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

The Arthrex DynaNite Compression Plate is intended to be used in conjunction with the Arthrex Compression FT Screws.

The Arthrex DynaNite Compression Plate is an implant with a number of threaded holes and a central region of articulating arms. Sizes range from approximately 15 to 30mm in hole-to-hole distance. Geometrically, the plate is offered in straight, 'T-shape', and 'X-shape' configurations. The Arthrex DynaNite Compression Plate is sold attached to a clamp delivery device, which constrains the implant in an elongated state, along its long axis. The clamp delivery device is removed after screw fixation is achieved, which in turn causes the plate to return to its original confirmation (shape memory effect), shortening along its long axis and generating compression. The Arthrex DynaNite Compression Plate is sold as sterile and is single-use. The Arthrex DynaNite Compression Plate is to be used with the Arthrex 3.0 mm Titanium VA Locking Screws and Locking Screws cleared under K143614 and K150456.

The provided text is related to a 510(k) premarket notification for a medical device called the "Arthrex DynaNite Compression Plate." This submission confirms that the device is substantially equivalent to legally marketed predicate devices, not an AI/ML device. Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device is not applicable to this document.

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The Arthrex DynaNite K-Wire is indicated for fixation of osteotomies and reconstruction of the lesser toes following correction procedure for hammertoe.

The Arthrex DynaNite K-Wire is a double tipped, unthreaded implantable Nickel Titanium (Nitinol) K-Wire consisting of two regions: a longer, superelastic end and a shorter, malleable end to allow fixation of bone fragments while being able to deform the protruding end. The Arthrex DynaNite K-Wire family ranges from 0.86 mm to 2.5 mm in diameter and is 5.91 inches in length. The Arthrex DynaNite K-Wire is sold sterile and is single-use.

This document, K200068, is a 510(k) premarket notification for the Arthrex DynaNite K-Wire. It's important to understand that a 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device, rather than providing the detailed clinical trial data and acceptance criteria typically associated with de novo classifications or PMA applications for novel devices or high-risk devices.

Therefore, the document describes engineering and biocompatibility testing to demonstrate performance and safety, not an AI model that requires a "study that proves the device meets acceptance criteria" in terms of performance metrics like sensitivity, specificity, or human reader improvement.

Based on the provided text, here's what can be extracted and how it differs from a typical AI/software as a medical device (SaMD) study:

1. Table of Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" here are based on meeting performance requirements comparable to the predicate device and established standards for metallic bone fixation fasteners, and ensuring biocompatibility.

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

• For the mechanical tests related to performance (tensile, bend, fatigue), the sample sizes are not explicitly stated but would be the number of test articles (K-wires) subjected to each specific test. These are in-vitro (lab-based) tests, not human data.
• For biocompatibility tests, sample sizes are implied to be sufficient for the specific biological tests (e.g., cell cultures for cytotoxicity, animal models for implantation/systemic toxicity, or specific chemical analyses). These are also in-vitro or in-vivo (animal model) tests, not human data.
• Data Provenance: The data comes from the manufacturer's internal testing as part of their design verification and validation process, conducted according to recognized ASTM and ISO standards. It is prospective in the sense that the tests were specifically performed for this submission, using newly manufactured devices. It is not patient data from a specific country.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This section is not applicable to this type of device and submission. "Ground truth" in the context of an AI/SaMD diagnostic device typically refers to clinical diagnosis or pathology verified by multiple expert readers. For a medical device like a K-wire, "ground truth" is established by adherence to engineering standards, material science principles, and biocompatibility guidelines. The "experts" are the engineers, material scientists, and toxicologists who conducted and interpreted these tests.

4. Adjudication Method for the Test Set:

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical trial data involving image interpretation or clinical outcomes where there might be inter-reader variability. For engineering and biocompatibility testing, success or failure is determined by whether the device meets predefined pass/fail criteria for each test according to the relevant standard.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This is not applicable. MRMC studies are used to evaluate the impact of an AI algorithm on human reader performance for diagnostic tasks. The Arthrex DynaNite K-Wire is a physical implantable device, not a diagnostic AI.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

This is not applicable. This concept applies to AI algorithms. The K-wire's "performance" is its physical and biological properties.

7. Type of Ground Truth Used:

As explained above, the "ground truth" is defined by:

• Engineering standards: ASTM and ISO specifications for mechanical properties (e.g., required tensile strength, fatigue life).
• Biocompatibility standards: ISO 10993 series and USP for biological safety (e.g., acceptable cytotoxicity limits, pyrogen limits).
• Predicate device performance: The performance of the predicate device (K132895: WMT Implantable K-Wires) serves as a benchmark for demonstrating substantial equivalence for mechanical properties.

8. Sample Size for the Training Set:

This is not applicable. "Training set" refers to data used to train machine learning models. This device does not involve machine learning.

9. How the Ground Truth for the Training Set Was Established:

This is not applicable.

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