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The TriMed® Small Compression Screws are indicated for fracture fixations, non-unions, and osteotomies of small bones and small bone fragments in the hand, wrist, elbow, ankle, and foot.

The TriMed® Large Compression Screws are indicated for fracture fixations, non-unions, and osteotomies of large bones and large bone fragments in the hand, wrist, elbow, ankle, and foot.

TriMed Compression Screws consists of small and large cannulated compression screws made of medical grade stainless steel and titanium. The small screws are indicated to be used as an aid in fracture fixations, non-unions and osteotomies of small bones and small bone fragments; the large screws are indicated to be used in fracture fixations, non-unions and osteotomies of large bones and large bone fragments. The TriMed Compression Screws are designed to provide additional constraint of movement of a fractured/osteotomized bone and non-unions and are intended only as an aid to fix the fracture/osteotomy in place during the healing process.

Based on the provided FDA 510(k) Clearance Letter for TriMed® Compression Screws (K243943), here's an analysis of the acceptance criteria and the study proving the device meets them.

It's important to note that this document is for a physical medical device (compression screws), not an AI/software-as-a-medical-device (SaMD). Therefore, many of the typical criteria for AI/ML-based devices (such as ground truth establishment by experts, adjudication, MRMC studies, standalone algorithm performance, training/test set sample sizes for AI, etc.) are not applicable here.

The "study" in this context refers to mechanical testing to demonstrate the device's performance and substantial equivalence to predicate devices, rather than clinical studies with human subjects or AI model validation.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for bone fixation fasteners like the TriMed® Compression Screws are primarily related to their mechanical properties, material biocompatibility, and intended use as compared to "predicate" devices already on the market. The core concept for a 510(k) clearance is "substantial equivalence."

Table of Acceptance Criteria and Reported Device Performance

The submission implies successful completion of these tests, leading to the substantial equivalence determination. |
| Material Compatibility | The materials used (medical grade stainless steel and titanium) must be biocompatible and suitable for long-term implantation in the human body. | "TriMed Compression Screws consists of small and large cannulated compression screws made of medical grade stainless steel and titanium."

The use of "medical grade" materials and comparison to predicate devices (some using stainless steel and titanium, others titanium only) implies conformance to established material safety standards. |
| Design and Principles of Operation | The device's design features, principles of operation, and manufacturing processes should be substantially equivalent to legally marketed predicate devices, ensuring similar safety and effectiveness profiles. | "TriMed Compression Screws are substantially equivalent to the predicate devices in terms of design features, principles of operation, manufacturing, packaging, and labeling."

The document specifically discusses the introduction of additional materials (stainless steel) and new screw diameters/lengths, asserting that these differences are "minor and do not raise different questions concerning safety or effectiveness." |
| Intended Use / Indications for Use | The stated indications for use for the device must align with historical use of similar devices and be supported by the device's design and performance. | TriMed® Compression Screws are indicated for "fracture fixations, non-unions, and osteotomies of small bones and small bone fragments in the hand, wrist, elbow, ankle, and foot" (Small Screws) and "large bones and large bone fragments" (Large Screws). This aligns with the use of predicate bone fixation fasteners. |
| Predetermined Change Control Plan (PCCP) | The PCCP outlines pre-approved modifications and the testing required to ensure continued safety and effectiveness without requiring new 510(k)s. This demonstrates a proactive approach to managing changes. | The PCCP details planned modifications (new materials, screw head designs, headed screw line extension) and specifies the test methods and validation activities (e.g., ASTM F543-17, FDA guidance, IEC 62366-1) that will be performed for each change. |

Study Details (as applicable to a physical medical device)

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

• Test Set Sample Size: Not explicitly stated as a "sample size" in the context of human data. For mechanical testing, this refers to the number of components or devices tested. ASTM F543-17 would specify the required number of samples for each mechanical test (e.g., torsional strength, bending strength, fatigue).
• Data Provenance: The document focuses on performance testing (mechanical studies) rather than clinical data from patients. The testing was conducted "in accordance with ASTM F543-17, FDA Guidance Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway, and/or in comparison to compression screws cleared under predicates K050681 and K093676." This implies the data is generated from laboratory testing of the manufactured devices. No country of origin for data (like patient data) is relevant here, as it's product engineering test data. It's prospective data generation from in vitro testing.

