(144 days)
SYSTEMS INTEGRATION ENDOALPHA (MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-3) Software Version 2
The Systems Integration ENDOALPHA 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.
UPGRADE KIT FOR UCES-3 (Version 2) MAJ-1943
This equipment has been designed to install software on the ENDOALPHA UCES-3, MAJ-1831, MAJ-1832, MAJ-1834, and MAJ-1862.
The Systems Integration ENDOALPHA has been designed to be used with an Olymous endoscope and ancillary equipment for central operation, central display, automatic initial setting, and interlocking operation of the ancillary equipment.
The ENDOALPHA integrated electrosurgical system has the following system functions.
- Centralized control from a non-sterilized area
- Centralized control from a sterilized area
- Centralized display
- Message display
- Voice reply
- Automatic settings
- Scene settings
- Display customization
- Still image viewing
- Automatic smoke evacuation
The Olympus Medical Systems Corp. 510(k) summary for the SYSTEMS INTEGRATION ENDOALPHA (MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-3) Software Version 2 describes design verification and software validation activities rather than a clinical study with human subjects. The device is a system for central operation, display, and control of ancillary endosurgery equipment, performing functions like centralized control, display customization, and automatic settings, with software modifications including additional compatible devices, improved interfacing, increased surgical light capacity, reduced startup time, and an additional language setting.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests / Criteria | Reported Device Performance |
|---|---|---|
| Risk Analysis | Based on ISO 14971:2007 (established in-house acceptance criteria). | Design verification tests performed as a result of risk analysis assessment. |
| Design Verification (Hardware & Integration) | Operation/verification testing for improved interfacing between UCES-3 and the Advanced System. | Implied successful, as the summary states the modifications are "minor and substantially equivalent" and have "similar technological characteristics" and "performance." No specific performance metrics or pass/fail rates are provided beyond the statement that tests were performed. |
| Operation/verification testing for new compatible ancillary equipment. | Implied successful. | |
| Operation/verification testing for the increase in the maximum number of connectable surgical lights. | Implied successful. | |
| Performance testing for the startup time of the UCES-3. | Implied successful, as reduced startup time is listed as a modification. | |
| Operation testing for additional language setting for text indications. | Implied successful. | |
| Software Validation (FDA Guidance) | Unit level testing (Module verification). | Implied successful. The software validation activities were performed in accordance with the FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." |
| Integration level testing (Task verification). | Implied successful. | |
| System level testing (System verification). | Implied successful. | |
| Simulated use testing (Validation). | Implied successful. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes software validation and design verification tests, not a clinical study involving human patients or a traditional "test set" of patient data. Therefore, information regarding human sample size or data provenance (country of origin, retrospective/prospective) is not applicable or provided. The "test set" in this context refers to the system itself, its components, and its software functions.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The "ground truth" for this type of device (an integration system for endosurgery equipment) is based on engineering specifications, functional requirements, and safety standards rather than expert clinical consensus on patient data.
4. Adjudication Method for the Test Set
Not applicable, as this was not a study involving human readers or interpretation of medical images. The acceptance of testing results for design verification and software validation would have been based on engineering and quality assurance protocols.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The device is a control system for endosurgery equipment, not a diagnostic or AI-assisted interpretation tool that would involve human readers or image analysis.
6. Standalone Performance Study
Yes, the testing described appears to be for the standalone system in a simulated environment. The "Operation/verification testing" and "Performance testing" for various aspects like interfacing, new equipment compatibility, surgical light capacity, startup time, and language settings, along with "Unit level testing," "Integration level testing," "System level testing," and "Simulated use testing" for software, all represent standalone performance evaluation of the device's functionality. This is "algorithm only without human-in-the-loop performance" in the sense that the system's functions are verified independently of live clinical use.
7. Type of Ground Truth Used
The ground truth used for this type of device is primarily based on:
- Engineering Specifications: Adherence to defined parameters for electrical, mechanical, and communication characteristics, as well as operational principles.
- Functional Requirements: Verification that the system performs its designed functions (e.g., centralized control, display, automatic settings, smoke evacuation) as intended.
- Safety Standards: Compliance with relevant medical device safety standards like ISO 14971:2007 for risk management.
- Software Design Documents: Verification against software requirements specifications and design documents.
8. Sample Size for the Training Set
Not applicable. This device is a control system, not an AI/ML algorithm that requires a "training set" of data in the typical sense (e.g., for image recognition or clinical prediction). The software developed for this system follows conventional software engineering principles rather than machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set for an AI/ML algorithm.
§ 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.