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The MaxLock Extreme System™ is indicated for the following:
•The MaxLock Extreme Universal Module is indicated for use in adult or pediatric patients as indicated for pelvic, small and long bone fracture fixation and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, humerus, ulna, radius, and bones in the hand, wrist, foot and ankle. • The MaxLock Extreme Clavicle Module is indicated for fractures, fusions and osteotomies of the clavicle and bones in the hand, wrist, foot and ankle. • The MaxLock Extreme Foot Module is indicated for fractures, fusions and osteotomies of bones in the hand, wrist, foot and ankle in pediatric and adult patients.
• The MaxLock Extreme Distal Radius Module is indicated for fractures and osteotomies of the distal radius in adult patients.

The MaxLock Extreme™ System consists of various size plates and screws used to stabilize and aid in the fusion or repair of fractured bones and bone fragments. The plates are offered in different lengths and sizes. The screws are offered in different diameters and lengths. All implantable components are manufactured from implant grade titanium alloy or PEEK.

The provided 510(k) summary describes a medical device, the MaxLock Extreme™ System, which consists of various size plates and screws for stabilizing and aiding in the fusion or repair of fractured bones.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not explicitly state a specific sample size for a "test set" in the context of a clinical study involving human patients. The studies described are primarily benchtop mechanical testing and finite element analysis. Therefore, the concept of data provenance (country of origin, retrospective/prospective) as it relates to human or clinical data is not applicable to the studies mentioned.

• For the finite element analysis, the "sample" would be the digital models of the subject and predicate devices used in the simulations.
• For the benchtop mechanical testing, the "sample" would be the physical implants (plates and screws) tested. The number of such implants tested is not specified but would typically involve multiple units for statistical significance in engineering tests.

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

This information is not applicable to the type of studies described. "Ground truth" established by experts, particularly in the context of diagnostic interpretation, medical imaging, or clinical outcomes, is relevant for performance studies involving human data or expert review. The studies mentioned are engineering and mechanical evaluations.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3. Adjudication methods (e.g., 2+1, 3+1) are used to resolve discrepancies among expert readers in clinical or image-based studies.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive technologies where human readers interact with AI output. The MaxLock Extreme™ System is a surgical implant, not a diagnostic or AI-powered device.

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

No, a standalone algorithm performance study was not done. This is also relevant for AI/software as a medical device (SaMD) where the algorithm performs a function independently. The MaxLock Extreme™ System is a physical implant.

7. The Type of Ground Truth Used

The "ground truth" for the mechanical performance studies was established by engineering principles and physical measurements.

• For Finite Element Analysis (FEA), the "ground truth" for validation would be the physical behavior of materials under stress, and the output (stress, strain, displacement) is compared against theoretical models and subsequent benchtop test results.
• For Benchtop Mechanical Testing, the "ground truth" is the directly measured physical properties (e.g., yield strength, ultimate tensile strength, fatigue life, and deformation under load) of the implants according to standardized testing protocols. The comparison is made against the performance of the predicate devices.

8. The Sample Size for the Training Set

The concept of a "training set" (in the context of machine learning) is not applicable to the studies described for the MaxLock Extreme™ System. There is no AI component that requires a training set.

If interpreting "training set" in a broader engineering context as data used to refine the device design prior to final testing, this information is not provided. However, given the context, it's highly likely referring to AI/ML.

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

As stated in point 8, the concept of a "training set" is not applicable.

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The MaxLock Extreme System is indicated for the following:
• The MaxLock Extreme Universal Module is indicated for use in adult or pediatric patients as indicated for pelvic, small and long bone fracture fixation and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, humerus, ulna, radius, and bones in the hand, wrist, foot and ankle.
• The MaxLock Extreme Clavicle Module is indicated for fractures, fusions and osteotomies of the clavicle and bones in the hand, wrist, foot and ankle.
• The MaxLock Extreme Foot Module is indicated for fractures, fusions and osteotomies of bones in the hand, wrist, foot and ankle in pediatric and adult patients.
• The MaxLock Extreme Distal Radius Module is indicated for fractures and osteotomies of the distal radius in adult patients.

The MaxLock Extreme™ System consists of various size plates and screws used to stabilize and aid in the fusion or repair of fractured bones and bone fragments. The plates are offered in different lengths and sizes. The screws are offered in different diameters and lengths. All implantable components are manufactured from implant grade titanium allov or PEEK.

