is a series of pre-clinical mechanical tests (implicitly, as detailed test reports are not in the summary) comparing its performance to a legally marketed predicate device, ensuring substantial equivalence in material, design, and function for its stated indications for use. The acceptance criteria primarily centered on material compliance (ASTM F 1537-00) and comparable mechanical performance to the predicate device.

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