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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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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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The Skeletal Dynamics REDUCT® Headless Compression Screw System is intended for fixation of osseous fragments or fractures, arthrodesis of small joints, and osteotomies, with the appropriately sized screw.

The REDUCT® Headless Compression Screw (HCS) System consists of the following screws from medical grade Titanium Alloy (ASTM F136).

• · 2.5mm cannulated HCS screws: 10mm 30mm
• 3.5mm cannulated HCS screws: 10mm 50mm
• 4.5mm cannulated HCS screws: 20mm 65mm
• · 2.0mm non-cannulated HCS Arthrodesis screws: 20mm 34mm
• 2.5mm cannulated HCS Arthrodesis screws: 26mm 40mm
• 3.5mm cannulated HCS Arthrodesis screws: 32mm 46mm
  The REDUCT® Headless Compression Screw includes appropriate instrumentation, as identified in the surgical technique.

The provided text describes the 510(k) premarket notification for the REDUCT® Headless Compression Screw System. This document details the device's technical specifications and claims of substantial equivalence to a predicate device, rather than providing a study on an AI/ML powered device. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics related to AI/ML devices is not present in the provided text.

However, I can extract the relevant information concerning the device's performance testing and acceptance criteria as described for this non-AI medical device.

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

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 the exact sample sizes for each mechanical test (e.g., number of screws tested for each parameter). The tests were performance-based, carried out in accordance with established ASTM standards. This type of testing is generally performed in a laboratory setting, not with patient data. Therefore, the concepts of "data provenance," "country of origin," "retrospective," or "prospective" do not apply in the context of this mechanical 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. The "ground truth" for this device is based on objective mechanical properties measured by instruments and adherence to established ASTM standards, not on expert interpretations of data.

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

This question is not applicable. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, which is not the case for the mechanical testing of a bone screw system.

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 AI/ML powered devices that interact with human interpretation of medical images or data. The REDUCT® Headless Compression Screw System is a physical medical device, not an AI/ML system.

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

This question is not applicable. The device is not an algorithm.

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

The ground truth for this device's performance testing is based on:

• Mechanical properties: Measured values (e.g., force, torque, strength) obtained through standardized laboratory testing.
• Adherence to standards: Compliance with the specifications and methodologies outlined in ASTM F543 and ASTM F2193.
• Substantial equivalence: Comparison of these mechanical properties and the device's design/materials to a legally marketed predicate device (K143624).

8. The sample size for the training set

This question is not applicable. There is no AI/ML model for which to define a training set.

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

This question is not applicable. There is no AI/ML model, and thus no training set or ground truth for a training set.

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The Headless Compression Screw System Micro-2.8 screw fasteners are intended for fixation of fractures and non-unions of small bones and small bone arthrodesis. Examples include, but are not limited to scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies.

The Headless Compression Screw System Mini-3.9 screw fasteners are intended for fixation of small bones and small bone fragments, such as fractures of the metatarsals, arthrodeses of the carpals and phalanges, steochondritis dissecans, and ligament fixation.

The screw fasteners are intended for single use only and may not be reused under any circumstances.

The system drills and guide wires are single use instruments.

The OsteoCentric Extremities Headless Compression Screw System within the product line of SMV Scientific Cannulated Screws consists of cannulated screws in a variety of lengths and diameters to accommodate different anatomic sizes of patients. The screws are provided nonsterile. The subject headless compression screws are manufactured from Titanium per ASTM F136. The Headless Compression Screw System fasteners are offered in diameters of Ø2.8mm or Ø3.9mm and lengths from 12mm to 50mm.

This document describes a 510(k) premarket notification for a medical device, specifically the "Headless Compression Screw System." It does not contain information about software, AI, or diagnostic performance studies that would involve acceptance criteria, test sets, expert ground truth, or statistical analyses typically associated with AI/ML medical devices.

Therefore, I cannot provide the requested information, which includes:

1. A table of acceptance criteria and the reported device performance.
2. Sample sizes used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study results.
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document focuses on the substantial equivalence of a physical medical device (screws) to legally marketed predicate devices based on identical or nearly identical technological characteristics, materials, principles of operation, and indications for use. Performance testing summarized here relates to mechanical testing (e.g., to ensure modifications introduce no new worst-case scenarios for mechanical performance), not diagnostic or interpretative performance.

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The DePuy Synthes 2.4 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of small bones in adults and in both 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 screw fixation.

The DePuy Synthes 4.0 mm Cortex Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneus, femur, fibula, and the bones of the foot and hand in adults and in both 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 screw fixation.

The DePuy Synthes 4.5 mm Cortex Screws are intended for fixation of fractures, fusion, osteotomies, non-unions, and malunions of various long bones, such as the humerus, femur and tibia; the pelvis, and the bones of the foot and hand in adults and in both 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 screw fixation.

The DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of small bone fragments in adults and in both 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 screw fixation.

The DePuy Synthes 4.5 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of long bones and long bone fragments; and the bones of the hand and foot, in adults and in both 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 screw fixation.

The DePuy Synthes 6.5 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of long bones and long bone fragments, pelvis, sacrum, and the bones of the foot in both 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 screw fixation. These screws are also indicated for femoral neck fractures; slipped capital femoral epiphysis; an adjunct to DHS in basilar neck fractures; ankle arthrodesis; pediatric femoral neck fractures; intercondylar femur fractures; SI joint disruptions; and subtalar arthrodesis.

The DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of long bone fragments, pelvis, sacrum, and the bones of the foot in adults and in both 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 screw fixation. These screws are also indicated for slipped capital femoral epiphysis; ankle arthrodesis; and subtalar arthrodesis.

The DePuy Synthes 1.5 mm Headless Compression Screws are intended for fixation of intra-articular fractures, avulsions, non-unions, and osteotomies of small bones and small bone fragments, as well as arthrodesis of small joints in adults and in both 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 screw fixation.

The DePuy Synthes 2.4 mm Headless Compression Screws are intended for fixation of fractures, non-unions, and malunions of small bones and small bone arthrodesis in adults and in both 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 screw fixation.

The DePuy Synthes 3.0 mm Headless Compression Screws are intended for fixation of intra-articular fractures, non-unions, malunions, and osteotomies of small bone fragments, as well as arthrodesis of small joints in adults and in both 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 screw fixation.

The DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screws are indicated for fixation of fractures, fusions, osteotomies, non-unions, and malunions of various bone fragments including bones of the foot, humerus, femur and tibia in adults and in both 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 screw fixation.

The DePuy Synthes Cortex, Cannulated, and Headless Compression Screws are metallic bone screws manufactured from Stainless Steel (ASTM F138), Commercially Pure Titanium (ASTM F67), and/or Titanium Alloy (ASTM F1295). The screws are available in multiple lengths and diameters, and are intended to be used as stand-alone bone screws for internal bone fixation of fractures, fusions, osteotomies, non-unions, and malunions in adults and in both 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 the screw fixation.

The DePuy Synthes Cannulated and Headless Compression screws are cannulated for use with guidewires for precise placement in bone with the exception of the 1.5 mm Headless Compression Screw, which is a solid screw and therefore does not allow for instrumentation with a guide wire. The Headless Compression Screws feature threaded heads that allow for purchase in the near cortex of bone during and after implantation, potentially reducing complications associated with countersinking of traditional cortex or cannulated screws.

This document is a 510(k) Pre-market Notification to the FDA for various bone fixation screws manufactured by DePuy Synthes. It aims to demonstrate substantial equivalence to previously cleared devices.

Based on the provided text, there is no acceptance criteria or study data related to an AI/ML powered medical device. This document pertains entirely to traditional medical devices (bone screws) and their mechanical properties, indications for use, and comparison to predicate devices. The "performance data" section explicitly states "There is no bench testing included in this submission," "There is no animal data included in this submission," and the "Clinical" section refers to "published clinical literature to support the safety and efficacy of the modifications to the Indications for Use" rather than a clinical study conducted by the manufacturer specifically for this submission.

Therefore, I cannot provide the requested information for an AI/ML powered medical device based on this document. The questions about test sets, data provenance, expert consensus, MRMC studies, standalone performance, and training sets are not applicable here.

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The Skeletal Dynamics Headless Compression Screw System is intended for fixation of osseous fragments or fractures, arthrodesis of small joints, and osteotomies, with the appropriately sized screw. Examples include: Scaphoid fractures, lunate fractures, capitate fractures, trapezial fractures, metacarpal and metatarsal fractures, phalangeal fractures, radial head fractures, ulnar styloid fractures, osteo-chondral fractures, small joint fusions, carpal fractures and non-unions, capitellum fractures, distal radius fractures, humeral head fractures, glenoid fractures, intercarpal fusions, interphalangeal fractures, metatarsal osteotomies, tarsal fusions, malleolar fractures, patellar fractures, odontoid fractures, and mandibular fractures.

The Skeletal Dynamics Headless Compression Screw System consists of 2.5mm and 3.5mm cannulated titanium screws and specialized instrumentation. The screws are available in 11 length configurations between 10mm - 30mm, with increments of 2mm. The system is provided non-sterile and is sterilized in the user facility.

This document describes the Skeletal Dynamics Headless Compression Screw System, a device for bone fixation. However, the provided text does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of AI/ML performance.

Instead, the document is a 510(k) premarket notification to the FDA for a medical device. The "performance testing" mentioned refers to mechanical testing of the hardware itself (compression and ASTM F543 testing), not the performance of an AI/ML algorithm or system.