The provided text describes the 510(k) summary for the MaxLock Extreme™ System, a medical device consisting of plates and screws for bone fixation. The submission focuses on establishing substantial equivalence to a previously cleared device (K123203).

Based on the provided information, no clinical study or performance data demonstrating specific acceptance criteria with reported device performance is available for an AI/ML powered device. The submission relies on non-clinical testing for substantial equivalence.

Here's an analysis of the provided text in relation to your questions, highlighting why most are not applicable in this context:

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

• Not Applicable. The submission for the MaxLock Extreme™ System is for a physical medical device (plates and screws) and primarily relies on demonstrating substantial equivalence to a predicate device through non-clinical means. It does not involve an AI/ML component with associated acceptance criteria for diagnostic accuracy, sensitivity, specificity, etc.
• The text states: "Finite element analysis was performed on the subject device to determine the worst case Benchtop mechanical testing comparing the strength of the implant. subject and predicate devices was performed and the results support substantial equivalence." This refers to mechanical performance, not AI/ML 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. As there are no AI/ML performance studies described, there is no "test set" of data in the context of an AI/ML model for this submission. The "test set" would refer to the mechanical testing described above, but the size and provenance of that data (e.g., number of implants tested, where the testing was performed) are not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. No ground truth establishment by human experts for an AI/ML model's performance is mentioned or relevant to this submission. Mechanical testing does not typically involve expert "ground truth" in this manner.

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

• Not Applicable. There is no AI/ML performance study with a test set requiring 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

• Not Applicable. This is a physical device, not an AI-assisted diagnostic or therapeutic tool. Therefore, no MRMC study involving human readers and AI assistance was conducted or is relevant.

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

• Not Applicable. There is no algorithm or software component for standalone performance.

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

• Not Applicable. For the mechanical testing mentioned, the "ground truth" would be the measured physical properties and performance against engineering standards or predicate device performance, not expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set

• Not Applicable. No AI/ML model is being trained.

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

• Not Applicable. No AI/ML model is being trained.

Summary of what is described (non-AI/ML):

The submission for the MaxLock Extreme™ System is a 510(k) premarket notification for a physical medical device. The primary method for proving substantial equivalence to the predicate device (K123203) involves:

• Finite element analysis: Used to determine the "worst case" strength of the implant.
• Benchtop mechanical testing: Performed to compare the strength of the subject device to the predicate device.

The premise for substantial equivalence is based on "similarities in indications, design, and materials." This is a typical approach for non-AI/ML device submissions where physical and material properties are key.

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The MaxLock Extreme System is indicated for the following:

•The MaxLock Extreme Universal Module is indicated for use in adult or pediatric patients as indicated for pelvic, small and long bone fracture fixation and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, humerus, ulna, radius, and bones in the hand, wrist, foot and ankle.
• The MaxLock Extreme Clavicle Module is indicated for fractures, fusions and osteotomies of the clavicle and bones in the hand, wrist, foot and ankle.
•The MaxLock Extreme Foot Module is indicated for fractures, fusions and osteotomies of bones in the hand, wrist, foot and ankle in pediatric and adult patients.

• The MaxLock Extreme Distal Radius Module is indicated for fractures and osteotomies of the distal radius in adult patients.

The MaxLock Extreme® System consists of various size plates and screws used to stabilize and aid in the fusion or repair of fractured bones and bone fragments. The plates are offered in different lengths and sizes. The screws are offered in different diameters and lengths. All implantable components are manufactured from implant grade titanium alloy or PEEK

Here's an analysis of the provided text regarding the MaxLock Extreme® System, focusing on the acceptance criteria and the study used to demonstrate it:

Summary of Acceptance Criteria and Device Performance for MaxLock Extreme® System

The acceptance criteria for the MaxLock Extreme® System are primarily based on its substantial equivalence to a previously cleared predicate device (K122005). The study performed to demonstrate this equivalence focused on the mechanical strength of the device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable in the traditional sense of a clinical trial. The "test set" for this clearance was a Finite Element Analysis (FEA) model of the device. There's no mention of in-vivo or ex-vivo physical testing on a sample of devices.
• Data Provenance: The data provenance is internal to the manufacturer (OrthoHelix Surgical Designs, Inc.) as it's based on their FEA and design comparisons. Country of origin for the model/analysis is not explicitly stated but would be presumed to be where OrthoHelix operates (USA). The study is retrospective in the sense that it relied on existing information about the predicate device for comparison.

