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The Sonoma Fifth Metatarsal Repair System is intended for use in the fixation of fractures of the fifth metatarsal, including Jones, avulsion and shaft fractures.

The Sonoma Fifth Metatarsal Repair System is intended for use in the fixation of fractures and osteotomies of the fifth metatarsal, including Jones, avulsion, and shaft fractures. The Fifth Metatarsal Repair System includes the Sonoma Fifth Metatarsal Nail, End Caps and related instruments. Sonoma's Fifth Metatarsal Nail differs from traditional nails or rods as it utilizes Sonoma's ActivLoc® fixation gripper system at the distal end of the rod to supplement distal fixation without the use of screws, threads or K-wires. The implants are composed of 316 stainless steel per ASTM F138.

The provided text is a 510(k) summary for the Sonoma Fifth Metatarsal Repair System, an intramedullary fixation rod. It describes the device, its intended use, and its substantial equivalence to a predicate device (K032548 IP-XS Compression Nail).

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states "Engineering analysis and mechanical testing in a clinically relevant fracture model." However, it does not specify the sample size for these tests.
The data provenance is also not explicitly stated beyond being "engineering analysis and mechanical testing." It's typically laboratory-based testing rather than patient data for this type of device.

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

This information is not provided in the document. The testing described is mechanical and engineering-based, not clinical interpretation requiring expert consensus.

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

This information is not applicable as the testing is mechanical and comparative to a predicate device, not interpretative and 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

An MRMC comparative effectiveness study was not performed. This device is an orthopedic implant, not an AI-assisted diagnostic tool for human readers.

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

This information is not applicable as the device is a physical implant, not an algorithm.

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

The ground truth for the performance testing appears to be based on established engineering standards and comparisons to the performance of a predicate device. For instance, material composition is verified against ASTM F138, and mechanical properties are compared to the predicate's known performance.

8. The sample size for the training set

This information is not applicable as the device is an intramedullary fixation rod, not a machine learning algorithm that requires a training set.

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

This information is not applicable for the same reason as point 8.

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The Sonoma Fibula Repair System is intended for use in the fixation of fibula fractures.

The Sonoma Fibula Repair System includes all implants and instruments required for the fixation of fibula fractures. The Fibula Repair System includes the Sonoma Fibula Rod, Sonoma Bone Screws, End Cap and related instruments. Sonoma's Fibula Rod differs from traditional nails or rods as it utilizes Sonoma's ActivLoc® fixation gripper system at the proximal end of the rod to allow for proximal fixation without the use of screws. The implants are composed of 316 stainless steel per ASTM F138.

The provided text describes the Sonoma Fibula Repair System, a medical device for fibula fracture fixation. It is a 510(k) premarket notification, which means it demonstrates substantial equivalence to a legally marketed predicate device rather than proving novel effectiveness. Therefore, the information provided focuses on comparative performance rather than a standalone clinical study with detailed acceptance criteria and expert reviews, as would be typical for an AI/CADe device.

Based on the provided document, here's an analysis of the "acceptance criteria" and "study" as they relate to this specific device (a hardware implant):

1. Table of Acceptance Criteria and Reported Device Performance:

For a hardware implant like the Sonoma Fibula Repair System, "acceptance criteria" are generally based on mechanical performance standards to ensure the device is at least as safe and effective as existing predicate devices.

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

• Sample Size: Not explicitly stated as a number of devices. The "test set" in this context refers to the physical devices (Sonoma Fibula Repair System) that underwent mechanical testing. Standard testing typically involves a sufficient number of samples to achieve statistical confidence in the results according to the ASTM standard, but the exact count isn't provided.
• Data Provenance: The testing was "engineering analysis and mechanical testing." This indicates in-vitro laboratory testing, not human or animal data. The country of origin of the data is implied to be within the US, given the FDA submission. It is prospective testing on newly manufactured devices.

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

• Ground Truth for Mechanical Testing: For mechanical testing of an implant, the "ground truth" is established by adherence to recognized engineering standards (e.g., ASTM F1264-03(07)) and comparison to the known performance of predicate devices. There wouldn't be "experts" establishing ground truth in the sense of clinical experts for interpretation of images or patient outcomes. The experts involved would be engineers and material scientists developing, conducting, and interpreting the mechanical tests according to established protocols.
• Qualifications: While not explicitly detailed, such testing would be overseen by qualified engineers with expertise in biomedical engineering, materials science, and mechanical testing, likely adhering to good laboratory practices.

