(59 days)
The Olympus Integrated Endosurgery System EndoALPHA (Control Unit for Endosurgery UCES-2) has been designed to be used with an Olympus endoscope and ancillary equipment for central operation, central display, automatic initial setting, and interlocking operation of the ancillary equipment.
The Olympus Integrated Endosurgery System EndoALPHA (Control Unit for Endosurgery UCES-2) is the remote control unit of legally marketed ancillary equipment. The new clinical functions are not added to the ancillary equipment by the subject device. The subject device enables the remote control of the ancillary equipment, the display of their active states and the memory of the previous set-up values. The remote control is achieved by a touch-panel monitor, remote controller, and voice control. The voice control function enables the subject device to control the ancillary equipment by voice. The subject device does not come in contact with patients and is not subject to sterilization.
The Olympus Integrated Endosurgery System EndoALPHA (Control Unit for Endosurgery UCES-2) Software Version 3 did not conduct a study with specific performance metrics such as sensitivity, specificity, or AUC against a ground truth. Instead, the device's modifications were verified against established in-house acceptance criteria based on ISO 14971:2000 through design verification tests.
Here is the information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Modification | Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Operating function for additional ancillary equipment | 1. Nurse's control panel operation test: Confirmed whether the Nurse's control panel operation is performed correctly. |
- Surgeon's controller operation test: Confirmed whether the Surgeon's controller operation is performed correctly.
- Voice operation test: Confirmed whether the voice operation is performed correctly. | 1. All the operations that are in specification operate.
- All the operations that are in specification operate.
- All the operations that are in specification operate. | The document implies that these tests were performed and passed, meeting the acceptance criteria, as the device was deemed substantially equivalent. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a "test set" in the traditional sense of a dataset for evaluating AI performance. The tests described are functional verification tests of the device's operational capabilities. Therefore, there is no information on sample size or data provenance as it pertains to clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable. The tests performed are functional verification tests related to the device's operation, not clinical performance requiring expert ground truth in the context of diagnostic accuracy.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set requiring adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The device is a control unit for endosurgery, and the modifications involved adding operating functions for new ancillary equipment and different input methods (wireless microphone, larger touch panel). The studies were functional verification tests.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
The device itself is a control unit that facilitates human interaction with other ancillary equipment. Its "performance" is inherently linked to its ability to control these devices. The tests performed are functional verification tests of these control capabilities, not an algorithm performing a task independently. Therefore, the concept of a "standalone" algorithm-only performance study as typically understood for AI/ML devices is not applicable here.
7. The Type of Ground Truth Used:
The "ground truth" for the functional verification tests was the device specification itself. The tests confirmed whether the operations performed by the device (nurse's control panel, surgeon's controller, voice operation) operated as specified.
8. The Sample Size for the Training Set:
Not applicable. The device is not described as an AI/ML device in the context of learning from a training set of data. The modifications are related to integrating new hardware and input methods.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no mention of a training set or an AI/ML component that requires establishing ground truth for training.
§ 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.