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The ARIX Cannulated Screw System is indicated for fracture fixation, fusions, osteotomies, and malunions of fragments of long bones of the pelvis, the femur, the humerus, and the foot. The system is not intended for use in the spine.

The ARIX Cannulated Screw System consists of cannulated screws and corresponding washer. The thread diameters of cannulated screws are 6.5 and 7.3 mm. They are either fully or partially threaded. Screws and a washer are made of Titanium Alloy (Ti-6Al-4V), which meet ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility. All devices in the system are provided non-sterile.

The provided document, K233912, is a 510(k) Premarket Notification for the ARIX Cannulated Screw System. This document outlines the premarket review by the FDA for a medical device, specifically a bone fixation fastener, and not an AI/ML-driven diagnostic or prognostic device.

Therefore, the information typically requested in your prompt regarding AI/ML device studies (such as acceptance criteria for AI performance, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, standalone AI performance, etc.) is not applicable to this submission.

The document discusses bench tests for mechanical performance to demonstrate substantial equivalence to a predicate device. Here's what can be extracted from the document regarding its performance criteria and testing:

1. Acceptance Criteria and Reported Device Performance (Mechanical Testing):

• Torsion Test
• Driving Torque Test
• Axial Pull-out Test |

2. Sample Size and Data Provenance:

• Sample Size: The document does not specify the sample size (number of screws) used for the mechanical bench tests.
• Data Provenance: Not applicable in terms of patient data. The tests were bench tests conducted on the physical device. The manufacturer is Jeil Medical Corporation in South Korea.

3. Number of Experts and Qualifications (for Ground Truth):

• Not applicable. Ground truth for mechanical performance is established through standardized engineering test methods (ASTM F543) and physical measurements, not human expert consensus.

4. Adjudication Method:

• Not applicable for mechanical bench testing.

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

• Not applicable. This is a physical medical device, not an AI/ML system requiring human reader performance evaluation. The document explicitly states: "No clinical studies were considered necessary and performed."

6. Standalone Performance:

• Not applicable. This refers to the performance of the physical device in bench tests, not an AI algorithm. The document states its performance was evaluated for each mechanical test according to ASTM F543.

7. Type of Ground Truth Used:

• Engineering Standards and Physical Measurements: For mechanical performance, the ground truth is based on the specifications and test methods outlined in ASTM F543. Measurements from the tests (e.g., torque, axial pull-out force) are compared against these established physical and material science standards.

8. Sample Size for Training Set:

• Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

9. How Ground Truth for Training Set was Established:

• Not applicable.

In summary, the provided document relates to the FDA clearance of a conventional medical device based on mechanical bench testing and substantial equivalence to a predicate device, rather than the evaluation of an AI-powered diagnostic or prognostic tool. Therefore, many of the requested details about AI/ML study methodologies are not present in this type of FDA submission.

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The 4.0 mm Cannulated Screws and associated washers are indicated for arthrodesis and osteotomies of small bones and small joints, and ankle fracture.

The 5.5 mm. 6.5 mm. 7.0 mm. and 8.0 mm Cannulated Screws. Cannulated Hip Pins and associated washers are indicated for fracture fixation, osteotomy, and arthrodesis of various bones and bone fragments appropriate for the size of the device.

The Smith & Nephew 2.5 mm, 3.0 mm Headless Compression Screws are indicated for fixation of fractures, bunionectomies and osteotomies of small bones, and arthrodesis of small joints.

The Smith & Nephew 2.0 mm QFX Screw is indicated for osteotomies of the lesser metatarsals, and osteotomies and fractures of the phalanges.

The subject Cannulated Screw System includes the 2.0 QFX Screw, 2.5mm and 3.0mm Headless Compression Screws, 4.0mm, 5.5mm, 6.5mm, 7.0mm, and 8.0mm Cannulated Screws and associated Washers (K090675, K111994, K213126).

The Smith & Nephew Cannulated Screw System consists of stainless steel (316L conforming to ASTM F139 and ISO 5832-1 or titanium (Ti-6Al-4V conforming to ASTM F1472/SO 5832-3) implantable devices of many styles for use in fracture fixation. The Smith & Nephew Cannulated Screws product family includes Large Cannulated Screws, Cannulated Hip Pins, Hip Screws, QFX Screws, and associated Washers. The components are available in various diameters, thread options, and lengths. All screws are designed with a self-drilling, self-tapping tip to facilitate easy implantion with a reverse cutting flute design to assist with implant removal. Select screws are designed with low-profile screw heads for reduced soft tissue irritation, and 3.0mm and 7.0mm screws are available headless.

