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The External Fixation Bone Distractor is intended for treatment of non-union or pseudoarthrosis of long bones and correction of bony or soft tissue defects or deformities.
The External Fixation Bone Distractor is indicated for adult and pediatric (greater than 2 through 21 years of age) patients.

The Paragon 28 External fixation Bone Distractor is a transverse bone transport system designed to assist in the controlled movement of a bone segment across a defect. The device can be used independently or in conjunction with the Monkey Rings External Fixation System (K232838) or Monkey Bars Pin to Bar External Fixation System (K242452) to form hybrid frames.

The provided FDA 510(k) clearance letter for the "External Fixation Bone Distractor" does NOT include information about acceptance criteria or a study that proves the device meets specific performance criteria through clinical data, especially not in the context of an AI/ML-driven medical device.

This document describes a traditional medical device (an external fixation system) and its clearance is based on substantial equivalence to existing predicate devices, rather than on meeting specific performance metrics derived from a study like an MRMC or standalone AI performance evaluation. The "Performance Testing" section explicitly states: "No additional bench testing was performed for the subject device. Instead, a worst-case analysis was conducted using existing data from other components within the device system." This means the clearance is based on engineering design analysis and comparison to mechanically similar, already cleared components, not on a study with clinical performance acceptance criteria.

Therefore, I cannot extract the requested information from the provided text. The questions posed relate to the evaluation of AI/ML-driven medical devices, which operate under different regulatory and performance evaluation paradigms.

To answer your request thoroughly, I will indicate that the information is not present in the provided document for each point.

Here's the breakdown, indicating the information is not present based on the provided FDA 510(k) letter:

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

• Information Not Present: The document does not specify quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy) nor does it report performance metrics from a clinical study. The clearance is based on substantial equivalence and mechanical properties derived from "worst-case analysis" using existing data, not a specific performance study against defined clinical criteria.

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

• Information Not Present: No test set is mentioned, as there was no clinical performance study conducted or reported for this 510(k) submission. The document relies on existing data from other components and worst-case analysis for mechanical performance.

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)

• Information Not Present: This is not applicable. There was no test set with clinical ground truth established by experts.

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

• Information Not Present: This is not applicable. No test set involving human expert adjudication was used.

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

• Information Not Present: An MRMC study was not done. The device is a mechanical medical device, not an AI/ML-driven diagnostic or assistive tool.

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

• Information Not Present: A standalone performance study was not done. The device is a mechanical bone distractor, not an algorithm.

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

• Information Not Present: Ground truth, in the context of clinical performance evaluation for AI/ML devices, is not relevant here as it's a mechanical device. The "ground truth" for this device's clearance relates to its mechanical integrity and biocompatibility, established through engineering standards (ASTM F1541-17) and material properties.

8. The sample size for the training set

• Information Not Present: A training set is not applicable. This is a mechanical device, not an AI/ML system.

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

• Information Not Present: This is not applicable. No training set or associated ground truth establishment method is mentioned.

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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 OrthoPediatrics Orthex External Fixation System is intended for external fixation with the following indications:

• · Stabilization of Fractures & Osteotomy
• · Rear and Mid-foot Foot Arthrodesis
• · Adult and Pediatric (greater than 2 through 21 years of age) Leg Lengthening
• · Correction of Bone Deformity in Upper & Lower Extremities
  The P&C Software is intended to be used as a component of multilateral external fixations listed above.

The OrthoPediatrics Orthex External Fixation System is an external fixator which includes typical components such as rings, partial rings, footplates, monolateral rails, and numerous hardware necessary for the construction of a frame to which tensioned wires, and half pins are attached to the bone and to the frame itself.
The components included in the external fixation system are made from various types of metal and plastic materials. Half pins and wires are manufactured from implant grade materials and are nonpyrogenic. External fixation components and implants are for single use only and not designed or sold for any use except as indicated.
The web based Orthex Point and Click (P&C) Software aids the surgeon in the use of the Orthex External Fixation System. The Point and Click (P&C) Software is only compatible with the Orthex External Fixation System. It can be accessed at www.orthex.net. The use of software is optional and is utilized with the bridging and additional necessary hardware elements of the frame.

