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The Arthrex DynaNite Nitinol Staple is intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.

The Arthrex DynaNite Nitinol Staples are indicated for:
• Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
• Fixation of proximal tibial metaphysis osteotomy.
• Hand and foot bone fragment and osteotomy fixation and joint arthrodesis.
• Fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula and sternum.
• When used with Arthrex FiberTape Cerclage System, the Arthrex DynaNite Nitinol Staple (sizes 13x10 and 15x12 only) is intended for sternotomy indications including the "rewiring" of osteotomized sternums.

The Arthrex DynaNite Nitinol Staples are Nickel Titanium (Nitinol) bone fixation devices intended to be permanently implanted. The implant is formed with two legs connected by a bridge and is offered in multiple combinations of bridge widths, leg lengths, and cross sections to accommodate various anatomy.

This document is a 510(k) Summary for the Arthrex DynaNite Nitinol Staples, which is a medical device. It describes the device's indications for use and states that the submission is to expand these indications. The document mainly focuses on proving substantial equivalence to a predicate device rather than presenting a study to meet specific performance acceptance criteria for a new device.

Therefore, the information provided does not directly describe a study that sets acceptance criteria for device performance in the sense of accuracy or efficacy (as would be typical for an AI/CADe device). Instead, it describes performance testing conducted to demonstrate safety and substantial equivalence for an implantable medical device.

Based on the provided text, here’s an extraction of the requested information, adapted for a medical device rather than an AI/CADe system:

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

The document does not explicitly state numerical acceptance criteria in a table format for specific performance metrics in the way one would for an AI model (e.g., sensitivity, specificity thresholds). Instead, it describes types of performance tests and implies the acceptance criterion is "perform substantially equivalent" or "meets specifications" for safety parameters.

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

The document does not specify sample sizes or data provenance for the performance tests conducted. These tests are typically biomechanical or material tests performed in a lab setting, not clinical studies with human 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 is not applicable as the studies described are laboratory performance tests for a physical implant, not diagnostic assessments requiring expert interpretation or ground truth establishment in a clinical sense.

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

This is not applicable for the types of engineering and material performance tests 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 is not applicable, as the device is a physical bone fixation staple, not an AI/CADe system for diagnostic imaging.

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

This is not applicable, as the device is a physical bone fixation staple, not an algorithm. Performance tests are inherently "standalone" in this context, evaluating the physical properties of the device.

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

For the performance tests described:

• Cyclic/Fatigue Testing: The "ground truth" or reference is the performance of the predicate device/construct (Arthrex Cerclage Suture construct).
• MRI Compatibility: The "ground truth" is established by relevant national and international standards (FDA guidance, ASTM standards).
• Bacterial Endotoxin: The "ground truth" is established by pharmacopeial standards (EP 2.6.14/USP pyrogen limit specifications).

8. The sample size for the training set

This is not applicable, as the device is a physical bone fixation staple and does not involve AI model training.

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

This is not applicable for the reasons mentioned above.

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The Arthrex DynaNite Nitinol Staples are indicated for:

• . Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
• . Fixation of proximal tibial metaphysis osteotomy.
• . Hand and foot bone fragment and osteotomy fixation and joint arthrodesis.
• . Fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extend to preclude staple placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula and sternum.

The Arthrex DynaNite Nitinol Staples are Nickel Titanium (Nitinol) bone fixation devices intended to be permanently implanted. The implant is formed with two legs connected by a bridge and is offered in multiple combinations of bridge widths, leg lengths, and cross sections to accommodate various anatomies.

The provided text describes the 510(k) premarket notification for the "Arthrex DynaNite Nitinol Staples." This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving the performance of an AI/ML powered device.

Therefore, the information required to answer your questions about acceptance criteria, study design for AI/ML performance, sample sizes, expert ground truth establishment, MRMC studies, and standalone algorithm performance is not present in the provided text. The document outlines performance testing related to the physical and material properties of the staples (e.g., pull-out strength, bend fatigue, biocompatibility, MRI compatibility), not the performance of a diagnostic AI.

Here's why each of your requested points cannot be addressed with the provided text:

1. A table of acceptance criteria and the reported device performance: The document states that testing was "conducted to demonstrate that the Arthrex DynaNite Nitinol Staples perform statistically equivalent to the devices cleared under K142292, K993714 and K172052." Specific numerical acceptance criteria and reported performance values beyond "statistically equivalent" are not provided. These are mechanical and material performance criteria, not related to AI.
2. Sample sized used for the test set and the data provenance: Not applicable. The "test set" here refers to physical samples of the device undergoing mechanical, chemical, and biocompatibility tests, not a dataset for an AI model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI test set is about correct diagnoses or classifications, which is not relevant to testing medical staples.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Pertains to expert consensus for AI ground truth.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is a study design for evaluating the impact of AI on human reader performance, not relevant for a surgical staple.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. There is no algorithm mentioned.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. "Ground truth" for this device would be its physical properties meeting standards.
8. The sample size for the training set: Not applicable. There is no AI model mentioned.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) submission for a physical medical device (surgical staples), not an AI/ML software as a medical device. Therefore, the questions related to AI/ML device performance and study design are not addressed.

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