Therefore, I cannot provide the requested information for an AI/ML device. The document explicitly states:

• "Compression testing and ASTM F543 testing were performed to demonstrate conformance to the requirements."
• "The substantial equivalence of the Skeletal Dynamics Headless Compression Screw System to the predicate device is demonstrated by similarities in intended use, indications for use, materials, design (fundamental scientific technology), performance, sterility and packaging, and does not present any new issues of safety or effectiveness."

This indicates a traditional medical device submission based on substantial equivalence for physical properties and intended use, not an AI/ML diagnostic or assistive device.

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The Medical Facet Bone Fixation Screws and Pins are intended to be used as fixation implants for bone fractures, joint fusion, bone reconstruction, or as guide pins for insertion of other implantable devices

Medical Facets Bone Screws are available in thread diameters ranging from 1.5mm to 7.3mm, lengths ranging from 6mm to 180mm, and either solid or cannulated, and made of stainless steel or titanium.

Medical Facets External Fixation Screws are available in thread diameters ranging from 4mm to 6mm, lengths ranging from 60mm to 250mm, and thread lengths ranging from 18mm to 80mm, and made of stainless steel or titanium.

Medical Facets Kirschner Wires are available in wire diameters ranging from 1.0mm to 2.5mm, in lengths ranging from 100mm to 150mm. 0.028 inches to 0.062 inches, in lengths ranging from 4.0 inches to 12.0 inches and are partially or completely threaded. or smooth. Made of stainless steel or titanium.

Medical Facets Guide Wires are available in wire diameters ranging from 0.8mm to 2.8mm, in lengths ranging from 100mm to 450mm, are partially threaded or smooth. Made of stainless steel, titanium, or cobalt.

Medical Facets Steinmann Pins are available in wire diameters ranging from 0.078 inches to 0.187 inches, in lengths ranging from 9.0 inches to 12.0 inches, are completely threaded, or smooth. Made of stainless steel or titanium.

The provided text describes the acceptance criteria and a study for Medical Facets Bone Fixation Screws and Pins.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify a distinct "test set" in the context of clinical trials or AI/algorithm performance. Instead, it refers to "Non-Clinical Testing (worse case)" where the device was mechanically tested according to the listed ASTM standards. The specific sample size for these mechanical tests is not provided, nor is the data provenance in terms of country of origin or retrospective/prospective nature, as these are typically associated with clinical studies involving human or animal subjects, which is not the type of study described here.

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

Not applicable. This is a mechanical testing study, not a study involving expert assessment of images or clinical outcomes to establish a ground truth.

4. Adjudication Method for the Test Set:

Not applicable. This is a mechanical testing study.

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

No. An MRMC comparative effectiveness study was not done. The study described is a non-clinical mechanical testing comparison between the subject device and predicate devices. There is no mention of human readers or AI assistance.

6. Standalone (Algorithm Only) Performance:

No. This is a medical device, specifically bone fixation screws and pins, not an algorithm or AI system. Therefore, a standalone algorithm performance study is not applicable.

7. Type of Ground Truth Used:

The "ground truth" in this context is defined by the mechanical performance requirements specified in the ASTM standards (F543, F2193, F1264, F1541). The device's performance was compared to the performance of "predicate devices" during "side-by-side testing," implicitly meaning it met or exceeded the established mechanical properties and stability criteria for similar devices on the market.

8. Sample Size for the Training Set:

Not applicable. This is a mechanical testing study of a physical device, not an AI or algorithm that requires a training set.

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

Not applicable. No training set was used.

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The Skeletal Dynamics Headless Compression Screw System is intended for fixation of osseous fragments or fractures, arthrodesis of small joints, and osteotomies, with the appropriately sized screw. Examples include: Scaphoid fractures, lunate fractures, capitate fractures, trapezial fractures, metacarpal and metatarsal fractures, phalangeal fractures, radial head fractures, ulnar styloid fractures, osteo-chondral fractures, small joint fusions, carpal fractures and non-unions, capitellum fractures, distal radius fractures, humeral head fractures, glenoid fractures, intercarpal fusions, interphalangeal fractures, metatarsal osteotomies, tarsal fusions, malleolar fractures, patellar fractures, odontoid fractures, and mandibular fractures.

The Skeletal Dynamics Headless Compression Screw System consists of 2.5mm and 3.5mm cannulated titanium screws and specialized instrumentation. The 2.5mm screw is available in 7 length configurations between 12mm - 24mm, with increments of 2mm. The 3.5mm screw is available in 7 length configurations between 14mm - 26mm, with increments of 2mm. The system is provided non-sterile and is sterilized in the user facility.

The provided 510(k) summary for the Skeletal Dynamics Headless Compression Screw System describes a medical device (bone screw), not an AI/ML powered device or diagnostic software. Therefore, many of the requested criteria, such as "number of experts used to establish ground truth," "adjudication method," "MRMC study," and "training set sample size," are not applicable to this type of device and submission.

