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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 WishBone Medical Plate and Screw System is indicated for pediatric and adult patients of the clavice, scapula, humerus, ulna, radius, metacarpals, pelvis acetabulum, femur, fibula, tibia, metatarsals and middle foot bones, and treatment of the calcaneus, and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis.

The system includes Femoral Locking Plates and Screws, which are in infant, child, and adolescent pediatric subgroups and small stature adult patients.

The WishBone Medical Femoral Locking Plate System was designed to address deformity correction in the proximal and distal femur where plating is an option for correction. It is intended to be used for temporary stable internal fixation of femoral osteotomies and fractures in pediatric patients. The system consists of two plate sizes, 3.5mm and 4.5mm, which align with the corresponding screw sizes, and are offered in varying lengths based on the quantity of screw holes needed. Plates have three screw holes in the "head" of each plate, plus 3, 4, 6, 8, or 10 screw holes in the shaft of the plates, based on plate configuration. Plates are also offered in varying angles ranging from 85° to 140°, with differing offsets and flares. These variations allow surgeons to best match the presenting patient's anatomy. New 3.5mm and 4.5mm locking and non-locking cortical screws are being added to the system for use with these new plates.

The subject Femoral Locking Plate System implants are composed of 316- Stainless Steel material (ASTM F138-19) and are supplied in one of two single-use sterile packaging configurations based on plate size: sterile packed Tyvek-covered trays or Nylon pouches, each with a double sterile barrier.

The Femoral Locking Plate System is a line extension of the WishBone Medical Plate and Screw System (K180736 & K213498).

The provided regulatory submission for the WishBone Medical Plate and Screw System (K230527) does not include acceptance criteria or the study data that typically demonstrates medical device performance against such criteria in the context of diagnostic or AI-driven devices.

This submission is for a mechanical orthopedic implant (plates and screws), and the "acceptance criteria" discussed are primarily related to ensuring the new device (Femoral Locking Plate System) is substantially equivalent to previously cleared predicate devices based on design, materials, manufacturing processes, and mechanical performance.

Here's why the requested information regarding acceptance criteria and performance studies in the context of an AI/diagnostic device is not present:

• Device Type: This is a Class II orthopedic implant (metallic bone fixation appliances). The clearance process for such devices heavily relies on demonstrating mechanical equivalence, biocompatibility, and sterilization validation compared to existing, legally marketed predicate devices. It is not an AI/diagnostic device that would typically have performance metrics like sensitivity, specificity, or AUC based on analyzing clinical data.
• "Acceptance Criteria" for this device: For this type of device, "acceptance criteria" are implied through the non-clinical performance testing. These are typically engineering specifications and thresholds (e.g., specific torque values for screw torsion, load limits for bend tests) that the device must meet to ensure its mechanical integrity and safety. These are not explicitly laid out in a table in the provided public summary.
• "Study that proves the device meets the acceptance criteria": This refers to the non-clinical performance testing mentioned.

Therefore, many of the specific questions (like sample size for test set, data provenance, ground truth, MRMC studies, AI performance, etc.) are not applicable to this type of medical device submission.

However, I can extract the relevant information that is present in the document regarding the justification for substantial equivalence.

Summary of Acceptance Criteria and Performance (Based on Device Type and Available Information)

Given that this is a mechanical orthopedic implant, "acceptance criteria" are implied by successful performance in biomechanical and material tests. The document states that engineering analyses and testing were conducted to reaffirm substantial equivalence, meaning the device met the established performance standards of the predicate devices.

Detailed Breakdown for AI/Diagnostic Device Questions (Not Applicable or Information Not Provided Herein):

1. 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 is a mechanical device, not a diagnostic or AI device that uses clinical data for performance evaluation in this context. The "test set" here refers to the physical devices subjected to mechanical and material testing, not a dataset of patient images or readings.
2. 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. Ground truth, in the context of clinical data interpretation, is not relevant for this mechanical device. The "ground truth" for mechanical testing would be the accepted engineering standards and specifications.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not Applicable. Adjudication methods are used for resolving disagreements in expert interpretations of clinical data, which is not part of this submission type.
4. 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-assisted diagnostic or interpretation device.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not Applicable. This is not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not Applicable. For mechanical performance, the "ground truth" is adherence to established ASTM standards and comparable performance to predicate devices.
7. The sample size for the training set: Not Applicable. There is no "training set" in the AI sense for this device.
8. How the ground truth for the training set was established: Not Applicable.

