(123 days)
The Bicortical Fixation Screw & Washer Nut System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.
The Bicortical Fixation Screw & Washer Nut System consists of screws in various diameters and lengths that mate with a washer nut to achieve bicortical fixation.
The provided text describes a medical device, the "Bicortical Fixation Screw & Washer Nut System," and its clearance by the FDA. However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of AI/ML or diagnostic accuracy.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device based on indications for use, technological characteristics, and nonclinical (mechanical) testing. It explicitly states, "Clinical data are not needed to support the safety and effectiveness of the subject device."
Therefore, I cannot provide the requested information regarding AI/ML-related acceptance criteria, clinical study details, sample sizes, ground truth establishment, or expert involvement. The questions you've asked are typically relevant for AI/ML-driven diagnostic devices, which this medical device (a bone screw system) is not.
Here's what I can extract based on the type of study described, even though it's not a clinical AI/ML study:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in the format of a table with reported performance. Instead, it relies on demonstrating substantial equivalence through nonclinical mechanical testing.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Performance: Equivalent or superior to predicate devices (Synthes Cortex Screws) | "Side-by-side performance testing demonstrates the substantial equivalence of the Bicortical Fixation Screw & Washer Nut System to the Synthes Cortex Screws." |
| Performance was characterized through: | |
| - Torsion testing: Performed on the worst-case Bicortical Fixation Screw & Washer Nut. |
- Static pullout testing: Performed in bone analog material on the worst-case Bicortical Fixation Screw & Washer Nut. |
| Material Biocompatibility: Conforms to established standards for permanent implants | "The subject and predicate devices are manufactured from titanium alloy conforming to ASTM F136. This is a material with a long history of biocompatibility and use in previously cleared permanent implants." |
| Design/Function Equivalence: No new issues of safety or effectiveness introduced | "The mechanical testing demonstrates that this minor difference in technology [how compression is achieved] introduces no new issues of safety or effectiveness." Functionally, both aim to achieve compression of fracture fragments. "The Bicortical Fixation Screw & Washer Nut System is substantially equivalent...with respect to its indications for use, material, design, and function." |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated numerically. The testing was performed on "test units representative of finished devices." This typically implies a limited number of samples for mechanical testing, not a large patient cohort.
- Data Provenance: The testing was "nonclinical," meaning it was conducted in a lab environment on bone analog material, not on human patients. The country of origin for the testing data is not specified but would likely be the USA where First Ray LLC is located. The study was essentially prospective in terms of the specific devices being manufactured and tested.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable. There was no clinical ground truth established by experts for this nonclinical mechanical testing. The "ground truth" for mechanical testing is derived from established engineering principles and material science standards.
4. Adjudication method for the test set
- This question is not applicable. There was no expert "adjudication" in the sense of clinical review or diagnosis. Mechanical testing results are typically analyzed against predefined engineering specifications.
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 MRMC clinical study was performed, as the device is a bone fixation system and not an AI/ML diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. The device is a physical medical implant, not an algorithm.
7. The type of ground truth used
- The "ground truth" for this device's evaluation was mechanical performance data gathered through specific engineering tests (torsion and static pullout) in a bone analog environment, compared against the known performance characteristics of the predicate device (Synthes Cortex Screws). It is not expert consensus, pathology, or outcomes data.
8. The sample size for the training set
- This question is not applicable. There was no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
- This question is not applicable. There was no "training set" or corresponding ground truth for an AI/ML context.
§ 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.