(44 days)
To provide a means to access the sinus space and to dilate the sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures.
The Sinus Balloon Catheter—Integrated Wire is a sinus balloon catheter that has an integrated guidewire. The Sinus Balloon Catheter—Integrated Wire allows access to and dilation of the sinus ostia and paranasal spaces with a single device.
The provided text describes a medical device, the "Sinus Balloon Catheter—Integrated Wire," and its 510(k) submission to the FDA. However, the document does not contain the specific details required to complete your request regarding acceptance criteria and the study that proves the device meets them.
The relevant section only states:
"The Sinus Balloon Catheter—Integrated Wire met all performance testing acceptance criteria."
And:
"The Sinus Balloon Catheter—Integrated Wire is substantially equivalent to the predicate devices as confirmed through relevant performance tests."
This indicates that performance testing was conducted and acceptance criteria were met, but the document does not elaborate on:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method.
- Whether a multi reader multi case (MRMC) comparative effectiveness study was done, or the effect size.
- Whether a standalone performance study was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
Therefore, I cannot provide the requested information based on the given text. This document is a summary of the 510(k) process and regulatory filing, not likely to contain detailed performance study protocols and results. Such details would typically be in an accompanying technical report or design validation documentation, which is not included here.
§ 874.4420 Ear, nose, and throat manual surgical instrument.
(a)
Identification. An ear, nose, and throat manual surgical instrument is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tube; malleous ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat trocar.(b)
Classification Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.