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The GIRO™ Growth Modulation System is intended as a temporary implant to aid in the correction of the angle of growth of long bones by modulating growth of the physis in pediatric (child and adolescent) patients. It is indicated for the following conditions:

• [ Femur and tibia: varus, valgus, flexion, or extension deformities of the knee.
• □ Humerus: valgus or varus deformities of the elbow.
• □ Radius and ulna: flexion or extension deformities of the wrist.
• □ Ankle: varus, valgus or plantar flexion deformities of the ankle.
• □ Limb length discrepancy of the femur and tibia.

The GIRO™ Growth Modulation System is a tether device used for quided growth and deformity correction. It includes two couplings linked via a flexible cable and anchored to the bone via screws and bi-cortical posts. By tethering the growth plate, angular deformities can be corrected. The implants are manufactured in medical grade 316L stainless steel (ASTM F138) and offered in two sizes: 4.5 and 6.0.

The provided text describes a 510(k) premarket notification for a medical device called "The GIRO™ Growth Modulation System." It outlines the device's intended use, description, and the basis for claiming substantial equivalence to legally marketed predicate devices.

However, the text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria related to an AI or algorithm-based system. The "Non-clinical Performance Data" section describes bench testing and mechanical property analyses comparing the GIRO™ System to predicate devices, focusing on the physical performance of the implant itself (e.g., tension, torque, bending, pullout). The "Clinical Performance Data" section explicitly states: "No clinical testing is provided as a basis for substantial equivalence."

Therefore, I cannot provide the requested information as it is not present in the given document. The document is for a mechanical orthopedic implant, not an AI/algorithm-based diagnostic or treatment device that would typically have the kind of acceptance criteria and study designs you're asking about (e.g., sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.).

If you have a document describing an AI/algorithm-based medical device, I would be happy to analyze it for the criteria you've outlined.

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The WishBone Medical Guided Growth System is designed for the express and sole purpose of redirecting the angle of growth of long bone(s). This is useful for gradually correcting angular deformities in growing children. Specific conditions/diseases for which the device will be indicated include: valgus, varus or flexion, extension deformities of the knee (femur and/or tibia), valgus, varus or plantar flexion deformities of the ankle, valgus or varus deformities of the elbow (humerus), radial or ulnar deviation, flexion or extension deformities of the wrist (radius).

The WishBone Medical Guided Growth System is intended to be used for the express and sole purpose of redirecting the angle of growth of long bone(s). This is useful for gradually correcting angular deformities in growing children. The WishBone Medical Guided Growth System implants are made of a 316-stainless steel material in compliance of ASTM F138, and Ti-6Al-4V Titanium alloy compliant to ASTM F136. 316 stainless steel and Ti-Al-4V are biocompatible materials that are readily available and commonly used in implanted medical devices.

Here's an analysis of the provided text regarding the WishBone Medical Guided Growth System, focusing on acceptance criteria and study details.

Important Note: The provided text is a 510(k) Premarket Notification summary. For Class II medical devices like this, the goal is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to "prove" efficacy or meet specific performance acceptance criteria in the same way a PMA device or a de novo device might. The "acceptance criteria" here are therefore inferred from the demonstration of substantial equivalence, primarily through engineering analysis and comparison to predicate devices, rather than explicit numerical thresholds for clinical performance.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set (Clinical Data): None required or performed.
• Data Provenance: Not applicable for clinical data. For non-clinical data (engineering tests), the provenance would be internal laboratory testing by WishBone Medical.

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

• Not applicable. No clinical test set with human-established ground truth was reported or required for this 510(k) submission.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set.

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 device is a physical implant (Guided Growth System), not an AI-assisted diagnostic or therapeutic device. Therefore, MRMC studies and AI-related effectiveness metrics are not applicable.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• For the purposes of this 510(k) submission, the "ground truth" for substantial equivalence was established by:
  • Predicate Device Characteristics: The characteristics (intended use, indications, materials, design, sterilization) of the legally marketed predicate devices (OrthoPediatrics Pedi-Plates, Orthofix Guided Growth System, BioPro Go-EZ Screw, BioPro Toe MP Joint) served as the primary reference point.
  • Engineering Standards: Compliance with recognized industry standards such as ASTM F138 (for 316-stainless steel) and ASTM F136 (for Ti-6Al-4V Titanium alloy) for material composition and biocompatibility.
  • Laboratory Testing Results: The results of the engineering analysis (mechanical performance) and cleaning/endotoxin testing.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI/machine learning model and therefore does not have a "training set" in that context.

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

• Not applicable. (See point 8.)

