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510(k) Data Aggregation
(94 days)
VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V has been designed to be used with an Olympus video system center, light source, document, display monitor, and other ancillary equipment for endoscopic diagnosis within the uterus. Do not use the instrument for any purpose other than its intended use.
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis within the uterus.
The provided document does not describe an AI medical device. It is a 510(k) summary for a "VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V (HYF-V)", which is a hysterovideoscope for endoscopic diagnosis within the uterus.
The document discusses various non-clinical bench tests (e.g., thermal safety, photobiological safety, noise and dynamic range, composite durability, color performance, image intensity uniformity, resolution, direction of view, field of view), biocompatibility evaluation, sterilization/reprocessing validation, and electrical safety/EMC testing. It explicitly states that software verification and validation testing was not applicable and not performed because the HYF-V does not include any software.
Therefore, I cannot provide details on acceptance criteria and study proving device meets acceptance criteria for an AI device based on this document. The questions regarding sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types are not applicable to the information provided for this hysterovideoscope.
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(448 days)
The Saneso Colonoscope 360-A is intended for diagnostic visualization of the lower gastrointestinal tract (including the rectum, colon and cecum) and Saneso Colonoscope 360-A is not indicated for ileoscopy procedures. The system also provides access for therapeutic interventions using standard endoscopy tools. The Saneso system consists of Saneso Colonoscope 360-A, Saneso Processor-A and other ancillary equipment.
The Saneso Gastroscope 360-A is intended for diagnostic visualization of the upper gastrointestinal tract (including the esophagus, stomach and duodenum). The system also provides access for therapeutic interventions using standard endoscopy tools. The Saneso system consistroscope 360-A/Saneso Single Camera Gastroscope-A, Saneso Processor-A and other ancillary equipment.
The Saneso Single Camera Colonoscope-A is intended for diagnostic visualization of the lower gastrointestinal tract (including the rectum, colon and ileocecal valve). The system also provides access for therventions using standard endoscopy tools. The Saneso system consists of Saneso Colonoscope 360-A/Saneso Single Camera Colonoscope-A, Saneso Processor-A and other ancillary equipment.
The Saneso Single Camera Gastroscope-A is intended for diagnostic visualization of the upper gastrointestinal tract (including the esophagus, stomach and duodenum). The system also provides access for therapeutic interventions using standard endoscopy tools. The Saneso system consists of Saneso Gastroscope 360-A/Saneso Single Camera Gastroscope-A. Saneso Processor-A and other ancillary equipment.
The Saneso Colonoscope 360-A is an endoscopic platform for diagnostic visualization and therapeutic access to the lower gastrointestinal tract (including the anus, rectum, sigmoid colon, colon and cecum) and Saneso Colonoscope 360-A is not indicated for ileoscopy procedures. The system enables physicians to view a high resolution wide field of view of up to 360°. The system consists of Saneso camera heads, colonoscope, video system, light source and other ancillary equipment. The Saneso Colonoscope 360-A is a full circular view video colonoscope and features multiple viewing options: 5 camera 360-degree raw images, 5 camera-stitched 360-degree images, and forward only view modes. The selection is made through the video interface.
The Saneso Colonoscope 360-A must be used in conjunction with the Saneso Processor-A. The Saneso Processor-A system serves as a control platform for the Saneso Colonoscope 360-A. The processor box consists of the electronics and mechanics required to operate the endoscope. It is responsible for image processing, transferring video signals from the colonoscope, pneumatic control of various external accessories that interface with the system. The accessories include the foot pedal, which is used to control the tissue wash water, the mouse, and the keyboard which are used for interfacing with the software and changing settings as needed. There are two monitors which can be connected, i.e. the master monitor and the slave monitor. The master monitor can be used for viewing and interfacing with controls on the image processor and the slave monitor is used only for viewing purposes.
The device is equipped with five cameras in order to provide a maximum 360° field of view (FOV) with high resolution video using external monitors connected through display ports. Each camera has LED light sources enabling the user to visualize in white light and other user selectable spectrum with Select Band Imaging or Dual Band Imaging modes (applicable only with SBI/DBI). The system is configured to transfer data to an external HL7 compliant electronic health record system. The system can be controlled using a mouse and keyboard.
The Saneso Gastroscope 360-A is an endoscopic platform for diagnostic visualization and therapeutic access to the upper gastrointestinal tract (including the esophagus, stomach and duodenum). The system enables physicians to view a high resolution wide field of view of up to 360°. The system consists of Saneso camera heads, gastroscope, video system, light source and other ancillary equipment. The Saneso Gastroscope 360-A is a full circular view video gastroscope and features multiple viewing options: 5 camera 360-degree raw images, 5 camera-stitched 360-degree images and forward only view modes. The selection is made through the video interface.
