(148 days)
The Galaxy System and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
The Galaxy System is designed with the intent to enable articulation and precise control of a flexible, single-use disposable bronchoscope under continuous and direct control by a physician operator. The Galaxy System™ includes full procedure navigation that integrates a pre-operative computed tomography scan to display scope tip location relative to the pre-operative scan anatomy. Additionally, Galaxy integrates a tomosynthesis spin to update the scope and target position to overcome any changes in anatomy not reflected in the pre-op CT scan.
The provided document focuses on the substantial equivalence of the Noah Medical Galaxy System to a predicate device (Monarch Endoscopy Platform) and a reference device (superDimension Navigation System). It details various performance tests conducted to support this claim, but it does not explicitly define specific acceptance criteria with numerical thresholds for device performance, nor does it present a study that reports numerical device performance against such criteria.
Instead, the document broadly states that the device has been "successfully tested" and "meets the intended user needs". It also mentions a simulated use study where users were able to "navigate to within 30 mm of the lesion, complete tomosynthesis, and acquire tissue". However, this is described as a capability demonstrated rather than a performance metric achieved against a pre-defined acceptance criterion.
Therefore, I cannot fully complete the table for acceptance criteria and reported device performance as requested, as these specific numerical values and direct comparisons are not present in the provided text.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
As stated above, no explicit numerical acceptance criteria or corresponding reported device performance metrics are provided in the document. The performance data section describes general testing and findings without quantifiable acceptance thresholds.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "human cadaver and animal models" for "Design Validation testing" and "Simulated Use" testing. It also refers to "representative users" for "Human Factor Usability Testing."
- Test Set Sample Size: Not explicitly stated as a number. The document refers to "human cadaver and animal models" and "representative users" without specifying the quantity.
- Data Provenance: The testing was performed by Noah Medical, implying it's internal study data. The document does not specify the country of origin of the cadavers or animals, nor does it explicitly state whether the study was retrospective or prospective, though design validation and usability testing are typically prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not describe a process for establishing ground truth for a test set through expert consensus in the context of clinical performance evaluation against a specific gold standard. The focus of the performance testing described is on functional verification, safety, and usability.
- For the simulated use, "The user group included physicians who have been trained and are actively using the predicate and reference devices." The number of these physicians is not specified, and their specific role in establishing "ground truth" (as opposed to being subjects performing tasks) is not detailed.
- Qualifications of these physicians are generally described as "trained and actively using the predicate and reference devices," suggesting experience with similar bronchoscopic navigation systems.
4. Adjudication Method for the Test Set
No adjudication method is described, as the testing focuses on functional and usability aspects rather than diagnostic or clinical accuracy requiring expert review and adjudication of findings.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a MRMC comparative effectiveness study or any effect size of human readers improving with AI vs. without AI assistance. The performance data focuses on the device's functionality, safety, and usability, demonstrating substantial equivalence to predicate devices, not on the comparative effectiveness of AI-assisted vs. unassisted human performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The document does not explicitly describe a standalone algorithm performance study. The Galaxy System's navigation component is integrated and described as used by physicians: "The Galaxy System enables a physician to utilize electro-mechanical articulation for precise control... By utilizing electromagnetic field-based sensors on the tip of the endoscope tip location relative to the pre-operative scan anatomy is continuously displayed." The software verification and validation section confirms that "Galaxy System software conforms to the design specifications and meets the intended use and needs of the intended users," but this is about software correctness rather than a standalone performance metric against a clinical ground truth.
7. Type of Ground Truth Used
For the simulated use testing, the "ground truth" for navigation was implicitly the ability to "successfully navigate to a peripheral lung lesion" and reach "within 30 mm of the lesion." This appears to be based on an expected outcome in the cadaver/animal models, rather than a clinical ground truth like pathology or outcomes data.
8. Sample Size for the Training Set
The document does not provide any information regarding a training set sample size. This suggests the described performance testing is for validation, not for the training of a machine learning model, or if there was training, its details are not included in this summary.
9. How the Ground Truth for the Training Set Was Established
As no information about a training set is provided, how its ground truth was established is also not available in this document.
§ 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.