The acceptance criteria and study described pertain to proving substantial equivalence to a predicate device based on mechanical performance.

Here's a breakdown of the available information:

1. Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated. The document mentions "Preclinical compressive force testing," implying a laboratory-based study on physical samples of the screws.
• Data Provenance: The data is generated from preclinical, laboratory-based mechanical testing of the device itself. This is not patient data from a specific country, nor is it retrospective or prospective in the clinical sense.

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

• Not Applicable. For a medical device like a bone screw, "ground truth" is typically defined by engineering specifications and material properties, validated through standardized mechanical testing methods, rather than expert interpretation of data.

4. Adjudication Method for the Test Set:

• Not Applicable. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, which is not the case for mechanical performance testing of bone screws.

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 hardware medical device; it does not involve human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Not Applicable. This is a hardware medical device; there is no algorithm involved.

7. The Type of Ground Truth Used:

• The "ground truth" for this type of device is the mechanical performance (e.g., compressive strength) of the screws as measured in a laboratory setting, compared against a predicate device. This is based on engineering specifications and established mechanical testing standards, not expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set:

• Not Applicable. There is no "training set" as this is not an AI/ML device.

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

• Not Applicable. There is no "training set" or corresponding ground truth establishment process for this type of device.

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Synthes 1.5mm Headless Compression Screws are indicated for fixation of intra-articular and extra-articular fractures, avulsions, non-unions, and osteotomies of small bones and small bone fragments; as well as arthrodeses of small joints.

The Synthes 1.5mm Headless Compression Screws are solid bone fixation screws featuring a partially threaded shaft and threaded head. The screws are available in stainless steel and titanium.

The provided text is a 510(k) summary for a medical device called "Synthes (USA) 1.5mm Headless Compression Screws." This document focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a study for acceptance criteria of an AI/ML powered device.

Therefore, the information required to answer your questions regarding acceptance criteria, study details, sample sizes, ground truth, and expert involvement for an AI/ML device is not present in the provided text. The document is typical for a traditional medical device submission, which relies on engineering and material testing, and comparison to predicate devices, rather than clinical performance studies with AI components.

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The AREX SCRU2 headless compression screw is intended for fixation of intra-articular and extra-articular fractures of the upper and lower extremities, as well as non-unions of small bones and bone fragments, arthrodesis of small joints, bunionectomies and osteotomies. Examples include scaphoid and other carpal bones, metacarpais, tarsals, metatarsals, patella, ulmar styloid, capitellum, radial head and radial styloid.

The AREX SCRU 2 Headless Compression Screws are cannulated, self drilling, self tapping, dual-pitch threaded devices which can be countersunk into the bone. The screw is available in titanium alloy with and OD of 2 5 or 3 mm and lengths from 10mm up to 45 mm, in increments of 5 mm. The screws are supplied non-sterile.

The provided text is a 510(k) Premarket Notification summary for the AREX SCRU 2 Headless Compression Screw. This document is for a medical device (a screw for bone fixation), not a software or AI-driven diagnostic device.

Therefore, the specific questions related to acceptance criteria for a study proving device performance, sample sizes for test and training sets, expert review, MRMC studies, standalone performance, and ground truth establishment are not applicable to this type of submission.

The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices already on the market, rather than proving novel performance through extensive clinical studies with specified acceptance criteria as would be required for a new diagnostic technology or a high-risk device.

Here's how the provided information relates to the request, focusing on the concept of "acceptance" in the context of this 510(k):

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria (for 510(k) submission): The primary "acceptance criteria" here is demonstrating substantial equivalence to legally marketed predicate devices. This is achieved by comparing the device's design, materials, and intended use to those of the predicates.
• Reported Device Performance: The document states that the "design, materials and indications for use demonstrate that the AREX SCRU 2 headless compression screws are substantially equivalent to the predicate devices, and safe and effective for use, when used in accordance with the supplied instructions for use."
  • No specific quantitative performance metrics (e.g., accuracy, precision, sensitivity, specificity) are provided, as these are typically not required for substantial equivalence claims for this type of device.

2. Sample size used for the test set and the data provenance: Not applicable. There was no "test set" in the context of clinical performance data in this 510(k) submission. The evaluation is based on a comparison to predicate devices, not on a new clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment with experts is not relevant for a substantial equivalence claim for a bone screw.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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 device is a passive implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.

8. The sample size for the training set: Not applicable. There is no "training set" for an AI model, as this is not an AI device.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission for a medical device (a bone screw) demonstrating substantial equivalence to already approved devices. It does not involve performance studies in the way one would analyze a diagnostic tool or an AI-driven device, and therefore most of the requested information regarding study design and performance metrics is not present. The "study" in this context is the comparison of the device's characteristics to those of predicate devices.

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