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The AperFix® Femoral Implant with Inserter is intended for use in tenodesis procedures with soft tissue grafts, utilizing cither arthroscopic or open techniques during Anterior Cruciate Ligament (ACL), Posterior Cruciate Ligament (PCL), Medial Collateral Ligament (MCL), Lateral Collateral Ligament (LCL), and Medial Patellofemoral Ligament (MPFL) reconstruction.

The Cayenne Medical AperFix® Femoral Implant with Inserter is a non-absorbable internal fixation device intended to provide tendon to bone fixation in arthroscopic or open procedures such as Anterior Cruciate Ligament (ACL), Posterior Cruciate Ligament (PCL), Medial Collateral Ligament (MCL), Lateral Collatcral Ligament (LCL), and Medial Patellofemoral Ligament (MPFL) reconstruction. It includes a body, wedge, two deployable arms, and compression pads. AperFix Femoral Implants are available in diameters of 9, 10 and 11 mm with two different lengths of 29 mm and 35 mm. Each device is intended for single use and is pre-loaded on a sterile inserter.

The AperFix® Femoral Implant with Inserter is a medical device and the provided text describes its 510(k) summary for FDA approval. For medical devices, "acceptance criteria" and "device performance" are typically related to regulatory requirements for safety and effectiveness, often demonstrated through bench testing and comparison to predicate devices, rather than clinical study metrics like sensitivity or specificity.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not specify a sample size for a "test set" in the context of clinical trials or performance studies involving human subjects for device performance metrics like sensitivity/specificity. The performance data mentioned relates to mechanical testing.

• Sample Size for Mechanical Testing: Not explicitly stated. The text only says "Mechanical testing was performed."
• Data Provenance: The mechanical testing was conducted as part of the regulatory submission by Cayenne Medical, Inc. The exact location or nature (e.g., in-house lab, third-party lab) is not specified, but it would be considered retrospective in the context of generating data for a premarket submission. No country of origin for patients or images is relevant here as it's mechanical testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the provided text describes a medical device (an implant), not an AI/imaging algorithm requiring expert interpretation of a "test set" for ground truth establishment. The "ground truth" for this device's performance would be the direct measurements from mechanical tests.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human experts in diagnostic tasks, which is not relevant here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This information is not applicable. An MRMC study compares the performance of human readers, typically in diagnostic imaging, with and without the assistance of an AI tool. The AperFix® Femoral Implant is a physical implant, not a diagnostic AI tool, so this type of study would not be performed for its approval.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. This question refers to the performance of an algorithm in isolation, which is relevant for AI-powered diagnostic tools. The AperFix® Femoral Implant is a physical device that functions in-vivo as an implant.

7. The Type of Ground Truth Used

For the AperFix® Femoral Implant, the "ground truth" for its performance is established through:

• Direct Mechanical Measurement: For attributes like pull-out strength.
• Material Science Principles: For the properties of the implant materials.
• Biological Equivalence: Implied by substantial equivalence to predicate devices which have established biocompatibility and clinical safety.

8. The Sample Size for the Training Set

This information is not applicable. "Training set" refers to data used to train an AI model. The AperFix® Femoral Implant is a physical medical device, not an AI model, and therefore does not have a "training set."

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the same reason as point 8.

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The AperFix™ Femoral Implant with Inserter is intended for use with soft tissue grafts to provide tendon to bone fixation during arthroscopic or open ACL reconstruction procedures.

The Cayenne Medical AperFix™ Femoral Implant with Inserter is a non-absorbable internal fixation device intended to provide tendon to bone fixation in hamstring tendon arthroscopic or open anterior cruciate ligament (ACL) reconstruction. It includes a body, wedge and two deployable arms with compression pads. AperFix Femoral Implants are available in diameters of 9, 10 and 11 mm with a standard length of 35 mm. Each device is intended for single use and is pre-loaded on a sterile inserter.

The AperFix Femoral Implant with Inserter will be supplied sterile. Sterilization will be accomplished by means of Co60 gamma irradiation at a dose of 25-40 kGy .

Mechanical testing was performed on the AperFix Femoral Implant. It was shown that pull-out strength is significantly higher than that of a predicate interference screw.

The provided text is a 510(k) summary for the AperFix™ Femoral Implant with Inserter, a medical device for ACL reconstruction. It focuses on administrative information, device description, and substantial equivalence to previously marketed devices. This type of documentation typically does not include the detailed information requested in your prompt regarding acceptance criteria and performance study specifics that are common for AI/software devices.

Therefore,Based on the provided 510(k) summary, I cannot provide the requested information for the following reasons:

• This document is for a mechanical medical implant, not a software or AI device. The questions you've posed (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set, ground truth) are highly relevant to the validation of AI/ML algorithms, particularly in medical imaging or diagnostic contexts.
• The 510(k) summary for this device focuses on demonstrating substantial equivalence to predicate mechanical devices. The primary "study" mentioned is "Mechanical testing... shown that pull-out strength is significantly higher than that of a predicate interference screw." This is a mechanical engineering test, not a clinical study involving human readers or AI performance metrics.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details as they pertain to AI/software validation, because this information is not present in the provided document about a mechanical implant.

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