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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 BiLok® ST Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures. The BiLok® ST Screw is used to provide suspensary fixation during femoral fixation in ACL reconstruction using a double looped (semitendinosus/gracilis) or quadruple (semitendinosus) graft.

The cannulated BiLok® ST Screws are 6 – 9mm diameters and 30 – 40mm lengths. The Bil.ok® ST Screw is moulded from a Poly L lactide/Beta Tri-Calcium Phosphate composite.

The provided text describes a 510(k) premarket notification for the BiLok® ST Screw, a device used in ACL reconstruction. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices based on:

• Identical material of construction and manufacturing methods to the previously cleared BiLok Screw (K002070).
• Same function and indications for use as Arthrex Bio Transfix Cross Pin (K011172) and Biosteon Cross Pin (K021351).
• Claimed equivalent functional mechanical performance characteristics to the predicate devices.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported performance, nor can I provide details on sample sizes, ground truth establishment, or AI-related study specifics, as this information is not present in the provided text.

The document is a regulatory submission for a medical device and thus does not include the type of detailed performance study data you are asking for.

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The Mitek Biocryl Interference Screw is indicated for the fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee.

The device described in this 510(k) is sterile, disposable implant designed to secure soft tissue to bone. The Mitek Biocryl Interference Screws are indicated for the fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee.

The provided text is a 510(k) summary for the Mitek Biocryl Interference Screws, which is a medical device. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a study proving performance against defined acceptance criteria in the typical sense for a new, novel device.

Therefore, the information requested regarding acceptance criteria, performance studies, sample sizes, expert involvement, and ground truth establishment, which are common for algorithms or diagnostic devices, is not applicable to this specific document as it describes a modification to an existing device type and relies on demonstrating equivalence through design control and performance testing, not clinical outcome studies.

Here's why and what information can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not Applicable. The document explicitly states: "This submission is a Special 510(k): Device Modification as described in FDA's guidance document entitled 'The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.' In support of this 510(k), Mitek has provided certification of compliance to 21 CFR 820.30 Design Control requirements, descriptions of Mitek's Design Control and Risk Analysis procedures, and the results of validation testing (performance testing) for the device modification."
• This indicates that performance was assessed against internal design control requirements and validation tests, not external, publicly defined acceptance criteria with reported metrics like sensitivity/specificity. The focus is on demonstrating that the modified device performs as intended and is equivalent to the predicate devices.

2. Sample Size for Test Set and Data Provenance:

• Not Applicable. No explicit "test set" in the context of clinical data or algorithm evaluation is mentioned. The "performance testing" referenced would likely involve bench testing (e.g., mechanical strength, degradation properties) for the device modification. The sample size for such engineering tests is not provided in this summary.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Applicable. This type of information is relevant for studies involving human interpretation or subjective assessment, typically with diagnostic algorithms or imaging. This document describes an orthopedic implant, not a diagnostic device requiring expert ground truth establishment in this manner.

4. Adjudication Method:

• Not Applicable. No adjudication method is described as there's no "ground truth" to adjudicate in the context of this device type and submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Not Applicable. This is not a diagnostic device or an AI-assisted interpretation tool. Therefore, an MRMC study is irrelevant.

6. Standalone Algorithm Performance:

• Not Applicable. This is a physical medical implant, not an algorithm.

7. Type of Ground Truth Used:

• Not Applicable. For a physical implant, "ground truth" would relate to its structural integrity, biocompatibility, and mechanical properties demonstrated through various engineering tests and material analyses, not clinical outcomes in the same way an algorithm is evaluated. The document states validation testing and compliance with design controls were performed.

8. Sample Size for Training Set:

• Not Applicable. This is a physical implant, not an algorithm that requires a training set.

9. How Ground Truth for Training Set was Established:

• Not Applicable. As above, it's not an algorithm requiring a training set and associated ground truth.

Summary of what is provided:

• Device Name: Mitek Biocryl Interference Screws
• Indication for Use: Fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee.
• Study/Basis for Equivalence: Special 510(k) submission based on device modification. Demonstrated substantial equivalence through:
  • Certification of compliance to 21 CFR 820.30 Design Control requirements.
  • Descriptions of Mitek's Design Control and Risk Analysis procedures.
  • Results of validation testing (performance testing) for the device modification.
• Conclusion: Based on indications for use, technological characteristics, and comparison to predicate devices, substantial equivalence was shown.

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