(288 days)
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.
§ 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.