(119 days)
The Fujifilm ultrasonic processors SU-1 PLATINUM and SU-1 are intended to be used in combination with Fujifilm ultrasonic endoscope, video processor, light source, monitor, recorder, and various peripheral devices. The product is intended to provide ultrasonic images of the trachea, bronchial tree and surrounding organs, or submucosal and peripheral organs of the upper gastrointestinal tract for observation, recording and in diagnosis during endoscopic evaluation.
The Fujifilm ultrasonic processors SU-1 PLATINUM and SU-1 are used with previously cleared ultrasonic endoscopes, EG-530UR2 & EG-530UT2 (K120446) and EB-530US (K121035) to provide ultrasonic images of the trachea, bronchial tree, and surrounding organs, or submucosal and peripheral organs of the upper gastrointestinal tract for observation, recording and to aid in diagnosis during endoscopic evaluation.
The Fujifilm ultrasonic processors SU-1 PLATINUM and SU-1 consist of two components, Processor and Keyboard, which are used in conjunction with one another. The SU-1 PLATINUM or SU-1 ultrasonic processors connect to an ultrasonic endoscope and transmit ultrasound waves into the body cavity by driving the transducer installed on the ultrasonic endoscope. The SU-1 PLATINUM or SU-1 ultrasonic processors process the reflected ultrasound signals received by the ultrasonic transducer in the body cavity and convert the electrical signals into image or video signals. The signals are displayed on the monitor or printer as ultrasonic images. The Keyboard, CP-1, is used to control operational features of the SU-1 PLATINUM or SU-1 ultrasonic processor.
The Fuifilm ultrasonic processor SU-1 PLATINUM and SU-1 can acquire and display real-time ultrasound data in different modes such as M, B, Color Doppler, Pulse Doppler, Duplex and Triplex. Additionally. SU-1 PLATINUM offers a feature/mode known as Elastrography, which is a medical imaging modality that maps the elastic properties of the target organs. Relative stiffness of the tissue is visualized as a color distribution map by a way of calculating the distortion of the tissue caused by external compression of inner vibration, and displaying disparities in stiffness levels as different colors.
This is a device that processes ultrasound images, not an AI / ML device. Hence most of the questions are not applicable to the context.
Here's an analysis of the provided text in relation to your request about acceptance criteria and a study proving device conformance:
The document describes a medical device submission (K153206) for Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1. It is a 510(k) submission, meaning the device is seeking clearance by demonstrating substantial equivalence to a legally marketed predicate device, not by proving efficacy through a comprehensive clinical trial.
Therefore, there is no mention of "acceptance criteria," "device performance," "sample size for test set," "data provenance," "number of experts," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for training set," or "how ground truth for training set was established" in the context of an AI/ML device or a traditional clinical study with outcome-based performance metrics.
Instead, the document focuses on demonstrating substantial equivalence through:
- Comparing technological characteristics.
- Compliance with recognized performance and safety standards.
- Bench testing.
Here's an attempt to extract relevant information given the nature of the document:
1. A table of acceptance criteria and the reported device performance
The document does not present acceptance criteria in a typical AI/ML or clinical study format (e.g., target sensitivity/specificity). Instead, equivalence is demonstrated by meeting technical specifications and safety standards.
| Acceptance "Criteria" (Derived from Predicate Comparison & Standards) | Reported Device Performance (as stated in the document) |
|---|---|
| Intended Use / Indications for Use: Similar to predicate (SU-8000), with expanded applications for trachea, bronchial tree, surrounding organs due to compatibility with EB-530US. | The SU-1 PLATINUM and SU-1 are intended to be used with Fujifilm ultrasonic endoscope, video processor, light source, monitor, recorder, and various peripheral devices to provide ultrasonic images of the trachea, bronchial tree and surrounding organs, or submucosal and peripheral organs of the upper gastrointestinal tract for observation, recording and to aid in diagnosis during endoscopic evaluation. |
| Technological Characteristics: Substantially similar to predicate (SU-8000), including compatible endoscopes, probe type, scanning method, image modes (with addition of Elastography for SU-1 PLATINUM), frequency, display range, data format, measuring functions. | All technological characteristics are stated to be "Same as the predicate device" or are explicitly listed as an enhancement (Elastography). Bench testing data demonstrated that the subject ultrasonic processors have substantially equivalent performance and safety to their predicate. |
| Safety and Performance Standards Compliance: Conformance to relevant IEC, ANSI/AAMI, and NEMA standards (listed in the "Performance Data" section). | All predetermined testing criteria were met, and the device functioned in all instances (as stated on page 6). |
| Attenuation Spatial Peak Temporal Average Intensity (Ispta.3): ≤ 720mW/cm² | Same as the predicate device (≤ 720mW/cm²) |
| Mechanical Index (MI): 1.9 or less | Same as the predicate device (1.9 or less) |
| Thermal Index (TI): 1.0 or less | Same as the predicate device (1.0 or less) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable in the context of clinical data for performance evaluation. The "Performance Data" section refers to software validation and EMC safety/performance testing. These are engineering/device-level tests, not imaging-data-based performance studies with a "test set" of patient data.
- Data Provenance: Not applicable. The "Performance Data" section describes engineering and safety testing of the device hardware and software.
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)
Not applicable. This is not a study involving expert readers and establishing ground truth for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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
Not applicable. This device is an ultrasonic processor, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm, but a hardware device with embedded software for image processing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" here pertains to the device meeting engineering specifications and safety standards, confirmed through various tests (e.g., electrical safety, electromagnetic compatibility, software validation).
8. The sample size for the training set
Not applicable. This is not an AI/ML device that undergoes training on a dataset.
9. How the ground truth for the training set was established
Not applicable.
§ 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.