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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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SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) is intended to be used for posttraumatic 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; open and closed fracture fixation; pseudo-arthrosis of long bones; limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformities; correction of bony or soft tissue defects; joint arthrodesis; infected fractures or nonunions.

The SixFix™ web application for the DACS software can be used with the SixFix™ Hexapod fixator. Use of the software is optional for clinicians using the SixFix™ Hexapod fixator.

The SixFix™ Deformity Analysis and Correction Software (DACS) can be used with the SixFix™ Hexapod fixator (K190069), otherwise known as a spatial frame external fixator. Use of the software is optional for clinicians using the SixFix™ Hexapod, which is a circular external fixator based on Illizarov principles. The software utilizes radiographs, along with surgeon inputs, to develop a patient prescription to correct the deformity.

The provided FDA 510(k) clearance letter and summary for the SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) contain details about the device's intended use, description, and comparison to a predicate device. However, it does not provide the specific quantitative acceptance criteria or detailed study results typically found in a comprehensive study report for software performance.

The document states:

• "Functional testing used the same approach as testing for the predicate device and included 43 test cases representing a range of clinical scenarios to ensure the device performed as intended."
• "Test results demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device predicates."

This indicates that testing was performed, but the precise acceptance criteria, the reported device performance against those criteria, or the detailed methodology (sample size for test set, data provenance, expert involvement, ground truth establishment, MRMC study, etc.) are not included in this summary.

Therefore, many of your requested details cannot be extracted from the provided text. I will provide a table and describe what information is available and what is missing based on the provided document.

Acceptance Criteria and Device Performance (Based on provided document)

Since the document does not explicitly state quantitative acceptance criteria or detailed performance metrics, the "acceptance criteria" can be inferred as successful completion of the functional tests and demonstrating equivalence to the predicate. The "reported device performance" is a general statement of successful testing.

Detailed Study Information (Based on provided document)

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

   • Sample Size for Test Set: The document states "43 test cases representing a range of clinical scenarios." It does not specify if these "test cases" refer to patient datasets or defined functional tests. Assuming "test cases" are distinct clinical scenarios/data points used to validate the software, the sample size for the test set is 43.
   • Data Provenance: Not specified. It does not mention the country of origin of the data or whether it was retrospective or prospective.

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

   • Not specified. The document broadly mentions "surgeon inputs" but does not detail how ground truth for the test set was established or the number/qualifications of experts involved in that process.

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

   • Not specified. This detail is not provided in the document.

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 MRMC study is mentioned. The document focuses on the software itself and its equivalence to a predicate, not on human-in-the-loop performance improvement. The "Use of the software is optional for clinicians using the SixFix™ Hexapod fixator" suggests it's a tool, but its impact on human reader performance is not discussed.

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

   • Yes, implicitly. The "Functional testing" involving 43 test cases likely refers to standalone software performance. The software "utilizes radiographs, along with surgeon inputs, to develop a patient prescription to correct the deformity." The testing would have evaluated the accuracy of these generated prescriptions based on input data.

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

   • Not explicitly stated for the test set. Given the nature of the software (deformity analysis and correction), the ground truth for the test cases would likely involve pre-defined, clinically correct "prescriptions" or measurements established by expert opinion or theoretical calculations validated by experts. It's not pathology or outcomes data in this context.

7. The sample size for the training set:

   • Not specified. The document mentions testing and validation but provides no information about a training set size, implying either it's not a machine learning model that requires a distinct, labeled training set of this type, or the information is simply not included in this summary. Given it's a "Deformity Analysis and Correction Software" and not explicitly termed an AI/ML device in the modern sense (though it performs "analysis"), it might be a rules-based or algorithmic system that doesn't rely on a separate training dataset in the same way a deep learning model would.

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

   • Not applicable/Not specified, as no training set information is provided.

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

The subject TrueLok Elevate is an external fixation component system (including its accessories) to be used with the Orthofix TrueLok family, for which Orthofix identified as a predicate device TrueLok Hexapod System (TL-HEX) V2.0 (K170650). The subject device consists in a further series of elements for external fixation added to the Orthofix TrueLok family with the aim of supporting the Orthofix TrueLok external fixator systems family falling within the indications for use of the more extensive, cleared indications for use of the chosen predicate device, for the specific use in bone transport treatment.
The subject TrueLok Elevate is intended for treatment of non-union or pseudoarthrosis of long bones and correction of bony or soft tissue defects or deformities.
The TrueLok Elevate is indicated for adult and pediatric (greater than 2 through 21 years of age) patients.
The subject device is constituted by an external fixator and related accessories (half pins, k-wires, drill positioning guide, template and template inserts and convenience kits).
The technique for the use of the subject device consists in fixing two half pins on the first cortical of the bone segment that the surgeon decided to transport, and two half pins on both cortexes of the bone.
The positioning of the half pins is driven by a template.
During the treatment, through the knob present on the device, the bone segment is gradually pulled outward by the patient/caregiver to laterally transport the bone segment.
The subject device, as the predicate, will be implanted only by Healthcare Professionals (HCP), with full awareness of the appropriate orthopedic procedures (including application and removal), in the operating theatre only. The distraction of the limb will be activated in home by the patient/caregiver or in clinic theatre by the HCP. Treatment activation for pediatric patients in the home environment may require the assistance of a caregiver.