4. Adjudication Method for the Test Set:

• Adjudication: Not applicable in the context of mechanical testing of devices. Adjudication methods like "2+1" typically apply to clinical studies where human readers interpret data or images. The "adjudication" here is the pass/fail criteria defined by the ASTM standards and the demonstration of equivalence to predicate devices.

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

• No MRMC Study: An MRMC comparative effectiveness study is not applicable as this is a physical implant, not an AI or imaging-based diagnostic/interpretive device. Therefore, there's no mention of human readers or AI assistance.

6. If a Standalone (Algorithm Only) Performance Study was Done:

• No Standalone Study (Algorithm): This device is a physical implant, not an algorithm or software. Therefore, an algorithm-only standalone performance study is not relevant or performed.

7. The Type of Ground Truth Used:

• Ground Truth Type:
  • Mechanical Performance Data: The ground truth for the device's mechanical performance is established by the results of standardized engineering tests (cyclic bending fatigue, static bending, static torsion) and direct comparison of these results to those of the predicate devices.
  • Material Composition Standards: ASTM F138 for 316 stainless steel.
  • Design Specifications: Comparison of dimensions and design features against predicate devices.

8. The Sample Size for the Training Set:

• Training Set (Not Applicable): This concept is specific to machine learning/AI algorithms. For a physical medical device, there isn't a "training set" in this sense. The design and manufacturing process are informed by engineering principles, material science, and the existing predicate device designs.

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

• Training Set (Not Applicable): As there is no "training set" in the AI sense, this question does not apply. The design of the Sonoma Fibula Repair System is informed by the principles proven by the predicate devices and established biomechanical understanding of fibula fixation.

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The Sonoma FasTrac Clavicle Fracture Repair Device is intended to be used to repair an acute fracture, mal-union or non-union of the clavicle.

The Sonoma FasTrac Clavicle Fracture Repair Devices are stainless steel or titanium intramedullary fixation devices that utilize threads for fixation and a hub with cross screw. The device is available in nominal 3, 4, 5, and 6mm nominal OD and sizes 70-150mm nominal lengths. The Sonoma FasTrac Clavicle Fracture Repair Device is intended to be made of Ti-6Al-4V Titanium or 316L Stainless Steel.

This document describes the premarket notification (510(k)) for the Sonoma FasTrac Clavicle Fracture Repair Device, which focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance data.

Here's a 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

The document does not explicitly state the sample sizes used for each specific test (e.g., number of devices tested for cyclic bending fatigue). The performance data is derived from non-clinical, empirical testing, and engineering analysis, as stated in the "Performance Data (Non clinical)" section and the "Performance Testing Summary" table headers. There is no information about data provenance in terms of country of origin or whether it's retrospective or prospective, as it's mechanical testing of physical devices.

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

This information is not applicable as this is a 510(k) submission for a mechanical medical device, and the "ground truth" is established through engineering and biomechanical testing against established standards and predicate devices (e.g., ASTM F1264-03). Expert clinical opinion or medical imaging interpretation is not the primary mode of evaluation for this type of device submission.

4. Adjudication method for the test set

This information is not applicable for mechanical device testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving expert interpretation (e.g., radiology reads) to resolve discrepancies.

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

This information is not applicable. An MRMC study is relevant for diagnostic imaging AI systems where human readers interpret medical images. This 510(k) is for an intramedullary fixation device, which is a physical implant.

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

This information is not applicable. This is a physical medical device, not an algorithm or AI system.

7. The type of ground truth used

The "ground truth" for the performance evaluation of the Sonoma FasTrac device is established through:

• Mechanical requirements of ASTM F1264-03 (07): These are established industry standards for intramedullary fixation devices.
• Performance of predicate devices: The predicate devices (Ensplint CMX and Depuy Rockwood Pin) against which the Sonoma FasTrac device's performance is compared serve as the benchmark or "ground truth" for substantial equivalence.

8. The sample size for the training set

This information is not applicable. This is a physical medical device, not an AI system that requires a "training set." The device is manufactured and tested based on design specifications and material properties.

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

This information is not applicable, as there is no "training set" in the context of this device's evaluation.

