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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 Nitinol Compression Plating System™ is indicated for:

• Fractures of various bones, including the clavicle, pelvis, scapula, long bones (humerus, radius, ulha, femur, tibia and fibula), and small bones such as metacarpals, metatarsals and phalanges.

The BME Nitinol Compression Plating System™ (NCP) consists of a sterile bone plate offered in various configurations (outlined below) and sterile titanium screws. The Nitinol bone plate is situated on two bones, across the fracture site, with titanium locking screws extending through the plate and cortex. The Nitinol bone plate is activated at room temperature upon release from a constraining instrument. In its final configuration, the plate actively provides continuous compression across the fusion site.
The NCP system contains plates and screws in the same shapes and sizes as those offered in the GPC system. The configurations of the BME system include Straight, T-shaped and X-shaped implants.
The main difference between the BME Nitinol Compression Plating System™ and the primary predicate, GPC Medical Bone Fixation Plates and Screw System™ is that the NCP plate component is made of Nitinol and provides active compression while the GPC plate is made of titanium alloy (Ti-6Al-4V) and does not provide active compression. The second difference is that the BME implants are offered sterile and for single use, while GPC Medical offers their products as non-sterile. BME Nitinol Compression Plating System™ is a fully sterilized kit comprised of the bone plate, titanium screws, sizing templates and instruments. The GPC Bone Plates and Bone Screws are offered non-sterile in reusable trays.

Here's a breakdown of the acceptance criteria and study information for the Nitinol Compression Plating System™ based on the provided document:

The document describes a 510(k) premarket notification for a Class II medical device, indicating that the primary goal of the studies was to demonstrate substantial equivalence to existing predicate devices, rather than establishing standalone performance against specific clinical efficacy metrics. Therefore, the "acceptance criteria" are predominantly related to mechanical and material performance benchmarks compared to predicates, and the "study" involves bench testing to demonstrate this equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" are typically defined by the performance of the predicate device or established ASTM standards. The "reported device performance" is the finding of substantial equivalence to these criteria.

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

• Sample Size for Test Set: The document mentions "The test device is the representative worst-case condition for all configurations" (Page 5). While it specifies the part number NP-35S-5 for the tested device, it does not explicitly state the number of samples tested for each benchmark. It implies that a sufficient number was tested to represent the worst-case and draw conclusions.
• Data Provenance: The data provenance is from bench testing conducted by BioMedical Enterprises, Inc. (BME). This is not clinical data, so it doesn't involve countries of origin or retrospective/prospective distinctions.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable as the described studies are bench tests, not clinical studies involving "ground truth" established by medical experts. The "ground truth" here is the adherence to engineering standards and comparison to predicate device performance.

4. Adjudication Method for the Test Set

This section is not applicable as the described studies are bench tests, not clinical studies requiring adjudication of outcomes by experts.

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. The device is a physical bone plating system, not an AI-powered diagnostic or decision-support tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to this submission.

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

This is not applicable. The device is a physical bone plating system, not an algorithm.

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

The "ground truth" for these studies is:

• Engineering Standards: Specifically, ASTM F382(2008) e1, ASTM F2129-08, and ASTM F3044-14.
• Predicate Device Performance: The observed mechanical and material performance characteristics of the GPC Medical Bone Fixation Plates and Screw System™ and BME Speed Triad™ (K133844).

8. The Sample Size for the Training Set

This section is not applicable. The described studies are bench tests for a physical medical device. There is no "training set" in the context of machine learning or AI models. The design and manufacturing process would involve internal development and testing, but not a "training set" in this sense.

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

This section is not applicable for the reasons stated in point 8.

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The Speed™, Speed Shift™, Speed Titan™ and Speed ArcTM 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 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 Speed™ product family consists of nitinol staple implants offered in a range of sizes for bone fixation. The Speed™ product family consists of Speed™, Speed Shift™, Speed Arc™, and Speed Titan™ with the primary difference being the shape of the bridge. The bridges range from flat (Speed™ and Speed Titan™), arched (Speed Arc™), and stepped (Speed Shift™) to conform to patient and osteotomy anatomy.

All of the Speed™ implants are delivered to the operating room with the legs parallel in a constraining plastic inserter. The implant is then released from the inserter and transformed by ambient and body heat after insertion so that the legs converge. The implants do not require any external heating; they are completely transformed at typical operating room temperatures or body heat.

The difference between the Speed™ implant staples and the primary predicate implant staples are their heat activating temperature as well as bridge shape (stepped or curved). The predicate BME OSStaple™ requires an external heating unit to warm the staples and activate the compression function. The bundled implant staples are activated at typical operating room temperatures or body temperature, and provide active compression without an external heating requirement.

The provided document describes the safety and performance of "Speed™," "Speed Shift™," "Speed Titan™," and "Speed Arc™" bone staples through various bench tests, comparing them to predicate devices. It does not contain information about studies involving human readers or AI.

Here's a breakdown of the available information regarding acceptance criteria and device performance:

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

2. Sample sized used for the test set and the data provenance

The document does not provide specific sample sizes for the test sets in any of the performance bench tests. The data provenance is controlled laboratory testing, not medical data from patients.

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

Not applicable. These are bench tests on physical devices, not assessments requiring expert interpretation of medical data.

4. Adjudication method for the test set

Not applicable. This is not a study involving human readers or 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

No MRMC comparative effectiveness study was done. This document focuses on the physical performance of bone staples, not AI-assisted diagnosis or human reader performance.

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 staple, not an algorithm.

7. The type of ground truth used

The ground truth for these tests is based on the established material science and mechanical engineering standards (ASTM standards) that define the test methods and the expected performance for such medical devices. For example, "superior pull-out resistance" is a direct measurement against a standard and comparison to a predicate, not an expert opinion or pathology.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not a machine learning or AI-based device.

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

Not applicable.

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