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The ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) is indicated for aspiration of bone marrow or autologous blood.
The ALARA BMA Neuro Access Kit is indicated for pedicle pilot hole preparation, locating, and identifying spinal roots / nerves by providing proximity feedback.
The ALARA BMAC Needle is intended for use in harvesting core biopsy samples of cancellous bone and/or bone marrow.

The ALARA BMA Neuro Access Kit utilizes a neuromonitoring platform in providing the surgeon with nerve / root location feedback during the approach to a pedicle to support a guidewire placement.

The ALARA BMAN and ALARA BMAC Kit includes various single-use needles designed for bone marrow aspiration and aspiration of autologous blood.

This document is an FDA 510(k) clearance letter for a medical device called the "ALARA BMA Neuro Access Kit." This type of document primarily focuses on establishing "substantial equivalence" to predicate devices, rather than presenting detailed study results for a new AI/ML-driven diagnostic device.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML diagnostic. The "Performance Testing" section lists various engineering and material tests (e.g., torque, pull, strength, sterilization, biocompatibility) relevant to the physical components of the device, not performance metrics for an AI algorithm.

Here's why the requested information cannot be extracted from this document:

• No AI/ML Component: The device description and performance testing sections indicate a physical medical instrument (needles for biopsy, aspiration, and a neuromonitoring platform for "proximity feedback" during pedicle preparation). There is no mention of an AI or machine learning algorithm. The "proximity feedback" is likely an electrical or mechanical system, not an AI interpreting images or data.
• Focus on Substantial Equivalence: A 510(k) clearance is primarily about demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This often relies on comparing design, materials, intended use, and non-clinical performance (like the engineering tests listed). It does not typically involve the rigorous clinical efficacy studies or AI performance validation described in your prompt.
• Lack of Diagnostic Claims: The device is for "aspiration of bone marrow or autologous blood," "pedicle pilot hole preparation, locating, and identifying spinal roots / nerves by providing proximity feedback," and "harvesting core biopsy samples." These are procedural/interventional uses, not diagnostic uses that would involve interpreting data (image, signal, etc.) with an AI.

In summary, as the provided document pertains to a physical medical device and not an AI/ML-driven diagnostic, the questions about acceptance criteria for AI performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for AI are not applicable to the content provided.

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The TiLink-P Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The TiLink-P SI Joint Fusion System contains various orthopedic instruments to assist the user in implanting a titanium sacroiliac implant into the sacroiliac joint. The SurGenTec TiLink-P SI Joint Fixation System includes TiLink Implants and associated Instruments (sterile or non-sterile). The TiLink-P SI Joint Fusion System may be used via lateral or posterior oblique. Bone graft material is used with the TiLink-P SI Joint Fusion System to facilitate bone growth.

This document is a 510(k) premarket notification decision letter from the FDA to SurGenTec LLC for their TiLink-P SI Joint Fusion System. It states that the device has been determined to be substantially equivalent to legally marketed predicate devices.

Based on the provided text, the device discussed is NOT an AI/ML medical device. The document describes a physical medical device (components of a sacroiliac joint fusion system) and its mechanical, material, and biological performance testing.

Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/ML performance (e.g., sensitivity, specificity, MRMC studies, ground truth establishment with experts) is not applicable to this submission.

The document discusses performance testing relevant to a physical implantable device, such as:

• Axial Pullout Testing per ASTM F543: This likely measures the force required to pull the implant out of bone, assessing its fixation strength.
• Static and Dynamic Cantilever Test per ASTM F3574: This assesses the implant's resistance to bending under various loading conditions, relevant for its structural integrity.
• Sterilization, Packaging, and Shelf-Life Validations: These ensure the device remains sterile and functional over time.
• Biocompatibility Assessment per ISO 10993: This confirms the materials used in the device are safe for contact with human tissue.

The "acceptance criteria" for these tests would be specific parameters and thresholds (e.g., minimum pullout force, maximum deflection under load) defined by the manufacturer and often guided by relevant ASTM/ISO standards. The "study" proving it meets these criteria would be the results of the physical tests.

Since the prompt specifically asks for details relevant to an AI/ML device, and this document does not pertain to AI/ML, I cannot provide the requested information in that context.

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The TiLink-P Joint Fusion System is intended for sacrolliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis.

The TiLink-P SI Joint Fusion System contains various orthopedic instruments to assist the user in implanting a titanium sacroiliac implant into the sacroiliac joint to transfix the joint. The SurGenTec TiLink-P SI Joint Fixation System includes TiLink Implants and associated Instruments. The TiLink-P SI Joint Fusion System fixates the sacroiliac joint by transfixing the cortices of the ilium and cortices of the sacrum.

The TiLink-P Compression Anchor is positioned so that it spans the cortices of ilium and cortices of sacrum, the TiLink-P Locking Screw is inserted through the TiLink-P Compression Anchor and across the SI Joint via a lateral approach, compressing the joint. Bone graft material is used with the TiLink-P SI Joint Fusion System to facilitate bone growth.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "TiLink-P Joint Fusion System." The purpose of these notifications is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it's as safe and effective.

The type of "device" in question here is a system of orthopedic implants and instruments used for sacroiliac joint fusion. This is a physical medical device, not software or an AI algorithm. Therefore, the questions related to "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/software device do not apply to this document.

The document describes performance testing for the physical device, which involves mechanical tests to ensure its structural integrity and functionality, rather than clinical performance based on an AI model's output.

Here's why the AI/software-related questions cannot be answered from this document:

• No AI or Software Component: The 510(k) summary explicitly describes the TiLink-P Joint Fusion System as "various orthopedic instruments to assist the user in implanting a titanium sacroiliac implant" and "TiLink Implants and associated Instruments." There is no mention of any AI, machine learning, or software component that would require assessment of diagnostic accuracy, image performance, or human-AI collaboration.
• Focus on Substantial Equivalence: The entire premise of a 510(k) is to prove substantial equivalence to a predicate device. This typically involves comparing indications for use, technological characteristics, materials, and mechanical performance for physical devices. It does not involve evaluating "device performance" in terms of diagnostic accuracy or impact on human readers, which are typical for AI/software clearances.
• Performance Testing Summary: The "Performance Testing Summary" lists "Axial Pullout Testing per ASTM F543," "Torsional Properties per ASTM F543-17," and "Static and Dynamic Cantilever Test per ASTM F3574." These are all standard mechanical tests for orthopedic implants, ensuring they can withstand physiological loads. They are not studies of algorithm performance.

Therefore, I cannot provide answers to the questions you've asked because they are tailored for AI/software-based medical devices, and the provided document describes a physical orthopedic implant system.

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