The implants within this system are single-use and are Gamma sterilized.

The provided text is a 510(k) summary for a "Cannulated Screw System" and details that the submission is for labeling updates, specifically updated indications for use. The critical information here is that there are no changes to the device's design, technological characteristics, function, sterilization, or packaging.

Therefore, the submission explicitly states: "no performance testing (bench, animal, clinical) was required." This means there is no study described in this document that proves the device meets specific acceptance criteria based on performance. The clearance is based on the substantial equivalence of the device itself (which was previously cleared) and the fact that the labeling changes do not impact safety or effectiveness.

Because no performance study was conducted for this specific submission, I cannot fill in the requested table and information points.

Here's a breakdown of why based on the input:

• 1. A table of acceptance criteria and the reported device performance: Not applicable. No performance study was conducted.
• 2. Sample size used for the test set and the data provenance: Not applicable. No performance study was conducted.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No performance study was conducted.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No performance study was conducted.
• 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 screw system, 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 a screw system, not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No performance study was conducted.
• 8. The sample size for the training set: Not applicable. No machine learning training was performed.
• 9. How the ground truth for the training set was established: Not applicable. No machine learning training was performed.

The core of this 510(k) submission is to update the indications for use based on existing, cleared devices, implying that the safety and effectiveness have already been established through prior submissions for functionally identical devices. The changes are specifically for "user clarification" of the indications.

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The RESPONSE 4.5/5.0 and 5.5/6.0 Spine Systems and the RESPONSE 5.5/6.0 Cannulated Screw System are intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of dicogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, or lordosis), turnor, pseudarthrosis, and/or failed previous fusion. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the RESPONSE 4.5/6.0 Spine System and the RESPONSE 5.5/6.0 Cannulated Screw System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis, neuromuscular scoliosis, and congental scoliosis. The RESPONSE 4.5/5.0 Spine Systems and the RESPONSE 5.5/6.0 Cannulated Screw System are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The RESPONSE 5.5/6.0 Cannulated Screw System is a cannulated screw spinal implant system consisting of anchors (screws) that attach to the longitudinal members (rods) and interconnection components (connectors) previously cleared in the RESPONSE 5.5/6.0 Spine System see K193100. Pedicle screws are placed in the spine that attach to rods that allow immobilization and stabilization of the spine. The RESPONSE 5.5/6.0 Cannulated Screws are cannulated screws that are passed over a guidewire to achieve insertion. The RESPONSE 5.5/6.0 Cannulated Screws are available in a 6mm to 9mm diameter range by 40mm to 100mm lengths. All implant components are manufactured from titanium alloy, cobalt chrome, and commercially pure titanium. All components are supplied non-sterile. The screws, which have a Ø1.750 mm cannulation, are available in the following diameters and lengths: Ø6.0 - 40-80mm Ø6.5 - 40-90mm Ø7.0 - 40-100mm Ø8.0 - 40-100mm Ø9.0 - 40-100mm. All screws are double lead with a 2.750 mm thread pitch which is identical to the predicate screws. For the subject screws, the minor diameter, neck diameter and thread runout length were increased and the hexalobe feature and root radius were modified from the predicate pedicle screw design to accommodate the cannulation. The subject drivers are cannulated with features to interface with the screw hexalobe.

The provided text is a 510(k) summary for the OrthoPediatrics RESPONSE 5.5/6.0 Cannulated Screw System, a medical device for spinal fixation. This document primarily focuses on demonstrating substantial equivalence to a predicate device through material and mechanical testing. It does not describe a study involving human readers or AI performance in diagnostic or clinical tasks.

Therefore, the requested information regarding AI performance, human reader studies, ground truth establishment for AI, and related metrics cannot be extracted from this document, as it is not relevant to the type of device review described.

Below is the information that can be extracted, primarily related to the mechanical performance testing of the device for its substantial equivalence determination.

Acceptance Criteria and Reported Device Performance

The document describes various performance tests conducted to support substantial equivalence. The acceptance criteria themselves are not explicitly detailed as numerical thresholds in this summary, but rather implied as meeting the standards set by the predicate device and relevant ASTM standards. The "reported device performance" is that the device "supports the differences between the subject and predicate devices" and "is substantially equivalent."