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

• Not Applicable (N/A). This is a physical medical device, not an AI/SaMD. "Ground truth" is established by engineering standards (e.g., ASTM F543-17) and direct comparison to the physical properties of predicate devices. The "experts" would be the engineers and scientists conducting the mechanical tests and comparing the results to the specified performance criteria, but their number and specific qualifications for "ground truth" establishment are not detailed in the context of expert consensus on an image or clinical finding.

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

• Not Applicable (N/A). Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical/imaging studies, typically for AI models. For mechanical testing, the results are quantitative and objective, measured against predefined standards.

4. 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 (N/A). MRMC studies are specific to evaluating the clinical performance of diagnostic or AI-assisted devices with human readers interpreting cases. This device is a surgical implant.

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

• Not Applicable (N/A). This criterion is for AI algorithms. The "standalone performance" of these screws refers to their mechanical integrity without human interaction, which is assessed through the mechanical testing mentioned.

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

• Engineering Standards and Predicate Device Performance Data. For a physical implant, "ground truth" for clearance is based on adherence to recognized mechanical engineering standards (e.g., ASTM F543-17) and demonstrating that the device performs equivalently or better than, and poses no new safety concerns compared to, the already cleared predicate devices.

7. The sample size for the training set:

• Not Applicable (N/A). This question is for AI/ML models. There is no "training set" in the context of clearing a physical medical device. The "training" for the device would be its design and manufacturing process, optimized through engineering principles.

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

• Not Applicable (N/A). As there's no training set for an AI model, this question is irrelevant here. The design and manufacturing of the screws are based on established biomechanical principles and material science.

In summary, the 510(k) clearance for the TriMed® Compression Screws relies on demonstrating substantial equivalence to predicate devices through a combination of engineering design comparisons, material characterization, and rigorous mechanical performance testing according to well-established standards. The typical criteria for AI/ML devices do not apply to this type of traditional medical device.

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The Arthrex VAL KreuLock™ Compression Screws (2.7 mm solid) are intended to be used in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, radius, ulna, calcaneus, and clavicle. When used with a plate, the screw may be used with the Arthrex Low Profile Plate, Small Fragment Plates, Distal Extremity Plates, Mesh Plates (2.7) and Distal Radius Plates.

The Arthrex VAL KreuLock™ Compression Screws (3.5 mm and larger, solid) are intended to be used in a plate-screw system for internal bone fixation for bone fractures, fusions, Osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneus, pelvis, acetabulum, metacarpals, metatarsals, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile Plate, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Distal Radius Plates, Humeral Fracture Plates, Osteotomy Plates, and Ankle Fusion Plates.

The Arthrex VAL Screws (2.7 mm solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions, in the ankle, foot, hand, wrist, tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, radius, ulna, calcaneus, and clavicle. When used with a plate, the screw may be used with the Arthrex Low Profile Plate, Small Fragment Plates, Distal Extremity Plates, Mesh Plates (2.7-3.0) and Distal Radius Plates.

The Arthrex VAL Screws (3.5 mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, pelvis, acetabulum, metacarpals, metatarsals, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile Plate, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Distal Radius Plates, Humeral Fracture Plates, Osteotomy Plates, and Ankle Fusion Plates.

The Arthrex SS VAL KreuLock™ Compression Screws are fracture fixation devices comprised of stainless steel (316L Stainless Steel per ASTM F138) self-tapping, solid, fully threaded, variable angle locking (VAL) screws. They are offered with a 2.7 mm or 3.5 mm diameter and range in lengths from 10 mm to 110 mm. The screws are sold single-use and non-sterile.

The Arthrex SS VAL Screws are fracture fixation devices comprised of stainless steel (316L Stainless Steel per ASTM F138) self-tapping, solid, fully threaded, variable angle locking (VAL) screws. They are offered with a 2.7 mm or 3.5 mm diameter and range in lengths from 8 mm to 110 mm. The screws are sold single-use and non-sterile.

The provided text describes mechanical performance testing for a medical device and not an AI/ML powered device, therefore the information required to answer the questions for an AI/ML powered device is not available.

