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The Smart Correction System is indicated for pediations (excluding newborns) and adults for the following:

• · Joint contracture resulting in loss of range of motion.
• · Fractures and disease which generally may result in joint contractures or loss of range of motion.
• · Fractures requiring distraction.
• · Open and closed fracture fixation, including fractures of long bones (intracapsular, intertrochanteric, supracondylar, condylar).
• · Correction of bony or soft tissue defects.
• · Correction of bony or soft tissue deformities.
• · Joint arthrodesis.
• Infected fractures or nonunions.
• · Limb Lengthening by epiphyseal or metaphyseal distraction.
• · Pseudoarthrosis of long bones.

The WishBone Medical Smart Correction System: a multilateral hexapod circular external fixator device used to stabilize and maintain alignment of complicated fractured bones, soft tissues and/or congenital deformity repairs of an extremity. The basic system consists of a minimum of two rings connected by six (6) telescopic struts that are lengthened and shortened independently. The struts' independent motion allows the surgeon to adjust the position of the proximal and distal ring. The system allows for movement in six different axes to correct difficult trauma extremity situations and/or congenital limb deformity correction. The Smart Correction System capitalizes on the body's natural ability of osteogenesis, guiding the orientation and position of this new bone to the desired corrected location in a steady, controlled fashion. In addition to the hardware, the Smart Correction System has a web-based software treatment planning tool with Radiographic Navigation. The surgeon enters data from direct examination, radiographic images, and the fixator parameters into the software. Post operatively, the surgeon enters the X-ray images and the current frame parameters into the software to establish an adjustment schedule for the patient during the healing process.

The Smart Correction System is modular and facilitates a multitude of frame configurations to serve a wide variety of patient needs. Listed below are the high-level components and accessories:

• The fixator bridge is constructed of two (2) or more ring components, and each ring component is connected to another via six (6) telescopic struts. Full, 2/3, and 1/3 ring components are available, along with standard and rapid adjust struts in multiple lengths. Threaded rods are used as needed to provide added frame stability. Rings are manufactured from aluminum material; struts from titanium, stainless steel, and aluminum; and threaded rods are made from stainless steel material.
• The fixator bridge is anchored to the patient's bone by crossed tensioned wires and half pins that are secured to the rings by connector elements (wire clamps, pin clamps, cubes, bolts, nuts, and washers). Standard, olive wires, and threaded wires are available, as well as multiple diameters and styles of half pins. Pins and wires may also be used to secure fragments of bone and are made from stainless steel. Connector elements are manufactured out of titanium material. This submission also includes a line extension to add Hydroxyapatite (HA)-coated stainless steel Half Pin components.
• A foot ring is available and connected to the distal ring when a procedure such as ankle arthrodesis is performed. The foot rings are manufactured out of aluminum material.
• Patient comfort accessories are also included: strut ID clips (PETG), foot walking attachment (POM-C), and pin/wire caps (silicone, PVC) are also included.

The Smart Correction System includes reusable surgical instruments to facilitate surgical assembly of the fixator construct. The non-sterile implants and other fixator elements are contained within sterilization cases, along with the reusable instruments.

This document is an FDA 510(k) clearance letter for a medical device called the "Smart Correction System (HA Half Pins)". It primarily establishes substantial equivalence to a predicate device and does not involve AI assistance, image interpretation, or diagnostic performance evaluation that would typically require the requested information about acceptance criteria for AI/ML models.

Therefore, the requested information on acceptance criteria, study details (sample size, data provenance, expert adjudication, MRMC studies, standalone performance), and ground truth establishment cannot be found in this document because the device in question is an external skeletal fixation system, not a diagnostic imaging AI.

The document discusses:

• Device identity: Smart Correction System (HA Half Pins)
• Regulatory information: Class II, Product Code KTT, Regulation 21 CFR 888.3030
• Intended Use and Indications for Use: For pediatric and adult patients for various orthopedic conditions like joint contractures, fractures, deformities, limb lengthening, etc.
• Substantial Equivalence: Claims equivalence to a predicate device (Smart Correction System K193368) based on intended use, indications for use, materials, design features, and sterilization.
• Performance Data: States that non-clinical testing (engineering analysis, construct stiffness, cleaning & sterilization validation, biocompatibility, HA coating characterization) was conducted in compliance with ASTM F1541-17.
• Clinical Testing: Explicitly states, "Clinical testing was not deemed necessary to demonstrate substantial equivalence."

Since the device is a mechanical orthopedic system and not an AI/ML-driven diagnostic tool, the concepts of "acceptance criteria for an AI model," "human readers improve with AI assistance," "standalone algorithm performance," "number of experts for ground truth," or "multi-reader multi-case studies" are not applicable to the information provided in this FDA clearance letter.

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The Smart Correction System is indicated for pediatric subpopulations (excluding newborns) and adults for the following: · Joint contracture resulting in loss of range of motion.
· Fractures and disease which generally may result in joint contractures or loss of range of motion.
· Fractures requiring distraction.
· Open and closed fracture fixation, including fractures of long bones (intracapsular, intertrochanteric, supracondylar, condylar).
· Correction of bony or soft tissue defects.
· Correction of bony or soft tissue deformities.
· Joint arthrodesis.
· Infected fractures or nonunion.
· Limb Lengthening by epiphyseal or metaphyseal distraction.
· Pseudoarthrosis of long bones.

