(27 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, interfocking operation of the ancillary equipment.
The "OLYMPUS INTEGRATED ENDOSURGERY SYSTEM EndoALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) Software Version 2" has been designed to be used with an Olympus endoscope and ancillary equipment for central operation, central display, automatic initial setting, interlocking operation of the ancillary equipment.
Addition of the operating function for ancillary equipment (UES-40, OTV-SP1C, LUS-2, DSR-45, UPA-P100MD and SonoSuro-IU) enables the following:
- The operating function for ancillary equipment operates the additional ancillary equipment (UES-40, OTV-SP1C, LUS-2, DSR-45, UPA-P100MD and SonoSurg-IU) by Nurse's control panel and voice control.
The voice control function enables the subject device to control the ancillary equipment by voice. You will find the details for voice commands and voice controllable equipment in "Standard set and ancillary equipment" and "Operation by voice control" in G. Device Description and Comparison.
The intended use of the EndoALPHA is to enable a central system to control various pieces of ancillary equipment. However, the approved indications for use for each separate ancillary device dictate the type of procedures that may be performed. This information is included in the instruction manual for each anciliary piece of equipment.
Here's an analysis of the provided text regarding the acceptance criteria and study for the OLYMPUS INTEGRATED ENDOSURGERY SYSTEM EndoALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) Software Version 2:
1. Table of Acceptance Criteria and Reported Device Performance:
| Modification | Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Voice operation function for additional ancillary equipment | 1. Voice recognition test (Confirmed whether voice recognition is performed correctly by some sample voice data) | 1. Recognize all words that are in specifications. | The document states, "The design verifications that were performed as a result of this risk analysis assessment are listed below." It then presents this table, implying that the tests were performed and the acceptance criteria were met. For the voice recognition test, the implicit reported performance is that the device did recognize all words in specifications with the sample voice data. Without explicit pass/fail statements, this is inferred from the presentation of the table as evidence of successful verification. |
| 2. Wrong recognition test (Confirmed whether EndoALPHA doesn't work by some noise in operation room) | 2. Never do wrong recognition. | Implicitly, the device did not perform wrong recognition with noise in the operation room. | |
| Operating function for additional ancillary equipment | 1. Nurse's control panel operation test (Confirmed whether the Nurse's control panel operation is performed correctly) | 1. All the operations that are in specification operate. | Implicitly, all operations specified for the Nurse's control panel did operate correctly. |
| 2. Surgeon's controller operation test (Confirmed whether the Nurse's control panel operation is performed correctly) | 2. All the operations that are in specification operate. | Implicitly, all operations specified for the Surgeon's controller did operate correctly. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size:
- For the voice recognition test: "some sample voice data." The exact number or duration of samples is not specified.
- For the wrong recognition test: "some noise in operation room." The exact number or types of noise samples are not specified.
- For the operating function tests (Nurse's control panel and Surgeon's controller): Not specified, though the phrasing "whether the... operation is performed correctly" implies testing of the various operations.
- Data Provenance: Not specified. It's likely an in-house test ("established in-house acceptance criteria") performed by the manufacturer, but the country of origin of the data is not mentioned. The study appears to be retrospective due to the focus on verification of developed features rather than prospective observation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not specified. The document does not mention the use of external experts or their qualifications for establishing ground truth for these performance tests. The ground truth for these functional tests would inherently be the correct operation and recognition as defined by the device's specifications.
4. Adjudication Method for the Test Set:
- Not applicable/Not specified. The tests described are functional verification tests ("Voice recognition test", "Wrong recognition test", "Nurse's control panel operation test", "Surgeon's controller operation test") rather than diagnostic or interpretative tests requiring adjudication of results between experts. The "ground truth" for these tests is the expected functional behavior based on specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a MRMC comparative effectiveness study was not done. The document describes functional verification tests for software and system operation, not a study involving human readers or cases to assess diagnostic performance or comparative effectiveness.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, in essence, standalone performance was evaluated. The "Voice recognition test" and "Wrong recognition test", as well as the "Operating function" tests, are evaluations of the system's performance (the algorithm/software) independent of continuous human intervention beyond initial commands or control inputs. The performance of the voice recognition and system functions is described as being directly from the device's actions.
7. Type of Ground Truth Used:
- Functional Specification/Expected Behavior. For the voice recognition and operation tests, the ground truth is implicitly defined by the device's design specifications and expected correct behavior as implemented by the manufacturer. For example, for the voice recognition test, the ground truth is simply whether the device correctly recognizes the specified words. For the wrong recognition test, the ground truth is that the device should not recognize noise as a command.
8. Sample Size for the Training Set:
- Training set information is not provided. The document describes verification tests for an existing software version and its new features. It does not mention the machine learning component (if any) or training data used in the development of the voice recognition capability.
9. How the Ground Truth for the Training Set Was Established:
- Not specified. As the training set size and details are not provided, how its ground truth was established is also not mentioned.
§ 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.