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The Intraosseous Fixation System is indicated to stabilize and aid in fixation of fractures, fusions, and osteotomies of the phalanges.

The Intraosseous Fixation System consists of various size implants to stabilize and aid in the fixation of fracture, fusions, and osteotomies of the phalanges. The implants are offered in different lengths and diameters. All implants are manufactured from implant grade titanium alloy or PEEK.

This document is a 510(k) premarket notification summary for the "Intraosseous Fixation System" by Tornier, OrthoHelix Surgical Designs, Inc. It details the device, its intended use, and its substantial equivalence to previously marketed devices. However, it does not describe an acceptance criteria table, a study proving device performance against such criteria, or any of the other specific items requested in your prompt (sample size, expert qualifications, adjudication, MRMC study, standalone performance, ground truth types, training set details).

This type of submission primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, often relying on mechanical testing to show similar performance characteristics to the predicate, rather than clinical efficacy studies with specific acceptance criteria as you've outlined.

Therefore, I cannot extract the requested information from the provided text. The document does not contain the details for:

1. A table of acceptance criteria and the reported device performance: This document reports mechanical testing (4-point bend, axial pull-out, insertion/removal torque, torque to failure) to establish substantial equivalence, but it doesn't present these as "acceptance criteria" for a specific study, nor does it provide the exact performance values against such criteria.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical study with ground truth establishment is described.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a physical medical device, not an AI or imaging diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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The OrthoHelix™ Staple System is indicated for fixation in the hand and foot including fractures, fusions, and osteotomies.

The OrthoHelix™ Staple System consists of various sizes of staples used for fixation in the hand and foot. The staples are offered in different lengths, widths, and thicknesses. All implantable devices within this system are manufactured from shape memory nickel titanium alloy.

This document is about the regulatory approval of a medical device, the OrthoHelix™ Staple System, and does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of an AI/ML medical device.

The document is a 510(k) premarket notification decision letter from the FDA, stating that the device is substantially equivalent to legally marketed predicate devices. It covers:

• Device Name: OrthoHelix™ Staple System
• Indications for Use: Fixation in the hand and foot (fractures, fusions, and osteotomies).
• Regulatory Class: Class II
• Material Composition: Nickel Titanium Alloy

The basis for substantial equivalence included:

• Engineering calculations
• Finite element analysis
• Mechanical bending and pullout tests (per ASTM F564)
• Corrosion testing (per ASTM F2129)

These are standard engineering and material science tests for a physical medical implant, not performance criteria or a validation study for an AI/ML device. Therefore, none of the specific information requested about acceptance criteria, study design, sample sizes, expert involvement, or ground truth is present in the provided text.

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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 OrthoHelixTM Syndesmosis Fixation Devices are indicated as adjunct fixation in repair involving metaphyseal and periarticular small bone fragments and surrounding soft-tissues where screws are not indicated and as an adjunct in external and intramedullary fixation systems involving plates and rods with fracture braces and casting. Specifically, the Syndesmosis Fixation Devices are intended to provide fixation during the healing process following a syndesmotic trauma such as fixation of ankle syndesmosis disruptions in connection with Weber B and C ankle fractures, as well as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.

The OrthoHelixTM Syndesmosis Fixation Devices are implant assembly constructs of metallic buttons and non-absorbable suture intended to aid in the reconstruction of bones in the hand, wrist, elbow, shoulder, foot, and ankle, particularly in the reconstruction of the syndesmosis joint in the ankle and the AC joint in the shoulder. The syndesmosis devices are offered in different configurations, one to be used with and one to be used without a plate. All metallic implant components are manufactured from titanium alloy. All suture implant components are UHMWPE non-absorbable suture.

The provided text is a 510(k) summary for a medical device (OrthoHelix™ Syndesmosis Fixation Devices) and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than an AI/ML device that would typically have acceptance criteria, study data, and ground truth establishment in the way described in your request.

The document discusses mechanical testing to verify the strength of the implant construct. This is a very different type of "study" than what would be performed for an AI/ML device.

Therefore, many of the requested fields are not applicable or cannot be extracted from this document because it describes a physical medical device, not an AI/ML system.