The WishBone Medical Smart Correction System: a multilateral hexapod circular external fixator device used to stabilize and maintain alignment of complicated fractured bones, soft tissues and/or congenital deformity repairs of an extremity. The basic system consists of a minimum of two rings connected by six (6) telescopic struts that are lengthened and shortened independently. The struts' independent motion allows the surgeon to adjust the position of the proximal and distal ring. The system allows for movement in six different axes to correct difficult trauma extremity situations and/or congenital limb deformity correction. The Smart Correction System capitalizes on the body's natural ability of osteogenesis, guiding the orientation and position of this new bone to the desired corrected location in a steady controlled fashion. In addition to the hardware, the Smart Correction System has a web-based software treatment planning tool with Radiographic Navigation. The surgeon enters data from direct examination, radiographic images and the fixator parameters into the software. The software is used preoperatively to plan the reconstruction/correction and identify the frame construction. Post operatively, the surgeon enters the X-ray images and the current frame parameters to establish an adjustment schedule for the patient during the healing process.

The Smart Correction System is modular and facilitates a multitude of frame configurations to serve a wide variety of patient needs. Listed below are the high-level components and accessories:
. The fixator bridge is constructed of two (2) or more ring components, and each ring component is connected to another via six (6) telescopic struts. Full, 2/3, and 1/3 ring components are available, along with standard and rapid adjust struts in multiple lengths. Femoral arches and threaded rods are used as needed to provide added frame stability. Rings and femoral arches are manufactured from aluminum material; struts from titanium, stainless steel, and aluminum; and threaded rods are made from titanium material.
. The fixator bridge is anchored to the patient's bone by crossed tensioned wires and half pins that are secured to the rings by connector elements (wire clamps, pin clamps, cubes, bolts, nuts, washers, and twisted plates). Standard, olive wires, and threaded wires are available, as well as multiple diameters and styles of half pins. Pins and wires may also be used to secure fragments of bone and are made from stainless steel and titanium. Connector elements are manufactured out of titanium material. This submission also includes a line extension to add HA-coated titanium Half Pin components.
. A foot ring is available and connected to the distal ring when a procedure such as ankle arthrodesis is performed. The foot rings are manufactured out of aluminum material.
. Patient comfort accessories are also included: strut ID bands (polycarbonate), foot walking attachment (POM-C), and pin/wire caps (silicone, PVC) are also included.
. The Smart Correction System includes reusable surgical instruments to facilitate surgical assembly of the fixator construct. The non-sterile implants and other fixator elements are contained within sterilization cases, along with the reusable instruments

The provided text describes a 510(k) premarket notification for the WishBone Medical Smart Correction System. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not contain information about an AI/ML-driven device, nor does it conduct a study with acceptance criteria in the typical sense of evaluating AI performance metrics like sensitivity, specificity, AUC, etc.

The "acceptance criteria" discussed are related to the mechanical and biological performance of the medical device itself, not the performance of an AI algorithm. The text explicitly states "Clinical testing was not deemed necessary to demonstrate substantial equivalence."

Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI-driven device, as the provided document does not describe such a device or study.

However, I can interpret the "acceptance criteria" and "study" in the context of this specific medical device submission, which are focused on non-clinical performance and substantial equivalence to a predicate medical device.

Here's an interpretation based on the provided text's context, assuming the core request is about criteria for device acceptance in general, not specifically AI performance:

1. Table of Acceptance Criteria and Reported Device Performance

The questions below are typically relevant for AI/ML device studies. Since this submission is for a traditional medical device (external fixator) with software as a planning tool rather than a diagnostic/interpretive AI, most of them are not applicable. I will state "Not Applicable" where appropriate based on the provided text.

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 submission is for a physical medical device (external fixator). The "Performance Data" section refers to engineering analyses and justifications (e.g., mechanical testing, biocompatibility), not a clinical test set with patient data for an algorithm. Clinical testing was explicitly stated as "not deemed necessary."

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 clinical test set requiring human expert ground truth was performed for this 510(k) submission.

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

• Not Applicable. No clinical test set requiring human expert adjudication was performed for this 510(k) 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. The device is an external skeletal fixator, and its software component is a "treatment planning tool with Radiographic Navigation." It's not an AI assisting human readers in diagnosing or interpreting medical images. No MRMC study was mentioned.

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

• Not Applicable. The device itself is a physical external fixator. Its software is a planning tool, not a standalone diagnostic algorithm. No standalone algorithm performance study was mentioned.

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

• Not Applicable. For the mechanical testing performed, the "ground truth" would be established by the ASTM standards and validated testing protocols themselves, verifying material properties and structural integrity against known engineering principles and reference devices.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device requiring a training set in the conventional sense.

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

• Not Applicable. This is not an AI/ML device requiring a training set in the conventional sense.