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

• Experts for Ground Truth: Not applicable. For an FEA study comparing mechanical strength for substantial equivalence, the "ground truth" would be the engineering principles and material properties used in the simulation, along with established standards for bone fixation devices (though specific standards aren't cited in this summary). The review and approval by the FDA (specifically the Division of Orthopedic Devices at CDRH) implicitly involves expert review of the submitted data. However, there's no mention of external clinical experts establishing "ground truth" for the FEA itself.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There was no clinical or reader-based test set requiring adjudication. The FDA's review process itself acts as an adjudication body for the submitted technical data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• MRMC Study: No. This type of study is typically done for imaging or diagnostic devices where human readers interpret results. The MaxLock Extreme® System is a mechanical implant, and the clearance was based on engineering analysis.

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

• Standalone Study: Yes, in a way. The "study" performed was a Finite Element Analysis (FEA), which is an independent, algorithm-based simulation of the device's mechanical behavior. An FEA is a computational method that doesn't involve human-in-the-loop performance in the same way an AI diagnostic tool would. It's a "standalone" engineering simulation.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this clearance relies on:
  • Engineering principles and material properties: Used in the FEA to model the mechanical behavior of both the subject and predicate devices.
  • Predicate device characteristics: The established mechanical performance and safety profile of the legally marketed predicate device (K122005) served as the benchmark.
  • Regulatory criteria for substantial equivalence: The FDA's definition and requirements for demonstrating that a new device is as safe and effective as a predicate device.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This was not a machine learning or AI-based device requiring a training set. The FEA uses design parameters and material properties as its input, rather than a "training set" of data in the AI sense.

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

• Ground Truth for Training Set Establishment: Not applicable, as there was no training set in the context of an AI/ML algorithm.

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The MaxLock Extreme System is indicated for the following:

• •The MaxLock Extreme Universal Module is indicated for use in adult or pediatric patients as indicated for pelvic, small and long bone fracture fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, humerus, ulna, radius, and bones in the hand, wrist, foot and ankle.
• · The MaxLock Extreme Clavicle Module is indicated for fractures, fusions and osteotomies of the clavicle and bones in the hand, wrist, foot and ankle.
• ·The MaxLock Extreme Foot Module is indicated for fractures, fusions and osteotomies of bones in the hand, wrist, foot and ankle in pediatric and adult patients.
• ·The MaxLock Extreme Distal Radius Module is indicated for fractures and osteotomies of the distal radius in adult patients.

The MaxLock Extreme® System consists of various size plates and screws used to stabilize and aid in the fusion or repair of fractured bones and bone fragments. The plates are offered in different lengths and sizes. The screws are offered in different diameters and lengths. All implantable components are manufactured from implant grade titanium alloy or PEEK

The MaxLock Extreme® System is an orthopedic device used for bone fixation. Here's an analysis of its acceptance criteria and the study that proves its equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

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

The submission states that "Finite element analysis comparing the strength of the subject and predicate devices was performed." This indicates that a physical test set of devices was not used in a clinical or benchtop comparative manner. Rather, the equivalence was demonstrated through a computational method (finite element analysis).

• Test Set Sample Size: Not applicable in the traditional sense of physical devices. The "sample" here refers to the parameters and models used in the finite element analysis. The number of such models or scenarios is not specified.
• Data Provenance: The finite element analysis is a computational study. Therefore, there is no country of origin for external data, and it is not retrospective or prospective in the clinical sense. The data used in the analysis would be material properties and geometric models of the devices.