I am sorry, but the provided text content does not contain the necessary information to answer your request about acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML-based medical device.

The document is a 510(k) Premarket Notification from the FDA regarding the Orthex External Fixation System, a physical medical device. It describes:

• Device Name: Orthex External Fixation System
• Indications for Use: Stabilization of Fractures & Osteotomy, Rear and Mid-foot Foot Arthrodesis, Adult and Pediatric Leg Lengthening, Correction of Bone Deformity.
• Components: Rings, partial rings, footplates, monolateral rails, hardware, tensioned wires, half pins.
• Materials: Various types of metal and plastic.
• Software Component: "The web based Orthex Point and Click (P&C) Software aids the surgeon in the use of the Orthex External Fixation System." It explicitly states the use of software is optional.
• Performance Data: Biocompatibility assessment, mechanical performance evaluations (self-taping, insertion torque, torsional strength, static and dynamic bending), and Hydroxyapatite (HA) Coating performance and characterization evaluations. These are physical/mechanical tests, not performance metrics for an AI/ML algorithm.

There is no mention of:

• AI/ML algorithms or their performance.
• Acceptance criteria for an AI/ML model (e.g., sensitivity, specificity, AUC).
• Test sets for AI/ML models (sample size, data provenance).
• Ground truth establishment by experts for imaging.
• Multi-reader multi-case (MRMC) studies.
• Standalone algorithm performance.
• Training sets for AI/ML models or their ground truth establishment.

Therefore, I cannot extract the information required to populate the table or answer the specific questions about the AI/ML study.

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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 Monkey Bars Pin to Bar External Fixation System is intended to be used in adult and pediatric patients (specifically, children and adolescents aged 2 through 21 years) for provisional fixation of open and/or unstable fractures in the lower and upper extremities and pelvis. It may also be used for temporary fixation of peri-articular or intra-articular fractures. Additionally, the device can be used on fractures where soft tissue injury or an infected fracture site may preclude the use of other fracture fixation treatments.

The device is used for the external stabilization of bone fractures. It consists of: Carbon fiber composite bars, 11mm diameter by 150mm to 500mm lengths, titanium combination clamp, aluminum 5 & 8 hole multi-pin clamps, aluminum straight and 30 degree angled posts, stainless steel 3mm, 4mm and 5mm thread diameter pins with 5mm diameter shanks that come in blunt tip and self tapping with 125mm through 230mm overall lengths and 20mm through 65mm thread lengths, stainless steel transfixing pin with 5mm shank, 7.2mm thread diameter, and 325mm overall length, and stainless steel instruments for implantation. The pins are implanted into bone and then they are connected using the clamps, rods and posts to form a rigid construct which holds the bone fragments rigidly in place. The pins are offered in various lengths and thicknesses.

The provided text describes the "Monkey Bars Pin to Bar External Fixation System" and its substantial equivalence to predicate devices, but it does not contain information about the acceptance criteria or a study proving that an AI/software device meets these criteria.

Instead, the document is a 510(k) summary for a physical medical device (an external fixation system), and it focuses on demonstrating substantial equivalence to legally marketed predicate devices through performance testing, primarily mechanical testing, rather than a clinical study or AI/software validation.

Therefore, I cannot provide the requested information in the format given, as the input document does not contain details about:

1. A table of acceptance criteria and the reported device performance for an AI/software device. The "Performance Testing" section mentions "Minimal Construct Static Compression Testing" and "predetermined acceptance criteria or were otherwise considered acceptable," but it doesn't quantify these criteria or results in a table for an AI system.
2. Sample size used for the test set and data provenance for an AI/software device.
3. Number of experts and qualifications for establishing ground truth for an AI/software device.
4. Adjudication method for an AI/software device.
5. Multi-reader multi-case (MRMC) comparative effectiveness study.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/software device.
8. Sample size for the training set for an AI/software device.
9. How the ground truth for the training set was established for an AI/software device.

The document explicitly states: "Clinical data are not needed to support the safety and effectiveness of the subject device." This further confirms that the provided text is not about an AI/software device's clinical performance.

