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Found 8 results
510(k) Data Aggregation
(202 days)
The AVID-NIT Nerve Stimulation Needles consist of an insulated hollow needles intended for locating peripheral nerves by electrical stimulation, and for the single shot administration of a local anesthetic drug. These needles are to be used with battery powered periphera1 nerve locators only. These needles are specifically not intended for nerve stimulation for purposes other than nerve location. These needles are specifically not intended for neurolytic ablation.
The AVID-NIT Nerve Stimulation Needles consist of an insulated hollow needles intended for locating peripheral nerves by electrical stimulation, and for the single shot administration of a local anesthetic drug.
This document is a 510(k) premarket notification letter from the FDA regarding the AVID-NIT Nerve Stimulation Needles. It does not contain information about acceptance criteria or a study proving the device meets those criteria.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. It outlines regulatory requirements that the manufacturer must comply with, but it does not detail any performance studies, test sets, ground truth, or expert involvement as requested in your prompt.
Therefore, I cannot provide the information requested in your prompt based on the provided document.
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(67 days)
The Avid-NIT Lutz Needle is used for the percutaneous puncture of the back, over the spine and into the epidural space for the administration of anesthetic agents. This needle is not intended for use with an epidural catheter.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for an epidural needle. This type of document does not contain information about acceptance criteria or a study proving device performance related to AI/algorithm performance.
The letter only states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It discusses regulatory matters such as good manufacturing practices, labeling, and other general controls.
Therefore, I cannot provide the requested information as it is not present in the given text.
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(53 days)
For the percutaneous punture of the abdomen or pelvis for the purpose of removing tissue of the soft tissue organs for microscopic examination, for the purpose of diagnosis of disease. The needle is to be used with the automatic biopsy devices marketed by C.R. Bard and Manan Medical Products.
Automatic Cutting Needle
I apologize, but the provided text from the FDA 510(k) clearance letter for the "Automatic Cutting Biopsy Needle" does not contain specific acceptance criteria, device performance data, details of a study (sample sizes, data provenance, expert qualifications, adjudication methods), or information about ground truth establishment.
This document is a regulatory clearance letter, primarily stating that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It does not typically include the detailed technical and scientific data from performance studies.
To answer your request, I would need a document specifically detailing the performance study, often found in an appendix to the 510(k) submission or a separate technical report.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based solely on the provided text.
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(313 days)
The Aldrete Single Shot Epidural Needle is intended to be used for the injection of local anesthetics to provide regional anesthesia.
Not Found
The provided text is a letter from the FDA regarding a 510(k) premarket notification for the "Aldrete Single Shot Epidural Needle." It states that the device has been found substantially equivalent to predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The letter is a regulatory approval document and does not detail the technical performance specifications or validation studies. It focuses on the legal and regulatory aspects of marketing the device based on its substantial equivalence to previously approved devices.
Therefore, I cannot extract the requested information (acceptance criteria, device performance, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from this document.
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(224 days)
A single patient use disposable device to hold radioactive seeds, in magazine fashion, in the MICK radionuclear 200-TP applicator. This device performs the same function as the reusable magazines sold by Mick Radionuclear Instruments, Inc.
A single patient use disposable device to hold radioactive seeds, in magazine fashion, in the MICK radionuclear 200-TP applicator.
The provided documents are a 510(k) clearance letter from the FDA and an "Indications For Use" statement for the NIT Radionuclide Seed Magazine.
These documents do not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML device evaluations.
The FDA clearance is for a physical medical device (radionuclide seed magazine) under the traditional 510(k) pathway, which focuses on substantial equivalence to a predicate device rather than performance metrics from AI/ML models.
Therefore, I cannot fulfill your request for information about acceptance criteria, study details, training/test set specifics, or MRMC studies, as none of this information is present in the provided text.
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(166 days)
The N.T., Inc. Radionuclide Seed Applicator is a manually operated device intended to apply a radionuclide source into the body for radiation therapy. This device is typically used in the transperineal approach for radionuclide seed application in the prostate.
The N.T., Inc. Radionuclide Seed Applicator is a manually operated device intended to apply a radionuclide source into the body for radiation therapy.
This looks like a 510(k) clearance letter from the FDA for a medical device called the "NIT Radionuclide Seed Applicator." This type of document declares that a device is "substantially equivalent" to a legally marketed predicate device, meaning it's considered safe and effective for its indicated use.
However, a 510(k) clearance letter does not typically contain detailed acceptance criteria or a study outlining specific performance metrics, sample sizes, ground truth establishment, or expert qualifications in the way you've described for an AI/CADe device.
The questions you've asked are highly relevant for the evaluation and clearance of AI-powered medical devices (often referred to as AI/CADx or AI/CADe). These types of devices typically undergo rigorous performance studies to demonstrate their efficacy, and the information you requested would be standard in their regulatory submissions and subsequent clearance documents.
Therefore, based solely on the provided text, I cannot answer the questions regarding acceptance criteria and the detailed study information. The document is a regulatory approval for a physical, manually operated medical device (a radionuclide seed applicator), not an AI-driven diagnostic or assistive technology.
To answer your questions, I would need a different type of document, specifically a regulatory submission summary or a published study for an AI/CADe device.
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(90 days)
The N.I.T., Inc. Needle Guiding Template is a device with needle guidance holes in a grid for the placement of radionuclide seeds into the body. Coordinate system assure to place the template in proximity to, but not touching the perineum for seed placement into and around the prostate.
The N.I.T., Inc. Needle Guiding Template is a device with needle guidance holes in a grid
The provided text is a 510(k) clearance letter from the FDA for the NIT Needle Guiding Template (Seed Applicator). It is a regulatory document confirming substantial equivalence to a predicate device, which allows the company to market the device.
This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device and we have determined the device is substantially equivalent...". This means the clearance is based on the device being similar enough to an already approved device, rather than requiring new performance studies meeting specific acceptance criteria as would be needed for a novel device or pre-market approval (PMA).
Therefore, I cannot fulfill your request for the tables and information about the study, as the provided text does not contain this data.
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(88 days)
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