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The Extremity Medical External Fixation System is indicated for adults and pediatric patients (2 years old and older) for treatment of:

• Open and closed fractures
• Osteotomies
• Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
• Pseudoarthrosis, infected union, non-union, or malunion of long bones
• Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction
• Correction of bony or soft tissue deformity (orthoplastic surgery)
• Joint arthrodesis
• Infected fractures
• Correction of segmental bony or soft tissue defects
• Management of comminuted intra-articular fractures
• Bone transport
• Revision procedures where other treatments or devices have been unsuccessful
• Bone reconstruction procedures
• Charcot foot reconstruction
• Offloading and/or immobilization of ulcers and/or wounds of the foot and ankle
• Ankle distraction (arthrodiastasis)
• Septic fusion

The Extremity Medical External Fixation System consists of three basic types of elements: bridge elements, connection elements and bone anchorage elements. The system is intended for use in a variety of applications including but not limited to Charcot foot reconstruction, open fracture fixation, joint arthrodesis, limb lengthening and bone transport. The assembly is made up of two or more circular rings that are connected by struts, rods or pillars to provide a framework for fixation. HA coated half pins and tensioned wires are then used to fixate and stabilize bones and joints.

Bridge elements include rings, manufactured from anodized aluminum, in various types and sizes to accommodate varying patient anatomy. Connection elements, manufactured from stainless steel and anodized aluminum, include threaded rods, threaded pillars, rancho cube pillars available in multiple lengths and struts available in multiple sizes. Bone anchorage elements include wires and HA coated half pins, manufactured from stainless steel, available in multiple diameters and lengths. HA coated half pins are provided sterile packed while all other system components are provided non-sterile.

All External Fixation components are for single use only.

The provided FDA 510(k) clearance letter and accompanying Special 510(k) Summary for the Extremity Medical External Fixation System do not contain information describing the acceptance criteria and a study proving the device meets those criteria in the context of an AI/Software as a Medical Device (SaMD).

The document is for a physical medical device (an external fixation system), not a software or AI-driven device. Therefore, the questions about sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and how ground truth for training was established are not applicable to this submission.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through:

• Design comparison: Listing similarities and differences in components, materials, and technological elements.
• Non-clinical testing: Mechanical testing in accordance with ASTM F1541-17 standard.
• Engineering analysis: Comparing the subject device's components to the predicates.

The "acceptance criteria" for this device would typically be defined by the performance requirements outlined in the relevant ASTM standard (ASTM F1541-17, titled "Standard Specification and Test Methods for External Skeletal Fixators") and demonstrated through the mechanical testing.

Therefore, I cannot provide the requested information as it does not exist in the context of this specific FDA submission.

If you have a document relating to an AI/SaMD, I would be happy to analyze it for the specific criteria you've outlined.

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The Extremity Medical External Fixation System is indicated for adults and pediatric patients (2 years old and older) for treatment of:
Open and closed fractures
Osteotomies
Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
Pseudoarthrosis, infected union, non-union, or malunion of long bones
Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction
Correction of bony or soft tissue deformity (orthoplastic surgery)
Joint arthrodesis
Infected fractures
Correction of segmental bony or soft tissue defects
Management of comminuted intra-articular fractures
Bone transport
Revision procedures where other treatments or devices have been unsuccessful
Bone reconstruction procedures
Charcot foot reconstruction
Offloading and/or immobilization of ulcers and/or wounds of the foot and ankle
Ankle distraction (arthrodiastasis)
Septic fusion

The Extremity Medical External Fixation System consists of three basic types of elements: bridge elements, connection elements and bone anchorage elements. The system is intended for use in a variety of applications including but not limited to Charcot foot reconstruction, open fracture fixation, joint arthrodesis, limb lengthening and bone transport. The assembly is made up of two or more circular rings that are connected by struts, rods or pillars to provide a framework for fixation. Pins and tensioned wires are then used to fixate and stabilize bones and joints.

Bridge elements include rings, manufactured from anodized aluminum, in various types and sizes to accommodate varying patient anatomy. Connection elements, manufactured from stainless steel and anodized aluminum, include threaded rods and threaded pillars available in multiple lengths and struts available in multiple sizes. Bone anchorage elements include wires and half pins, manufactured from stainless steel, available in multiple diameters and lengths.

All External Fixation components are for single use only.

