Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device