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The Sonoma CWG Clavicle fracture repair device is intended to be used to repair an acute fracture, mal-union or non-union of the clavicle.

Sonoma CWG devices are 316L SS intramedullary fixation devices that utilize internal grippers for fixation, similar to the Sonoma CMx predicate and also use a compression screw similar to the predicate Rockwood pin, to compress the fracture. The device is available in 4 & 5mm OD and sizes 90-120mm in length.

This submission describes the Sonama CWG Clavicle Fracture Repair Device, an intramedullary fixation device for clavicle fractures. The submission leverages non-clinical performance data against predicate devices to demonstrate substantial equivalence.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

This submission relies entirely on non-clinical (in-vitro and cadaveric) testing, not on human clinical data. Therefore, there isn't a "test set" in the traditional sense of patient data.

• Cadaveric Torso Specimens: The "Indications for Use Test" and "Fixation Verification Test" were performed using cadaveric torso specimens. The exact number of specimens is not specified in the provided text, but it included "one clavicle" for the predicate device and "the opposite clavicle" for the subject device within the same specimens, implying paired testing.
• Data Provenance: The data provenance is internal laboratory testing and cadaveric studies. The country of origin of the data is not explicitly stated but is implied to be in the USA given the company and FDA review. The studies are prospective in their conduct within the testing environment.

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

Not applicable. As this is a non-clinical study, there are no human experts establishing ground truth for a patient test set. The "ground truth" is established through the physical measurement and biomechanical performance directly observed in the testing environments (e.g., force required for distraction, range of motion).

4. Adjudication Method for the Test Set

Not applicable. There is no human test set or human interpretation involved that would require an adjudication method. The outcome measures are based on direct physical measurements and observations during mechanical and cadaveric performance tests.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This submission focuses on the biomechanical equivalence of the device to predicate devices through non-clinical testing, not on the effectiveness of human readers with or without AI assistance.

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

Not applicable. This device is a physical intramedullary fixation rod, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for these studies is based on direct biomechanical measurements and observations in controlled laboratory and cadaveric settings. This includes:

• Static bending, torque, and cyclic bending fatigue measurements against defined standards (ASTM F1264-008).
• Proprietary in-vitro cyclic fatigue data.
• Observations of fracture fixation and anatomical alignment in cadaveric specimens.
• Measurements of tensile force required to distract fractures in explanted cadaveric bones.

The comparison is made against the performance of a legally marketed predicate device (Sonoma CRx WG), establishing the "ground truth" for acceptable performance.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of this device. The device is a physical medical implant, not an AI or machine learning model that requires training data.

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

Not applicable, as there is no training set for this device.

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The Waveon™ WRx (WristRocket™ Distal Radius System) is intended to be used for the fixation of unstable distal radius fractures in which closed reduction is not suitable:

• Joint destruction and/or subluxation visible on x-ray;
• Osteotomy and repair of distal radius malunion with or without bone graft;
• Non-displaced fractures.
• Transverse fractures of the distal radius with or without comminution (e.g. AO classifications A2 and A3);
• Transverse fractures of the distal radius with an extension into the joint with or without comminution (e.g. AO classification C2 and C1 respectively);
• Failed fracture fixation with or without bone graft for the types of fractures above;
• The above types of fractures (i.e. AO classifications non-displaced transverse, A2, A3, C1 and C2) in which reduction has been lost following fixation with percutaneous pins with or without an external fixator.

The WavEon™ WRx configuration consists of a flexible implant manufactured from stainless steel.

This 510(k) summary describes a new version of an intramedullary distal radius fixation device called WavEon™ WRx, which is an updated version of a predicate device, the Ensplint Rx. The submission primarily seeks to extend the indications for use to include C2 Distal Radius fractures.

Here's an analysis of the provided text with respect to the requested information:

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)

The document mentions "cadaver studies" for the surgical feasibility performance data.

• Sample size: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective/prospective).
• Test set: The "test set" would be the cadaver specimens used in the studies.

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 specified. The document only states "cadaver studies demonstrate." It does not mention who conducted these demonstrations or established the ground truth for "safe insertion, reduction, and fixation."

