(125 days)
EXALT Model B Single-Use Bronchoscope:
The EXALT Model B Single-Use Bronchoscope is intended for use with the EXALT Monitor for endoscopic procedures within the airways and tracheobronchial tree.
EXALT Monitor:
The EXALT Monitor is intended for use with a Boston Scientific single-use endoscope for endoscopic diagnosis, treatment, and video observations.
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.
The EXALT Monitor is an electronic device that:
- Receives video signals from a Boston Scientific single-use endoscope,
- Processes the video signals,
- Displays image on integrated display
- Outputs video images to a secondary video monitor when connected to AC mains,
- Outputs electrical signal(s) that interface with external image capture systems, and
- Saves and exports procedure images and videos.
The EXALT Monitor also controls the light transmitted by the tip of the single-use endoscope to illuminate the area of interest within the anatomy. Buttons on the Monitor touch screen enable the user to control the brightness level of the light.
The provided text pertains to a 510(k) premarket notification for the Boston Scientific EXALT Model B Single-Use Bronchoscope and EXALT Monitor. This document is a regulatory submission for a medical device and describes its equivalence to predicate devices, focusing on design, physical characteristics, and basic performance parameters.
Based on the provided text, the device is a bronchoscope and monitor system, not an AI/ML-enabled diagnostic device. Therefore, the standard acceptance criteria and study design elements typically associated with AI/ML devices (like sensitivity, specificity, AUC, ground truth establishment by experts, MRMC studies, or training/test set sample sizes for AI models) are not present in this document.
The "study" described in the document is a series of non-clinical, bench performance tests to demonstrate substantial equivalence to predicate devices, rather than a clinical trial or AI model validation study.
Here's an analysis based solely on the provided information, framed to address your query about acceptance criteria and study to the best extent possible given the document's nature:
Acceptance Criteria and Device Performance (Based on provided text)
The document outlines performance testing to establish substantial equivalence to predicate devices. The "acceptance criteria" are implied to be that the subject device's performance characteristics are equivalent or superior to the predicate device's, or fall within similar operational parameters.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied: Equivalent or Superior to Predicate) | Reported Device Performance (EXALT Model B) | Predicate Device Performance (Ambu aScope 4) |
|---|---|---|---|
| Field of View | ≥ 85° | 90° | 85° |
| Direction of View | 0° | 0° | 0° |
| Depth of Field | 6-50 mm | 6-50 mm | 6-50 mm |
| Working Length | 60 cm | 60 cm | 60 cm |
| Articulation Angle (Slim, Regular) | 180° up, 180° down | 180° up, 180° down | 180° up, 180° down |
| Articulation Angle (Large) | ≥ 160° down | 180° up, 180° down | 180° up, 160° down |
| Insertion Tube Outer Diameter (Slim) | 3.8 mm | 3.8 mm | 3.8 mm |
| Insertion Tube Outer Diameter (Regular) | 5.0 mm | 5.0 mm | 5.0 mm |
| Insertion Tube Outer Diameter (Large) | 5.8 mm | 5.8 mm | 5.8 mm |
| Insertion Portion Max Diameter (Slim) | 4.3 mm | 4.3 mm | 4.3 mm |
| Insertion Portion Max Diameter (Regular) | 5.5 mm | 5.5 mm | 5.5 mm |
| Insertion Portion Max Diameter (Large) | 6.3 mm | 6.3 mm | 6.3 mm |
| Minimum Working Channel Diameter (Slim) | ≤ 1.2 mm | 1.0 mm | 1.2 mm |
| Minimum Working Channel Diameter (Regular) | ≤ 2.0 mm | 2.0 mm | 2.0 mm |
| Minimum Working Channel Diameter (Large) | ≤ 2.6 mm | 2.6 mm | 2.6 mm |
| Average Working Channel Diameter (Slim) | 1.2 mm | 1.2 mm | 1.2 mm |
| Average Working Channel Diameter (Regular) | 2.2 mm | 2.2 mm | 2.2 mm |
| Average Working Channel Diameter (Large) | 2.8 mm | 2.8 mm | 2.8 mm |
| Minimum ETT Inner Diameter Size (Slim) | 5.0 mm | 5.0 mm | 5.0 mm |
| Minimum ETT Inner Diameter Size (Regular) | 6.0 mm | 6.0 mm | 6.0 mm |
| Minimum ETT Inner Diameter Size (Large) | 7.0 mm | 7.0 mm | 7.0 mm |
| Minimum DLT Inner Diameter Size (Slim) | 35 Fr | 35 Fr | 35 Fr |
| Minimum DLT Inner Diameter Size (Regular) | 41 Fr | 41 Fr | 41 Fr |
| Minimum DLT Inner Diameter Size (Large) | N/A | N/A | N/A |
| Monitor: Max Resolution | ≥ 800 x 480 | 2736 x 1824 | 800 x 480 |
| Monitor: Orientation | Landscape | Landscape | Landscape |
| Monitor: Display Size | ≥ 8.5" | 12.3" | 8.5" |
| Monitor: Brightness Control | Yes | Yes | Yes |
| Monitor: Contrast Control | Implied Yes (predicate has) | No | Yes |
| Monitor: Storage | ≥ 8 GB | 85 GB | 8 GB |
