(75 days)
The Vent-Os™ Sinus Dilation System is an instrument intended to provide a means to access the sinus space and to dilate the maxillary sinus ostia and associated spaces in adults for diagnostic and therapeutic procedures.
The Vent-OsTM Sinus Dilation System is an osmotically driven device that dilates maxillary sinus ostia and associated spaces. The Vent-Os™ Sinus Dilation System is comprised of a Dilation Device preloaded on a Placement Instrument. The Placement Instrument accesses the target site through the nasal passageway and delivers the Dilation Device. The Vent-Os™ Sinus Dilation Device then expands and remodels the target tissues and then is removed.
Here's a breakdown of the acceptance criteria and the study details for the Vent-Os™ Sinus Dilation System, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary focuses on demonstrating "substantial equivalence" rather than providing explicit numeric acceptance criteria for each test. Instead, it reports "Passed" or specific outcomes that are compared to a literature control for clinical efficacy.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | |
| Non-cytotoxic | Non-cytotoxic |
| Non-sensitizing | Non-sensitizing |
| Non-irritating | Non-irritating |
| In Vitro Bench Evaluation | |
| Device weight acceptable | Passed |
| Placement System Working Length Profile acceptable | Passed |
| Placement System Working Length acceptable | Passed |
| Crossing Profile acceptable | Passed |
| Deployment Force acceptable | Passed |
| Dilation Device Diameter @ 1 hour acceptable | Passed |
| Dilation Device Working Length @ 1 hour acceptable | Passed |
| Dilation Device Integrity acceptable | Passed |
| Bond Strength acceptable | Passed |
| Proximal Anchoring Force acceptable | Passed |
| Sterilization & Packaging | |
| Sterilization compliant | Compliant with ANSI/AAMI/ISO 11137-2 |
| Transportation integrity | Passed (Transit Testing) |
| Sterile barrier integrity | Passed (Bubble Test) |
| Packaging & System visual inspection acceptable | Passed |
| Pouch seal integrity | Passed |
| Clinical Efficacy (Maxillary Ostia Patency) | SinuSys Study (Per Protocol) |
| Acute Patency comparable to literature | 54/57 (95%) with 95% CI: 85.6% - 98.2% |
| 3 Months Patency comparable to literature | 51/55 (93%) with 95% CI: 82.7% - 97.1% |
Study That Proves the Device Meets Acceptance Criteria:
The 510(k) submission details several studies to demonstrate safety and effectiveness for substantial equivalence:
- Biocompatibility Studies: In compliance with EN ISO 10993 requirements (ISO 10993-5:2009 and ISO 10993-10:2010).
- In Vitro Bench Evaluation: Performance testing was completed on various physical and mechanical attributes of the device.
- Transportation, Sterilization, and Shelf-life Testing: Sterilization compliant with ANSI/AAMI/ISO 11137-2. Transportation and packaging validation included transit testing, sterile barrier integrity, packaging/system visual inspection, and pouch seal testing.
- Animal Studies: Four (4) Dilation Devices were deployed into four (4) separate sheep maxillary sinuses to confirm safe placement and dilation.
- Cadaver Testing: Performed by multiple users (investigators) using two (2) adult cadaveric head specimens. The device was placed four (4) times into each target site.
- Clinical Trial: A prospective, non-randomized, single-arm, open-label study was conducted.
2. Sample Size Used for the Test Set and Data Provenance
- Clinical Trial Test Set Sample Size:
- Patients: 34 patients
- Maxillary Ostia Treated: 57 maxillary ostia
- Data Provenance: The study was conducted at five (5) clinical sites. The summary does not specify the country of origin, but given the applicant is a US company (Palo Alto, CA) and the FDA submission is for the US market, it's highly probable the study was conducted in the United States.
- Retrospective or Prospective: Prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The summary states that five (5) investigators conducted the clinical trial at five (5) clinical sites.
- Their specific qualifications are not explicitly stated beyond being "investigators," but for a study involving sinus dilation, they would typically be Ear, Nose, and Throat (ENT) specialists or Otolaryngologists. Their years of experience are not mentioned.
- The "ground truth" for the clinical trial was likely established by these investigators through post-procedure assessments of ostia patency, potentially using endoscopy or other clinical evaluation methods.
4. Adjudication Method for the Test Set
- The information provided does not specify an explicit adjudication method (e.g., 2+1, 3+1). For a single-arm, open-label study, it's common for the treating physician/investigator to evaluate the outcome. There is no mention of independent reviewers or a consensus process for the clinical trial results presented in the table.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This device is a surgical instrument, not an AI diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. This device is a manual surgical instrument, not an algorithm, so a standalone algorithmic performance study was not performed.
7. Type of Ground Truth Used
- Biocompatibility: Standardized laboratory test results based on established ISO guidelines.
- In Vitro Bench: Quantitative measurements and qualitative assessments ("Passed") against pre-defined performance specifications.
- Animal Studies: Direct observation and assessment of safe placement and dilation in sheep maxillary sinuses by qualified personnel.
- Cadaver Testing: Endoscopic delivery and placement of the device confirmed by investigators.
- Clinical Trial: Clinical assessment of maxillary ostia patency at acute and 3-month follow-ups, likely by the treating investigators based on clinical examination (e.g., endoscopy). This falls under expert clinical assessment/outcomes data.
8. Sample Size for the Training Set
- Not applicable. This is a physical medical device, not an AI/Machine Learning algorithm, so there is no "training set" in the computational sense. The "training" for the device would involve manufacturing process controls, design iterations, and perhaps early prototype testing, none of which are detailed as a formal "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for an algorithm. The "ground truth" during device development and manufacturing would be established through engineering specifications, material standards, and quality control metrics.
§ 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.