The device in question, the "Arthrex SS VAL and VAL KreuLock™ Compression Screw System," is a physical medical device (fracture fixation screws) and the performance data described relates to mechanical properties (pull-out, compression, torque, etc.) and MRI compatibility. There is no mention of any AI/ML components, software algorithms, or clinical performance metrics typically associated with AI/ML device evaluations (e.g., sensitivity, specificity, AUC).

Therefore, I cannot provide a table of acceptance criteria and reported device performance in the context of AI/ML, nor can I answer questions regarding sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth for a training set was established. These categories are specifically designed for the evaluation of AI/ML-powered devices.

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The Arthrex VAL KreuLock™ Compression Screws (2.0-3.0 mm solid) are intended to be used in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, radius, ulna, calcaneus, clavicle and scapula. When used with a plate, the screw may be used with the Arthrex Low Profile Plate, Small Fragment Plates, Distal Extremity Plates, Mesh Plates (2.7-3.0) and Distal Radius Plates.

The Arthrex Hybrid KreuLock™ Compression Screws (3.5 mm and larger, solid) are intended to be used in a plate-screw system for internal bone fixation for bone fractures, fusions, Osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneus, pelvis, acetabulum, metatarsals, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile Plate, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Distal Radius Plates, Humeral Fracture Plates, Osteotomy Plates, and Ankle Fusion Plates.

The Arthrex Hybrid Low Profile VAL Screws (3.5mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneus, pelvis, acetabulum, metacarpals, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile Plate, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Distal Radius Plates, Humeral Fracture Plates, Osteotomy Plates, and Ankle Fusion Plates.

The Arthrex VAL and VAL KreuLock™ Compression Screw System is a fracture fixation device system comprised of titanium (Titanium Ti-6AL-4V per ASTM F1472) self-tapping, solid, fully threaded, variable angle locking (VAL) screws that are offered in standard and hybrid configurations. The Arthrex VAL KreuLock™ Compression Screws are offered in 2.0, 2.7 and 3.0 diameters and range in lengths from 6 mm to 80 mm. The Arthrex Hybrid KreuLock™ Compression Screws and Hybrid Low Profile VAL Screws consist of line extension screws with the locking head geometry of the existing 2.7 mm screws and a shaft geometry of the existing 3.5 mm screws. The Arthrex Hybrid KreuLock™ Compression Screws range in lengths from 12 mm to 80 mm and the Arthrex Hybrid Low Profile VAL Screws range in lengths from 10 mm to 80 mm. Arthrex VAL and VAL KreuLock™ Compression Screw System consist of single-use, non-sterile devices intended for end-user sterilization.

The provided text describes a 510(k) premarket notification for the Arthrex VAL and VAL KreuLock™ Compression Screw System. This is a medical device submission, and the information is primarily focused on demonstrating substantial equivalence to previously cleared predicate devices, rather than an AI/ML algorithm's performance study with acceptance criteria and ground truth.

Therefore, many of the requested details, such as sample size for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for an AI/ML model, are not applicable to this document.

However, I can extract information related to the performance data and the conclusion regarding substantial equivalence.

Here's a summary of the available information:

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

Since this is a mechanical fixation device, the "acceptance criteria" are not framed in terms of metrics like sensitivity or specificity, but rather in terms of compliance with established ASTM standards for mechanical properties. The reported performance is that the device meets these standards.

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

• Sample Size for Test Set: Not explicitly stated in terms of the number of screws or test repetitions. Testing was conducted "on the proposed Arthrex VAL and VAL KreuLock™ Compression Screw Systems."
• Data Provenance: Not applicable in the context of clinical data provenance. The data comes from mechanical and MRI compatibility testing of the physical device.

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

• Not Applicable. This is a mechanical device, not an AI/ML diagnostic system requiring expert interpretation for ground truth. The "ground truth" is adherence to established engineering and safety standards.

4. Adjudication method for the test set:

• Not Applicable. Mechanical testing to standards does not typically involve adjudication in the clinical sense. Results are measured against predefined engineering specifications.

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 medical implant, not an AI/ML diagnostic or assistive technology.

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

• Not Applicable. This is a medical implant, not an AI/ML algorithm.

7. The type of ground truth used:

• The "ground truth" for this device's performance is adherence to recognized ASTM International standards and FDA guidance documents for mechanical properties (e.g., pull-out strength, torsional strength, driving torque) and MRI compatibility (e.g., force, torque, image artifact, heating).