The Saneso Gastroscope 360-A must be used in conjunction with the Saneso Processor-A. The Saneso Processor-A system serves as a control platform for the Saneso Gastroscope 360-A. The processor box consists of the electronics and mechanics required to operate the endoscope. It is responsible for image processing, transferring video signals from the gastroscope, pneumatic control, and control of various external accessories that interface with the system. The accessories include the foot pedal, which is used to control the tissue wash water, the mouse and the keyboard which are used for interfacing with the software and changing settings as needed. There are two monitors which can be connected, i.e. the master monitor and the slave monitor. The master monitor can be used for viewing and interfacing with controls on the image processor and the slave monitor is used only for viewing purposes.
The device is equipped with five cameras in order to provide a maximum 360° field of view (FOV) with high resolution video using external monitors connected through display ports. Each camera has LED light sources enabling the user to visualize in white light and other user selectable spectrum with select either single band imaging or dual band imaging modes (applicable only with SBI/DBI). The system is configured to transfer data to an external HL7 compliant electronic health record system. The data is transferred using Wi-Fi or Ethernet. The system can be controlled using a mouse and keyboard.
The Saneso Single Camera Colonoscope-A is an endoscopic platform that provides diagnostic visualization and therapeutic access to the lower gastrointestinal tract including the rectum, colon and ileocecal valve. The system employs Select Band Imaging mode. The Saneso Single Camera Colonoscope-A features a single camera at the distal end that offers a 140° Field of View. The distal end features the front camera. LED light assembly, instrument channel outlet, nozzle, tissue wash outlet.
The Saneso Single Camera Colonoscope-A comprises programmable control buttons, insertion tube, suction valve, air/water valve, instrument channel port, umbilical cord, connector, angulation knobs and the bending section.
The Saneso Single Camera Colonoscope-A must be used in conjunction with Saneso Processor-A. The Saneso Processor-A is preinstalled with the Saneso Image Processing software and serves as a control platform for the Saneso Single Camera Colonoscope-A. The Saneso Processor processes the image and relays the video signals from the colonoscope to external display monitors. The Saneso Processor also offers pneumatic/water controls and interfaces for insufflation, tissue irrigation and camera lens wash. The Saneso processor also controls various external accessories that interface with the system. The software is operated via a mouse and keyboard. Two monitors are connected to the system i.e a master monitor and slave monitor. The master monitor can be used for viewing and interfacing with controls on the image processor and the slave monitor is used only for viewing purposes.
The Saneso Single Camera Gastroscope-A is an endoscopic platform that provides diagnostic visualization and therapeutic access to the upper Gastrointestinal (G.I) tract including the esophagus, stomach and duodenum. The system employs Select Band Imaging mode. The Saneso Single Camera Gastroscope-A consists of the Saneso Single Camera Gastroscope-A which is used in conjunction with the Saneso Processor-A and other ancillary equipment. The gastroscope features a single camera at the distal end that offers a 140° Field of View. The distal end features the front camera, LED light assembly, instrument channel outlet, nozzle, tissue wash outlet.
The Saneso Single Camera Gastroscope-A comprises programmable control buttons, insertion tube, suction valve, air/water valve, instrument channel port, umbilical cord, connector, angulation knobs and the bending section.
The Saneso Single Camera Gastroscope-A must be used in conjunction with Saneso Processor-A. The Saneso Processor-A is preinstalled with the Saneso Image Processing Software and serves as a control platform for the Saneso Single Camera Gastroscope-A. The Saneso Processor processes the image and relays the video signals from the colonoscope to external display monitors. The Saneso Processor also offers pneumatic/water controls and interfaces for insufflation, tissue irrigation and camera lens wash. The Saneso processor also controls various external accessories that interface with the system. The software is operated via a mouse and keyboard. Two monitors are connected to the system i.e a master monitor and slave monitor. The master monitor can be used for viewing and interfacing with controls on the image processor and the slave monitor is used only for viewing purposes.
