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The Biomet Forerunner™ Plating System is used for adult or pediatric 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 internal fixation of the tibia, fibula, femur, metacarpals, metatarsals, humerus, ulna, radius, middle hand, and middle foot bones. This 510(k) expands the indications for use to the forefoot, and adds specific indications for midfoot/forefoot procedures:

1. Treatment of fractures and fracture-dislocations of the midfoot/forefoot
2. Malunions
3. Non-unions
4. Joint fusions/arthrodesis
5. Corrective osteotomies for deformities
   These procedures in the midfoot/forefoot may be indicated as a result of trauma, deformity, osteoarthritis, and rheumatoid arthritis.

The Biomet Forerunner" Plating System is an internal fixation system consisting of various sized plates and screws. The plates and screws are fabricated from Ti-6Al-4V.

The provided text describes a 510(k) premarket notification for the Biomet Forerunner Plating System, which is a metallic bone fixation device. This specific submission expands the indications for use of the system to include the forefoot and adds specific midfoot/forefoot procedures.

However, the document is a regulatory submission describing a device and its intended use, rather than a study evaluating its performance against specific acceptance criteria. The FDA's review concludes that the device is "substantially equivalent" to predicate devices, meaning it does not raise new issues of safety or effectiveness compared to existing, legally marketed devices.

Therefore, the requested information regarding acceptance criteria, reported device performance, study details (sample sizes, data provenance, ground truth, experts, adjudication, MRMC, standalone performance), and training set information is not present in this document.

The "Summary of Technologies" section states: "The technological characteristics of the Forerunner" Plating System are the same as, or similar to, the predicate devices." This implies that the device's performance would be considered similar to the predicate devices, which have already been deemed safe and effective.

In summary, this document does not contain the information required to populate the table or answer the specific questions about acceptance criteria and a study proving device performance, as it is a substantial equivalence claim for a physical medical device, not an AI/software performance study.

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The SMPle™ Pediatric Submuscular Plating System is intended for adult or pediatric patients as indicated for long bone fracture fixation of bones that have been surgically prepared (osteotomy) for correction of deformity, malunions, non-union or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, humerus, ulna, and radius.

In pediatric femoral applications, the SMPle™ Pediatric Submuscular Plating System is intended for use in the treatment of femoral fractures, malunions or non-unions, femoral osteotomies required for the correction of deformity, and arthrodesis. Indications for buttressing multi-fragmentary distal femoral fractures include: supracondylar, intra-articular and extra-articular condylar, periprosthetic fractures and fractures in normal or osteopenic bone, non-unions and mal-unions, and osteotomies of the femur.

Single/multiple metallic bone fixation appliances and accessories (21 CFR 888.3030)

The provided text is a 510(k) Summary for the Biomet Trauma SMPLe™ Pediatric Submuscular Plating System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study with performance metrics.

Therefore, the following information is not available in the provided text:

• A table of acceptance criteria and reported device performance.
• Details about a specific study, including sample sizes, data provenance, number or qualifications of experts, ground truth establishment, or adjudication methods for any test or training sets.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.

Explanation Based on the Provided Text:

The 510(k) Summary states the following as its primary method for regulatory approval:

• Substantial Equivalence: "The SMPle™ Pediatric Submuscular Plating System is substantially equivalent to its predicate devices with respect to intended use and indications, technological characteristics, and principles of operation and does not present any new issues of safety or effectiveness."

Instead of presenting performance data against defined acceptance criteria, the submission relies on demonstrating that the new device is as safe and effective as pre-existing, legally marketed devices (predicates). The "study" referenced here is likely a combination of engineering analysis and comparison to predicate device characteristics, which doesn't typically involve a clinical trial with specific performance metrics as would be seen for AI/diagnostic devices.

Predicates mentioned are:

• Synthes 3.5 and 4.5 Locking Compression Plates for expanded indications (K082807)
• Orthopediatrics PediLoc™ Plating Systems (K083286)
• Biomet IQL Plating System (K020221)
• Biomet OptiLock® Periarticular Plating System (K061098)

In summary, this document is a regulatory submission for a medical device (bone plating system) using the 510(k) pathway, which primarily seeks to establish substantial equivalence to predicate devices, not to present a clinical study with detailed performance acceptance criteria and results as might be expected for software-as-a-medical-device or diagnostic tools.

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The OptiLock® VL Distal Radius Plating System consists of a series of plates, screws and locking pegs that are intended for the fixation of intra-articular and extra-articular fractures involving the distal radius, ulna (and other small bones). This system is also intended for use in osteopenic bone. Specific indications include:

1. Fixation of intra-articular and extra-articular fractures
2. Treatment of mal-unions
3. Treatment of non-unions
4. Osteotomies
5. Wrist arthrodesis

The OptiLock® VL Distal Radius Plating System is comprised of a series of anatomically contoured plates, and locking, variable angle locking and non-locking screws, as well as locking pegs intended to be used in the distal radius, ulna (and other small bones). This system may also be used in osteopenic bone. The plates are available in several styles to address the anatomy of the distal radius/ulna. The screws are available in two diameters, in locking, non-locking and variable angle locking styles. Locking pegs are also available as an option for stabilizing the plate to the bone.

The plates and screws of the OptiLock® VL Distal Radius Plating System are fabricated from titanium alloy (Ti-6Al-4V), which conforms to ASTM specification F-136, or stainless steel alloy which conforms to ASTM specification F-138 or F-139. Plates and screws fabricated from titanium alloy are anodized to color-code the different sizes to assist the surgeon with size selection.

The provided text is a 510(k) Summary for the Biomet Trauma OptiLock® VL Distal Radius Plating System. This type of submission is for medical devices, specifically orthopedic implants, which are typically evaluated based on substantial equivalence to existing legally marketed predicate devices, rather than through studies involving AI or diagnostic performance metrics.

Therefore, the document does not contain the information requested in the prompt, such as acceptance criteria based on device performance metrics (like accuracy, sensitivity, specificity), details of a study proving such performance, sample sizes for test or training sets, data provenance, expert ground truthing, adjudication methods, or MRMC studies.

Instead, the document focuses on:

• Device Description: What the device is made of and its components.
• Indications for Use: What the device is intended to treat.
• Summary of Technologies: Stating that the technology is similar to other legally marketed devices.
• Substantial Equivalence: Arguing that the device is as safe and effective as predicate devices already on the market, primarily based on engineering analysis rather than clinical performance studies against specific criteria.

Therefore, I cannot fulfill the request as the essential information related to performance criteria and a study proving device performance (as would be applicable for diagnostic or AI-driven devices) is not present in the provided text.

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