The original document is a 510(k) summary for the Extremity Medical External Fixation System. It describes a medical device, its indications for use, and a comparison to predicate devices, focusing on non-clinical testing for substantial equivalence.

It does not contain information about acceptance criteria or a study proving that an AI/Software as a Medical Device (SaMD) meets acceptance criteria. The document focuses on the substantial equivalence of a physical external fixation system through engineering analysis and static/dynamic construct testing, not on the performance of a software algorithm.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/SaMD from this document. The sections you asked about, such as sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not relevant to the content of this 510(k) summary for a physical medical device.

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The Omni Foot and Ankle Plating System is intended for use in internal fixation of arthrodeses, osteotomies, fractures and nonunions of the small bones of the foot & ankle including the fore-, mid-, and hind foot and ankle applications.

The Omni Foot and Ankle Plating System is a bone fixation system consisting of unalloyed Titanium plates and Titanium Alloy (Ti-6AL-4V) locking and non-locking plate screws, which meet ASTM F67 and ASTM F136, and a set of instruments used for implant site preparation and delivery. The plates are available in various configurations, essentially differing by the lengths and number of holes. The plate screws are provided in diameters of 2.8mm and 3.5mm in lengths from 8mm to 50mm. The System offers 3.5mm cannulated screws and 4.0mm solid screws in various lengths to be used as adjunctive fixation. The 3.5mm cannulated screw can also be used with a specialized locking screw ("Post") which contains a locking feature at the distal end for compression/stabilization.

The provided text is for a 510(k) premarket notification for a medical device called the "Omni Foot and Ankle Plating System." This document does not describe the acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML powered device. Instead, it details the regulatory process for establishing substantial equivalence to previously cleared devices.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, test set details, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set specifics for an AI/ML powered device from the provided text.

The document explicitly states: "No clinical testing was performed." and relies on "engineering analysis" for comparison to predicate devices, which is typical for non-AI/ML mechanical devices.

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The Axis Charcot Fixation System in diameters of 4.5 to 8.5mm is indicated for reconstruction procedures, non-unions and fusions of bones in the foot and ankle including the metatarsals, cuneiforms, cuboid, navicular, calcaneus and talus; specific examples include: medial and lateral column fusion resulting from neuropathic osteoarthropathy (Charcot).

The Axis Charcot Fixation System consists of 5.5, 6.5 and 7.5mm cannulated, titanium alloy fixation beams and accessories used for midfoot reconstruction. The modified device adds additional sizes, 4.5 and 8.5mm cannulated, titanium alloy fixation beams, previously cleared under Extremity Medical's 4.5 to 8.5 Screw System (K171018). The additional sizes offer the surgeon options for placement based on patient anatomy.

The provided text is a 510(k) summary for the Axis Charcot Fixation System, a medical device. It does not include information about AI/ML device performance, acceptance criteria, or studies involving human readers, as it describes a bone fixation system.

Therefore, most of the requested information cannot be extracted from this document as it pertains to AI/ML device evaluation.

However, based on the provided text, I can infer the following:

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

The document does not explicitly state acceptance criteria in a quantitative manner typical for AI/ML performance. Instead, it refers to "engineering analyses evaluating mechanical strength" and "pullout strength". The performance determined was "substantially equivalent to the predicate devices for the intended use."

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

This information is not applicable and not provided. The testing described is mechanical, not involving patient data or a "test set" in the context of an AI/ML device.

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 information is not applicable and not provided. The "ground truth" for this device would be established through engineering standards and physical measurements, not expert consensus on medical images or clinical outcomes.

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

This information is not applicable and not provided. Mechanical testing does not involve adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No such study was performed or is relevant to this device. This device is a physical bone fixation system, not an AI-assisted diagnostic tool.

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

This information is not applicable. This device is a physical bone fixation system, not an algorithm.

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

The "ground truth" for this device's performance is based on engineering standards and physical measurements of mechanical properties (strength, pullout force).

8. The sample size for the training set

This information is not applicable and not provided. There is no AI/ML model being "trained" for this device.

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

This information is not applicable and not provided. There is no AI/ML model being "trained" for this device.

In summary, the provided document describes a 510(k) submission for a physical medical device (bone fixation system) and does not contain information related to AI/Machine Learning device performance or ground truth establishment in the context of diagnostic or interventional AI.

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The Intraosseous Fixation System is intended for reduction of arthrodeses, osteotomies, intra- and extra-articular fractures and nonunions of the small bones and joints of the hand, wrist, foot and ankle, appropriate for the size of the device.

