(73 days)
The Fiagon Navigation - PointerTube Straight and the PointerTube Keat are intended as aids for precisely locating anatomical structures in either open or percutaneous procedures. They are indicated for use with the Fiagon Navigation system using electromagnetic navigation.
The instruments are indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomy.
Example procedures include, but are not limited to:
ENT Procedures; Transphenoidal access procedures. Intranasal procedures. Sinus procedures, such as Maxillary antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies. Skull base procedures for ENT access
The Fiagon Navigation - PointerTube Straight and the PointerTube Keat are 10 time use instruments intended to be used with the Fiagon Navigation system.
Each device incorporates a sensor, which is tracked by the navigation system within the lowenergy magnetic field of a field generator (part of the navigation system). The navigation software (part of the navigation system) displays the position of the instruments in preoperative scans (e.g., CT, MRI, fluoroscopy).
The provided document is a 510(k) premarket notification letter and summary for the Fiagon Navigation - PointerTube Straight and PointerTube Keat. It addresses the substantial equivalence of these devices to previously cleared predicate devices.
Acceptance Criteria and Device Performance:
The document explicitly states that the purpose of the submission is for clearance of modified versions of existing instruments and that "Testing was performed in order to confirm continued precision and accuracy of the modified devices. Testing was also completed to ensure functionality and compatibility with the Fiagon Navigation system, as well as to confirm that the change in design of the modified instrument does not alter the performance characteristics of the device."
However, no specific acceptance criteria or quantitative performance data are provided in the document. The submission relies on the concept of "substantial equivalence" to predicate devices (Fiagon Navigation - PointerTube Straight (K141456) and PointerTube Sinus Frontalis (K141456)).
Therefore, a table of acceptance criteria and reported device performance cannot be generated from the given text as this detailed information is not included.
Study Information Pertaining to Device Acceptance:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified.
- Data Provenance: Not specified.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable/Not specified. This document describes a medical device (surgical tools) and its navigation system, not an AI or diagnostic imaging device that requires expert ground truth for interpretation. The testing likely involved engineering and performance validation rather than medical expert assessment of diagnostic accuracy.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. (See point 2).
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is not an AI or diagnostic imaging device. It is a surgical navigation instrument. Therefore, an MRMC study is not relevant here.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical surgical instrument used with a navigation system, not a standalone algorithm. The device itself (PointerTube) is a tool for human use, and its performance is inherently tied to being "in-the-loop" with the human surgeon and the navigation system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not explicitly stated. Given the nature of the device (surgical navigation tools), the "ground truth" for performance testing would typically involve engineering metrics related to precision, accuracy, and functionality (e.g., tracking accuracy, mechanical integrity, compatibility with the navigation system). This is not a diagnostic device where pathology or expert consensus on images would be the ground truth.
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The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. (See point 7).
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).