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The Guided Growth Plate System Plus is intended for redirecting the growth of long bones. It is indicated for gradually correcting angular growth deformities in growing children. Specific conditions/diseases for which the device will be indicated include: valgus, varus or flexion, extension deformities of the knee (femur and/or tibia); valgus, varus, or plantar flexion deformities of the ankle; valgus or varus deformities of the elbow (humerus), and radial or ulnar deviation, flexion or extension deformities of the wrist (radius).

The Subject new 3.5mm thread diameter screw is a gamma extension of the existing screws (thread Ø4.5mm), components of the predicate Guided Growth Plate System Plus (K172183). The Subject device is a 3.5mm thread diameter screw, available in three lengths and manufactured by the same material (Ti6Al4V), as the 4.5mm diameter gamma screws, included in the predicate Guided Growth Plate System Plus (K172183).

The provided text describes a 510(k) premarket notification for the "Guided Growth Plate System Plus" and a new 3.5mm thread diameter screw, which is an extension of the existing screws for the system. The submission focuses on demonstrating substantial equivalence to a predicate device (K172183) rather than proving the device meets acceptance criteria through a clinical study in the traditional sense of a diagnostic AI device.

Therefore, many of the requested categories for AI/diagnostic device studies are not directly applicable. However, I can extract the relevant information regarding performance testing and how substantial equivalence was demonstrated.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The submission is for a new screw size, so the "performance" is in demonstrating that this new size is as safe and effective as the existing screws within the Guided Growth Plate System Plus. The acceptance criteria relate to mechanical testing standards.

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

• Sample Size: Not explicitly stated regarding the number of screws or plates tested, but implies tests were conducted on the new 3.5mm thread diameter screws.
• Data Provenance: The testing was mechanical, performed by the manufacturer, Orthofix Srl, in Italy. This is laboratory/bench testing, not patient data.

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

• This is not applicable as the "ground truth" for mechanical testing is adherence to engineering standards and robust physical properties, not expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

• Not applicable for mechanical testing. The results are quantitative measurements against defined standards.

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

• No. This is a hardware device (bone plate system components), not an AI/diagnostic software, so an MRMC study is not relevant.

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

• Not applicable. This is a hardware device.

7. The Type of Ground Truth Used

• Mechanical Testing Standards: The "ground truth" for the performance data in this submission is the fulfillment of established engineering and material standards (ASTM F564, ASTM F1264, ASTM F543) for bone fixation devices and screws.
• Clinical Literature Analysis: Supported by analysis of clinical literature to demonstrate clinical equivalence between the plate and screw system and staples (the reference devices).

8. The Sample Size for the Training Set

• Not applicable. This is a hardware device, not an AI model.

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

• Not applicable. This is a hardware device.

Additional Information from the document:

• Device Description: The "Subject new 3.5mm thread diameter screw is a gamma extension of the existing screws (thread Ø4.5mm), components of the predicate Guided Growth Plate System Plus (K172183)." It is made of the same Ti6Al4V material.
• Technological Characteristics & Substantial Equivalence: The submission claims substantial equivalence based on:
  • Indications for use
  • Intended patient population
  • System composition
  • Implant material
  • Method of fixation
  • Packaging configuration
  • Sterilization method
  • Biocompatibility
  • MRI compatibility
  • The only change is a design dimensional specification for the new 3.5mm thread diameter screw.
• Biocompatibility Data: No additional assessment was required because the subject device is equivalent in material, manufacturing, sterilization, etc., to the predicate device (K172183).
• Conclusion: The analysis of performance data (mechanical testing and clinical literature review) supports the conclusion that the new 3.5mm thread diameter screw is safe and effective and substantially equivalent to the predicate (K172183).

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The Guided Growth Plate System Plus is intended for redirecting the growth of long bones. It is indicated for gradually correcting angular growth deformities in growing children. Specific conditions/diseases for which the device will be indicated include: valgus, varus or flexion, extension deformities of the knee (femur and/or tibia); valgus, varus, or plantar flexion deformities of the ankle; valgus or varus deformities of the elbow (humerus), and radial or ulnar deviation, flexion or extension deformities of the wrist (radius).

The Guided Growth Plate System Plus is designed for the gradual correction of pediatric congenital as well as acquired deformities in both the upper and lower extremities, provided that the physis (growth plates) are not fused. It consists of different sizes of eight-Plate and quad-Plate plus with different cannulated and solid screw options. The plates feature a contoured waist and low profile for pediatric usage. There is a center hole in the plates for a temporary guide pin to be implanted, in order to aid application and removal of the plate. The plates are attached to the external surface of the bone by screws, which are not locked to the plate but rather they are allowed to swivel and diverge in their position as bone growth occurs. The implant acts like a flexible hinge, permitting growth at the growth plate to gradually straighten the limb.