8. The sample size for the training set:

• Not Applicable. This is a medical implant, not an AI/ML algorithm.

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

• Not Applicable. This is a medical implant, not an AI/ML algorithm.

In summary: The provided document is a 510(k) clearance letter for a traditional medical device (bone screws), not an AI/ML software device. Therefore, most of the requested information pertinent to AI/ML model validation is not found here and is not relevant to this type of device submission. The study described focuses on demonstrating the physical and mechanical properties of the screws meet established industry standards and are substantially equivalent to predicate devices.

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The Arthrex VAL KreuLock™ Compression Screws (3.5 mm and larger, solid) are intended to be used in a plate-screw system for internal bone fixation for bone fractures, fusions, Osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneus, pelvis, acetabulum, metacarpals, metatarsals, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile Plate, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Distal Radius Plates, Humeral Fracture Plates, Osteotomy Plates, and Ankle Fusion Plates.

The Arthrex VAL Screws (3.5 mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneus, pelvis, acetabulum, metacarpals, metatarsals, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile Plate, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Distal Radius Plates, Humeral Fracture Plates, Osteotomy Plates, and Ankle Fusion Plates.

The Arthrex VAL KreuLock™ Compression Screws are fracture fixation devices comprised of titanium (Titanium Ti-6AL-4V per ASTM F1472) self-tapping, solid, fully threaded, variable angle locking screws that are offered in standard and reinforced configurations. They are offered with a 3.5 mm diameter and the standard versions range in lengths from 10 mm to 90 mm while the reinforced versions range in lengths from 10 mm to 110 mm. The reinforced configurations have a larger minor diameter with the same major diameter as the standard configurations.
The Arthrex VAL Screws are fracture fixation devices comprised of titanium (Titanium Ti-6AL-4V per ASTM F1472) self-tapping, solid, fully threaded, variable angle locking screws that are offered in standard and reinforced configurations. They are offered with a 3.5 mm diameter and range in lengths from 10 mm to 110 mm. The reinforced configurations have a larger minor diameter with the same major diameter as the standard configurations.

The provided text describes the 510(k) summary for the Arthrex VAL and VAL KreuLock™ Compression Screw System. This document outlines the device's technical specifications, indications for use, and a comparison to predicate devices, primarily focusing on demonstrating substantial equivalence through various mechanical and material tests.

However, there is no information within this document that describes a study involving an "AI device" or "algorithm." The document pertains to a medical device for bone fixation (screws), not a diagnostic or AI-powered imaging/analysis tool. Therefore, it does not contain the details typically sought when asking about acceptance criteria and study designs for AI/algorithmic devices, such as:

• A table of acceptance criteria and reported device performance (in terms of AI metrics like sensitivity, specificity, etc.)
• Sample sizes for test sets of AI data
• Data provenance for AI training/test sets
• Number of experts for ground truth establishment for AI
• Adjudication methods for AI ground truth
• Multi-reader multi-case (MRMC) studies for AI assistance
• Standalone performance of an AI algorithm
• Type of ground truth used for AI models
• Sample size and ground truth establishment for AI training sets

To directly answer your request based on the provided text, the answer is that the given document does not contain the information you are asking for, as it is not about an AI/algorithmic device.

The "Performance Data" section of the document describes the following types of tests for the mechanical bone screws:

• Mechanical Testing:
  • Pullout testing
  • Cantilever testing
  • Pushout testing
  • Head locking testing
  • Compression testing
  • Torque testing
  • Axial pullout analysis
  • Torsional strength testing
  • Driving torque testing
  • These tests were conducted in accordance with ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws to demonstrate that the changes do not affect performance and that the proposed devices are substantially equivalent to the primary predicate device.
• MRI Compatibility Testing:
  • MRI force, torque, and image artifact testing were conducted in accordance with
    • FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment"
    • ASTM F2052 (Measurement of Magnetically Induced Displacement Force)
    • ASTM F2119 (Evaluation of MR Image Artifacts from Passive Implants)
    • ASTM F2182 (Measurement of Radio Frequency Induced Heating near Passive Implants)
    • ASTM F2213 (Measurement of Magnetically Induced Torque on Medical Devices)

The acceptance criteria for these mechanical tests would typically be defined by the relevant ASTM standards and comparative data against the predicate device to demonstrate equivalent or superior performance in the specified mechanical properties. The study "proves" the device meets these criteria by showing that the results of these tests fall within acceptable ranges as compared to the predicate device.

