(92 days)
The Airway Balloon Catheter is an instrument intended to dilate strictures of the airway tree.
The Inflation Device is an instrument intended to inflate, deflate and monitor pressure in balloon catheters used in sinus procedures and dilation of the airway tree.
The Airway Balloon Catheter is a catheter with a high pressure balloon on the distal tip. The device is designed with a coaxial lumen for inflation and guidewire access, if required. There are two accessories for the Airway Balloon Catheter: Inflation Device and Relieva Vigor Guidewire (optional).
Here's an analysis of the provided text regarding the acceptance criteria and study for the Acclarent Airway Balloon Catheter and Accessories (K090660):
1. Table of Acceptance Criteria and Reported Device Performance
Unfortunately, the provided 510(k) summary (K090660) does not explicitly list the specific acceptance criteria for the Airway Balloon Catheter and Accessories. It only states:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly listed | "The Airway Balloon Catheter and Accessories met all performance acceptance criteria." |
This is a common characteristic of 510(k) summaries, where the detailed test protocols and acceptance criteria are part of the full submission but are not always fully redacted into the public summary. The summary notes that the device demonstrated substantial equivalence to predicate devices through "relevant tests."
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not include any information about the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This level of detail is typically found in the detailed test reports within the 510(k) submission, not the summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The provided text does not include any information about the number of experts used to establish ground truth or their qualifications. This information would be relevant if clinical studies involving expert interpretation were conducted, but the summary focuses on technical and performance testing against predicate devices.
4. Adjudication Method for the Test Set
The provided text does not include any information about an adjudication method. Adjudication is usually relevant for studies involving human interpretation or subjective assessments, which are not detailed in this summary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided text does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The submission focuses on demonstrating substantial equivalence through performance data and technological characteristics, not on comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance
This device is a medical instrument (catheter, inflation device), not an Artificial Intelligence (AI) algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable to this submission.
7. Type of Ground Truth Used
Given that this is a physical medical device (catheter and inflation device), the "ground truth" for its performance would typically involve:
- Engineering specifications and standards: Confirming the balloon inflates to specified pressures, maintains integrity, fits through lumens, etc.
- Biocompatibility testing: Ensuring the materials are safe for use in the human body.
- Mechanical testing: Evaluating tensile strength, burst pressure, fatigue, etc.
- Bench testing: Simulating clinical use in a controlled environment.
- Animal studies (potentially): To assess in-vivo performance and safety if novel aspects are present.
The summary simply states it "met all performance acceptance criteria," implying these types of objective measures were used. It does not mention expert consensus, pathology, or outcomes data in the context of establishing ground truth for the core device performance.
8. Sample Size for the Training Set
As this is a physical medical device and not an AI algorithm, the concept of a "training set" in the context of machine learning is not applicable. The device's design and manufacturing processes are validated, not "trained" on a dataset.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" in the AI sense, this question is not applicable. The ground truth for the device's design and performance validation would be established through engineering principles, material science, applicable medical device standards, and in vitro and potentially in vivo testing to ensure it meets its intended use and safety profile.
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.