| Monitor: Battery Life | Implied ≥ 1.5 hours | 1.5 hours | 3 hours |
| Monitor: Operating Env. (Temp) | Within 10-40°C range | 10-33°C | 10-40°C |
| Monitor: Operating Env. (Humidity) | Within 30-85% range | 30-85% | 30-85% |
| Monitor: Operating Env. (Pressure) | Within 700-1090 hPa range | 700-1090 hPa | 800-1090 hPa |
| Monitor: Dimensions (W x H x D) | Comparable | 13.6" x 8.4" x 2.3" | 9.49" x 6.89" x 1.32" |
| Monitor: Weight | Comparable | 4.7 lbs. | 3.31 lbs. |
| Suction Rate | Equivalent or Superior | Superior | (Implicit) |
| Resolution (Bronchoscope) | Satisfactory | (Implicit) | (Implicit) |
| Light Output | Satisfactory | (Implicit) | (Implicit) |
| Durability | Satisfactory | (Implicit) | (Implicit) |
| Photobiological Safety | Satisfactory | (Implicit) | (Implicit) |
| Image Intensity Uniformity | Satisfactory | (Implicit) | (Implicit) |
| Geometric Distortion | Satisfactory | (Implicit) | (Implicit) |
| Noise | Satisfactory | (Implicit) | (Implicit) |
| Dynamic Range | Satisfactory | (Implicit) | (Implicit) |
| Color Performance | Satisfactory | (Implicit) | (Implicit) |
| Biocompatibility | ISO 10993-1 compliant | Compliant | (Implicit) |
| Electrical Safety & EMC | AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-18 compliant | Compliant | (Implicit) |
Notes on Acceptance Criteria:
- For characteristics like "Field of View" or "Max Resolution," the acceptance criterion is implied to be "at least as good as the predicate" or "within a clinically acceptable range similar to the predicate."
- For physical dimensions (e.g., Insertion Tube Outer Diameter, Monitor Dimensions, Weight), the acceptance criterion is implied to be "comparable to the predicate" such that it does not raise new questions of safety or effectiveness.
- For "Suction Rate," the document explicitly states "equivalent or superior."
- For "Contrast control" on the monitor, the subject device does not have it, while the predicate does. This is presented as a difference but not as a failure to meet acceptance criteria, likely because it was deemed not to affect substantial equivalence for the intended use.
- For "Battery Life," the subject device's 1.5 hours is less than the predicate's 3 hours. This is also a difference but not framed as a failure.
2. Sample Size and Data Provenance
- Test Set Sample Size: The document does not specify a "test set sample size" in the context of an AI/ML model. The evaluation described is "performance testing (bench)" on the physical devices. It would involve a sample of the manufactured bronchoscope and monitor units. The exact number of units tested is not stated.
- Data Provenance: Not applicable in the context of clinical/image data for an AI/ML device. The testing is bench-based, likely performed in the manufacturer's labs.
3. Number of Experts and Qualifications for Ground Truth
- Not applicable. This device is a bronchoscope and monitor, not an AI/ML diagnostic tool. There is no human image interpretation "ground truth" involved in the substantial equivalence testing described. The "ground truth" for these tests would be objective measurements of physical and performance parameters (e.g., measuring diameter, resolution charts, light meters, suction flow rates).
4. Adjudication Method
- Not applicable. There's no subjective interpretation or annotation process requiring adjudication for this type of device and testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC study was not conducted. This type of study is relevant for AI/ML-assisted diagnostic tools where human reader performance is being evaluated with and without AI assistance. This document describes a medical device (bronchoscope hardware) and its performance validation through bench testing, not an AI algorithm.
6. Standalone Performance (Algorithm Only)
- Not applicable. There is no AI algorithm being evaluated for standalone performance. The document describes the performance of a physical device system (bronchoscope and monitor).
7. Type of Ground Truth Used
- The "ground truth" for the performance tests described (e.g., field of view, resolution, suction rate) is based on objective physical measurements and engineering specifications obtained through bench testing, often against industry standards (e.g., ISO 8600 series). It is not clinical "expert consensus, pathology, or outcomes data."
8. Sample Size for Training Set
- Not applicable. This document does not describe the development or training of an AI/ML model, so there is no "training set."
9. How Ground Truth for Training Set Was Established
- Not applicable. As there is no AI/ML model, there is no training set and no associated ground truth establishment process in the context of medical image analysis.
§ 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.