To reiterate, if you're looking for information specific to AI/algorithmic device acceptance criteria and study designs, this document does not provide it because the device described is a physical bone screw system.

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The OSSIO® Pin Product Family is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis, and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace) in adults and children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by fixation.

OSSIOfiber® Compression Screws are indicated for maintenance of alignment and fixation of bone fractures, comminuted fractures, fragments, osteotomies, arthrodesis, and bone grafts, of the upper extremity, fibula, knee, ankle and foot in the presence of appropriate brace and/or immobilization in adults and children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by fixation.

The OSSIOfiber® Trimmable Fixation Nails are indicated for maintenance of alignment and fixation of bone fractures, ostectomies, arthrodesis and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace) in adults and children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by fixation.

The OSSIOfiber® devices are made of degradable poly (L-lactide-co-D, L-lactide) (PLDLA) reinforced with continuous mineral fibers. The polymer content degrades by hydrolysis into alphahydroxy acids that are metabolized by the body. The fibers are made from minerals that are found in natural bone. As the OSSIOfiber® implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the osteotomy, fusion, or fracture. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery.

The provided text is a 510(k) summary for the OSSIO® Pin Product Family, OSSIOfiber® Compression Screw, and OSSIOfiber® Trimmable Fixation Nail. This document primarily focuses on demonstrating substantial equivalence to predicate devices for expanding the indications for use to include children and adolescents.

Therefore, this document does not contain the acceptance criteria or a study proving the device meets those criteria in the format typically associated with AI/ML-based device performance evaluations. The information provided is for a traditional medical device (fixation pins, screws, and nails) where the performance is assessed through non-clinical data (toxicological risk assessment, chemical characterization, and mechanical performance testing) comparing it to predicate devices.

Based on the provided text, I cannot complete the requested table or answer the questions related to AI/ML device performance studies because the document pertains to a traditional medical device and not an AI/ML diagnostic or therapeutic device.

Here's an analysis of why the requested information is absent:

• No AI/ML Component: The devices described are physical implants (pins, screws, nails) made of degradable materials. There is no mention of any software, AI, or machine learning component.
• Performance Evaluation Method: The substantial equivalence argument is based on:
  • Identical/Similar Intended Use: Expanding the age range for existing indications.
  • Material Composition: Degradable poly (L-lactide-co-D, L-lactide) (PLDLA) reinforced with continuous mineral fibers.
  • Design Characteristics: Similar to predicate devices.
  • Manufacturing and Sterilization Methods.
  • Principles of Operation.
  • Non-Clinical Data: Toxicological risk assessment, chemical characterization, and mechanical performance testing (where new worst-case scenarios were not identified).
• Lack of Study Design for AI/ML: There are no details about test sets, data provenance, ground truth establishment by experts, adjudication methods, or MRMC studies because these are not relevant to the type of device being cleared.

In summary, the provided document describes a traditional medical device clearance, not an AI/ML-enabled device. Therefore, the information required to fill out the table and answer the questions regarding acceptance criteria and performance study details for an AI/ML device is not present.

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APTUS® Cannulated Compression Screws and headed Cannulated Compression Screws are indicated for the treatment of fractures, osteotomies and arthrodesis of bones with the appropriate screw size in the shoulder, elbow, wrist, hand, knee, and the foot and ankle.

APTUS® K-Wire System is intended for use in fixation of bone reconstruction, and as guide pins for insertion of other implants.

The purpose of this submission is to obtain marketing clearance for APTUS® Cannulated Compression Screw, and APTUS® K-Wire System designs to expand the range of Medartis APTUS fixation devices previously cleared in K133460. K110658. K092038 and K202589.