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Arthrex Small External Fixation System is intended to be used in the stabilization of open and/or unstable fractures in anatomies such as the hand, wrist, forearm, foot, and ankle where soft tissue injury may preclude the use of other fracture treatments. The Arthrex Small External Fixation System is intended to be non-weight bearing.

The Arthrex Small External Fixation System is an external fixation device comprised of rods, clamps, and threaded half pins used for the management of bone fractures and reconstructive orthopedic surgery. The Arthrex Small External Fixation System is a modular system designed to provide options in frame construction, simplicity in frame components, and ease of use. The system is comprised of titanium (Ti-6Al-4V ELI conforming to ASTM F136), stainless steel (316L and 304 conforming to ASTM F138 and A276), and Aluminum (6061-T6 conforming to ASTM B211) clamps (pin-to-rod and multi-pin); stainless steel (316L conforming to ASTM F138) threaded half pins; and carbon fiber connector rods. The Arthrex Small External Fixation System is manufactured with threaded half pins and rods of 5.0 mm shaft diameter, which allows for support with small, long bone or short bone fractures. The Arthrex Small External Fixation System is a singleuse, non-sterile device intended for end-user sterilization. The Arthrex Small External Fixation System is manufactured with pins and rods of 5.0 mm shaft diameter, which allows for connectivity for support of bone fractures. The pin-to-rod clamps are designed to clamp the 5.0 mm carbon fiber rods to the 2.0 mm and 3.0 mm stainless steel threaded half pins, or other rods. The multi-pin clamps are designed to attach to other external fixator pieces to build constructs for a variety of fracture types and allows for angulated pin insertion. The stainless steel threaded pins come in 2.0 mm and 3.0 mm in diameter, and in total lengths of 55 mm, 75 mm, 100 mm, or 140 mm. The thread lengths come in 10 mm, 15 mm, 20 mm, and 25 mm. The threaded pins have twist flutes so that they are self-drilling and selftapping. The stainless steel Drill Guide Pins are supplied in 1.5 mm diameter. The connecting rods are carbon fiber with an overall diameter of 5.0 mm and are in lengths of 50 mm, 75 mm, 100 mm, 125 mm, 150 mm, 200 mm, 250 mm, and 300 mm.

This document (K232897) is an FDA 510(k) clearance for the Arthrex Small External Fixation System. It explicitly states that the device is substantially equivalent to a previously cleared predicate device (AOS Small External Fixation System, K141912).

Crucially, this document confirms that no new testing or studies were conducted for this 510(k) submission. The basis for clearance is that the device design, materials, and intended use are identical to the predicate device, and therefore, the performance data from the predicate device is considered sufficient.

Therefore, I cannot provide the requested information about acceptance criteria, specific performance results, sample sizes, expert ground truth establishment, or multi-reader studies for this specific submission (K232897) because no such studies were performed or submitted.

The relevant section from the document that supports this is titled "Performance Data" on page 5, which states:

• "The Arthrex Small External Fixation System has the same intended use and fundamental technology as the predicate device cleared, K141912."
• "The device is the same design as the predicate device. No design modifications were made to the Arthrex Small External Fixation System and the transition from AOS to Arthrex do not present a new worst case."
• "Therefore, the mechanical testing conducted for the predicate devices still represents worst case testing and additional verification testing are not required for the devices."
• "There has been no change in the device materials or manufacturing materials/process..."
• "...no new biocompatibility testing has been provided."

In summary, the "study" proving the device meets acceptance criteria for K232897 is the previous clearance (K141912), as this submission relied on the substantial equivalence principle rather than new performance testing.