Here's an attempt to answer based on the provided text, highlighting where information is not present or relevant:

1. Table of Acceptance Criteria and Reported Device Performance

(Specific quantitative results or specific acceptance thresholds are not provided in this summary. The summary states that the testing confirmed no new safety/effectiveness issues compared to predicates, implying the performance was deemed acceptable relative to established predicate device performance.) |

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

• Sample Size for Test Set: Not applicable in the context of an AI/ML device. For mechanical testing of a physical device, the "sample size" would refer to the number of devices tested. This specific number is not provided in the summary.
• Data Provenance: Not applicable in the context of an AI/ML device. The testing was mechanical testing of the physical OrthoHelix™ Syndesmosis Fixation Devices, not clinical data from patients.

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

• Not Applicable. This device is a physical implant, not an AI/ML device that requires expert-established ground truth from medical images or patient records. The "ground truth" for mechanical testing would be the physical properties and performance metrics measured in a lab.

4. Adjudication Method for the Test Set

• Not Applicable. This is relevant for AI/ML studies involving human interpretation or clinical outcomes, not for mechanical testing of a physical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No. This is not an AI/ML device. Therefore, no MRMC study, human reader improvement, or AI assistance enhancement analysis was performed or is relevant.

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

• No. This is not an AI/ML device, so no standalone algorithm performance study was performed.

7. The Type of Ground Truth Used

• Mechanical Testing Results / Physical Properties: For this physical device, the "ground truth" for demonstrating substantial equivalence was derived from the results of mechanical tensile testing, which verified the strength and integrity of the implant construct. This is in comparison to the known performance of predicate devices.
• Not expert consensus, pathology, or outcomes data, as these relate to clinical data for diagnostics or prognostics, which is not the function of this device.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device that requires a training set.

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

• Not Applicable. This is not an AI/ML device that requires a training set or ground truth establishment for it.

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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 OrthoHelix™ Staple System is indicated for fixation in the hand and foot including fractures, fusions, and osteotomies.

The OrthoHelix™ Staple System consists of various sizes of staples used for fixation in the hand and foot. The staples are offered in different lengths, widths, and thicknesses. All implantable devices within this system are manufactured from shape memory nickel titanium alloy.

The provided text describes a medical device, the OrthoHelix™ Staple System, and its clearance process with the FDA. However, it does not include information about acceptance criteria, device performance studies, or details relevant to artificial intelligence (AI) performance evaluation.

The document is a 510(k) summary and an FDA clearance letter for a Class II medical device (bone staple). The information provided focuses on demonstrating substantial equivalence to predicate devices through engineering calculations, finite element analysis, and mechanical/corrosion testing. This type of submission generally does not involve clinical performance studies with human subjects or AI-based analyses.

Therefore, I cannot fulfill the request for information regarding acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or AI-related study details, as this information is not present in the provided text.

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The MaxTorque™ Screw System is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments.

The MaxTorque™ Screw System is indicated for use in long and small bone fracture, fusion, and osteotomy fixation, which includes but is not limited to the following:

• Fractures of the tarsal and metatarsals
• Fractures of the olecranon, distal humerus
• Fractures of the radius and ulna
• Patellar fractures
• Distal tibia and pilon fractures
• Fractures of the fibula, medial malleolus, os calcis
• Tarso-metatarsal and metatarsal-phalangeal Arthrodesis
• Metatarsal and Phalangeal osteotomies
• Osteochondritis dissecans
• Ligament fixation
• Other small fragment, cancellous bone fractures and osteotomies

The submission is a modification to the MaxTorque™ Screw System to add additional screw styles and lengths. No modifications were made to the existing implants. The MaxTorque™ Screw System consists of screws of various diameters, lengths and thread configurations. The system also includes correspondingly sized washers, the use of which is optional.

The furnished information pertains to a conventional medical device (MaxTorque™ Screw System), not an AI/ML-driven device. As such, the typical acceptance criteria and study designs associated with AI/ML device performance (e.g., accuracy, sensitivity, specificity, reader studies, ground truth establishment by experts) are not applicable here.

This submission is for a modification to an existing screw system, adding new screw styles and lengths. The substantial equivalence is based on similarities in indications, design, and materials to previously cleared devices, supported by calculations and finite element analysis comparing the strength of the new and predicate devices.

Therefore, the specific information requested in the prompt, which is tailored for AI/ML-based medical devices, cannot be extracted from this document. The document focuses on demonstrating physical and mechanical equivalence for a hardware modification, not an algorithmic performance.

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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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