(280 days)
For patients aged 18 and older, the Relieva Seeker Balloon Sinuplasty System is intended to provide a means to access the frontal sinus space and to dilate the frontal recess, frontal sinus ostia and spaces within the frontal sinus cavity for diagnostic and therapeutic procedures. In addition, the device is intended to illuminate within and transilluminate across nasal and sinus structures.
The Relieva Seeker Balloon Sinuplasty System (Seeker) is an integrated device with a low-profile rail, balloon catheter, sinus illumination system with an illuminated ball tip, and a handle. The sinus balloon may be inflated to dilate the frontal recess, frontal sinus ostia, and spaces within the frontal sinus cavity.
Here's a summary of the acceptance criteria and study information for the Relieva Seeker Balloon Sinuplasty System based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Dimensional attributes (e.g., precise measurements, fits as intended) | Met all acceptance criteria for dimensional attributes. |
| Cycle fatigue (e.g., withstands repeated stress without failure) | Met all acceptance criteria for cycle fatigue. | |
| Balloon burst (e.g., ability of balloon to withstand specified pressure without bursting prematurely) | Met all acceptance criteria for balloon burst. | |
| Bond separation (e.g., strength of connections between components) | Met all acceptance criteria for bond separation. | |
| Biocompatibility | Compatibility with biological systems (e.g., non-toxic, non-irritating) | Testing showed that the Seeker Balloon Sinuplasty System is biocompatible. |
| Sterilization | Sterility Assurance Level (SAL) of 10^-6 (e.g., less than 1 in a million chance of non-sterile product) | Achieved by ethylene oxide, validated according to AAMI/ANSI/ISO 11135-1: 2007 (overkill/half-cycle approach). Demonstrated a sterility assurance level of 10^-6. Ethylene oxide residuals met ISO 10993-7:2008 requirements. (Note: Device not tested or labeled as "non-pyrogenic"). |
| Packaging & Shelf Life | Maintenance of sterility and device integrity over time and during transport (e.g., protection from damage, degradation) | Established per ASTM F1980-07, ISTA 2A:2011, ASTM F88-09, ASTM F2096-11, F1886, and F1929-98 requirements. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text only details bench testing for performance data. It does not elaborate on a specific "test set" in the context of clinical or image-based diagnostic studies. The performance data is derived from:
- Bench testing: In vitro laboratory tests on the device materials and components.
- Biocompatibility testing: Laboratory tests on the materials.
- Sterilization validation: Laboratory tests to confirm a sterility assurance level.
- Packaging shelf life tests: Laboratory tests to simulate transport and storage conditions.
Therefore, there isn't a "sample size for the test set" or "data provenance" (country of origin, retrospective/prospective) in the sense of patient data because clinical data were not found necessary for this device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. As clinical data was not required, there was no need for experts to establish ground truth for a clinical or diagnostic test set.
4. Adjudication Method for the Test Set
Not applicable. No clinical or diagnostic test set requiring adjudication was performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "Clinical data were not necessary for the Seeker Balloon Sinuplasty System."
6. Standalone Performance Study
Yes, in a way. The "performance data" described (bench testing, biocompatibility, sterilization, packaging) represents the "standalone" performance of the device itself, separate from human interaction in a diagnostic or interpretive context. However, it's not a standalone algorithm performance in the context of AI, as this is a physical medical device.
7. Type of Ground Truth Used
The "ground truth" for the performance data (as opposed to a diagnostic ground truth) was established by:
- Engineering specifications and industry standards: For dimensional attributes, cycle fatigue, balloon burst, bond separation.
- Biomedical testing standards: For biocompatibility.
- Standardized sterilization protocols and verification methods: For sterilization efficacy and residuals.
- Industry packaging and aging standards: For packaging shelf life.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical instrument, not an AI/machine learning algorithm requiring a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI algorithm, there is no ground truth to establish for it.
§ 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.