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The Monkey Rings™ External Fixation System is indicated in pediatric patients and adults for the treatment and fixation of:

• · Open and closed fractures
• · Post-traumatic joint contracture which has resulted in loss of range of motion
• · 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 (e.g. orthoplastic surgery)
• · Correction of segmental bony or soft tissue defects
• · Joint arthrodesis
• · Management of comminuted intra-articular fractures
• · Bone transport

The Monkey Rings™ External Fixation System is indicated in adults for:

• · Osteotomy
• · Revision procedure where other treatments or devices have been unsuccessful
• · Bone reconstruction procedures
• · Fusions and replantations of the foot
• · Charcot foot reconstruction
• · Offloading and/or immobilization of ulcers and/or wounds of the foot and ankle
• · Lisfranc dislocations
• · Ankle distraction (arthrodiastasis)
• · Septic fusion

The Monkey Rings™ External Fixation System is a modular, ring-based, external fixation system designed for the treatment and fixation of a variety of conditions in pediatric and adult patients. The Monkey Rings™ External Fixation System utilizes wires, pins, struts, rods, bolts, fasteners, clamps, and plates that connect to rings statically placed or gradually manipulated in order to fixate or correct the bone. The modular design of the system allows for a customized treatment for the patient.

Components of the Monkey Rings™ External Fixation System may be used in conjunction with all Paragon 28 legally marketed devices.

The components of the device are offered in a variety of sizes, which allow for a truly customized external fixation device.

The provided text describes a 510(k) premarket notification for the "Monkey Rings™ External Fixation System" and asserts its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria or a study that specifically proves the device meets those criteria, especially in the context of an AI/ML device.

The document outlines the device's indications for use, its description, and references non-clinical performance testing. This testing focuses on engineering analysis for bending strength, biocompatibility, and sterilization, which are standard for mechanical medical devices. It explicitly states, "An engineering analysis of bending strength was conducted to provide evidence that the original testing and subsequent performance is not adversely affected by the modifications to the subject devices."

Since this device is an external fixation system (a mechanical device) and not explicitly an AI/ML device, the questions about sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth for training data are not applicable to the information provided in this document.

Therefore, I cannot provide the requested information because the document does not discuss acceptance criteria or studies related to AI/ML device performance.

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The Para-Fix External Fixation System is intended to provide stabilization of open and/or unstable fractures and where tissue injury precludes the use of other fracture treatments such as IM rodding or casting.

The specific indications for the Para-Fix External Fixation System include:

· Bone fracture fixation
· Osteotomy
· Arthrodesis
· Correction of deformity
· Revision procedure where other treatments or devices have been unsuccessful
· Bone reconstruction procedures

The New Paradigm Biomedical (NPB) Para-Fix External Fixation System is intended for use in external fixation of various long bone fractures, including tibial, femoral, pelvic, and humeral fractures in adults. The Para-Fix system consists of implants, & instrumentation for external fixation. The system features implants (Schanz Screws) in various diameters (05 – 6mm) and lengths (120 – 300mm) to accommodate different anatomic sizes of patients. Schanz Screws are manufactured from medical grade stainless steel per ASTM F138. Para-Fix frame components include Clamps are available in Combination (pin to rod, rod to rod) or Multi-Pin clamps are manufactured from stainless steel. Ø11mm rods are available in lengths ranging from 65 – 500mm and are manufactured from carbon fiber. The Para-Fix system is provided non-sterile.

The provided text describes a 510(k) premarket notification for the "Para-Fix External Fixation System." This is a medical device for orthopedic use, specifically for stabilizing bone fractures and other orthopedic conditions.

The document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than describing a study to prove acceptance criteria for a new AI/software-based medical device. Therefore, much of the requested information regarding "acceptance criteria," "device performance," "sample sizes," "ground truth," "expert readers," and "MRMC studies" is not applicable or present in this specific 510(k) summary.

Here's how the provided information relates to the request:

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

• Acceptance Criteria: The primary acceptance criterion for a 510(k) submission like this is substantial equivalence to a predicate device. This is typically demonstrated through a comparison of technological characteristics, intended use, and performance data (often non-clinical in this case).
• Reported Device Performance: The performance is reported in terms of mechanical testing showing substantial equivalence to the predicate device.

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

• Sample Size for Test Set: Not explicitly stated as a number of patients or clinical cases. For mechanical testing, the "sample size" would refer to the number of devices or components tested. This information (e.g., number of replicates for each mechanical test) is not detailed in the summary but would be part of the full test reports.
• Data Provenance: The mechanical testing was performed by "Element Materials Technology (Fairfield, OH)" and "NexTek Innovations (Logan, UT)". This is laboratory-based testing, not human clinical or retrospective/prospective data collection from patients.

