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510(k) Data Aggregation
(97 days)
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(97 days)
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(124 days)
The MedNet LOCATOR, INC., ULTRABUR is to be used by ear, nose and throat physicians for forming a hole in the footplate for the placement of middle ear prostheses in stapedectomy procedures.
ULTRABUR (Pheumatic Surgical Drill, Surgical Drill and Bur)
I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a pneumatic surgical drill (MedNet UltraBur) and its indications for use. It does not include details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
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(45 days)
The MedNet Locator, INC., Piston Prosthesis is to be used by ear, nose and throat physicians to restore the hearing mechanism related to loss or destruction or damage to the ear ossicles due to prolonged chronic infection.
Piston Prosthesis
I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets specific acceptance criteria. The documents are an FDA 510(k) clearance letter and an Indications For Use statement for a "Piston Prosthesis" by MedNet Locator, Inc. They confirm the device's substantial equivalence to a predicate device and its intended use, but they do not contain details on performance studies, acceptance criteria, or the methodology of such studies.
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(45 days)
The MedNet Locator, INC., Partial Ossicular Replacement Prosthesis (PORP) is to be used by ear, nose and throat physicians to restore the hearing mechanism related to loss or destruction or damage to the ear ossicles due to prolonged chronic infection.
Partial Ossicular Replacement Prosthesis (PORP)
The provided text is an FDA 510(k) clearance letter for a medical device: "Partial Ossicular Replacement Prosthesis (PORP)". This type of document declares substantial equivalence to a predicate device, allowing it to be marketed. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
Therefore, I cannot provide the requested information. The 510(k) process primarily focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive de novo performance studies with acceptance criteria as might be seen for novel technologies or PMA applications.
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(45 days)
The MedNet LocaTOR, INC., Total Ossicular Replacement Prosthesis (TORP) is to be used by ear, nose and throat physicians to restore the hearing mechanism related to loss or destruction or damage to the ear ossicles due to prolonged chronic infection.
Total Ossicular Replacement Prosthesis (TORP)
This document is a 510(k) clearance letter from the FDA for a Total Ossicular Replacement Prosthesis (TORP). It is a regulatory document, not a study report or a technical performance document. Therefore, it does not contain any of the requested information regarding acceptance criteria, device performance, study details, or ground truth establishment.
The letter primarily states that the device is substantially equivalent to legally marketed predicate devices, allowing its manufacturer, MedNet Locator, Inc., to market it. It also outlines the general regulatory requirements the device must meet.
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(54 days)
The MedNet LOCATOR, INC., pediatric myringotomy tube is to be used by ear, nose and throat physicians for insertion into the eardrum for the purpose of ventilating and/or draining the middle ear in the case of mild to chronic otitis media which causes earache and discomfort for the patient.
Myringotomy Tube - Pediatric
This letter is a 510(k) clearance for a Myringotomy Tube - Pediatric device and does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.
The document states:
- The device is a "Myringotomy Tube - Pediatric" (K972126).
- It is for "insertion into the eardrum for the purpose of ventilating and/or draining the middle ear in the case of mild to chronic otitis media which causes earache and discomfort for the patient."
- The FDA has determined the device to be "substantially equivalent" to devices marketed prior to May 28, 1976. This means it has met the regulatory requirements for clearance based on its similarity to an already approved device, rather than through a direct study demonstrating its performance against specific acceptance criteria.
Therefore, I cannot provide the requested information from this document. It does not include:
- A table of acceptance criteria or reported device performance.
- Sample sizes for test sets or data provenance.
- Information on experts for ground truth establishment or adjudication methods.
- Details on MRMC comparative effectiveness studies or standalone algorithm performance.
- Specific types of ground truth used.
- Sample sizes for training sets or how ground truth for training sets was established.
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(57 days)
The MedNet LOCATOR, INC., bobbin myringotomy tube is to be used by ear, nose and throat physicians for insertion into the eardrum for the purpose of ventilating and/or draining the middle ear in the case of mild to chronic otitis media which causes earache and discomfort for the patient.
Myringotomy Tube - Bobbin
The provided documents are a 510(k) premarket notification letter from the FDA and the associated "Indications For Use" statement for a medical device. These documents do not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as requested.
The FDA letter (K971943) simply states that the "Myringotomy Tube - Bobbin" device is substantially equivalent to legally marketed predicate devices and can proceed to market. The "Indications For Use" defines the intended use of the device.
Therefore, I cannot provide a response to your request, as the necessary information is not present in the given text.
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(48 days)
The MedNet Locator, INC., bobbin with tab myringotomy tube is to be used by ear, nose and throat physicians for insertion into the eardrum for the purpose of ventilating and/or draining the middle ear in the case of mild to chronic otitis media which causes earache and discomfort for the patient.
Myringotomy Tube - Bobbin with Tab
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study details (like sample size, data provenance, expert qualifications, adjudication methods), or any comparative effectiveness studies.
The document is a 510(k) clearance letter from the FDA for a "Myringotomy Tube - Bobbin with Tab." It primarily states that the device is substantially equivalent to legally marketed devices and can therefore be marketed. It also includes the stated "Indications For Use" for the device.
Therefore, I cannot provide the requested information.
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