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The Arthrex Tibial GraftBolt is intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon during cruciate ligament reconstruction procedures

The Arthrex Tibial GraftBolt consists of a pre-packaged mating sheath and a screw pair offered in two new sizes which extend the current size range.

The Arthrex Tibial GraftBolt is a medical device for fixing tissue to bone during cruciate ligament reconstruction. The provided text describes the device and its substantial equivalence to a predicate device, but it does not contain acceptance criteria or detailed study results that prove the device meets specific performance criteria beyond general statements about "ultimate load strength."

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes, ground truth establishment, expert qualifications, or MRMC studies for this specific device from the provided text.

Here's what can be extracted based on the limited information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective). The study is described as "mechanical testing data."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not applicable. The "ground truth" for mechanical testing would typically refer to established engineering standards or physical measurements, not expert consensus on medical images or diagnoses.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable. Mechanical testing typically involves objective measurement against pre-defined standards, not human adjudication.

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:

• MRMC Study Done: No. This device is a mechanical implant, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant here.

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

• Standalone Study: The "mechanical testing data" can be considered a form of standalone testing, as it evaluates the device's physical properties independently. However, this is not an "algorithm only" study.

7. The type of ground truth used:

• Type of Ground Truth: Mechanical testing standards and physical measurements of "ultimate load strength."

8. The sample size for the training set:

• Sample Size: Not applicable. This is a physical device undergoing mechanical testing, not a machine learning model requiring a training set.

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

• How Ground Truth Established: Not applicable.

Summary of what is known from the provided text:

• The device is "Arthrex Tibial GraftBolt."
• It is intended for fixation of tissue during cruciate ligament reconstruction.
• It was compared for substantial equivalence to a predicate device (K093912: Arthrex Tibial GraftBolt).
• Mechanical testing was performed to demonstrate that its ultimate load strength "meets or exceeds the minimum acceptance criteria." The specific criteria are not detailed.
• The mechanical testing is the "study" that supports the device meeting its performance claims for substantial equivalence in terms of strength.

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The Arthrex Tibial GraftBolt is intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon during rruciate ligament reconstruction procedures.

The Arthrex Tibial GraftBolt consists of a pre-packaged mating sheath and screw pair offered in three sizes. The Arthrex Tibial GraftBolt is intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon during cruciate ligament reconstruction procedures.

The provided text is for a 510(k) summary for the "Arthrex Tibial GraftBolt," a bone fixation screw. This document focuses on demonstrating substantial equivalence to predicate devices based on device description and intended use, rather than presenting a study with specific acceptance criteria that the device's performance, as measured by a study, needs to meet.

Therefore, many of the requested elements for describing an acceptance criteria study are not present in the provided text. The document does not describe a performance study for the Arthrex Tibial GraftBolt that measures specific performance metrics against pre-defined acceptance criteria.

Here's a breakdown of the requested information based on the provided text, indicating where information is not available:

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

• Not Available. The provided document does not contain a table of acceptance criteria or reported device performance metrics from a study. The 510(k) is based on showing substantial equivalence in design and intended use to predicate devices, not on a performance study with specific quantitative outcomes.

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

• Not Available. No specific test set or data provenance from a study is mentioned.

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 Available. This information is relevant to studies involving expert review for ground truth, which is not described here.

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

• Not Available. This is relevant to studies requiring expert adjudication, which is not described here.

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

• Not Applicable. The device is a bone fixation screw, not an AI or imaging diagnostic tool. An MRMC study is not relevant to this type of medical device.

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

• Not Applicable. The device is a bone fixation screw, not an algorithm.

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

• Not Available. No ground truth for a study is mentioned. The "ground truth" for this 510(k) process is the established safety and effectiveness of the predicate devices based on their prior clearance and market history.

8. The sample size for the training set

• Not Available. No training set for a study is mentioned.

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

• Not Available. No training set or its ground truth establishment is mentioned.

Summary based on the provided document:

The Arthrex Tibial GraftBolt 510(k) (K093912) demonstrates substantial equivalence to predicate devices (K032167: Bio-Intrafix™ Tibial Screw and Sheath - Mitek Worldwide and K083607: AperFix® Tibial Implant with Inserter -- Cayenne Medical). The argument for substantial equivalence is based on the device's basic features and intended uses being very similar to the predicate devices. The document explicitly states: "Any differences between the Arthrex Tibial GraftBolt and the predicate devices are considered minor and do not raise questions concerning safety and effectiveness." This type of 510(k) submission does not rely on a dedicated performance study with acceptance criteria and measured device performance in the way described in your request.

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