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

• Number of Experts: Not applicable. For a finite element analysis, "ground truth" typically refers to established engineering principles, material properties, and computational modeling standards. Experts in biomechanical engineering or materials science would be involved in performing and validating such an analysis, but they are not establishing a "ground truth" in the clinical sense (e.g., diagnosing a condition).
• Qualifications of Experts: Not specified, but generally, experts conducting finite element analyses in this context would be engineers with expertise in mechanical engineering, biomechanics, and material science.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Since the evaluation was based on finite element analysis, there isn't a need for expert adjudication that would be used for clinical interpretations or image assessments. The validation of the finite element model and its results would typically follow established engineering validation protocols.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a bone fixation system, not a diagnostic imaging device. Therefore, the concept of human readers improving with or without AI assistance does not apply.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study: No, a standalone study (in the context of an algorithm's performance without human intervention) was not conducted. The evaluation method was a finite element analysis comparing the mechanical strength of the new device to a predicate device, not an algorithmic performance assessment.

7. Type of Ground Truth Used

• Ground Truth Type: Not applicable in the clinical sense. For the finite element analysis, the "ground truth" relies on established engineering principles, validated material properties, and the accuracy of the computational models used to represent the devices and the forces they would experience. The aim was to demonstrate equivalent mechanical performance.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. Finite element analysis is not a machine learning approach that typically involves training sets. It is a simulation method based on physical laws and material properties.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no "training set" in the context of finite element analysis.

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The Mini MaxLock Extreme® Plating System is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments.

The submission is a modification to the Mini MaxLock Extreme® Plating System to add additional plate styles. No modifications were made to the existing plates or screws

The provided text describes a 510(k) submission for a medical device (Mini MaxLock Extreme® Plating System), which is a premarket notification to demonstrate that the device is at least as safe and effective as a legally marketed predicate device.

For this type of device (bone fixation appliances), the FDA review primarily focuses on establishing substantial equivalence to a predicate device, rather than defining specific acceptance criteria for a new, standalone performance study in the way one might for a diagnostic AI algorithm. The 510(k) summary explicitly states:

"Calculations and finite element analysis comparing the strength of the subject and predicate devices were performed and the results support substantial equivalence. Due to similarities in indications, design, and materials, no other testing was required. No new issues of safety and effectiveness have been raised."

This means that a direct "acceptance criteria" and "device performance" in terms of clinical outcomes or diagnostic accuracy were not established or tested in this submission. Instead, the acceptance criteria were implicitly met by demonstrating mechanical equivalence to an already approved device.

Therefore, many of the requested points regarding acceptance criteria, study details, and ground truth establishment are not applicable to this specific 510(k) submission.

Here's an breakdown of the requested information based on the provided text:

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 or animal test set data was used. The study relied on computational analysis (calculations and Finite Element Analysis).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not Applicable. No expert-established ground truth was required for this type of substantial equivalence demonstration. The "ground truth" was derived from engineering principles and comparison to the predicate device's established properties.

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

• Not Applicable. No human adjudication was involved as no patient data or expert review was part of this 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. This is a hardware device (bone plating system), not an AI diagnostic tool. MRMC studies are irrelevant here.

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

• Not Applicable. This is a hardware device.

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

• Not Applicable / Engineering Equivalent. The "ground truth" for showing substantial equivalence was the known mechanical properties and performance of the predicate device, as assessed through engineering calculations and finite element analysis.

8. The sample size for the training set

• Not Applicable. No machine learning or AI models were involved; therefore, no training set was used.

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

• Not Applicable. No training set was used.

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The Mini MaxLock Extreme® Plating System is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments.

The submission is a modification to the Mini MaxLock Extreme® Plating System to add Mini MTP Plates. This submission also includes the ISO plate that was previously cleared through internal documentation. No modifications were made to the existing plates or screws. The OrthoHelix Mini MTP Plates are designed for 18 MTP joint fusions.

This document describes a 510(k) submission for a medical device called the Mini MaxLock Extreme® Plating System. The submission is for a modification to an existing system, specifically the addition of Mini MTP Plates for MTP joint fusions.

However, the provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria in the way typically expected for a diagnostic AI/ML device.

Instead, this 510(k) summary focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices. For mechanical devices like bone plates, this usually involves showing that the new device has similar:

• Indications for use
• Design
• Materials
• Performance (often through mechanical testing and/or finite element analysis)

Therefore, the requested information elements related to AI/ML device performance (like accuracy metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment) are not applicable or available in this specific regulatory filing.

Based on the provided text, here’s an analysis of what is available:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
Not applicable. This is a mechanical device, not an AI/ML diagnostic. The "test set" would refer to mechanical test samples, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a mechanical device.