This submission includes for APTUS® Cannulated Compression Screws (non-sterile):

• additional thread lengths for previously cleared thread diameters (2.2 mm, 3.0 mm, and 4.0 mm) - fully threaded screws for two previously cleared thread diameters (2.2 mm and 3.0 mm)

Additionally, the purpose of this submission is to obtain marketing clearance for various APTUS® Kwire designs (non-sterile and sterile) to expand the range of the Medartis APTUS® K-Wire System, previously cleared in K092038, K133460 and K202589, to include longer versions in two (2) diameters (0.8, 1.1 mm). The K-wires are compatible with the subject device cannulated compression screws and APTUS® Cannulated Compression Screws previously cleared in K110658, K133460 and K202589.

All subject device cannulated compression screws are manufactured from titanium alloy conforming to ASTM F136, Standard Specification for Wrought Titanium-6Aluminum- 4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401), the same material for screws previously cleared in K110658, K133460 and K202589.

The subject device K-wires are manufactured from stainless steel conforming to ASTM F138, Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673), the same material for K-wires previously cleared in K092038, K133460 and K202589.

The provided text describes a 510(k) premarket notification for a medical device (APTUS Cannulated Compression Screws Line Extension and APTUS K-Wire System Line Extension). This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance data.

Crucially, this document does NOT contain information about an AI/ML device, nor does it detail acceptance criteria or a study design for evaluating AI/ML performance.

The "Performance Data" section explicitly states: "Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence include: Mechanical testing according to ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws, ASTM F1839-08(2021) Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments and FDA Guidance "Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway". Based on the results of the testing, the performance of the subject device was judged to be substantially equivalent to the predicate devices K202589, K110658 and K963192. Clinical data were not provided in this submission."

Therefore, I cannot extract the information required to answer your specific questions (e.g., acceptance criteria for AI performance, sample size for test sets of an AI, number of experts, MRMC studies, standalone AI performance, ground truth establishment, training set details) because the provided text is for a hardware medical device (screws and K-wires) and does not involve AI or any form of algorithmic performance evaluation with clinical data.

I am unable to provide the requested table and study details because the provided input does not describe an AI/ML medical device or its performance evaluation.

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The Accelerate Compression Screw System is indust and skeletally mature pediatic patients (aged 12-21 years), for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.

The Trax Accelerate Compression Screw System is intended to be used to treat fracture and reconstruction of the small bones of the extremities (hands and feet). The screws are manufactured from 6AL-4V titanium and are anodized in various colors for easy size recognition. Washers will be provided for some screw sizes as appropriate. The fixation screws come in three (3) different configurations, headed, headless and break away. The headed and headless screws are cannulated. The breakaway screws are solid. They vary in diameter and length to allow the surgeon to select the appropriate device for the patient's anatomy. All devices are intended to be provided in an autoclavable instrument tray that includes a set of Class I instruments. The set will be provided non-sterile to the end user. The surgical instruments are intended to prepare the site and fixate the screws. The screws and instruments shall be designed to be maintained in an autoclavable tray. Replacement implants and instruments will be available separately as required.

The provided text is a 510(k) Summary for the Trax Surgical Accelerate Compression Screw System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies or AI algorithm evaluation.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, reported device performance, sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established.

Instead, it addresses the following for the Accelerate Compression Screw System:

• Indications for Use: For fracture repair and fixation, osteotomy, joint fusion, reconstruction, and arthrodesis of bones appropriate for the device size, in adult and skeletally mature pediatric patients (12-21 years).
• Performance Data (Non-Clinical): Evaluated according to ASTM F543-17 and FDA guidance for Orthopedic Non-Spinal Metallic Bone Screws and Washers. Static torsion (torque to failure), Insertion/Removal torque, and Axial pullout testing were performed to demonstrate substantial equivalence to predicate devices.
• Biocompatibility: Demonstrated using materials that meet applicable standards and/or are used in 510(k) cleared devices (K172383).
• Technological Characteristics: Similar to predicate devices in indications for use, materials and coatings, function, and range of sizes.
• Predicate Devices: Captivate Compression Screws (K222409), GEO Bone Screw System (K202817), Treace Medical Concepts Snap-off Screw System (K183363). A reference device is Arthrosurface Bone Screws (K172383).

In summary, this document is a 510(k) submission and primarily relies on non-clinical performance data and technological characteristics to assert substantial equivalence to existing devices, not on human clinical trials or AI algorithm performance against acceptance criteria.

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Forma Medical Headless Compression Screws are indicated for fixation of intra-articular and extra articular fractures, avulsions, non-unions, and osteotomies of small bone fragments; as well as arthrodesis of small joints.