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

• This question is not applicable to this type of device (an external fixation system). "Ground truth" in the context of mechanical testing is established by the test standards (ASTM F1541-17) and the results obtained from the testing equipment, not by expert human interpretation like in diagnostic AI.

4. Adjudication method for the test set

• This question is not applicable. There is no human adjudication for mechanical test results; the results are quantitative measurements against defined 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. This device is a mechanical external fixation system, not an AI-assisted diagnostic tool. No human reader studies (MRMC) were conducted or are relevant.

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

• This question is not applicable. There is no algorithm or software for "standalone performance" in this context.

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

• The "ground truth" for demonstrating substantial equivalence for this device is based on pre-defined mechanical testing standards (ASTM F1541-17) and the measured performance of both the subject device and the predicate device under these standardized conditions.

8. The sample size for the training set

• This question is not applicable. This device does not involve machine learning or a "training set."

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

• This question is not applicable. As there is no training set for an AI algorithm, no ground truth was established for it.

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The OrthoPediatrics Orthex External Fixation System is intended for external fixation with the following indications:

• Stabilization of Fractures & Osteotomy
• Rear and Mid-foot Foot Arthrodesis
• Adult and Pediatric Leg Lengthening
• Correction of Bone Deformity in Upper & Lower Extremities

The P&C Software is intended to be used as a component of multilateral external fixations listed above.

The OrthoPediatrics Orthex External Fixation System is an external fixator which includes typical components such as rings, partial rings, footplates, monolateral rails, and numerous hardware necessary for the construction of a frame to which tensioned wires and half pins are attached to the bone and to the frame itself. The system has an optional software to assist the user in adjusting the hexapod.

The components included in external fixation systems are made from various types of metal and plastic materials. Half pins and wires are manufactured from implant grade materials and are non-pyrogenic. External fixation components and implants are for single use only and not designed or sold for any use except as indicated.

The web-based Orthex Point and Click (P&C) Software aids the surgeon in the use of the Orthex External Fixation System. The software is optional to use. The Orthex Point and Click (P&C) Software does not control any hardware (such as rings, struts, wires, half pins) directly. The Point and Click (P&C) Software is only compatible with the Orthex External Fixation System. It can be accessed at www.orthex.net. The Pre-Operative planning function of the software aids the surgeon in pre-operative deformity analysis which includes determining where an osteotomy will be made, visualizing corrections, and planning for hexapod construction by positioning rings and calculating the initial strut lengths in preparation for frame application. The Post-Operative planning function of the software aids the surgeon in producing a strut length schedule to achieve the desired correction. The patient or caregiver manually adjusts the struts according to the strut length schedule.

This document is a 510(k) Premarket Notification from the FDA regarding the OrthoPediatrics Orthex External Fixation System. It grants clearance for the device based on its substantial equivalence to a predicate device.

The prompt requires information about acceptance criteria and a study that proves the device meets them, specifically for a software component ("P&C Software"). However, this document primarily discusses the hardware aspects and the software's role as an optional component. It states that the key updates to the software relate to adding a pre-operative planning function, changing schedule output formatting, and improving X-ray page functionality. The most significant software-related change mentioned is the re-addition of the "Rear and Mid-foot Foot Arthrodesis" indication to the software, as the software now includes the necessary modules and icons.

Crucially, this document does not describe any specific clinical study demonstrating accuracy or clinical effectiveness for the software. Instead, it relies on:

• Substantial Equivalence: The primary argument is that the device (hardware and updated software) is substantially equivalent to a previously cleared predicate device.
• Verification and Validation (V&V) Testing: It broadly states, "The safety and effectiveness of all the updates made to the software since its initial clearance have been successfully verified and validated. The software documentation including the verification and validation testing support that the subject software has met applicable design requirements established based on their intended use."

Given this, I cannot provide detailed answers to many of the sub-questions as they pertain to clinical or performance studies that are not described in this document. The V&V testing mentioned is typically internal engineering testing, not a comparative effectiveness study with human readers or standalone performance data in the way implied by the questions.

Therefore, the following table and explanations reflect what can be inferred or directly stated from the provided text, and where information is not present.