Information Not Applicable to this Device/Study:

• Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This is a mechanical device, and the "tests" refer to laboratory-based mechanical and material performance evaluations, not diagnostic image analysis or clinical data.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for mechanical testing is defined by engineering specifications and material properties, assessed in a lab, not by expert human interpretation.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This concept is relevant for clinical or diagnostic studies involving human assessment, not for mechanical testing.
• 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. There is no AI component in this device.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. There is no AI component.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): For mechanical tests, the ground truth is based on physical scientific principles, engineering standards (ASTM), and direct measurement of material and structural performance, not expert consensus or clinical pathology.
• The sample size for the training set: Not applicable. Pertains to AI model development.
• How the ground truth for the training set was established: Not applicable. Pertains to AI model development.

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The Asnis III 4.0 and 5.0 mm Cannulated Screws are intended for fixations, osteotomies, non-unions, and malunions of fragments of small and long bones, the pelvis and bones of the foot.

The Asnis III 6.5 and 8.0 mm Cannulated Screws are intended for:

· fracture fixation, fusions, osteotomies, and malunions of fragments of small and long bones, the pelvis, sacrum, and bones of the foot

· sacroiliac joint fusion for conditions including sacroiliac joint disruptions

The Asnis PRO 6.5 and 8.0 mm Cannulated Screws are intended for:

· fracture fixation, fusions, osteotomies, nonunions of fragments of small and long bones, the pelvis, sacrum, and bones of the foot

· sacroiliac joint fusion for conditions including sacroiliac joint disruptions

The Asnis® III Cannulated Screw System, previously cleared in K213199, consists of self-tapping cannulated screws and the corresponding washers. All devices in the system are provided sterile and non-sterile. The thread diameters are 4.0, 5.0. 6.5, and 8.0 mm. They are either fully or partially threaded. All screws are self-drilling and self-tapping. There are corresponding washers to the 4.0 and 5.0 mm screws respectively and one washer fitting for both diameters, 6.5 and 8.0 mm. Screws and washers are made of stainless steel and titanium alloy.

The Asnis® PRO Cannulated Screw System consists of self-tapping cannulated screws. All devices in the system are provided sterile and non-sterile. The thread diameters are 6.5, and 8.0 mm. They are either fully or partially threaded. All screws are self-drilling and self-tapping. There are corresponding washers to the 4.0 and 5.0 mm screws respectively and one washer fitting for both diameters, 6.5 and 8.0 mm. Screws and washers are made of stainless steel and titanium alloy.

The subject of this bundled traditional submission is to clarify the indications to the Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System, cleared in K213199 and to introduce a new washer to the Asnis® PRO Cannulated Screw System cleared in K213199.

The provided document is an FDA 510(k) clearance letter for the Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System. This document focuses on the substantial equivalence of a medical device to a legally marketed predicate device, rather than proving a device meets specific performance criteria through clinical or AI-based studies.

Therefore, the information required to answer your request (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, and training data details) is not present in this type of regulatory submission.

The document explicitly states under "Performance Data (Nonclinical)":

• "No mechanical testing was deemed necessary as the new washers does not create a new worst case."
• "All bench tests performed in accordance with ASTM F543 and previously presented in Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System (K213199), remain true and accurate. Static Cantilever Bending Test was performed according to ASTM F2193."
• "Tests performed to establish compatibility with a magnetic resonance environment...Magnetically Induced Displacement per ASTM F2052 Magnetically Induced Torque per ASTM F2213 RF Heating per ASTM F2182 Image Artifacts per ASTM F 2119"
• "Clinical data and conclusions were not needed for this device."

This indicates that the assessment for this device clearance relied on bench testing and comparison to existing data from a predicate device (K213199), rather than a clinical study evaluating diagnostic accuracy, reader performance, or AI algorithm performance as you've outlined in your request.

In summary, none of the specific details you requested regarding acceptance criteria based on a clinical study, sample sizes, expert adjudication, MRMC studies, or AI algorithm performance can be extracted from this 510(k) document because such a study was not conducted or required for this particular type of device clearance.

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The Asnis® III Cannulated Screw System intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use.
The Asnis® PRO Cannulated Screw System intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use.