4. Adjudication method for the test set
Not applicable. This is a mechanical device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a mechanical device, not an AI/ML system assisting human readers.

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

7. The type of ground truth used
Not applicable in the context of diagnostic performance. For a mechanical device, "ground truth" would relate to material properties, mechanical limits, and biomechanical performance data, which are typically established through engineering standards, material science, and physical testing.

8. The sample size for the training set
Not applicable. This is a mechanical device. There is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established
Not applicable. There is no "training set" or "ground truth establishment" in the AI/ML sense for this mechanical device.

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The MaxLock Extreme® System is indicated for the following:

• The Universal Module is indicated for use in adult or pediatric patients as indicated for pelvic, small and long bone fracture fixation and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, humerus, ulna, radius, and bones in the hand, wrist, foot and ankle.
• The Clavicle Module is indicated for fractures, fusions and osteotomies of the clavicle and bones in the hand, wrist, foot and ankle.
• The Foot Module is indicated for fractures, fusions and osteotomies of bones in the hand, wrist, foot and ankle in pediatric and adult patients.
• The Distal Radius Module is indicated for fractures and osteotomies of the distal radius in adult patients.

The MaxLock Extreme® System consists of various size plates and screws used to stabilize and aid in the fusion or repair of fractured bones and bone fragments. The plates are offered in different lengths and sizes. The screws are offered in different diameters and lengths. All implantable components are manufactured from implant grade titanium alloy or PEEK

The provided text describes a 510(k) summary for the MaxLock Extreme® System, which is a bone fixation device (plates/screws). This type of medical device submission (510(k)) focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials. Therefore, the information requested about acceptance criteria, test sets, ground truth establishment, expert adjudication, and MRMC studies, which are typical for AI/ML device evaluations, are not applicable to this submission.

The "study" conducted for this device to prove it meets acceptance criteria (i.e., substantial equivalence) largely relied on mechanical testing, finite element analysis, and mathematical analyses, comparing its performance to predicate devices.

Here's an breakdown based on the provided document:

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

The document doesn't provide a specific table of quantitative acceptance criteria and reported device performance in the same way an AI/ML study would (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" for a 510(k) in this context are primarily qualitative, focusing on whether the new device can be demonstrated to be "substantially equivalent" to predicate devices without raising new issues of safety and effectiveness.

The "performance" demonstration is stated as:

• Performance: "Substantial equivalence was demonstrated with mechanical testing, finite element analysis and mathematical analyses."
• Result: "No new issues of safety and effectiveness have been raised."

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

• Sample Size: Not applicable in the context of clinical "test sets" for performance metrics like sensitivity/specificity. The "samples" used would be physical device prototypes for mechanical testing and computational models for finite element analysis. The document does not specify the number of prototypes tested.
• Data Provenance: Not applicable for a non-clinical submission like this. The "data" comes from engineering tests and analyses, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable. Ground truth as understood in AI/ML (e.g., disease presence confirmed by experts) is not relevant here. The "truth" is established by engineering principles and comparison to known performance of predicate devices.

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

• Not applicable. There is no human reading or adjudication of a test set in this context.

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. This is not an AI-assisted device. MRMC studies are not relevant to demonstrating substantial equivalence for a mechanical medical device like this.

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

• Not applicable. This is not an algorithmic device. The "standalone" performance relates to the mechanical integrity and function of the physical plates and screws themselves, which was assessed via mechanical testing and FEA.

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

• The "ground truth" for this device's performance is based on established engineering standards for bone fixation devices and the known performance and safety profiles of the predicate devices. It relies on the physical properties and mechanical behavior of the materials and designs, validated through testing, rather than clinical outcomes or diagnostic accuracy.

8. The sample size for the training set:

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

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

• Not applicable.

Summary of the "Proof" for this Device:

The "proof" that the MaxLock Extreme® System meets its "acceptance criteria" (which in this context means "is substantially equivalent and introduces no new safety/effectiveness issues") is entirely based on:

• Mechanical Testing: Physical tests to assess strength, fatigue, and other biomechanical properties.
• Finite Element Analysis (FEA): Computational simulations to predict mechanical behavior under various loads.
• Mathematical Analyses: Calculations to support design choices and material properties.
• Comparison to Predicate Devices: Demonstrating that the results of the above analyses and tests are comparable to or better than those of previously cleared, legally marketed predicate devices (MaxLock Extreme® System previous versions, Biomet Forerunner System, OrthoHelix Calcaneal Trauma System, Biomet/E.B.I. OptiLock Periarticular Plating System).

