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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).

Device Description

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.

AI/ML Overview

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

Acceptance Criteria (Inferred from Substantial Equivalence)	Reported Device Performance (as per 510(k) for substantial equivalence)
Intended Use: Same as predicates.	Same Intended Use: "The subject device has the same intended use... as the predicate guided growth/plating systems."
Indications for Use: Same as predicates.	Same Indications for Use: "all the WishBone Medical Guided Growth System indications are the same as predicate indications."
Materials: Same as predicates (biocompatible and commonly used).	Same Materials: "Implants are made of a 316-stainless steel material in compliance of ASTM F138, and Ti-6Al-4V Titanium alloy compliant to ASTM F136." These are "biocompatible materials that are readily available and commonly used in implanted medical devices."
Design Features: Similar to predicates.	Similar Design Features: "Similar to predicates."
Sterilization: Same as predicates.	Same Sterilization: "Same as BioPro predicate (K061798 and K041595)."
Mechanical Performance: Equivalent to predicate components (demonstrated through engineering analysis).	Equivalent through Engineering Analysis: "Engineering analysis was conducted to demonstrate substantial equivalence to the OrthoPediatrics Pedi-Plates predicate components." This implies the device performs mechanically at least as well as the predicate for its intended use.
Cleaning and Endotoxin Testing: Successful.	Successful Testing: "Cleaning testing, including endotoxin testing, was performed."
No New Questions of Safety and Effectiveness: Differences from predicates do not raise new concerns.	No New Questions: "Any differences do not raise new questions of safety and effectiveness."

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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