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

Not applicable/Not specified. The study described is a non-clinical cadaver study focused on the physical manipulation and fixation of the device, not an assessment of medical images or patient outcomes requiring expert adjudication in that 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

Not applicable. This is a medical device (intramedullary fixation) and not an AI/imaging diagnostic device. Therefore, an MRMC study related to AI assistance for human readers is not relevant to this submission.

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

Not applicable. This is a medical device (intramedullary fixation) and not an AI/imaging diagnostic device.

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

For the mechanical performance (ASTM 1264), the ground truth is defined by the standardized test methods and acceptance criteria of ASTM 1264.

For the cadaver studies, the "ground truth" would be the physical demonstration of safe insertion, reduction, and fixation of C2 fractures as observed and assessed by the surgical team or researchers conducting the cadaveric procedures. This is an observational, procedural ground truth rather than a diagnostic one.

8. The sample size for the training set

Not applicable. This device is a physical implant, not an AI model that requires a training set.

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

Not applicable. This device is a physical implant, not an AI model that requires a training set.

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The ENSPLINTCMx™ Clavicle Pin is intended to be used to repair an acute fracture, mal-union or non-union of the clavicle.

The EnsplintCMxTM configuration consists of an implant made of 316 stainless steel.

This device is a traditional medical implant, not an AI/ML powered device. As such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (like sensitivity, specificity, or AUC) does not apply directly. Instead, the device's acceptance is based on demonstrating substantial equivalence to a predicate device through non-clinical performance data.

Here's a breakdown of the requested information based on the provided text, adapted for a non-AI device:

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

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 for Test Set: The document mentions "bench top and cadaver" testing. The specific number of samples (e.g., number of cadavers, number of devices tested in benchtop) is not provided.
• Data Provenance: The origin of the data (country) is not specified. The testing described is non-clinical, suggesting a laboratory setting, which aligns with prospective testing for device characterization.

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)

This question is not applicable as the device is a physical medical implant, not an AI diagnostic tool. There is no "ground truth" in the sense of expert annotation of medical images or data. The "ground truth" for this device would be established engineering and biomechanical principles and measurements.

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

This question is not applicable for a non-AI medical device. Adjudication methods are typically used to resolve discrepancies in expert labeling for AI training/testing. Performance was assessed through non-clinical (benchtop and cadaver) laboratory testing.

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

This question is not applicable for a non-AI medical device. MRMC studies are designed for assessing the impact of AI on human reader performance, which doesn't apply here. The device itself is an implant for physical fixation.

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

This question is not applicable as there is no algorithm involved. The performance evaluation was of the physical device's mechanical properties and function.

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

As explained previously, the concept of "ground truth" in the context of expert consensus or pathology is not directly applicable to this type of device. The "truth" in this context is based on:

• Biomechanical testing results: Measuring parameters like strength, stiffness, fatigue resistance in laboratory (benchtop) settings.
• Anatomical compatibility: Assessing fit and function in cadaveric models.
• Material properties: Verifying that the 316 stainless steel meets established standards.

8. The sample size for the training set

This question is not applicable. As a non-AI device, there is no "training set" in the machine learning sense. Device design and validation are based on engineering principles, materials science, and non-clinical testing.

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

This question is not applicable for the same reasons as point 8.

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The Ensplint™ Bone Screws are intended to treat fractures of various small and long bones. The Ensplint™ Bone Screws can also be used with the EnsplintRx Distal Radius System.

HA Cortical Self-Tapping Bone Screws in diameters of 1.5mm to 5.0mm and lengths of 4mm to 90mm.

This 510(k) summary describes a medical device, the Ensplint™ Bone Screw, that is seeking clearance as substantially equivalent to a predicate device. The primary method for demonstrating substantial equivalence is through comparison to existing, legally marketed devices and adherence to relevant standards, rather than extensive new performance studies.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

Study that Proves Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a comparison to a predicate device and adherence to an industry standard, rather than a clinical trial or a performance study generating new data. The rationale for substantial equivalence explicitly states:

"The Ensplint™ Bone Screw utilizes the same material and technology characteristics as the Syntec Scientific Corp. Bone Screws and conforms to the ASTM F543-2 Standard Specification for HA Bone Screws. The diameters and lengths are within the diameters and lengths of the predicate Syntec Scientific Corp bone screws. Therefore testing is not needed to demonstrate that the subject devices are substantially equivalent to other legally marketed bone screws."

This indicates that the "study" is a benchmarking and documentation exercise showing direct equivalence or adherence to established standards and the predicate.