The Asnis® III Cannulated Screw System, previously cleared in K000080, K024060, consists of self-tapping cannulated screws and the corresponding washers. All devices in the system are provided sterile and non-sterile. The thread diameters are 4.0, 5.0. 6.5, and 8.0 mm. They are either fully or partially threaded. All screws are self-drilling and self-tapping. There are corresponding washers to the 4.0 and 5.0 mm screws respectively and one washer fitting for both diameters, 6.5 and 8.0 mm. Screws and washers are made of stainless steel and titanium alloy.
The Asnis® PRO Cannulated Screw System consists of self-tapping cannulated screws. All devices in the system are provided sterile and non-sterile. The thread diameters are 6.5, and 8.0 mm. They are either fully or partially threaded. All screws are self-drilling and self-tapping. Screws are made of stainless steel and titanium alloy.
The subject of this bundled traditional submission is to introduce minor design specification changes; MRI Labeling, shelf-life update of existing package to 10 years, and re-branding Ø6.5/8.0 mm long screws (130-180 mm to Asnis® PRO Cannulated Screw System) to the Asnis® III Cannulated Screw System, cleared in K000080 and K024060 and to introduce a new system Asnis® PRO Cannulated Screw System.

The provided document is a 510(k) Summary for the Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System. It outlines the reasons for the submission and compares the new devices to predicates. However, it explicitly states there was no clinical data or clinical trials needed for this device submission. The changes made (minor design specification changes, MRI labeling, shelf-life update, and re-branding) did not create a new "worst case" scenario that would necessitate mechanical testing beyond what was already performed for the predicate device.

Therefore, the following information regarding acceptance criteria and studies to prove device performance cannot be extracted from this document:

1. A table of acceptance criteria and the reported device performance: No new performance data is presented, as the document states "No mechanical testing was deemed necessary."
2. Sample size used for the test set and the data provenance: No new test set was used for mechanical performance, and no clinical data was collected.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there was no test set requiring expert ground truth.
4. Adjudication method 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 is a medical device (screws), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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.
9. How the ground truth for the training set was established: Not applicable.

What the document does state regarding performance:

• Performance Data (Nonclinical):
  • "No mechanical testing was deemed necessary as the design modifications and the new system introduction do not create a new worst case. All bench tests performed in accordance with ASTM F543 and previously presented in Asnis® III Cannulated Screw System (K024060), remain true and accurate."
  • Tests performed to establish compatibility with a magnetic resonance environment:
    • Magnetically Induced Displacement per ASTM F2052
    • Magnetically Induced Torque per ASTM F2213
    • RF Heating per ASTM F2182
    • Image Artifacts per ASTM F 2119
• Clinical Performance and Conclusions: "Clinical data and conclusions were not needed for this device."

In summary, this 510(k) submission relies on the substantial equivalence to its predicate devices and the existing non-clinical performance data for those predicates (K000080, K024060, and K140891), along with new MRI compatibility testing for the modified/new devices. No new trials or studies to establish performance against acceptance criteria in a traditional sense (e.g., diagnostic accuracy, clinical outcomes) were conducted or deemed necessary for this submission.

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The DART-FIRE EDGE Cannulated Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of foot and ankle bones appropriate for the device. Screws gre intended for single use only.

The DART-FIRE EDGE Cannulated Screw System contains partially and fully threaded, cannulated screws offered in a variety of diameters and lengths. The screws are manufactured from titanium alloy (ASTM F136).

Here's a summary of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

Not applicable. The study was non-clinical and involved performance testing of the device itself rather than a test set of data.

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

Not applicable. This was a non-clinical study based on engineering performance tests.

4. Adjudication Method for Test Set

Not applicable. There was no test set requiring expert adjudication.

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

Not applicable. This was a non-clinical study for a bone fixation device, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a physical medical implant, not an algorithm. The performance described is for the device's physical properties.

7. Type of Ground Truth Used

The ground truth or benchmark for performance was the performance of the legally marketed predicate device (K082320: Wright Compression Screws, K080850: DARCO Headless Compression Screw, K183696: PERFORM Reverse). The study aimed to demonstrate "substantial equivalence" to these devices through various mechanical and MR Safety tests.

8. Sample Size for Training Set

Not applicable. This was a non-clinical study for a physical device, not an AI model.

9. How Ground Truth for Training Set Was Established

Not applicable. There was no training set in the context of this device.