Forma Medical Headless Compression Screws are designed to hold bones in relative stability for fracture fixation and arthrodesis. The screws are available in multiple diameters and lengths based on patient anatomy and clinical application. The screws are manufactured from titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136, F1537, and F138. The system includes screws and instruments. The system instrumentation is manufactured from stainless steel, aluminum, and other surgical grade materials.

The provided text is a 510(k) summary for the Forma Medical Headless Compression Screw. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

It does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of clinical performance, specifically regarding AI/ML device performance or human reader improvement.

The document solely focuses on demonstrating substantial equivalence based on technological characteristics and mechanical performance compared to predicate devices. It mentions mechanical testing per ASTM F543 for torsional strength, insertion/removal torque, and pullout strength. However, it does not provide specific acceptance criteria values or detailed results of these tests.

Therefore, it is not possible to answer the user's request based on the provided text. The request asks for details about acceptance criteria and a study proving "the device meets the acceptance criteria," implying a performance study, likely clinical, which is entirely absent from this 510(k) summary for a mechanical orthopedic implant.

To reiterate, the document details:

• Device name and indications for use.
• Comparison of technological characteristics (classification, regulation, product code, indications for use, description, material, lengths, cannulation) between the Forma Medical screw and several predicate devices.
• Mention of mechanical testing (torsional strength, insertion/removal torque, pullout strength per ASTM F543) to support substantial equivalence.

It does not contain information regarding:

• A table of acceptance criteria with reported device performance values.
• Sample sizes for a test set or data provenance.
• Number of experts or their qualifications for ground truth establishment.
• Adjudication methods.
• MRMC comparative effectiveness studies or effect sizes for human reader improvement with AI.
• Standalone algorithm performance.
• Types of ground truth (expert consensus, pathology, outcomes data).
• Training set sample size.
• How ground truth for the training set was established.

These specific points are relevant to AI/ML software as a medical device (SaMD) clearances, not directly to a mechanical orthopedic implant like a compression screw where the focus is on mechanical and material equivalence.

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Cut Screw - Percutaneous Compression Screw are single use devices indicated for fixing and stabilizing the bones of the mid foot, metatarsal and phalanges of the foot using an appropriate relation bone-screw size.

The Cut Screw - Percutaneous Compression Screw for bone synthesis, with a hole in the center in order to allow the passage of the guide wire, thus facilitating its placement, as the surgeon is able to verify the positioning of the screw through the radiological image of the guide wire before its placement. In addition, the Cut Screw -Percutaneous Compression Screw, provides anatomical reduction, stable fixation, and preservation of blood supply by using a percutaneous incision. The screws have a hexagonal connection for a wrench. They are found in a variety of diameters to meet the range of anatomies of the patients, are presented in Titanium Alloy according to the standard ASTM F136, it could be provided in sterile condition sterilized by Ethylene Oxide or non-sterile condition to end user and must be cleaned, and steam sterilized before use.

The provided document is a 510(k) Premarket Notification for a medical device called "Cut Screw - Percutaneous Compression Screw." This document focuses on demonstrating substantial equivalence to an already legally marketed device (predicate device) rather than clinical performance (e.g., diagnostic accuracy of an AI/ML algorithm). Therefore, the information requested in your prompt, which pertains to the acceptance criteria and study design for proving the performance of a device, particularly for AI/ML-based medical devices, is not present in this document.

Specifically, the document states:

• "No clinical data were included in this submission." (page 5)
• The performance data provided is limited to non-clinical mechanical testing (Torsional Properties, Driving Torque, Axial Pullout Strength per ASTM F543) to demonstrate safety and efficacy in terms of mechanical properties. (page 5 & 6)

Therefore, I cannot provide answers to the questions regarding acceptance criteria, study types (MRMC, standalone), ground truth, sample sizes for test/training sets, or expert qualifications as these are not relevant to this type of device submission as described in the provided text.

The document's purpose is to show similarity in design, materials, and mechanical performance to an already approved device, rather than proving a new diagnostic or therapeutic capability through clinical studies.

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Acutrak 3 Headless Compression Screw System screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the device. The screws are not intended for interference or soft tissue fixation.