The Orthofix TrueLok™ Elevate is an external fixation component system intended for the treatment of non-union or pseudoarthrosis of long bones and correction of bony or soft tissue defects or deformities in adult and pediatric patients (greater than 2 through 21 years of age).

Here's an analysis of the acceptance criteria and the study performed, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific pass/fail acceptance criteria values for the mechanical tests conducted. Instead, it describes comparative testing against predicate or reference devices to demonstrate similarity in performance. The assessment for each technological characteristic indicates that "no different questions have been raised" or that the subject device's indications fall within the predicate's, suggesting that the goal was to demonstrate equivalence rather than meeting pre-defined numerical thresholds for acceptance.

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

The document does not explicitly state the sample sizes used for the mechanical tests (e.g., number of external fixators or half pins tested).
The provenance of the data is not specified regarding country of origin or whether it was retrospective or prospective, as these were bench tests performed on devices rather than patient data.

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

This information is not applicable to this type of submission. The ground truth for mechanical performance is established through standardized testing protocols (e.g., ASTM standards) and comparisons to previously cleared predicate devices, not through expert consensus on medical images or patient outcomes.

4. Adjudication Method for the Test Set

This information is not applicable to this type of submission as the mechanical tests are objectively measured, not subject to subjective interpretation requiring adjudication.

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

An MRMC study was not performed. This type of study is typically relevant for AI/imaging devices where human reader performance is being evaluated with and without AI assistance. The TrueLok™ Elevate is a physical external fixation system.

6. Standalone (Algorithm Only) Performance Study

A standalone study was not performed, as the device is a physical medical device, not a software algorithm.

7. Type of Ground Truth Used

The ground truth used for demonstrating performance was based on objective mechanical measurements conducted in accordance with recognized industry standards (e.g., ASTM F1541-17) and comparisons to the established performance characteristics of legally marketed predicate devices. The "truth" is that the new device's mechanical properties fall within acceptable limits or are comparable to those of the predicate, as determined by these tests.

8. Sample Size for the Training Set

This information is not applicable. The TrueLok™ Elevate is a physical medical device, not a machine learning algorithm that requires a training set.

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

This information is not applicable for the reasons stated in point 8.

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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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The Response Ortho Metaphyseal Fixation System is indicated for treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation.

The Response Ortho Metaphyseal Hinge Fixator System is a unilateral fixation device intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality. The system is designed to provide low profile and comprehensive solution invasively. Implants, reusable instruments, accessories, case&tray are included in the system. Products are non-sterile and implants that exist in the set, are single use. Instruments that are in the system, can be used repeatedly after cleaning and sterilization.

The provided text describes the Response Ortho Metaphyseal Hinge Fixator System, a medical device for orthopedic use. This document does not contain information related to AI/ML software, and therefore, the entire prompt requesting details about AI/ML acceptance criteria and a study proving device meets acceptance criteria cannot be fulfilled.

The text focuses on the device's indications for use, technological characteristics compared to predicate devices, and non-clinical tests performed to demonstrate substantial equivalence. These tests include:

• Determination and Comparison of Stiffness for Response Ortho Metaphyseal Hinge Fixator and EBI XFIX DFS Metaphyseal Correction System Constructs using Half Pins
• Evaluation of The Response Ortho Metaphyseal Hinge Fixator System and EBI XFIX DFS Metaphyseal Correction System Bridging Element Fatigue
• Evaluation of Function and Strength for Response Ortho Metaphyseal Hinge Fixator Distraction Mechanism under Constant Loading
• Evaluation of Response Ortho Half Pin Performance

The conclusion states that the device is substantially equivalent to predicate devices based on these non-clinical tests.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies related to an AI/ML device.

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The Revolution External Plating System is indicated for treatment of a variety of broken or deformed bones:

• Stabilizes open and/or unstable fracture of complex proximal and/or distal tibial fractures
• Fusions of the joints and bone (hand, foot, long-bone)
• Correction of bone or soft tissue deformities
• Correction of segmental or non-segmental bone, soft tissue defects or bone loss
• Neutralization of fractures stabilized with limited internal fixation
• Adult and Pediatric subgroups except newborns

The Revolution External Plating System is an external open ring fixation system to provide stability for long bone fractures, limb lengthening, and correction of bone deformities all at a distance from the operative focus. When used with other components, this device stabilizes open and/or unstable fractures of long bones including intracapsular, intertrochanteric, supracondylar, or condylar. It is also used for joint fusions and limb lengthening of deformity corrections which involve cutting the bone.

