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The A.I.M. Lead Loop Suturing Device is intended for use in securing Spinal Cord Stimulation (SCS) leads and catheters to the fascia or intra-spinous/supra-spinous ligament.

The A.I.M. Lead Loop Suturing Device is a singular anchor threaded with an adjustable loop of non-absorbable size 0 suture. The suture material is commercially available Ultra-High Molecular Weight Polyethylene or Polyester braid. The anchor is composed of carbon fiber reinforced polyetheretherketone (PEEK OPTIMA®) supplied by Invibio®. The device is provided sterile and pre-loaded in a needle-tipped, disposable-delivery device to facilitate insertion into tissue. A sterile, disposable ancillary instrument is available separately, or included with the Lead Loop Suturing Device, to assist with tensioning the construct and trimming the suture once the appropriate tension is achieved.

The provided document describes a medical device, the A.I.M. Lead Loop Suturing Device, and its 510(k) submission for substantial equivalence to a predicate device. The information is related to the regulatory approval process and includes a summary of performance testing, but it does not contain the kind of detailed information about acceptance criteria, specific study designs (like MRMC), expert involvement, or ground truth establishment that would be typically found for an AI/ML-based medical software device.

Therefore, many of the requested items cannot be extracted from this document as they are not applicable to the type of device being described (a physical suturing device, not an AI/ML diagnostic tool).

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria (Implied): The document states that "Comparative performance testing with the predicate demonstrated equivalent performance and did not raise any new questions of safety or effectiveness." This implies the acceptance criterion was equivalence or non-inferiority to the predicate device in terms of performance and safety.
• Reported Device Performance: "Bench testing was conducted to confirm that the A.I.M. Lead Loop Suturing Device performs as well or better than the predicate in cyclic loading and ultimate device/construct failure."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• This information is not provided in the document. The testing described is "bench testing," which typically involves laboratory simulations, not clinical patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This information is not applicable/provided. The device is a physical suturing tool, not an AI/ML algorithm requiring expert-labeled ground truth for diagnostic accuracy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This information is not applicable/provided. Adjudication methods are typically used for establishing ground truth in clinical trials or for AI/ML performance evaluation, which is not the type of testing described.

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

• This information is not applicable/provided. This type of study relates to AI/ML devices assisting human interpretation, which is not relevant to a physical suturing device.

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

• This information is not applicable/provided. This refers to AI/ML algorithm performance, which is not relevant to this physical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the described bench testing, the "ground truth" would be objective physical measurements of device properties like cyclic loading capacity and ultimate failure strength, compared against the predicate device's known performance or established engineering standards. It is not based on clinical ground truth types like expert consensus or pathology reports.

8. The sample size for the training set

• This information is not applicable/provided. A physical device does not have a "training set" in the context of AI/ML.

9. How the ground truth for the training set was established

• This information is not applicable/provided. As above, there is no "training set" for this type of device.

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The A.I.M. Knotless Meniscal Repair Device is an implantable suture retention device which facilitates percutaneous or endoscopic soft tissue repair, including the repair of meniscal tears.

The A.I.M. Knotless Meniscal Repair Device is comprised of two implants pre-threaded with commercially available Ultra High Molecular Weight Polyethylene, USP Size 0 suture pre-loaded into a needle delivery device that will allow the surgeon to repair soft tissue, including a meniscal repair. The needle tip may be available straight, curved, and/or reverse-curved.

The provided text describes a medical device, the A.I.M. Knotless Meniscal Repair Device, and its 510(k) summary, but it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way typically associated with diagnostic AI/imaging devices.

The document states: "Bench testing was conducted to confirm that the A.I.M. Knotless Meniscal Repair Device performs as well or better than the predicate on pull-out performance and cyclic loading." This indicates performance testing was done, but the specific acceptance criteria (e.g., minimum pull-out strength in Newtons, number of cycles survived at a certain load) and the detailed results are not provided in the given text.

Therefore, I cannot fill out the requested table or answer most of the questions as the necessary data is absent from the provided text.

Here's what I can infer from the text, acknowledging the limitations:

1. Table of Acceptance Criteria and Reported Device Performance:

All other requested information regarding sample size, data provenance, experts, adjudication, MRMC studies, standalone performance, ground truth types, training set details, and ground truth establishment methods is not available in the provided document, as it focuses on a a physical medical device (suture retention device) and its substantial equivalence and not an AI or imaging diagnostic device. The 'study' mentioned is a bench test to compare mechanical properties with a predicate, not a clinical or AI performance study.

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