Conclusion:

The provided document details a 510(k) submission for a mechanical bone plate and screw system. The "acceptance criteria" and "studies" are related to mechanical engineering tests, material science, and sterilization validation to demonstrate substantial equivalence to predicate devices, rather than the performance metrics typically associated with AI or diagnostic clinical performance studies.

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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 Plate and Screw System is used for pediatric and adult patients as indicated for pelvic, small and long bone fracture fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis.

Indications for use include fractures of the clavicle, scapula, humerus, ulna, radius, middle hand, metacarpals, pelvis acetabulum. femur. fibula. tibia. metatarsals and middle foot bones. and treatment of the calcaneus.

Specifically, the Straight Fibula Plates are in infant, child, and adolescent pediatric subgroups and adult patients.

The WishBone Medical 7-Hole Straight Fibula Plate and WishBone Medical 3.0mm Cortical Screws and Locking Screws are wrought titanium alloy plate and screws (per ASTM F136) that are being added to the existing WishBone Medical Plate and Screw System as a line extension.

The provided document is a 510(k) premarket notification for a medical device (WishBone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a full-scale clinical trial or an AI algorithm's performance study.

Therefore, the document does NOT contain information relevant to the following points of your request:

• 1. A table of acceptance criteria and the reported device performance: This document does not establish performance criteria in terms of accuracy, sensitivity, or specificity for an AI algorithm.
• 2. Sample sized used for the test set and the data provenance: There is no "test set" in the context of an AI algorithm's performance study described here. The "testing" refers to mechanical and engineering analyses.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment by experts is relevant for AI model training and validation, which is not discussed here.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for this type of device 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: This is relevant for AI-assisted diagnostic devices, which this is not.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No AI algorithm is described.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for the type of testing described (mechanical/engineering analyses).
• 8. The sample size for the training set: There is no AI model or training set discussed.
• 9. How the ground truth for the training set was established: Not applicable, as there is no AI model or training set.

What the document does describe regarding "acceptance criteria" and "proof":

The "acceptance criteria" for a 510(k) submission generally revolve around demonstrating substantial equivalence to a predicate device. The "proof" is provided through non-clinical (engineering) testing and analysis.

Here's a breakdown of the relevant information provided in the document:

Acceptance Criteria (Implied by Substantial Equivalence Framework):

The device is considered "accepted" if it is demonstrated to be substantially equivalent to a predicate device, meaning:

• Same intended use: Yes, stated multiple times ("The subject device and predicate systems have the same intended use").
• Same indications for use: Yes, stated multiple times ("The subject device and predicate systems have the same intended use" and specific indications for use are listed and align with the predicate's general category).
• Same materials: Yes, "The subject device is manufactured from the same materials." (wrought titanium alloy per ASTM F136).
• Similar design features: Yes, "The subject device design is similar to the predicates."
• Same sterilization method and dose: Yes, "The subject and predicate devices have the same sterilization method and dose."
• No new or increased risks identified: This is the overarching goal of the performance data.

Study Proving Device Meets Acceptance Criteria (Non-Clinical Testing):

The "study" in this context refers to engineering analyses and non-clinical testing.

• Type of Testing: Engineering analyses were conducted to demonstrate substantial equivalence with the predicate device.

  • Axial Pullout Strength (per FDA Guidance "Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway" issued December 11, 2020).
  • Engineering analysis for Screw Torsion (per ASTM F543) - no new worst case.
  • Engineering analysis for Bending Fatigue (per ASTM F382) - no new worst case.
  • Engineering analysis for Insertion and Removal - no new worst case.
  • Engineering analysis for Pull-through Strength - no new worst case.
  • Engineering analysis for Fretting and Corrosion (per ASTM F897) - no new worst case.
  • Engineering analysis for Biocompatibility Risk Assessment (per ISO 10993-1 and FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" issued September 2020).

• Reported Device Performance (Results of Non-Clinical Testing):

  • "The devices performed within the intended use."
  • "No new questions of safety or efficacy were raised."
  • "The devices were found to be substantially equivalent to predicate devices."

• Sample Size: Not specified for each mechanical test, but implies sufficient samples were tested to conduct the engineering analyses.

• Data Provenance: The testing is laboratory-based engineering analysis, not patient data.

• Clinical Testing: "Clinical testing was not deemed necessary to demonstrate substantial equivalence."

