(236 days)
The Acumed Clavicle Screw System is intended to be used to repair an acute fracture, mal-union or non-union of the clavicle.
The Acumed Clavicle Screw System includes screws with associated instruments to repair acute fractures, mal-unions or non-unions of the clavicle.
This submission pertains to a medical device, the Acumed Clavicle Screw System, rather than an AI/ML powered device. As such, the information typically requested for AI/ML device studies (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance) is not applicable or available in the provided text.
However, I can extract information regarding the device's performance data and how substantial equivalence was demonstrated.
Here's the relevant information based on the provided text:
Acceptance Criteria and Device Performance (for a non-AI/ML device):
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance and Equivalence (implied from the submission, focusing on material and dimensional characteristics, and function for clavicle repair) | The Acumed Clavicle Screw System is made of titanium alloy per ASTM F136 and is supplied in multiple diameters and lengths. These characteristics are shared with predicate devices. A cadaver study was performed to demonstrate substantial equivalence. |
| Safety and Effectiveness (demonstrated through substantial equivalence to legally marketed devices) | Based on similarities in technological characteristics and performance to predicate devices (DePuy Rockwood Clavicle Pin - K991649, True/Flex Clavicle Rod System - K934148, Hagie Pin - K903258, Steinmann, Knowles, and Hagie Pins - K863734, Herbert Bone Screw - K792022), the device is deemed substantially equivalent in safety and effectiveness. |
| Intended Use (to repair an acute fracture, mal-union or non-union of the clavicle) | The cadaver study supports the intended use, aiding in demonstrating substantial equivalence. |
Study Information (Non-AI/ML Device):
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a numerical sample size in the context of individual cases. The study mentioned is a "cadaver study."
- Data Provenance: A cadaver study. The country of origin is not specified but implicitly within the context of the manufacturer (Acumed, LLC) being in the USA. This is a prospective study design for demonstrating performance.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For a cadaver study of a bone fixation device, "ground truth" would relate to mechanical stability, anatomical fit, and repair efficacy, typically assessed by orthopedic specialists or biomechanical engineers, but no specific number or qualifications are provided in this regulatory submission.
-
Adjudication method for the test set: Not applicable. This type of study would involve direct observation and measurement, not typically an adjudication process in the sense of expert review for diagnostic accuracy.
-
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/ML powered device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML powered device.
-
The type of ground truth used: In the context of a cadaver study for a bone fixation device, the "ground truth" would be objective biomechanical data, observable anatomical fit and stability, and the ability of the device to facilitate the repair as intended.
-
The sample size for the training set: Not applicable. This is not an AI/ML powered device, so there is no "training set."
-
How the ground truth for the training set was established: Not applicable. There is no training set for this device.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.