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

• Sample Size: Not applicable in the context of a traditional performance "test set." The basis for clearance is comparison to a predicate device and adherence to a standard, not empirical testing of a "test set" of devices from this specific manufacturer. The "device performance" in the table above refers to descriptive characteristics matching the predicate/standard, not measured performance data from a specific test sample.
• Data Provenance: Not applicable for new data generation. The provenance stems from the characteristics of the predicate device (Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, K983495) and the published ASTM F543-2 standard. This is not prospective or retrospective patient data but rather existing device specifications and industry standards.

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

• Not applicable. There's no "ground truth" established by experts for a test set in the traditional sense of a clinical or diagnostic study. The "ground truth" for the equivalence claim is implicitly the established safety and effectiveness profile of the predicate device and the criteria defined in the ASTM standard.

4. Adjudication Method for the Test Set

• Not applicable. No "test set" requiring adjudication in the context of this 510(k) submission.

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

• No. This is not a diagnostic imaging device or an AI-assisted tool where human reader performance would be a relevant metric.

6. Standalone Performance Study

• No, a standalone (algorithm only without human-in-the-loop performance) study was not done. The submission explicitly states "testing is not needed" due to direct equivalence to a predicate and conformance to a standard. This is a characteristic-based comparison.

7. Type of Ground Truth Used

• The "ground truth" in this context is based on:
  • Predicate Device Characteristics: The established design, material, and technological specifications of the legally marketed predicate device (Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, K983495).
  • Industry Standard: The requirements and specifications outlined in the ASTM F543-2 Standard Specification for HA Bone Screws.

8. Sample Size for the Training Set

• Not applicable. This is not an AI/ML device that requires a training set. The device design is based on established engineering principles and comparison to an existing device, not on learning from a data set.

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

• Not applicable, as there is no training set for this type of device submission.

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The ENSPLINTRx™ Distal Radius System is intended to be used for the fixation of unstable distal radius fractures in which closed reduction is not suitable:

• Joint destruction and/or subluxation visible on x-ray; .
• Osteotomy and repair of distal radius malunion with or without bone graft; .
• Non-displaced fractures in which the physician and patient opt for rigid stability .
• Transverse fractures of the distal radius with or without comminution (e.g. AO . classifications A2 and A3)
• Transverse fractures of the distal radius with an extension into the joint without . comminution (e.g. AO classification C1);
• Failed fracture fixation with or without bone graft for the types of fractures above; .
• The above types of fractures (i.e. AO classifications non-displaced transverse, A2, . A3, and C1) in which reduction has been lost following fixation with percutaneous pins with or without an external fixator.

The EnsplintRx™ configuration consists of a flexible implant manufactured from stainless steel.

Here's a breakdown of the acceptance criteria and study information for the ENSPLINTRx Distal Radius System, based on the provided 510(k) summary:

This device is not an AI/ML device, so many of the requested fields (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance) are not applicable. The device is a traditional medical device, relying on bench testing for substantial equivalence.

1. Table of Acceptance Criteria and 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: This device is a traditional implantable medical device, and its performance was demonstrated through non-clinical (bench-top) laboratory testing, not a clinical study involving human test sets or data provenance.

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: As this was non-clinical bench testing, there was no human "test set" and thus no need for experts to establish ground truth in the context of clinical interpretation or diagnosis.

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

• Not Applicable: There was no clinical 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 not an AI/ML device, so no MRMC study was conducted.

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

• Not Applicable: This is not an AI/ML device, so standalone algorithm performance is not relevant.

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

• Engineer-defined performance metrics through bench testing: The "ground truth" for this device's performance was established by engineering specifications and comparative mechanical testing against predicate devices. This involves measuring various mechanical properties (e.g., strength, stiffness, fatigue life) under controlled laboratory conditions, rather than clinical outcomes or diagnostic accuracy.

8. The sample size for the training set

• Not Applicable: This is not an AI/ML device, so there is no training set in the context of machine learning. The "training" for the device development would refer to engineering design, materials science, and manufacturing processes.

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

• Not Applicable: As above, this is not an AI/ML device. The "ground truth" for the device's design and manufacturing (analogous to a training set for an AI) would be established through established engineering principles, material science standards, and regulatory requirements, informed by the performance of the predicate devices.

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