This document describes a medical device, the Guided Growth Plate System Plus, and its clearance through the FDA 510(k) pathway. This pathway establishes substantial equivalence to a predicate device rather than necessarily proving new efficacy. Therefore, the information provided focuses on demonstrating equivalence rather than establishing novel acceptance criteria and proving performance against them in the traditional sense of a clinical study.

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

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission, the "acceptance criteria" are primarily related to demonstrating substantial equivalence to the predicate device and meeting applicable performance standards. There aren't specific quantitative accuracy metrics for a diagnostic device given here, but rather engineering and biocompatibility criteria.

• "All testing met or exceeded the requirements, as established by the test protocols and applicable standard."
• "A review of the mechanical data indicates that the components of the Subject device continues to be capable of withstanding expected loads without failure."
• "The Subject device was therefore found to be substantially equivalent to the Predicate device and has the mechanical properties to perform its indications safely." |
  | Biocompatibility | - Tests performed on equivalent system devices according to USP 38:2014 "Bacterial endotoxin test (LAL)", USP 38:2014 "Medical devices – bacterial endotoxin and pyrogen tests", ANSI/AAMI ST72:2011 "Bacterial endotoxins - Test methodologies, routine monitoring and alternative batch testing", and FDA 2012 Q&A "Guidance for Industry Pyrogen and Endotoxins Testing: Question and Answers."
• "to establish the Subject device non-pyrogenicity" |
  | Substantial Equivalence | - Demonstrated similarity to the predicate device (Guided Growth System Quad-Plate, K093442) in: intended use, indications for use, site of application, patient population, condition of use, technological characteristics, materials, mechanical performances, and implantable components. |
  | Design Improvements | - The subject device provides "design improvements and additional dimensions for implantable components, new sterile components and new related packaging configuration" while maintaining substantial equivalence. |
  | Risk Management | - "The potential hazards have been evaluated and controlled through a Risk Management Plan." |

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

This document describes a medical device (surgical implant) and its review for substantial equivalence, not an AI/software as a medical device (SaMD) or diagnostic study with a "test set" of patient data in the typical sense.

• Test Set Sample Size: Not applicable in the context of a clinical performance test set for an AI device. The "test set" for this device consists of the physical devices themselves and materials for mechanical and biocompatibility testing. No specific number of devices/materials tested is provided, but it's stated that "All testing met or exceeded the requirements."
• Data Provenance: Not applicable for patient data. The provenance of the performance data (mechanical and biocompatibility) would be from in-vitro laboratory testing conducted by or for Orthofix Srl in Italy. The document mentions "test reports and rationale references list."

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

Not applicable. This is not a study that requires expert adjudication for ground truth on clinical images or patient data. The "ground truth" for mechanical testing is defined by the standards (e.g., ASTM F564-10) and for biocompatibility by the international standards listed (e.g., USP 38, ANSI/AAMI ST72). These standards themselves are developed by expert consensus in their respective fields.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical test set requiring adjudication in 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 physical medical device (guided growth plate) for surgical implantation, not an AI or imaging diagnostic device that would involve human readers or MRMC studies.

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

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is based on:

• Engineering Standards: For mechanical performance (e.g., ASTM F564-10).
• Biocompatibility Standards: For non-pyrogenicity (e.g., USP 38, ANSI/AAMI ST72).
• Regulatory Substantial Equivalence Criteria: Comparing the device's characteristics to a legally marketed predicate device.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. As there is no training set, there is no ground truth to establish for one.

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The Guided Growth Plates are designed for the express and sole purpose of redirecting the angle of growth of long bone(s). This is useful for gradually correcting angular deformities in growing children. Specific conditions/diseases for which the device will be indicated include: valgus, varus or flexion; extension deformities of the knee (femur and/or tibia), valgus, varus or plantar flexion deformities of the ankle, valgus or varus deformities of the elbow (humerus), radial or ulnar deviation, flexion or extension deformities of the wrist (radius).

The Guided Growth System is designed for the gradual correction of pediatric deformities in both the upper and lower extremities. The device can be used for correction of congenital and acquired deformities provided that the physis (growth plates) are not fused. The plates feature a contoured waist and low profile for pediatric usage. There is a center hole in the plate for a temporary guide pin to be implanted to ensure accurate application of the plate. The plates are attached to the external surface of the bone over the growth plate by two or four screws. These screws are not locked to the plate, but rather are allowed to swivel and diverge in their position as bone growth occurs. The implant acts like a flexible hinge, permitting growth at the growth plate to gradually straighten the limb. Immediately after implantation, the patient is allowed mobility and weight bearing. The plates and screws are made from implant quality stainless steel conforming to ASTM F-138.

