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Concert™ Cranioplast is a resinous material for repair of cranial defects.

Concert™ Cranioplast is a resinous material for repair of cranial defects.

The provided text is a 510(k) summary for a medical device called "Concert™ Cranioplast," which is a methyl methacrylate material for cranioplasty. The document states that the device is substantially equivalent to a predicate device, Codman Cranioplastic™, Acrylic Cranioplasty Material (K873689).

However, the provided text does not contain any information regarding acceptance criteria, specific device performance metrics, clinical study details, sample sizes, expert involvement, ground truth establishment, or any of the other specific items you requested in your prompt.

The 510(k) summary focuses on demonstrating substantial equivalence through non-clinical performance testing. It simply states:

"Performance testing demonstrated that Concert™ Cranioplast is substantially equivalent to Cranioplastic with regard to functional characteristics."

Without further documentation, it is impossible to fulfill your request for detailed information about acceptance criteria, study design, and results. This summary is at a very high level and indicates that detailed performance data was submitted, but it is not publicly available in this document.

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Fixation of prostheses to living bone in orthopedic musculoskeletal surgical procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, severe joint destruction secondary to trauma or other conditions and revision of previous arthroplasty.

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I am sorry, but the provided text is a letter from the FDA regarding a medical device clearance. It does not contain information about acceptance criteria, study details, or performance data for a device. The document is primarily about the regulatory approval of "Concert Radiopaque Bone Cement" and its intended use.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

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Fractures of the long bones and pelvis, joint fusion, limb lengthening, osteotomies, and peri-articular fractures.

TransFx Angled Rods

This document is an FDA 510(k) clearance letter for the TransFX Angled Rods, indicating substantial equivalence to pre-amendment devices. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

Therefore, I cannot fulfill your request using the provided input. This document is a regulatory clearance, not a technical performance report.

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Ask a specific question about this device

Ask a specific question about this device

Unstable fractures of the distal radius: intra-articular, extra-articular, and preliminary Exation before internal fixation. Fractures and fracture dislocations of the hand, wrist, forearm, mandible, foot, ankle, and long bones; joint fusion, osteotomies, and peri-articular fractures.

TransFx Multi-Pin Clamp

The provided document, an FDA 510(k) clearance letter for the TransFx Multi Pin Clamp, does not contain information about acceptance criteria, device performance studies, or any of the detailed technical study parameters requested.

This document is a regulatory approval letter based on substantial equivalence to a predicate device, not a performance study report. Therefore, I cannot generate the requested table and study details from the provided text.

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Unstable fractures of the distal radius: intra-articular, extra-articular, and preliminary fixation before internal fixation. Fractures and fracture dislocations of the hand, wrist, forearm, mandible, foot, ankle, and long bones; joint fusion, osteotomies, and peri-articular fractures.

TransFx Small External Fixation System, TransFx Intermediate External Fixation System, TransFx Mini External Fixation System

This document is not a study, but rather a letter from the FDA to a medical device manufacturer, Immedica, Inc., regarding their 510(k) premarket notification for the TransFx External Fixation Systems.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be found in the provided text.

The document states that the FDA has determined the device is "substantially equivalent" to predicate devices, allowing it to be marketed. This determination is based on the information submitted in the 510(k) notification, which would have included performance data, but that specific data and the acceptance criteria used are not detailed in this letter itself.

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Fractures of the long bones and pelvis, joint fusion, limb lengthening, osteotomies, and peri-articular fracture

TransFx External Fixation System

It appears the provided document is an FDA 510(k) clearance letter for the "TransFx External Fixation System." This document primarily grants clearance for a medical device based on substantial equivalence to a predicate device, rather than detailing a specific study proving the device meets acceptance criteria derived from a performance study.

FDA 510(k) clearances typically do not contain the type of detailed performance study information requested (e.g., specific acceptance criteria for AI algorithms, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment) because the basis of clearance is substantial equivalence. The device's performance is assumed to be similar to legally marketed predicate devices, and often bench testing or limited clinical data is used to demonstrate this equivalence, not a rigorously designed performance study as would be required for a novel AI-powered diagnostic device.

Therefore, the provided document does not contain the information necessary to answer the questions about acceptance criteria and the study that proves the device meets those criteria.

The document states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..." This is the core of a 510(k) clearance.

To answer your questions for an AI/ML medical device, one would typically need a much more detailed clinical study report or a 510(k) summary that specifically addresses the performance of such an algorithm.

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