Acceptance Criteria and Device Performance (Based on available information)

• Pre-operative planning function
• Changing schedule outputs formatting
• Improved X-Ray pages' functionality
• Inclusion of foot and ankle modules/icons to support "Rear and Mid-foot Foot Arthrodesis" indication. |
  | Safety (Hardware, MR Environment) (Explicitly for hardware) | "The Orthex External Fixation System is MR unsafe" due to ferromagnetic materials. |
  | Substantial Equivalence (Overall regulatory criterion) | "The Orthex External Fixation System is as safe and effective as the predicate device." |

Study Details (As much as can be gleaned from the document):

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

   • Not specified. The document mentions "verification and validation testing" but does not detail a test set in terms of patient data or clinical cases. This testing is likely internal engineering and functional testing of the software itself and its algorithms, rather than a clinical study with a patient data test set.

2. 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 specified. Ground truth establishment, if any, for software function would likely be based on engineering specifications or perhaps orthopedic surgical principles, not necessarily expert adjudication of clinical cases as would be done for an AI diagnostic device.

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

   • Not specified. This pertains to clinical studies often involving AI, which is not detailed here.

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

   • No such study is described. The document indicates the software "aids the surgeon" and "is optional to use." It explicitly states, "The P&C Software is intended to be used as a component of multilateral external fixations listed above," implying an assistive role. However, no MRMC study or data on human reader improvement with or without AI assistance is provided.

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

   • No standalone performance study is explicitly described in terms of clinical accuracy. The "verification and validation testing" would represent internal standalone performance assessments against design requirements, but not typically a stated accuracy metric like AUC or sensitivity/specificity for a diagnostic AI. The software's role is assistive, not a standalone diagnostic.

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

   • Not explicitly stated for a clinical ground truth. For the software's functionality, ground truth would be based on engineering specifications, mathematical models for hexapod adjustments, and established orthopedic principles for deformity correction and planning.

7. The sample size for the training set:

   • Not applicable / Not specified. This device's software is described as tool-based (calculating strut lengths, pre-operative planning) rather than a machine learning model that requires a "training set" in the conventional sense of deep learning or AI. It seems to be based on deterministic algorithms.

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

   • Not applicable / Not specified. As it does not appear to be an AI/ML model with a "training set," this question is not relevant based on the information provided. Its "ground truth" would be the mathematical correctness of its calculations and the accurate representation of orthopedic planning principles.

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Smith & Nephew's MAVERICK and MAVERICK Mini External Fixation System is intended to be used for temporary stabilization of the long bones, feet, pelvis, and wrist.

The indications for the Smith & Nephew MAVERICK Mini External Fixation System are the following:

• Open and closed fracture fixation
• Bony or soft tissue deformities

The subject of this premarket notification is the MAVERICK Mini External Fixation System. The system is an external fixation system that consists of various components used in the management of pelvic, feet, wrist, and long bone fractures and reconstructive and corrective orthopedic surgery. The system consists of stainless steel bone pins, composite and titanium bars, and titanium clamps. These components can be combined to build a frame which is appropriate for each specific application.

This is a medical device submission, specifically a Pre-Market Notification (510(k)) for the MAVERICK Mini External Fixation System. It describes the device, its intended use, and states that it has been determined to be substantially equivalent to previously cleared predicate devices.

However, this document does not contain information regarding acceptance criteria and a study proving a device meets those criteria in the context of AI/ML or diagnostic performance. The "performance testing" section refers to bench testing for mechanical properties (e.g., torsional grip strength, axial grip strength, rigidity testing) typical for orthopedic fixation devices, not a study evaluating diagnostic accuracy, sensitivity, specificity, or human-in-the-loop performance which would require the acceptance criteria and study details you've outlined.

Therefore, I cannot provide the requested information for acceptance criteria and a study that proves the device meets those criteria based on the provided text, as this document focuses on mechanical substantial equivalence for an external fixation system.

The questions you've asked are typically relevant for submissions of AI/ML-driven diagnostic devices or imaging analysis software, which require clinical performance studies with specific statistical endpoints and ground truth establishment. This document is for a traditional medical device (an external fixation system).

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