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The Osteo ACL Screw™ is intended for use in interference fixation of bone-patellar tendon - bone and soft tissue grafts in anterior and posterior cruciate ligament reconstructions.

The Osteo ACL Screw™ is not intended for use in and is contraindicated for 1) insufficient quality and quantity of bone for attachment of graft, 2) Blood supply limitation and/or previous infections, which could retard healing, 3) Foreign body sensitivity to the implant material. Where the material is suspected a test should be made prior to implantation to rule out sensitivity, 4) Patients with active separas or infection, 5) Conditions, which tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing and rehabilitation period, 6) ACL repairs, which would not be appropriate for fixation with metallic screws.

The implant is composed of mixture of poly-96L/4D-lactide copolymer and tri-calsium phosphate. The predicate devices like Mitek Biocryl Interference Screws (013572) and Biocomposites Ltd Biolok (K993630, K002070) are utilizing mixture of poly-L-lactide and tri-calsium phosphate.
Lengths of implant are 20 30 mm
-Diameters of implant are 7mm-11mm.

The only modifications that were made are:
Amendment of a new raw material option, mixture of poly-961/4D-lactide copolymer and tricalsiumphosphate (TCP).
Design of driver hole is adapted of Linvatec BioScrew implant (K933719, -K952831, K973758).
Thread profile is adjusted to fit with bone taps of Linvatec BioScrew implant -(K933719, K952831, K973758).
Reference numbers for these new screw versions. These changes are updated in labelling.
New trade name to separate it from SmartScrew ACL. This change is updated in labelling.
Revision of insert sheet concerning adaption of instrumentation of BioScrew. -

The provided document is a 510(k) summary for the Linvatec Biomaterials Osteo ACL Screw, an orthopedic device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

The 510(k) summary is focused on:

• Device Identification: Trade name, common name, classification, product code.
• Predicate Device Comparison: Listing similar previously cleared devices.
• Intended Use and Contraindications: What the device is for and situations where it should not be used.
• Device Description: Material composition, dimensions, and modifications from previous versions.
• Substantial Equivalence Argument: A statement that the modified device does not raise new safety or efficacy concerns compared to the predicate devices.

There are no acceptance criteria or study results presented in this document concerning performance metrics like accuracy, sensitivity, specificity, or reader improvement with AI assistance, as this is not the purpose of a 510(k) premarket notification.

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The BioButton™ is a cortical fixation device used for secondary fixation in conjunction with an interference screw to secure soft tissue or bone-tendon-bone grafts in ACL and PCL reconstruction.

The BioButton™ is a sterile, single-use fixation device made from an absorbable homopolymer derived from Poly (L-lactic) Acid that will gradually be metabolized by the body. The implant is attached to a soft tissue or bone-tendon-bone allograft during anterior and posterior cruciate ligament autograph or reconstruction. The implant is radiotranslucent with regard to intraoperative fluoroscopy, but it can be visualized with MRI and CAT scan.

The provided text describes the BioButton™ - Recessed Ligament Button, a medical device. However, it does not contain information about acceptance criteria, detailed study designs, sample sizes for test or training sets, expert qualifications, or ground truth establishment relevant to the performance of an AI/ML powered device.

The document is a 510(k) Summary of Safety and Effectiveness for a physical medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance metrics for an AI algorithm.

Therefore, I cannot populate the requested table or answer the specific questions about AI/ML device performance from the provided text.

Here's what I can extract based on the type of document provided:

Summary of what the document does offer:

• Device Name: BioButton™ - Recessed Ligament Button
• Intended Use: Cortical fixation device used for secondary fixation in conjunction with an interference screw to secure soft tissue or bone-tendon-bone grafts in ACL and PCL reconstruction.
• Predicate Devices: Hewson Ligament Button (Richards Manufacturing Co., Inc.) for function and intended use, and BioScrew® Absorbable Interference Screw (Linvatec Corporation) for materials.
• Testing: "Testing has been done to prove safety and effectiveness of the device." (No details provided)
• Regulatory Conclusion: Substantially equivalent to legally marketed predicate devices.

Missing Information (as it pertains to AI/ML device performance studies):

All the specific questions you asked are geared towards the evaluation of an AI/ML-powered device. The provided text describes a physical surgical implant, not an AI algorithm. Therefore, none of the following information is present:

• Acceptance criteria and reported device performance (in terms of AI metrics like sensitivity, specificity, AUC, etc.)
• Sample sizes for test sets or training sets.
• Data provenance (country of origin, retrospective/prospective for AI data).
• Number of experts or their qualifications for establishing AI ground truth.
• Adjudication methods.
• MRMC comparative effectiveness study results (effect size of AI assistance).
• Standalone (algorithm-only) performance.
• Type of ground truth used for AI models.
• How ground truth for training sets was established.

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