(25 days)
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
| Acceptance Criteria Category | Reported Device Performance (Summary from Submission) |
|---|---|
| Intended Use | The subject device and predicate systems have the same intended use. No new or increased risks are identified. |
| Indications for Use | The subject device and predicate systems have the same indications for use. No new or increased risks are identified. |
| Materials | The subject device is manufactured from similar materials to the predicate. No new or increased risks have been identified. |
| Design Features | The subject device design is similar to the predicate. No new or increased risks are identified. |
| Sterilization | The subject system has the same sterilization method for similar elements as the predicate (supplied nonsterile for end-user sterilization). No new or increased risks have been identified. |
| Mechanical Performance (Stiffness) | Engineering analyses were conducted for Ring Compressive Stiffness and Construct Stiffness in compliance with ASTM 1541-17. (The submission claims these justifications demonstrate substantial equivalence, implying performance is comparable or acceptable). |
| Mechanical Performance (Fatigue/Failure) | Engineering analyses were conducted for Construct Fatigue & Load to Failure in compliance with ASTM 1541-17. (The submission claims these justifications demonstrate substantial equivalence, implying performance is comparable or acceptable). |
| Biocompatibility | Engineering analyses were conducted for Cleaning for Biocompatibility and Biocompatibility Assessment. (The submission claims these justifications demonstrate substantial equivalence, implying performance is comparable or acceptable). Clinical Cleaning & Sterilization Validation Justification was also performed. |
| Overall Safety and Effectiveness | The performance data and analyses demonstrate that any differences (between subject and predicate device) do not raise new questions of safety and effectiveness, leading to the conclusion that the proposed device is at least as safe and effective and performs as well or better than the legally marketed predicate device. |
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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June 6, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
WishBone Medical, Inc. Kellie Myers Regulatory Affairs Manager 100 Capital Drive Warsaw, Indiana 46582
Re: K221366
Trade/Device Name: Smart Correction System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: KTT Dated: May 11, 2022 Received: May 12, 2022
Dear Kellie Myers:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Ting Song, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221366
Device Name Smart Correction System
Indications for Use (Describe)
- 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | ---------------------------------------------------------------- |
|X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image contains the logo for WishBone Medical. The logo consists of a blue circle with a white wishbone inside, followed by the text "WishBone" in a sans-serif font. Below "WishBone" is the word "MEDICAL" in a smaller, sans-serif font.
In accordance with 21 CFR $807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the WishBone Medical Smart Correction System Small Rings and compatible HA-Coated Half-Pins Special 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document The Special 510(k) Program, issued September 13, 2019.
| SUBMITTER INFORMATION | |
|---|---|
| Applicant | WishBone Medical, Inc. |
| Address | 100 Capital DriveWarsaw, IN 46582 |
| Phone Number | (574)306-4006 |
| Establishment Registration Number | 3013680140 |
| Name of Contact Person | Kellie Myers |
| Date Prepared | June 6, 2022 |
| NAME OF DEVICE | |
| Trade or Proprietary Name | Smart Correction System |
| Common or usual name | External Skeletal Fixation Device, |
| Classification Name | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, |
| Regulatory Classification | II |
| 510(k) Review Panel | Orthopedic Devices (OHT6) |
| Regulation | 888.3030 Single/multiple component metallic bone fixation appliances andaccessories. |
| Product Code(s) | KTT |
| Legally marketed device towhich equivalence is claimed | Smart Correction System, (K193368) |
| Reference Device | ST.A.R. 90 F4 External Fixation Screws with Hydroxyapatite (K150661) |
| Device Description | The WishBone Medical Smart Correction System: a multilateral hexapodcircular external fixator device used to stabilize and maintain alignment ofcomplicated fractured bones, soft tissues and/or congenital deformityrepairs of an extremity. The basic system consists of a minimum of two ringsconnected by six (6) telescopic struts that are lengthened and shortenedindependently. The struts' independent motion allows the surgeon to adjustthe position of the proximal and distal ring. The system allows formovement in six different axes to correct difficult trauma extremitysituations and/or congenital limb deformity correction. The SmartCorrection System capitalizes on the body's natural ability of osteogenesis,guiding the orientation and position of this new bone to the desired correctedlocation in a steady controlled fashion. In addition to the hardware, theSmart Correction System has a web-based software treatment planning toolwith Radiographic Navigation. The surgeon enters data from directexamination, radiographic images and the fixator parameters into the |
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Image /page/4/Picture/2 description: The image contains the logo for WishBone Medical. The logo consists of a blue circle with a white wishbone inside of it on the left. To the right of the circle is the company name, "WishBone" in a larger font and "MEDICAL" in a smaller font below it.
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 Intended Use of the Device The WishBone Medical Smart Correction System is intended for use in pediatric subgroups (except newborns) and adult patients for the treatment of open and closed fractures, arthrodesis and pseudoarthrosis of long bones, limb lengthening, deformity and angular correction, bony or soft
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Image /page/5/Picture/1 description: The image shows the logo for WishBone Medical. The logo consists of a blue circle with a white wishbone inside on the left. To the right of the circle is the text "WishBone" in a sans-serif font, with the word "MEDICAL" in smaller letters below.
| Indications for Use | radiographic measurements, the software provides a schedule ofadjustments for the fixator frame.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 contracturesor 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. |
|---|---|
| --------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICE
The rationale for substantial equivalence is based on consideration of the following characteristics:
- a. Intended Use: The subject device and predicate systems have the same intended use. No new or increased risks are identified.
- b. Indications for Use: The subject device and predicate systems have the same intended use. No new or increased risks are identified
- c. Materials: The subject device is manufactured from similar materials. No new or increased risks have been identified.
- d. Design Features: The subject device design is similar to the predicates. No new or increased risks are identified.
- e. Sterilization: The Smart Correction System is supplied nonsterile for the end user to sterilize in the provided sterilization cases. While the predicate system offers some pins sterile, there are pins that are provided nonsterile. The subject system has the same sterilization method for similar elements as the predicate. Therefore, no new or increased risks have been identified.
PERFORMANCE DATA NON-CLINICAL TESTING
Engineering analyses were conducted in compliance with ASTM 1541-17: Standard Specification and Test Methods for External Skeletal Fixation Devices. Evaluations conducted include:
- Ring Compressive Stiffness Justification
- Construct Stiffness Test Justification
- Construct Fatigue & Load to Failure Test Justification
Engineering analyses were also conducted for the following:
- . Clinical Cleaning & Sterilization Validation Justification
- Cleaning for Biocompatibility Test Justification
- Biocompatibility Assessment Justification
CLINICAL TESTING
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Image /page/6/Picture/2 description: The image shows the logo for WishBone Medical. The logo consists of a blue circle with a white wishbone inside, followed by the text "WishBone" in a sans-serif font. Below the word "WishBone" is the word "MEDICAL" in a smaller, sans-serif font.
Clinical testing was not deemed necessary to demonstrate substantial equivalence.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The subject device has the same intended use and indications as the predicate Smart Correction System (K193368). It also has similar technological characteristics as the predicate device, and the performance data and analyses demonstrate that any differences do not raise new questions of safety and effectiveness. Therefore, we conclude that the proposed device is at least as safe and effective and performs as well or better than the legally marketed predicate device.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.