Acutrak 3 Headless Compression Screw System is a set of screws and instruments that are provided in case and tray configurations when distributed non-sterile as well as sterile packaged product. The system is an extension of the core technology cleared for Acumed's Acutrak 2 Headless Compression Screw Systems, per K930834, K944330 and K221333.

Acutrak 3 Headless Compression Screw System screws are designed for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. The system provides screws in different diameters and lengths to suit different anatomical locations, patient size, and fracture patterns. All the screws are manufactured from Titanium alloy per ASTM F136, are single use and are provided both sterile and non-sterile.

The AT3 System screws are an extension of the Acutrak family with new lengths and the addition of a new smaller screw size. AT3 System screws include 4 sizes, which are referred to as Nano, Micro, Mini and Standard. The screw naming scheme is not to imply the presence of any additional features in the screws. Screws are intended for single patient use only. The AT3 System introduces a modified variable pitch screw design designed to accommodate various fracture patterns for which the AT3 System can be used.

Instruments supplied with the AT3 System are intended to aid in the screw insertion and removal. Instruments are supplied sterile, to be sterilized by the end users. System cases consisting of screw trays, instrument trays, caddies and lids are also provided to house non-sterile implants and instruments.

The provided text is a 510(k) summary for a medical device (Acumed Acutrak 3 Headless Compression Screw System). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical testing.

Crucially, this document does not describe a study involving an AI/Machine Learning (AI/ML) powered device that would have acceptance criteria related to accuracy, sensitivity, specificity, or human-in-the-loop performance improvement.

The "device" in this context is a physical medical implant (a bone screw system), not a software or AI-powered diagnostic/analytic tool. Therefore, the questions related to AI/ML device performance metrics (such as acceptance criteria for AI algorithms, sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone performance, training sets, etc.) are not applicable to this document.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the engineering and material performance of the physical screw system, through non-clinical bench testing.

However, to directly answer your request based on the provided text, and to clarify that the nature of the device means many of your specific questions are not relevant, here's what can be extracted:

Device: Acumed Acutrak 3 Headless Compression Screw System

Type of Device: Physical medical implant (bone screw system)

Study Focus: Non-clinical (bench) testing to demonstrate substantial equivalence to predicate devices and ensure safety and performance of the physical screw system.

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

The document lists the non-clinical tests performed, implying that the device "passed" or "met" the performance requirements for these tests to be deemed substantially equivalent. The specific acceptance criteria values (e.g., minimum torsional yield strength in Nm) and reported performance values for each test are not explicitly provided in this summary. They would typically be in the full submission, but not in the public 510(k) summary.

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

• Sample Size for Test Set: Not specified in the summary. For mechanical tests like these, sample sizes are typically determined by the relevant ASTM standards or internal validation protocols.
• Data Provenance: Not explicitly stated, but assumed to be from laboratory testing related to the manufacturer (Acumed LLC, based in Hillsboro, Oregon, United States). These are laboratory bench tests, not clinical data from patients. The terms "retrospective" or "prospective" are not applicable to this type of device testing.

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 question is not applicable. Ground truth, in the sense of expert consensus on medical images or patient outcomes, is not established for this type of non-clinical, mechanical device testing. The "ground truth" for these tests are the objective measurements against
established engineering and material science standards (e.g., precise force measurements, torque values, etc.).

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

This question is not applicable. Adjudication methods are relevant for cases where human experts interpret data (e.g., medical images) to establish a ground truth. For mechanical testing of a medical implant, the results are measured directly against predefined engineering and material standards.

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 question is not applicable. An MRMC study is relevant for evaluating the performance of AI-assisted diagnostic aids where human readers are involved in interpreting medical cases. This device is a surgical implant, not an AI diagnostic tool. The document explicitly states: "Clinical testing was not necessary."

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

This question is not applicable. This device is a physical screw, not an algorithm.

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

The "ground truth" for this type of device testing relies on adherence to international and national engineering standards (e.g., ASTM, ISO) for material properties and mechanical performance. The device's performance is measured directly against the specifications and requirements outlined in these standards, and in comparison to predicate devices.

8. The sample size for the training set:

This question is not applicable. This device is a physical product, not an AI algorithm that requires a "training set."

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

This question is not applicable. As above, there is no "training set" for a physical medical implant.

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