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The Dilator Tube Set is intended for use in surgical procedures to provide surgical access by dilating the soft tissue to the intended surgical site and to identify motor nerves, spinal nerve roots and to aid the surgeon in assessing nerve function during surgery. The Dilator Tube Set is single use only.

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I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for a "Dilator Tube Set" and primarily discusses the regulatory approval process and the intended use of the device. It does not include details about performance studies, acceptance criteria, or ground truth establishment.

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Device is intended for use in surgical procedures to provide surgical access to the spine by placing the retractor in incision prepared by the surgeon down towards the land the sure is michael for use in surgical procedures to provide surgical access to the specifical access to the splacing .

Self-Retaining Lumbar Retractor

The provided document is a 510(k) premarket notification letter from the FDA to Koros USA, Inc. regarding a Self-Retaining Lumbar Retractor. It is a regulatory approval document confirming substantial equivalence to a predicate device.

This document does not contain any information about acceptance criteria or a study proving the device meets those criteria, as it is a Class I device and does not typically require extensive performance studies for 510(k) clearance. The information requested in the prompt (acceptance criteria table, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, etc.) are typically found in the 510(k) submission itself or in a detailed study report, not in the FDA's clearance letter.

Therefore, I cannot fulfill your request using the provided input.

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Device is intended for use in surgical procedures to repair Pectus Excavatum and sternal deformities.

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I am sorry, but the provided text does not contain information about acceptance criteria, device performance, a study to prove acceptance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details. The document is an FDA 510(k) clearance letter for the Adkins-Fonkalsrud Pectus Excavatum Strut, which confirms the device's substantial equivalence to a legally marketed predicate device. It outlines regulatory information but does not include any performance study details as requested.

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Flex Arm Retractor System intended to provide surgeons with instruments such as retractors, dilators, probes, protecting shield to perform a variety of neurological procedures utilizing MR visualization. The device may be used in surgical procedures requiring dissection and retraction of tissue. It is intended to be used by trained medical professional in operating room environment.

Flex Arm Retractor System intended to provide surgeons with instruments such as retractors, dilators, probes, protecting shield

I am sorry, but based on the provided document, I cannot extract the acceptance criteria and the study details as requested. This document is a 510(k) premarket notification letter from the FDA regarding the "Flex Arm Retractor System." It primarily confirms the substantial equivalence of the device to a legally marketed predicate device and outlines regulatory compliance.

The document does not contain:

• A table of acceptance criteria and reported device performance.
• Details about a specific study, including sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
• Information on how ground truth was established for training or test sets.

Essentially, this document is an administrative approval letter and does not delve into the technical study details that would typically support such an approval.

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