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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 Monster® Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair and fracture fixation, appropriate for the device. Specific examples include:

Fractures and Osteotomies

• · Fractures of the tarsals, metatarsals and other fractures of the foot (i.e. LisFranc)
• · Avulsion fractures and fractures of the 5th metatarsal (i.e. Jones Fracture)
• · Talar fractures
• · Ankle fractures
• Navicular fractures
• · Fractures of the fibula, malleolus, and calcaneus
• · Metatarsal and phalangeal osteotomies
• · Weil osteotomy
• · Calcaneal osteotomy

Hallux Valgus Correction

• · Fixation of osteotomies (i.e. Akin, Scarf, Chevron)
• Interphalangeal (IP) arthrodesis
• · Proximal, midshaft, or distal osteotomy
• Lapidus arthrodesis

Arthrodesis/Deformity Correction

• 1st MTP arthrodesis
• Metatarsal deformity correction
• · Tarsometatarsal joint arthrodesis
• · Naviculocuneiform joint arthrodesis
• · Talonavicular arthrodesis
• Subtalar joint arthrodesis
• · Triple arthrodesis
• Medial column arthrodesis
• Subtalar joint distraction arthrodesis
• · Ankle arthrodesis
• · Lateralizing calcaneal osteotomy
• Lateral column lengthening
• · Hammertoe

Fusion resulting from neuropathic osteoarthropathy (Charcot) such as:

• Medial and lateral column
• · Subtalar, talonavicular, and calcaneocuboid

The Monster Screw System is comprised of threaded bone screws (Ti Alloy or Stainless Steel) offered in 2.0mm to 9.5mm diameters (in 0.5mm increments). In addition, a 2.7mm diameter is also part of the system. The overall screw length ranges from 8mm (for smaller diameters) thru 200mm (for larger diameters). The screws are available in a variety of designs including: fully or partially threaded, self-drilling or blunt, cannulated or solid, and headed or headless. Sizedmatched washers are also available.

The provided document is a 510(k) summary for the Paragon 28 Monster® Screw System. This document DOES NOT contain information regarding acceptance criteria or a study that proves a device meets acceptance criteria related to AI/ML device performance.

Instead, it's a regulatory submission for a medical device (bone fixation screws) demonstrating substantial equivalence to previously marketed predicate devices. The "studies" mentioned are preclinical tests (engineering analysis, torsional, pullout, insertion/removal evaluations, sterilization validations) to show that modifications to the screws do not adversely affect performance compared to the predicate devices.

Therefore, I cannot fulfill your request as the information requested is not present in the provided text.

Here's a breakdown of why this document doesn't fit your request:

• Acceptance Criteria for AI/ML Performance: Not applicable. This is a traditional medical device (hardware).
• Study Proving Device Meets Acceptance Criteria (AI/ML): Not applicable. The "studies" are mechanical and material tests for screws, not AI/ML performance evaluations.
• Table of Acceptance Criteria and Reported Device Performance: Not applicable for AI/ML.
• Sample Size for Test Set and Data Provenance: Not applicable for AI/ML.
• Number of Experts for Ground Truth and Qualifications: Not applicable for AI/ML.
• Adjudication Method: Not applicable for AI/ML.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. There are no human readers or AI assistance.
• Standalone (algorithm only) Performance: Not applicable.
• Type of Ground Truth Used: Not applicable for AI/ML. (For the screws, the "ground truth" would be the established mechanical properties and safety profiles of predicate devices).
• Sample Size for Training Set & How Ground Truth Established for Training Set: Not applicable. This device does not use a training set in the AI/ML sense.

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