The provided document is a 510(k) summary for the Revolution External Plating System. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive studies against predefined acceptance criteria in the same way a drug or novel high-risk device might.

Therefore, the document does not contain the kind of information requested regarding acceptance criteria related to device performance metrics for a study proving the device meets those criteria. Specifically, it lacks:

• A table of acceptance criteria and reported device performance: This document reports on "Performance Testing" but does not explicitly state acceptance criteria or detailed performance results in table format.
• Sample size and data provenance for a test set: Not applicable, as this is a mechanical device undergoing performance testing, not a study involving patient data.
• Number and qualifications of experts for ground truth: Not applicable for mechanical performance testing.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is a mechanical implant, not an AI or imaging diagnostic device.
• Standalone performance: While the device's mechanical performance is tested "standalone," the nature of the information isn't a human-in-the-loop setting.
• Type of ground truth used: Not applicable. Performance testing for mechanical devices involves measuring physical properties against engineering standards.
• Sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
• How ground truth for the training set was established: Not applicable.

What the document does provide regarding performance testing:

The document states:
"Performance testing (ASTM F1541, and torque to failure testing) was completed to support the modifications to the system and demonstrate its substantial equivalence to the predicate device."

This indicates that:

• Type of testing: Mechanical performance testing.
• Specific tests: ASTM F1541 (Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implants) and "torque to failure testing."
• Purpose: To demonstrate that the modified device's performance is equivalent to that of the predicate device (K181630) and a reference device (K152171), ensuring that "the differences in geometry versus the predicate do not raise different questions of safety and effectiveness."

In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence through mechanical performance tests against recognized standards and comparison to a predicate device, rather than presenting a clinical study with detailed acceptance criteria and performance metrics for an AI or diagnostic device.

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The LINK™ External Fixator is indicated for 1) hand and foot bone fragment and joint arthrodesis, 2) fixation of proximal tibial metaphysis osteotomy and 3) adjunctive fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude LINK™ Bone Pin placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bones such as the pelvis, scapula and sternum.

The LINK™ External Fixator is a single use External Fixator consisting of a stainless steel flat spring formed into a box shape so that when released it applies forces and moments to Bone Pins, K-wires or Steinmann pins embedded in bone to actively pull together and compress or distract bone.

In clinical use the LINK™ External Fixator is held with its holes aligned using surqical needle drivers while wires or pins are advanced through the LINK™ External Fixator, skin and into bone. Once pins are placed the needle drivers are released, the LINK™ External Fixator bridge shortens to apply forces and the LINK™'s side elements swing outward to create moments on the wires or pins.

The LINK™ External Fixator uses spring heat treated 17-7 stainless steel which is uniquely formed from a flat plate to create a shape changing spring. The Bone Pins in this kit are formed with 316 Stainless Steel. The LINK™ External Fixator has a separate removable silicon elastomer cover to protect the LINK™ External Fixator and the patient from the pin ends. Only the Bone Pins are in contact with the patient while the LINK™ External Fixator and its cover are external to the body and not intended for patient contact.

The provided text is an FDA 510(k) clearance letter and summary for a medical device called the "LINK™ External Fixator." This document details the device, its intended use, comparison to a predicate device, and the basis for its substantial equivalence determination.

However, the information requested in your prompt (acceptance criteria, details of a study proving device meets criteria, sample sizes, expert involvement, ground truth establishment, etc.) is not present in this document.

The text focuses on mechanical bench testing to demonstrate the device's physical performance characteristics, such as:

• Construct pull out
• 4-point bending for bone pin
• 4-point bending for fixator construct in a bone analog
• Static ultimate strength in tension bending
• Fatigue in tension bending
• LINK™ force applied to bone

It explicitly states: "Performance Data: Bench testing included construct pull out, 4-point bending for bone pin, 4-point bending for fixator construct in a bone analog, static ultimate strength in tension bending, fatigue in tension bending and the LINK™ force applied to bone."

This is a physical medical device, not an AI or software-based diagnostic tool. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of diagnostic performance (e.g., sensitivity, specificity, clinical accuracy, MRMC studies, human reader improvement with AI assistance, independent algorithm performance) are not applicable here.

In summary, based only on the provided text, I cannot fill out the requested table or answer the questions related to clinical study performance, AI component validation, or expert-based ground truth because the document describes a traditional mechanical medical device cleared based on bench testing and comparison to a predicate device, not clinical validation of diagnostic performance.

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