(134 days)
The Precision S 4K Sinuscope is intended for use in otolaryngology and Head and Neck procedures, including thinology, and endoscopic plastic and reconstructive surgery.
Stryker's Precision S 4K Sinuscopes are tubular optical instruments used to provide a view of internal patient anatomy for examination, diagnosis, and therapy during otorhinolaryngology procedures. The devices are available in a variety of outer diameters and working lengths.
The sinuscopes are reusable devices initially supplied as non-sterile to the user and requiring the user to process (i.e. clean and sterilize) the device for initial use, as well as to reprocess the device after each use. The sinuscope connects to the camera system through a separate coupler. The coupler is provided by the camera system and is not subject of this premarket notification.
The sinuscopes achieve their intended use by guiding light to illuminate and image a patient's internal anatomy, then relaying the image out of the surgical site for processing and display by a separate camera system. The sinuscope's optical system consists of a series of lenses, which includes an objective lens to image the intended object, a relay rod lens system to transmit the image along the working length, and an ocular lens to form the final image size.
Based on the provided text, the device in question is the Stryker Precision S 4K Sinuscope. The document describes its intended use, technological characteristics, and various performance tests conducted for its 510(k) submission to the FDA.
However, the document does not describe acceptance criteria and associated study details in the manner requested for an AI/device performance study. This document is a 510(k) summary for a medical device that is a sinuscope (a rigid optical instrument), not an AI/software device. The performance testing listed (Biocompatibility, Cleaning, Sterilization, Electrical Safety, Optical Performance, etc.) are standard tests for a physical medical device, demonstrating its safety and effectiveness for its intended use, and not evaluation of an algorithm's diagnostic performance against a ground truth.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets those criteria in the context of AI/algorithm performance. The document describes the device as a physical instrument that helps human practitioners visualize internal anatomy, rather than an AI system providing diagnostic outputs.
Here's why the provided text doesn't contain the information you're looking for, followed by what can be extracted:
- No AI/Algorithm: The "Precision S 4K Sinuscope" is described as a "tubular optical instrument" with "rigid rod lenses" that "relays the image out of the surgical site for processing and display by a separate camera system." This clearly indicates it's a hardware device for viewing, not an AI or software that analyzes images/data or makes diagnostic recommendations.
- No Diagnostic Performance Claims: The document focuses on the physical and functional aspects of the sinuscope itself (e.g., optical properties, reusability, sterilization, biocompatibility). There are no claims about its ability to detect or diagnose any conditions, which would necessitate performance metrics like sensitivity, specificity, or AUC, and thus, ground truth, expert readers, etc.
What information can be extracted relevant to the physical device's "performance" criteria (though not for an AI study):
The document lists various performance tests carried out and their results, which for a physical device serve as a form of "acceptance criteria" demonstrating its safety and functionality.
1. Table of "Acceptance Criteria" (as Performance Tests) and Reported Device Performance
| Acceptance Criteria Category (Test Category) | Reported Device Performance (Result) |
|---|---|
| Biocompatibility | Pass |
| Cleaning | Pass |
| Disinfection | Pass |
| Sterilization | Pass |
| Electrical Safety & Temperature Testing | Pass |
| Packaging Qualification | Pass |
| Optical Performance | Pass |
| Design Validation (Human Factors) | Pass |
| Performance - Bench (Device Specifications) | Pass |
2. Sample Size for Test Set and Data Provenance:
This concept is not applicable here as it's a physical device, not an AI algorithm evaluated on a data set. The "tests" performed are on the device itself (e.g., how well it can be cleaned, how durable it is, its optical clarity). The document does not specify a "sample size" for these physical tests in terms of number of manufactured units, nor does it refer to "data provenance" as one would for a medical image dataset.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable. Ground truth for an AI algorithm is established by experts labeling data. For a physical medical device like a sinuscope, "ground truth" relates to measurable physical properties or successful execution of reprocessing protocols, not diagnostic accuracy.
4. Adjudication Method for Test Set:
Not applicable. This is relevant for resolving discrepancies in labels in AI datasets.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This type of study measures human reader performance with/without AI assistance. The device is a viewing instrument, not an AI.
6. Standalone (Algorithm Only) Performance:
Not applicable. This applies to AI algorithms.
7. Type of Ground Truth Used:
Not applicable in the context of AI. For this physical device, "ground truth" implicitly refers to established scientific and engineering standards (e.g., ISO for biocompatibility and sterilization, IEC for electrical safety), against which the device must demonstrate compliance.
8. Sample Size for Training Set & 9. How Ground Truth for Training Set was Established:
Not applicable. This is for AI/machine learning models. The manufacturing process of a physical device does not involve a "training set" in this sense.
In summary, the provided document describes the regulatory clearance of a physical medical device (a sinuscope), not an AI-powered diagnostic or assistive tool. Therefore, the requirements for describing an AI study's acceptance criteria and proven performance cannot be fulfilled from this text.
§ 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.