The Extremity Medical Intraosseous Fixation System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extra-articular fractures and nonunion of the small bones and joints of the hand, wrist, foot, and ankle. The system consists of solid and cannulated screws, with the option of adding Washers; a standard/flat Washer, a Washer Post (referred to as an X-Post) for engaging the head of the Screw, and an X-Clip for engaging the threads of the screw. The X-Post/X-Clip come in varying sizes and lengths. Similarly, the lag screws come in varying diameters and lengths, and are also available in short and long thread configurations. The modified device is a product line extension and improvement to the Screw and Washer System, cleared under K121349, intended to provide modularity to the end user. New components to the system consist of cannulated 3.5 mm screws and implant accessories, X-Posts and X-Clips, to offer surgeons options for placement. Additionally, the system will offer additional thread length options for the 4.5mm screws cleared under K121349 and 6.5mm screws substantially equivalent to those cleared under K121349.

This document, K201556, pertains to a 510(k) premarket notification for a medical device called the "Intraosseous Fixation System," manufactured by Extremity Medical, LLC. It is a Class II device (21 CFR 888.3040) classified as a smooth or threaded metallic bone fixation fastener.

The provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria for software or an AI/ML algorithm. The document describes a traditional medical device (implants for bone fixation) and its substantial equivalence to predicate devices based on design, materials, and mechanical properties. There is no mention of an AI/ML component, image analysis, or any performance metrics typically associated with such systems.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria, test set details, ground truth establishment, or human reader studies related to an AI/ML device, as none of that information is present in the provided FDA 510(k) clearance document.

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The KinematX Total Wrist Arthroplasty System is indicated for the replacement of wrist joints disabled by pain, deformity, and/or limited motion caused by:

1. Non-inflammatory degenerative wrist disease of the radiocarpal joint including osteoarthritis, post-traumatic arthritis, and Kienbock's disease
2. Revision where other devices or treatments have failed
3. Scapholunate Advanced Collapse (SLAC)
4. Rheumatoid Arthritis
   The device is intended to be implanted with bone cement.

The KinematX Total Wrist Arthroplasty System is a semi-constrained implant system designed to replace the joints of the wrist to alleviate pain while restoring functionality and mobility of the wrist joints. The system consists of two main, modular components:

1. Radial Implant Assembly: CoCr radial stem and an ultra-high molecular weight polyethylene (UHMWPE) bearing surface that interlocks onto a CoCr tray
2. Carpal Implant Assembly: Baseplate with central peg, index metacarpal screw, hamate screw, and CoCr cap.

This FDA document, K191525, describes the KinematX Total Wrist Arthroplasty System. However, it does not include details about acceptance criteria, device performance tables, sample sizes for test or training sets, ground truth establishment, expert qualifications, or multi-reader multi-case studies. It explicitly states that "No clinical testing was performed."

Therefore, I cannot provide the requested information based on the provided text. The document focuses on establishing substantial equivalence to predicate devices through non-clinical testing (mechanical and cadaveric evaluations) and a comparison of indications for use, materials, and design.

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The Axis Plating System is indication and fixation of fractures or osteotomies, reconstruction procedures, nonunions and fusions of bones in the foot and ankle including the metatarsals, cuneiforms, cuboid, navicular, calcaneus and talus; specific examples include: medial and lateral column fusion resulting from neuropathy (Charcot).

The Axis Plating System is a bone fixation system consisting of Titanium Alloy (Ti-6AL-4V) plates, locking and non-locking plate screws, which meet ASTM F136, and a set of instruments used for implant site preparation and delivery. The plates are available in various configurations, essentially differing by geometry and number of holes. The plate screws are provided in diameters of 3.5mm and 4.5mm in lengths from 8mm to 50mm. The System offers 4.0mm cannulated screws and beams in various lengths to be used as adjunctive fixation. The 4.0mm cannulated screws and beams can also be used with a specialized locking screw ("Post") which contains a locking feature at the distal end for compression/stabilization.

This document is a 510(k) summary for the Axis Plating System, a medical device for bone fixation. It explicitly states: "No clinical testing was performed."

Therefore, based on the provided text, it's impossible to describe acceptance criteria or a study that proves the device meets those criteria from an AI/algorithm perspective, as no clinical study involving an AI or algorithmic component was conducted or described in this submission.

