(252 days)
The Modular Endoscope is intended for use for visualization and to magnify and illuminate body cavities, hollow organs and canals in ENT procedures. The Modular Endoscope is intended for use for visualization and to magnify and illuminate dental surfaces. The Modular Endoscope is intended for using additional accessories to perform various diagnostic and therapeutic procedures in ENT surgery, including but not limited to, salivary gland diseases.
The Modular Endoscope utilizes a fiberoptic technology to allow visualization of body cavities. The 6000/10,000 pixel optic system is semi rigid and is contained within a very small diameter of less than 1mm. The endoscope contains a working channel to allow access of various accessories for different therapeutic applications.
The Modular Endoscope is used with single use, multi port (2 or 3 port), sterile cannulas with diameters ranging from 0.9-2.3 mm, which provide the surgeon good flexibility in choosing the right equipment for the clinical procedure.
The single lumen cannula is inserted into the salivary gland or other body cavities or canals and serves as a working and irrigation channel, as well as containing the fiberoptic system. The fiberoptic system is protected from surgical tools and instruments by a nitinol coating.
An ocular is connected at the proximal end and light is transmitted via a light source cable from various commercially available Xenon lamp light sources to the optic system. The image can be visualized by connecting the endoscope to a camera and a monitor screen. The light source, camera and monitor are user-supplied.
The provided text describes the Sialo Technologies Ltd. Modular Endoscope and its 510(k) submission (K093785). The document primarily focuses on demonstrating substantial equivalence to predicate devices and lists various performance standards the device complies with. However, it does not contain explicit acceptance criteria or a detailed study description of how the device meets specific performance metrics beyond compliance with general standards.
Therefore, I cannot fully complete the requested table and answer all questions based solely on the provided text. I will, however, extract all relevant information to the best of my ability and indicate where information is missing.
Here's the breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance (as stated in document) |
|---|---|
| Electrical & Mechanical Safety (IEC 60601-1 & IEC 60601-2-18) | Complies |
| Electromagnetic Compatibility (IEC 60601-1-2) | Complies |
| Optic system (ISO 8600 Parts 1, 3, 4, and 5) | Complies |
| Cleaning (AAMI TIR30:2003) | Complies |
| Sterilization (Ethylene oxide - ISO 11135-1:2007) | Complies |
| Biological evaluation (Ethylene oxide residuals - ISO 10993-7:2008) | Complies |
| Sterilizing agent/process development/validation (ISO 14937:2000) | Complies |
| Reprocessing reusable devices (AAMI TIR12:2004) | Complies |
| Moist heat sterilization (ANSI/AAMI/ISO 17665-1:2006) | Complies |
| Steam sterilization & sterility assurance (ANSI/AAMI ST79:2006) | Complies |
| Containment devices for sterilization (AAMI/ANSI ST77:2006) | Complies |
| Resolution and Distortion | Tested (results not detailed beyond "tested for performance") |
Missing Information:
- Specific numerical acceptance criteria for "Resolution and Distortion testing" are not provided.
- The actual results of the "Resolution and Distortion testing" are not detailed beyond the statement that it was performed.
2. Sample Size Used for the Test Set and Data Provenance
The document states: "The Modular Endoscope has been tested for performance as follows: - Resolution and Distortion testing" and "Although clinical data is not required to support the substantial equivalence of the Sialo Modular Endoscope, information regarding the use of the device for dental surfaces is presented in Section 20."
- Sample Size for Test Set: Not specified for non-clinical testing. Clinical data was deemed not required, and no specific test set sample size for "Resolution and Distortion" is provided.
- Data Provenance: Not specified. It's non-clinical performance data, so country of origin isn't directly applicable in the same way as clinical data. The testing would have been conducted by the manufacturer, Sialo Technologies Ltd. (Israel).
- Retrospective/Prospective: Not applicable, as no clinical data is primarily presented for substantial equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable, as detailed clinical data requiring expert ground truth is not the primary basis for the 510(k) clearance in this document. The "Resolution and Distortion" testing likely involved objective measurements rather than expert consensus on images.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable, as there is no mention of a human-reviewed test set or a need for adjudication for the performance testing described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: No, the document explicitly states: "Although clinical data is not required to support the substantial equivalence of the Sialo Modular Endoscope..." Therefore, an MRMC comparative effectiveness study was not conducted or presented for the 510(k) submission.
- Effect Size: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This device is an endoscope, a hardware device for visualization, not an algorithm. Its performance is inherent in its optical and mechanical characteristics, not an AI algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the "Resolution and Distortion testing," the ground truth would typically be established based on standardized test patterns and objective measurements, not pathology, outcomes data, or expert consensus in the clinical sense. For compliance with standards, the ground truth is the adherence to the requirements outlined in those specific standards.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The device is a hardware endoscope, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not applicable, as there is no training set for an AI model.
Summary of what's missing and why:
The provided document is a 510(k) summary for a physical medical device (an endoscope). While it details compliance with various engineering and safety standards, it does not involve artificial intelligence, machine learning, or extensive clinical trials with human readers. Therefore, many of the questions related to AI performance, expert ground truth, sample sizes for test/training sets, MRMC studies, and adjudication methods are not applicable to this specific device as described in this regulatory submission. The primary "proof" that this device meets acceptance criteria is its stated compliance with established voluntary standards and the performance testing of resolution and distortion.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.