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Soft tissue fixation to bone, specifically during ligament reconstructive procedures.
Small Cannulated Screws (4.0mm and smaller diameter) are intended for use in:

1. Fixation of small bones, including those in the foot, patella, ankle, wrist and elbow.
2. Arthrodesis of the foot, wrist and elbow.
3. Small and long bone osteotomies.
4. Fracture fixation of small bones, small bone fragments and long bones.
   Large Cannulated Screws (5mm and larger in diameter) are intended for use in:
5. Fixation of fractures in long bones and long bone fragments.
6. Long bone osteotomies (femur, tibia, foot, ankle, olecranon).
7. Arthrodesis, and fracture fixation of the foot and ankle, such as Jones fractures of the fifth metatarsal, and Calcaneal fractures.
   Large Cannulated Screws (6.5mm and larger in diameter) are intended for use in:
8. Slipped capital femoral epiphysis
9. Pediatric femoral neck fractures
10. Tibial plateau fractures
11. SI joint disruptions
12. Intercondylar femur fractures
13. Subtalar arthrodesis
14. Fixation of pelvis and iliosacral joint.
    The Biomet Headless Compression Screws and Twist-Off Screws are indicated for fixation of bone fractures, fusion of a joint (arthrodesis) or bone reconstruction (osteotomy) of the mid-foot bones, metatarsal and phalanges of the foot or the phalanges, metacarpals and carpals of the hand. In the foot, these include procedures to correct Hallux Valgus (bunions), Hallux Varus and Hallux Rigidus, Hammer toe, Claw toe and Mallet toe.

The WasherLoc™ and No-Profile Screw and Washer Systems are internal soft tissue fixation devices that aid in arthroscopic and orthopedic reconstructive procedures. The system includes instrumentation allowing for proper preparation and placement of the soft tissue fixation device.
The No-Profile Screw and Washer System includes titanium alloy (Ti-6A1-4V) screws and washers in various lengths/sizes. Both 4.5mm and 6.0mm diameter screws in lengths from 24mm to 70mm are available. The No-Profile Washers are available in 14mm, 16mm, and 18mm diameters with and without spikes. The spikes on the washers are not intended for additional fixation as used with the No-Profile screws.
The WasherLoc™ Tibial Fixation System includes titanium alloy (Ti-6Al-4V) screws and washers in various lengths and sizes. Both 4.5mm and 6.0mm diameter screws in lengths from 24mm to 60mm are available. The WasherLoc™ Washers are available in 14mm, 16mm, and 18mm diameters with spikes intended for additional fixation.
The Biomet Cannulated Screw System is designed for a variety of internal fixation, aiding in the alignment, stabilization, and healing of fractures or osteotomies to the skeletal system. The Biomet Cannulated Screw System has multiple variants included which fluctuate in screw diameters and lengths, and include the associated essential instruments that aid in fracture fixation.
The Biomet Cannulated Screw System consists of screw variants, which are available in diameters of 3.0mm, 4.0mm, 5.0mm, 6.5mm, and 8.0mm. Each screw diameter is accompanied by instruments that are designed specifically for a given diameter. Washers are also part of the Biomet Cannulated Screw System and are sized 3.0mm, 4.0mm, 5.0mm, 6.5mm, and 8.0mm to specifically match each screw diameter. The washers are provided to add additional support under the head of the screw in situations where the bone quality is poor. Washers are also utilized for more surface area contact with the bone which needed in order to maintain proper fixation of the fracture or osteotomy.
The Biomet Headless Compression and Twist-Off Screws are used for fixation of bone fractures, fusion of a joint, or bone reconstruction, osteotomies of the mid-foot bones, metatarsals and phalanges of the foot and metacarpals, phalanges and carpals of the hand. The Ti-6Al-4V alloy Biomet Headless Compression and Twist-Off Screws have multiple lengths and diameters associated with the different screws ranging from 2.0 to 3.0mm in diameter and lengths from 8 to 40mm. Both sets of screws will be available in sterile and non-sterile configurations. The screws include the associated essential instruments that aid in fracture fixation.
The Biomet Headless Compression Screw is a cannulated headless screw which is inserted below the bone surface. This feature helps to minimize soft tissue irritation by sitting recessed and provides compression due to a dual thread design in the shaft and head.
The Biomet Twist-Off Screw is a solid one-piece screw that has a drive shaft that has the ability to connect to a drill or large diameter pin driver. In addition, the screw incorporates a breakaway zone between the head and direct connection that allows the screw to break-off cleanly upon insertion. The Biomet Twist-Off Screw also has compression capabilities with a thread-free segment that achieves compression at the osteotomy site.