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The WishBone Medical Smart Correction® System is indicated for pediatric subpopulations (excluding newborns) and adults for the following:

• · Joint contracture resulting in loss of range of motion
• · Fractures and disease which generally may result in joint contractures or loss of range of motion
• · Fractures requiring distraction
• · Open and closed fracture fixation, including fractures of long bones (intracapsular, intertrochanteric, supracondylar, condylar)
• Correction of bony or soft tissue defects
• · Correction of bony or soft tissue deformities
• · Joint arthrodesis
• Infected fractures or nonunions
• Limb Lengthening by epiphyseal or metaphyseal distraction
• · Pseudoarthrosis of long bones

The WishBone Medical Smart Correction System is a multilateral hexapod circular external fixator device used to stabilize and maintain alignment of complicated fractured bones, soft tissues and/or congenital deformity repairs of an extremity. The basic system consists of a minimum of two rings connected by six (6) telescopic struts that are lengthened and shortened independently. The struts' independent motion allows the surgeon to adjust the position of the proximal and distal ring. The system allows for movement in six different axes to correct difficult trauma extremity situations and/or congenital limb deformity correction. The Smart Correction System capitalizes on the body's natural ability of osteogenesis, guiding the orientation and position of this new bone to the desired corrected location in a steady controlled fashion. In addition to the hardware, the Smart Correction System has a web-based software treatment planning tool with Radiographic Navigation. The surgeon enters data from direct examination, radiographic images and the fixator parameters into the software. The software is used preoperatively to plan the reconstruction/correction and identify the frame construction. Post operatively, the surgeon enters the X-ray images and the current frame parameters to establish an adjustment schedule for the patient during the healing process.

The provided text describes the WishBone Medical Smart Correction System. However, it does not contain specific acceptance criteria, reported device performance measurements against those criteria, or details regarding a study (such as sample size, ground truth establishment, or expert qualifications) that proves the device meets such criteria.

Instead, the document details the device's technical characteristics, indications for use, and a summary of non-clinical performance data (mechanical testing, software testing, and engineering analysis) that was conducted to demonstrate substantial equivalence to predicate devices. It explicitly states that clinical data was not deemed necessary for the subject device.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be answered:

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

• Cannot be provided: The document does not list specific, quantifiable acceptance criteria (e.g., minimum accuracy percentages, specific strength thresholds beyond "similar to predicate") nor does it report numerical device performance against such criteria. It states that non-clinical tests were conducted to demonstrate substantial equivalence.

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

• Cannot be provided: Since "clinical data was not deemed necessary," there is no test set in the traditional sense of patient data. The "test reports" listed are for non-clinical, mechanical, and software testing. The sample sizes for these engineering tests are not specified.

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

• Cannot be provided: No clinical test set with human-established ground truth was used.

4. Adjudication method for the test set

• Cannot be provided: No clinical test set with adjudication was performed.

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

• Cannot be provided: No MRMC study was conducted. The device is a physical external fixation system with associated planning software, 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

• Partially answerable, but not in the diagnostic sense: The document mentions "Software Validation Reports" and "Software Accuracy Verifications." These imply standalone testing of the software component, but it's for planning and adjustment scheduling of the physical fixator, not for diagnostic performance like an AI algorithm detecting disease. No specific results or metrics for these software tests are provided beyond their completion.

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

• Cannot be provided (for clinical): As no clinical study was done, no clinical ground truth was established. For the non-clinical tests, the "ground truth" would be established engineering principles, reference measurements, or simulated conditions for mechanical and software evaluations.

8. The sample size for the training set

• Cannot be provided: As clinical data was not deemed necessary and the software's primary function is planning and adjustment scheduling (rather than learning from a large dataset), the concept of a "training set" for an AI model is not applicable or mentioned.

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

• Cannot be provided: Not applicable for this device and the type of evaluation performed.

Summary based on the provided text:

The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing (mechanical, software, and engineering analysis), rather than proving specific clinical performance against acceptance criteria in a clinical study.

The document lists the following non-clinical tests performed:

• Determination and Comparison of Stiffness for Smart Correction and TSF Constructs using Wires
• Engineering Analysis of Half Pins and Wires
• Determination of In-Plane Compressive Properties of Smart Correction and TSF Rings
• Determination of Smart Correction Half Pin-Connector Joint Strength
• Evaluation of Smart Correction and TSF Bridging Element Fatigue
• Determination and Comparison of Stiffness for Smart Correction and TSF Constructs using Half Pins
• Smart Correction Foot and Ankle Frame Testing
• Smart Correction Closed Foot Ring Compression Testing
• Clinical Cleaning & Sterilization Validation Testing
• Cleaning for Biocompatibility Test
• Biocompatibility Assessment Report
• Sterilization Case Transit Test
• Sterilization Case Drop Test
• Software Validation Reports
• Software Accuracy Verifications

The conclusion states that these tests demonstrate:

• Any differences [from predicates] do not raise new questions of safety and effectiveness; and
• The proposed subject device is at least as safe and effective as the legally marketed predicate devices.

Key takeaway: The regulatory pathway chosen (510(k) based on substantial equivalence and non-clinical data) does not require the type of detailed clinical study performance metrics or AI-specific evaluation criteria that your questions address.

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