Here's a breakdown of the acceptance criteria and study details for the Saneso-A Series devices, based on the provided text:
1. Table of Acceptance Criteria & Reported Device Performance
The FDA clearance letter refers to "acceptance criteria" through various performance tests, but it doesn't explicitly list numerical thresholds that were accepted. Instead, it states that the devices "met all acceptance criteria" for the respective tests. The reported device performance is generally described in terms of equivalence to predicate devices and successful completion of procedures.
| Acceptance Criteria Category | Specific Test / Characteristic | Reported Device Performance |
|---|---|---|
| Safety & Effectiveness | General Performance | "Performs as intended" and "safe and effective as the predicate device" |
| Electrical Safety & EMC | IEC 60601-1-2, ANSI AAMI ES60601-1 | Met all acceptance criteria in accordance with these standards. |
| Biocompatibility | Cytotoxicity, Sensitization, Irritation | Biocompatible. Testing performed on Saneso Endoscope 360-A (same components/manufacturing as Saneso Single Camera Endoscope-A). Reprocessing steps met worst-case scenario for assessment. |
| Reprocessing Effectiveness | Cleaning Validation | Met all acceptance criteria; demonstrated cleaning process does not impact functionality. |
| High Level Disinfection Report | Met all acceptance criteria; demonstrated high-level disinfection does not impact functionality. | |
| Performance (Bench) | Design Verification & Validation, Performance Test Requirements | Met all design verification & validation, performance test requirements. |
| Software Performance | Software Verification and Validation Testing | Conducted and documented as recommended by FDA guidance; software considered 'moderate' level of concern. |
| Clinical Performance (Gastroscope) | Primary Outcome: Successful intubation of the third portion of the duodenum | 100% successful procedure rate (achieved with both Saneso and Olympus gastroscopes). |
| Secondary Outcome: Qualitative rating by endoscopists | Saneso gastroscope rated superior to Olympus gastroscope in terms of field of view. Rated substantially equivalent in other visualization and mechanical characteristics. | |
| Secondary Outcome: Mucosal injury | No complications or evidence of mucosal injury reported/observed. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 22 subjects
- Data Provenance: Prospective, multi-center clinical study. The document does not specify the country of origin for the sites.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The text mentions "endoscopists who performed the procedure" but does not specify the exact number of experts or their specific qualifications (e.g., years of experience). They were responsible for qualitative ratings and assessing mucosal injury.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The "qualitative rating by the endoscopists" suggests individual assessments, and it doesn't mention a process for resolving discrepancies if multiple endoscopists were evaluating the same case.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
While a comparative study was done using the Saneso gastroscope and a traditional gastroscope (Olympus GIF-H180), it was not a traditional MRMC study with AI assistance. It was a comparison of two different endoscopy devices.
- Comparison: Saneso gastroscope vs. traditional gastroscope (Olympus GIF-H180).
- Effect Size (Human Readers with/without AI assistance): Not applicable, as this study compared devices, not the effect of AI assistance on human readers. The Saneso device itself does not appear to incorporate AI for assisted reading, but rather offers a wider field of view.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not Applicable. The described device is an endoscopic visualization system, not an AI algorithm for standalone image interpretation. The "software" mentioned is for control and image processing, not for AI analysis.
7. The Type of Ground Truth Used
- Clinical Ground Truth: For the clinical study, the primary outcome of "successful intubation of the third portion of the duodenum" served as a procedural success ground truth. This would have been determined by the performing endoscopist.
- Expert Opinion: Qualitative ratings by endoscopists on aspects like field of view and mucosal injury assessment were also part of the evaluation, relying on expert observation and judgment.
8. The Sample Size for the Training Set
The document does not mention any training set size. This is consistent with the device being a visualization tool rather than an AI-driven diagnostic algorithm that typically requires a large training dataset.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As no AI training set is mentioned for this device, a method for establishing its ground truth is also not described.
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(80 days)
Olympus GF-UM130 Ultrasound Gastroscope has been designed to be used with an Olympus Endoscopic Ultrasound Center, EVIS Video System Center, light source, documentation equipment, video monitor, Endo-Therapy accessories and other ancillary equipment for endoscopic ultrasound imaging of the gastrointestinal wall, biliary and pancreatic duct, and surrounding organs.
Olympus GF-UM130 Ultrasound Gastrovideoscope, its associated accessories and ancillary equipment.
The provided documentation is a K971660 FDA 510(k) clearance letter and summary for the Olympus GF-UM130 Ultrasound Gastrovideoscope. This type of document focuses on establishing substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study as would be detailed for a novel device or software.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of AI/software performance. It primarily details the regulatory classification, intended use, and substantial equivalence to existing devices.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for a test set, data provenance, or details about a test set.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for a test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
- Results of a standalone algorithm performance study.
- The type of ground truth used for performance evaluation.
- Sample size for a training set.
- How ground truth for a training set was established.
This document precedes widespread AI in medical devices and focuses on the hardware and its established uses.
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