Search Results

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.

Ask a specific question about this device

The SMV Bone Plate and Screw System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, including, periarticular and intraarticular fractures.

The SMV 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, bone screws for fixation, 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. Plates and screws are provided non-sterile. The implants in this submission can be used with the screws cleared in K150981 and K150188.

This is a premarket notification (510(k)) for a medical device, the SMV Bone Plate and Screw System. It does not describe a clinical study or acceptance criteria for an AI/CADe device. Instead, it demonstrates substantial equivalence to predicate devices through technological characteristics and non-clinical performance testing. Therefore, most of the requested information regarding acceptance criteria and study details for AI performance cannot be extracted from this document.

Here's what can be extracted based on the provided text, and where gaps exist:

1. A table of acceptance criteria and the reported device performance

The document does not specify "acceptance criteria" in the sense of a numerical threshold for clinical performance (e.g., sensitivity, specificity) that an AI device would need to meet. Instead, it describes a non-clinical testing approach to demonstrate substantial equivalence.

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. This document refers to mechanical/non-clinical testing, not a clinical test set with 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. Ground truth for clinical data is not relevant for this type of non-clinical device testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

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/CADe device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/CADe device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the mechanical testing, the "ground truth" is implied by the ASTM F382 standards and the performance of the predicate devices. The study aims to show that the new device's mechanical properties are comparable.

8. The sample size for the training set

Not applicable. This is not an AI/CADe device.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/CADe device.

Summary of the study:

The study described is a non-clinical performance testing to demonstrate the mechanical strength and substantial equivalence of the SMV Bone Plate and Screw System to legally marketed predicate devices.

• Test Methods:
  • Static Four-point Bending per ASTM F382
  • Dynamic Four-point Bending per ASTM F382
• Outcome: The results showed that "the strength of the Bone Plate and Screw System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."
• Purpose: To support the 510(k) premarket notification for the SMV Bone Plate and Screw System by showing its mechanical characteristics are comparable to existing, legally marketed devices.

Ask a specific question about this device