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510(k) Data Aggregation
(26 days)
The OsteoCentric Bone Plate and Screw System
The OsteoCentric Bone Plate and Screw is intended for fixation of fractures, osteotomies, and nonunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, including, but not limited to periarticular, and intraarticular fractures
The subject system is a line extension that includes clavices (superior lateral, anterior mideral, and anterior midshaft) and additional locking and non-locking screws (2.1mm, and 2.7mm diameter). The plates and screws are fabricated from either medical grade stainless steel per ASTM F138 or Titanium per ASTM F136. Plates and screws are provided non-sterile. Instruments are provided non-sterile with instructions for sterilization.
This FDA 510(k) clearance letter is for a physical medical device (The OsteoCentric Bone Plate and Screw System), not an AI/Software as a Medical Device (SaMD). Therefore, the specific information requested in your prompt regarding AI/SaMD performance criteria, such as acceptance criteria based on accuracy, sensitivity, specificity, MRMC studies, training/test sets, and ground truth establishment, is not applicable to this document.
For traditional medical devices like the OsteoCentric Bone Plate and Screw System, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are typically addressed through non-clinical performance testing (e.g., mechanical testing, biocompatibility, sterilization validation) and comparison to predicate devices, rather than clinical studies involving human readers or AI algorithms.
However, I can extract the relevant information regarding the non-clinical testing and conclusions provided in the document:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a formal table of acceptance criteria with numerical targets and reported performance in the way an AI/SaMD submission would. Instead, it states:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Intermediate screw sizes do not present a new worst-case. | "Engineering analysis was performed to demonstrate that the intermediate screw sizes did not present a new worst-case..." (This implies the performance of these new sizes is within acceptable limits compared to existing sizes, likely established through mechanical testing or a justifiable engineering rationale.) |
| Clavicle plates have similar bending performance (strength and stiffness) compared to the predicates. | "...and also that the subject device clavicle plates had similar bending performance (strength and stiffness) compared to the predicates." (This implies that the measured strength and stiffness values of the new clavicle plates were within a range deemed equivalent or acceptable when compared to the established performance of the predicate devices, likely through standardized mechanical testing methods relevant to bone fixation.) |
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: Not applicable. For mechanical testing of physical devices, "sample size" refers to the number of test articles (plates, screws) subjected to the engineering analyses. This specific number is not disclosed in the clearance letter but is part of the detailed test reports provided to the FDA.
- Data Provenance: Not applicable. The data comes from "Engineering analysis," which means laboratory testing and simulations performed on the device components themselves, not clinical data from patients or a specific country. This is in vitro 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. Ground truth for mechanical performance is established through objective, quantifiable engineering measurements against predefined standards or predicate device performance, not expert consensus interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are relevant for subjective interpretations by multiple human readers, not for objective mechanical test results.
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 device is a bone plate and screw system, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this type of device's performance is based on objective engineering and mechanical properties (e.g., material strength, fatigue life, torsional rigidity, bending stiffness, screw pull-out strength). These properties are measured and evaluated against established industry standards (e.g., ASTM F138 for stainless steel, ASTM F136 for titanium) and/or comparison to predicate devices, which have a known history of safe and effective use.
8. The sample size for the training set:
Not applicable. This is a physical medical device, not an AI algorithm.
9. How the ground truth for the training set was established:
Not applicable. This is a physical medical device, not an AI algorithm.
In summary, the FDA 510(k) clearance for The OsteoCentric Bone Plate and Screw System relies on non-clinical engineering analysis and comparison to predicate devices to demonstrate substantial equivalence, rather than the types of performance studies typically conducted for AI/SaMD products.
Ask a specific question about this device
(28 days)
OsteoCentric Bone Plate and Screw System
The OsteoCentric Bone Plate and Screw is intended for fixation of fractures, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, including, but not limited to periarticular, and intraarticular fractures
The OsteoCentric Bone Plate and Screw System consists of implants and instruments designed for fixation to treat fractures, deformations, revisions and replantations of bones and bone fragments. The system features nineteen (19) types of plates and bone screws for fixation that are locking or non-locking, and a set of instruments to facilitate installation and removal of the implants. The plates have screw holes, which allow for attachment to the bones or bone fragments. The plates are fabricated from medical grade stainless steel (ASTM F138), and offered in various widths and lengths.
The provided text is a 510(k) summary for the OsteoCentric Bone Plate and Screw System. It details the device's characteristics, indications for use, and a comparison to predicate devices, but it does not contain information about an AI/ML-based medical device or any study proving a device meets acceptance criteria related to AI/ML performance.
Therefore, I cannot extract the information required to answer your questions regarding acceptance criteria, study details, sample sizes, expert involvement, or MRMC studies, as these concepts are not discussed in this document. The document describes a traditional medical device (bone plates and screws) and relies on substantial equivalence to previously cleared predicate devices, primarily through engineering analysis and existing performance testing of those predicates (ASTM F543 and ASTM F382).
The 510(k) clearance process for this type of device does not involve the kind of performance studies (e.g., clinical trials, AI algorithm validation) that would generate the data you're asking about.
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