The document is about a hardware medical device (plates and screws), and its substantial equivalence is based on non-clinical testing (engineering analysis for plate and screw properties) and comparison to predicate devices, not on the performance of a diagnostic algorithm or AI.

If this was a misunderstanding and you intended to ask about the acceptance criteria and non-clinical testing specifically for the Axis Plating System (a physical device), then here's a summary of what's provided:

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

The document doesn't provide a table of acceptance criteria with specific numerical targets and results for device performance. Instead, it lists the types of non-clinical engineering analyses performed. The "performance" is implicitly deemed acceptable if these tests demonstrate equivalence to predicate devices and satisfy relevant ASTM standards (ASTM F136 mentioned for Titanium Alloy).

• Pullout
• Torsion/bending
• Torque to failure |
  | Acceptable Mechanical Performance of Plates | Plate Engineering Analysis |
  | Equivalence in Design, Principle of Operation | Comparison to predicate devices (K190365, K180808, K140792) |

Regarding the other points, as they relate to an AI/algorithm study, they are not applicable to this submission:

• 2. Sample sized used for the test set and the data provenance: Not applicable. No clinical test set or data described.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set requiring expert ground truth.
• 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...: Not applicable. This is not a diagnostic AI device.
• 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 concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's substantial equivalence is based on engineering principles, material standards, and comparison to existing legally marketed devices.
• 8. The sample size for the training set: Not applicable. No AI model trained.
• 9. How the ground truth for the training set was established: Not applicable.

In conclusion, the provided FDA document pertains to a physical medical device (bone fixation system) and explicitly states "No clinical testing was performed" for its substantial equivalence determination. Therefore, no information regarding acceptance criteria, test sets, ground truth establishment, or clinical studies involving AI or human readers can be extracted from this text.

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The AlignX Ankle Fusion System is intended to facilitate arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints.

The AlignX Ankle Fusion System is a bone fixation device consisting of an anatomical, anterior and lateral tibia plates and various locking and non-locking screws and a set of instruments used for implant site preparation and delivery. The plates are available in various geometries. The anterior plate is available three configurations, a slim plate and a 2-tab plate (available in two widths). A central hole in the plate allows for angled placement of a "home run" screw to obtain axial compression across the tibiotalar (TT) or (tibiotalarcalcaneal) (TTC) joints. The 2-tab plate is designed with an anterior "window" to allow autologous grafting of the TT and visualization of fusion under fluoroscopy. The lateral plate is available in two geometries, one for tibiotalar (TT) joint fusion and one for tibiotalarcalcaneal (TTC) fusions.

The provided text is a 510(k) summary for a medical device called the "AlignX Ankle Fusion System." This summary does not include acceptance criteria or the results of a study proving a device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices through engineering analysis and the assertion that no clinical testing was performed.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample size, ground truth, or expert qualifications based on the given text.

The document states:

• "No clinical testing was performed."
• "An engineering analysis demonstrated that the new plates and screw sizes do not introduce a new worse case in terms of strength."

This indicates that equivalence was established through non-clinical testing (engineering analysis) and comparison to predicate devices, rather than through a study with acceptance criteria often seen with performance claims for AI/ML devices or diagnostic tools.

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The Omni Foot Plaing System is internal fixation of arthrodeses, osteotomies, fractures and nonunions of the small bones of the foot & ankle including the fore-, mid-, and hind foot and ankle applications.

The Omni Foot Plating System is a bone fixation system consisting of unalloyed Titanium plates and Titanium Alloy (Ti-6AL-4V) locking and non-locking plate screws, which meet ASTM F67 and ASTM F136, and a set of instruments used for implant site preparation and delivery. The plates are available in various configurations, essentially differing by the lengths and number of holes. The plate screws are provided in diameters of 2.8mm and 3.5mm in lengths from 8mm to 50mm. The System offers 3.5mm cannulated screws in various lengths to be used as adjunctive fixation. The 3.5mm cannulated screw can also be used with a specialized locking screw ("Post") which contains a locking feature at the distal end for compression/stabilization.

This document is a 510(k) premarket notification for the Omni Foot Plating System, a medical device. It does not describe an AI/ML device or present data from a study to prove a device meets acceptance criteria related to AI/ML performance. Instead, it demonstrates substantial equivalence to predicate devices through engineering analysis and materials comparison.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance for an AI/ML system, as this document pertains to a traditional metallic bone fixation system.