The 510(k) process for a Class II mechanical device like this does not typically involve clinical data or the detailed AI/ML study design questions you've posed.

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The MaxLock Extreme® Distal Radius Plates and Screws are indicated for fractures and osteotomies of the distal radius in adult patients.

The MaxLock Extreme® System Distal Radius Plates and Screws are a modification to the previously cleared Modular Foot System to include site-specific plates and screws for distal radius fixation. The plates are offered in different lengths and sizes. The screws are offered in different diameters and lengths. All implantable components are manufactured from implant grade titanium alloy. The MaxLock Extreme® System Distal Radius Plates and Screws have the same technological characteristics as the predicate devices.

The provided text describes a medical device submission (K102156) for the "MaxLock Extreme® System Distal Radius Plates and Screws." This is a Class II medical device, and the submission is a 510(k) premarket notification, which means the manufacturer is claiming substantial equivalence to an already legally marketed device (predicate device).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The text explicitly states: "Mechanical testing was conducted to confirm that the MaxLock Extreme® System Distal Radius Plates and Screws are equivalent to the predicate and meet the specified requirements for their intended use."

• Test Set Sample Size: Not specified. The document refers to "mechanical testing" and "a screw bending moment study" but does not provide details on the number of devices or components tested.
• Data Provenance: Not specified. The testing was conducted by the submitter (OrthoHelix Surgical Designs, Inc.). The location (e.g., country of origin) of the testing is not mentioned, nor is whether the data is retrospective or prospective. Given it's a device premarket notification, it's generally prospective testing specifically performed for this submission.

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

• Number of Experts: Not applicable for this type of submission. Mechanical testing of a medical device (like a bone plate and screws) does not typically involve human experts establishing a "ground truth" in the way clinical studies or diagnostic AI algorithms do. Instead, the "ground truth" or standard for acceptance is based on established engineering principles, regulatory standards, and performance of the predicate device.
• Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. As discussed above, mechanical testing doesn't involve subjective human assessment requiring adjudication. The comparison is against objective, measurable mechanical properties of a predicate device and industry-accepted benchmarks.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices or AI algorithms where human interpretation of images or data is involved. This submission concerns mechanical fixation devices.
• Effect Size of Human Readers Improvement with AI: N/A, as no such study was performed or is relevant here.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: No, a standalone "algorithm only" study was not done. This device is a physical implant, not a software algorithm.

7. The Type of Ground Truth Used

• Ground Truth Type: For mechanical testing, the "ground truth" or benchmark is the performance of the legally marketed predicate devices and generally accepted mechanical performance standards for bone fixation devices. The tests are designed to show that the new device performs at least as well as, or better than, the predicate. The text states: "Mechanical testing was conducted to confirm that the MaxLock Extreme® System Distal Radius Plates and Screws are equivalent to the predicate and meet the specified requirements for their intended use."

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is a physical implant, not a machine learning model or algorithm that requires a "training set" in the conventional sense.

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

• Ground Truth Establishment for Training Set: Not applicable, as there is no training set for this type of device.

In summary:

This 510(k) submission primarily relies on mechanical testing to demonstrate substantial equivalence of a bone fixation device. The acceptance criteria are that the new device's mechanical properties (like strength and bending moment) are at least equivalent to, or superior to, those of the predicate devices already on the market and meet "specified requirements for their intended use." The study conducted was mechanical testing and a screw bending moment study. No clinical studies involving patients, human readers, or AI algorithms were part of this specific submission to demonstrate substantial equivalence.

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The Mini MaxLock Extreme® Plating System is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments.

The Mini MaxLock Extreme® Plating System consists of various size plates and screws used to stabilize and aid in the fusion or repair of fractured small bones and bone fragments. The plates are offered in different lengths and sizes. The screws are offered in different diameters and lengths. All implantable components are manufactured from implant grade titanium alloy.