This document describes the FDA's decision regarding the 510(k) premarket notification for several orthopedic screw systems (WasherLoc™ and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, and Biomet Headless Compression and Twist-Off Screws). The core of this submission is not about a novel AI/ML device or a device that performs diagnostic or prognostic functions based on data analysis. Instead, it's about a change in the manufacturing process (bioburden reduction) for existing, already cleared devices.

Therefore, the requested information categories related to acceptance criteria for AI performance, clinical studies, sample sizes for test/training sets, expert ground truth, adjudication methods, and MRMC studies are not applicable to this document. This submission focuses on demonstrating that a manufacturing process change does not alter the safety or effectiveness of physical medical devices.

However, I can extract the relevant information regarding the rationale for substantial equivalence:

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

Since this is a submission for a manufacturing process change for physical medical devices, acceptance criteria are generally related to the physical and biological properties of the devices after the new process, and the ability to maintain the same performance as the predicate devices. The document explicitly states:

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

• Not Applicable. This submission is not a clinical study to assess diagnostic or prognostic performance of an AI model. The "tests" mentioned are non-clinical, laboratory-based tests on the physical devices.
• The document implies that the tests performed (e.g., cytotoxicity, analytical testing, bioburden reduction, sterilization validation, BET) were conducted on the subject devices that underwent the new REVOX bioburden reduction process. No specific sample sizes for these in-vitro/bench tests are reported in this summary.

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):

• Not Applicable. No ground truth in the context of expert review of data is established for this type of submission. The "ground truth" for non-clinical tests would be defined by validated laboratory standards and methodologies.

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

• Not Applicable. No adjudication method for medical image interpretation or similar data is mentioned as this is a device modification submission, not a diagnostic AI clearance.

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. No MRMC study was performed as this is not an AI/ML diagnostic or assistive device.

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

• Not Applicable. This is not an AI algorithm.

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

• Not Applicable. For the non-clinical tests conducted, the "ground truth" is defined by established scientific and engineering principles, material science standards, and biological safety testing protocols (e.g., sterility assurance level (SAL), pyrogenicity limits, material composition standards).

8. The sample size for the training set:

• Not Applicable. No training set exists as this is not an AI/ML device.

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

• Not Applicable. No training set or associated ground truth.

In summary, this FDA clearance is for a change in the manufacturing process (bioburden reduction) of existing orthopedic screws, not for a new AI/ML medical device. Therefore, most of the requested information regarding AI performance criteria and studies is not relevant to this document. The "study" referenced is a series of non-clinical, laboratory-based tests to ensure the REVOX process does not negatively impact the safety and performance characteristics of the devices compared to their previously cleared versions.

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The Osteomed ExtremiFix Mini & Small Cannulated Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the device. Screws are intended for single use only.

The OsteoMed Mini & Small Cannulated Screw System is comprised of screws and washers used for bone fixation of the hand and foot following trauma or osteotomy. The System features cannulated screws in the following dimensions:

2.0mm screw diameter - 6 mm to 42 mm screw length; 2.4mm screw diameter - 6 mm to 50 mm screw length; 3.0mm screw diameter - 10 mm to 40 mm screw length; 4.0mm screw diameter - 12 mm to 52 mm screw length;

The system instruments include depth gauges, screwdrivers, countersinks, guide wires, and other instruments to facilitate the placement of screws.

The implants (screws and washers) of the OsteoMed ExtremiFix Mini & Small Cannulated Screw System are made from titanium alloy (ASTM F136). Modifications to the screws include changing the screw drive connection from a trilobe to a hexalobe and adding a headed screw option for each of the screw size offerings (2.0, 2.4, 3.0, and 4.0 mm diameters). The screws and washers are intended for single use only.

The subject device's system instruments include k-wires, drills, countersinks, drivers, tissue protectors, and screw extractor. The instrumentation is made from various grades of stainless steel, anodized aluminum, and/or medical grade polymer. The k-wires, screw extractor, and drills are intended for single use only.

The provided text is a 510(k) summary for the OsteoMed ExtremiFix Mini & Small Cannulated Screw System. This document describes a medical device, specifically bone fixation fasteners, and its equivalence to a predicate device already on the market.

