(18 days)
The BioRCI® Screw is used for fixation of bone-tendon-bone or soft tissue grafts during Anterior/Posterior Cruciate Ligament (ACL/PCL) reconstruction procedures.
The Modified BioRCI® Screw is an interference screw in the range of 7-12mm in diameter and 20-35mm in length.
The provided document is a 510(k) summary for the BioRCI® Screw Modification, a bone fixation screw. It does not describe an AI/ML powered device or a study involving human readers and AI assistance.
Therefore, I cannot provide details on acceptance criteria and a study proving device performance in the context of AI/ML, human readers, or related metrics.
The document discusses the substantial equivalence of the modified device to a predicate device based on traditional medical device manufacturing and performance testing.
Here's an analysis of what is provided, framed by your request, showing why AI/ML specific information is absent:
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A table of acceptance criteria and the reported device performance:
The document states: "In vitro performance testing, material biocompatibility and sterilization validation demonstrate the modified device is safe, substantially equivalent and performs as intended."
It does not provide a table with specific quantitative acceptance criteria (e.g., tensile strength thresholds, biocompatibility indices) or the exact numerical results from these tests. It only makes a summary statement that these tests demonstrate "safe, substantially equivalent and performs as intended." -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document mentions "in vitro performance testing," but does not specify the sample sizes (e.g., number of screws tested) for these tests, nor the data provenance beyond "in vitro." It's highly likely these were laboratory tests conducted by the manufacturer. -
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 is not applicable to traditional in-vitro performance testing of a bone fixation screw. "Ground truth" in this context would be defined by engineering specifications and material science standards, not expert medical opinion on an output. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods like 2+1 are typically used for establishing ground truth in image interpretation or diagnostic studies involving human consensus, not for mechanical testing of a screw. -
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, a MRMC comparative effectiveness study was not done. This device is a physical bone fixation screw, not an AI diagnostic or assistive tool. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
No, a standalone algorithm performance study was not done. This is a physical device, not an algorithm. -
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
For "in vitro performance testing," the ground truth would be established by engineering specifications, material properties, and relevant ASTM or ISO standards for medical devices (e.g., strength requirements, material composition standards). For "biocompatibility," ground truth is established by ISO 10993 standards and related testing for biological response. For "sterilization validation," ground truth is established by standards like ISO 11135 or 11137. -
The sample size for the training set:
This is not applicable. The device is a physical screw, not an AI/ML model that requires a training set. -
How the ground truth for the training set was established:
This is not applicable as there is no training set for a physical medical device.
In summary, the provided information relates to the regulatory submission for a physical medical device (a bone fixation screw) and, as such, does not contain the AI/ML specific information requested.
§ 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.