The provided text describes the "Mini MaxLock Extreme® Plating System," a medical device, and its 510(k) submission to the FDA. The submission focuses on demonstrating substantial equivalence to existing devices through mechanical testing. This type of regulatory submission for a physical implantable device (bone fixation system) does not involve AI or machine learning. Therefore, most of the requested information regarding AI study design (like ground truth, expert consensus, MRMC studies, training/test sets, etc.) is not applicable.

However, I can extract the relevant information regarding the device's acceptance criteria and the type of study used to prove it.

Here's the information based on the provided text:

Device: Mini MaxLock Extreme® Plating System

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable: This is a physical device, not an AI/ML product. The "test set" in this context refers to the samples used in mechanical testing. The text does not specify the exact number of plates and screws tested, but it refers to "various size plates and screws." The provenance is internal testing by OrthoHelix Surgical Designs, Inc.

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

• Not Applicable: There is no "ground truth" in the AI/ML sense for a mechanical device. The "ground truth" for mechanical properties would be established by validated engineering standards and testing protocols. No human experts are mentioned as establishing a ground truth for mechanical performance, as it's a quantitative measurement.

4. Adjudication method for the test set:

• Not Applicable: As there are no human interpretations or classifications involved, no adjudication method like 2+1 or 3+1 is relevant. Mechanical tests are typically governed by standardized protocols.

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: This is a physical medical device (bone fixation system), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is not relevant.

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

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

7. The type of ground truth used:

• Mechanical Engineering Standards and Measurements: For the mechanical testing, the "ground truth" would be the direct measurements of bending and torsional strength, compared against established engineering standards and the performance of predicate devices.

8. The sample size for the training set:

• Not Applicable: There is no "training set" in the context of an AI/ML model for this physical device.

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

• Not Applicable: There is no "training set" or corresponding "ground truth" in the AI/ML sense for this physical device.

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Variable Angle technology in MTP, TMT, MFT, MXL, DFX, and EDL plates are indicated for fractures, fusions and osteotomies for small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.

Variable Angle Technology in MXL and CLA plates are indicated for the fractures, fusions, and osteotomies of the clavicle and small bones in the hand, wrist, foot and ankle.

This special 510(K) submission is a modification to the previously cleared Modular Foot and Clavicle systems to add a variable angle locking screw construct. No changes have been made to the current locking plates; this addition will be compatible with all plates currently in the system. The OrthoHelix variable angle construct consists of a polymer ring which mates with the locking plate and allows for a specially designed locking screw to be inserted at angles up to 15° in any direction while maintaining angular stability.

The provided text describes a medical device, the MaxLock Extreme® Extremity Plating System with Variable Angle Technology, and its substantial equivalence to predicate devices. It does not contain information about a study proving the device meets acceptance criteria in the typical sense of a clinical trial or a performance study with metrics like sensitivity, specificity, or accuracy.

Instead, the acceptance criteria and proof of their fulfillment for this type of device (bone fixation system) are primarily based on mechanical testing demonstrating substantial equivalence to previously cleared devices.

Here's the breakdown based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details (Mechanical Testing)

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

   • The text does not specify the exact sample size (number of implants tested) for the dynamic and static mechanical testing.
   • Data Provenance: The testing was conducted by OrthoHelix Surgical Designs Inc., a US-based company, as part of their development process for this modification. This would be considered prospective data generation for the purpose of demonstrating device performance.

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

   • This type of mechanical testing does not typically involve "experts" establishing a "ground truth" in the same way clinical or diagnostic studies do. The "ground truth" here is adherence to established engineering and mechanical testing standards (e.g., ASTM standards for orthopedic implants), which are often industry-accepted benchmarks for performance. Product engineers and test lab personnel would conduct and assess these tests.

3. Adjudication method for the test set:

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on clinical or image-based ground truth, not for mechanical testing results. Mechanical test results are quantitative and compared directly to specified performance metrics or predicate device performance.

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:

   • Not applicable. This is a bone fixation system, not a diagnostic or AI-assisted device. Therefore, no MRMC study involving human readers or AI assistance would have been conducted or is relevant.

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

   • Not applicable. This device is a mechanical implant, not an algorithm.

6. The type of ground truth used:

   • For mechanical testing, the "ground truth" is defined by established engineering standards and the performance of the predicate devices. The new device's performance is compared against these benchmarks to establish substantial equivalence.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device.

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

   • Not applicable.

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