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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 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.

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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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