(91 days)
The Endosee System is used to permit viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic procedures. Generally recognized indications for diagnostic hysteroscopy include:
- Abnormal bleeding
- Infertility and pregnancy wastage
- Evaluation of abnormal hysterosalpingogram
- Intrauterine foreign body
- Amenorrhea
- Pelvic pain
The Endosee System can also be used to permit viewing of the adult urinary bladder through a minimally invasive approach by utilizing natural orifices for the purpose of performing diagnostic procedures.
The Endosee System is a handheld, battery-operated, portable endoscope that consists of a reusable display module with an LCD touchscreen monitor and a sterile, single-use cannula. It is intended for use in viewing the adult cervical canal, uterine cavity, or female urinary tract, including the bladder, to perform diagnostic hysteroscopy or cystoscopy procedures in an operating room, outpatient, or office setting. The cannula has a light source and camera at the distal end, which are used for visualization and to capture image and video of the diagnostic area. The image and video signals are electronically transferred from the cannula to the display module via an electrical connector and cable, and the LCD monitor is used for viewing. The Endosee is provided with a docking station that recharges the battery in the display module and allows the user to download images/video from the internal device memory to an external computer.
The provided text describes the Endosee® System, a medical device used for diagnostic hysteroscopy and cystoscopy. The document, an FDA 510(k) summary, focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria for performance, a standalone study, or an MRMC study related to AI.
Therefore, many of the requested details about acceptance criteria, study design, and ground truth are not present in the provided text. The document primarily reports on non-clinical performance testing conducted to ensure safety and equivalence.
Here's a breakdown of the information that can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document doesn't provide a table of acceptance criteria with corresponding performance metrics for diagnostic accuracy or clinical effectiveness. Instead, it lists various non-clinical engineering and safety tests performed. While these tests have internal acceptance criteria, they are not typically clinical performance metrics. The closest general "performance" reported are the specifications that match the predicate device, such as Field of View and Direction of View, which are design specifications rather than clinical performance outcomes.
| Test Category | Specific Test (with implicit acceptance criteria of meeting standards) | Reported Device Performance |
|---|---|---|
| Sterility | Sterility Testing per ISO 11135-1:2014, EO Residuals per ISO 10993-7:2008, Bioburden per ISO 11737-1:2006 & 11737-2:2009 | Not explicitly stated as pass/fail in detail, but the overall conclusion of substantial equivalence implies these tests were met. |
| Biocompatibility | Cytotoxicity per ISO 10993-5:2009, Sensitization per ISO 10993-10:2010, Irritation per ISO 10993-10:2010 | Not explicitly stated as pass/fail in detail, but the overall conclusion of substantial equivalence implies these tests were met. |
| Shelf Life | Aged to 6-months per ASTM F1980-16. Tested for Seal Tensile Strength, Seal Peel, Functional (Image Quality, Flow Rate, Leak, Bend), and Bubble Leak per ASTM 2096-11 on aged samples. | Cannula Shelf-Life: 6 months (This implies acceptance criteria related to maintaining functionality and integrity for 6 months). For the aged samples, the functional tests (Image Quality, Flow Rate, Leak, Bend) were performed. |
| Functional Testing | Image Quality Test (Including Resolution), Optical Distortion Test, Saline Flow Rate Test, Leak Test, 90° Bend Test, 3-Point Bend Test, LED Temperature Test, Drop Test per IEC 60601-1-15, IPX2 Ingress Test per IEC 60529:2004, System Level Verification | Not explicitly stated as pass/fail in detail, but the overall conclusion of substantial equivalence implies these tests were met. For basic specifications, the device's Field of View is $100° ± 5°$ and Direction of View is $20° ± 3°$, matching the predicate. |
| Electrical Standards | UL Electrical Safety per ANSI/AAMI ES 60601-1:2005/(R)2012 and IEC 60601-2-18:2009, UL EMC per IEC 60601-1-2:2014 and IEC 60601-2-18:2009 | Not explicitly stated as pass/fail in detail, but the overall conclusion of substantial equivalence implies these tests were met. |
| Software | Software Verification per IEC 62304:2006 and FDA guidance | Information provided as recommended in FDA guidance. |
| Cybersecurity/Wireless | Cybersecurity/Intraoperability Information, Wireless information provided as recommended in FDA guidance | Information provided as recommended in FDA guidance. |
| Design Validation | Performed (no specific criteria or results detailed) | Not detailed. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a clinical test set or data provenance in terms of patient data. The "test set" refers to physical samples of the device components (cannulas, display modules) subjected to various engineering and safety tests. For example, for shelf-life testing, samples were "Aged to 6-months" but the number of samples is not specified. There is no information about country of origin for any clinical data as none was presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to the provided document. The "ground truth" in this context would typically refer to diagnostic accuracy established by expert clinicians (e.g., confirming the presence or absence of abnormalities in patient images). The provided document focuses on engineering and safety testing, not clinical diagnostic performance, and thus does not involve human experts establishing a clinical ground truth for a diagnostic test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are used in clinical studies to resolve discrepancies among expert interpretations. The tests described are engineering and safety tests, which do not involve expert adjudication in this manner.
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
There is no mention of an MRMC comparative effectiveness study, nor is there any indication that the Endosee System incorporates AI or is intended for AI-assisted interpretation. The device is a direct visualization tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The Endosee System is a hardware device for direct visualization; it does not feature an algorithm that would operate in a "standalone" mode for diagnostic interpretation.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. As noted above, since no clinical performance study focused on diagnostic accuracy is described, there's no mention of how clinical ground truth would be established. The "ground truth" for the engineering tests would be adherence to the specified technical standards and design requirements.
8. The sample size for the training set
Not applicable. The document does not describe any machine learning or algorithm development that would involve a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set described.
§ 884.1690 Hysteroscope and accessories.
(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.