Specifically:

1. Table of acceptance criteria and reported device performance: Not applicable. This document is about a mechanical device, not an AI/ML system with performance metrics like sensitivity, specificity, etc.
2. Sample size for test set and data provenance: Not applicable. No test set for AI/ML performance. The engineering analysis compares mechanical properties.
3. Number of experts and qualifications for ground truth: Not applicable. Ground truth as typically defined for AI/ML (e.g., disease diagnosis) is not relevant here.
4. Adjudication method for test set: Not applicable.
5. MRMC comparative effectiveness study: Not applicable. This is not an AI-assisted diagnostic device.
6. Standalone (algorithm only) performance: Not applicable. This is a physical device, not an algorithm.
7. Type of ground truth used: Not applicable for AI/ML. The "ground truth" for this device's performance would be engineering standards and material properties, confirmed by engineering analysis.
8. Sample size for training set: Not applicable. There is no AI/ML model to train.
9. How ground truth for training set was established: Not applicable.

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The Omni Foot Plating System is intended for use in internal fixation, reconstruction, or arthrodesis of the 1st Metatarsalphalangeal joint.

The Omni Foot Plating System is a bone fixation system consisting of unalloyed Titanium plates and Titanium Alloy (Ti-6AL-4V) locking and non-locking plate screws, which meet ASTM F67 and ASTM F136, and a set of instruments used for implant site preparation and delivery. The plates are available in various configurations, essentially differing by the lengths and number of holes. The plate screws are provided in diameters of 2.8mm and 3.5mm in lengths from 8mm to 50mm. The System offers 3.5mm cannulated screws in various lengths to be used as adjunctive fixation. The 3.5mm cannulated screw can also be used with a specialized locking screw ("Peg") which contains a locking feature at the distal end for compression/stabilization.

The provided document is a 510(k) premarket notification for the Omni Foot Plating System, which is a metallic bone fixation device. This type of device is classified as a Class II medical device. For such devices, clinical performance studies using patient data (like those involving AI-powered diagnostic tools) are typically not required, as substantial equivalence is often demonstrated through technological comparison, engineering analysis, and non-clinical bench testing.

Therefore, the requested information regarding acceptance criteria and studies proving the device meets those criteria, particularly aspects like sample size for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth for training data, is not applicable to this type of device submission.

The document explicitly states under "Clinical Testing": "No clinical testing was performed."

Instead, the acceptance criteria and proof of meeting them for the Omni Foot Plating System are based on:

1. Technological Comparison: Demonstrating that the design, materials, and principle of operation are substantially equivalent to legally marketed predicate devices.
2. Engineering Analysis: Detailed analysis of the device's design and function.
3. Mechanical/Bench Testing: Physical tests conducted in a laboratory setting to verify performance specifications.

Here's a breakdown of the relevant information provided for the Omni Foot Plating System in relation to its acceptance criteria:

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):

• Not Applicable. No human subjects test set or clinical data was used for this submission. The "test set" primarily refers to the physical samples of the device components used for bench testing. The document does not specify the exact number of samples tested for each bench test (e.g., how many screws were tested for pullout strength).

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

• Not Applicable. Ground truth, in the context of clinical studies with human data, is not relevant here. Device equivalence was established through engineering principles and mechanical testing, which would involve qualified engineers and technicians performing the tests.

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

• Not Applicable. Adjudication methods apply to the interpretation of clinical data by multiple experts. Not relevant for this type of device submission.

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. The device is a physical implant, not an AI-powered diagnostic tool. MRMC studies are not relevant.

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

• Not Applicable. This is a physical medical device, not an algorithm.

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

• Not Applicable. For this device, the "ground truth" for demonstrating safety and effectiveness is primarily established through adherence to engineering design specifications, material standards (ASTM), and the results of validated mechanical bench tests demonstrating properties (like pullout strength, torque, static bend) that are equivalent to or meet the requirements of predicate devices.

8. The sample size for the training set:

• Not Applicable. "Training set" refers to data used to train algorithms, which is not relevant for this physical device.

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

• Not Applicable. As per point 8, there is no training set in the context of this device submission.

In summary, the 510(k) submission for the Omni Foot Plating System relies on non-clinical data (engineering analysis and mechanical bench testing) to demonstrate substantial equivalence to predicate devices, rather than clinical studies with human data. Therefore, many of the questions related to clinical study design and data analysis are not applicable.

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