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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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Fracture and osteotomy fixation and joint arthrodesis of the hand and foot. Fixation of proximal tibial metaphysis osteotomy. Fixation of small fragments of bone (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 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 Elite™ Nitinol Fixation System, like primary predicate Speed Titan™ K133780, is a Nitinol implant for bone fixation and is designed to be delivered to the operating room in an "open" (legs parallel) and constrained state. The Elite™ Nitinol Fixation System was designed for surgeons who desire additional fixation points for increased rotational stability. The implant does not require any external heating. The implant is fully active at room and body temperature so that the legs compress after release from instrument (additional legs in Straight design compress in tandem). The primary differences between the Elite™ Nitinol Fixation System and the cleared Speed Titan™ K133780 are the configurations featured. The Speed Titan™ K133780 is a staple with two legs, while the Elite™ Nitinol Fixation System introduces three configurations: a Straight (with two and four legs), a Y-shape (three and four legs) and an H-shape (four legs).

The provided text is a 510(k) summary for the Elite™ Nitinol Fixation System, which is a bone staple. Medical device submissions like this primarily focus on showing substantial equivalence to a predicate device rather than comprehensive clinical studies proving specific performance metrics against acceptance criteria like those seen for AI/ML devices. Therefore, a direct answer for all your requested points, especially related to AI/ML device testing (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies), cannot be fully provided based solely on this document.

However, I can extract the information that is present and indicate where information is not available in the given text.

Here's the breakdown based on the provided document:

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

The document does not explicitly state "acceptance criteria" in the traditional sense of a specified threshold (e.g., Sensitivity > X%, Specificity > Y%). Instead, it relies on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. The "reported device performance" is framed as meeting or exceeding the performance of the predicate in these tests.

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the implied "acceptance criteria" (i.e., substantial equivalence) is a non-clinical performance testing study. The document states: "Performance testing includes: Corrosion (ASTM F2129-08), Elastic Static Bending (ASTM F564-10, A4) Pull-out Fixation Strength (ASTM F564-10, A2) and MR Compatibility (ASTM F2052, ASTM F2213, ASTM F2119, ASTM F2182) results of which demonstrate substantial equivalence or better."

Information Not Available (or Not Applicable for this type of device according to the document):

2. Sample sized used for the test set and the data provenance: Not applicable/provided in this document format. This is a physical bone staple, not an AI/ML device. The "test set" would refer to the samples used in the physical performance tests (e.g., number of staples tested for pull-out strength). This detail is not specified in the summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This concept is for AI/ML diagnostic devices.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This concept is for AI/ML diagnostic devices.
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. This is a physical bone staple, not an AI/ML diagnostic device meant to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical bone staple.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable/Provided. For non-clinical performance testing of a physical device, the "ground truth" is typically defined by the ASTM standard test methods themselves and the physical measurements obtained.
8. The sample size for the training set: Not applicable. This is a physical staple, not an AI/ML device that requires a "training set."
9. How the ground truth for the training set was established: Not applicable. This is a physical staple.

Summary of what the document focuses on:

The Elite™ Nitinol Fixation System is cleared based on substantial equivalence to existing predicate devices (Speed Titan™ K133780, Speed Triad™ K133844, OSSplate™ K993714). The rationale for substantial equivalence is based on:

• Identical Indications for Use.
• Same technological characteristics: both are made of nitinol, follow the same manufacturing procedures, and function similarly.
• Non-clinical performance testing: demonstrating that the new device performs "substantially equivalent or better" than the predicate in terms of corrosion resistance, elastic static bending, pull-out fixation strength, and MR compatibility, according to specific ASTM standards.
• No new questions of safety or effectiveness are raised by the design changes (changes in geometry, number of legs, width, and implant shapes).
• No clinical evidence was deemed necessary ("N/A" for "Substantial Equivalence Clinical Evidence").

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The OSStaple™ Chill is indicated for: Fracture and osteotomy fixation and joint arthrodesis of the hand and foot and, Fixation of proximal tibial metaphysis osteotomy.

The OSStaple M Chill is a nitinol implant that comes in a range of sizes and models for use in extremity bone fragment fixation, osteotomy fixation, and joint arthrodesis. The implant is delivered to the operating room in an "open" martensitic state. The implant is. then transformed by body heat after insertion, and contracts to a "closed" austenitic state. The OSStaple TM Chill differs from the OSStaple TM in that the staples:do not require any external heating; they are completely transformed by body heat. The OSStaple! 100 Chill also includes staples with smooth and barbed legs to achieve increased pull-out resistance: All other characteristics of the implant are identical to the OSStapleTM predicate.

This is a medical device 510(k) premarket notification for a bone staple. It does not contain information about the acceptance criteria and study proving a device meets acceptance criteria related to software or AI/ML performance. Therefore, I cannot provide the requested information about AI/ML device performance.

The document describes the OSStaple™ Chill, a nitinol implant for bone fixation. The "Device Description and Testing" section mentions "Bench testing of the OSStaple™ Chill showed that the implants remain in their open martensitic state at operating room temperatures (20°C - 24°C), and fully transform to their closed shape by body temperature (37°C). Testing also showed that both the smooth and barbed versions of the OSStaple™ Chill achieve equivalent or superior pullout resistance to the OSStaple™."

This relates to the physical and mechanical properties of the staple, not to an AI/ML device.

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Original indications for the Memograph® Staple System are as defined in 510(k) K993714. Additional indications fro the OSStaple" are the fixation of maxillofacial and mandibulofacial fractures and osteotomies.

The BioWarm™ represents a modification to the Warmsystem currently in use with the OSStaple" bone staple system. The BioWarm" has an on/off switch and two user adjusted controls. A user adjusted current and user adjusted time controls are on the front of the console. The controls are set to the requirements of a specific staple size and configuration. The BioWarm" gives both visual and audible indications of current delivery and an audible signal upon automatic completion of current delivery. The BioWarm", on the electrode handle, also provides visual indication of positive contact between the electrode and staple to be heated and visual indication of actual current flow. Current is activated with a button switch on the handle of the BioWarm™ electrode and will cease if the button is released prior to the automatic cessation by the circuitry

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any study details that would allow me to answer your request. The document is a 510(k) summary for a medical device modification (BioWarm™) and the FDA's response letter indicating substantial equivalence to a predicate device. It discusses the device's intended use and classification but offers no data from studies or specific performance metrics.

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