However, the questions posed (acceptance criteria, study details like sample size, experts, adjudication, MRMC, standalone performance, ground truth establishment for training and test sets) are typically relevant for Artificial Intelligence/Machine Learning (AI/ML) powered medical devices which involve complex algorithms, image analysis, or clinical decision support systems.

The OsteoMed ExtremiFix Mini & Small Cannulated Screw System is a physical medical device (screws and instruments). Its "performance data" refers to bench testing for mechanical strength and material properties to ensure it functions as intended and is equivalent to existing devices. Therefore, the detailed questions about AI/ML study methodologies, such as those concerning "ground truth," "expert consensus," "training set," "test set," "human-in-the-loop," "MRMC," and "effect size of human readers improving with AI" do not apply to this type of device.

The document explicitly states: "Clinical testing is not required to support substantial equivalence." This reinforces that the evaluation is based on mechanical and material properties compared to a predicate, not on a clinical AI/ML performance study.

Therefore, I cannot extract the requested information (acceptance criteria as per AI/ML studies, details of AI/ML study design, MRMC, training/test set specifics, etc.) from this document because it describes a traditional hardware medical device, not an AI/ML device.

The relevant "performance data" provided are:

• Type of Study: Bench testing.
• Purpose of Study: To ensure the design features met the required mechanical strength criteria for their intended use and to show performance equivalence to the predicate device (OsteoMed Headless Cannulated Screw System, K063298).
• Conclusion: The device "demonstrates the subject devices are as safe, as effective, and performs as well as the predicate device."

This document does not contain the information required to answer your specific questions related to AI/ML device validation.

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The ARIX Cannulated Screw System is intended for use in internal fixation, reconstruction, or arthrodesis of small bones including the fore, mid-and hind foot and ankle. Also, the ARIX Cannulated Screw System is internal fixation of the bones of hand and wrist. Examples of these procedures may include but are not limited to replantation, lag screw techniques, joint fusions, corrective osteotomies, and the treatment of fractures.

The ARIX Cannulated Screw System consists of cannulated screw with diameters raging from 2.3mm to 6.0mm. The cannulate screws are made of Titanium Alloy(Ti-6AI-4V), ASTM F136, which are widely used for surgical implants with well-known biocompatibility and provided nonsterile. This submission is to reclassify the previously approved device and to add 4.0mm diameter screws.

It also includes washer various manual surgical instruments, such as drill bit, screwdriver shaft, countersink, screwdriver handle, depth gauge, guide pin, cleaning stylet, dispenser, forceps and drill guide.

The ARIX Cannulated Screw System not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10-6 by the hospital prior to surgery. The sterilization method is presented in the instruction, which was validated per ISO 17665-1: 2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.

The provided text is a 510(k) summary for the ARIX Cannulated Screw System, which is a medical device. This type of document focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing acceptance criteria and proving performance through a study with the detailed elements you've requested.

Therefore, much of the information you've asked for, particularly regarding acceptance criteria, specific performance metrics, sample sizes for test sets, data provenance, expert adjudication, MRMC studies, standalone algorithm performance, and training set details, is not available in this document.

However, I can extract the relevant information from the document:

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

The document doesn't define specific "acceptance criteria" in terms of performance thresholds for the device itself against clinical outcomes or diagnostic accuracy. Instead, it relies on demonstrating compliance with recognized standards and equivalence to predicate devices. The "reported device performance" is primarily the successful passing of these non-clinical tests.

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

• Sample Size: Not applicable. The document describes non-clinical laboratory testing of bone screws, not a study involving a test set of data or patient samples.
• Data Provenance: Not applicable. The testing was non-clinical and conducted in a laboratory setting. There is no mention of country of origin for data or whether it was retrospective or prospective.

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

• Number of Experts: Not applicable. There was no "ground truth" to establish in the context of diagnostic accuracy or clinical outcomes for this device.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable. There was no test set requiring expert 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:

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a bone screw, not an AI-assisted diagnostic tool.

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

• Standalone Performance: Not applicable. This device is a physical medical implant, not an algorithm.

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

• Type of Ground Truth: Not applicable. The "ground truth" for this device involved engineering specifications and biomechanical performance standards (ASTM F543).

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. This device is not an AI algorithm requiring a training set.

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

• How Ground Truth for Training Set was Established: Not applicable.

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