(20 days)
The EXALT Model B Single-Use Bronchoscope is intended for use with the EXALT Monitor for endoscopic procedures within the airways and tracheobronchial tree.
The EXALT Model B Single-Use Bronchoscope is a sterile, single-use bronchoscope available in three sizes (Slim, Regular, and Large). The proposed device facilitates examination of the airways and trachea. delivery of accessories (Regular and Large sizes only), and delivery of live video when connected to an EXALT Monitor.
This document is an FDA 510(k) summary for the EXALT Model B Single-Use Bronchoscope. It states that the proposed device is identical to its predicate device (EXALT Model B Single-Use Bronchoscope, K211030). The purpose of the Special 510(k) was only to revise the specifications for insertion tube stiffness. Therefore, the document does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of device performance or clinical effectiveness.
Instead, it focuses on demonstrating substantial equivalence to a predicate device, which largely means showing that the new device has the same technological characteristics and indications for use as the predicate.
Here's a breakdown of why the requested information cannot be fully provided based on the given document:
- Acceptance Criteria and Reported Device Performance: This document states the device is identical to the predicate and only revised a specification for insertion tube stiffness. It does not provide performance metrics or acceptance criteria for clinical outcomes or device effectiveness.
- Study That Proves the Device Meets Acceptance Criteria: No such study is described for the proposed device. The only "testing" mentioned was on new, unopened samples of the original predicate device (Ambu aScope 4 Broncho, K173727) to establish insertion tube stiffness in commercial use, which informed the revised specifications for the EXALT Model B.
- Absence of specific information regarding clinical trials or performance studies for the EXALT Model B: The document explicitly states, "Performance testing was not required to establish a finding of substantial equivalence between the proposed device and the predicate device, since the device is unchanged."
Therefore, it is not possible to fill in the requested table or answer the specific questions about clinical performance, test sets, ground truth, experts, or MRMC studies based solely on this 510(k) summary.
Table of Acceptance Criteria and Reported Device Performance:
| Feature/Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| NOTE: This document is a 510(k) Special Notification for a device that is identical to its predicate model (K211030) with only a change in insertion tube stiffness specifications. Therefore, it does not include acceptance criteria or reported performance data related to clinical effectiveness or new functional metrics for the device itself. The clearance is based on substantial equivalence. | ||
| Insertion Tube Stiffness | (Not explicitly stated for clinical performance, but the change in specification for the proposed device was based on test results from the original predicate device K173727) | New specifications for insertion tube stiffness were set based on test results from new, unopened samples of the Ambu aScope 4 Broncho (K173727). Specific numerical performance values are not provided in this summary. |
Missing Information (Not available in the provided document):
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No clinical "test set" for performance evaluation of the EXALT Model B is described.
- 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, as no such test set or ground truth establishment is described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable; this is a bronchoscope, not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable, as this is not an AI/algorithm-based device.
- How the ground truth for the training set was established: Not applicable.
Summary of what the document does state regarding performance/testing:
- The proposed EXALT Model B Single-Use Bronchoscope is identical to its predicate device (K211030).
- The "special" nature of this 510(k) is to revise the specifications for insertion tube stiffness for the Slim, Regular, and Large sizes.
- Performance testing was NOT required to establish substantial equivalence for the EXALT Model B because it is "unchanged" from the predicate, except for the stiffness specification.
- "Performance testing was conducted on new, unopened samples of the original predicate device (Ambu aScope 4 Broncho, K173727) to establish the insertion tube stiffness seen in commercial use." This testing informed the new specifications for the EXALT Model B.
In essence, this FDA letter and summary confirm that the EXALT Model B is substantially equivalent to a previously cleared device, and the specific change addressed (insertion tube stiffness specifications) was supported by testing performed on the original predicate device, not the EXALT Model B itself as a new performance study.
§ 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.