(309 days)
Peregrine Endoscopy System is intended to visualize the internal cavities of the ear, airways, nose and sinus cavities during diagnostic and therapeutic endoscope procedures.
The Peregrine Endoscopy System is a single-use flexible ENT (ear, nose & throat) endoscope (provided sterile) which allows the user to steer through the anatomy and visualize it. The device is used in patients in whom endoscopic evaluation of, or intervention in, the ear, airways, nose, and sinus cavities is indicated.
The modified Peregrine endoscopy system consists of:
- A Single-use Endoscope - includes a distal CMOS imager, an illumination source, and a working channel which enables irrigation and suction. The endoscope is provided sterile. The multi-use handle and the endoscope attachment cable, which were separate components in the cleared 3NT Endoscopy System, are now an integral part of the single-use endoscope, thus eliminating all multi-use components from the system.
- A Video Console (formerly named Camera Control Unit, or CCU) which includes a video board and a tablet-based display, connects to the endoscope through the endoscope cable to receive video images from the endoscope and display them.
Based on the provided text, the Peregrine Endoscopy System is a medical device, and the document is a 510(k) summary for its premarket notification to the FDA. This document does not describe an AI medical device or a study involving AI assistance for human readers.
Therefore, many of the requested points, such as sample sizes for test/training sets, blinding, adjudication methods, number of experts for ground truth, MRMC studies, standalone AI performance, and AI-specific ground truth establishment, are not applicable to this document. The document describes a traditional medical device (an endoscope system) and its performance against acceptance criteria largely focused on safety, electrical compatibility, software validation, and bench testing.
Here's an analysis based on the information available in the document:
1. A table of acceptance criteria and the reported device performance
The document provides a table summarizing bench testing, but it doesn't explicitly list specific quantitative acceptance criteria alongside the numeric results for all tests. Instead, it generally states "The tests passed and all acceptance criteria were met" or "substantial equivalence is determined."
| Test Category | Reported Device Performance and Substantial Equivalence Discussion |
|---|---|
| Biocompatibility Testing | • Conducted per ISO 10993-1:2018 and FDA guidance. |
| • Tests included: Cytotoxicity, Sensitization, Irritation, Acute systemic toxicity. | |
| • Result: Complies with same biocompatibility requirements as predicate device, hence substantial equivalence determined. | |
| Electrical Safety and Electromagnetic Compatibility (EMC) | • Electrical safety: Passed IEC 60601-1:2012 and IEC 60601-2-18:2009. |
| • EMC: Tested per IEC 60601-1-2:2014. | |
| • Result: Complies with same electrical safety and EMC requirements as predicate device, hence substantial equivalence determined. | |
| Software Verification and Validation | • Conducted per IEC 62304:2006 and FDA guidance for software in medical devices. |
| • Level of Concern: Moderate (same as predicate device). | |
| • Result: Software validated following same standard requirements and FDA guidelines, hence substantial equivalence demonstrated. | |
| Bench Testing | |
| • Peregrine Scope Functionality and Simulated use, 3NT Console: Passed all functionality and simulated use tests. All acceptance criteria were met. | |
| • Functionality and dimensions verification: Verified same indications for use as predicate. Substantial equivalence demonstrated. | |
| • Photobiological safety: Based on IEC 62471:2006. Assigned Exempt Group classification under clinically realistic worst-case conditions. | |
| • Display Color Gamut Measurement: Provides good coverage of sRGB (99.7%) and AdobeRGB (91.7%) color spaces. | |
| • Peregrine Scope Visual and Dimensions: Passed all visual and dimensions inspections. All acceptance criteria were met. | |
| • Peregrine Scope Mechanical Properties Verification: Tests passed and all acceptance criteria were met. | |
| • Peregrine Scope System Image Quality Performance: Image is accurate, well reflects observed items in terms of color accuracy. Tests passed and all acceptance criteria were met. Image quality found to be superior to predicate device. | |
| • Peregrine Scope Optical performance and MTF: Tests passed and all acceptance criteria were met. Optical performance found to be equal or better than predicate device. | |
| • Geometric distortion: Measured, met predefined criteria. | |
| • Peregrine Scope Labeling Verification and 3NT Console label verification: Labels and IFU include all required information and risk mitigations. | |
| • Transportation and Shelf life: Test passed and all acceptance criteria were met. |
2. Sample sized used for the test set and the data provenance
- Sample Size: Not specified in terms of patient data. For bench testing, it refers to the number of devices or components tested. The document does not provide raw numbers but implies enough for a statistically sound conclusion for the type of testing performed (e.g., "The Peregrine Endoscopy System passed all the functionality and simulated use tests.").
- Data Provenance: The tests are "bench tests," meaning they were conducted in a controlled lab environment on the device itself, not on patient data. The company is based in Israel (3NT Medical Ltd., Rosh Ha'ayin, Israel).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable as the document describes performance data for a medical device (endoscopy system), not an AI algorithm. Ground truth, in the context of diagnostic AI, refers to confirmed disease status, which isn't relevant here. The "ground truth" for this device's performance is established by objective engineering and safety standards (e.g., passing electrical safety tests, meeting specified dimensions, or achieving certain image quality parameters).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This relates to human expert consensus for diagnostic tasks, which is not relevant to the acceptance criteria for an endoscope system.
5. 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
- No. This document does not mention an MRMC study or any study involving human readers or AI assistance. The device is an endoscope system, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a physical endoscope system, not a standalone AI algorithm. While it has software, its "performance" is tied to its function as a visualization tool, not independent algorithmic interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's acceptance is based on compliance with established international and national standards (e.g., ISO, IEC, FDA guidelines) for medical device performance, safety, and functionality, as verified through bench testing. For example:
- Biocompatibility: Conformance to ISO 10993-1.
- Electrical Safety: Conformance to IEC 60601-1, IEC 60601-2-18.
- EMC: Conformance to IEC 60601-1-2.
- Software V&V: Conformance to IEC 62304.
- Physical/Optical Properties: Meeting predefined engineering specifications and visual/dimensional inspections.
- Image Quality: Objective measurements like sRGB/AdobeRGB coverage, MTF, and color accuracy, likely against defined benchmarks for endoscopic visualization.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a training set. The software mentioned underwent verification and validation, but this refers to traditional software engineering V&V, not machine learning model training.
9. How the ground truth for the training set was established
- Not applicable, as there is no mention of a training set for an AI/ML model in this document.
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.