The provided text describes the acceptance criteria and a study for the "Guided Growth System Stainless Steel eight-Plate/quad-Plate". 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

The document describes biomechanical testing rather than clinical or performance data from human subjects. Therefore, the concept of a "test set" in the context of clinical data provenance (country of origin, retrospective/prospective) and sample size for human subjects is not applicable here. The testing was performed on the device itself.

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

Not applicable. Ground truth for mechanical testing is established by engineering standards and measurements, not by expert medical consensus in the typical sense of a clinical study.

4. Adjudication Method for the Test Set

Not applicable. This is typically relevant for clinical studies involving human interpretation or assessments.

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 device is a bone plate for surgical use, not an AI-powered diagnostic tool. The study described is biomechanical testing.

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

Not applicable. This section is irrelevant as the device is a medical implant and not an algorithm.

7. The Type of Ground Truth Used

For the biomechanical testing, the ground truth was established by:

• Engineering Requirements/Standards: The device needed to meet or exceed "all testing requirements" and perform "as well as the predicate device." These requirements would be based on established engineering principles and standards for medical implants.
• Predicate Device Performance: The performance of the legally marketed predicate devices (Growth Guidance Plate - eight-Plate K031439/11-20-03 and Guided Growth System - quad-Plate K093442/06-10-10) served as a benchmark for comparison.

8. The Sample Size for the Training Set

Not applicable. This concept is for machine learning models, and this document describes mechanical testing of a physical device.

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

Not applicable. As above, this is for machine learning models.

Ask a specific question about this device

The Guided Growth System plates are designed for the express and sole purpose of redirecting the angle of growth of long bone(s). This is useful for gradually correcting angular deformities in growing children. Specific conditions/diseases for which the device will be indicated include: valgus, varus or flexion, extension deformities of the knee (femur and/or tibia), valgus, varus or plantar flexion deformities of the ankle, valgus or varus deformities of the elbow (humerus), radial or ulnar deviation, flexion or extension deformities of the wrist (radius).

The Guided Growth System is designed for the gradual correction of pediatric deformities in both the upper and lower extremities. The device can be used for correction of congenital deformities as well as correction of acquired deformities, provided that the physis (growth plates) are not fused. The plates feature a contoured waist and low profile for pediatric usage. There is a center hole in the plate for a temporary guide pin to be implanted to ensure accurate application of the plate. The plates are attached to the external surface of the bone over the growth plate by two or four screws. These screws are not locked to the plate, but rather are allowed to swivel and diverge in their position as bone growth occurs. The implant acts like a flexible hinge, permitting growth at the growth plate to gradually straighten the limb. Immediately after implantation, the patient is allowed mobility and weight bearing.

The provided document describes the Orthofix Guided Growth System Quad-Plate, a medical device designed for correcting angular deformities in growing children. The submission focuses on demonstrating substantial equivalence to a predicate device through biomechanical testing, rather than a clinical study evaluating the device's diagnostic or predictive capabilities.

Therefore, many of the requested points, particularly those related to a study proving diagnostic performance, ground truth establishment, expert review, MRMC studies, or standalone algorithm performance, are not applicable to this type of device and submission.

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

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are related to mechanical performance and substantial equivalence to a predicate, rather than diagnostic accuracy.

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

Not applicable for a biomechanical testing submission. The "test set" here refers to the actual physical devices tested, not a dataset of patient information. The testing was conducted in a laboratory setting. No patient data (e.g., country of origin, retrospective/prospective) was used.

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

Not applicable. "Ground truth" in this context would refer to the true mechanical properties. These were established by standardized testing protocols (ASTM) rather than expert consensus on patient data.

4. Adjudication method for the test set

Not applicable. This concept applies to human review of data, not to standardized mechanical 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

No. This is a hardware device (bone plate) submission, not an AI/software device. Therefore, no MRMC study or AI-related effectiveness study was conducted.

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

No. This is a hardware device, not an algorithm.

7. The type of ground truth used

The "ground truth" for the device's mechanical performance was established using standardized biomechanical testing methods (ASTM F564-02). For the purpose of substantial equivalence, the "ground truth" for its clinical purpose is its similarity in function and indications to the legally marketed predicate device.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not a machine learning or AI device.

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

Not applicable. As there is no training set, this question is irrelevant.

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