In summary, this document is a regulatory submission for a traditional medical device (bone plate and screws), not an AI/software as a medical device. Therefore, the questions related to AI algorithm performance are not applicable. The device's "acceptance criteria" are met by demonstrating substantial equivalence through a series of specific engineering tests and analyses, indicating no new safety or effectiveness concerns compared to already approved devices.

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The WishBone Bone Plate and Screw System is used for pediatric and adult patients as indicated for pelvic, small and long bone fracture fixation and fixation of bones that have been surgically prepared (osteotion of deformity or arthrodesis.

Indications for use include fractures of the clavicle, scapula, humerus, ulna, radius, middle hand, metacarpals, pelvis acetabulum, femur, fibula, tibia, metatarsals and middle foot bones, and treatment of the calcaneus.

The purpose of this subject 510(k) is to introduce 4.0mm diameter cannulated screws and washers to the bone plate and screw system cleared under K180736.

This document describes a 510(k) premarket notification for the WishBone Medical Plate and Screw System. It is a submission for an orthopedic device, specifically bone plates and screws.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The submission refers to acceptance criteria, but doesn't explicitly state a table with quantitative values for each criterion and the device's performance against them. Instead, it indicates that the device met certain standards.

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

• Test Set Sample Size: Not explicitly stated in terms of number of screws or plates tested. The document mentions "Engineering analysis and mechanical testing," but does not provide specific sample numbers for these tests.
• Data Provenance: The studies were non-clinical engineering and mechanical tests performed to demonstrate compliance with standards (ASTM F543-17) and FDA guidance documents. This indicates the testing was likely conducted in a controlled lab environment. There is no information regarding country of origin for the data, nor whether it was retrospective or prospective, as these terms typically apply to clinical studies.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is not applicable as the studies were non-clinical mechanical tests, not clinical studies involving human patients or expert interpretation of medical data (like imaging). Therefore, no "ground truth" derived from expert consensus was required for this particular submission.

4. Adjudication Method for the Test Set

This information is not applicable as the studies were non-clinical mechanical tests. Adjudication methods (like 2+1, 3+1) are relevant for clinical studies where multiple experts evaluate cases and discrepancies need to be resolved.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/radiology devices where human readers' performance with and without AI assistance is evaluated. The WishBone Medical Plate and Screw System is a physical orthopedic implant, not an AI diagnostic or assistive device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone study (in the context of an algorithm's performance without human interaction) was not done. This is because the device in question is a physical medical implant, not an algorithm or AI software.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests was established by industry standards (ASTM F543-17) and performance criteria defined within FDA guidance documents for metallic bone screws and washers. These define the expected mechanical properties and failure limits.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical implant, not an AI/machine learning model 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 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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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 WishBone Medical Plate and Screw System is used for pediatric and adult patients as indicated for pelvic, small and long bone fracture fixation and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis.

Indications for use include fractures of the clavicle, scapula, humerus, ulna, radius, middle hand, metacarpals, pelvis acetabulum, femur, fibula, tibia, metatarsals and middle foot bones, and treatment of the calcaneus.

Not Found

The provided text is a 510(k) premarket notification letter and the "Indications for Use" for the WishBone Medical Plate and Screw System. It is a regulatory document concerning a bone fixation device, not a study report for an AI/algorithm-driven medical device. Therefore, it does not contain information on acceptance criteria, device performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, or comparative effectiveness studies typically associated with AI device evaluations.

The document primarily states that the FDA has determined the device to be "substantially equivalent" to legally marketed predicate devices.

Missing Information:

The document lacks all the requested details regarding acceptance criteria and the study proving the device meets them because it is not a study report for an AI/algorithm device. Specifically, it does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number of experts or their qualifications.
4. Adjudication method.
5. Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Information on standalone (algorithm-only) performance studies.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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The WishBone K-Wire System, is intended to be used for fixation of pediatric bone fractures, bone reconstruction; and guide pins for insertion of other implants.

Not Found

This document is a 510(k) clearance letter from the FDA for the WishBone K-Wire System. It indicates that the device has been found substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about acceptance criteria or specific study data proving the device met those criteria. The document is a regulatory clearance letter, not a clinical study report or a technical performance specification document.

Therefore, I cannot provide the requested information based on the input text. The questions asked are typically addressed in a clinical or performance study report that would be submitted to the FDA as part of the 510(k) application, but this letter is the FDA's response to that application, not the application itself.

To answer your questions, I would need a different type of document, such as:

• A summary of safety and effectiveness (SSE) for the 510(k).
• A clinical study report.
• A performance testing report.

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