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The Stryker ProCinch Adjustable Loop Fixation Device is intended for the fixation of bone-to-bone or soft tissue-to-bone as fixation posts, a distribution bridge, or for distributing suture tension during Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) Repair and Reconstruction.

The Stryker ProCinch Adjustable Loop Device is a cortical suspensory fixation implant that consists of an adjustable nonabsorbable suture loop assembled to a titanium button. The device is offered in two configurations. Standard Tensioning and Reverse Tensioning.

The provided text is a 510(k) premarket notification for a medical device called the "Stryker ProCinch Adjustable Loop Device." The document focuses on establishing substantial equivalence to a predicate device through non-clinical bench testing. It does not contain information about acceptance criteria or a study proving device performance in the manner typically associated with clinical studies involving AI or imaging devices.

Therefore, many of the requested categories cannot be filled as the information is not present in the provided text.

Here's a breakdown of what can be extracted:

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

   Acceptance Criteria	Reported Device Performance
   Not specified	"Statistically equivalent or better than the predicate device" in Cyclic Extension and Ultimate Tensile Strength after cyclic loading.

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

   • Sample Size: Not specified for the bench testing.
   • Data Provenance: Not applicable as this was "Non-clinical bench testing."

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)

   • Not applicable; "Clinical testing was not required." The ground truth was established through engineering tests.

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

   • Not applicable; "Clinical testing was not required."

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

   • No. This is a physical orthopedic device, not an AI or imaging device.

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

   • Not applicable; this is a physical orthopedic device.

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

   • Ground Truth: Engineering measurements (Cyclic Extension, Ultimate Tensile Strength) against a predicate device.

8. The sample size for the training set

   • Not applicable; this is non-clinical bench testing, not an AI model requiring a training set.

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

   • Not applicable; this is non-clinical bench testing, not an AI model requiring a training set.

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